[Federal Register Volume 83, Number 234 (Thursday, December 6, 2018)]
[Rules and Regulations]
[Pages 62720-62724]
[FR Doc No: 2018-26359]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2018-0778; FRL-9987-38-Region 9]

Findings of Failure To Submit Complete State Implementation Plans
Required for the 1997, 2006, and 2012 PM2.5 NAAQS; California; San
Joaquin Valley

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to find that California has failed to submit complete state
implementation plans (SIPs) required under the Clean Air Act (CAA or
``Act'') to implement the 1997, 2006, and 2012 national ambient air
quality standards (NAAQS or ``standards'') for fine particulate matter
(PM2.5) in the San Joaquin Valley. For the 1997 annual and
24-hour PM2.5 NAAQS, California was required to submit by
December 31, 2016, a SIP submission that provides for, among other
things, annual reductions in emissions of direct PM2.5 or a
PM2.5 plan precursor pollutant within the area of not less
than five percent of the amount of such emissions as reported in the
most recent inventory for the area. For the 2006 24-hour
PM2.5 NAAQS, California was required to submit by August 21,
2017, a SIP submission that meets the requirements for Serious
PM2.5 nonattainment areas, including the requirement for
best available control measures (BACM). For the 2012 annual
PM2.5 NAAQS, California was required to submit by October
15, 2016, a SIP submission that meets the requirements for Moderate
PM2.5 nonattainment areas, including the requirement for
reasonably available control measures (RACM). California submitted
substantial portions of each of these required SIP submissions as part
of an integrated plan on November 16, 2018, but each of these
submissions fails to meet the EPA's minimum criteria for completeness.
    If the EPA has not affirmatively found that the State has submitted
complete SIPs that correct the deficiencies in each of these SIP
submissions within 18 months of this finding, the offset sanction will
apply in the area. If within 6 additional months the EPA still has not
affirmatively determined that the State has submitted complete SIPs
that

correct the deficiencies, the highway funding sanction will apply in
the area. No later than 2 years after the EPA makes these findings, if
the State has not submitted, and the EPA has not approved, each of the
required SIP submissions, the EPA must promulgate a federal
implementation plan (FIP) to address any remaining requirements.

DATES: This action will be effective on January 7, 2019.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R09-OAR-2018-0778. Generally, documents in the docket
are listed and publicly available at http://www.regulations.gov.
Although listed in the index, some information is not publicly
available, i.e., Confidential Business Information 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 in hard copy form. Publicly available docket
materials are available either electronically at http://www.regulations.gov or in hard copy at EPA Region IX, 75 Hawthorne
Street, San Francisco, CA 94105-3901. 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, EPA Region IX, (415) 947-
4192, [email protected].

SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA.

Notice and Comment Under the Administrative Procedure Act (APA)

    Section 553 of the APA, 5 U.S.C. 553(b)(3)(B), provides that, when
an agency for good cause finds that notice and public procedure are
impracticable, unnecessary or contrary to the public interest, the
agency may issue a rule without providing notice and an opportunity for
public comment. The EPA has determined that there is good cause for
taking this final agency action without prior proposal and opportunity
for comment because no significant EPA judgment is involved in making a
finding of failure to submit complete SIPs, or elements of SIPs,
required by the CAA, where a state has made incomplete submissions, to
meet the requirement. Thus, notice and public procedures are
unnecessary. The EPA finds that this constitutes good cause under 5
U.S.C. 553(b)(3)(B).

Table of Contents

I. Background
    A. Statutory Requirements
    B. Minimum Criteria for Completeness of a SIP Submission
    C. California's SIP Submissions
II. Consequences of Findings of Failure To Submit Complete SIPs
III. Final Action
IV. Statutory and Executive Order Reviews

