[Federal Register Volume 82, Number 2 (Wednesday, January 4, 2017)]
[Rules and Regulations]
[Pages 729-733]
[FR Doc No: 2016-31643]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R10-OAR-2015-0067; FRL-9957-71-Region 10]

Partial Approval and Partial Disapproval of Attainment Plan for
the Idaho Portion of the Logan, Utah/Idaho PM2.5 Nonattainment Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action on portions of a state implementation plan (SIP) submission from
the State of Idaho. The SIP submission addresses attainment plan
requirements for the Idaho portion of the Logan, Utah-Idaho
nonattainment area (Logan UT-ID) for the 2006 24-hour PM2.5
National Ambient Air Quality Standards (NAAQS). The Idaho Department of
Environmental Quality (IDEQ) submitted the attainment plan to the EPA
on December 14, 2012 (2012 SIP submission), and supplemented the
attainment plan on December 24, 2014 (2014 amendment). The EPA is
approving certain portions, disapproving other portions, and deferring
action on the remaining portions of the attainment plan.

DATES: This final rule is effective February 3, 2017.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R10-OAR-2015-0067. All documents in the docket are
listed on the http://www.regulations.gov Web site. Although listed in
the index, some information may not be publicly available, i.e.,
Confidential Business Information or other information the disclosure
of which is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the Internet and is publicly
available only in hard copy form. Publicly available docket materials
are available at http://www.regulations.gov or at EPA Region 10, Office
of Air and Waste, 1200 Sixth Avenue, Seattle, Washington 98101. The EPA
requests that you contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to schedule your inspection. The Regional
Office's official hours of business are Monday through Friday, 8:30 to
4:30, excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Jeff Hunt, Air Planning Unit, Office
of Air and Waste (OAW-150), Environmental Protection Agency, Region 10,
1200 Sixth Ave, Suite 900, Seattle, WA 98101; telephone number: (206)
553-0256; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background Information
II. Response to Comments
III. Final Action
IV. Consequences of a Disapproved SIP
V. Statutory and Executive Orders Review

I. Background Information

    On October 27, 2016, the EPA proposed to approve certain portions
and disapprove other portions of Idaho's 2012 SIP submission and 2014
amendment (81 FR 74741). An explanation of the CAA requirements, a
detailed analysis of the submittals, and the EPA's reasons for
proposing partial approval and partial disapproval were provided in the
notice of proposed rulemaking, and will not be restated here. In this
action, the EPA is approving Idaho's determination of which pollutants
must be evaluated for control in the Idaho portion of the Logan, UT-ID
nonattainment area for purposes of the Moderate area plan for the 2006
24-hour PM2.5 NAAQS. The EPA is also approving Idaho's
evaluation of, and imposition of, reasonably available control measure
and reasonably available control technology (RACM/RACT) level controls
on appropriate sources in the Idaho portion of the nonattainment area.
The EPA is disapproving the Idaho attainment plan with respect to the
contingency measure requirement. Finally, the EPA is deferring action
on the submissions with respect to the attainment demonstration,
reasonable further progress, quantitative milestone, and motor vehicle
emission budget requirements to a future date.
    With respect to the deferred Moderate area plan elements the EPA
notes that on December 16, 2016, the Agency published a proposed
determination, based on complete, quality-assured air quality and
certified monitoring data, that the Logan UT-ID nonattainment area
failed to attain the 24-hour PM2.5 NAAQS by the applicable
attainment date (81 FR 91088). If the EPA finalizes the determination
that Logan UT-ID did not attain, then the nonattainment area will be
reclassified from ``Moderate'' to ``Serious'' and Idaho will be
required to submit a Serious area attainment plan to meet additional
statutory requirements. The EPA anticipates that Idaho may elect to
reevaluate and address the deferred elements of the Moderate area plan,
as well as the contingency measure requirements, in the context of
developing the Serious area attainment plan.
    The EPA received three sets of comments on the proposed action that
pertain to portions of the 2012 SIP submission and 2014 amendment that
are relevant to this final action. The EPA is responding to those
comments in this notice. Comments that pertain to the attainment
demonstration, reasonable further progress, quantitative milestone, and
motor vehicle emissions budget requirements will be addressed when the
EPA takes final action on these plan elements.

II. Response to Comments

    Commenter 1, comment 1: A citizen observed, ``As I have traveled
north out of Logan toward Idaho I have noticed that the inversion gets
lighter. The PM2.5 that hangs thick and cloudy over Logan
turns to spidery, wispy clouds that just reach across the mountains.
They reach and then disappear completely. I don't think the emissions
and PM2.5 are coming from cars in Franklin County Idaho. I
think that they are coming from Logan and traveling up the valley into
Franklin County, Idaho.''

