[Federal Register Volume 84, Number 127 (Tuesday, July 2, 2019)]
[Rules and Regulations]
[Pages 31471-31478]
[FR Doc No: 2019-14096]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 10 and 800

[Docket No. FDA-2016-N-2378]
RIN 0910-AH37

Internal Agency Review of Decisions; Requests for Supervisory
Review of Certain Decisions Made by the Center for Devices and
Radiological Health

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing a
final rule to amend its regulations regarding internal agency
supervisory review of certain decisions related to devices regulated by
the Center for Devices and Radiological Health (CDRH or the Center)
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to conform to
the applicable provisions in the FD&C Act, as amended by the Food and
Drug Administration Safety and Innovation Act (FDASIA) and the 21st
Century Cures Act (Cures Act). This final rule codifies the procedures
and timeframes for supervisory review of significant decisions
pertaining to devices within CDRH. FDA is also finalizing regulations
to provide new procedural requirements for requesting internal agency
supervisory review within CDRH of other types of decisions made by CDRH
not addressed in FDASIA and the Cures Act. This action is also part of
FDA's implementation of Executive Orders (EOs) 13771 and 13777. Under
these EOs, FDA is comprehensively reviewing existing regulations to
identify opportunities for repeal, replacement, or modification that
will result in meaningful burden reduction, while allowing the Agency
to achieve its public health mission and fulfill statutory obligations.

DATES: This rule is effective August 1, 2019.

ADDRESSES: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number found in brackets in the heading of this final rule into
the ``Search'' box and follow the prompts, and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: With regard to the final rule: Adaeze
Teme, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5574, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>; or the Ombudsman for the Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, Rm. 4282, Silver Spring, MD 20993-
0002,<PHONE_NUMBER>, or<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Final Rule
    B. Summary of the Major Provisions of the Final Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
    A. Need for the Regulation/History of the Rulemaking
    B. Summary of Comments in Response to the Proposed Rule
IV. Legal Authority
V. Comments on the Proposed Rule and FDA Response
    A. Introduction
    B. Description of Comments and FDA Responses
VI. Effective Date
VII. Economic Analysis of Impacts
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With Indian Tribal Governments

I. Executive Summary

A. Purpose of the Final Rule

    FDA is issuing this final rule to implement regulations on the
procedures regarding internal agency supervisory review of certain
decisions made by CDRH under the FD&C Act. Section 603 of FDASIA (Pub.
L. 112-144) added new section 517A to the FD&C Act (21 U.S.C. 360g-1),
which was amended by sections 3051 and 3058 of the Cures Act (Pub. L.
114-255). These provisions established procedures and timeframes for
supervisory review under Title 21 of the Code of Federal Regulations
(CFR) Sec.  10.75 (21 CFR 10.75) of significant decisions by CDRH
pertaining to devices. After the enactment of FDASIA, FDA issued a
guidance document entitled ``Center for Devices and Radiological Health
Appeals Processes: Questions and Answers About 517A--Guidance for
Industry and Food and Drug Administration Staff'' (Q&A Guidance) to
provide interpretation of key provisions of section 517A of the FD&C
Act, including those that pertain to requests for supervisory review of
significant decisions by CDRH (available at: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM352254.pdf). FDA is finalizing this regulation to codify: (1) The
procedures and timeframes for Sec.  10.75 appeals of ``significant
decisions'' by CDRH established under section 517A and (2) the
interpretation of key provisions of section 517A of the FD&C Act
regarding supervisory review. In addition, the regulations codify new
procedural requirements for supervisory review within CDRH of other
CDRH decisions that were not addressed in FDASIA and the Cures Act.
    The final rule provides transparency and clarity for internal and
external stakeholders on CDRH's process for supervisory review of
decisions and provides requesters new predictability through binding
deadlines for FDA action on a request for supervisory review within
CDRH and the Center's internal agency review of ``significant
decisions.'' Furthermore, this final rule codifies the types of
decisions that are considered ``significant decisions,'' for which the
timeframes apply. The final regulations also codify the timeframe for
submission of requests for the review of other decisions within CDRH.

B. Summary of the Major Provisions of the Final Rule

    FDA is amending part 10 (21 CFR part 10) by adding Sec.  10.75(e).
Section 10.75 currently provides that an interested person outside the
Agency may request internal agency review of a decision of an FDA
employee. FDA is amending Sec.  10.75 to add paragraph (e) to require
that requests for internal agency supervisory review of a decision
within CDRH also comply with new Sec.  800.75 (21 CFR 800.75). This
change to the regulations encompasses both significant decisions under
section 517A of the FD&C Act and other decisions by CDRH employees for
which review is requested through the supervisory chain within CDRH.
    The final rule also adds new Sec.  800.75 to part 800 (21 CFR part
800). Section 800.75 incorporates in the regulations the provisions of
section 517A of the FD&C Act for review of ``significant decisions''
related to devices regulated under the FD&C Act by CDRH. Section 800.75
defines ``significant decisions.'' Section 800.75 also includes the
timeframes for submission of requests for internal agency review of
significant decisions within CDRH and for responses to such requests.
    Section 800.75 further addresses requests for supervisory review
within CDRH of decisions other than section 517A decisions and
indicates the timeframe for submission of these requests for internal
agency review.

C. Legal Authority

    FDA's legal authority to implement requirements pertaining to the
process and timelines for Sec.  10.75 appeals of decisions within CDRH
derives from sections 510(k), 515, 515B, 517A, and 520(g) of the FD&C
Act (21 U.S.C. 360(k), 360e, 360e-3, 360g-1, and 360j(g)) and other
provisions under which a decision might be appealed, and 701(a) of the
FD&C Act (21 U.S.C. 371(a)). Section 701(a) of the FD&C Act gives FDA
general rulemaking authority to issue regulations for the efficient
enforcement of the FD&C Act.

D. Costs and Benefits

    We expect the costs and benefits of the final rule will be
negligible.