I. Background

A. Statutory Requirements

1. 1997 PM2.5 NAAQS
    The EPA first promulgated NAAQS for PM2.5 on July 18,
1997, setting the primary and secondary annual standards at 15
micrograms per cubic meter ([mu]g/m\3\) and the primary and secondary
24-hour standards at 65 [mu]g/m\3\.\1\ Effective April 5, 2005, the EPA
designated the San Joaquin Valley as nonattainment for the 1997
PM2.5 NAAQS.\2\ Following a January 4, 2013 decision of the
U.S. Court of Appeals for the D.C. Circuit (``D.C. Circuit'') remanding
the EPA's 2007 PM2.5 Implementation Rule for the 1997
PM2.5 NAAQS,\3\ the EPA published a final rule on June 2,
2014, classifying the San Joaquin Valley, among other areas, as a
``Moderate'' nonattainment area for the 1997 PM2.5 NAAQS
under subpart 4, part D of title I of the Act.\4\
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    \1\ 62 FR 38652 (July 18, 1997) (codified at 40 CFR 50.7).
    \2\ 70 FR 944 (January 5, 2005).
    \3\ Natural Resources Defense Council v. EPA, 706 F.3d. 428 (DC
Cir. 2013) (``NRDC''). In NRDC, the court held that the EPA erred in
implementing the 1997 PM2.5 standards solely pursuant to
the general implementation requirements of subpart 1, without also
considering the requirements specific to nonattainment areas for
particles less than or equal to 10 [mu]m in diameter
(PM10) in subpart 4, part D of title I of the CAA. The
court reasoned that the plain meaning of the CAA requires
implementation of the 1997 PM2.5 standards under subpart
4 because PM2.5 falls within the statutory definition of
PM10 and is thus subject to the same statutory
requirements as PM10. The court remanded the rule,
without vacatur, and instructed the EPA ``to repromulgate these
rules pursuant to Subpart 4 consistent with this opinion.''
    \4\ 79 FR 31566.
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    Effective May 7, 2015, the EPA reclassified the San Joaquin Valley
as a ``Serious'' nonattainment area for the 1997 PM 2.5
NAAQS.\5\ Upon reclassification as a Serious Area, the San Joaquin
Valley became subject to a December 31, 2015 deadline under CAA section
188(c)(2) for attaining the 1997 PM2.5 NAAQS. On February 9,
2016, the EPA proposed to grant the State's request for extensions of
the December 31, 2015 attainment date under CAA section 188(e), to
December 31, 2018, for the 1997 24-hour PM2.5 NAAQS and to
December 31, 2020, for the 1997 annual PM2.5 NAAQS in the
San Joaquin Valley.\6\ On October 6, 2016, after considering public
comments, the EPA denied California's request for these extensions of
the attainment date.\7\ Consequently, on November 23, 2016, the EPA
determined that the San Joaquin Valley had failed to attain the 1997
annual and 24-hour PM2.5 NAAQS by the December 31, 2015
Serious Area attainment date.\8\ This determination triggered a
requirement for California to submit, by December 31, 2016, a revised
PM2.5 attainment plan that satisfies the requirements of CAA
section 189(d).\9\
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    \5\ 80 FR 18528 (April 7, 2015).
    \6\ 81 FR 6936. California's request for extension of the
Serious Area attainment date for the San Joaquin Valley accompanied
its Serious Area attainment plan for the 1997 PM2.5 NAAQS
and related motor vehicle emission budgets, submitted June 25, 2015
and August 13, 2015, respectively.
    \7\ 81 FR 69396.
    \8\ 81 FR 84481.
    \9\ CAA section 189(d).
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    The section 189(d) plan must, among other things, demonstrate
expeditious attainment of the 1997 PM2.5 NAAQS within the
time period provided under CAA section 179(d) and provide for annual
reductions in emissions of direct PM2.5 or a
PM2.5 plan precursor pollutant within the area of not less
than five percent per year from the most recent emissions inventory for
the area until attainment.\10\ The section 189(d) plan must also
include, among other things:
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    \10\ Id. and 40 CFR 51.1010(c).
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    1. A comprehensive, accurate, current inventory of actual emissions
from all sources of PM2.5 and PM2.5 precursors in
the area (CAA section 172(c)(3));
    2. plan provisions that require reasonable further progress (RFP)
(CAA 172(c)(2));
    3. quantitative milestones which are to be achieved every 3 years
until the area is redesignated attainment and which demonstrate RFP
toward attainment by the applicable date (CAA section 189(c)); and
    4. contingency measures to be implemented if the area fails to meet
RFP or to attain by the applicable attainment date (CAA section
172(c)(9)).
2. 2006 PM2.5 NAAQS
    On October 17, 2006, the EPA revised the 24-hour PM2.5
NAAQS by lowering it from 65 [micro]g/m\3\ to 35 [micro]g/m\3\.\11\
Effective December 14, 2009, the EPA designated the San Joaquin Valley
as nonattainment for the 2006 24-hour PM2.5 NAAQS. The EPA
initially classified the San Joaquin Valley area as a Moderate Area
effective July 2, 2014, and reclassified the area as

