[Federal Register: March 10, 2009 (Volume 74, Number 45)]
[Rules and Regulations]
[Page 10176-10182]
[DOCID:fr10mr09-11]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2008-0677; FRL-8770-1]

Approval and Promulgation of Implementation Plans; State of
California; 2003 State Strategy and 2003 South Coast Plan for One-Hour
Ozone and Nitrogen Dioxide

AGENCY: U.S. Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is taking final action to approve one state implementation
plan (SIP) revision, and to approve in part and to disapprove in part a
second SIP revision, submitted by the California Air Resources Board to
provide for attainment of the one-hour ozone standard and maintenance
of the nitrogen dioxide standard in the Los Angeles-South Coast Air
Basin. The two SIP revisions include the 2003 State Strategy and the
2003 South Coast SIP, both of which were submitted on January 9, 2004.
    With respect to the 2003 State Strategy, EPA is taking final action
to approve the commitment by the State to develop and propose near-term
defined measures sufficient to achieve specific emissions reductions in
the South Coast and to continue implementation of an existing measure.
With respect to the 2003 South Coast SIP, EPA is taking final action to
approve certain elements, and to disapprove other elements. The plan
elements that are being disapproved are not required under the Clean
Air Act because they represent revisions to previously-approved SIP
elements, and thus, the disapprovals will not affect the requirements
for the State to have an approved SIP for these SIP elements.
Therefore, the disapprovals do not trigger sanctions clocks nor EPA's
obligation to promulgate a Federal implementation plan.
    EPA is taking these actions under provisions of the Clean Air Act
regarding EPA action on SIP submittals and plan requirements for
nonattainment areas.

DATES: Effective Date: This rule is effective on April 9, 2009.

ADDRESSES: EPA has established docket number EPA-R09-OAR-2008-0677 for
this action. The index to the docket is available electronically at
http://www.regulations.gov and in hard copy at EPA Region IX, 75
Hawthorne Street, San Francisco, California. While all documents in the
docket are listed in the index, some information may be publicly
available only at the hard copy location (e.g., copyrighted material),
and some may not be publicly available in either location (e.g., CBI).
To inspect the hard copy materials, please schedule an appointment
during normal business hours with the contact listed in the FOR FURTHER
INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Wienke Tax, Air Planning Office (AIR-
2), U.S. Environmental Protection Agency, Region IX,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to EPA.

Table of Contents

I. Proposed Action
II. Public Comments
III. EPA Action
IV. Statutory and Executive Order Reviews

I. Proposed Action

    On October 24, 2008 (73 FR 63408), under the Clean Air Act (CAA or
``Act''), EPA proposed to approve one state implementation plan (SIP)
revision, and to approve in part and to disapprove in part, a second
SIP revision, submitted by the California Air Resources Board (ARB) to
provide for attainment of the one-hour ozone national ambient air
quality standard (NAAQS) and for maintenance of the nitrogen dioxide
NAAQS in the Los Angeles-South Coast Air Basin Area (South Coast).\1\
The two SIP revisions include the Final 2003 State and Federal Strategy
(``2003 State Strategy'') and the 2003 revisions to the SIP for ozone
and nitrogen dioxide in the South Coast Air Basin (``2003 South Coast
SIP''),\2\ both of which were submitted by ARB on January 9, 2004.
These SIP revisions were developed in recognition of a need for
additional emissions reductions to attain the one-hour ozone NAAQS than
had been planned for in the late 1990s, and to establish new motor
vehicle emissions budgets (MVEBs) for transportation conformity.
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    \1\ The area referred to as ``Los Angles-South Coast Air Basin''
(South Coast Air Basin or ``South Coast'') includes Orange County,
the southwestern two-thirds of Los Angeles County, southwestern San
Bernardino County, and western Riverside County. For a precise
description of the boundaries of the Los Angeles-South Coast Air
Basin, see 40 CFR 81.305.
    \2\ The ``2003 South Coast SIP'' refers to the January 9, 2004
submittal of the Final 2003 South Coast Air Quality Management Plan
(AQMP) adopted by the SCAQMD on August 1, 2003, as modified by ARB
through its resolution of adoption (Resolution 03-23) on October 23,
2003.
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    With respect to the 2003 State Strategy, we proposed to approve the
commitments by ARB to develop and propose for adoption 15 near-term
defined control measures, and the commitment by the California Bureau
of Automotive Repair (BAR) to develop and propose one near-term defined
control measure, sufficient to achieve specified emissions reductions
in the South Coast. We also proposed to approve the continuation of the
existing SIP pesticide strategy adopted by the California Department of
Pesticide Regulation (DPR).
    With respect to the 2003 South Coast SIP, we proposed to approve
the base year and projected baseline emissions inventories, the South
Coast Air Quality Management District's (District's or SCAQMD's)
commitment to adopt and implement near-term stationary and mobile
source control measures (with the exception of ``FSS-05--Mitigation Fee
Program for Federal Sources'') and commitment to achieve aggregate
emission reductions through a schedule of rule adoption and
implementation, the District's contingency measure (``CTY-01--
Accelerated Implementation of Control Measures''), the District's
``black box'' emission reduction commitment,\3\ the vehicle emissions
offset demonstration, and the nitrogen dioxide maintenance
demonstration and related MVEBs.
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    \3\ ``Black box'' commitment refers to the provisions under CAA
section 182(e)(5) that anticipate development of new control
techniques or improvement of existing control technologies.
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    Also, in connection with the 2003 South Coast SIP, we proposed to
disapprove the District commitment to adopt one particular control
measure (``FSS-05--Mitigation Fee Program for Federal Sources''); the
``black box'' emissions reduction assignment to EPA; the revised rate-
of-progress (ROP) and attainment demonstrations; and the ozone MVEBs.
    The primary rationale for proposing approval of certain control
measures and the specific SIP elements described above is that they
would strengthen the SIP by adding to, or updating, SIP elements
previously approved by EPA. The reasons for proposing disapproval of
the other specified elements of the 2003 South Coast SIP include
incorrect ROP calculation methods and the withdrawal by ARB of the
state emissions reductions commitments in the 2003 State Strategy that
were relied upon in the 2003 South Coast SIP. In our proposed rule, we
explained that no sanctions clocks or Federal implementation plan (FIP)
requirement would be triggered by our disapprovals because the plan
revisions that are the subject of the proposed disapprovals represent
revisions to previously-approved SIP elements that EPA determined met
the CAA requirements, and thus, the revisions are not required under
the Act. For additional information, please see our October 24, 2008
proposed rule.

