[Federal Register Volume 76, Number 141 (Friday, July 22, 2011)]
[Rules and Regulations]
[Pages 43906-43912]
[FR Doc No: 2011-18421]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-R08-OAR-2009-0809; FRL-9442-1]

Approval and Promulgation of State Implementation Plan Revisions;
Infrastructure Requirements for the 1997 8-Hour Ozone National Ambient
Air Quality Standard; Colorado

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is approving the State Implementation Plan (SIP)
submission from the State of Colorado to demonstrate that the SIP meets
the requirements of Sections 110(a)(1) and (2) of the Clean Air Act
(CAA) for the National Ambient Air Quality Standards (NAAQS)
promulgated for ozone on July 18, 1997. Section 110(a)(1) of the CAA
requires that each state, after a new or revised NAAQS is promulgated,
review their SIPs to ensure that they meet the requirements of the
``infrastructure elements'' of section 110(a)(2). The State of Colorado
submitted a certification, dated January 7, 2008, that its SIP met
these requirements for the 1997 ozone NAAQS. The certification was
determined to be complete on March 27, 2008 (73 FR 16205).

DATES: Effective Date: This final rule is effective August 22, 2011.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R08-OAR-2009-0809. All documents in the docket are listed on
the http://www.regulations.gov Web site. Although listed in the index,
some information is not publicly available, e.g., Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the Internet and will be publicly available only in hard
copy form. Publicly available docket materials are available either
electronically through http://www.regulations.gov or in hard copy at
the Air Program, Environmental Protection Agency (EPA), Region 8, 1595
Wynkoop Street, Denver, Colorado 80202-1129. EPA requests that if at
all possible, you contact the individual listed in the FOR FURTHER
INFORMATION CONTACT section to view the hard copy of the docket. You
may view the hard copy of the docket Monday through Friday, 8 a.m. to 4
p.m., excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Kathy Dolan, Air Program, U.S.
Environmental Protection Agency (EPA), Region 8, Mail Code 8P-AR, 1595
Wynkoop Street, Denver, Colorado 80202-1129.<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Definitions

    For the purpose of this document, we are giving meaning to certain
words or initials as follows:
    (i) The words or initials Act or CAA mean or refer to the Clean Air
Act, unless the context indicates otherwise.
    (ii) The words EPA, we, us or our mean or refer to the United
States Environmental Protection Agency.
    (iii) The initials SIP mean or refer to State Implementation Plan.

Table of Contents

I. Background
II. Response to Comments
III. Final Action
IV. Statutory and Executive Order Reviews

I. Background

    On July 18, 1997, EPA promulgated new NAAQS for ozone based on 8-
hour average concentrations. The 8-hour averaging period replaced the
previous 1-hour averaging period, and the level of the NAAQS was
changed from 0.12 parts per million (ppm) to 0.08 ppm (62 FR 38856). By
statute, SIPs meeting the requirements of sections 110(a)(1) and (2)
are to be submitted by states within three years after promulgation of
a new or revised standard. Section 110(a)(2) provides basic
requirements for SIPs, including emissions inventories, monitoring, and
modeling, to assure attainment and maintenance of the standards. These
requirements are set out in several ``infrastructure elements,'' listed
in section 110(a)(2).
    Section 110(a) imposes the obligation upon states to make a SIP
submission to EPA for a new or revised NAAQS, and the contents of that
submission may vary depending upon the facts and circumstances. In
particular, the data and analytical tools available at the time a state
develops and submits its SIP for a new or revised NAAQS affects the
content of the submission. The contents of such SIP submissions may
also vary depending upon what provisions a state's existing SIP already
contains. In the case of the 1997 ozone NAAQS, states typically have
met the basic program elements required in section 110(a)(2) through
earlier SIP submissions in connection with previous NAAQS. In a
guidance issued on October 2, 2007, EPA noted that, to the extent an
existing SIP already meets the section 110(a)(2) requirements, states
need only to certify that fact via a letter to EPA.\1\
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    \1\ Memorandum from William T. Harnett, Director, Air Quality
Policy Division, ``Guidance on SIP Elements Required Under Sections
110(a)(1) and (2) for the 1997 8-hour Ozone and PM2.5
National Ambient Air Quality Standards'' (Oct. 2, 2007).
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    On March 27, 2008, EPA published a final rule entitled,
``Completeness Findings for Section 110(a) State Implementation Plans
for the 8-hour Ozone NAAQS'' (73 FR 16205). In the rule, EPA made a
finding for each state that it had submitted or had failed to submit a
complete SIP that provided the basic program elements of section
110(a)(2) necessary to implement the 1997 8-hour ozone NAAQS. In
particular, EPA found that Colorado had submitted a complete SIP
(``Infrastructure SIP'') to meet these requirements.
    On May 18, 2011, EPA published a notice of proposed rulemaking
(NPR) for the State of Colorado (76 FR 28707) to act on the State's
Infrastructure SIP for the 1997 ozone NAAQS. Specifically, in the NPR
EPA proposed approval of Colorado's SIP as meeting the requirements of
all section 110(a)(2) elements with respect to the 1997 ozone NAAQS,
aside from elements 110(a)(2)(D)(i), 110(a)(2)(I), and the visibility
protection requirement of element 110(a)(2)(J), on which EPA did not
propose action.\2\ EPA received a comment on section 110(a)(2)(E)(ii),
and EPA is not finalizing today its proposed approval for this sub-
element in order to fully respond to that comment.
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    \2\ See the NPR (76 FR 28707) for further explanation regarding
the omission of elements 110(a)(2)(D)(i) and 110(a)(2)(I) from the
proposal.
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    EPA proposed to approve element 110(a)(2)(C) for the 1997 ozone
NAAQS in the event that the State clarified (or modified) its January
7, 2008 certification to ensure consistency with two rules related to
regulation of

greenhouse gas (GHG) emissions: ``Prevention of Significant
Deterioration and Title V Greenhouse Gas Tailoring Rule'' (``Tailoring
Rule''), 75 FR 31514 (June 3, 2010), and ``Limitation of Approval of
Prevention of Significant Deterioration Provisions Concerning
Greenhouse Gas Emitting-Sources in State Implementation Plans'' (``PSD
SIP Narrowing Rule''), 75 FR 82536 (Dec. 30, 2010). In the PSD SIP
Narrowing Rule, EPA withdrew its previous approval of Colorado's
prevention of significant deterioration (PSD) program to the extent
that it applied PSD permitting to GHG-emissions increases from GHG-
emitting sources below thresholds set in the Tailoring Rule. EPA
withdrew its approval on the basis that the State lacked sufficient
resources to issue PSD permits to such sources at the statutory
thresholds in effect in the previously-approved PSD program. After the
PSD SIP Narrowing Rule, the portion of Colorado's PSD SIP from which
EPA withdrew its approval had the status of having been submitted to
EPA but not yet acted upon. In its February 1, 2008 certification,
Colorado relied on its PSD program as approved at that date--which was
before December 30, 2010, the effective date of the PSD SIP Narrowing
Rule--to satisfy the requirements of infrastructure element
110(a)(2)(C). Given EPA's basis for the PSD SIP Narrowing Rule, EPA
proposed approval of the Colorado Infrastructure SIP for infrastructure
element (C) if either the State clarified (or modified) its
certification to make clear that the State relies only on the portion
of the PSD program that remains approved after the PSD SIP Narrowing
Rule issued on December 30, 2010, and for which the State has
sufficient resources to implement, or the State acted to withdraw from
EPA consideration the remaining portion of its PSD program submission
that would have applied PSD permitting to GHG sources below the
Tailoring Rule thresholds. On May 10, 2011, EPA received a letter from
Colorado clarifying that the State relies only on the portion of the
PSD program that remains approved after the PSD SIP Narrowing Rule
issued on December 30, 2010.\3\
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    \3\ Colorado's May 10, 2011 clarification letter is available in
the docket for this action.
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Scope of Infrastructure SIPs