a Serious Area for the 2006 PM2.5 NAAQS effective February
19, 2016.\12\
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    \11\ 71 FR 61144 (October 17, 2006) (codified at 40 CFR 50.13).
    \12\ 79 FR 31566 (June 2, 2014), 81 FR 2993 (January 20, 2016),
and 81 FR 42263 (June 29, 2016) (correcting amendment).
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    Upon the area's reclassification as a Serious Area for the 2006
PM2.5 NAAQS, California was required to submit additional
SIP revisions by August 21, 2017, to satisfy the statutory requirements
that apply to Serious PM2.5 nonattainment areas, including
the requirements of subpart 4 of part D, title I of the Act.\13\
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    \13\ Id.
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    The Serious Area plan must include, among other things:
    1. A comprehensive, accurate, current inventory of actual emissions
from all sources of PM2.5 and PM2.5 precursors in
the area (CAA section 172(c)(3));
    2. provisions for the implementation of BACM, including best
available control technology (BACT), for sources of direct
PM2.5 and all PM2.5 plan precursors no later than
4 years after the area is reclassified (CAA section 189(b)(1)(B));
3. a demonstration (including air quality modeling) that the plan
provides for attainment as expeditiously as practicable but no later
than December 31, 2019, or where the State is seeking an extension of
the attainment date under section 188(e), a demonstration that
attainment by December 31, 2019, is impracticable and that the plan
provides for attainment by the most expeditious alternative date
practicable and no later than December 31, 2024, (CAA sections
188(c)(2) and 189(b)(1)(A)); \14\
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    \14\ A state seeking an extension of a Serious Area attainment
date under section 188(e) must also meet additional requirements
under that provision, including the requirement to demonstrate that
the SIP for the area includes the most stringent measures that are
included in any SIP or are achieved in practice in any state, and
can feasibly be implemented in the area. CAA section 188(e).
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    4. plan provisions that require RFP (CAA 172(c)(2));
    5. quantitative milestones which are to be achieved every 3 years
until the area is redesignated attainment and which demonstrate RFP
toward attainment by the applicable date (CAA section 189(c));
    6. provisions to assure that control requirements applicable to
major stationary sources of PM2.5 also apply to major
stationary sources of PM2.5 precursors, except where the
state demonstrates to the EPA's satisfaction that such sources do not
contribute significantly to PM2.5 levels that exceed the
standard in the area (CAA section 189(e));
    7. contingency measures to be implemented if the area fails to meet
RFP or to attain by the applicable attainment date (CAA section
172(c)(9)); and
    8. a revision to the nonattainment NSR program to lower the
applicable ``major stationary source'' thresholds from 100 tpy to 70
tpy (CAA section 189(b)(3)).
    3. 2012 PM2.5 NAAQS
    On December 14, 2012, the EPA revised the primary annual
PM2.5 standard by lowering it from 15.0 to 12.0 [micro]g/
m\3\.\15\ Effective April 15, 2015, the EPA designated and classified
the San Joaquin Valley as a Moderate nonattainment area for the 2012
annual PM2.5 NAAQS.\16\ This designation and classification
triggered a requirement for California to submit a Moderate Area plan
addressing attainment of the 2012 annual PM2.5 NAAQS in the
San Joaquin Valley no later than 18 months after the designation, i.e.,
by October 15, 2016.\17\
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    \15\ 78 FR 3086 (January 15, 2013) (codified at 40 CFR 50.18).
    \16\ 80 FR 2206 (January 15, 2015).
    \17\ CAA section 189(a)(2)(B).
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    The Moderate Area plan must include, among other things:
    1. A comprehensive, accurate, current inventory of actual emissions
from all sources of PM2.5 and PM2.5 precursors in
the area (CAA section 172(c)(3));
    2. provisions for the implementation of RACM, including reasonably
available control technology (RACT), for sources of direct
PM2.5 and all PM2.5 plan precursors no later than
4 years after designation (CAA section 189(a)(1)(C));
    3. a demonstration (including air quality modeling) that the plan
provides for attainment as expeditiously as practicable but no later
than December 31, 2021, or a demonstration that attainment by that date
is impracticable (CAA section 189(a)(1)(B));
    4. plan provisions that require RFP (CAA 172(c)(2));
    5. quantitative milestones which are to be achieved every 3 years
until the area is redesignated attainment and which demonstrate RFP
toward attainment by the applicable date (CAA section 189(c));
    6. provisions to assure that control requirements applicable to
major stationary sources of PM2.5 also apply to major
stationary sources of PM2.5 precursors, except where the
state demonstrates to the EPA's satisfaction that such sources do not
contribute significantly to PM2.5 levels that exceed the
standard in the area (CAA section 189(e));
    7. contingency measures to be implemented if the area fails to meet
RFP or to attain by the applicable attainment date (CAA section
172(c)(9)); and
    8. Any revisions to the nonattainment NSR program necessary to
implement the requirements of CAA section 189(a)(1)(A) for the 2012
PM2.5 NAAQS.

B. Minimum Criteria for Completeness of a SIP Submission

    Section 110(k)(1)(A) of the CAA requires that the EPA promulgate
minimum criteria that any plan submission must meet before the EPA is
required to act on such submission. The EPA has promulgated these
criteria at 40 CFR part 51, appendix V. We refer to these requirements
as the ``completeness criteria.'' Section 2.1 of the completeness
criteria requires that each plan submission include, among other
things: (1) Evidence that the State has adopted the plan in the State
code or body of regulations, including the date of adoption or final
issuance as well as the effective date of the plan, if different from
the adoption/issuance date, and (2) evidence that the State followed
all of the procedural requirements of the State's laws and constitution
in conducting and completing the adoption/issuance of the plan. Section
2.2 of the completeness criteria requires that each plan submission
contain certain technical support, including (1) a demonstration that
the SIP will protect RFP if approved, and (2) modeling to support the
proposed revision. The completeness criteria also identify other
administrative materials and technical support documentation that must
be included in each plan submission.\18\
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    \18\ See generally 40 CFR part 51, appendix V, sections 2.1 and
2.2.
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    Section 110(k)(2) of the CAA requires the EPA to act on a SIP
submission only after the State has submitted a SIP submission (or part
thereof) that meets the completeness criteria, either by EPA
determination or by operation of law under CAA section 110(k)(1)(B).