II. Public Comments

    EPA's October 24, 2008 proposed rule provided a 30-day public
comment period. We received comments dated November 17, 2008 from the
Center on Race, Poverty & the Environment (CRP&E) on behalf of a number
of environmental and community groups. CRP&E submitted additional
comments by letter dated November 24, 2008. We also received comments
from the Natural Resources Defense Council (NRDC) by letter dated
November 24, 2008 that was followed shortly thereafter by a revised
letter reflecting minor edits to the original letter. We summarize the
comments and provide responses in the paragraphs below.
    Comment: ARB's Executive Officer does not have the authority to
withdraw certain portions of the 2003 State Strategy as it applies to
the South Coast Air Basin and does not have the authority to withdraw
the TCM portion of the 2003 South Coast AQMP. The withdrawal letter
submitted by the Executive Officer cannot be approved by EPA because it
was not subject to the notice and hearing requirements for SIPs under
the CAA. Also, due to procedural deficiencies, EPA should not take into
consideration the supplemental material submitted by the SCAQMD. EPA
must act on the 2003 State Strategy and 2003 South Coast AQMP as
submitted on January 9, 2004 and defer action on the subsequent
withdrawals and supplemental material until such time as ARB completes
the necessary public process.
    Response: In our proposed rule, we describe in detail the letter
from James Goldstene, ARB Executive Officer, dated February 13, 2008
(``February Goldstene Letter'') withdrawing several portions of the
2003 State Strategy that relate to the South Coast Air Basin. See 73 FR
63408, at 63410-63411. We also cite a second letter from the ARB
Executive Officer, dated October 14, 2008 (``October Goldstene
Letter''), that corrects an error in the February Goldstene Letter and

withdraws the TCM portion of the 2003 South Coast SIP. Id.
    We acknowledge that our proposed action gives full effect to the
two Goldstene letters cited above and thus we have proposed action only
on those portions of the 2003 State Strategy and 2003 South Coast SIP
that remain post-withdrawal. From the standpoint of CAA procedural
requirements, we find nothing in the CAA that prevents states from
withdrawing SIPs or SIP revisions prior to EPA approval. To be sure,
such withdrawals may lead to sanctions under the CAA depending on the
circumstances of the submittal, but the Act does not prevent states
from subjecting themselves to potential liability for failure to submit
SIPs and SIP revisions if they so choose. Moreover, no public process
is required for withdrawal, once again, prior to the time EPA acts to
approve the submittal as part of the applicable SIP.
    Once SIPs or SIP revisions have been approved by EPA, however, then
a state must submit a request for a withdrawal of, or rescission of,
for example, a portion of a SIP, and EPA must approve the request to
effectively amend the SIP. In other words, a state's post-approval
rescission is considered a SIP revision, and subject to CAA public
process procedural requirements, whereas a state's pre-approval
rescission is not considered a SIP revision and takes effect upon
receipt by EPA regardless of the procedure that was followed so long as
the procedure for withdrawal is consistent with state law. In this
instance, we had not approved the portions of the 2003 State Strategy
and the 2003 South Coast SIP that the Goldstene letters purport to
withdraw and thus we gave the letters full effect under the belief that
the ARB Executive Officer had the authority under State law to make the
subject withdrawals.
    As to the challenge by the commenters to the authority of the ARB
Executive Officer under State law to withdraw portions of the 2003
State Strategy and 2003 South Coast SIP, we take note of a letter dated
March 26, 2008 from Mary D. Nichols, chairperson of the ARB (``Nichols
Letter''), to various environmental organizations defending the
Executive Officer's authority to make the withdrawals set forth in the
February Goldstene Letter. In the Nichols Letter, the chairperson of
the ARB explains: ``California Health & Safety Code Sec. Sec.  39515
and 39516 empower the Executive Officer to act on behalf of the Board,
and provide that any power that the Board may lawfully delegate shall
be conclusively presumed to have been delegated to the Executive
Officer, unless the Board specifically has reserved that power for the
Board's own action. Withdrawal of still-pending SIP submittals is not
among the powers the Board has reserved for itself.'' As to the
specific Board language in the resolution of adoption for the 2003
South Coast SIP, the Nichols Letter explains: ``Moreover, the language
of Resolution 03-23 * * * does not constitute such a reservation of
powers. Resolution 03-23 directs the Executive Officer to take certain
actions in 2003, which the Executive Officer did at that time.
Resolution 03-23 does not prohibit the Executive Officer from taking
different actions in 2008 when warranted by changed circumstances,
which in this case is a logical administrative action to follow the
Board's adoption of the new 2007 strategy.'' For the proposed rule, we
reviewed the citations in the California Heath & Safety Code and the
relevant provisions in ARB resolutions 03-22 and 03-23, adopting the
2003 State Strategy and 2003 South Coast SIP, respectively, and found
the Nichols Letter to be a reasonable interpretation of California law.
We continue to believe that the ARB Executive Officer acted in a manner
consistent with State law in withdrawing the SIP submittal elements set
forth in the February Goldstene Letter and that we took into account
the subject withdrawals appropriately. The same holds true also for the
withdrawal of the TCM element in the 2003 South Coast SIP in the
October Goldstene Letter.
    Lastly, a commenter challenges EPA's reliance on a September 10,
2008 letter from Elaine Chang, DrPH, Deputy Executive Officer, SCAQMD
(``Chang Letter''), because it had not been subject to the public
notice, hearing and adoption process required for SIP submittals. We
describe the contents of the Chang Letter on page 63417 of the proposed
rule as ``supplemental motor vehicle emissions data drawn largely from
emissions inventory estimates presented in appendix III of the 2003
South Coast AQMP.'' We agree generally that amendments by a state to
submitted SIPs (as opposed to withdrawals thereof) must undergo the
necessary public process prior to submittal to meet CAA procedural
requirements, but, in this instance, the supplemental information
provided in the Chang Letter simply collects in a single table certain
emissions data that had already been subject to the required public
process and estimates certain other values through simple
interpolation. Because we find that the underlying emissions data
included in the Chang Letter were subject to the necessary public
process, we continue to believe that reliance on the Chang Letter as
support for the conclusion that the 2003 South Coast SIP meets the TCM
offset requirement under CAA section 182(d)(1)(A) is appropriate.
    Comment: EPA must ensure that the 2003 South Coast AQMP provides
for attainment of the 1-hour ozone NAAQS and cannot simply rely on
previous approvals because existing commitments to achieve certain
emissions reductions have not come to fruition and because the new
inventory shows that the plan does not provide sufficient emissions
reductions to attain the standard by 2010. Furthermore, ambient data
for year 2008 already shows that the South Coast will not attain the 1-
hour ozone standard by 2010. EPA must ensure that there is a viable
path to reaching the 1-hour ozone standard.
    Response: We had a responsibility to ensure that the South Coast
had a viable path to attainment for the 1-hour ozone NAAQS. In 1997 (62
FR 1150, January 9, 1997), and then again in 2000 (65 FR 18903, April
10, 2000), we fulfilled that responsibility through our final
rulemaking actions approving South Coast attainment demonstrations for
the 1-hour ozone NAAQS. Our final approvals of the attainment
demonstrations for the South Coast were based on the best information
available at the time.
    As to unfulfilled commitments, we believe that a state is required
to fulfill its commitments that have been approved into the SIP, but
failure by a state to do so is a separate issue from our action on the
2003 State Strategy and 2003 South Coast SIP and does not trigger a
requirement to prepare a new plan. Further, we note that, absent a
commitment by a state such as a mid-course correction or an action by
EPA such as a ``SIP call'' under CAA section 110(k)(5), a state is not
required to submit a new attainment demonstration to account for
changed circumstances, such as new technical information reflected in
the emissions estimates in the 2003 South Coast SIP or the ambient
ozone concentration data from 2008.\4\
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    \4\ In support of the statement that the South Coast Air Basin
will not attain the 1-hour ozone NAAQS by 2010, the commenter
attached tables containing ARB summaries of preliminary 2008 ozone
monitoring data from five sites in the South Coast: Asuza, Glendora-
Laurel, Crestline, Santa Clarita, and Perris. The summary tables
submitted by the commenter highlight exceedance-days relative to the
more stringent state 1-hour ozone standard (0.09 ppm) rather than
the federal 1-hour ozone standard (0.12 ppm). The data shows that
the number of days during which hourly ozone concentrations equaled
or exceeded 0.125 ppm (i.e., exceedance-days for the revoked federal
1-hour ozone standard) at the five sites cited by the commenter are
as follows: Asuza (3), Glendora-Laurel (10), Crestline (16), Santa
Clarita (8), and Perris (2). These numbers reflect substantial
improvement in air quality in the South Coast Air Basin since the
area's classification as an ``extreme'' nonattainment area for ozone
under the 1990 Clean Air Act Amendments when the corresponding
number of exceedance-days (year 1990) at these sites were as
follows: Asuza (84), Glendora-Laurel (103), Crestline (103), Santa
Clarita (62), and Perris (62).
    The total number of exceedance-days per monitor over the 2008-
2010 time period will determine if the area attains by 2010.
However, CAA section 181(a)(5) allows EPA to approve up to two one-
year extensions of the attainment date if all requirements and
commitments have been complied with and if no more than one
exceedance of the standard occurs in the year preceding the
extension year. We will not know whether the South Coast Air Basin
qualifies for the first one-year extension until the end of 2010.