II. Table of Abbreviations/Commonly Used Acronyms in This Document

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             Abbreviation                        What it means
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510(k)...............................  Premarket notification.
513(f)(2)............................  De Novo classification process.
517A decision........................  A significant decision regarding
                                        a device as set forth in section
                                        517A of the FD&C Act.
Agency...............................  Food and Drug Administration.
CDRH or Center.......................  Center for Devices and
                                        Radiological Health.
CFR..................................  Code of Federal Regulations.
CLIA.................................  Clinical Laboratory Improvement
                                        Amendments, 42 U.S.C. 263a.
EO...................................  Executive Order.
FD&C Act.............................  Federal Food, Drug, and Cosmetic
                                        Act, 21 U.S.C. 301 et seq.
FDA..................................  Food and Drug Administration.
FDASIA...............................  Food and Drug Administration
                                        Safety and Innovation Act.
FDASIA amendments....................  Section 603 of FDASIA.
HDE..................................  Humanitarian Device Exemption.
IDE..................................  Investigational Device Exemption.
Non-517A decision....................  CDRH decisions outside the scope
                                        of section 517A of the FD&C Act.
NSE..................................  Not substantially equivalent.
OMB..................................  Office of Management and Budget.
Part 10..............................  21 CFR part 10.
PMA..................................  Premarket approval.
PRA..................................  Paperwork Reduction Act of 1995,
                                        44 U.S.C. 3501-3520.
PHS Act..............................  Public Health Service Act.
Section 10.75........................  21 CFR 10.75.
U.S.C................................  United States Code.
We or us.............................  Food and Drug Administration.
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III. Background

A. Need for the Regulation/History of the Rulemaking

    FDA has long provided a path for outside parties to request
internal agency review of decisions. A procedure for this type of
review was first published as a proposed regulation in 1975 (40 FR
40682, September 3, 1975). In the preamble for that proposed rule, the
Agency recognized that a process for administrative review of Agency
decisions would advise outside parties on how they should pursue
matters that interest and concern them (40 FR 40682 at 40693). A final
rule published in 1977 incorporated these provisions into the Code of
Federal Regulations at Sec.  2.17 (21 CFR 2.17) (42 FR 4680, January
25, 1977).
    These regulations provided that any decision of an FDA employee,
other than the Commissioner, on any matter was subject to review by the
employee's supervisor under any of the following circumstances: (1) At
the request of the employee, (2) on the initiative of the supervisor,
(3) at the request of any interested person outside of the Agency, or
(4) as required by duly promulgated delegations of authority. The
review shall be accomplished by consultation between the employee and
the supervisor, by review of the administrative file, or both. The
review shall ordinarily follow established Agency channels of
supervision. Internal agency review shall be based on the data and
information available in the administrative file. If an interested
person presents new data or information not contained in the
administrative file, then the matter shall be returned to the
appropriate lower level within the Agency for a reevaluation based upon
the new information (42 FR 4680 at 4707).
    The following year, in 1978, a proposed rule was published to
reorganize and revise the Agency's administrative practices and
procedures regulations (43 FR 51966, November 7, 1978). When the final
rule for that action was published, the regulations for internal agency
review were moved from Sec.  2.17 and redesignated as Sec.  10.75 (44
FR 22318, April 13, 1979), where these regulations remain today.
    In 1998, Sec.  10.75 was amended to add provisions allowing a
sponsor, applicant, or manufacturer of a drug or device to request
review of a scientific controversy by an appropriate scientific
advisory panel or advisory committee (63 FR 63978, November 18, 1998).
Aside from the specific situation addressed by the amendment, the
elements of internal agency review under Sec.  10.75 relating to who
may request the review and the information on which the review must be
based remained unchanged.
    Section 10.75 contains regulations that establish an orderly
process for internal agency review of decisions, based on information
in the FDA administrative file. Section 10.75 applies to requests for
review of decisions made by any FDA employee, other than decisions by
the Commissioner of Food and Drugs. Section 10.75 does not establish
timelines for requests for Agency review or for the Agency to act upon
these requests. The FDA guidance document entitled ``Center for Devices
and Radiological Health Appeals Processes: Guidance for Industry and
Food and Drug Administration Staff'' describes the Sec.  10.75 appeal
processes available to outside stakeholders to request review of
decisions or actions by CDRH employees (available at: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM284670.pdf).
    On July 9, 2012, the FD&C Act (21 U.S.C. 301 et seq.) was amended
by FDASIA. Section 603 of FDASIA added new section 517A to the FD&C
Act, which specifies procedures and timeframes for the supervisory
review of significant decisions pertaining to devices regulated by
CDRH.
    On December 13, 2016, the FD&C Act was further amended by the Cures
Act. Section 3051 of the Cures Act, ``Breakthrough Devices,'' added
section 515B to the FD&C Act (as amended by