C. California's SIP Submissions

    On November 16, 2018, California submitted to the EPA a draft of
the ``2018 Plan for the 1997, 2006, and 2012 PM2.5
Standards'' (``2018 PM2.5 Plan''), a comprehensive plan for
attainment of the PM2.5 NAAQS in the San Joaquin Valley.
This submission includes substantial portions of a section 189(d) plan
addressing attainment of the 1997 PM2.5 NAAQS, a Serious
Area plan addressing attainment of the 2006 PM2.5 NAAQS, and
a Moderate Area plan addressing attainment of the 2012 PM2.5
NAAQS in the San Joaquin Valley. The

San Joaquin Valley Air Pollution Control District adopted the 2018
PM2.5 Plan on November 15, 2018.
    As a threshold matter, however, the California Air Resources Board
(CARB) noted in its letter transmitting the SIP submission to the EPA
that CARB had not yet presented the 2018 PM2.5 Plan to its
Board or adopted it for submission to the EPA as a revision to the
California SIP. CARB stated that it was providing the submission to the
EPA now so that EPA staff can begin its review while CARB completes the
final step in plan development when it considers approval of the 2018
PM2.5 Plan at its hearing scheduled for January 24-25,
2019.\19\
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    \19\ Letter dated November 16, 2018, from Kurt Karperos, Deputy
Executive Officer, CARB, to Mike Stoker, Regional Administrator, EPA
Region IX.
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    Accordingly, the EPA cannot at this time find that California has
submitted the required complete PM2.5 SIP revisions for the
San Joaquin Valley nonattainment area. CARB's November 16, 2018 SIP
submission does not include evidence that the State has adopted the
plan in the State code or body of regulations or evidence that the
State followed all of the procedural requirements of the State's laws
and constitution in conducting and completing the adoption/issuance of
the plan, as required by 40 CFR part 51, appendix V, section 2.1. Based
on these deficiencies alone, the SIP submission fails to meet the EPA's
minimum completeness criteria. In addition, until we receive the formal
SIP submission, we cannot determine whether the plan that CARB
ultimately adopts will contain all of the necessary components of the
required PM2.5 attainment plans for the San Joaquin Valley
and the associated technical support required for each submission under
40 CFR part 51, appendix V, section 2.2.
    We note, however, that CARB's submission represents a significant
step in the State's and District's multi-year effort to address the
Act's attainment planning requirements for the PM2.5 NAAQS
in the San Joaquin Valley, and we commit to continue working closely
with both agencies as they implement and enforce the requirements of
these plans going forward.

II. Consequences of Findings of Failure To Submit Complete SIPs

    Under section 110(k)(1)(C) of the Act, where the EPA determines
that a SIP submission (or part thereof) does not meet the EPA's minimum
completeness criteria established in 40 CFR part 51, appendix V, the
state shall be treated as not having made the submission (or part
thereof). Sections 179(a) and 110(c) of the CAA establish specific
consequences for failure to submit complete SIP submissions or SIP
elements required under part D of title I of the Act, including the
eventual imposition of mandatory sanctions in the affected area.
    In accordance with the EPA's sanctions sequencing rule in 40 CFR
52.31, the offset sanction identified in CAA section 179(b)(2) would
apply in the San Joaquin Valley area 18 months after the effective date
of these findings, if the EPA has not affirmatively determined by that
date that the State has submitted a complete SIP addressing the
deficiency that is the basis for these findings. If, within 6 months
after the offset sanction applies, the EPA still has not affirmatively
determined that the State has submitted a complete SIP addressing the
deficiency that is the basis for the findings, the highway funding
sanction identified in CAA section 179(b)(1) would also apply in the
San Joaquin Valley. Under 40 CFR 52.31(d)(5), neither sanction would
apply if the EPA determines within 18 months after the effective date
of these findings that the State has submitted a complete SIP
submission addressing the deficiency that is the basis for these
findings.
    Additionally, a finding of failure to submit a complete SIP
submission triggers an obligation under CAA section 110(c) for the EPA
to promulgate a FIP no later than 2 years after the finding, unless the
state has submitted, and the EPA has approved, the required SIP
submittal. Thus, the EPA would be required to promulgate a
PM2.5 FIP for the San Joaquin Valley, in relevant part, if
California does not submit and the EPA does not approve all of the
necessary SIP submissions within 2 years after the effective date of
these findings.

III. Final Action

    The EPA is finding that California has failed to submit complete
SIP revisions for implementation of the 1997, 2006, and 2012
PM2.5 NAAQS in the San Joaquin Valley as required under
subparts 1 and 4 of part D, title I of the CAA and the PM2.5
SIP Requirements Rule. The consequences of these findings are discussed
above in section II of this notice.

IV. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Executive Order
13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was,
therefore, not submitted to the Office of Management and Budget (OMB)
for review.

B. Executive Order 13771: Reducing Regulation and Controlling
Regulatory Costs

    This action is not an Executive Order 13771 regulatory action
because this action is not significant under Executive Order 12866.

C. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under
the provisions of the PRA. This final rule does not establish any new
information collection requirement apart from what is already required
by law. This rule relates to the requirements in the CAA for states to
submit SIPs under sections 172, 188 and 189 which address the statutory
requirements that apply to areas designated as nonattainment for the
PM2.5 NAAQS.

D. Regulatory Flexibility Act (RFA)

    I certify that this rule will not have a significant economic
impact on a substantial number of small entities under the RFA. This
action will not impose any requirements on small entities. The rule is
a finding that California has not submitted the necessary SIP
revisions.

E. Unfunded Mandates Reform Act of 1995 (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. The action imposes no enforceable duty on any state,
local or tribal governments or the private sector.

F. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government.

G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications as specified in
Executive

Order 13175. This rule finds that California has failed to submit SIP
revisions that satisfy certain nonattainment area planning requirements
under sections 172, 188 and 189 of the CAA for the 1997, 2006, and 2012
PM2.5 NAAQS for the San Joaquin Valley nonattainment area.
No tribe is subject to the requirement to submit an implementation plan
under section 172 or under subpart 4 of part D of Title I of the CAA.
Thus, Executive Order 13175 does not apply to this action.

H. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern health or safety risks that the EPA has
reason to believe may disproportionately affect children, per the
definition of ``covered regulatory action'' in section 2-202 of the
Executive Order. This action is not subject to Executive Order 13045
because it is a finding that California has failed to submit certain
SIP revisions that satisfy the nonattainment area planning requirements
under sections 172, 188 and 189 of the CAA for the 1997, 2006, and 2012
PM2.5 NAAQS for the San Joaquin Valley nonattainment area
and does not directly or disproportionately affect children.

I. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution or Use

    This action is not subject to Executive Order 13211, because it is
not a significant regulatory action under Executive Order 12866.

J. National Technology Transfer and Advancement Act

    This rulemaking does not involve technical standards.

K. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    The EPA believes the human health or environmental risk addressed
by this action will not have potential disproportionately high and
adverse human health or environmental effects on minority, low-income,
or indigenous populations. In finding that California has failed to
submit SIP revisions that satisfy certain nonattainment area planning
requirements under sections 172, 188 and 189 of the CAA for the1997,
2006, and 2012 PM2.5 NAAQS for the San Joaquin Valley
nonattainment area, this action does not directly affect the level of
protection provided to human health or the environment.

L. Congressional Review Act (CRA)

    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. The 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).

M. Judicial Review

    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 February 4, 2019. 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, Administrative practice and procedures,
Air pollution control, Approval and promulgation of implementation
plans, Administrative practice and procedures, Incorporation by
reference, Intergovernmental relations, Particulate matter, and
Reporting and recordkeeping requirements.

    Dated: November 19, 2018.
Deborah Jordan,
Acting Regional Administrator, Region IX.
[FR Doc. 2018-26359 Filed 12-4-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: April 18, 2008 (Volume 73, Number 76)]
[Notices]
[Page 21139-21142]
[DOCID:fr18ap08-71]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-N-0321] (formerly Docket No. 2007N-0485)

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Application for Food
and Drug Administration Approval to Market a New Drug

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by May 19,
2008.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or e-mailed to<EMAIL_ADDRESS>All comments
should be identified with the OMB control number 0910-0111 and
Application for Food and Drug Administration Approval to Market a New
Drug. Also include the FDA docket number found in brackets in the
heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Application for Food and Drug Administration Approval to Market a New
Drug--(OMB Control Number 0910-0001--Extension)

    Under section 505(a) of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 355(a)), a new drug may not be commercially
marketed in the United States, imported, or exported from the United
States, unless an approval of an application filed with FDA under
section 505(b) or 505(j) of the act is effective with respect to such
drug. Under the act, it is the sponsor's responsibility to provide the
information needed by FDA to make a scientific and technical
determination whether the product is safe and effective for use.
    This information collection approval request is for all information
requirements imposed on sponsors by the regulations under part 314 (21
CFR part 314), who apply for approval of a new drug application (NDA)
or abbreviated new drug application (ANDA) in order to market or to
continue to market a drug.
    Section 314.50(a) requires that an application form (Form FDA 356h)
be submitted that includes introductory information about the drug as
well as a checklist of enclosures.
    Section 314.50(b) requires that an index be submitted with the
archival copy of the application and that it reference certain sections
of the application.
    Section 314.50(c) requires that a summary of the application be
submitted that presents a good general synopsis of all the technical
sections and other information in the application.
    Section 314.50(d) requires that the NDA contain the following
technical sections about the new drug: Chemistry, manufacturing, and
controls; nonclinical pharmacology and toxicology; human
pharmacokinetics and bioavailability; microbiology; clinical data; and
statistical section.
    Section 314.50(e) requires the applicant to submit samples of the
drug if requested by FDA. In addition, the archival copy of the
application must include copies of the label and all labeling for the
drug.
    Section 314.50(f) requires that case report forms and tabulations
be submitted with the archival copy.
    Section 314.50(h) requires that patent information, as described
under Sec.  314.53, be submitted with the application. (The burden
hours for Sec.  314.50(h) are already approved by OMB under OMB control
number 0910-0513 and are not included in the burden estimates in table
1 of this document.)
    Section 314.50(i) requires that patent certification information be
submitted in section 505(b)(2) applications for patents claiming the
drug, drug product, or method of use.
    Section 314.50(j) requires that applicants that request a period of
marketing exclusivity submit certain information with the application.
    Section 314.50(k) requires that an archival, review, and field copy
of the application be submitted.
    Section 314.52 requires that any notice of certification of
invalidity or noninfringement of a patent to each patent owner and the
NDA holder be sent by a section 505(b)(2) applicant that relies on a
listed drug. A 505(b)(2) applicant is required to amend its application
at the time notice is provided to include a statement certifying that
the required notice has been provided. A 505(b)(2) applicant also is
required to amend its application to document receipt of the required
notice.
    Section 314.54 sets forth the content requirements for applications
filed under section 505(b)(2) of the act. (The information collection
burden estimate for 505(b)(2) applications is included in table 1 of
this document under the estimates for Sec.  314.50 (a), (b), (c), (d),
(e), (f), and (k)).
    Section 314.60 sets forth reporting requirements for sponsors who
amend an unapproved application.
    Section 314.65 states that the sponsor must notify FDA when
withdrawing an unapproved application.
    Sections 314.70 and 314.71 require that supplements be submitted to
FDA for certain changes to an approved application.
    Section 314.72 requires sponsors to report to FDA any transfer of
ownership of an application.
    Section 314.80(c)(1) and (c)(2) sets forth requirements for
expedited adverse drug experience postmarketing reports and followup
reports, as well as for periodic adverse drug experience postmarketing
reports (Form FDA 3500A). (The burden hours for Sec. Sec.  314.80(c)(1)
and (c)(2) are already approved by OMB under OMB control numbers 0910-
0230 and 0910-0291 and are not included in the burden estimates in
table 1 of this document.)
    Section 314.80(i) establishes recordkeeping requirements for
reports of postmarketing adverse drug experiences. (The burden hours
for Sec.  314.80(i) are already approved by OMB under OMB control
numbers 0910-0230 and 0910-0291 and are not included in the burden
estimates in table 1 of this document.)