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    Lastly, we agree that EPA must ensure a viable path to attainment,
and previously did so for the 1-hour ozone NAAQS in the South Coast,
but EPA's responsibility at the present time is to ensure that states
adopt viable paths toward attainment of the 8-hour NAAQS, rather than
the revoked 1-hour ozone NAAQS, and EPA will fulfill its obligations in
this respect through review and action on submitted 8-hour ozone SIPs.
For the South Coast, EPA is currently reviewing the 2007 South Coast
AQMP to ensure that it meets all applicable requirements for
demonstrating attainment of the 8-hour ozone NAAQS. By this, we do not
mean to suggest that attainment of, or failure to attain, the revoked
1-hour ozone standard by the applicable attainment date is irrelevant.
Indeed, failure to attain the 1-hour ozone standard, in this case, by
2010 (or 2011 or 2012 if the South Coast qualifies for an extension),
can lead to regulatory consequences (such as the imposition of fees
under CAA section 185 and the implementation of contingency measures)
that are triggered to prevent backsliding during the transition from a
1-hour ozone standard to the 8-hour ozone standard.
    Comment: EPA improperly fails to require a transportation control
measure (TCM) plan pursuant to CAA section 182(d)(1)(A). Specifically,
EPA has improperly construed section 182(d)(1)(A) not to require
offsets for the emissions increases attributable to the increase in
vehicle miles traveled (VMT) since 1990 despite clear guidance
contained in a related House Committee report included in the
legislative history of the Clean Air Act Amendments of 1990. Also, EPA
has also failed to assess the adequacy of the 2003 South Coast AQMP's
compliance with section 182(d)(1)(A) against the additional statutory
requirement that the SIP provide adequate enforceable TCMs sufficient
to allow total area emissions to comply with reasonable further
progress (RFP) and attainment requirements.
    Response: CAA section 182(d)(1)(A), referred to herein as the TCM
provision, requires a state to submit a SIP revision, for certain
nonattainment areas such as the South Coast, that identifies and adopts
specific enforceable transportation control strategies and TCMs to
offset any growth in emissions from growth in VMT or numbers of vehicle
trips in such areas and to attain reductions in motor vehicle emissions
as necessary, in combination with other emission reduction
requirements, to comply with ROP and attainment requirements. In our
proposed rule, we indicate that ARB withdrew the TCM element of the
2003 South Coast SIP, and we conclude that compliance with the VMT
offset requirement under CAA section 182(d)(1)(A) is shown in the 2003
South Coast SIP through supplemental material provided by SCAQMD
showing a decline in motor vehicle emissions each year in the South
Coast through the applicable attainment date (2010). See 73 FR 63408,
at 63417 (October 24, 2008). EPA believes that it is appropriate to
treat the three required elements of section 182(d)(1)(A) (i.e.,
offsetting growth, attainment of the ROP reduction, and attainment of
the ozone NAAQS) as separable,\5\ and while not stated as such in the
proposed rule, our proposed approval in this instance relates only to
the first element of CAA section 182(d)(1)(A) (i.e., offsetting
growth). The second and third elements of CAA section 182(d)(1)(A) were
satisfied in 1997 when we approved the 1994 South Coast AQMP's
transportation control strategies and TCMs, such as TCM-1
(``Transportation Improvements''), which includes the capital and non-
capital facilities, projects, and programs contained in the Regional
Mobility Element and programmed through the Regional Transportation
Improvement Program (RTIP) process to reduce emissions, in the same
action in which we approved the South Coast ROP and attainment
demonstrations. See 62 FR 1150, at 1180-1181 (January 8, 1997).
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    \5\ We believe that the three elements of section 182(d)(1)(A)
are separable because of the timing problem created by Congress in
requiring a TCM SIP to be submitted years before the broader SIP
submittals, such as the ROP and attainment demonstration SIPs. The
SIP submittals showing attainment of the 1996 15 percent ROP and the
post-1996 RFP and NAAQS attainment demonstration are broader in
scope than growth in VMT or in numbers of vehicle trips in that they
necessarily address emissions trends and control measures for non
motor vehicle emissions sources and, in the case of attainment
demonstrations, involve complex photochemical modeling studies. It
was neither practicable nor reasonable to expect that the
subsequently required submissions could be developed and implemented
so far ahead of schedule as to effectively influence the TCM SIP
submission.
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    As to EPA's interpretation of the first element of CAA section
182(d)(1)(A), we point to the following excerpt on this subject from
our General Preamble for the Implementation of Title I of the Clean Air
Act Amendments of 1990 (``General Preamble''):

    ``The EPA has received comment indicating that section
182(d)(1)(A) should be interpreted to require areas to offset any
growth in VMT above 1990 levels, rather than offsetting VMT growth
only when such growth leads to actual emissions increases. Under
this approach, areas would have to offset VMT growth even while
vehicle emissions are declining. Proponents of this interpretation
cite language in the House Committee Report which appears to support
the interpretation. The report states that `(t)he baseline for
determining whether there has been growth in emissions due to
increased VMT is the level of vehicle emissions that would occur if
VMT held constant in the area.' (H.R. No. 101-490, part 1, 101st
Cong. 2nd Sess., at 242).
    Although the statutory language could be read to require
offsetting of any VMT growth, EPA believes that the language can
also be read so that only actual emissions increases resulting from
VMT growth need to be offset. The statute by its own terms requires
offsetting of `any growth in emissions from growth in VMT.' It is
reasonable to interpret this language as requiring that VMT growth
must be offset only where such growth results in emissions increases
from the motor vehicle fleet in the area.
    While it is true that the language of the H.R. 101-490 appears
to support the alternative interpretation of the statutory language,
such an alternative interpretation would have drastic implications
for many of the areas subject to this provision. Since VMT is
growing at rates as high as 4 percent per year in some cities such
as Los Angeles, these cities would have to impose draconian TCM's
such as mandatory no-drive restrictions, to fully offset the effects
of increasing VMT if the areas where [sic] forced to ignore the
beneficial impacts of all vehicle tailpipe and alternative fuel
controls.
    Although the original authors of the provision and H.R. 101-490
may in fact have intended this result, EPA does not believe the
Congress as a whole, or even the full House of Representatives,
believed at the time it voted to pass the CAAA that the words of
this provision would impose such severe restrictions. There is no
further legislative history on this aspect of the provision; it was
not discussed at all by any member of the Congress during subsequent
legislative debate and adoption.
    Given the susceptibility of the statutory language to these two
alternative interpretations, EPA believes that it is the Agency's
role in administering the statute to take the interpretation most
reasonable in light of the practical implications of such