    Response: The commenter's observation concerning the appearance of
air quality during inversions is generally consistent with Idaho's
monitoring data and air quality studies for the area which show lower
PM2.5 concentrations outside of the immediate Logan area.
Monitored levels of ambient PM2.5 are typically higher in
Utah than in Idaho. For example, the measured 98th percentile of
PM2.5 concentrations at the Franklin, Idaho monitor in 2015
was 19 [micro]g/m\3\. However, in the context of the nonattainment area
designations that were finalized in 2009, the EPA determined that
emissions from sources in Idaho, including not only cars but also other
area sources of emissions, were contributing to violations of the 2006
24-hour PM2.5 NAAQS in the Logan, UT-ID nonattainment area
as part of the CAA section 107(d)(1)(A) designation process.\1\
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    \1\ Technical Support Document for 2006 24-Hour PM2.5
National Ambient Air Quality Standards (NAAQS) Designations, Chapter
4.0 ``Technical Analyses of Individual Nonattainment Areas'' Section
4.10 ``Region 10 Nonattainment Areas'' Part 4.10.2 ``EPA Technical
Analysis for Idaho'' (204_supplementary material_EPA-HQ-OAR-2007-
0562-0439.pdf).
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    Commenter 1, comment 2: The commenter also stated, ``Putting auto
emissions mandates in Franklin County, Idaho will not help anything. It
will only add more financial issues to a rural community. I don't think
it is necessary for auto emissions to be put in place in Franklin
County, Idaho.''
    Response: As discussed in the proposed rulemaking for this action,
the EPA proposed to agree with the IDEQ's determination that a Franklin
County inspection and maintenance (I&M) program for motor vehicles was
not a reasonable control approach based on factors including the cost
of control and economic feasibility (see pages 81 FR 74745-6). We are
now finalizing that determination. We also note that existing federal
motor vehicle emission regulations and requirements are having, and
will continue to have, significant emission reduction benefits in this
airshed (see section 5.3.8 of the 2012 SIP submittal).
    Commenter 1, comment 3: The commenter also stated, ``I think that
the wood stove change-out and burn ban are good things to have in place
to help reduce the carbon that is being put into the air; however, I
think there needs to be more done in the Logan area to reduce their
emissions and I'm sure they are working on it also. Logan is continuing
to get more people to ride the bus.'' The commenter then elaborated on
several suggested control strategies for Utah portion of the
nonattainment area.
    Response: As discussed in our proposed rulemaking, the EPA proposed
to approve the woodstove curtailment, device restrictions, and burn ban
control measures for Franklin County, that are already incorporated
into the SIP, as meeting the requirements of the CAA for purposes of
RACM/RACT level control of appropriate sources in this area for
purposes of the 2006 24-hour PM2.5 NAAQS (see pages 81 FR
74746-7). The EPA is finalizing this determination. To the extent that
the commenter has additional suggestions for the Utah portion of the
Logan, UT-ID nonattainment area, these suggestions are outside the
scope of this action which is directed at the EPA's review of Idaho's
attainment plan.
    Commenter 2, comment 1: Another commenter noted, ``We like the air
the way it is. Your meddling in these situations is not welcome. Please
do not pursue these ridiculous `rules' further.''
    Response: Under the CAA, states and the EPA are required to take
actions to protect public health from air pollution. Exposure to
elevated levels of PM2.5 results in serious health impacts
up to and including premature death from respiratory or cardiovascular
diseases, and is especially unhealthy for sensitive populations such as
children. Thus, CAA section 189(a) requires states with areas
designated as Moderate nonattainment for the 2006 24-hour
PM2.5 NAAQS to develop and submit a plan to improve air
quality to meet the standards, including provisions to assure
implementation of RACM/RACT level controls to reduce emissions. Under
CAA section 110(k) the EPA has a mandatory duty to act on these state
SIP submissions. In evaluating and acting upon Idaho's attainment plan
SIP submission in this action, the EPA is complying with its own duty
under the CAA.
    State of Idaho, comment 1: On behalf of the State of Idaho, the
IDEQ submitted several comments. The first comment questions the basis
of the EPA's December 14, 2009 decision to include Franklin County as
part of the Logan UT-ID nonattainment area (74 FR 58688). The IDEQ
states, ``Upon review of the plans submitted by both Idaho and Utah it
is readily apparent that Idaho's emission sources are truly de minimis
and the motor vehicle commuter pattern is equal with respect to the
number of vehicles traveling from Idaho to Utah and from Utah to Idaho.
Consequently, Idaho questions the technical reasons for its inclusion
in this NAA, and the jurisdictional authority issues have not only held
the state of Idaho back from obtaining plan approval, but also from
obtaining a one-year extension to demonstrate compliance with the
PM2.5 NAAQS. As a result, DEQ intends to request that the
current NAA be split into two separate PM2.5 NAAs, similar
to the revision that occurred in the Power-Bannock Counties. 63 FR
59722.''
    Response: As noted by the commenter, the determination to designate
Franklin County, Idaho as part of the Logan UT-ID nonattainment area
was completed in December 2009 and is outside the scope of this action
which is directed at the EPA's review of Idaho's attainment plan SIP
submission. In addition, should Idaho submit a petition to split the
nonattainment area, the EPA will review the technical merits of the
petition. However, such a review is also outside the scope of this
action.
    State of Idaho, comment 2: The IDEQ resubmitted its February 26,
2016 request for a one-year extension of the Moderate area attainment
date and questions the EPA's rationale for determining that the area
did not attain by the attainment date, stating ``DEQ should not be
punished for Utah's acts or omissions.''
    Response: The EPA has addressed whether the Logan, UT-ID
nonattainment area attained the 2006 24-hour PM2.5 NAAQS and
the IDEQ's attainment date extension request in the rulemaking
Determinations of Attainment by the Attainment Date, Determinations of
Failure to Attain by the Attainment Date and Reclassification for
Certain Nonattainment Areas for the 2006 24-Hour Fine Particulate
Matter National Ambient Air Quality Standards (81 FR 91088, December
16, 2016). This comment is thus outside the scope of this action and
the EPA is not restating our rationale here.
    State of Idaho, comment 3: The IDEQ states, ``It should also be
noted that on May 25, 2016, a Consent Decree was filed in U.S. District
Court for the Northern District of California, Oakland Division,
wherein EPA committed to act on the remaining items in Idaho's Plan by
December 8, 2016. In the same Decree EPA did not commit to act on
Utah's NAA plan. EPA is treating the two areas separately. Thus, not
only should the area be split in two NAA for technical reasons, for
planning purposes, the area is on two very separate tracts--with Idaho
further along.''
    Response: The EPA acknowledges that the Consent Decree in the
litigation identified by the commenter did not include any deadline for
an attainment plan submission from the State of Utah