    Section 314.81(b)(1) requires that field alert reports be submitted
to FDA (Form FDA 3331).
    Section 314.81(b)(2) requires that annual reports be submitted to
FDA (Form FDA 2252).
    Section 314.81(b)(3)(i) requires that drug advertisements and
promotional labeling be submitted to FDA (Form FDA 2253). Form FDA 2253
has been revised by FDA as follows: On line 8, ``Please check one or
both'' has been revised to read ``Please check only one.'' In the
instruction for line 8, the sentence ``Consumer and professional pieces
should be submitted separately'' has been added.
    Section 314.81(b)(3)(iii) sets forth reporting requirements for
sponsors who withdraw an approved drug product from sale. (The burden
hours for Sec.  314.81(b)(3)(iii) are already approved by OMB under OMB
control number 0910-0045 and are not included in the burden estimates
in table 1 of this document.)
    Section 314.90 sets forth requirements for sponsors who request
waivers from FDA for compliance with Sec. Sec.  314.50 through 314.81.
(The information collection burden estimate for NDA waiver requests is
included in table 1 of this document under estimates for Sec. Sec.
314.50, 314.60, 314.70 and 314.71.)
    Section 314.93 sets forth requirements for submitting a suitability
petition in accordance with 21 CFR 10.20 and 10.30. (The burden hours
for Sec.  314.93 are already approved by OMB under control number 0910-
0183 and are not included in the burden estimates in table 1 of this
document.)
    Section 314.94(a) and (d) requires that an ANDA contain the
following information: Application form; table of contents; basis for
ANDA submission; conditions of use; active ingredients; route of
administration, dosage form, and strength; bioequivalence; labeling;
chemistry, manufacturing, and controls; samples; patent certification.
    Section 314.95 requires that any notice of certification of
invalidity or noninfringement of a patent to each patent owner and the
NDA holder be sent by ANDA applicants.
    Section 314.96 sets forth requirements for amendments to an
unapproved ANDA.
    Section 314.97 sets forth requirements for submitting supplements
to an approved ANDA for changes that require FDA approval.
    Section 314.98(a) sets forth postmarketing adverse drug experience
reporting and recordkeeping requirements for ANDAs. (The burden hours
for Sec.  314.98(a) are already approved by OMB under OMB control
numbers 0910-0230 and 0910-0291 and are not included in the burden
estimates in table 1 of this document.)
    Section 314.98(c) requires other postmarketing reports for ANDAs:
Field alert reports (Form FDA 3331), annual reports (Form FDA 2252),
and advertisements and promotional labeling (Form FDA 2253). (The
information collection burden estimate for field alert reports is
included in table 1 of this document under Sec.  314.81(b)(1); the
estimate for annual reports is included under Sec.  314.81(b)(2); the
estimate for advertisements and promotional labeling is included under
Sec.  314.81(b)(3)(i).)
    Section 314.99(a) requires that sponsors comply with certain
reporting requirements for withdrawing an unapproved ANDA and for a
change in ownership of an ANDA.
    Section 314.99(b) sets forth requirements for sponsors who request
waivers from FDA for compliance with Sec. Sec.  314.92 through 314.99.
(The information collection burden estimate for ANDA waiver requests is
included in table 1 of this document under estimates for Sec.
314.94(a) and (d) and Sec. Sec.  314.96 and 314.97.)
    Section 314.101(a) states that if FDA refuses to file an
application, the applicant may request an informal conference with FDA
and request that the application be filed over protest.
    Section 314.107(c) requires notice to FDA by the first applicant to
submit a substantially complete ANDA containing a certification that a
relevant patent is invalid, unenforceable, or will not be infringed of
the date of first commercial marketing.
    Section 314.107(e) requires that an applicant submit a copy of the
entry of the order or judgment to FDA within 10 working days of a final
judgment.
    Section 314.107(f) requires that ANDA or section 505(b)(2)
applicants notify FDA immediately of the filing of any legal action
filed within 45 days of receipt of the notice of certification. A
patent owner may also notify FDA of the filing of any legal action for
patent infringement. If the patent owner or approved application holder
who is an exclusive patent licensee waives its opportunity to file a
legal action for patent infringement within the 45-day period, the
patent owner or approved application holder must submit to FDA a waiver
in the specified format.
    Section 314.110(a)(3) and (a)(4) states that, after receipt of an
FDA approvable letter, an applicant may request an opportunity for a
hearing on the question of whether there are grounds for denying
approval of the application. (The burden hours for Sec.  314.110(a)(3)
and (a)(4) are included under parts 10 through 16 (21 CFR part 16)
hearing regulations, in accordance with Sec.  314.201, and are not
included in the burden estimates in table 1 of this document.)
    Section 314.110(a)(5) states that, after receipt of an approvable
letter, an applicant may notify FDA that it agrees to an extension of
the review period so that it can determine whether to respond further.
    Section 314.110(b) states that, after receipt of an approvable
letter, an ANDA applicant may request an opportunity for a hearing on
the question of whether there are grounds for denying approval of the
application. (The burden hours for Sec.  314.110(b) are included under
parts 10 through 16 hearing regulations, in accordance with Sec.
314.201, and are not included in the burden estimates in table 1 of
this document.)
    Section 314.120(a)(3) states that, after receipt of a not
approvable letter, an applicant may request an opportunity for a
hearing on the question of whether there are grounds for denying
approval of the application. (The burden hours for Sec.  314.120(a)(3)
are included under parts 10 through 16 hearing regulations, in
accordance with Sec.  314.201, and are not included in the hour burden
estimates in table 1 of this document.)
    Section 314.120(a)(5) states that, after receipt of a not
approvable letter, an applicant may notify FDA that it agrees to an
extension of the review period so that it can determine whether to
respond further.
    Section 314.122(a) requires that an ANDA or a suitability petition
that relies on a listed drug that has been voluntarily withdrawn from
sale must be accompanied by a petition seeking a determination whether
the drug was withdrawn for safety or effectiveness reasons. (The burden
hours for Sec.  314.122(a) are already approved by OMB under OMB
control number 0910-0183 and are not included in the burden estimates
in table 1 of this document.)
    Section 314.122(d) sets forth requirements for relisting petitions
for unlisted discontinued products. (The burden hours for Sec.
314.122(d) are already approved by OMB under OMB control number 0910-
0183 and are not included in the burden estimates in table 1 of this
document.)
    Section 314.126(c) sets forth requirements for a petition to waive
criteria for adequate and well-controlled studies. (The burden hours
for Sec.  314.126(c) are already approved by OMB under 0910-0183 and
are not included in the burden estimates in table 1 of this document.)