interpretation, taking into consideration the purposes and intent of
the statutory scheme as a whole. In the context of the intricate
planning requirements Congress established in title I to bring areas
towards attainment of the ozone standard, and in light of the
absence of any discussion of this aspect of the VMT offset provision
by the Congress as a whole (either in floor debate or in the
Conference Report), EPA concludes that the appropriate
interpretation of section 182(d)(1)(A) requires offsetting VMT
growth only when such growth would result in actual emissions
increases.'' 57 FR 13498, at 13522-13523 (April 16, 1992).

    For the reasons given in the General Preamble excerpt provided
above, EPA believes that the first element of CAA section 182(d)(1)(A)
requires states to adopt sufficient TCMs so that projected motor
vehicle emissions, taking into account motor-vehicle-related emissions
controls and growth in VMT, will never be higher during the ozone
season in one year than during the ozone season in the year before, but
that a state may comply with this provision through a demonstration of
declining motor vehicle emissions each year through the attainment year
rather than through submittal of TCMs.\6\ Thus, we continue to accept
the supplemental material submitted by letter dated September 10, 2008
from Elaine Chang, Deputy Executive Officer, SCAQMD, showing a decline
in motor vehicle emissions each year in the South Coast through 2010,
as a demonstration showing that the 2003 South Coast SIP meets the TCM
offset requirement under CAA section 182(d)(1)(A).
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    \6\ EPA has previously discussed its interpretation of the
section 182(d)(1)(A) requirement in our approval of the VMT offset
plan for the Houston/Galveston ozone nonattainment area. See 66 FR
57247 (November 14, 2001).
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    Comment: Because conformity is still applicable under the 1-hour
ozone standard and because the 8-hour ozone motor vehicle emissions
budgets are less stringent than the 1-hour ozone budgets, EPA cannot
allow the use of the former to serve as the conformity budgets for
attainment of the 1-hour ozone standard.
    Response: In our proposed rule, we proposed to disapprove the VOC
and NOX motor vehicle emissions budgets (MVEBs) for 1-hour
ozone (``1-hour ozone MVEBs'') based on our proposed disapprovals of
the one-hour ozone ROP and attainment demonstrations in the 2003 South
Coast SIP. See 73 FR 63408, at 63418. We noted in our proposed rule
that the 1-hour ozone MVEBs would not be used for conformity purposes
even if we were to approve them because EPA has revoked the 1-hour
ozone standard and transportation conformity determinations are no
longer required for that air quality standard, and because we have
already found 8-hour ozone MVEBs from the 2007 South Coast AQMP to be
adequate for transportation conformity purposes. See 73 FR 63408, at
63418.
    The commenter takes issue with our statement in the proposed rule
that transportation conformity determinations are no longer required
for the 1-hour ozone standard, citing the D.C. Circuit's decision in
South Coast Air Quality Management District v. EPA, 472 F.3d 882 (D.C.
Cir. 2006), and with our conclusion that the 1-hour ozone MVEBs would
not be used for conformity even if we approved them.
    We agree that the D.C. Circuit's decision in the South Coast
overruled EPA's decision that 1-hour ozone MVEBs do not constitute one
of the ``applicable requirements'' that must be retained for anti-
backsliding purposes during the transition from the 1-hour to the 8-
hour ozone standard, but the regulatory impact of the South Coast
ruling is not what the commenter believes. On June 8, 2007, the D.C.
Circuit amended its opinion to limit the scope of its decision
regarding continued application of the 1-hour ozone conformity
obligation to clarify that the court's reference to conformity
determinations speaks only to the use of 1-hour ozone MVEBs as part of
8-hour ozone conformity determinations until 8-hour ozone MVEBs are
found adequate or are approved. See EPA memorandum from Robert J.
Meyers, Acting Assistant Administrator, to Regional Administrators,
dated June 15, 2007. The court thus clarified that 1-hour ozone
conformity determinations are not required for anti-backsliding
purposes. Therefore, the court's decision does not change the
transportation conformity regulations in place before the court's
ruling on December 22, 2006.
    In this instance, the relevant transportation conformity
regulations are the amendments to the conformity regulations that EPA
promulgated to address conformity in nonattainment and maintenance
areas for the 8-hour ozone NAAQS. See 69 FR 40004 (July 1, 2004) and
also 73 FR 4420, at 4434 (January 24, 2008). Under the 2004 amendments
to the transportation conformity rule, 8-hour MVEBs replace the
existing 1-hour ozone MVEBs once the 8-hour MVEBs are found adequate or
are approved. See 40 CFR 93.109(e)(1) and (2). In this instance, we
found certain 8-hour ozone MVEBs in the 2007 South Coast AQMP
(specifically, ROP milestone years 2008, 2011, 2014, 2017, and 2020) to
be adequate for transportation conformity purposes. See 73 FR 28110
(May 15, 2008), as corrected at 73 FR 34837 (June 18, 2008). As a
result of our finding, the U.S. Department of Transportation and the
area's Metropolitan Planning Organization, the Southern California
Association of Governments, must use the 8-hour ozone MVEBs, and may
not use the 1-hour ozone MVEBs, for transportation conformity
determinations.
    Lastly, the commenter juxtaposes the 8-hour ozone MVEBs, that have
been found adequate, with the 1-hour ozone MVEBs that the 8-hour MVEBs
replaced, to show that the 8-hour ozone MVEBs in 2011 are higher than
the 1-hour ozone MVEBs, and concludes therefore the EPA cannot allow
use of the former to serve as the MVEBs for attainment of the 1-hour
ozone standard. However, as discussed above, conformity need no longer
be shown for the 1-hour ozone NAAQS, and 1-hour ozone MVEBs no longer
apply once a finding of adequacy is made for 8-hour ozone MVEBs, a
circumstance that applies to the South Coast.
    Comment: EPA should disapprove the Pesticide Strategy portion of
the 2003 State Strategy because of a recent Ninth Circuit Court of
Appeals decision that held that a particular document that had
supported EPA's approval of the original Pesticide Strategy in the 1994
California Ozone SIP was not a part of the California SIP and thus was
unenforceable under provisions of the Clean Air Act.
    Response: One of the State's original purposes in adopting the 2003
State Strategy was to entirely replace the existing State control
strategy for the South Coast (primarily comprised by commitments from
the approved 1994 Ozone SIP) with a new strategy that included three
components: an annual adoption schedule for aggregate emissions
reductions, defined measures, and a set of long-term commitments
including aggregate long-term emissions reductions. See section I,
chapter D, of the 2003 State Strategy. In this context, the State
included PEST-1 (``Implement Existing Pesticide Strategy''), which
simply retains the existing SIP commitment, into the list of defined
measures for the sake of completeness to allow for the wholesale
replacement of the existing strategy for the South Coast with the new
strategy from the 2003 State Strategy.
    As described in the proposed rule (73 FR 63408, at 63410-63411),
however, the State withdrew several components of the new State
Strategy as it relates to the South Coast, including the aggregate
annual emissions reductions commitments and long-term