for the Utah portion of the Logan, UT-ID nonattainment area. This is
because although the litigation at issue initially included a claim
that the EPA had failed to act on such a SIP submission from Utah, the
State of Utah elected to withdraw the SIP submission. Thus, at the time
of that Consent Decree, the EPA did not have a mandatory duty to act on
the withdrawn Utah SIP submission. Utah subsequently resubmitted an
attainment plan for the Utah portion of the Logan, UT-ID nonattainment
area on December 16, 2014. The EPA is currently evaluating that later
SIP submission in order to meet its statutory obligations under CAA
section 110(k).
    State of Idaho, comment 4: The IDEQ states, ``DEQ, in good faith,
complied with all regulations and guidance in place at the time of
submittal for both the original Plan in 2012 and the amendment in 2014.
Table 10 in the 2012 Plan submittal lists how DEQ complied with each
requirement at that time. In the current proposed action, the EPA is
evaluating DEQ' s submittal against current regulations. Instead of
disapproving portions of Idaho's Plan, the EPA could request DEQ
address certain deficiencies due to the new regulations and court
decisions; as was done to address the Court decision in 2013.'' In
particular, the IDEQ calls into question the EPA's proposed disapproval
of the attainment plan with respect to the reasonable further progress,
quantitative milestones, and contingency measure requirements.
    Response: The EPA acknowledges the difficulties the January 4,
2013, NRDC v. EPA, D.C. Circuit Court decision (706 F.3d 428) and
remand of the prior PM2.5 implementation rule presented for
both the EPA and Idaho. As noted by the commenter, the EPA provided
states with additional time to withdraw and resubmit, or to supplement,
prior attainment plan SIP submissions in order to address any impacts
that resulted from the court's decision. See, Identification of
Nonattainment Classification and Deadlines for Submission of State
Implementation Plan (SIP) Provisions for the 1997 Fine Particle
(PM2.5) National Ambient Air Quality Standard (NAAQS) and
2006 PM2.5 NAAQS (79 FR 31566, June 2, 2014). The EPA
appreciates the efforts of Idaho to update its attainment plan in the
2014 amendment. However, the EPA is required by statute to evaluate the
attainment plan for compliance with statutory and regulatory
requirements, and must do so consistent with the requirements of the
CAA, as interpreted by the courts. The EPA will continue to work with
the IDEQ to meet the statutory attainment plan requirements, such as
the contingency measure requirement addressed in this action. In
addition, the EPA recently promulgated the 2016 PM2.5
Implementation Rule in order to provide additional regulatory certainty
and guidance concerning attainment plan requirements for the 2006 24-
hour PM2.5 NAAQS and future PM2.5 NAAQS. See,
Fine Particulate Matter National Ambient Air Quality Standards; State
Implementation Plan Requirements; Final Rule (81 FR 58010, August 24,
2016).
    State of Idaho, comment 5: The IDEQ questions the EPA's proposed
disapproval of the Idaho contingency measures citing the EPA's basis
that the emissions reductions were not precisely quantified in terms of
1-year's worth of reasonable further progress (RFP). The IDEQ also
notes that while discussed in the preamble of the 2016 PM2.5
Implementation Rule, the requirement for 1-year's worth of RFP is not
cited in the regulatory text of 40 CFR 51.1014.
    Response: The EPA agrees that it did not include regulatory text in
the final 2016 PM2.5 Implementation Rule imposing the
requirement that contingency measures reflect emissions reductions
comparable to 1-year's worth of RFP in the attainment plan at issue.
Nevertheless, this has been the EPA's guidance on the proper
interpretation of the statutory requirements of CAA section 172(c)(9)
for many years, and remains so in the preamble to the 2016
PM2.5 Implementation Rule (see page 81 FR 58066). Because
the contingency measures in a Moderate area attainment plan are
intended to be available in the event that the area fails to meet the
RFP requirement, the EPA has long interpreted CAA section 172(c)(9) to
require control measures that would result in emissions reductions
comparable to 1-year's worth of RFP in the area.
    The EPA acknowledges the IDEQ's concern with the challenges to
identify and impose additional control measures to meet the contingency
measure requirement in the Logan, UT-ID nonattainment area. As
discussed in the proposal for this action, Franklin County is a
sparsely populated, rural area with a unique emissions inventory. Idaho
estimated that over 75% of the directly emitted PM2.5 comes
from road dust, using the EPA's AP-42 road dust emission estimation
methodology (see Appendix C of the 2012 SIP submittal). Idaho
calculated the remaining directly emitted PM2.5 to be 13%
residential wood combustion, 6% on-road and non-road mobile emissions,
and 6% all other remaining source categories. Also as discussed in the
proposal for this action, Idaho estimated that the limiting
PM2.5 precursors from Franklin County, nitrogen oxides
(NOX) and volatile organic compounds (VOC), come primarily
from motor vehicles, which are expected to decline significantly due to
federal motor vehicle standards already in place (see page 81 FR
74747). In considering these emission sources, the IDEQ established
road sanding agreements, woodstove curtailment ordinances, and the
woodstove change-out program. Because Idaho and Utah modeled that the
Logan UT-ID nonattainment area would attain based solely on the Utah
control measures, the IDEQ reasoned that anticipated reductions from
the Idaho control measures (i.e., the road sanding agreements,
woodstove curtailment ordinances, and the woodstove change-out
program), were not otherwise relied upon in the control strategy for
the area. As such, the IDEQ considered these early implemented
contingency measures, as allowed under the EPA's longstanding guidance
interpreting section 172(c)(9) to allow this approach.
    However, as discussed in the proposed rulemaking, a recent decision
by the U.S. Court of Appeals for the 9th Circuit rejected the EPA's
interpretation of CAA section 172(c)(9) to allow already implemented
control measures to meet the contingency measure requirements. Bahr v.
EPA, No. 12-72327 (Sept. 12, 2016). The Court concluded that
contingency measures must be control measures that will take effect at
the time the area fails to meet RFP or fails to attain by the
applicable attainment date, not before. Id.at 35-36. The IDEQ road
sanding agreements, woodstove curtailment ordinances, and the woodstove
change-out program which have already been implemented, do not meet the
standard for section 172(c)(9) contingency measures set out by the Bahr
decision which is controlling for EPA actions on SIP submissions from
states located within the jurisdiction of the 9th Circuit. For this
reason, the EPA is disapproving the contingency measures in this final
action. Because the contingency measures are invalid as early
implemented measures, the EPA is not addressing whether they would
otherwise be approvable as contingency measures at this time.