    Section 314.151(a) and (b) set forth requirements for the
withdrawal of approval of an ANDA and the applicant's opportunity for a
hearing and submission of comments. (The burden hours for Sec.
314.151(a) and (b) are included under parts 10 through 16 hearing
regulations, in accordance with Sec.  314.201, and are not included in
the burden estimates in table 1 of this document.)
    Section 314.151(c) sets forth the requirements for withdrawal of
approval of an ANDA and the applicant's opportunity to submit written
objections and participate in a limited oral hearing. (The burden hours
for Sec.  314.151(c) are included under parts 10 through 16 hearing
regulations, in accordance with Sec.  314.201, and are not included in
the burden estimates in table 1 of this document.)
    Section 314.152(b) sets forth the requirements for suspension of an
ANDA when the listed drug is voluntarily withdrawn for safety and
effectiveness reasons, and the applicant's opportunity to present
comments and participate in a limited oral hearing. (The burden hours
for Sec.  314.152(b) are included under parts 10 through 16 hearing
regulations, in accordance with Sec.  314.201, and is not included in
the burden estimates in table 1 of this document.)
    Section 314.161(b) and (e) sets forth the requirements for
submitting a petition to determine whether a listed drug was
voluntarily withdrawn from sale for safety or effectiveness reasons.
(The burden hours for Sec.  314.161(b) and (e) are already approved by
OMB under OMB control number 0910-0183 and are not included in the
burden estimates in table 1 of this document.)
    Section 314.200(c), (d), and (e) requires that applicants or others
subject to a notice of opportunity for a hearing who wish to
participate in a hearing file a written notice of participation and
request for a hearing as well as the studies, data, and so forth,
relied on. Other interested persons may also submit comments on the
notice. This section also sets forth the content and format
requirements for the applicants' submission in response to notice of
opportunity for hearing. (The burden hours for Sec.  314.200(c), (d),
and (e) are included under parts 10 through 16 hearing regulations, in
accordance with Sec.  314.201, and are not included in the burden
estimates in table 1 of this document.)
    Section 314.200(f) states that participants in a hearing may make a
motion to the presiding officer for the inclusion of certain issues in
the hearing. (The burden hours for Sec.  314.200(f) are included under
parts 10 through 16 hearing regulations, in accordance with Sec.
314.201, and are not included in the burden estimates in table 1 of
this document.)
    Section 314.200(g) states that a person who responds to a proposed
order from FDA denying a request for a hearing provide sufficient data,
information, and analysis to demonstrate that there is a genuine and
substantial issue of fact which justifies a hearing. (The burden hours
for Sec.  314.200(g) are included under parts 10 through 16 hearing
regulations, in accordance with Sec.  314.201, and is not included in
the burden estimates in table 1 of this document.)
    Section 314.420 states that an applicant may submit to FDA a drug
master file in support of an application, in accordance with certain
content and format requirements.
    Section 314.430 states that data and information in an application
are disclosable under certain conditions, unless the applicant shows
that extraordinary circumstances exist. (The burden hours for Sec.
314.430 is included under parts 10 through 16 hearing regulations, in
accordance with Sec.  314.201, and is not included in the burden
estimates in table 1 of this document.)
    Section 314.530(c) and (e) states that, if FDA withdraws approval
of a drug approved under the accelerated approval procedures, the
applicant has the opportunity to request a hearing and submit data and
information. (The burden hours for Sec.  314.530(c) and (e) are
included under parts 10 through 16 hearing regulations, in accordance
with Sec.  314.201, and are not included in the burden estimates in
table 1 of this document.)
    Section 314.530(f) requires that an applicant first submit a
petition for stay of action before requesting an order from a court for
a stay of action pending review. (The burden hours for Sec.  314.530(f)
are already approved by OMB under 0910-0194 and are not included in the
burden estimates in table 1 of this document.)
    Section 314.610(b)(1) requires that applicants include a plan or
approach to postmarketing study commitments in applications for
approval of new drugs when human efficacy studies are not ethical or
feasible, and provide status reports of postmarketing study
commitments. (The information collection burden estimate for Sec.
314.610(b)(1) is included in table 1 of this document under the
estimates for Sec. Sec.  314.50 (a), (b), (c), (d), (e), (f), and (k)
and 314.81(b)(2)).
    Section 314.610(b)(3) requires that applicants propose labeling to
be provided to patient recipients in applications for approval of new
drugs when human efficacy studies are not ethical or feasible. (The
information collection burden estimate for Sec.  314.610(b)(3) is
included in table 1 of this document under the estimates for Sec.
314.50(e)).
    Section 314.630 requires that applicants provide postmarketing
safety reporting for applications for approval of new drugs when human
efficacy studies are not ethical or feasible. (The burden hours for
Sec.  314.630 are already approved by OMB under OMB control numbers
0910-0230 and 0910-0291 and are not included in the burden estimates in
table 1 of this document.)
    Section 314.640 requires that applicants provide promotional
materials for applications for approval of new drugs when human
efficacy studies are not ethical or feasible. (The information
collection burden estimate for Sec.  314.640 is included in table 1 of
this document under the estimates for Sec.  314.81(b)(3)(i)).
    Respondents to this collection of information are all persons who
submit an application or abbreviated application or an amendment or
supplement to FDA under part 314 to obtain approval of a new drug, and
any person who owns an approved application or abbreviated application.
    In the Federal Register of January 4, 2008 (73 FR 865), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
  21 CFR Section          No. of         No. of Responses       Total Annual        Hours Per
   [Form Number]       Respondents        Per Respondent         Responses          Response        Total Hours
----------------------------------------------------------------------------------------------------------------
314.50 (a), (b),                   85                  1.41                120          1,917            230,040
 (c), (d), (e),
 (f), and (k)
----------------------------------------------------------------------------------------------------------------