commitments, leaving just the bare commitment to bring certain measures
(listed in table 1 of our October 24, 2008 proposed rule) to the ARB's
Board for any action within the Board's discretion and to implement the
existing Pesticide Strategy. The withdrawal of key components of the
new State Strategy eliminated any possibility for the wholesale
replacement of the existing State strategy for the South Coast with the
new strategy.
    Given the changed circumstances, PEST-1 did not need any longer to
be brought forward as part of the 2003 State Strategy, but because ARB
did not specifically withdraw it, EPA had to propose action on it. We
did so through a proposed approval. A footnote to table 1 (of the
proposed rule) sets forth our interpretation of what approval of PEST-1
would mean: ``We interpret our approval of this measure as maintaining
the status quo with respect to the existing pesticide strategy (i.e.,
the SIP will continue to reflect the strategy as approved by EPA in
1997).'' Furthermore, since disapproval of PEST-1 in the 2003 State
Strategy would not act to rescind the existing Pesticide Strategy,
approval or disapproval of PEST-1 amounts to the same thing: namely,
the continuation of the existing EPA-approved Pesticide Strategy.
Therefore, deficiencies in the enforceability of the Pesticide Element,
whatever they might be, are the same whether EPA approves PEST-1 or
disapproves PEST-1.
    Comment: EPA should disapprove the State's commitments to adopt new
measures because they are unenforceable.
    Response: With the withdrawal of key components of the 2003 State
Strategy, including the aggregate annual and long-term emissions
reductions commitments for the South Coast, the State has left only the
bare commitment to bring certain near-term measures (listed in table 1
of our October 24, 2008 proposed rule) to the ARB's Board (for any
action within the Board's discretion) and to implement the existing
Pesticide Strategy. We acknowledge the limited scope of the State's
commitment, but do not find it to be entirely unenforceable. For
instance, ARB staff must bring to the Board the measures listed in
table 1 of the proposed rule (drawn from the 2003 State Strategy)
consistent with the schedule set forth in table 1. Further, the ARB
staff proposal for each measure must, at a minimum, achieve the lower
end of a range of reductions. Failure by ARB to act accordingly is
subject to enforcement under applicable provisions of the Act once EPA
approves the commitment into the California SIP. We concluded in our
proposed approval that the California SIP would be more effective with
the commitment than without the commitment. We explained our rationale
for proposing approval of the State defined measures as follows:
``Assuming that the remaining component of the 2003 State Strategy adds
to, but does not replace, the existing SIP ozone strategy, we propose
to approve the State commitments with respect to the near-term defined
measures listed in table 1 as described above as strengthening the
SIP.'' See 73 FR 63408, at 63414. On this limited basis, we take final
action today to approve the State's near-term defined measures from the
2003 State Strategy as part of the California SIP.

III. EPA Action

    Under section 110(k)(3) of the CAA, and for the reasons discussed
above and in the proposed rule, EPA is taking the following actions on
the 2003 State Strategy, as submitted on January 9, 2004:
    (1) Approval of commitments by State agencies to develop and
propose 16 near-term defined control measures (15 for ARB and 1 for
BAR) to achieve specified emissions reductions in the South Coast as
listed in table 1 of the proposed rule and the continuation of the
existing pesticide strategy.
    Also under section 110(k)(3) of the CAA, and for the reasons
discussed above and in the proposed rule, EPA is taking the following
actions on the 2003 South Coast SIP, as submitted on January 9, 2004:
    (1) Approval of base year and projected baseline emission
inventories under CAA sections 172(c)(3) and 182(a)(1);
    (2) Approval of the District's commitment to adopt and implement
near-term control measures as shown in table 2 of the proposed rule
(except FSS-05), the District's commitment to achieve emissions
reduction through a schedule of adoption and implementation as shown in
table 3 of the proposed rule, and the District's contingency measure
CTY-01 (``Accelerated Implementation of Control Measures''), as
strengthening the SIP;
    (3) Disapproval of District control measure FSS-05 (``Mitigation
Fee Program for Federal Sources'') that assigns control measure
responsibility to the Federal Government;
    (4) Approval of District's ``black box'' VOC emission reduction
commitment of 31 tpd;
    (5) Disapproval of the ``black box'' emission reduction commitment
of 68 tpd of NOX and 18 tpd of VOC assigned to the Federal
Government;
    (6) Disapproval of the attainment demonstration because control
measures upon which the demonstration relies have been withdrawn;
    (7) Disapproval of the ROP demonstrations because the calculations
do not properly account for the emissions reductions from the pre-1990
Federal Motor Vehicle Control Program (FMVCP) and certain federal
gasoline volatility requirements;
    (8) Approval of the demonstration that no TCM offsets are required
under CAA section 182(d)(1)(A) based on baseline motor vehicle
emissions projections as supplemented by the District;
    (9) Approval of the revised nitrogen dioxide maintenance
demonstration based on the downward trend in baseline NOX
emissions;
    (10) Disapproval of the 1-hour ozone (VOC and NOX) motor
vehicle emissions budgets in the wake of proposed disapprovals of the
ROP and attainment demonstrations; and
    (11) Approval of the nitrogen dioxide motor vehicle emissions
budget of 686 tpd (year 2003), winter planning inventory.
    No sanctions clocks or FIP requirement are triggered by our
disapprovals because the approved SIP already contains the plan
elements that we are disapproving. A disapproval of the revisions to
the already-approved elements does not alter the fact that the SIP
already meets these statutory requirements.

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 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 Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and 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 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; 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. section 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
rule 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.
section 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 May 11, 2009. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule 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, Incorporation by
reference, Intergovernmental relations, Oxides of nitrogen, Ozone,
Reporting and recordkeeping requirements, Volatile organic compounds.

    Dated: January 15, 2009.
Wayne Nastri,
Regional Administrator, Region IX.

0
Part 52, chapter I, title 40 of the Code of Federal Regulations 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 F--California

0
2. Section 52.220 is amended by revising paragraph (c)(339)
introductory text and by adding paragraph (c)(339)(ii) to read as
follows:

Sec.  52.220  Identification of plan.