    EPA is currently acting upon SIPs that address the infrastructure
requirements of CAA section 110(a)(1) and (2) for ozone and
PM2.5 NAAQS for various states across the country.
Commenters on EPA's recent proposals for some states raised concerns
about EPA statements that it was not addressing certain substantive
issues in the context of acting on the infrastructure SIP
submissions.\4\ The commenters specifically raised concerns involving
provisions in existing SIPs and with EPA's statements that it would
address two issues separately and not as part of actions on the
infrastructure SIP submissions: (i) Existing provisions related to
excess emissions during periods of start-up, shutdown, or malfunction
at sources, that may be contrary to the CAA and EPA's policies
addressing such excess emissions (``SSM''); and (ii) existing
provisions related to ``director's variance'' or ``director's
discretion'' that purport to permit revisions to SIP approved emissions
limits with limited public process or without requiring further
approval by EPA, that may be contrary to the CAA (``director's
discretion''). EPA notes that there are two other substantive issues
for which EPA likewise stated that it would address the issues
separately: (i) Existing provisions for minor source new source review
programs that may be inconsistent with the requirements of the CAA and
EPA's regulations that pertain to such programs (``minor source new
source review (NSR)''); and (ii) existing provisions for PSD programs
that may be inconsistent with current requirements of EPA's ``Final NSR
Improvement Rule,'' 67 FR 80,186 (December 31, 2002), as amended by 72
FR 32,526 (June 13, 2007) (``NSR Reform''). In light of the comments,
EPA now believes that its statements in various proposed actions on
infrastructure SIPs with respect to these four individual issues should
be explained in greater depth with respect to these issues.
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    \4\ See, Comments of Midwest Environmental Defense Center, dated
May 31, 2011. Docket  EPA-R05-OAR-2007-1179 (adverse
comments on proposals for three states in Region 5). EPA notes that
these public comments on another proposal are not relevant to this
rulemaking and do not have to be directly addressed in this
rulemaking. EPA will respond to these comments in the appropriate
rulemaking action to which they apply.
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    EPA intended the statements in the proposals concerning these four
issues merely to be informational, and to provide general notice of the
potential existence of provisions within the existing SIPs of some
states that might require future corrective action. EPA did not want
states, regulated entities, or members of the public to be under the
misconception that the Agency's approval of the infrastructure SIP
submission of a given state should be interpreted as a reapproval of
certain types of provisions that might exist buried in the larger
existing SIP for such state. Thus, for example, EPA explicitly noted
that the Agency believes that some states may have existing SIP
approved SSM provisions that are contrary to the CAA and EPA policy,
but that ``in this rulemaking, EPA is not proposing to approve or
disapprove any existing state provisions with regard to excess
emissions during SSM of operations at facilities.'' EPA further
explained, for informational purposes, that ``EPA plans to address such
State regulations in the future.'' EPA made similar statements, for
similar reasons, with respect to the director's discretion, minor
source NSR, and NSR Reform issues. EPA's objective was to make clear
that approval of an infrastructure SIP for these ozone and
PM2.5 NAAQS should not be construed as explicit or implicit
reapproval of any existing provisions that relate to these four
substantive issues.
    Unfortunately, the commenters and others evidently interpreted
these statements to mean that EPA considered action upon the SSM
provisions and the other three substantive issues to be integral parts
of acting on an infrastructure SIP submission, and therefore that EPA
was merely postponing taking final action on the issue in the context
of the infrastructure SIPs. This was not EPA's intention. To the
contrary, EPA only meant to convey its awareness of the potential for
certain types of deficiencies in existing SIPs, and to prevent any
misunderstanding that it was reapproving any such existing provisions.
EPA's intention was to convey its position that the statute does not
require that infrastructure SIPs address these specific substantive
issues in existing SIPs and that these issues may be dealt with
separately, outside the context of acting on the infrastructure SIP
submission of a state. To be clear, EPA did not mean to imply that it
was not taking a full final agency action on the infrastructure SIP
submission with respect to any substantive issue that EPA considers to
be a required part of acting on such submissions under section 110(k)
or under section 110(c). Given the confusion evidently resulting from
EPA's statements, however, we want to explain more fully the Agency's
reasons for concluding that these four potential substantive issues in
existing SIPs may be addressed separately.
    The requirement for the SIP submissions at issue arises out of CAA
section 110(a)(1). That provision requires that states must make a SIP
submission ``within 3 years (or such shorter period as the
Administrator may