314.50(i) and                      96                  9.61                923              2              1,846
 314.94(a)(12)
----------------------------------------------------------------------------------------------------------------
314.50(j)                          71                  4.02                286              2                572
----------------------------------------------------------------------------------------------------------------
314.52 and 314.95                  71                  3.66                260             16              4,160
----------------------------------------------------------------------------------------------------------------
314.60                            305                 15.05              4,590             80            367,200
----------------------------------------------------------------------------------------------------------------
314.65                             13                  1.08                 14              2                 28
----------------------------------------------------------------------------------------------------------------
314.70 and 314.71                 281                  9.30              2,613            150            391,950
----------------------------------------------------------------------------------------------------------------
314.72                             69                  3.40                235              2                470
----------------------------------------------------------------------------------------------------------------
314.81(b)(1)                      114                  2.68                306              8              2,448
 [3331]
----------------------------------------------------------------------------------------------------------------
314.81(b)(2)                      724                 11.15              8,073             40            322,920
 [2252]
----------------------------------------------------------------------------------------------------------------
314.81(b)(3)(i)                   390                 61.39             23,942              2             47,884
 [2253]
----------------------------------------------------------------------------------------------------------------
314.94(a)(1)-(11)                 110                  7.21                793            480            380,640
 and (d)
----------------------------------------------------------------------------------------------------------------
314.96                            300                 28                 8,400             80            672,000
----------------------------------------------------------------------------------------------------------------
314.97                            215                 20.66              4,442             80            355,360
----------------------------------------------------------------------------------------------------------------
314.99(a)                          40                  2.02                 81              2                162
----------------------------------------------------------------------------------------------------------------
314.101(a)                          1                  1                     1               .50             .50
----------------------------------------------------------------------------------------------------------------
314.107(c) -                       56                  4.1                 230               .50             115
314.107(e) -                       25                  3.92                 98               .50              49
314.107(f) -                       56                  4.1                 230               .50             115
----------------------------------------------------------------------------------------------------------------
314.110(a)(5)                      45                  1.15                 52               .50              26
----------------------------------------------------------------------------------------------------------------
314.120(a)(5)                      10                  1.20                 12               .50               6
----------------------------------------------------------------------------------------------------------------
314.420                           487                  1.98                964             61             58,804
----------------------------------------------------------------------------------------------------------------
Total                                                                                2,836,795.5
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: April 10, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-8459 Filed 4-17-08; 8:45 am]

BILLING CODE 4160-01-S