* * * * *
    (c) * * *
    (339) New and amended plans were submitted on January 9, 2004, by
the Governor's designee.
* * * * *
    (ii) Additional material.
    (A) The following portions of the Final 2003 State and Federal
Strategy (2003 State Strategy) for the California State Implementation
Plan, adopted by the California Air Resources Board (ARB) on October
23, 2003:
    (1) State agency commitments with respect to the following near-
term defined measures for the South Coast Air Basin: LT/MED-DUTY-1 [Air
Resources Board (ARB)], LT/MED-DUTY-2 (Bureau of Automotive Repair),
ON-RD HVY-DUTY-1 (ARB), ON-RD HVY-DUTY-3 (ARB), OFF-RD CI-1 (ARB), OFF-
RD LSI-1 (ARB), OFF-RD LSI-2 (ARB), SMALL OFF-RD-1 (ARB), SMALL OFF-RD-
2 (ARB), MARINE-1 (ARB), MARINE-2 (ARB), FUEL-2 (ARB), CONS-1 (ARB),
CONS-2 (ARB), FVR-1 (ARB), FVR-2 (ARB), and PEST-1 (Department of
Pesticide Regulation) in Resolution 03-22 Attachments A-2, A-3, A-4 and
A-6 Table I-7 and in 2003 State Strategy Section I Appendix I-1 and
Sections II and III.
    (B) The following portions of the South Coast 2003 Air Quality
Management Plan (AQMP), adopted by the South Coast Air Quality
Management District (SCAQMD) on August 1, 2003 and adopted by the
California Air Resources Board on October 23, 2003:
    (1) Base year and future year baseline planning inventories (summer
and winter) in AQMP Chapter III and Appendix III; SCAQMD commitment to
adopt and implement control measures CTS-07, CTS-10, FUG-05, MSC-01,
MSC-03, PRC-07, WST-01, WST-02, FSS-04, FLX-01, CMB-10, MSC-05, MSC-07,
MSC-08, FSS-06, and FSS-07 in AQMP Chapter 4, Table 4-1, as qualified
and explained in AQMP, Chapter 4, pages 4-59 through 4-61 and in
Appendix IV-A Section 1, and SCAQMD commitments to achieve near-term
and long-term emissions reductions through rule adoption and
implementation in AQMP Chapter 4, Tables 4-8A and 4-8B; contingency
measure CTY-01 in AQMP Chapter 9, Table 2 and in Appendix IV-A Section
2 (excluding FSS-05); nitrogen dioxide maintenance demonstration in
AQMP Chapter 6 page 6-11; and motor vehicle emissions budget for
nitrogen dioxide in year 2003 of 686 tons per day (winter planning
inventory) in AQMP Chapter 6 Table 6-7.
    (2) Letter from Elaine Chang, Deputy Executive Officer, South Coast
Air Quality Management District, dated September 10, 2008, containing
supplemental material related to on-road motor vehicles emissions.
* * * * *
 [FR Doc. E9-4593 Filed 3-9-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 125 (Friday, July 2, 2021)]
[Notices]
[Page 35282]
[FR Doc No: 2021-14242]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Number: PR21-51-000.
    Applicants: Columbia Gas of Ohio, Inc.
    Description: Tariff filing per 284.123(b),(e)/: COH SOC Rates
effective May 28 2021 to be effective 5/28/2021.
    Filed Date: 6/25/2021.
    Accession Number:<PHONE_NUMBER>74.
    Comments/Protests Due: 5 p.m. ET 7/16/2021.

    Docket Number: PR21-46-001.
    Applicants: DCP Guadalupe Pipeline, LLC.
    Description: Tariff filing per 284.123(b), (e) + (g): Guadalupe SOC
7.1.0 to be effective 5/1/2021.
    Filed Date: 6/25/2021.
    Accession Number:<PHONE_NUMBER>43.
    Comments Due: 5 p.m. ET 7/16/2021.
    284.123(g) Protests Due: 5 p.m. ET 7/16/2021.

    Docket Numbers: RP21-909-000.
    Applicants: Bobcat Gas Storage.
    Description: Sec.  4(d) Rate Filing: Updates to Tariff Contact
Person to be effective 7/24/2021.
    Filed Date: 6/24/21.
    Accession Number: 20210624-5025.
    Comments Due: 5 p.m. ET 7/6/21.

    Docket Numbers: RP21-910-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Agreement
Filing-Presidion WAB LLC to be effective 7/1/2021.
    Filed Date: 6/25/21.
    Accession Number: 20210625-5038.
    Comments Due: 5 p.m. ET 7/7/21.

    Docket Numbers: RP21-911-000.
    Applicants: MMGJ Arkansas Upstream, LLC, Riverbend Oil and Gas
VIII, LLC.
    Description: Joint Petition for Limited Waiver of Capacity Release
Regulations, et al. of MMGJ Arkansas Upstream, LLC, et al. under RP21-
911.
    Filed Date: 6/25/21.
    Accession Number: 20210625-5151.
    Comments Due: 5 p.m. ET 7/2/21.

    Docket Numbers: RP21-912-000.
    Applicants: Paiute Pipeline Company.
    Description: Sec.  4(d) Rate Filing: Cover Page Address and Fax
Change to be effective 6/28/2021.
    Filed Date: 6/25/21.
    Accession Number: 20210625-5187.
    Comments Due: 5 p.m. ET 7/7/21.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: June 28, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-14242 Filed 7-1-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: February 4, 2009 (Volume 74, Number 22)]
[Notices]
[Page 6084]
[DOCID:fr04fe09-101]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

Reports, Forms and Recordkeeping Requirements; Agency Information
Collection Activity Under OMB Review

AGENCY: National Highway Traffic Safety Administration, DOT.

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.), this notice announces that the Information
Collection Request (ICR) abstracted below has been forwarded to the
Office of Management and Budget (OMB) for review and comment. The ICR
describes the nature of the information collections and their expected
burden. The Federal Register Notice with a 60-day comment period was
published on November 13, 2008, Vol. 73, No.220, Pages 67248-67249.

DATES: Comments must be submitted on or before March 6, 2009.

FOR FURTHER INFORMATION CONTACT: Ann Burton at the National Highway
Traffic Safety Administration, Office of Regional Operations and
Program Delivery (NTI-200),<PHONE_NUMBER>, 1200 New Jersey Avenue, SE.,
W46-492, Washington, DC 20590.

SUPPLEMENTARY INFORMATION:

National Highway Traffic Safety Administration

    Title: 23 CFR, Part 1313, Alcohol Impaired Driving
Countermeasures--Section 410.
    OMB Number: 2127-0501.
    Type of Request: Extension to a previously approved collection of
information.
    Abstract: An impaired driving incentive grant is available to
States that have an alcohol fatality rate of 0.5 or less per 100
million vehicle miles traveled as determined by using the most recent
Fatality Analysis Reporting System (FARS) data or that are one of the
ten States that have the highest alcohol related fatality rates as
determined by using the most recent FARS data. States designated as a
high fatality rate State must submit a comprehensive plan for
conducting high visibility enforcement and a report on the previous
years activities.
    States may also qualify through meeting specified program criteria.
To demonstrate compliance using program criteria a State must submit an
application that shows how they met three of eight criteria in FY2006,
four of eight criteria in FY2007 and five of eight criteria in FY2008
and FY2009.
    Affected Public: The 50 States, the District of Columbia, Puerto
Rico.
    Estimated Total Annual Burden: 1350.

ADDRESSES: Send comments, within 30 days, to the Office of Information
and Regulatory Affairs, Office of Management and Budget, 725-17th
Street, NW., Washington, DC 20503, Attention NHTSA Desk Officer.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Departments estimate of the burden of the
proposed information collection; ways to enhance the quality, utility
and clarity of the information to be collected; and ways to minimize
the burden of the collection of information on respondents, including
the use of automated collection techniques or other forms of
information technology.
    A Comment to OMB is most effective if OMB receives it within 30
days of publication.

