Document ID: FDA-2011-N-0697-0005
Agency: fda
Document Type: Rule
Title: Amendments to Regulations on Citizen Petitions, Petitions for Stay of Action, and Submission of Documents to Dockets
Posted Date: 2016-11-08T05:00Z

[Federal Register Volume 81, Number 216 (Tuesday, November 8, 2016)]
[Rules and Regulations]
[Pages 78500-78507]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26912]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 10

[Docket No. FDA-2011-N-0697]
RIN 0910-AG26

Amendments to Regulations on Citizen Petitions, Petitions for 
Stay of Action, and Submission of Documents to Dockets

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
amending certain regulations relating to citizen petitions, petitions 
for stay of action (PSAs), and the submission of documents to the 
Agency. In particular, the final rule establishes new regulations to 
implement certain provisions of the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act), which concern certain citizen petitions and PSAs 
that involve a request for FDA to take any form of action relating to a 
pending abbreviated new drug application (ANDA), 505(b)(2) application, 
or certain applications submitted under the Public Health Service Act 
(PHS Act). We are making these changes to implement provisions of the 
Food and Drug Administration Amendments Act of 2007 (FDAAA) and the 
Food and Drug Administration Safety and Innovation Act (FDASIA).

DATES: This rule is effective January 9, 2017.

ADDRESSES: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number (FDA-2011-N-0697) into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Darren Eicken, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6206, Silver Spring, MD, 20993-0002, 240-
402-0978.

SUPPLEMENTARY INFORMATION: 

Table of Contents

Executive Summary
I. Background
II. Overview of the Final Rule, Including Significant Changes to the 
Proposed Rule
    A. Overview
    B. Significant Changes to the Proposed Rule
III. Comments on the Proposed Rule and FDA Responses
    A. Introduction
    B. Scope of the Proposed Rule (Sec.  10.31)
    C. Certification and Verification Requirements
    D. Nonretroactivity of the Rule
    E. Additional Comments
IV. Legal Authority
V. Analysis of Environmental Impact
VI. Economic Analysis of Impacts
    A. Introduction and Summary
    B. Summary of Final Regulatory Impacts Analysis
VII. Paperwork Reduction Act of 1995
VIII. Federalism
IX. References

Executive Summary

Purpose of the Rule

    This rule establishes new regulations implementing section 505(q) 
of the FD&C Act (21 U.S.C. 355(q)) as enacted by FDAAA (Pub. L. 110-85) 
and amended by FDASIA (Pub. L. 112-144). Section 505(q) of the FD&C Act 
governs the manner in which FDA handles certain citizen petitions and 
PSAs that ask the Agency to take any form of action related to an ANDA, 
a 505(b)(2) application, or an application submitted under section 
351(k) of the PHS Act (351(k) application) (42 U.S.C. 262(k)). Section 
505(q) of the FD&C Act specifies that FDA must not delay approval of a 
pending application because of any request to take any form of action 
relating to the application, unless the request is in writing and in a 
citizen petition or a PSA, and the Agency determines, upon reviewing 
the petition, that a delay is necessary to protect the public health. 
Section 505(q) of the FD&C Act also requires that all submitters of a 
petition (or PSA) include with their submission a verbatim 
certification statement specifying the date on which the information 
relied on in the petition first became known. Similarly, section 505(q) 
of the FD&C Act requires that the submitters of a supplement or a 
comment to a petition include with their submission a verbatim 
verification statement specifying the date on which the information 
relied on in their submission first became known. By enacting section 
505(q) of the FD&C Act, Congress indicated a desire to ensure that 
petitions not be used to improperly delay approval of ANDAs, 505(b)(2) 
applications, or 351(k) applications. This rule clarifies the 
requirements of section 505(q) of the FD&C Act.

Summary of the Major Provisions of the Rule

    This rule amends FDA's regulations on general administrative 
procedures in part 10 (21 CFR part 10).

[[Page 78501]]