section 901(f)(2) of the FDA Reauthorization Act of 2017 (Pub. L. 115-
52)) and amended section 517A(a)(1) to include any significant decision
by CDRH regarding a request for designation as a breakthrough device
under section 515B.
    In addition, section 3058, ``Least Burdensome Device Review,'' of
the Cures Act amended section 517A(a) by adding paragraph (3), which
requires that the substantive summary include a brief statement of how
the least burdensome requirements were considered and applied
consistent with sections 513(i)(1)(D), 513(a)(3)(D), and 515(c)(5) of
the FD&C Act (21 U.S.C. 360c(i)(1)(D), 360c(a)(3)(D), and 360e(c)(5)),
as applicable.
    Section 517A of the FD&C Act provides that any person may request a
supervisory review of any significant decision of CDRH regarding the
submission or review of a report under section 510(k), an application
under section 515, a request for designation under section 515B, or an
application for an exemption under section 520(g) of the FD&C Act. Any
person may request such review, which may be conducted at the next
supervisory level or higher above the individual who made the
significant decision. Where the request for supervisory review was made
at the organizational level, any person may request a supervisory
review to the next organizational level or higher above the level at
which the decision was made. In addition, the Office or Center Director
may designate a subordinate to be their representative, as the
authority for a request made to that level. In this situation, a
request for review heard by a designated subordinate is rendered on
behalf of the Director and constitutes a review by that level of the
organization.
    Section 517A of the FD&C Act includes specific timeframes both for
the person requesting review and for FDA to respond to such a request.
A request for review of a significant decision is required to be
submitted to FDA not later than 30 days after such decision. In
responding to this request, if the requester seeks an in-person meeting
or a teleconference review, FDA is required to schedule the requested
interaction not later than 30 days after the request is made. FDA is
required to issue a decision not later than 30 days after the
interaction, or, in the case of a person who does not seek an in-person
meeting or teleconference review, FDA is required to issue a decision
no later than 45 days after the request for supervisory review is
received by FDA. An exception to the timeframes related to scheduling
an in-person meeting or teleconference review, and to FDA's decision on
a request for supervisory review of the significant decision, is
provided in cases that are referred to experts outside of FDA. Although
the procedures and timeframes in section 517A of the FD&C Act apply to
an initial request for supervisory review of a significant decision by
CDRH, CDRH has chosen to enhance transparency and predictability and
apply those procedures and timeframes as well to sequential requests
for supervisory review of significant decisions that are submitted to
CDRH.
    On January 17, 2018, FDA published a proposed rule to incorporate
the procedures and timeframes in section 517A of the FD&C Act to an
initial or sequential request for supervisory review within CDRH of
``significant decisions'' by CDRH into FDA's regulations (83 FR 2388).
The proposed regulation also introduced new procedural requirements for
requests for supervisory review within CDRH under Sec.  10.75 of
decisions that do not fall under ``significant decisions'' under
section 517A of the FD&C Act. We are finalizing this rule as described
below.
1. Amendments to Sec.  10.75
    Part 10 is amended to add Sec.  10.75(e). FDA is adding language to
clarify that requests by interested persons outside the Agency for
internal agency review of a decision within CDRH must also comply with
new Sec.  800.75. The amendments to Sec.  10.75(e) are not limited to
significant decisions under section 517A of the FD&C Act. Rather, Sec.
10.75(e) also encompasses supervisory review within CDRH of decisions
other than 517A decisions made by CDRH.
2. New Sec.  800.75
    Section 517A of the FD&C Act establishes procedural requirements,
including timeframes for a request for internal agency review of a
``significant decision'' by CDRH. ``Significant decision'' is not
defined in the statutory provision. FDA defines ``significant
decision'' in Sec.  800.75 to provide greater clarity regarding which
decisions fall within this statutory term.
    A ``517A decision'' is defined as a significant decision made by
CDRH, as set forth in section 517A of the FD&C Act. We use the term
``517A decision'' rather than the term ``significant decision'' because
we do not want to imply that any other decisions of CDRH that do not
fall within section 517A of the FD&C Act are not significant.
Similarly, we do not use the term ``non-significant decision'' when
speaking of decisions outside of the scope of section 517A, as that
might imply some unintended assessment on our part concerning the
importance of these types of decisions. In addition, because we include
regulatory decisions by CDRH in addition to those set forth in section
517A of the FD&C Act, we believe that this will avoid any confusion
that might occur in distinguishing between these two categories of
decisions. For these reasons, we instead are using the term ``517A
decision'' for those decisions that are identified under section 517A
as significant decisions and refer to other decisions by CDRH as ``non-
517A decisions.''
    The review procedures under section 517A of the FD&C Act apply only
to a request for review of a significant decision by CDRH regarding
submission or review of a report under section 510(k) (Premarket
Notification), an application under section 515 (Premarket Approval
Application (PMA)/Humanitarian Device Exemption (HDE)), a request for
designation under section 515B (Breakthrough Devices), or an
application for an exemption under section 520(g) of the FD&C Act
(Investigational Device Exemption (IDE)). Under the new Sec.  800.75,
only the following decisions are considered significant decisions under
section 517A of the FD&C Act and, thus, defined for purposes of this
rule as ``517A decisions'':
     510(k): Not substantially equivalent; Substantially
equivalent.
     PMA/HDE: Not approvable; Approvable; Approval; Denial.
     Breakthrough Device Designation Request (request for
breakthrough designation for devices subject to premarket notification,
premarket approval, or De Novo classification process (see
``Breakthrough Devices Program: Guidance for Industry and FDA Staff'';
available at: https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm581664.pdf): Grant; Denial of request
for breakthrough designation.
     IDE: Disapproval; Approval.
     Failure to reach agreement on protocol under section
520(g)(7) of the FD&C Act.
     ``Clinical Hold'' determinations under section 520(g)(8)
of the FD&C Act.
    We are mindful that outside parties may use Sec.  10.75 to request
review of decisions other than 517A decisions. For this reason, we
provided procedural requirements for internal agency supervisory review
within CDRH under Sec.  10.75 of non-517A decisions made by CDRH
employees. A request for supervisory review of a CDRH decision other
than a 517A decision is to be received no later than 60 days after the

date of the decision that is subject to review. Any request received
after 60 days in these cases will be denied as untimely, unless CDRH,
for good cause related to circumstances beyond the control of the
submitter, such as snow emergency, Federal Government shutdown, or
other unforeseen emergency event, permits the request to be filed after
60 days.
    Section 800.75 provides that requests for CDRH review of 517A
decisions and non-517A decisions must be addressed to the next
organizational level or higher above the individual who made the
decision. Requests to elevate the review of such decisions should
include a rationale. The decision to collapse two or more levels of
review or to elevate a review would solely be at CDRH's discretion. In
addition, requesters should have exhausted review through the
supervisory chain below the Center Director level prior to request for
review at the Center Director level.
    As provided in the FDA guidance entitled ``eCopy Program for
Medical Device Submissions: Guidance for Industry and Food and Drug
Administration Staff'' (eCopy guidance), appeals to submission types
identified under section 745A(b) of the FD&C Act are subject to the
electronic format requirements (available at: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm313794.pdf). Therefore, Sec.  10.75 requests for supervisory review
of 517A decisions within CDRH, and certain decisions other than 517A
decisions, must be submitted in accordance with section 745A(b) of the
FD&C Act and the standards established by the eCopy guidance, when
applicable. In addition, requests for breakthrough designation under
section 515B of the FD&C Act for devices under sections 510(k),
513(f)(2), and 515(c) of the FD&C Act would be considered
``presubmissions'' to those submission types as identified under
section 745A, and, therefore, requests for breakthrough designation
would be subject to section 745A(b) of the FD&C Act, and likewise,
Sec.  10.75 requests for review within CDRH.
    Further, Sec.  800.75 requires that requests for supervisory review
of CDRH decisions other than 517A decisions be sent to the CDRH
Ombudsman, and if subject to section 745A of the FD&C Act, are to be
submitted in electronic format.

B. Summary of Comments in Response to the Proposed Rule

    The comments on the proposed rule were generally favorable and
supportive of the proposal to codify the procedures and timeframes for
supervisory review of 517A and non-517A decisions pertaining to devices
regulated by CDRH.
    A comment appreciated the Agency's actions to clarify the CDRH
process for supervisory review of decisions along with deadlines for
certain FDA actions. Another comment, however, requested clarification
about escalating review beyond the next organizational level above the
decision maker (telescoping review). Another comment questioned whether
the scope of significant decisions under section 517A of the FD&C Act
should be expanded; specifically, recognition of additional CDRH
decisions as 517A decisions. A comment was received on clarifying
timeframes for receipt of a substantive summary upon request as
required for a 517A decision. The comment also expressed concern over
the proposed timeframe for requests for supervisory review of non-517A
decisions, requested clarification on specific timeframes for non-517A
decisions for requesters that seek to schedule a meeting or
teleconference, and requested the addition of timeframes for when CDRH
will render a decision.

IV. Legal Authority

    We are issuing this final rule to codify the procedures and
timeframes in section 517A of the FD&C Act, added by section 603 of
FDASIA and amended by the Cures Act, for Sec.  10.75 appeals of
``significant decisions'' regarding the submission or review of a
report under section 510(k), an application under section 515, a
request for designation under section 515B, or an application for an
exemption under section 520(g) of the FD&C Act.
    We are also finalizing additional procedural requirements for Sec.
10.75 appeals submitted to CDRH of other types of CDRH decisions not
addressed in FDASIA and the Cures Act.
    FDA's legal authority to implement requirements pertaining to the
process and timelines for Sec.  10.75 appeals submitted to CDRH derives
from sections 510(k), 515, 515B, 517A, and 520(g) of the FD&C Act and
other provisions under which a decision might be appealed, and 701(a)
of the FD&C Act. Section 701(a) of the FD&C Act gives FDA general
rulemaking authority to issue regulations for the efficient enforcement
of the FD&C Act.