III. Final Action

    The EPA is approving parts of Idaho's attainment plan for the Idaho
portion of the Logan, UT-ID nonattainment area for the 2006 24-hour
NAAQS PM2.5 NAAQS. In particular, the EPA is approving
Idaho's determination of which pollutants must be evaluated for control
in the Idaho portion of the

Logan, UT-ID nonattainment area for purposes of the Moderate area plan
for the 2006 24-hour PM2.5 NAAQS. The EPA is also approving
Idaho's evaluation of, and imposition of, RACM/RACT level controls on
appropriate sources in the Idaho portion of the area for this NAAQS.
This includes approval of Idaho's woodstove curtailment ordinances,
burn ban, heating device restrictions, and woodstove change-out
programs as meeting the RACM/RACT requirements in this area. The EPA is
deferring action on the submitted attainment plan with respect to the
Moderate area attainment demonstration, RFP, quantitative milestone,
and motor vehicle emissions budget requirements. Lastly, for the
reasons set forth in our proposed rulemaking and discussed above, the
EPA has determined that the contingency measures submitted as part of
Idaho's 2012 SIP submittal and 2014 amendment do not meet CAA
requirements, as interpreted in the 9th Circuit.

IV. Consequences of a Disapproved SIP

    This section explains the consequences of disapproval, in whole or
in part, of a SIP submission required under the CAA. The Act provides
for the imposition of sanctions and the promulgation of a federal
implementation plan (FIP) if a state fails to submit, and the EPA
approve, a plan revision that corrects the deficiencies identified by
the EPA in its disapproval of the initial SIP submission.