Marlene Markison,
Associate Administrator, Regional Operations and Program Delivery.
[FR Doc. E9-2279 Filed 2-3-09; 8:45 am]

BILLING CODE 4910-59-P


[Federal Register Volume 83, Number 2 (Wednesday, January 3, 2018)]
[Rules and Regulations]
[Pages 232-234]
[FR Doc No: 2017-28342]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 864

[Docket No. FDA-2017-N-6599]

Medical Devices; Hematology and Pathology Devices; Classification
of a Cervical Intraepithelial Neoplasia Test System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the cervical intraepithelial neoplasia (CIN) test system into class II
(special controls). The special controls that apply to the device type
are identified in this order and will be part of the codified language
for the CIN test system's classification. We are taking this action
because we have determined that classifying the device into class II
(special controls) will provide a reasonable assurance of safety and
effectiveness of the device. We believe this action will also enhance
patients' access to beneficial innovative devices, in part by reducing
regulatory burdens.

DATES: This order is effective January 3, 2018. The classification was
applicable on March 4, 2017.

FOR FURTHER INFORMATION CONTACT: Steven Tjoe, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4550, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the cervical intraepithelial
neoplasia (CIN) test system as class II (special controls), which we
have determined will provide a reasonable assurance of safety and
effectiveness. In addition, we believe this action will enhance
patients' access to beneficial innovation, in part by reducing
regulatory burdens by placing the device into a lower device class than
the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate by means of the procedures
for premarket notification under section 510(k) of the FD&C Act and
part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the

FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA shall
classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval application in order to market a substantially
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial
equivalence''). Instead, sponsors can use the less-burdensome 510(k)
process, when necessary, to market their device.

II. De Novo Classification

    On May 23, 2016, Ventana Medical Systems, Inc., submitted a request
for De Novo classification of the CINtec Histology. FDA reviewed the
request in order to classify the device under the criteria for
classification set forth in section 513(a)(1) of the FD&C Act. We
classify devices into class II if general controls by themselves are
insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on March 4, 2017, FDA issued an order to the requestor
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 864.1865. We have named
the generic type of device the cervical intraepithelial neoplasia (CIN)
test system, and it is identified as a device used to detect a
biomarker associated with CIN in human tissues. The device is indicated
as an adjunct test and not to be used as a stand-alone device. The test
results must be interpreted in the context of the patient's clinical
history including, but not limited to, prior and current cervical
biopsy results, Papanicolaou (Pap) test results, human papillomavirus
(HPV) test results, and morphology on hematoxylin and eosin (H&E)
stained sections. This device is not intended to detect the presence of
HPV.
    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

 Table 1--Cervical Intraepithelial Neoplasia (CIN) Test System Risks to
                     Health and Required Mitigations
------------------------------------------------------------------------
                                           Required mitigations/21 CFR
            Identified risks                         section
------------------------------------------------------------------------
Inaccurate test results, such as false   General controls and special
 positive or false negative results.      controls (1) and (2) (21 CFR
                                          864.1865(b)(1); 21 CFR
                                          864.1865(b)(2)).
Failure to correctly interpret test      General controls and special
 results can lead to false positive or    controls (1) and (2) (21 CFR
 false negative results.                  864.1865(b)(1); 21 CFR
                                          864.1865(b)(2)).
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act.

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) 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.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations. 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 in 21
CFR parts 801 and 809, regarding labeling, have been approved under OMB
control number 0910-0485; the collections of information in part 807,
subpart E, regarding premarket notification submissions, have been
approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 814, subparts A through E, regarding
premarket approval, have been approved under OMB control number 0910-
0231; and 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.

List of Subjects in 21 CFR Part 864

    Blood, Medical devices, Packaging and containers.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 864 is amended as follows:

PART 864--HEMATOLOGY AND PATHOLOGY DEVICES

0
1. The authority citation for part 864 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  864.1865 to subpart B to read as follows:

Sec.  864.1865  Cervical intraepithelial neoplasia (CIN) test system.

    (a) Identification. A cervical intraepithelial neoplasia (CIN) test
system is a device used to detect a biomarker associated with CIN in
human tissues. The device is indicated as an adjunct test and not to be
used as a stand-alone device. The test results must be interpreted in
the context of the patient's clinical history including, but not
limited to, prior and current cervical biopsy results, Papanicolaou
(Pap) test results, human papillomavirus (HPV) test results, and
morphology on hematoxylin and eosin (H&E) stained sections. This device
is not intended to detect the presence of HPV.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Premarket notification submissions must include the following
information:
    (i) The indications for use must specify the biomarker that is
intended to be identified and its adjunct use (e.g., adjunct to
examination of H&E stained slides) to improve consistency in the
diagnosis of CIN.
    (ii) Summary of professional society recommendations, as
applicable.
    (iii) A detailed device description including:
    (A) A detailed description of all test components, including all
provided reagents and required, but not provided, ancillary reagents.
    (B) A detailed description of instrumentation and equipment,
including illustrations or photographs of non-standard equipment or
manuals.
    (C) If applicable, detailed documentation of the device software,
including, but not limited to, stand-alone software applications and
hardware-based devices that incorporate software.
    (D) A detailed description of appropriate positive and negative
controls that are recommended or provided.
    (E) Detailed specifications for sample collection, processing, and
storage.
    (F) A detailed description of methodology and assay procedure.
    (G) A description of the assay cutoff (the medical decision point
between positive and negative) or other relevant criteria that
distinguishes positive and negative results, including the rationale
for the chosen cutoff or other relevant criteria and results supporting
validation of the cutoff.
    (H) Detailed specification of the criteria for test results
interpretation and reporting.
    (iv) Detailed information demonstrating the performance
characteristics of the device, including:
    (A) Analytical specificity studies such as, but not limited to,
antibody characterization (e.g., Western Blot, peptide inhibition
analysis), studies conducted on panels of normal tissues and neoplastic
tissues, interference by endogenous and exogenous substances as well as
cross-reactivity, as applicable.
    (B) Device analytical sensitivity data generated by testing an
adequate number of samples from individuals with the target condition
including limit of blank, limit of detection, and limit of
quantification, as applicable.
    (C) Device precision/reproducibility data to evaluate within-run,
between-run, between-day, between-lot, between-site, between-reader,
within-reader and total precision, as applicable, using a panel of
samples covering the device measuring range and/or the relevant disease
categories (e.g. No CIN, CIN1, CIN2, CIN3, cervical cancer) and testing
in replicates across multiple, nonconsecutive days.
    (D) Device robustness/guardbanding studies to assess the tolerance
ranges for various critical test and specimen parameters.
    (E) Device stability data, including real-time stability and
shipping stability under various storage times, temperatures, and
freeze-thaw conditions.
    (F) Data from a clinical study demonstrating clinical validity
using well-characterized prospectively or retrospectively obtained
clinical specimens, as appropriate, representative of the intended use
population. The study must evaluate the consistency of the diagnosis of
CIN, for example, by comparing the levels of agreements of diagnoses
rendered by community pathologists to those rendered by a panel of
expert pathologists. Agreement for each CIN diagnostic category (e.g.,
No CIN, CIN1, CIN2, CIN3, cancer) and for alternate diagnostic
categories (e.g., No CIN, low grade squamous intraepithelial lesion
(LSIL)-histology, high grade squamous intraepithelial lesion (HSIL)-
histology, cancer) between reference diagnosis by expert pathologist
and community pathologist must be evaluated, as applicable. In
addition, agreements for CIN binary categories as >=CIN2 (i.e., CIN2 or
CIN3 or cancer) and <=CIN1 (i.e., No CIN or CIN1) between reference
diagnosis by expert pathologist with H&E staining and community
pathologist with H&E staining and agreements for alternate CIN binary
categories as >=HSIL-histology (i.e., HSIL-histology or cancer) and
<=LSIL-histology (i.e., No CIN or LSIL-histology) between reference
diagnosis by an expert pathologist with H&E + [biomarker specified in
paragraph (b)(1)(i) of this section] and a community pathologist with
H&E + [biomarker specified in paragraph (b)(1)(i) of this section] must
be evaluated and compared, as applicable.
    (G) The staining performance of the device as determined by the
community pathologists during review of the study slides must be
evaluated. The staining performance criteria assessed must include
overall staining acceptability, background staining acceptability, and
morphology acceptability, as applicable.
    (H) Appropriate training requirements for users, including
interpretation manual, as applicable.
    (I) Identification of risk mitigation elements used by the device,
including a description of all additional procedures, methods, and
practices incorporated into the instructions for use that mitigate
risks associated with testing.
    (2) The device's 21 CFR 809.10(b) compliant labeling must include a
detailed description of the protocol, including the information
described in paragraph (b)(1)(ii) of this section, as applicable, and a
detailed description of the performance studies performed and the
summary of the results, including those that relate to paragraph
(b)(1)(ii) of this section, as applicable.