V. Comments on the Proposed Rule and FDA Response

A. Introduction

    We received various comments from a trade organization and an
individual on the proposed rule by the close of the comment period;
however, only one commenter provided comments on issues relevant to the
proposed rule.
    We describe and respond to the comments below. We have separated
different issues discussed in the same set of comments and designated
them as distinct comments for purposes of our responses. The number
assigned to each comment topic is purely for organizational purposes
and does not signify the comment's value or importance.

B. Description of Comments and FDA Responses

    (Comment 1) One comment appreciates FDA's efforts to provide
clarity to industry on the CDRH process for supervisory review of
decisions, along with binding deadlines for certain FDA actions related
to supervisory review and other related timeframes.
    (Response 1) FDA proposed the regulation to provide clarity on the
process for supervisory review and instruction on how external
stakeholders, who disagree with a decision or action taken by CDRH, may
seek resolution. FDA believes a well-informed process for CDRH reviews
of significant decisions under 517A of the FD&C Act, as well as non-
517A decisions, promotes consistency, predictability, efficiency, and a
transparent pathway of our review process.
    (Comment 2) A comment requested that FDA expand the definition of
significant decision as set forth in section 517A of the FD&C Act by
including: (1) a grant or denial of Clinical Laboratory Improvement
Amendments (CLIA) waiver and a (2) grant or decline of a De Novo
classification request.
    (Response 2a) When Congress passed CLIA in 1988 (Pub. L. 100-578),
amending section 353 of the Public Health Service (PHS) Act (42 U.S.C.
263a), they established clinical laboratory quality standards for all
laboratory testing. While the Centers for Medicare & Medicaid Services
has primary responsibility for administering CLIA, FDA also has certain
responsibilities under CLIA, including categorizing tests as high
complexity, moderate complexity, or waived. However, Congress did not
include CLIA waived categorization under the PHS Act as regulatory
decisions that trigger the requirements under section 517A of the FD&C
Act. Therefore, FDA does not intend to expand the definition of a
significant decision to the grant or denial of a CLIA waiver because it
is outside the scope of the types of

decisions expressly included under section 517A of the FD&C Act.
    (Response 2b) FDA recognizes that the De Novo classification
process is an important part of our regulatory framework. In accordance
with section 513(f)(2)(A)(i) of the FD&C Act, any person who submits a
510(k) for a type of device that has not been previously classified
under the FD&C Act, and that is classified into class III, may request,
after receiving written notice of such classification, FDA to classify
the device based on the criteria set forth in section 513(a)(1) of the
FD&C Act. Under section 513(f)(2)(A)(ii) of the FD&C Act, a person who
determines that there is no legally marketed device upon which to base
a determination of substantial equivalence may request FDA to classify
the device based on the criteria set forth in section 513(a)(1) of the
FD&C Act without first submitting a 510(k). The process created by
section 513(f)(2) of the FD&C Act, which was added by the Food and Drug
Administration Modernization Act of 1997 (Pub. L. 105-115) and referred
to therein as the Evaluation of Automatic Class III Designation, is
what is now referred to as the De Novo classification process. Although
the decision to grant or decline a De Novo request is within FDA's
regulatory authority, it is not a decision type identified in section
517A of the FD&C Act as a significant decision. Because section 517A of
the FD&C Act does not identify decisions on requests under section 513
of the FD&C Act as one of the types of significant decisions subject to
section 517A, FDA believes that a De Novo request appropriately remains
within the regulatory category of a non-517A decision.
    (Comment 3) One comment requested that FDA permit the collapsing of
two or more levels of review, which is otherwise referred to as
``telescoped review'' to support assessment at the appropriate level
and, alternatively, recommended emphasizing that requesters should
exhaust review through the supervisory chain below the Center Director
level prior to request for review at the Center Director level, absent
adequate rationale.
    (Response 3) FDA has recognized that CDRH preserves ``telescoped
review'' as a discretionary action in matters pertaining to regulatory
issues, new policy questions, or highly complex scientific questions.
As explained in the guidance entitled ``Center for Devices and
Radiological Health Appeals Processes: Guidance for Industry and Food
and Drug Administration Staff,'' engagement of a next-level supervisor
in a matter under dispute does not necessarily disqualify the next-
level supervisor from hearing the dispute on appeal; however, elevation
of a dispute may be appropriate if the next-level supervisor has been
significantly and substantively involved in the regulatory action under
review. Certain circumstances may also warrant referral of the review
directly to the next-level supervisor, up to and including the Center
Director. In these situations, the Center intends that the review will
be undertaken and decided by the next-level supervisor. For example,
circumstances such as imminent risk to public health may warrant
elevation of a Division-level appeal directly to the Center Director. A
stakeholder wishing to elevate a dispute should indicate a request for
telescoped review with an accompanying rationale. The decision to
collapse two or more levels of review or to elevate a review is made
solely at the Center's discretion and the Center intends to document
the rationale for the decision in the review decision letter.
    Absent approval for ``telescoped review,'' requesters must exhaust
review through the supervisory chain below the Center Director level
prior to requesting review at the Center Director level.
    (Comment 4) A comment requested clarification on the timeframe for
receipt of a substantive summary and requested that FDA allow
additional time to request supervisory review following a company's
receipt of a substantive summary under section 517A of the FD&C Act.
    (Response 4) In accordance with section 517A(a) of the FD&C Act,
FDA shall furnish, upon request, a substantive summary of the
scientific and regulatory rationale for any significant decision
regarding a report under section 510(k), an application under section
515, a request under section 515B, or an application under section
520(g) of the FD&C Act, to the person who is seeking to submit, or who
has submitted, such report or application. The substantive summary must
include documentation of significant controversies or differences of
opinion and the resolution of such controversies or differences of
opinion for any such significant decision of CDRH, as well as a brief
statement of how least burdensome requirements were considered and
applied consistently with sections 513(i)(1)(D), 513(a)(3)(D), and
515(c)(5) of the FD&C Act, as applicable.
    CDRH prepares and furnishes the final decision, as well as the
substantive summary of the scientific and regulatory rationale, solely
on the basis of the information in the administrative record, including
in a report under section 510(k), an application under 515, a request
for designation under 515B, or an application for an exemption under
520(g) of the FD&C Act. Therefore, both the substantive summary and the
final decision rely upon the same information in the administrative
record, including the information submitted by the sponsor or
applicant.
    Additionally, CDRH provides the information necessary to file an
appeal in its final decision rendered for one of these reports or
applications, including CDRH's rationale for the decision. In other
words, the sponsor or applicant has the requisite information needed to
submit an appeal in accordance with the timelines designated in the
statute or identified as part of this final rule. While the substantive
summary may include additional information, such as documentation of
significant controversies or differences of opinion and the resolution
of such, if applicable, that additional information is not necessary to
file an appeal. Nonetheless, CDRH is committed to its current practice
of furnishing the request for a substantive summary in a timely manner.
    (Comment 5) Another comment suggested that FDA update the final
rule to include the following: (1) Revise the deadline for requests for
supervisory review of non-517A decisions from 60 to 90 days and, in the
alternative and (2) further clarify the meaning of ``good cause'' as
well as expand ``good cause'' to include matters pertaining to public
health and other justifications.
    (Response 5a) Although section 517A of the FD&C Act does not
require FDA to implement procedures regarding CDRH decisions other than
for 517A decisions, we are mindful that outside parties may use Sec.
10.75 to request review of non-517A decisions. For this reason, we
proposed that a request for supervisory review of a CDRH decision other
than a 517A decision is to be received no later than 60 days after the
date of the decision. Any request received after 60 days in these cases
will be denied as untimely absent good cause.
    We believe 60 days is timely and appropriate for submission of a
request for supervisory review of a non-517A decision. We note that
this timeframe is twice as long as that for submission of a request for
supervisory review of a 517A decision. The primary purpose regarding
the deadline of a request for supervisory review of non-517A decisions
in this final rule is to provide predictability, and to ensure that
such requests are filed in a timely manner.