The Act's Provisions for Sanctions

    Once the EPA finalizes disapproval of a required SIP submission,
such as an attainment plan submission, or a portion thereof, CAA
section 179(a) provides for the imposition of sanctions, unless the
deficiency is corrected within 18 months of the final rulemaking of
disapproval. The first sanction would apply 18 months after the EPA
disapproves the SIP submission, or portion thereof. Under the EPA's
sanctions regulations at 40 CFR 52.31, the first sanction imposed would
be 2:1 offsets for sources subject to the new source review
requirements under section 173 of the CAA. If the state has still
failed to submit a SIP submission to correct the identified
deficiencies for which the EPA proposes full or conditional approval 6
months after the first sanction is imposed, the second sanction will
apply. The second sanction is a prohibition on the approval or funding
of certain highway projects.\2\
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    \2\ On April 1, 1996 the US Department of Transportation
published a notice in the Federal Register describing the criteria
to be used to determine which highway projects can be funded or
approved during the time that the highway sanction is imposed in an
area. (See 61 FR 14363).
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Federal Implementation Plan Provisions That Apply if a State Fails To
Submit an Approvable Plan

    In addition to sanctions, once the EPA finds that a state failed to
submit the required SIP revision, or finalizes disapproval of the
required SIP revision or a portion thereof, the EPA must promulgate a
FIP no later than two years from the date of the finding--if the
deficiency has not been corrected within that time period.

Ramifications Regarding Transportation Conformity

    The proposal discussed conformity freeze implications due to
disapproval of the control strategy SIP.\3\ This final action only
disapproves the contingency measures. Section 93.120(a) of the
conformity rule is not triggered by disapproval of contingency
measures, so the area is not subject to a conformity freeze as
discussed in the proposal.
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    \3\ Control strategy SIP revisions as defined in the
transportation conformity rules include reasonable further progress
plans and attainment demonstrations (40 CFR 93.101).
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V. Statutory and Executive Orders Review

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. 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 Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     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 CAA; and
     does not provide the 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).
    The SIP is not approved to apply on any Indian reservation land in
Idaho and is also not approved to apply in any other area where the EPA
or an Indian tribe has demonstrated that a tribe has jurisdiction. In
those areas of Indian country, the rule does not have tribal
implications and will not impose substantial direct costs on tribal
governments or preempt tribal law as specified by Executive Order 13175
(65 FR 67249, November 9, 2000).
    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).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by March 6, 2017. Filing a petition for
reconsideration by the Administrator of this final rule does not

affect the finality of this action for the purposes of judicial review
nor does it extend the time within which a petition for judicial review
may be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2)).

List of Subjects in 40 CFR Part 52

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

    Dated: December 20, 2016.
Michelle L. Pirzadeh,
Acting Regional Administrator, Region 10.
    For the reasons set forth in the preamble, 40 CFR part 52 is
amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart N--Idaho

0
2. In Sec.  52.670, the table in paragraph (e) is amended by adding an
entry at the end of the table for ``Fine Particulate Matter Attainment
Plan.''
    The addition reads as follows:

Sec.  52.670   Identification of plan.

* * * * *
    (e) * * *

                    EPA-Approved Idaho Nonregulatory Provisions And Quasi-Regulatory Measures
----------------------------------------------------------------------------------------------------------------
                                     Applicable
     Name of SIP provision          geographic or         State       EPA approval date          Comments
                                 nonattainment area  submittal date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Fine Particulate Matter          Franklin County,         12/19/12;  1/4/2017, [Insert   Approved: reasonably
 Attainment Plan.                 Logan UT-ID PM2.5        12/24/14   Federal Register    available control
                                  Nonattainment                       citation].          measures and
                                  Area.                                                   reasonably available
                                                                                control technology
                                                                                requirements.
                                                                                Disapproved:
                                                                                contingency measures.
                                                                                Deferred: Moderate area
                                                                                attainment
                                                                                demonstration,
                                                                                reasonable further
                                                                                progress, quantitative
                                                                                milestone, and year
                                                                                motor vehicle
                                                                                emissions budget
                                                                                requirements.
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[FR Doc. 2016-31643 Filed 1-3-17; 8:45 am]
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7. Title Superfund Site Evaluation and Hazard Ranking System ( Renewal)

8. Agency form number( s) ( If applicable) EPA ICR No. 1488.06 9. Keywords Hazard Ranking System, National Priorities List,

10. Abstract This ICR summarizes the burden imposed upon the States and Indian Tribes for assessing hazardous waste sites under EPA's Superfund program. Information collected under this ICR supports EPA's revised Hazard Ranking System ( HRS) model used to evaluate the relative threats to human health and the environment posed by actual or potential releases of hazardous substances, pollutants, and contaminants. EPA uses a multi phase evaluation process guided by criteria outlined in the HRS to determine which sites brought to the attention of the Superfund Program may warrant cleanup work and to help determine whether a site is eligible to be included on the National Priorities List ( NPL)

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. Business or other for profit e. X Federal Government c. Not for profit institutions f. P State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c. O P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 607 b. Total annual responses 905 1. Percentage of these responses collected electronically 25 % c. Total hours requested 150,285 d. Current OMB inventory 230,533 e. Difference  80,248 f. Explanation of difference 1. Program Change 0 2. Adjustment  80,248 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars) a. Total annualized capital/ startup costs 0 b. Total annual costs ( O& M) 0 c. Total annualized cost requested 0 d. Current OMB inventory 0 e. Difference 0 f. Explanation of difference 1. Program change 0 2. Adjustment 0 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. __ Application for benefits e. X Program planning or management b. __ Program evaluation f. __ Research c. X General purpose statistics g. P Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. O Recordkeeping b. Q Third party disclosure c. O Reporting 1. O On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. Q Semi annually 6. Q Annually 7. Q Biannually 8. Q Other ( describe)