    Dated: December 27, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-28342 Filed 1-2-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: April 8, 2009 (Volume 74, Number 66)]
[Proposed Rules]
[Page 15910-15911]
[DOCID:fr08ap09-25]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

49 CFR Part 26

[Docket No. OST-2009-0081]
RIN 2105-AD76

Disadvantaged Business Enterprise; Overall Goal Schedule and
Substitution

AGENCY: Office of the Secretary (OST), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This notice of proposed rulemaking (NPRM) would propose to
improve administration of the Disadvantaged Business Enterprise (DBE)
program by calling upon recipients of DOT financial assistance to
transmit overall goals to the Department for approval every three
years, rather than annually.

DATES: Comments on this proposed rule must be received by July 7, 2009.

ADDRESSES: You may submit comments (identified by the agency name and
DOT Docket ID Number OST-2009- ) by any of the following methods:
     Federal eRulemaking Portal: Go to www.regulations.gov and
follow the online instructions for submitting comments.
     Mail: Docket Management Facility: U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., between 9 a.m. and 5 p.m. ET,
Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Instructions: You must include the agency name (Office of the
Secretary, DOT) and Docket number (OST- 2009- ) for this notice at the
beginning of your comments. You should submit two copies of your
comments if you submit them by mail or courier. Note that all comments
received will be posted without change to www.regulations.gov including
any personal information provided and will be available to internet
users. You may review DOT's complete Privacy Act Statement in the
Federal Register published on April 11, 2000 (65 FR 19477) or you may
visit http://DocketsInfo.dot.gov.
    Docket: For internet access to the docket to read background
documents and comments received, go to www.regulations.gov. Background
documents and comments received may also be viewed at the U.S.
Department of Transportation, 1200 New Jersey Ave., SE., Docket
Operations, M-30, West Building Ground Floor, Room W12-140, Washington,
DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except
Federal holidays.

FOR FURTHER INFORMATION CONTACT: Robert C. Ashby, Deputy Assistant
General Counsel for Regulation and Enforcement, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., Washington, DC 20590, Room
W94-302,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    The current DBE rule (49 CFR part 26) requires recipients to submit
overall goals for review by the applicable DOT operating administration
on August 1 of each year. The process of setting annual overall goals
can be time-consuming, particularly given the requirements for public
participation by the recipient. The Department's experience has been
that many goals are submitted after the August 1 date, and the
Department's workload involved in reviewing annual goals from 52 state
departments of transportation and hundreds of transit authorities and
airports has often resulted in delays in the Department's response to
recipients' submissions.
    In the Department's 2005 airport concessions disadvantaged business
enterprise (ACDBE) regulation (49 CFR part 23), the Department
established a staggered three-year schedule for the submission by
airports of ACDBE goals. The purpose of this provision was to better
manage the workloads of both airports and the Federal Aviation
Administration (FAA). This approach appears to have been successful in
achieving that objective, and we are now proposing to establish a
similar system for Part 26 DBE goals. We seek comment on whether such a
system should, like its Part 23 counterpart, permit operating
administrations to grant program waivers for different schedules that
recipients suggest.
    Under the proposal, each Part 26 recipient would submit an overall
goal every three years, based on a schedule established by the
operating administrations. Some recipients would submit a goal in
August 2009, as per the existing requirement. Others would not submit
an overall goal until August 2010, and others not until August 2011.
With respect to airports, FAA would arrange the schedule so that an
airport would not have to submit both a Part 23 and Part 26 goal in the
same year. The Department seeks comment on the concept of submitting
DBE goals every three years as well as the proposed schedules for
submission. We also seek comment on whether the rule should provide for
annual reviews of goals or adjustments for new opportunities, similar
to what is provided in section 23.45 of the airport concessions DBE
rule.

Regulatory Analyses and Notices

    The Department has determined that this action is not considered a
significant regulatory action for purposes of Executive Order 12866 or
the Department's regulatory policies and procedures. The NPRM would
ease administrative burdens on recipients by reducing the frequency of
overall goal submissions and would improve protections for DBE
subcontractors by requiring recipient approval of certain contracting
actions.
    The NPRM would affect some small entities, easing administrative
burdens related to goal submission on any recipients that are
considered small entities and enhancing contracting process protections
for DBEs, which are small entities. However, the economic effects of
these changes on small entities are negligible. For that reason, the
Department certifies that the NPRM, if made final, would not have a
significant economic impact on a substantial number of small entities.
    The Department has analyzed this proposed action in accordance with
the principles and criteria contained in Executive Order 13132, and has
determined that the proposed amendments are consistent with the
Executive Order and that no consultation is necessary. This NPRM does
not propose information collection requirements covered by the
Paperwork Reduction Act.

List of Subjects in 49 CFR Part 26

    Administrative practice and procedures, Airports, Civil rights,
Government contracts, Grant programs--transportation, Highways and
roads, Mass transportation, Minority business, Reporting and
recordkeeping requirements.

    Issued at Washington DC this 25th day of March 2009.
Ray LaHood,
Secretary of Transportation.

    For reasons discussed in the preamble, the Department of
Transportation proposes to amend Title 49 of the Code of Federal
Regulations, Part 26, as follows:
    1. The authority citation for 49 CFR part 26 is amended to read as
follows:

    Authority:  23 U.S.C. 324; 42 U.S.C. 2000d et seq.; 49 U.S.C.
1615, 47107, 47113, 47123; Public Law 105-59, sec. 1101(b).

    2. Revise Sec.  26.45(f)(1) to read as follows:

Sec.  26.45  How do recipients set overall goals?

* * * * *
    (f)(1) If you set overall goals on a fiscal year basis, you must
submit them to the applicable DOT operating administration by August 1
at three-year intervals, based on a schedule established by the FAA,
FTA, or FHWA, as applicable, and posted on that agency's Web site.
* * * * *
[FR Doc. E9-7904 Filed 4-7-09; 8:45 am]

BILLING CODE 4910-9X-P