We believe that the timely filing of such requests within the 60-day
timeframe will aid CDRH in efficiently handling disputes of non-517A
decisions. However, expanding the 60-day timeframe for a request for
supervisory review of a non-517A decision may negatively impact other
decisions on CDRH regulated medical products. For example, a longer
deadline may delay actions and resolutions of other pending matters
that may be interrelated. This could negatively affect FDA's ability to
act timely in fulfilling its mission to protect and promote the public
health. For these reasons, we believe 60 days is an appropriate and
reasonable timeframe.
    (Response 5b) On the occasion of an unforeseen emergency event, FDA
will consider the basis for causes beyond the control of the submitter.
As such, FDA may permit the request for supervisory review of a non-
517A decision to be filed after 60 days for good cause related to a
snow emergency, Federal Government shutdown, or other unforeseen
emergency event. We believe that good cause related to ``other
unforeseen emergency event'' can include issues impacting public
health. If a request for supervisory review of a non-517A decision is
filed after 60 days, FDA will consider whether there is good cause for
extending the timeline based on the circumstances.
    (Comment 6) A comment requested that FDA provide specific timelines
for non-517A decisions related to when CDRH will schedule a meeting or
teleconference, if requested by the person requesting supervisory
review and when CDRH will render a decision if no teleconference or
meeting is requested.
    (Response 6) We disagree that timelines for these actions are
needed for FDA to provide timely responses for supervisory review of
non-517A decisions. This final rule does not negatively affect CDRH's
current practice of providing timely responses regarding requests for
supervisory review of non-517A decisions. Apart from this rulemaking,
we continue to work with industry and welcome stakeholder feedback on
how to improve our communication regarding how CDRH will respond to an
appeal of an adverse non-517A decision.

VI. Effective Date

    This rule will become effective 30 days after its publication in
the Federal Register.

VII. Economic Analysis of Impacts

    We have examined the impacts of the final rule under E.O. 12866,
E.O. 13563, E.O. 13771, the Regulatory Flexibility Act (5 U.S.C. 601-
612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).
E.O.s 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). E.O. 13771 requires that
the costs associated with significant new regulations ``shall, to the
extent permitted by law, be offset by the elimination of existing costs
associated with at least two prior regulations.'' We believe that this
final rule is not a significant regulatory action as defined by E.O.
12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because we lack information about the number of firms
affected and because the affected firms will incur minimal costs to
read and understand the rule, 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 proposing ``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 $154 million, using the most current (2018) 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.
    In our preliminary regulatory impact analysis, we estimated that
the costs and benefits of the rule would be negligible. We received no
comments on our preliminary regulatory impact analysis of the proposed
rule and thus retain our original estimate for the final regulatory
impact analysis. Because the final rule does not change the effort
needed to prepare and submit a request for supervisory review, we
anticipate that affected firms will incur only negligible costs to read
and learn about the provisions of the final rule. The final rule will
clarify the supervisory review process. However, we do not expect
additional costs for FDA.

VIII. Analysis of Environmental Impact

    We have 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.

IX. Paperwork Reduction Act of 1995

    This final rule contains previously approved information
collections found in FDA regulations and guidance. These collections of
information 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 collections of information regarding the appeals process for
devices in the guidance document entitled ``Center for Devices and
Radiological Health Appeals Processes'' have been approved under OMB
control number 0910-0738; the collections of information in 21 CFR part
807, subpart E (premarket notification) have been approved under OMB
control number 0910-0120; the collections of information in 21 CFR part
812 (investigational device exemption) have been approved under OMB
control number 0910-0078; the collections of information in 21 CFR part
814, subparts A through E (premarket approval) have been approved under
OMB control number 0910-0231; the collections of information in 21 CFR
part 814, subpart H (humanitarian use devices) have been approved under
OMB control number 0910-0332; the collections of information regarding
``Requests for Feedback on Medical Device Submissions'' have been
approved under OMB control number 0910-0756; the collections of
information in the guidance document, ``De Novo Classification Process
(Evaluation of Automatic Class III Designation)'' have been approved
under OMB control number 0910-0844; the collections of information
regarding ``Recommendations for Clinical Laboratory Improvement
Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In
Vitro Diagnostic Devices: Guidance or Industry and Food and Drug
Administration Staff'' have been approved under OMB control number
0910-0598; and the collections of information regarding
``Administrative Procedures for CLIA Categorization: Guidance for
Industry and Food and Drug Administration Staff'' have been approved
under OMB control number 0910-0607.

X. Federalism

    We have analyzed this rule in accordance with the principles set
forth in Executive Order 13132. We have determined that the rule does
not contain policies that would 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.

XI. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this rule in accordance with the principles set
forth in Executive Order 13175. We have determined that the rule does
not contain policies that have substantial direct effects on one or
more Indian Tribes, on the relationship between the Federal Government
and Indian Tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian Tribes. Accordingly, we
conclude that the rule does not contain policies that have tribal
implications as defined in the Executive Order and, consequently, a
tribal summary impact statement is not required.

List of Subjects

21 CFR Part 10

    Administrative practice and procedure, News media.

21 CFR Part 800

    Administrative practice and procedure, Medical devices, Ophthalmic
goods and services, Packaging and containers, Reporting and
recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
10 and 800 are 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.  10.75, add paragraph (e) to read as follows:

Sec.  10.75  Internal agency review of decisions.

* * * * *
    (e) Each request by an interested person for review of a decision
within the Center for Devices and Radiological Health shall also comply
with Sec.  800.75 of this chapter.