prescribe) after the promulgation of a national primary ambient air
quality standard (or any revision thereof)'' and that these SIPS are to
provide for the ``implementation, maintenance, and enforcement'' of
such NAAQS. Section 110(a)(2) includes a list of specific elements that
``[e]ach such plan'' submission must meet. EPA has historically
referred to these particular submissions that states must make after
the promulgation of a new or revised NAAQS as ``infrastructure SIPs.''
This specific term does not appear in the statute, but EPA uses the
term to distinguish this particular type of SIP submission designed to
address basic structural requirements of a SIP from other types of SIP
submissions designed to address other different requirements, such as
``nonattainment SIP'' submissions required to address the nonattainment
planning requirements of part D, ``regional haze SIP'' submissions
required to address the visibility protection requirements of CAA
section 169A, NSR permitting program submissions required to address
the requirements of part D, and a host of other specific types of SIP
submissions that address other specific matters.
    Although section 110(a)(1) addresses the timing and general
requirements for these infrastructure SIPs, and section 110(a)(2)
provides more details concerning the required contents of these
infrastructure SIPs, EPA believes that many of the specific statutory
provisions are facially ambiguous. In particular, the list of required
elements provided in section 110(a)(2) contains a wide variety of
disparate provisions, some of which pertain to required legal
authority, some of which pertain to required substantive provisions,
and some of which pertain to requirements for both authority and
substantive provisions.\5\ Some of the elements of section 110(a)(2)
are relatively straightforward, but others clearly require
interpretation by EPA through rulemaking, or recommendations through
guidance, in order to give specific meaning for a particular NAAQS.\6\
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    \5\ For example, section 110(a)(2)(E) provides that states must
provide assurances that they have adequate legal authority under
state and local law to carry out the SIP; section 110(a)(2)(C)
provides that states must have a substantive program to address
certain sources as required by part C of the CAA; section
110(a)(2)(G) provides that states must have both legal authority to
address emergencies and substantive contingency plans in the event
of such an emergency.
    \6\ For example, section 110(a)(2)(D)(i) requires EPA to be sure
that each SIP contains adequate provisions to prevent significant
contribution to nonattainment of the NAAQS in other states. This
provision contains numerous terms that require substantial
rulemaking by EPA in order to determine such basic points as what
constitutes significant contribution. See, e.g., ``Rule To Reduce
Interstate Transport of Fine Particulate Matter and Ozone (Clean Air
Interstate Rule); Revisions to Acid Rain Program; Revisions to the
NOX SIP Call; Final Rule,'' 70 FR 25,162 (May 12,
2005)(defining, among other things, the phrase ``contribute
significantly to nonattainment'').
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    Notwithstanding that section 110(a)(2) states that ``each'' SIP
submission must meet the list of requirements therein, EPA has long
noted that this literal reading of the statute is internally
inconsistent, insofar as section 110(a)(2)(I) pertains to nonattainment
SIP requirements that could not be met on the schedule provided for
these SIP submissions in section 110(a)(1).\7\ This illustrates that
EPA must determine which provisions of section 110(a)(2) may be
applicable for a given infrastructure SIP submission. Similarly, EPA
has previously decided that it could take action on different parts of
the larger, general ``infrastructure SIP'' for a given NAAQS without
concurrent action on all subsections, such as section 110(a)(2)(D)(i),
because the Agency bifurcated the action on these latter ``interstate
transport'' provisions within section 110(a)(2) and worked with states
to address each of the four prongs of section 110(a)(2)(D)(i) with
substantive administrative actions proceeding on different tracks with
different schedules.\8\ This illustrates that EPA may conclude that
subdividing the applicable requirements of section 110(a)(2) into
separate SIP actions may sometimes be appropriate for a given NAAQS
where a specific substantive action is necessitated, beyond a mere
submission addressing basic structural aspects of the SIP. Finally, EPA
notes that not every element of section 110(a)(2) would be relevant, or
as relevant, or relevant in the same way, for each new or revised NAAQS
and the attendant infrastructure SIP submission for that NAAQS. For
example, the monitoring requirements that might be necessary for
purposes of section 110(a)(2)(B) for one NAAQS could be very different
than what might be necessary for a different pollutant. Thus, the
content of an infrastructure SIP submission to meet this element from a
state might be very different for an entirely new NAAQS, versus a minor
revision to an existing NAAQS.\9\
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    \7\ See, e.g., Id., 70 FR 25,162, at 63-65 (May 12, 2005)
(explaining relationship between timing requirement of section
110(a)(2)(D) versus section 110(a)(2)(I)).
    \8\ EPA issued separate guidance to states with respect to SIP
submissions to meet section 110(a)(2)(D)(i) for the 1997 ozone and
1997 PM2.5 NAAQS. See, ``Guidance for State
Implementation Plan (SIP) Submissions To Meet Current Outstanding
Obligations Under Section 110(a)(2)(D)(i) for the 8-Hour Ozone and
PM2.5 National Ambient Air Quality Standards,'' from
William T. Harnett, Director Air Quality Policy Division OAQPS, to
Regional Air Division Director, Regions I-X, dated August 15, 2006.
    \9\ For example, implementation of the 1997 PM2.5
NAAQS required the deployment of a system of new monitors to measure
ambient levels of that new indicator species for the new NAAQS.
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    Similarly, EPA notes that other types of SIP submissions required
under the statute also must meet the requirements of section 110(a)(2),
and this also demonstrates the need to identify the applicable elements
for other SIP submissions. For example, nonattainment SIPs required by
part D likewise have to meet the relevant subsections of section
110(a)(2) such as section 110(a)(2)(A) or (E). By contrast, it is clear
that nonattainment SIPs would not need to meet the portion of section
110(a)(2)(C) that pertains to part C, i.e., the PSD requirement
applicable in attainment areas. Nonattainment SIPs required by part D
also would not need to address the requirements of section 110(a)(2)(G)
with respect to emergency episodes, as such requirements would not be
limited to nonattainment areas. As this example illustrates, each type
of SIP submission may implicate some subsections of section 110(a)(2)
and not others.
    Given the potential for ambiguity of the statutory language of
section 110(a)(1) and (2), EPA believes that it is appropriate for EPA
to interpret that language in the context of acting on the
infrastructure SIPs for a given NAAQS. Because of the inherent
ambiguity of the list of requirements in section 110(a)(2), EPA has
adopted an approach in which it reviews infrastructure SIPs against
this list of elements ``as applicable.'' In other words, EPA assumes
that Congress could not have intended that each and every SIP
submission, regardless of the purpose of the submission or the NAAQS in
question, would meet each of the requirements, or meet each of them in
the same way. EPA elected to use guidance to make recommendations for
infrastructure SIPs for these NAAQS.
    On October 2, 2007, EPA issued guidance making recommendations for
the infrastructure SIP submissions for both the 1997 8-hour ozone NAAQS
and the 1997 PM2.5 NAAQS.\10\ Within this