    In Sec.  10.31, paragraph (a) states that Sec.  10.31 applies to 
all citizen petitions and PSAs that request that the Agency take any 
action that could, if taken, delay approval of an ANDA, a 505(b)(2) 
application, or a 351(k) application (i.e., petitions and PSAs that are 
or may be subject to section 505(q) of the FD&C Act). Section 10.31(b) 
clarifies that the date of submission for petitions submitted under 
Sec.  10.31 is the date on which the petition is received by FDA's 
Division of Dockets Management.
    The rule also codifies the certification and verification 
requirements of section 505(q) of the FD&C Act. Section 10.31(c) 
clarifies that the Agency will consider a certification deficient if 
every word in the petitioner's certification does not match every word 
of the certification provided in section 505(q)(1)(H) of the FD&C Act. 
Likewise, Sec.  10.31(d) clarifies that the Agency will consider the 
verification deficient if every word in the petitioner's or commenter's 
verification does not match every word of the verification provided in 
section 505(q)(1)(I) of the FD&C Act. However, because we believe 
section 505(q)(1)(I) of the FD&C Act contains a technical error when it 
specifies the word ``petition'' in the last sentence of the 
verification, we will accept either the word ``petition'' or 
``document'' in the last sentence of the petitioner's or commenter's 
verification.
    The rule also amends Sec. Sec.  10.30 and 10.35. Section 
10.30(e)(5) states that FDA intends to respond to a petition subject to 
section 505(q) of the FD&C Act within 150 days after the date on which 
the petition is received. This amendment incorporates a statutory 
change enacted by FDASIA. In addition, Sec.  10.35(i) clarifies that a 
petitioner requesting a stay of action may supplement, amend, or 
withdraw a PSA, similar to the provision for citizen petitions in 
current Sec.  10.30(g). Finally, Sec. Sec.  10.30(e)(3) and 10.35(e) 
are amended to reflect that the Commissioner of Food and Drugs (the 
Commissioner) may dismiss a petition if changes in law, facts, or 
circumstances since the date on which the petition was submitted render 
the petition moot.

Costs and Benefits

    We estimate one-time costs to industry from this rule at about 
$613,800. We estimate annual costs at about $1,700. These costs equate 
to an estimated total annualized cost of about $89,100 at a 7 percent 
discount rate over 10 years and about $73,700 at a 3 percent discount 
rate over 10 years. The total annualized costs include the 
administrative cost to review the rule ($87,400) plus the cost for the 
additional effort preparing certifications for petitions and 
verifications for both responses to petitions and supplements to 
petitions ($1,700).
    By providing additional clarity on the statutory requirements, we 
expect the rule will slightly reduce the number of deficient 505(q) 
petitions, leading to lower administrative costs for both industry and 
FDA.

I. Background

    In the Federal Register of January 3, 2012 (77 FR 25), FDA issued a 
proposed rule to amend certain regulations relating to citizen 
petitions, PSAs, and the submission of documents to the Agency, to 
implement provisions of section 505(q) of the FD&C Act. Section 505(q) 
of the FD&C Act governs certain citizen petitions and PSAs 
(collectively referred to as petitions) that ask FDA to take any form 
of action that could, if taken, delay approval of a pending application 
submitted under section 505(b)(2) or (j) of the FD&C Act or a pending 
application for licensure of a biological product as a biosimilar or 
interchangeable product that is submitted under section 351(k) of the 
PHS Act. An application submitted under section 505(b)(2) of the FD&C 
Act is a type of new drug application (NDA) described in that 
subsection and is referred to in this document as a ``505(b)(2) 
application.'' An application submitted under section 505(j) of the 
FD&C Act is an ANDA seeking approval for a generic drug product. An 
application submitted under section 351(k) of the PHS Act is referred 
to in this document as a ``351(k) application.''
    Over the years, FDA has received numerous petitions asking the 
Agency not to approve a particular ANDA or 505(b)(2) application (or 
classes of these applications concerning a particular drug product or 
active ingredient) unless certain criteria set forth in the petition 
are met. In many cases, the petitions have raised scientific and/or 
legal issues relating to the standards for approval of an application. 
Examples include petitions suggesting a particular method for 
demonstrating the bioequivalence of a proposed generic product to the 
reference listed drug (RLD) and petitions maintaining that a proposed 
generic product does not contain the same active ingredient as the RLD. 
When submitted early, such as when we are making decisions about the 
bioequivalence requirements for a generic drug product or before we 
have received the first ANDA, 505(b)(2) application, or 351(k) 
application for a drug or biological product, a petition may contain 
information that can contribute towards our evaluation of an 
application. However, when petitions are submitted late in the review 
process for challenged applications and do not raise valid scientific 
and/or legal issues, they may have the effect of improperly delaying 
the approval of an application. By enacting section 505(q) of the FD&C 
Act, Congress indicated a desire to ensure that petitions not be used 
to improperly delay approval of ANDAs, 505(b)(2) applications, or 
351(k) applications.
    Scope of section 505(q) of the FD&C Act: FDAAA was enacted on 
September 27, 2007. Section 914 of Title IX of FDAAA added section 
505(q) to the FD&C Act. Section 505(q) of the FD&C Act was subsequently 
amended by FDASIA on July 9, 2012.
    Section 505(q)(1)(A) of the FD&C Act specifies that FDA must not 
delay approval of a pending ANDA, a 505(b)(2) application, or a 351(k) 
application because of any request to take any form of action relating 
to the application, unless the request is in writing and in a citizen 
petition submitted under Sec.  10.30 or a PSA submitted under Sec.  
10.35, and the Agency determines, upon reviewing the petition, that a 
delay is necessary to protect the public health. In section 505(q)(5) 
of the FD&C Act 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 defined in 
section 505(q)(1)(A)(i).
    Section 505(q)(1)(B) of the FD&C Act states in this context that 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 (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 (3) a brief summary 
of the specific substantive issues raised in the petition that form the 
basis of FDA's determination. At FDA's discretion, the information is 
to be conveyed either in writing or in a meeting with the applicant. 
The information conveyed in the notification is to be considered part 
of the application and is subject to the disclosure requirements 
applicable to information in the application.
    Section 505(q)(1)(F) of the FD&C Act governs the timeframe for 
final Agency action on a petition. Under this provision, FDA must take 
final Agency action on a petition not later than 150