PART 800--GENERAL

0
3. The authority citation for part 800 is revised to read as follows:

    Authority: 5 U.S.C. 551-559; 21 U.S.C. 301-399f.

0
4. Add Sec.  800.75 to subpart C to read as follows:

Sec.  800.75  Requests for supervisory review of certain decisions made
by the Center for Devices and Radiological Health.

    (a) Definitions. The following definitions shall apply to this
section:
    (1) FDA means the Food and Drug Administration.
    (2) 517A decision means a significant decision made by the Center
for Devices and Radiological Health, as set forth in section 517A of
the Federal Food, Drug, and Cosmetic Act, and includes one of the
following decisions:
    (i) A substantially equivalent order under Sec.  807.100(a)(1) of
this chapter, or a not substantially equivalent order under Sec.
807.100(a)(2) of this chapter;
    (ii) An approval order under Sec.  814.44(d) of this chapter, an
approvable letter under Sec.  814.44(e) of this chapter, a not
approvable letter under Sec.  814.44(f) of this chapter, or an order
denying approval under Sec.  814.45 of this chapter;
    (iii) An approval order under Sec.  814.116(b) of this chapter, an
approvable letter under Sec.  814.116(c) of this chapter, a not
approvable letter under Sec.  814.116(d) of this chapter, or an order
denying approval under Sec.  814.118 of this chapter;
    (iv) A grant or denial of a request for breakthrough device
designation under section 515B of the Federal Food, Drug, and Cosmetic
Act;
    (v) An approval order under Sec.  812.30(a) of this chapter or a
disapproval order under Sec.  812.30(c) of this chapter;
    (vi) A failure to reach agreement letter under section 520(g)(7) of
the Federal Food, Drug, and Cosmetic Act; or
    (vii) A clinical hold determination under section 520(g)(8) of the
Federal Food, Drug, and Cosmetic Act.
    (3) CDRH means the Center for Devices and Radiological Health.
    (b) Submission of request--(1) Review of 517A decisions. (i) An
initial or sequential request for supervisory review within CDRH of a
517A decision under Sec.  10.75 of this chapter must be addressed to
the next organizational level or higher above the individual who made
the decision; submitted in electronic format in accordance with section
745A(b) of the Federal Food, Drug, and Cosmetic Act; marked ``Appeal:
Request for Supervisory Review''; and received by CDRH no later than 30
days after the date of the decision involved. Any such request for
supervisory review not received by CDRH within 30 days after the date
of the decision involved is not eligible for review. Except as provided
in paragraph (b)(1)(ii) or (iii) of this section, FDA will render a
decision within 45 days of the request for supervisory review.
    (ii) A person requesting supervisory review under paragraph
(b)(1)(i) may request an in-person meeting or teleconference with the
supervisor reviewing the request for supervisory review. Except as
provided in paragraph (b)(1)(iii) of this section, if a request for in-
person meeting or teleconference is included in the request for
supervisory review to CDRH, CDRH will schedule the meeting or
teleconference to occur within 30 days of receipt of the request.
Except as provided in paragraph (b)(1)(iii) of this section, a decision
will be rendered within 30 days of such meeting or teleconference.
    (iii) The timeframes for CDRH to render a decision provided in
(b)(1)(i) and (ii) of this section, and the timeframe to schedule an
in-person meeting or teleconference review in (b)(1)(ii) of this
section, do not apply if a matter related to the 517A decision under
review is referred by CDRH to external experts, such as an advisory
committee, as provided in Sec.  10.75(b) of this chapter.
    (2) Supervisory review. An initial or sequential request for
supervisory review within CDRH under Sec.  10.75 of this chapter of a
decision other than a 517A decision that is not received by CDRH within
60 days after the date of the decision involved will be denied as
untimely, unless CDRH, for good cause, permits the request to be filed
after 60 days. An initial or sequential request for supervisory review
within CDRH of a decision other than a 517A decision must be addressed
to the next organizational level or higher above the individual who
made the decision; submitted in electronic format in accordance with
section 745A(b) of the Federal Food, Drug, and Cosmetic Act, when
applicable; marked, ``Appeal: Request for Supervisory Review'' in the
subject line of the electronic request; and sent to the CDRH Ombudsman
at<EMAIL_ADDRESS>

    Dated: June 20, 2019.
Norman E. Sharpless,
Acting Commissioner of Food and Drugs.
    Dated: June 25, 2019.

Eric D. Hargan,
Deputy Secretary, Department of Health and Human Services.
[FR Doc. 2019-14096 Filed 7-1-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 166 (Tuesday, August 27, 2019)]
[Proposed Rules]
[Pages 44801-44804]
[FR Doc No: 2019-18432]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2019-0240; FRL-9998-84-Region 9]

Extreme Area Submission Requirements, Coachella Valley
Nonattainment Area; California Ozone

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) recently granted a
request by the State of California to voluntarily reclassify the
Coachella Valley nonattainment area from ``Severe-15'' to ``Extreme''
for the 1997 8-hour ozone national ambient air quality standards
(NAAQS) under section 182(b)(3) of the Clean Air Act (CAA). In this
action, the EPA is proposing a schedule for the State to submit an
Extreme ozone nonattainment area plan and revised title V and new
source review (NSR) rules. The EPA is proposing deadlines for submittal
of those state implementation plan (SIP) revisions and for
implementation of the related control requirements. Under the EPA's
proposed schedule, California would be required to submit these
elements no later than July 10, 2020 (12 months from the effective date
of the area's reclassification). We are also clarifying some language
related to tribal areas that was included in our reclassification rule.

DATES: Any comments must arrive by September 26, 2019.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2019-0240 at https://www.regulations.gov. For comments submitted at
Regulations.gov, follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or removed from
Regulations.gov. The EPA may publish any comment received to its public
docket. Do not submit electronically any information you consider to be
confidential business information (CBI) or other information whose
disclosure is restricted by statute. Multimedia submissions (audio,
video, etc.) must be accompanied by a written comment. The written
comment is considered the official comment and should include
discussion of all points you wish to make. The EPA will generally not
consider comments or comment contents located outside of the primary
submission (i.e., on the web, cloud, or other file sharing system). For
additional submission methods, please contact the person identified in
the FOR FURTHER INFORMATION CONTACT section. For the full EPA public
comment policy, information about CBI or multimedia submissions, and
general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Tom Kelly, EPA Region IX, 75 Hawthorne
Street, San Francisco, CA 94105,<PHONE_NUMBER> or by email at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA.