guidance document, EPA described the duty of states to make these
submissions to meet what the Agency characterized as the
``infrastructure'' elements for SIPs, which it further described as the
``basic SIP requirements, including emissions inventories, monitoring,
and modeling to assure attainment and maintenance of the standards.''
\11\ As further identification of these basic structural SIP
requirements, ``attachment A'' to the guidance document included a
short description of the various elements of section 110(a)(2) and
additional information about the types of issues that EPA considered
germane in the context of such infrastructure SIPs. EPA emphasized that
the description of the basic requirements listed on attachment A was
not intended ``to constitute an interpretation of'' the requirements,
and was merely a ``brief description of the required elements.'' \12\
EPA also stated its belief that with one exception, these requirements
were ``relatively self explanatory, and past experience with SIPs for
other NAAQS should enable States to meet these requirements with
assistance from EPA Regions.''\13\ For the one exception to that
general assumption, however, i.e., how states should proceed with
respect to the requirements of section 110(a)(2)(G) for the 1997
PM2.5 NAAQS, EPA gave much more specific recommendations.
But for other infrastructure SIP submittals, and for certain elements
of the submittals for the 1997 PM2.5 NAAQS, EPA assumed that
each state would work with its corresponding EPA regional office to
refine the scope of a state's submittal based on an assessment of how
the requirements of section 110(a)(2) should reasonably apply to the
basic structure of the SIP for the NAAQS in question.
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    \10\ See, ``Guidance on SIP Elements Required Under Section
110(a)(1) and (2) for the 1997 8-hour Ozone and PM2.5
National Ambient Air Quality Standards,'' from William T. Harnett,
Director Air Quality Policy Division, to Air Division Directors,
Regions I-X, dated October 2, 2007 (the ``2007 Guidance''). EPA
issued comparable guidance for the 2006 PM2.5 NAAQS
entitled ``Guidance on SIP Elements Required Under Sections
110(a)(1) and (2) for the 2006 24-Hour Fine Particle
(PM2.5) National Ambient Air Quality Standards (NAAQS),''
from William T, Harnett, Director Air Quality Policy Division, to
Regional Air Division Directors, Regions I-X, dated September 25,
2009 (the ``2009 Guidance'').
    \11\ Id., at page 2.
    \12\ Id., at attachment A, page 1.
    \13\ Id., at page 4. In retrospect, the concerns raised by
commenters with respect to EPA's approach to some substantive issues
indicates that the statute is not so ``self explanatory,'' and
indeed is sufficiently ambiguous that EPA needs to interpret it in
order to explain why these substantive issues do not need to be
addressed in the context of infrastructure SIPs and may be addressed
at other times and by other means.
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    Significantly, the 2007 Guidance did not explicitly refer to the
SSM, director's discretion, minor source NSR, or NSR Reform issues as
among specific substantive issues EPA expected states to address in the
context of the infrastructure SIPs, nor did EPA give any more specific
recommendations with respect to how states might address such issues
even if they elected to do so. The SSM and director's discretion issues
implicate section 110(a)(2)(A), and the minor source NSR and NSR Reform
issues implicate section 110(a)(2)(C). In the 2007 Guidance, however,
EPA did not indicate to states that it intended to interpret these
provisions as requiring a substantive submission to address these
specific issues in the context of the infrastructure SIPs for these
NAAQS. Instead, EPA's 2007 Guidance merely indicated its belief that
the states should make submissions in which they established that they
have the basic SIP structure necessary to implement, maintain, and
enforce the NAAQS. EPA believes that states can establish that they
have the basic SIP structure, notwithstanding that there may be
potential deficiencies within the existing SIP. Thus, EPA's proposals
mentioned these issues not because the Agency considers them issues
that must be addressed in the context of an infrastructure SIP as
required by section 110(a)(1) and (2), but rather because EPA wanted to
be clear that it considers these potential existing SIP problems as
separate from the pending infrastructure SIP actions.
    EPA believes that this approach to the infrastructure SIP
requirement is reasonable, because it would not be feasible to read
section 110(a)(1) and (2) to require a top to bottom, stem to stern,
review of each and every provision of an existing SIP merely for
purposes of assuring that the state in question has the basic
structural elements for a functioning SIP for a new or revised NAAQS.
Because SIPs have grown by accretion over the decades as statutory and
regulatory requirements under the CAA have evolved, they may include
some outmoded provisions and historical artifacts that, while not fully
up to date, nevertheless may not pose a significant problem for the
purposes of ``implementation, maintenance, and enforcement'' of a new
or revised NAAQS when EPA considers the overall effectiveness of the
SIP. To the contrary, EPA believes that a better approach is for EPA to
determine which specific SIP elements from section 110(a)(2) are
applicable to an infrastructure SIP for a given NAAQS, and to focus
attention on those elements that are most likely to need a specific SIP
revision in light of the new or revised NAAQS. Thus, for example, EPA's
2007 Guidance specifically directed states to focus on the requirements
of section 110(a)(2)(G) for the 1997 PM2.5 NAAQS because of
the absence of underlying EPA regulations for emergency episodes for
this NAAQS and an anticipated absence of relevant provisions in
existing SIPs.
    Finally, EPA believes that its approach is a reasonable reading of
section 110(a)(1) and (2) because the statute provides other avenues
and mechanisms to address specific substantive deficiencies in existing
SIPs. These other statutory tools allow the Agency to take appropriate
tailored action, depending upon the nature and severity of the alleged
SIP deficiency. Section 110(k)(5) authorizes EPA to issue a ``SIP
call'' whenever the Agency determines that a SIP is substantially
inadequate to attain or maintain the NAAQS, to mitigate interstate
transport, or otherwise to comply with the CAA.\14\ Section 110(k)(6)
authorizes EPA to correct errors in past actions, such as past
approvals of SIP submissions.\15\ Significantly, EPA's determination
that an action on the infrastructure SIP is not the appropriate time
and place to address all potential existing SIP problems does not
preclude the Agency's subsequent reliance on provisions in section
110(a)(2) as part of the basis for action at a later time. For example,
although it may not be appropriate to require a state to eliminate all
existing inappropriate director's discretion provisions in the course
of acting on the infrastructure SIP, EPA believes that section
110(a)(2)(A) may be among the statutory bases that the Agency cites in
the course of addressing the issue in a subsequent action.\16\
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    \14\ EPA has recently issued a SIP call to rectify a specific
SIP deficiency related to the SSM issue. See, ``Finding of
Substantial Inadequacy of Implementation Plan; Call for Utah State
Implementation Plan Revision,'' 74 FR 21,639 (April 18, 2011).
    \15\ EPA has recently utilized this authority to correct errors
in past actions on SIP submissions related to PSD programs. See,
``Limitation of Approval of Prevention of Significant Deterioration
Provisions Concerning Greenhouse Gas Emitting-Sources in State
Implementation Plans; Final Rule,'' 75 FR 82,536 (Dec. 30, 2010).
EPA has previously used its authority under CAA 110(k)(6) to remove
numerous other SIP provisions that the Agency determined it had
approved in error. See, e.g., 61 FR 38,664 (July 25, 1996) and 62 FR
34,641 (June 27, 1997) (corrections to American Samoa, Arizona,
California, Hawaii, and Nevada SIPs); 69 FR 67,062 (November 16,
2004) (corrections to California SIP); and 74 FR 57,051 (November 3,
2009) (corrections to Arizona and Nevada SIPs).
    \16\ EPA has recently disapproved a SIP submission from Colorado
on the grounds that it would have included a director's discretion
provision inconsistent with CAA requirements, including section
110(a)(2)(A). See, e.g., 75 FR 42,342 at 42,344 (July 21,2010)
(proposed disapproval of director's discretion provisions); 76 FR
4,540 (Jan. 26, 2011) (final disapproval of such provisions).
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II. Response to Comments

    EPA received one letter on June 17, 2011 containing comments from

WildEarth Guardians (WG), an environmental organization. The
significant comments made in WG's June 17, 2011 letter and EPA's
responses to those comments are given below.
    Comment No. 1: The commenter claimed that Colorado ``lacks adequate
funding in accordance with CAA section 110(a)(2)(E)(i).'' As evidence
of this question of sufficient funding, the commenter cited a Colorado
Legislative Council (CLC) fiscal note stating that the Colorado Air
Pollution Control Division's (APCD) resources are inadequate to process
all of the approximately 2,500 to 3,000 air permit applications the
State receives annually, causing a backlog of approximately 1,200
unprocessed permits as of April 2011. The commenter argued that this
indicates Colorado lacks adequate resources to implement its SIP (in
particular, permitting programs) and that the SIP is therefore
deficient with respect to section 110(a)(2)(E)(i).
    The commenter attributed APCD's lack of adequate resources to the
State charging Title V permit applicants permit fees ``far below the
minimum requirements under Title V.'' The commenter described the fees
charged by the State and compared them to amounts in an EPA memorandum
discussing the presumptive minimum fee for 40 CFR part 70 (title V)
programs. Although the commenter noted that the State does charge a
variety of fees in connection with the title V program, the commenter
argued that there is no indication that the fees charged by the State,
in aggregate, meet the presumptive minimum fee.
    Finally, the commenter used the same arguments to claim EPA does
not have an adequate basis to approve Colorado's SIP for the
requirements of CAA section 110(a)(2)(L).
    EPA Response: EPA disagrees with the commenter's conclusions
concerning the adequacy of the Colorado infrastructure SIP with respect
to both section 110(a)(2)(E)(i) and (L). First, with regard to the
reported statement by the CLC, EPA notes that the commenter in a number
of places referred to this as a statement by ``Colorado'' as though the
CLC is the equivalent of the State. However, the cited document is an
analysis by the CLC staff of a Colorado Senate bill. The CLC staff is a
nonpartisan research arm of the State Assembly; in other words, the CLC
staff is part of the legislative branch of the State government. EPA
has no reason to question the conclusions of the CLC, but those
conclusions are not the equivalent of an official statement by the
State itself with respect to the issue relevant in this action.
    On the other hand, Colorado's infrastructure SIP certification that
is before EPA for approval was submitted by the director of the
Colorado Department of Public Health and Environment (CDPHE), an
executive branch agency that includes the Colorado APCD. EPA considers
the submission to have come from the organization within the State that
is the best judge of the overall resources available for implementation
of the SIP. In its certification, CDPHE discussed the budget and staff
of the APCD and indicated that both were sufficient to carry out
Colorado's SIP. Section 110(a)(2)(E) requires that the SIP provide
(among other things) necessary assurances that the State have adequate
personnel and funding to carry out the SIP. EPA concludes that the
certification provides these necessary assurances.
    In addition, EPA notes that the CLC statements cited by the
commenter speak only to the resources available to process permits.
Based on the information provided by the commenter, the backlog would
appear to amount to a delay of approximately 5-6 months for a permit.
While delays are very problematic, such delays are not evidence of an
inability to implement the requirements of the SIP at all. Moreover,
the CLC staff analysis noted that the purpose of the bill is to address
the backlog; the bill does so by providing for APCD-approved third
party contractors to perform modeling for sources not subject to PSD.
The bill was signed into law by the Governor of Colorado on June 9,
2011. EPA therefore disagrees with the commenter's conclusion that EPA
cannot approve Colorado's infrastructure SIP for section
110(a)(2)(E)(i) on the basis of the statement in the CLC staff
analysis.
    Turning to fees charged by Colorado under its title V program, EPA
notes that, in general, title V programs are not part of the SIP.\17\
Thus, such programs are not part of the requirements of section
110(a)(2). Furthermore, section 502(b)(3) of the Act requires not only
that title V program fees cover the reasonable direct and indirect
costs of developing and administering the title V program, but also
requires that the fees be used only to cover those costs. EPA therefore
disagrees with the comment that the alleged flaws in the title V
program with respect to the amount of fees charged by the State prevent
EPA from approving the Colorado infrastructure SIP for the 1997 ozone
NAAQS for element 110(a)(2)(E)(i). The State provided evidence that its
overall budget is sufficient to carry out its obligations and the issue
raised by the commenter does not refute that overall budget.
---------------------------------------------------------------------------