[[Page 78502]]

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) of the FD&C Act regarding 
delay of approval of an application (i.e., that delay is necessary to 
protect the public health), the submission of comments or supplemental 
information, or the consent of the petitioner. In addition, FDA may 
deny a petition at any point if it 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 (section 
505(q)(1)(E) of the FD&C Act).
    Section 505(q) of the FD&C Act also includes certification and 
verification requirements for certain documents. Under section 
505(q)(1)(H) of the FD&C Act, FDA may not consider a petition for 
review unless the petition is in writing and is signed and contains a 
certification that is specified in that section. Section 505(q)(1)(H) 
of the FD&C Act sets forth the exact words to be used in the 
certification. In addition, FDA may not accept for review any 
supplemental information or comments on a petition unless the 
submission is in writing and is signed and contains a specific 
verification. Section 505(q)(1)(I) of the FD&C Act sets forth the exact 
words to be used in the verification.
    Section 505(q)(2) of the FD&C Act governs judicial review of final 
Agency action on a petition subject to section 505(q). Under section 
505(q)(2)(A) of the FD&C Act, FDA will be considered to have taken 
final Agency action on a petition if FDA makes a final decision within 
the meaning of Sec.  10.45(d) during the 150-day period, or the 150-day 
period expires without FDA having made a final decision. Under section 
505(q)(2)(B) of the FD&C Act, 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) of 
the FD&C Act, however, does not apply to a petition containing requests 
relating to a 351(k) application.

II. Overview of the Final Rule, Including Significant Changes to the 
Proposed Rule

A. Overview

    In this rulemaking, the Agency finalizes the provisions outlined in 
the January 2012 proposed rule. In addition, the final rule 
incorporates changes enacted by FDASIA and responds to comments made to 
the proposed rule. FDA also is making editorial and organizational 
changes to clarify provisions. The final rule amends part 10 of FDA 
regulations on general administrative procedures. The amendment adds 
Sec.  10.31, which includes the following provisions:
     Section10.31(a) states that Sec.  10.31 will encompass all 
citizen petitions and PSAs that request that the Agency take any action 
that could, if taken, delay approval of an ANDA, a 505(b)(2) 
application, or a 351(k) application (i.e., petitions and PSAs that are 
or may be subject to section 505(q) of the FD&C Act).
     Section 10.31(b) clarifies the date of submission for 
petitions submitted under Sec.  10.31.
     Section 10.31(c) and (d) codify the certification and 
verification requirements of section 505(q)(1)(H) and (I) of the FD&C 
Act. Section 10.31(c) clarifies that the Agency will consider a 
certification deficient if every word in the petitioner's certification 
does not match every word of the certification provided in section 
505(q)(1)(H) of the FD&C Act. Likewise, Sec.  10.31(d) clarifies that 
the Agency will consider the verification deficient if every word in 
the petitioner's or commenter's verification does not match every word 
of the verification provided in section 505(q)(1)(I) of the FD&C Act. 
As discussed in section II.B.4 of the preamble to the proposed rule, we 
are making one minor editorial change to the language of the 
verification set out in the statute. We are changing ``I verify under 
penalty of perjury that the foregoing is true and correct as of the 
date of this petition'' to ``I verify under penalty of perjury that the 
foregoing is true and correct as of the date of this document'' 
(emphasis added). Because the statute specifies the word ``petition'', 
we will accept either ``petition'' or ``document'' in the last sentence 
of the verification. In addition, section 505(q) of the FD&C Act 
requires both the certification and verification to be signed and 
executed under penalty of perjury. FDA interprets the signature 
provision to require a handwritten or electronic signature by the 
person whose name appears as the signatory to the petition, supplement, 
or comment. If the certification or verification is signed by another 
person with the notation ``for,'' signature/[initials], ``on behalf 
of,'' or with similar notation that indicates one person signed for 
another, we will consider the certification or verification to be 
deficient and will not consider the petition for review.
    The final rule amends Sec. Sec.  10.20, 10.30, and 10.35 as 
follows:
     Adds Sec.  10.30(e)(5) to incorporate a statutory change 
enacted by FDASIA. New Sec.  10.30(e)(5) states that FDA intends to 
respond to a petition subject to section 505(q) of the FD&C Act within 
150 days after the date on which the petition is received.
     Revises Sec.  10.30(e)(2) to conform with the addition of 
Sec.  10.30(e)(5).
     Makes minor revisions to Sec. Sec.  10.20 and 10.30 to 
conform to the addition of Sec.  10.31.
     With respect to Sec.  10.35, administrative stay of 
action, makes revisions to conform with the implementation of section 
505(q) of the FD&C Act. The final rule also adds new Sec.  10.35(i) to 
clarify that a petitioner requesting a stay of action may supplement, 
amend, or withdraw a PSA, similar to the provision for citizen 
petitions in current Sec.  10.30(g).
    In addition to implementing the provisions in section 505(q) of the 
FD&C Act, the final rule makes minor technical changes by revising 
Sec. Sec.  10.30(e)(3) and 10.35(e) to allow the Commissioner to 
dismiss a petition if changes in law, facts, or circumstances since the 
date on which the petition was submitted render the petition moot.