Table of Contents

I. Background
II. Proposed Action and Public Comment
III. Statutory and Executive Order Reviews

I. Background

    This action concerns SIP revisions for the Coachella Valley portion
of Riverside County, California (``Coachella Valley''), upon the area's
reclassification to Extreme nonattainment for the 1997 ozone NAAQS. The
Coachella Valley is overseen by the South Coast Air Quality Management
District (``District'').
    Effective June 15, 2004, we classified the Coachella Valley as
``Serious'' nonattainment for the 1997 ozone NAAQS.\1\ Our
classification of Coachella Valley as a Serious ozone nonattainment
area established a requirement that the area attain the 1997 ozone
NAAQS as expeditiously as practicable, but no later than eight years
from designation, i.e., June 15, 2012. On November 28, 2007, the
California Air Resources Board (CARB) voluntarily

requested that the EPA reclassify the Coachella Valley from Serious to
Severe-15. The EPA granted the voluntary reclassification, effective
June 4, 2010, establishing a new Severe-15 attainment date of not later
than June 15, 2019.\2\ On June 11, 2019, CARB submitted a request that
the EPA reclassify the Coachella Valley from Severe-15 to Extreme for
the 1997 ozone NAAQS. The EPA granted CARB's request for
reclassification in a separate action, effective July 10, 2019.\3\ As
explained in the notice for that action, the EPA's reclassification to
Extreme nonattainment applies only to the portions of the Coachella
Valley subject to the State's jurisdiction, and the EPA did not
reclassify any areas of Indian country within the boundaries of the
nonattainment area.\4\
---------------------------------------------------------------------------

    \1\ 69 FR 23858 (April 30, 2004).
    \2\ 75 FR 24409 (May 5, 2010). Under CAA section 181(b)(3), the
EPA must approve a state's request for voluntary reclassification to
a higher ozone nonattainment classification.
    \3\ 84 FR 32841 (July 10, 2019).
    \4\ Id.
---------------------------------------------------------------------------

    The EPA's reclassification notice recognized a recent decision of
the United States Court of Appeals for the District of Columbia
Circuit, South Coast Air Quality Management District v. EPA, 882 F.3d
1138 (D.C. Cir. 2018) (``South Coast II''), as it relates to the EPA's
obligations for a revoked NAAQS. As described in that notice, the EPA
revoked the 1997 ozone NAAQS in 2015, and the Court in South Coast II
held that the EPA's obligation to reclassify areas failing to meet an
attainment date is an anti-backsliding control applicable to the
revoked 1997 NAAQS. The notice stated that although the Court did not
address voluntary reclassifications requested by states, such
reclassifications are consistent with the general scheme for
implementing CAA emissions controls to achieve attainment and serve to
clarify an area's anti-backsliding obligations with respect to the
revoked 1997 NAAQS.\5\ This proposal clarifies the anti-backsliding
obligations for the Coachella Valley by establishing a schedule for the
State to submit the plan elements for an Extreme area.
---------------------------------------------------------------------------

    \5\ Id.
---------------------------------------------------------------------------

II. Proposed Action and Public Comment

    In this action, we are proposing to require the State to submit SIP
revisions to address the requirements resulting from the EPA's
reclassification of the Coachella Valley to Extreme nonattainment for
the 1997 ozone NAAQS by no later than July 10, 2020, one year from the
effective date of the reclassification. The State's submittal must
include an Extreme area plan that addresses the requirements of CAA
section 182(e) as well as revisions to the NSR and title V rules
applicable to the area. In this proposed action, we are also clarifying
one aspect of our July 10, 2019 rule related to Indian country of the
Santa Rosa Band of Cahuilla Indians.

A. Extreme Area Plan Requirements

    Under CAA section 182(e), an attainment plan for an Extreme area
must include the elements required for a Severe area as well as
additional plan elements for an Extreme area.\6\ Where applicable, the
plan elements should reflect the reduction of the major source
threshold under 182(e) from 25 tons per year for a Severe area to 10
tons per year for an Extreme area. The requirements for an Extreme area
plan include, but are not limited to: (1) An attainment demonstration;
(2) a reasonable further progress (RFP) demonstration showing ozone
precursor reductions of at least 3 percent per year until the
attainment date; \7\ (3) additional reasonably available control
technology (RACT) rules to address sources subject to the lower Extreme
area major source threshold; (4) use of clean fuels or advanced control
technology for boilers as described at CAA section 182(e)(3); and (5)
contingency measures.
---------------------------------------------------------------------------

    \6\ CAA section 182(e) specifically excludes certain Severe area
requirements from the Extreme area requirements, e.g., CAA section
182(c)(6), (7), and (8).
    \7\ CAA section 182(e) does not allow the state to use the
provision at CAA section 182(c)(2)(B)(ii) that allows RFP reductions
of less than 3 percent per year based on additional demonstrations.
---------------------------------------------------------------------------

    For the Coachella Valley, the District and State will need to
submit a plan that includes all elements required under CAA section
182(e), and that demonstrates attainment of the 1997 ozone NAAQS as
expeditiously as practicable but no later than June 15, 2024. The plan
should identify adopted measures sufficient to make the required RFP
and attainment demonstrations for the area.\8\
---------------------------------------------------------------------------

    \8\ CAA section 182(e)(5) allows the EPA to approve an Extreme
area attainment demonstration based on anticipated development of
new control techniques or improvement of existing control
technologies. This option requires a state to demonstrate that
provisions based on these new techniques or improvements are not
necessary to meet emission reductions required within the first 10
years after an area's designation as Extreme, and to submit, at
least three years before implementation of the proposed provisions
relying on new technology, contingency measures to be implemented in
case the anticipated technologies do not achieve the planned
reductions. Based on the shorter timeline to attainment (roughly 5
years from reclassification), use of CAA section 182(e)(5) is not
appropriate in this instance.
---------------------------------------------------------------------------

    For areas initially designated Extreme, the CAA provides 4 years
from the date of designation to submit the required SIP elements to the
EPA. The statutory deadline for SIP submissions for areas initially
designated as Extreme for the 1997 ozone NAAQS passed in June 2008.
Under its general CAA section 301(a) authority, the EPA is establishing
a new deadline of July 10, 2020, i.e., 12 months from the effective
date of reclassification, for the State to submit SIP revisions
addressing the Extreme area requirements for the Coachella Valley. This
timeframe is consistent with how the EPA has handled establishing SIP
submission deadlines under CAA section 182(i) for ozone areas
reclassified by operation of law under CAA section 181(b)(2).\9\ The
EPA has also considered that for pollutants other than ozone, the Clean
Air Act provides twelve months for states to submit revised attainment
demonstration SIP submissions when an area fails to attain by its
attainment date.\10\ This timeframe generally allows for the time
necessary for states and local air districts to finish reviews of
available control measures, adopt revisions to necessary attainment
strategies, address other SIP requirements and complete the public
notice process necessary to adopt and submit timely SIP revisions.
---------------------------------------------------------------------------

    \9\ See, e.g., 75 FR 79302 (Dec. 20, 2010) (Dallas-Ft. Worth,
Texas, reclassification to Serious for the 1997 8-hour ozone NAAQS);
69 FR 16483 (March 30, 2004) (Beaumont-Port Arthur, Texas,
reclassification to Serious for the 1979 1-hour ozone NAAQS); 68 FR
4836 (Jan. 30, 2003) (St. Louis, Missouri, reclassification to
Serious for the 1979 1-hour ozone NAAQS).
    \10\ See CAA section 179(d)(1) (providing 12 months for a state
to submit a new attainment demonstration after a determination that
the area failed to attain by its attainment date).
---------------------------------------------------------------------------

    The RACT controls for an area classified as Extreme for the 1997
ozone NAAQS should be implemented before the ozone season of the
classification's attainment year, i.e., the ozone season immediately
preceding the maximum attainment date. For the Coachella Valley, which
has a year-round ozone season and a June 15, 2024 Extreme area
attainment date, RACT controls must be implemented by January 1, 2023.