    \17\ In the case of Colorado, the Title V program is not part of
the SIP, with the exception of the fee program. Section
110(a)(2)(E)(i) requires adequate resources to carry out the SIP. As
the Title V program--except the fee program itself--is not part of
the SIP, 110(a)(2)(E)(i) does not require an assessment of whether
the fees are adequate to implement the Title V program in its
entirety.
---------------------------------------------------------------------------

    EPA also disagrees with the commenter's argument that the amount of
fees charged by the State in its title V program renders the
infrastructure SIP unapprovable with respect to section 110(a)(2)(L).
As stated in the text of the section, 110(a)(2)(L) is no longer
applicable to title V operating permit programs after approval of such
programs. As noted in the NPR, 76 FR at 28714, final approval of
Colorado's title V operating permit program became effective October
16, 2000 (65 FR 49919). EPA therefore disagrees with the comment that
EPA cannot approve Colorado's infrastructure SIP for section
110(a)(2)(L) on the basis of alleged flaws in Colorado's title V
program.
    Comment No. 2: The commenter argued that Colorado's SIP fails to
meet the PSD requirements of section 110(a)(2)(J) due to a lack of
ozone impact analysis for new or modified major sources. The commenter
alleged a number of specific inadequacies, which EPA discusses
separately below.
    Comment 2.a: The commenter asserted that the SIP does not require
the APCD to ensure that a new or modified source does not cause or
contribute to violations of the ozone NAAQS prior to issuance. The
commenter cited section 165(a)(3) of the Act and quoted the language of
40 CFR 51.166(k)(1). The commenter later stated that nothing in the
Colorado SIP explicitly requires that ozone impacts be addressed in the
context of issuing a PSD permit.
    EPA Response: EPA disagrees with the commenter's interpretation of
the Colorado SIP. Section VI.A.2 of part D of Regulation Number 3 in
the Colorado SIP, applicable to sources subject to PSD, specifically
requires a source impact analysis.\18\ The language of section VI.A.2
mirrors the language in 40 CFR 51.166(k)(1) quoted by the commenter. In
addition, there is nothing

in this section or any other section of the SIP that exempts sources
from carrying out the source impact analysis for the 1997 ozone NAAQS.
Nor does the commenter cite any provision of the SIP that creates such
an exemption. EPA concludes that the commenter is therefore in error in
stating that the Colorado SIP does not require the source impact
analysis set out in 40 CFR 51.166(k)(1). Furthermore, section VI.A.2
requires the owner or operator of the proposed new source or
modification to demonstrate that the construction or modification of
the source will not cause or contribute to a violation of any NAAQS.
Such language includes the 1997 8-hour ozone NAAQS; thus the commenter
is also in error in stating that the SIP does not specifically require
ozone impacts to be addressed.
---------------------------------------------------------------------------

    \18\ This provision was previously in part B of Regulation
Number 3. On May 31, 2011, Region 8 finalized an action that (among
other things) approved Colorado's reorganization of its PSD program
into the new part D of Regulation Number 3. The notice of the final
action has not yet been published in the Federal Register, but a
copy of Colorado's submittal and the signed notice can be found in
Docket No. [xxx].
---------------------------------------------------------------------------

    Comment 2.b: The commenter stated that the SIP is deficient because
it does not identify any significant impact levels for ozone.
    EPA Response: EPA has not identified significant impact levels
(SILs) for ozone.\19\ The comment therefore does not provide any basis
for EPA to change its proposed approval of the Colorado infrastructure
SIP for section 110(a)(2)(C) or (J) for the 1997 ozone NAAQS.
---------------------------------------------------------------------------

    \19\ For an explanation and discussion of SILs, in the context
of PM2.5, see 75 FR 64864 (Oct. 20, 2010).
---------------------------------------------------------------------------