B. Significant Changes to the Proposed Rule

    The final rule reflects revisions to the proposed rule in response 
to the enactment of FDASIA. Section 1135 of FDASIA amended section 
505(q) of the FD&C Act in several ways. First, it shortened from 180 
days to 150 days FDA's deadline for responding to petitions subject to 
section 505(q) of the FD&C Act. Second, it expanded the scope of 
section 505(q) of the FD&C Act to include certain petitions related to 
351(k) applications. Lastly, FDASIA also added section 505(q)(4)(B) of 
the FD&C Act, which excludes such petitions from section 505(q)(2).
    Accordingly, the final rule includes the following changes to the 
proposed rule:
     Adds Sec.  10.30(e)(5) and revises Sec.  10.30(e)(2) to 
reflect FDA's 150-day deadline for responding to petitions subject to 
section 505(q) of the FD&C Act.
     Revises Sec.  10.31(a)(1) to reflect the applicability of 
section 505(q) of the FD&C Act to 351(k) applications.
    These changes conform the final rule to reflect amendments to 
section 505(q) of the FD&C Act enacted by FDASIA that became law after 
publication of the proposed rule.

[[Page 78503]]

III. Comments on the Proposed Rule and FDA Responses

A. Introduction

    We received one submission containing several comments from the 
Pharmaceutical Research and Manufacturers of America (PhRMA). These 
comments primarily focused on the scope of proposed Sec.  10.31 and the 
certification and verification requirements. PhRMA also raised several 
issues we deemed outside the scope of the proposed rule. In the 
discussion that follows, we address the comments.
    We describe and respond to the comments in sections III.B through 
III.E. We have numbered each comment to help distinguish between 
different comments. The number assigned to each comment is purely for 
organizational purposes and does not signify the comment's value or 
importance or the order in which comments were received.

B. Scope of the Proposed Rule (Sec.  10.31)

    (Comment 1) We received a comment from PhRMA concerning the scope 
of the rule. PhRMA stated that, in some instances, the rule would 
require unnecessary certifications for petitions outside the scope of 
section 505(q) of the FD&C Act that could cause confusion among 
petitioners, commentators, and the courts regarding which rules to 
apply to any given petition. PhRMA claimed the proposed rule could 
compromise a petitioner's fundamental right to know which statutory 
requirements and timelines FDA will apply to the petition. Accordingly, 
PhRMA requested that FDA revise the proposed rule to limit the rule's 
application to cases in which there is evidence that a relevant ANDA or 
505(b)(2) application is pending before FDA.
    (Response 1) We decline to make this revision. Normally, the 
existence of a pending application is not made public by FDA. (See 
e.g., 21 CFR 314.430.) To prevent uncertainty as to when a 
certification or verification is required and to protect against the 
unintended release of information acknowledging the existence of an 
ANDA, a 505(b)(2) application, or a 351(k) application, we are making 
Sec.  10.31 apply to all petitions that request an action that could 
delay the approval of an ANDA, a 505(b)(2) application, or a 351(k) 
application, regardless of whether an application subject to the 
petition's requested action is pending at the time the petition is 
submitted. Otherwise, if petitioners were to omit the certification 
statement and wait for FDA to inform them that the certification is 
required (because of the existence of a pending application), the 
filing of petitions could become a way for individuals to uncover the 
existence of certain pending applications. Neither FDAAA nor FDASIA 
suggest such an outcome. Moreover, rather than causing confusion, as 
PhRMA suggests, we believe that requiring certifications and 
verifications for all applicable petitions would remove any uncertainty 
as to whether a petitioner should submit or not submit a certification 
or verification. If there is no related ANDA, 505(b)(2) application, or 
351(k) application pending at the time the petition is submitted, then 
the requirements of Sec.  10.31 will apply to the petition, but we will 
not consider the provisions of section 505(q) of the FD&C Act to apply 
to the petition.

