[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