    Comment 2.c: The commenter asserted that section VI.A.3.e of Part D
of Regulation Number 3 ``explicitly allows the owner or operator of a
proposed major source or major modification to forego a pre-
construction ozone analysis altogether.''
    EPA Response: EPA disagrees with the commenter's characterization
of the Colorado SIP. First, EPA notes that section VI.A.3.e (and the
parallel provision in 40 CFR 51.166(m)(1)(v)) applies only if a
proposed major stationary source or major modification of volatile
organic compounds (VOCs) meets the requirements of 40 CFR part 51,
Appendix S, Section IV, including, in particular, the requirement to
satisfy the lowest achievable emissions rate (LAER) for VOCs. Second,
the commenter appears to misunderstand the scope of this provision.
Contrary to the commenter's assertion, the provision does not exempt
any sources from the requirement to perform the source impact analysis
in section VI.A.2 (discussed in the response to comment 2.a above).
Instead, the provision allows sources that (among other things) employ
LAER for VOCs to use post-construction monitoring to replace the pre-
application air quality analysis requirements of section VI.A.3.a. This
option is specifically provided for in 40 CFR 51.166(m)(1)(v).
    Comment 2.d: The commenter alleged that the SIP does not meet the
requirements of 40 CFR 51.166(l)(1), which requires the SIP to base
applications of air quality modeling in PSD permitting on the
applicable models, data bases, and other requirements specified in
Appendix W of 40 CFR part 51, and requires modification and
substitution of such models to be approved by the Administrator. The
commenter also asserted that the Colorado SIP does not specify any
approved methodology for analyzing ozone impacts, contrary to PSD
requirements under the CAA.
    EPA Response: EPA disagrees with the commenter's reading of the
requirements of the Colorado SIP. The Colorado SIP includes section
VIII.A of part A of Regulation Number 3, which specifically requires
estimates of ambient air concentrations required under Regulation
Number 3 to be based on applicable models, data bases, and other
requirements generally required by the EPA. Although section VIII.A
does not specifically reference Appendix W, in the context of the
source impact analysis in section VI.A.2 for PSD permitting, we
interpret this language to include the requirements specified in
Appendix W. In addition, section VIII.A requires any modification or
substitution of a model to be subject to public notice and comment and
to be approved in writing by EPA (which we interpret to mean the
Administrator or her delegee). EPA therefore disagrees with the comment
that the Colorado SIP does not meet the requirements of 40 CFR
51.166(l)(1). Furthermore, the comment implies that the Colorado SIP
must specify an approved methodology for analyzing ozone impacts, but
did not explain what provision creates such a requirement for the
Colorado SIP. EPA therefore disagrees with the comment that the
Colorado SIP is contrary to PSD requirements under the Act.
    Comment 2.e: The commenter stated that the APCD has not interpreted
its SIP to require an analysis of ozone impacts. As evidence, the
commenter quoted the following statement in APCD's modeling guidance:
``ozone modeling is not routinely requested for construction permits,
although it could be in unusual cases such as situations where the
Division believes ozone standards could realistically be violated by
the proposed source or modification.''
    EPA Response: EPA disagrees with the commenter's characterization
of APCD's position. EPA first notes that the quoted language is in the
chapter of the APCD modeling guidance regarding the demonstration to be
made for construction permits for minor sources. While the relevant
chapter of the APCD modeling guidance (regarding new major stationary
sources and major modifications) does refer to the minor source
chapter, it is not clear that the statement in the minor source chapter
about the frequency of requests for ozone modeling applies to sources
subject to PSD. Furthermore, the modeling guidance elsewhere states
(see pages 7-9) that a source impact analysis (as discussed in the
response to comment 2.a above and as required by the SIP) must be
performed for sources subject to PSD.
    As discussed above in the response to comment 2.d, the Colorado SIP
requires estimates of ambient air concentrations to be based on the
applicable models, data bases, and other requirements generally
required by the EPA, which EPA interprets to include the requirements
of Appendix W of 40 CFR part 51, Guideline on Air Quality Models.
Section 5.2.1 of Appendix W includes the Guideline recommendations for
models to be utilized in assessing ambient air quality impacts for
ozone. Section 5.2.1.c provides that the model users (state and local
permitting authorities and permitting applicants) should work with the
appropriate EPA Regional Office on a case-by-case basis to determine an
adequate method for performing an air quality analysis for assessing
ozone impacts. Due to the complexity of modeling ozone and the
dependency on the regional characteristics of atmospheric conditions,
this is an appropriate approach for assessing ozone impacts rather than
specifying one particular preferred model nationwide, which may not be
appropriate in all circumstances. Instead, the choice of method
``depends on the nature of the source and its emissions. Thus, model
users should consult with the Regional Office * * * '' Appendix W
Section 5.2.1.c. Therefore, it is appropriate for permitting
authorities to consult and work with EPA Regional Offices as described
in Appendix W, including section 3.0.b and c, 3.2.2, and 3.3, to
determine the appropriate approach to assess ozone impacts as required
for sources subject to PSD. Although EPA has not selected one
particular preferred model in Appendix A to Appendix W (Summaries of
Preferred Air Quality Models) for conducting ozone impact analyses for
individual sources, state/

local permitting authorities must comply with the appropriate PSD
Federal Implementation Plan (FIP) or SIP requirements with respect to
ozone.
    EPA has had a standard approach in its PSD SIP and FIP rules of not
mandating the use of a particular model for all circumstances, instead
treating the choice of a particular method for analyzing ozone impacts
as circumstance-dependent. EPA then determines whether the State's
implementation plan revision submittal meets the PSD SIP requirements.
As explained above, in this case the Colorado SIP meets the
requirements of 40 CFR part 51.166(k) and (l).

III. Final Action

    In this action, EPA is approving in full the following section
110(a)(2) infrastructure elements for Colorado for the 1997 ozone
NAAQS: (A), (B), (C), (D)(ii), (E)(i), (E)(iii), (F), (G), (H), (J),
(K), (L), and (M). EPA is taking no action today on section
110(a)(2)(E)(ii) for the 1997 ozone NAAQS. EPA will address this sub-
element in a later action.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations (42 USC 7410(k), 40 CFR 52.02(a)). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves some state law as meeting Federal requirements
and disapproves other state law because it does not meet Federal
requirements; this action does not impose additional requirements
beyond those imposed by state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     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);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999); is not an
economically significant regulatory action based on health or safety
risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 USC 272
note) because application of those requirements would be inconsistent
with the CAA; and,
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have Tribal implications as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000), because the
SIP is not approved to apply in Indian country located in the State,
and EPA notes that it will not impose substantial direct costs on
Tribal governments or preempt Tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by September 20, 2011. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incoporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: June 30, 2011.
James B. Martin,
Regional Administrator, Region 8.
    40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for Part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart G--Colorado

0
2. Section 52.353 is added to read as follows:

Sec.  52.353  Section 110(a)(2) infrastructure requirements.

    On January 7, 2008 James B. Martin, Executive Director of the
Colorado Department of Public Health and Environment for the State of
Colorado, submitted a certification letter which provides the State of
Colorado's SIP provisions which meet the requirements of CAA Section
110(a)(1) and (2) relevant to the 1997 Ozone NAAQS.

[FR Doc. 2011-18421 Filed 7-21-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 196 (Wednesday, October 12, 2022)]
[Notices]
[Pages 61605-61608]
[FR Doc No: 2022-21835]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2274]

Medical Devices; Voluntary Total Product Life Cycle Advisory
Program Pilot

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration's (FDA, Agency, or we) Center
for Devices and Radiological Health (CDRH or Center) is announcing its
voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot
that will begin in fiscal year (FY) 2023 with the initial phase,
hereafter referred to as the TAP Pilot Soft Launch. The TAP Pilot is
one of the commitments agreed to between FDA and industry as part of
the reauthorization of the Medical Device User Fee Amendments for FY
2023 through FY 2027 (MDUFA V). The long-term vision for TAP is to help
spur more rapid development and more rapid and widespread patient
access to safe, effective, high-quality medical devices of public
health importance. Over the course of MDUFA V, the voluntary TAP Pilot
is intended to demonstrate the feasibility and benefits of process
improvements to FDA's early interactions with participants and of FDA's
facilitation of interactions between participants and stakeholders that
support the vision for TAP.

DATES: Beginning January 1, 2023, FDA is seeking requests for
enrollment in the TAP Pilot Soft Launch for FY 2023. Either electronic
or written comments on this notice must be submitted by January 10,
2023 to ensure that the Agency considers your comment on this notice
before it begins work on the next phase of the TAP Pilot.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 10, 2023. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions.'')