C. Certification and Verification Requirements

    (Comment 2) PhRMA expressed specific concerns regarding the 
certification and verification requirements of the rule. First, PhRMA 
requested that the discretionary language found in the preamble to the 
proposed rule, i.e., ``[t]he failure to provide any information relied 
upon (and the date) in the certification or verification may result in 
the failure of FDA to consider that information . . . .'', be clarified 
to prevent confusion over how FDA intends to interpret and implement 
the certification and verification requirements. Second, PhRMA 
questioned FDA's assertion that a failure to certify or verify a 
``became known'' date would foreclose a petitioner from relying on that 
information when seeking judicial review. Accordingly, PhRMA requested 
that FDA: (1) Revise the proposed rule and provide additional 
explanation and examples to clarify what types of information 
petitioners must provide ``became known'' dates for and (2) ``provide 
support for, modify, or expressly withdraw'' the preamble statement 
concerning judicial review.
    (Response 2) We recognize that a petition, supplement, or comment 
could be based on more than one type of information or multiple pieces 
of information. Section 505(q) of the FD&C Act requires that the 
petitioner provide in the certification the date on or about which 
information first became known to the petitioner. We interpret section 
505(q) of the FD&C Act to require an on or about date for each piece of 
information that is relied upon in the petition. Section II.B.7 of the 
preamble to the proposed rule provides an example illustrating how a 
petition may list different types of information. A petition, 
supplement, or comment will meet the certification/verification 
requirement if it contains a date followed by a short description of 
the information. This requirement is essential to carrying out the 
legislative intent of Congress and does not impose an unreasonable 
burden on petitioners. Because of the fact-based nature of a petition, 
it is impracticable for FDA to specifically define or categorize all 
types of information that may be relied upon by a petitioner. A 
petitioner or commenter can, however, reasonably be expected to 
identify the main categories of information on which the petition, 
supplement, or comment relies and to provide dates for such categories. 
Indeed, this interpretation of the certification has worked well to 
date. The failure to certify or verify a ``became known'' date for any 
item of information contained in a petition would preclude the 
petitioner from relying on that information when seeking judicial 
review since section 505(q)(1)(H) and (I) of the FD&C Act requires that 
FDA not consider and/or accept for review any petition or information 
that fails to meet the certification and verification requirements.

D. Nonretroactivity of the Rule

    (Comment 3) PhRMA expressed concern that the rule could be read as 
retroactively imposing requirements on petitions filed after September 
26, 2007, but before the effective date of the final rule. Based on its 
concern, PhRMA requested that FDA revise the rule to clarify that Sec.  
10.31 will not apply to any petition that was pending at FDA before the 
final rule's effective date, to any supplement to such a petition, or 
to any comments on such a petition.
    (Response 3) FDA's guidance for industry ``Citizen Petitions and 
Petitions for Stay of Action Subject to Section 505(q) of the Federal 
Food, Drug, and Cosmetic Act'' (Ref. 1), describes FDA's current 
thinking on the applicability of section 505(q) to petitions submitted 
after September 27, 2007. As that guidance notes, section 505(q) of the 
FD&C Act applies to all petitions that are submitted on or after 
September 27, 2007 (or July 9, 2012, if the subject matter of the 
petition relates to the approval of a 351(k) application). To the 
extent the final rule imposes any additional requirements, those 
requirements will apply only to those petitions submitted on or after 
the effective date of the final rule.

E. Additional Comments

    (Comment 4) PhRMA requested that FDA include or otherwise establish 
a

[[Page 78504]]