17. Statistical methods Does this information collection employ statistical methods?

Q Yes O No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Angelo Carasea Phone: ( 703) 603 8828 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( I) Why the information is being collected' ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( I) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Official Elizabeth Southerland, Director Assessment and Remediation Division Office of Superfund Remediation and Technology Innovation Date 8/ 30/ 2004 Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95


[Federal Register Volume 84, Number 117 (Tuesday, June 18, 2019)]
[Rules and Regulations]
[Pages 28202-28205]
[FR Doc No: 2019-13022]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-0414; Product Identifier 2019-NE-15-AD; Amendment
39-19656; AD 2019-12-01]
RIN 2120-AA64

Airworthiness Directives; CFM International S.A. Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain CFM International S.A. (CFM) LEAP-1B21, -1B23, -1B25, -1B27, -
1B28, -1B28B1, -1B28B2, -1B28B3, -1B28B2C, -1B28BBJ1, and -1B28BBJ2
model turbofan engines. This AD requires initial and repetitive
inspections of the transfer gearbox (TGB) scavenge screens and,
depending on the results of the inspection, possible removal of the
engine from service. This AD was prompted by multiple reports of in-
flight shutdowns (IFSDs) due to radial drive shaft (RDS) bearing
failure. The FAA is issuing this AD to address the unsafe condition on
these products.

DATES: This AD is effective July 3, 2019.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of July 3,
2019.
    The FAA must receive comments on this AD by August 2, 2019.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this final rule, contact CFM
International Inc., Aviation Operations Center, 1 Neumann Way, M/D Room
285, Cincinnati, OH 45125; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>You may view this service
information at the FAA, Engine and Propeller Standards Branch, 1200
District Avenue, Burlington, MA 01803. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. It is also
available on the internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2019-0414.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2019-
0414; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, the regulatory evaluation, any comments received, and
other information. The street address for the Docket Operations is
listed above. Comments will be available in the AD docket shortly after
receipt.

FOR FURTHER INFORMATION CONTACT: Christopher McGuire, Aerospace
Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803;
phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    The FAA learned of five commanded IFSD events that occurred on
certain CFM LEAP-1B model turbofan engines beginning in August 2018.
CFM's investigations identified debris on the TGB scavenge screen, A-
sump screen, and other screens. Subsequently, CFM determined that these
IFSD events were the result of inadequate oil flow to the RDS bearing,
which caused the RDS bearing cage to fail. This condition, if not
addressed, could result in failure of one or more engines, loss of
thrust control, and loss of the airplane. The FAA is issuing this AD to
address the unsafe condition on these products.

Related Service Information Under 1 CFR part 51

    The FAA reviewed CFM Service Bulletin (SB) LEAP-1B-72-00-0222-01A-
930A-D, Issue 007, dated May 17, 2019. The SB describes procedures for
inspections of TGB scavenge screens and borescope inspection (BSI) of
the RDS bearing. This service information is reasonably available
because the interested parties have access to it through their normal
course of business or by the means identified in the ADDRESSES section.

Other Related Service Information

    The FAA reviewed CFM SB LEAP-1B-72-00-0256-01A-930A-D, Issue 003,
dated May 17, 2019. The SB describes procedures for an optional BSI of
the RDS bearing. CFM has cancelled this SB and transferred its content
to CFM SB LEAP-1B-72-00-0222-01A-930A-D, Issue 007, dated May 17, 2019.

FAA's Determination

    The FAA is issuing this AD because it evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

AD Requirements

    This AD requires initial and repetitive inspections of the TGB
scavenge screens and, depending on the results of the inspection,
possible removal of the engine from service.

Interim Action

    The FAA considers this AD interim action. The manufacturer is
currently developing a modification that will address the unsafe
condition identified in this AD. Once this modification is developed,
approved, and available, the FAA might consider additional rulemaking.

FAA's Justification and Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD without providing an opportunity for public comments prior to
adoption. The FAA has found that the risk to the flying public
justifies waiving notice and comment prior to adoption of this rule.
The affected CFM LEAP-1B model turbofan engines experienced multiple
RDS bearing cage failures in the last five months resulting in five
IFSDs. The TGB scavenge screens must be inspected before accumulating
between 100-250 flight hours since new on the RDS bearing or within 50
FHs after the effective date of this AD to prevent the failure of the
RDS bearing, which could lead to in-flight shutdown of both engines,
loss of thrust control, and loss of the airplane. Therefore, the FAA
finds good cause that notice and opportunity for prior public comment
are impracticable. In addition, for the reason stated above, the FAA
finds that good cause exists for making this amendment effective in
less than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety and was not preceded by notice and an opportunity for public
comment. However, the FAA invites you to send any written data, views,
or arguments about this final rule. Send your comments to an address
listed under the ADDRESSES section. Include the docket number FAA-2019-
0414 and Product Identifier 2019-NE-15-AD at the beginning of your
comments. The FAA specifically invites comments on the overall
regulatory, economic, environmental, and energy aspects of this final
rule. The FAA will consider all comments received by the closing date
and may amend this final rule because of those comments.
    The FAA will post all comments received, without change, to http://www.regulations.gov, including any personal information you provide.
The FAA will also post a report summarizing each substantive verbal
contact received about this final rule.