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2022-N-2274 for ``Medical Devices; Voluntary Total Product Life
Cycle

Advisory Program Pilot.'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff office
between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Matthew Hillebrenner, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 2302, Silver Spring MD 20993, 301-
796-6358, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    As part of the reauthorization of the MDUFA V,\1\ FDA committed to
establish the TAP Pilot during the course of MDUFA V.\2\ The long-term
vision for TAP is to help spur more rapid development and more rapid
and widespread patient access to safe, effective, high-quality medical
devices of public health importance. A mature TAP is also intended to
help ensure the sustained success of the Breakthrough Devices program
(see more information on this program below in Section I.C). Through
the TAP Pilot, as described in the MDUFA V commitment letter, FDA will
provide the following types of strategic engagement for innovative
devices of public health importance:
---------------------------------------------------------------------------

    \1\ MDUFA V spans from FY 2023 through FY 2027. The fiscal year
runs from October 1 through September 30, so FY 2023 runs from
October 1, 2022 through September 30, 2023.
    \2\ For more information on FDA's TAP Pilot, see the TAP Pilot
web page at: https://www.fda.gov/medical-devices/how-study-and-market-your-device/total-product-life-cycle-advisory-program-tap.
---------------------------------------------------------------------------

     Improving participants' experiences with FDA by providing
for more timely premarket interactions;
     Enhancing the experience of all participants throughout
the device development and review process, including FDA staff;
     Facilitating improved strategic decision-making during
device development, including earlier identification, assessment, and
mitigation of device development risk;
     Facilitating regular, solutions-focused engagement between
FDA review teams, participants, and other stakeholders, such as
patients, providers, and payers, beginning early in device development;
and
     Collaborating to better align expectations regarding
evidence generation, improve submission quality, and improve the
efficiency of the premarket review process (Ref. 1).\3\
---------------------------------------------------------------------------

    \3\ For more information on the goals and objectives of the TAP
Pilot, see the MDUFA V commitment letter, MDUFA Performance Goals
and Procedures, Fiscal Years 2023 Through 2027, available at https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/medical-device-user-fee-amendments-2023-mdufa-v.
---------------------------------------------------------------------------

    Consistent with the MDUFA V commitment letter, FDA initially
intends to include only devices with a granted Breakthrough designation
in the TAP Pilot in FY 2023-FY 2025 and intends to include devices with
a granted Breakthrough designation or request for inclusion in the
Safer Technologies Program (STeP) in FY 2026-FY 2027. At this time,
devices regulated by the Center for Biologics Evaluation and Research
(CBER) are outside the scope of the TAP Pilot.\4\ In addition, given
the complexities involved with the review of combination products,\5\
including coordination with review staff outside of CDRH, we anticipate
that it will be difficult for sponsors of combination products to
benefit fully from the TAP Pilot. Therefore, at this time, we do not
intend to enroll combination products in the Pilot.
---------------------------------------------------------------------------

    \4\ In the MDUFA V commitment letter, FDA committed to
conducting the TAP Pilot within Offices of Health Technology (OHTs),
which are offices that review devices regulated by CDRH.
    \5\ See 21 CFR 3.2(e).
---------------------------------------------------------------------------

A. Enrollment and Pilot Expansion Schedule

    To implement the TAP Pilot and in accordance with the MDUFA V
commitment letter, FDA intends to take a phased-enrollment approach
throughout the duration of MDUFA V. The first phase is the TAP Pilot
Soft Launch, which will be conducted during FY 2023 (Ref. 1). During
the TAP Pilot Soft Launch phase, FDA intends to enroll up to 15 devices
in the Office of Health Technology 2 (OHT2): Office of Cardiovascular
Devices. Selection of OHT2 for the TAP Pilot Soft Launch was based on
consideration of multiple factors, including OHT2's historical number
of granted Breakthrough designations, workload, staffing levels, and
expertise, as well as experience with review paradigms involving rapid
interactions, such as Early Feasibility Studies. For example, OHT2 has
granted 163 Breakthrough Device designations as of June 30, 2022, which
represents 23.7 percent of the 687 Breakthrough Device designations
granted by CDRH.
    In subsequent fiscal years, FDA intends to expand the TAP Pilot to
enroll more devices and to include devices reviewed in other OHTs.\6\
Specifically, as stated in the MDUFA V commitment letter, in FY 2024,
the TAP Pilot will continue to support devices enrolled in the previous
fiscal year and will expand to enroll up to 45 additional devices in at
least two OHTs (i.e., up to 60 total devices enrolled through FY 2024).
In FY 2025, the TAP Pilot will continue to support devices enrolled in
previous fiscal years and will expand to enroll up to 65 additional
devices in at least four OHTs (i.e., up to 125 total devices enrolled
through FY 2025). In FY 2026 and FY 2027, the TAP Pilot will continue
to support devices enrolled in previous

fiscal years and will expand to enroll up to 100 additional devices
each fiscal year within existing OHTs or expand to additional OHTs,
depending on lessons learned from the FY 2023 to FY 2025 experience
(i.e., up to 225 total devices enrolled through FY 2026 and up to 325
total devices enrolled through FY 2027). For FY 2024-FY 2027, selection
of the OHTs will include consideration of the factors mentioned above
regarding the selection of OHT2 for the Soft Launch, experience from
prior years, and input from industry and other stakeholders (Ref. 1).
For FY 2024-FY 2027, FDA plans to announce the OHT(s) selected for
future participation in the TAP Pilot via the TAP Pilot web page no
later than 30 days prior to the start of each fiscal year.
---------------------------------------------------------------------------

    \6\ During the TAP Pilot, if spaces remain available in
participating OHTs for any fiscal year, or if resources permit, FDA
may consider enrolling devices from OHTs not yet participating in
the TAP Pilot.
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B. Enrollment in the TAP Pilot

    FDA will inform potential participants of the TAP Pilot as part of
the Breakthrough designation process or request for inclusion in the
STeP process, as applicable. Eligible TAP Pilot participants will be
enrolled on a first-come, first-served basis. The Pilot's capacity for
additional participating devices and the number of participating OHTs
within CDRH will increase each fiscal year as described in Section I.A.
As noted above, at this time, devices regulated by CBER are outside the
scope of the TAP Pilot, and we do not intend to enroll combination
products in the Pilot.
    FDA intends to enroll devices reviewed in a participating OHT in
the voluntary TAP Pilot using the following enrollment criteria,
consistent with the MDUFA V commitment letter:
    1. Devices will be those with either a granted Breakthrough
designation or (during FY 2026 and FY 2027) a granted request for
inclusion in the Safer Technologies Program (STeP);
    2. Potential participants will not have submitted a Pre-Submission
about the device after being granted a Breakthrough designation or
inclusion in STeP;
    3. Devices will be early in their device development process (e.g.,
have not yet initiated a pivotal study for the device) at time of
enrollment; and
    4. Each potential participant will have a maximum of one device
enrolled in the TAP Pilot per fiscal year.
    Enrollment in the TAP Pilot, including in the Soft Launch, does not
change any statutory or regulatory requirements that may apply to the
TAP Pilot device or participant, including, but not limited to,
investigational device exemption (IDE) requirements under 21 CFR part
812; premarket notification requirements under 21 CFR part 807, subpart
E; premarket approval requirements under 21 CFR part 814; and/or De
Novo classification requirements under 21 CFR part 860, subpart D. It
is the sponsor's responsibility to ensure compliance with applicable
laws and regulations.