mechanism for notifying a petitioner if the Agency determines that a 
delay of approval of an ANDA or 505(b)(2) application is not necessary 
to protect the public health.
    (Response 4) We decline to implement such a mechanism for notifying 
petitioners. As PhRMA pointed out, section 505(q) of the FD&C Act does 
not require such a notification. The only notification provision in 
section 505(q) of the FD&C Act is found in section 505(q)(1)(B), which 
requires FDA to inform an ANDA applicant, a section 505(b)(2) 
applicant, or a 351(k) applicant that a delay in approval is necessary 
to protect the public health. Moreover, such a notification mechanism 
would be burdensome for the Agency and could inadvertently inform the 
public of pending ANDAs, 505(b)(2) applications, or 351(k) 
applications.
    (Comment 5) PhRMA requested that FDA issue a regulation 
establishing (or clarifying) the administrative consequence of a 
decision to approve an ANDA or a 505(b)(2) application prior to making 
a final decision on a related 505(q) petition (i.e., whether such an 
approval would be considered a denial of the petition under section 
505(q)(2)(A)(i) of the FD&C Act).
    (Response 5) We believe the statute clearly defines what 
constitutes an exhaustion of administrative remedies with regard to 
section 505(q) petitions. Section 505(q)(2) of the FD&C Act governs 
judicial review of final Agency action on certain petitions filed under 
section 505(q). Under section 505(q)(2)(A) of the FD&C Act, FDA is 
considered to have taken final Agency action on a petition if either: 
(1) FDA makes a final decision within the meaning of Sec.  10.45(d) 
during the 150-day period or (2) the 150-day period expires without FDA 
making a final decision. Section 505(q)(2) of the FD&C Act is silent as 
to the effect of approving an ANDA or a 505(b)(2) application prior to 
FDA's action on a petition. In our view, the language of section 
505(q)(2) of the FD&C Act is clear and decouples a final action on a 
petition from a decision on an underlying ANDA or 505(b)(2) 
application. (We note that petitions addressing issues concerning 
351(k) applications are excluded from the scope of section 505(q)(2) of 
the FD&C Act). Therefore, a decision on an ANDA or a 505(b)(2) 
application that occurs prior to the issuance of a petition response 
will not constitute final Agency action on the petition.
    (Comment 6) PhRMA requested that FDA issue a regulation 
establishing (or clarifying) that a delay in approval of an ANDA or a 
505(b)(2) application can extend beyond the 180-day (now 150-day) 
review period for a petition.
    (Response 6) We decline to issue a regulation establishing or 
clarifying that a delay in approval of an ANDA or a 505(b)(2) 
application can exceed the 150-day review period for petitions. Because 
of the uncertainty in predicting the time it will take to resolve a 
particular issue, establishing an expectation on the possible length of 
a delay would be neither practical nor feasible. We believe that based 
on the language of section 505(q) of the FD&C Act, no clarification is 
necessary.
    (Comment 7) Finally, PhRMA requested that FDA abandon its practice 
of not providing a substantive response to every section 505(q) 
petition regardless of the review status of a pending ANDA or 505(b)(2) 
application.
    (Response 7) This issue is outside the scope of this rulemaking. 
FDA's current thinking on this issue is outlined in section III.E of 
its guidance for industry ``Citizen Petitions and Petitions for Stay of 
Action Subject to Section 505(q) of the Federal Food, Drug, and 
Cosmetic Act'' (Ref. 1), and we do not believe further elaboration is 
necessary.

IV. Legal Authority

    This rule amends Sec. Sec.  10.20, 10.30, and 10.35, and adds Sec.  
10.31 in a manner consistent with the Agency's current understanding 
and application of these provisions. FDA is implementing certain 
provisions of FDAAA and FDASIA that govern petitions subject to section 
505(q) of the FD&C Act. FDA has authority to issue regulations for the 
efficient administration of these provisions under section 701(a) of 
the FD&C Act (21 U.S.C. 371(a)).

V. Analysis of Environmental Impact

    FDA has determined under 21 CFR 25.30(h) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VI. Economic Analysis of Impacts

A. Introduction and Summary

    We have examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct us to assess all costs 
and benefits of available regulatory alternatives and, when regulation 
is necessary, to select regulatory approaches that maximize net 
benefits (including potential economic, environmental, public health 
and safety, and other advantages; distributive impacts; and equity). We 
have developed a comprehensive Economic Analysis of Impacts that 
assesses the impacts of the final rule (Ref. 2). We believe that this 
final rule is not a significant regulatory action as defined by 
Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because the annualized compliance costs to industry members, 
including small entities, is estimated to be slightly above $100, we 
certify that the final rule will not have a significant economic impact 
on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before issuing ``any rule that includes 
any Federal mandate that may result in the expenditure by State, local, 
and tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted annually for inflation) in any one 
year.'' The current threshold after adjustment for inflation is $146 
million, using the most current (2015) Implicit Price Deflator for the 
Gross Domestic Product. This final rule would not result in an 
expenditure in any year that meets or exceeds this amount.