Regulatory Flexibility Act

    The requirements of the Regulatory Flexibility Act (RFA) do not
apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt
a rule without prior notice and comment. Because the FAA has determined
that it has good cause to adopt this rule without notice and comment,
RFA analysis is not required.

Costs of Compliance

    The FAA estimates that this AD affects 136 engines installed on
airplanes of U.S. registry.
    The FAA estimates the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Inspect TGB scavenge screens..........  1 work-hour x $85 per                 $0             $85         $11,560
                                         hour = $85.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation Programs''
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to engines, propellers, and
associated appliances to the Manager, Engine and Propeller Standards
Branch, Policy and Innovation Division.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect 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.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866, and
    (2) Will not affect intrastate aviation in Alaska.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2019-12-01 CFM International S.A.: Amendment 39-19656; Docket No.
FAA-2019-0414; Product Identifier 2019-NE-15-AD.

(a) Effective Date

    This AD is effective July 3, 2019.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all CFM International S.A. (CFM) LEAP-1B21, -
1B23, -1B25, -1B27, -1B28, -1B28B1, -1B28B2, -1B28B3, -1B28B2C, -
1B28BBJ1, and -1B28BBJ2 model turbofan engines with radial drive
shaft (RDS) bearing, part number (P/N) 92D08200 or P/N 92D08201,
installed.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7260, Turbine Engine
Accessory Drive.

(e) Unsafe Condition

    This AD was prompted by multiple reports of in-flight shutdowns
(IFSDs) due to RDS bearing cage failure. The FAA is issuing this AD
to prevent failure of the RDS bearing. The unsafe condition, if not
addressed, could result in failure of one or more engines, loss of
thrust control, and loss of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Required Actions

    (1) Inspect the transfer gearbox (TGB) 1 and TGB2 scavenge
screens in accordance with the Accomplishment Instructions,
paragraph 5.A.(1), of CFM Service Bulletin (SB) LEAP-1B-72-00-0222-
01A-930A-D, Issue 007, dated May 17, 2019, as follows:
    (i) For affected engines with engine serial number (ESN) 602499
and lower:
    (A) After the RDS bearing accumulates 50 flight hours (FHs)
since new but before accumulating 250 FHs since new, or within 50
FHs after the effective date of this AD, whichever occurs later,
perform an initial inspection of the TGB1 and TGB2 scavenge screens.
    (B) Thereafter, perform repetitive inspections of the TGB1 and
TGB2 scavenge screens at intervals not exceeding 250 FHs since the
last inspection.
    (ii) For affected engines with ESN 602500 and higher:
    (A) After the RDS accumulates 50 FHs since new but before
accumulating 100 FHs since new, or within 50 FHs after the effective
date of this AD, whichever occurs later, perform an initial
inspection of the TGB1 and TGB2 scavenge screens.
    (B) Thereafter, perform repetitive inspections of the TGB1 and
TGB2 scavenge screens at intervals not exceeding 100 FHs since the
last inspection.
    (iii) Based on the results of these inspections, remove the
engine from service or return the engine to service using the
criteria in the Accomplishment Instructions, Paragraphs 5.A.(2)
through 5.A.(5), of CFM SB LEAP-1B-72-00-0222-01A-930A-D, Issue 007,
dated May 17, 2019.
    (2) [Reserved]

(h) Optional Borescope Inspection (BSI)

    (1) Once the RDS bearing has accumulated 1,000 FHs since new,
you may perform a BSI of the RDS bearing in accordance with the
Accomplishment Instructions, paragraphs 5.B.(1) through 5.B.(8), of
CFM SB LEAP-1B-72-00-0222-01A-930A-D dated May 17, 2019. If the
results of this BSI are ``satisfactory'' according to the criteria
in the Accomplishment Instructions, paragraphs 5.B.(6)(g), of CFM SB
LEAP-1B-72-00-0222-01A-930A-D, Issue 007, dated May 17, 2019, then
you are not required to perform the repetitive inspections in
paragraphs (g)(1)(i)(B) or (g)(1)(ii)(B) of this AD until the RDS
bearing accumulates 4,250 FHs since new.
    (2) [Reserved]

(i) Optional Terminating Action

    (1) As an optional terminating action to the repetitive
inspections required by paragraphs (g)(1)(i)(B) and (g)(1)(ii)(B) of
this AD, you may perform a BSI of the RDS bearing in accordance with
the Accomplishment Instructions, Paragraphs 5.B.(1) through 5.B.(8),
of CFM SB LEAP-1B-72-00-0222-01A-930A-D, Issue 007, dated May 17,
2019 after the RDS bearing accumulates 3,750 FHs since new.
    (i) If the results of the BSI are ``satisfactory'' using the
criteria in Accomplishment Instructions, paragraph 5.B.(6)(g), of
CFM SB LEAP-1B-72-00-0222-01A-930A-D, Issue 007, dated May 17, 2019,
then you have met the repetitive inspection requirements of this AD
and no further action is required.