C. Procedures for Enrollment in the TAP Pilot

    To have a device considered for enrollment in the voluntary TAP
Pilot, sponsors should submit an amendment to the Q-submission under
which their device was granted Breakthrough designation or (during FY
2026 and FY 2027) inclusion in STeP, with the following information:
    1. A subject heading clearly indicating ``TAP Pilot Request for
Enrollment'';
    2. Name and address of the device sponsor; and
    3. The Q-Submission number under which the device proposed for
enrollment in the TAP Pilot was granted Breakthrough designation or
inclusion in STeP.
    For more information on the Breakthrough Devices program, see FDA's
website, https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program, and FDA Guidance, Breakthrough
Devices Program (Ref. 2). For more information on STeP, see FDA's
website, https://www.fda.gov/medical-devices/how-study-and-market-your-device/safer-technologies-program-step-medical-devices and FDA
Guidance, Safer Technologies Program for Medical Devices (Ref. 3).
    Following receipt of a request for enrollment in the TAP Pilot, FDA
intends to consider the request using the enrollment criteria outlined
in Section I.B if spaces remain available in the TAP Pilot for the
relevant fiscal year. Within 30 days of receipt, FDA intends to notify
the potential participant in writing whether or not the device has been
enrolled into the TAP Pilot. If a participant's device is enrolled into
the TAP Pilot, FDA will contact the participant to schedule an initial
meeting to provide an overview of the TAP Pilot processes,
expectations, and engagement opportunities. If, after review of a
request for enrollment, a device is not enrolled in the TAP Pilot, FDA
will identify the reason(s) for that decision.
    As noted in Section I.B., eligible TAP Pilot participants will be
enrolled on a first-come, first-served basis, for which we plan to use
the date of receipt of requests for enrollment in each respective
fiscal year. To facilitate an orderly enrollment process, FDA does not
intend to consider requests to enroll in the TAP Pilot until the start
of the fiscal year in which the participant wishes to enroll. (For
example, beginning on October 1, 2023, FDA intends to consider requests
to enroll in the TAP Pilot for FY 2024.) If the maximum number of
devices has been enrolled for the fiscal year in which a request is
received, FDA intends to notify the sponsor submitting the request that
enrollment in the TAP Pilot has reached capacity for the current fiscal
year. FDA also intends to provide enrollment updates, including a
notification that we have reached capacity for a given fiscal year, on
the TAP Pilot web page.\7\
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    \7\ For more information on FDA's TAP Pilot, see the TAP Pilot
web page at: https://www.fda.gov/medical-devices/how-study-and-market-your-device/total-product-life-cycle-advisory-program-tap.
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D. Performance Metrics

    In an effort to achieve the TAP Pilot objectives, FDA committed to
implement and track the following quantitative performance metrics \8\
beginning in FY 2024:
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    \8\ See section J.3 of the MDUFA V commitment letter, MDUFA
Performance Goals and Procedures, Fiscal Years 2023 Through 2027,
available at: https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/medical-device-user-fee-amendments-2023-mdufa-v.
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     CDRH will engage in a teleconference with the participant
on requested topic(s) pertaining to the TAP device within 14 days of
the request for 90 percent of requests for interaction.
     CDRH will provide written feedback on requested
biocompatibility and sterility topics(s) pertaining to the TAP device
within 21 days of the request for 90 percent of such requests for
written feedback.
     CDRH will provide written feedback on requested topic(s)
pertaining to the TAP device other than biocompatibility and sterility
within 40 days of the request for 90 percent of requests for written
feedback.
    During this voluntary TAP Pilot, CDRH staff intend to be available
to answer questions or address concerns that may arise. The TAP Pilot
Program participants may comment on and discuss their experiences with
the Center.
    For informational purposes, FDA will conduct an assessment of the
TAP Pilot using an independent third party (or parties) to assess the
TAP Pilot. This assessment will include a participant survey and
quantitative and qualitative success metrics, starting in FY 2024, that
include, but are not limited to: (a) the extent to which FDA is
successful at meeting the quantitative goals described above; (b)
participant satisfaction with

the timeliness, frequency, quality, and efficiency of interactions with
and written feedback from FDA; (c) participant satisfaction with the
timeliness, frequency, quality, and efficiency of voluntary
interactions with non-FDA stakeholders facilitated by FDA (if
utilized); and (d) an overall assessment of the outcomes of the Pilot
and opportunities for improvement (Ref. 1).

II. Request for Comments

    FDA understands that to make this program the most effective, we
will need additional feedback and suggestions from industry and other
stakeholders. FDA encourages all stakeholders to comment on the TAP
Pilot generally. The Agency is particularly interested in feedback on
the following topics:
    1. TAP Pilot participation will expand to include additional
Offices of Health Technology (OHTs) in FY 2024 through FY 2027. In what
order do you believe additional OHTs should be included in the TAP
Pilot? Please provide the reasons/rationale/justification to support
your recommendations in your response.
    2. The TAP Pilot is intended to facilitate improved strategic
decision-making and better align expectations regarding evidence
generation during device development, including through facilitating
interactions between TAP participants and stakeholders, such as
patients, providers, and payers. These interactions are voluntary and
may, for example, help provide a better understanding of the current
treatment options used to treat or manage a given condition, which
outcomes are most important to patients and providers, how a new
technology may fit into clinical care paradigms and patient lives, how
patients and providers consider tradeoffs between anticipated benefits
and risks, and the evidence that may help support clinical adoption and
coverage.
    (1) What additional questions or topics could patients, providers,
and/or payers address that could help inform sponsors' strategic
decision-making?
    (2) Are there specific patient, provider, or payer organizations
whose members may be well-suited and willing to provide insights
regarding evidence generation strategies to sponsors who wish to obtain
such input?

III. Paperwork Reduction Act of 1995

    This notice refers to previously approved collections of
information. 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. 3501-3521). The collections of information
regarding Q-Submissions have been approved under OMB control number
0910-0756.

IV. References

    The following references are on display at the Dockets Management
Staff (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 https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.

1. U.S. Food and Drug Administration, ``MDUFA Performance Goals and
Procedures, Fiscal Years 2023 Through 2027,'' available at https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/medical-device-user-fee-amendments-2023-mdufa-v.
2. U.S. Food and Drug Administration, ``Breakthrough Devices
Program,'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breakthrough-devices-program.
3. U.S. Food and Drug Administration, ``Safer Technologies Program
for Medical Devices,'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safer-technologies-program-medical-devices.
4. U.S. Food and Drug Administration, ``Requests for Feedback and
Meetings for Medical Device Submissions: The Q-Submission Program,''
available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program.
5. U.S. Food and Drug Administration, ``Total Product Life Cycle
Advisory Program (TAP),'' available at https://www.fda.gov/medical-devices/how-study-and-market-your-device/total-product-life-cycle-advisory-program-tap/.

    Dated: October 3, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-21835 Filed 10-11-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 237 (Tuesday, December 12, 2023)]
[Notices]
[Page 86125]
[FR Doc No: 2023-27220]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 6550-005]

JBS Rentals, LLC, 5J's LLC; Notice of Transfer of Exemption

    1. On October 10, 2023, 5J's LLC filed a notification of the
transfer for the 30-kilowatt Biber Spellenberg Hydroelectric Project
No. 6550 from JBS Rentals, LLC to 5J's LLC. The exemption from
licensing was originally issued on February 14, 1983.\1\ The project is
located on Bidden Creek, Trinity County, California. The transfer of an
exemption does not require Commission approval.
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    \1\ Frank M. Biber and Steven Spellenberg, 22 FERC ] 62,182
(1983). Subsequently, on August 15, 2017, the project was
transferred to JBS Rentals, LLC.
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    2. 5J's LLC is now the exemptee of the Biber Spellenberg
Hydroelectric Project No. 6550. All correspondence must be forwarded to
Cynthia Anderson, Owner, and Manager, 5J's LLC, P.O. Box 127, Willow
Creek, CA 95573, Phone:<PHONE_NUMBER>, email: [email protected].

    Dated: December 6, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-27220 Filed 12-11-23; 8:45 am]
BILLING CODE 6717-01-P