B. Summary of Final Regulatory Impacts Analysis

1. Industry Costs
    We estimate one-time costs to industry from this final rule at 
about $626,300. We estimate annual costs at about $1,800. These costs 
equate to an estimated total annualized cost of about $91,000 at a 7 
percent discount rate over 10 years and about $75,200 at a 3 percent 
discount rate over 10 years. The total annualized costs include the 
administrative cost to review the rule ($89,200) plus the cost for the 
additional effort preparing certifications for petitions and 
verifications for both responses to petitions and supplements to 
petitions ($1,800).
2. Benefits
    The final rule contains several clarifications to the language 
provided in FDAAA and small additions to the statute's provisions. It 
reinforces the need for exact wording of both the certification and 
verification statements for petitions, supplements to petitions, and 
responses to petitions. Furthermore,

[[Page 78505]]

the rule clarifies the exact dating procedures for these documents. By 
providing additional clarity on the statutory requirements, we expect 
the final rule will slightly reduce the number of deficient 505(q) 
petitions. We do not have enough information to estimate this reduction 
in deficient 505(q) petitions, but the reduction should result in lower 
administrative costs for both industry and FDA.
    The Economic Analysis of Impacts of the final rule, performed in 
accordance with Executive Order 12866, Executive Order 13563, the 
Regulatory Flexibility Act, and the Unfunded Mandates Reform Act, is 
available at http://www.regulations.gov under the docket number for 
this final rule (FDA-2011-N-0697) and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

VII. Paperwork Reduction Act of 1995

    This final rule contains no new 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 
PRA). The final rule refers to previously approved collections of 
information found in FDA regulations. The collections of information in 
Sec. Sec.  10.30 and 10.35 have been approved under OMB control number 
0910-0191. The collections of information in Sec.  10.31 have been 
approved under OMB control number 0910-0679. The collections of 
information in 21 CFR part 314 have been approved under OMB control 
number 0910-0001. The certification and verification statements 
required under Sec.  10.31(c) and (d) are ``public disclosure[s] of 
information originally supplied by the Federal government to the 
recipient for the purpose of disclosure to the public . . . ,'' (5 CFR 
1320.3(c)(2)) and therefore not subject to OMB review.

VIII. Federalism

    We have analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, we conclude that the rule 
does not contain policies that have federalism implications as defined 
in the Executive order and, consequently, a federalism summary impact 
statement is not required.

IX. References

    The following references are on display in the Division of Dockets 
Management (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at http://www.regulations.gov. FDA has 
verified the Web site addresses, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

1. FDA Guidance for Industry, ``Citizen Petitions and Petitions for 
Stay of Action Subject to Section 505(q) of the Federal Food, Drug, 
and Cosmetic Act,'' November 2014, available at http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm079353.pdf.
2. Final Regulatory Impact Analysis, ``Amendments to Regulations on 
Citizen Petitions, Petitions for Stay of Action, and Submission of 
Documents to Dockets,'' Docket No. FDA-2011-N-0697, available at 
http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

List of Subjects in 21 CFR Part 10

    Administrative practice and procedure, News media.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
10 is amended as follows:

PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURES

0
1. The authority citation for part 10 continues to read as follows:

    Authority:  5 U.S.C. 551-558, 701-706; 15 U.S.C. 1451-1461; 21 
U.S.C. 141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 
U.S.C. 201, 262, 263b, 264.

0
2. In Sec.  10.20, revise paragraph (e) to read as follows:

Sec.  10.20   Submission of documents to Division of Dockets 
Management; computation of time; availability for public disclosure.

* * * * *
    (e) Except as provided in Sec.  10.31(b), all submissions to the 
Division of Dockets Management will be considered as submitted on the 
date they are postmarked or, if delivered in person during regular 
business hours, on the date on which they are delivered, unless a 
provision in this part, an applicable Federal Register notice, or an 
order issued by an administrative law judge specifically states that 
the documents must be received by a specified date, e.g., Sec.  
10.33(g) relating to a petition for reconsideration, in which case they 
will be submitted on the date received.
* * * * *

0
3. Section 10.30 is amended as follows:
0
a. Revise paragraph (b) introductory text;
0
b. Revise the first sentence of paragraph (c);
0
c. Revise the second sentence of paragraph (d);
0
d. Revise the first sentence of paragraph (e)(2);
0
e. Remove from paragraph (e)(2)(ii) the word ``or'';
0
f. Redesignate paragraph (e)(2)(iii) as paragraph (e)(2)(iv);
0
g. Add new paragraph (e)(2)(iii);
0
h. Add to paragraph (e)(3) a new sentence after the first sentence; and
0
i. Add new paragraph (e)(5).
    The additions and revisions read as follows:

Sec.  10.30   Citizen petition.