B. NSR and Title V Program Revisions

    In addition to the required plan revisions discussed in section
II.A of this notice, the State must submit, by July 10, 2020, revised
District NSR rules for the Coachella Valley that reflect the Extreme
area definitions for new major sources and modifications, and to
increase the offset ratios for these sources and modifications
consistent with CAA section 182(e)(1) and (2). Under CAA section
182(e)(1), the volatile organic compound and oxides

of nitrogen offset ratios for major sources and modifications in an
Extreme nonattainment area must be at least 1.5 to 1, or at least 1.2
to 1 if the plan requires all existing major sources in the
nonattainment area to use best available control technology. Under CAA
section 182(e)(2), any change at a major stationary source that results
in an increase in emissions from any discrete operation, unit, or other
pollutant emitting activity at the source is generally considered a
modification, subject to additional provisions for emissions increases
offset through internal reductions and for equipment that is installed
to comply with CAA requirements. The District must also make any
changes in its title V operating permits program for the Coachella
Valley necessary to reflect the change in the major source threshold
from 25 tons per year for Severe areas to 10 tons per year for Extreme
areas. The rationale for the EPA's deadline of July 10, 2020 is
discussed in Section II.A.

C. Clarification of Indian Country in the Coachella Valley
Reclassification

    Our July 10, 2019 rule approving the State's request to reclassify
the Coachella Valley to Extreme for the 1997 ozone NAAQS applied only
to areas under state jurisdiction and did not change the nonattainment
classification for any areas subject to tribal jurisdiction. Our rule
identified tribes located within the Coachella Valley and indicated
that Indian country under the jurisdiction of these tribes would remain
classified as Severe-15, including land under the jurisdiction of the
Santa Rosa Band of Cahuilla Indians. However, the rule did not mention
that the reservation lands of the Santa Rosa Band of Cahuilla Indians
includes lands located in both the Coachella Valley and the South Coast
ozone nonattainment (``South Coast'') areas. The portion of the Santa
Rosa Reservation located in the South Coast is classified as Extreme
nonattainment.\11\ In this proposal, we reiterate that our
reclassification did not change the nonattainment classification of any
areas of Indian country and clarify that references to Indian country
of the Santa Rosa Band of Cahuilla Indians in our reclassification rule
apply only to the portions of the Santa Rosa Reservation located within
the Coachella Valley. The portion of the reservation lands of the Santa
Rosa Band of Cahuilla Indians located within the South Coast
nonattainment area remains classified as Extreme for the 1997 ozone
NAAQS. The portion of the reservation lands of the Santa Rosa Band of
Cahuilla Indians located within the Coachella Valley nonattainment area
remains classified as Serious for the 1997 ozone NAAQS.
---------------------------------------------------------------------------

    \11\ See 75 FR 24409, 24416 (May 5, 2010).
---------------------------------------------------------------------------

    We will accept comments from the public on this proposal until
September 26, 2019.

IV. Statutory and Executive Order Reviews

    Under Executive Orders 12866 (58 FR 51735, October 4, 1993) and
13563 (76 FR 3821, January 21, 2011), this proposed action is not a
``significant regulatory action'' and therefore is not subject to
review by the Office of Management and Budget. Because the statutory
requirements are clearly defined with respect to the differently
classified areas, and because those requirements are automatically
triggered by classification, the timing of the submittal of the Extreme
area requirements does not impose a materially adverse impact under
Executive Order 12866. For these reasons, this proposed action is also
not subject to Executive Order 13211, ``Actions Concerning Regulations
That Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001). Furthermore, this action is not an Executive
Order 13771 (82 FR 9339, February 2, 2017) regulatory action because
this action is not significant under Executive Order 12866.
    In addition, I certify that this proposed rule will not have a
significant economic impact on a substantial number of small entities
under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). This
proposed action does not contain any unfunded mandate or significantly
or uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4), because the EPA is seeking
comment solely on the timing of submittal requirements.
    Executive Order 13175 (65 FR 67249, November 9, 2000) requires the
EPA to develop an accountable process to ensure ``meaningful and timely
input by tribal officials in the development of regulatory policies
that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal government and Indian tribes, or
on the distribution of power and responsibilities between the Federal
government and Indian tribes.'' The reclassification does not apply to
tribal areas, and the proposed rule would not impose a burden on Indian
reservation lands or other areas where the EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction within the Coachella Valley,
and thus, this proposed rule does not have tribal implications and will
not impose substantial direct costs on tribal governments or preempt
tribal law as specified by Executive Order 13175.
    This proposed action also does not have federalism implications
because it does not 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, as specified in Executive Order 13132 (64 FR 43255,
August 10, 1999). This proposed action does not alter the relationship,
or the distribution of power and responsibilities established in the
Clean Air Act.
    This proposed rule also is not subject to Executive Order 13045,
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), because the EPA interprets
Executive Order 13045 as applying only to those regulatory actions that
concern health or safety risks, such that the analysis required under
section 5-501 of the Executive Order has the potential to influence the
regulation.
    As this proposal would set a deadline for the submittal of CAA
required plans and information, the requirements of section 12(d) of
the National Technology Transfer and Advancement Act of 1995 (15 U.S.C.
272 note) do not apply. This proposed rule does not impose an
information collection burden under the provisions of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
    Executive Order 12898 (59 FR 7629, February 16, 1994) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs
policies, and activities on minority populations and low-income
populations in the United States. The EPA believes that this action,
which addresses the timing for the submittal of Extreme area ozone
planning requirements, does not have disproportionately high and
adverse human health or environmental health effects on minority
populations, low-income populations and/or indigenous

peoples, as specified in Executive Order 12898.

List of Subjects in 40 CFR Part 52

    Environmental protection, Incorporation by reference, Ozone.

    Dated: August 14, 2019.
Deborah Jordan,
Acting Regional Administrator, Region IX.
[FR Doc. 2019-18432 Filed 8-26-19; 8:45 am]
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