* * * * *
    (b) A petition (including any attachments) must be submitted in 
accordance with Sec.  10.20 and, if applicable, Sec.  10.31. The 
certification requirement in this section does not apply to petitions 
subject to the certification requirement of Sec.  10.31. The petition 
must also be submitted in accordance with the following paragraphs, as 
applicable:
* * * * *
    (c) A petition that appears to meet the requirements of paragraph 
(b)(3) of this section, Sec.  10.20, and, if applicable, Sec.  10.31, 
will be filed by the Division of Dockets Management, stamped with the 
date of filing, and assigned a unique docket number. * * *
    (d) * * * The comments are to specify the docket number of the 
petition and include, if applicable, the verification under Sec.  
10.31, and may support or oppose the petition in whole or in part. * * 
*
    (e) * * *
    (2) Except as provided in paragraphs (e)(4) and (5) of this 
section, the Commissioner shall furnish a response to each petitioner 
within 180 days of receipt of the petition. * * *
    (iii) Dismiss the petition if at any time the Commissioner 
determines that changes in law, facts, or circumstances since the date 
on which the petition was submitted have rendered the petition moot; or
* * * * *
    (3) * * * If, at any time, the Commissioner determines that changes 
in law, facts, or circumstances since the date on which the petition 
was submitted have rendered the petition

[[Page 78506]]

moot, the Commissioner may dismiss the petition. * * *
* * * * *
    (5) The Commissioner intends to furnish a response to each 
petitioner within 150 days of receipt of a petition subject to section 
505(q) of the Federal Food, Drug, and Cosmetic Act.
* * * * *

0
4. Add Sec.  10.31 to subpart B to read as follows:

Sec.  10.31   Citizen petitions and petitions for stay of action 
related to abbreviated new drug applications, certain new drug 
applications, or certain biologics license applications.

    (a) Applicability. This section applies to a citizen petition or 
petition for stay of action that meets all of the following criteria:
    (1) The petition requests that the Commissioner take any form of 
action that could, if taken, delay approval of an abbreviated new drug 
application submitted under section 505(j) of the Federal Food, Drug, 
and Cosmetic Act, a new drug application submitted through the pathway 
described by section 505(b)(2) of the Federal, Food, Drug and Cosmetic 
Act, or a biologics license application submitted under section 351(k) 
of the Public Health Service Act.
    (2) The petition is submitted on or after September 27, 2007.
    (3) The petition is submitted in writing and under Sec.  10.30 (for 
citizen petitions) or Sec.  10.35 (for petitions for stay of action).
    (b) Date of submission. A petition subject to this section and 
submitted in accordance with Sec.  10.20, Sec.  10.30, Sec.  10.31, or 
Sec.  10.35 is regarded as submitted on the date on which the petition 
is received by the Division of Dockets Management.
    (c) Certification. (1) FDA will not consider for review a petition 
that is subject to this section unless the petition is in writing and 
contains the following certification:
[GRAPHIC] [TIFF OMITTED] TR08NO16.000

    (2) The certification in paragraph (c)(1) of this section must 
contain one or more specific dates (month, day, and year) in the first 
blank space provided. If different categories of information become 
known at different times, the certification must contain each estimated 
relevant date. The information associated with a particular date must 
be identified.
    (d) Verification. (1) FDA will not accept for review any 
supplemental information or comments on a petition that is subject to 
this section unless the supplemental information or comments are in 
writing and contain the following verification:
[GRAPHIC] [TIFF OMITTED] TR08NO16.001

    (2) The verification in paragraph (d)(1) of this section must 
contain one or more specific dates (month, day, and year) in the first 
blank space provided. If different categories of information become 
known at different times, the verification must contain each estimated 
relevant date. The information associated with a particular date must 
be identified.

0
5. In Sec.  10.35 revise the third sentence of paragraph (b); in 
paragraph (e)

[[Page 78507]]

introductory text add a new sentence after the second sentence; and add 
paragraph (i) to read as follows:

Sec.  10.35  Administrative stay of action.

* * * * *
    (b) * * * A request for stay must be submitted in accordance with 
Sec.  10.20 and in the following form (except that a request for stay 
subject to Sec.  10.31 must also include the certification provided in 
Sec.  10.31(c)) no later than 30 days after the date of the decision 
involved. * * *
* * * * *
    (e) * * * If, at any time, the Commissioner determines that changes 
in law, facts, or circumstances since the date on which the petition 
was submitted have rendered the petition moot, the Commissioner may 
dismiss the petition. * * *
* * * * *
    (i) A petitioner may supplement, amend, or withdraw a petition for 
stay of action in writing without Agency approval and without prejudice 
to resubmission at any time until the Commissioner rules on the 
petition, provided the resubmission is made in accordance with 
paragraph (b) of this section, unless the petition for stay of action 
has been referred for a hearing under parts 12, 13, 14, or 15 of this 
chapter. After a ruling or referral, a petition for stay of action may 
be supplemented, amended, or withdrawn only with the approval of the 
Commissioner. The Commissioner may approve withdrawal with or without 
prejudice against resubmission of the petition for stay of action.

    Dated: November 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26912 Filed 11-7-16; 8:45 am]
 BILLING CODE 4164-01-P