    (ii) If the results of the BSI are ''unsatisfactory'' using the
criteria in Accomplishment Instructions, paragraph 5.B.(6)(g), of
CFM SB LEAP-1B-72-00-0222-01A-930A-D, Issue 007, dated May 17, 2019,
then you must continue the repetitive inspections required by
paragraphs (g)(1)(i)(B) or (g)(1)(ii)(B) of this AD.
    (2) [Reserved]

(j) Definition

    For the purpose of this AD, ``flight hours (FHs) since new'' are
the FHs accumulated on the RDS bearings on new engines delivered
from production and on engines that have had the RDS bearing
replaced during an engine shop visit.

(k) No Reporting Requirement

    The reporting requirement in paragraph 5.A.(6) in CFM SB LEAP-
1B-72-00-0222-01A-930A-D, Issue 007, dated May 17, 2019, is not
required by this AD.

(l) Credit for Previous Actions

    You may take credit for the inspections that are required by
paragraph (g)(1) of this AD, if you performed those actions before
the effective date of this AD using CFM SB LEAP-1B-72-00-0222-01A-
930A-D, Issue 006, dated March 22, 2019, or an earlier revision. You
may also take credit for the optional BSI in paragraphs (h)(1) or
the optional terminating inspection in paragraph (i)(1) of this AD,
if you performed that action before the effective date of this AD
using CFM SB LEAP-1B-72-00-0256-01A-930A-D, Issue 002, dated May 6,
2019, or an earlier revision.

(m) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, ECO Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the manager of the
certification office, send it to the attention of the person
identified in paragraph (n) of this AD. You may email your request
to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(n) Related Information

    For more information about this AD, contact Christopher McGuire,
Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue,
Burlington, MA, 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
(o) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) CFM Service Bulletin LEAP-1B-72-00-0222-01A-930A-D, Issue
007, dated May 17, 2019.
    (ii) [Reserved]
    (3) For CFM service information identified in this AD, contact
CFM International Inc., Aviation Operations Center, 1 Neumann Way,
M/D Room 285, Cincinnati, OH, 45125; phone:<PHONE_NUMBER>; fax: 877-
432-3329; email<EMAIL_ADDRESS>    (4) You may view this service information at FAA, Engine &
Propeller Standards Branch, 1200 District Avenue, Burlington, MA,
01803. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Burlington, Massachusetts, on June 14, 2019.
Karen M. Grant,
Acting Manager, Engine & Propeller Standards Branch, Aircraft
Certification Service.
[FR Doc. 2019-13022 Filed 6-17-19; 8:45 am]
BILLING CODE 4910-13-P


Residual Risk Information Relative to Magnetic Tape Manufacturing at Kodak Park Response to EPA Request September 26, 2002 Source A Source B Source C Annual HAP emissions relative to 40 CFR Part 63 Subpart EE operations 8,500 lb Volatile HAP 0.001 lb Cobalt 70 lb Volatile HAP 0.002 lb Cobalt Stack/ Fugitive ? Stack Stack Stack Stack height 100 ft 73 ft 74 ft Stack Diameter 144 in 6 in 15 in Stack Gas Temperature 100 0F Ambient Ambient Stack Gas Flow Rate 160,000 scfm 30 acfm 3700 acfm Stack Gas Velocity 35 ft/ s 2.6 ft/ s 50 ft/ s Stack Latitude 430, 12', 10" 430, 12', 10" 430, 12', 10" Stack Longitude 770, 38', 45" 770, 37', 45" 770, 37', 45" Estimated Annual Operating Hours 3000 630 630 Shifts per Day 2 1 1 Control Techniques Regenerative Thermal Oxidizer with Caustic Scrubber Fabric Filter with Non Regenerative Carbon Adsorber Fabric Filter Previous risk assessment relative to 40 CFR Part 63 Subpart EE operations None None None


[Federal Register Volume 87, Number 1 (Monday, January 3, 2022)]
[Notices]
[Page 135]
[FR Doc No: 2021-28422]

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

SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-475, OMB Control No. 3235-0536]

Submission for OMB Review; Comment Request; Extension: Regulation
FD

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget this request for extension of the previously approved
collection of information discussed below.
    Regulation FD (17 CFR 243.100 et seq.)--Other Disclosure Materials
requires public disclosure of material information from issuers of
publicly traded securities so that investors have current information
upon which to base investment decisions. The purpose of the regulation
is to require that: (1) When an issuer intentionally discloses material
information, to do so through public disclosure, not selective
disclosure; and (2) to make prompt public disclosure of material
information that was unintentionally selectively disclosed. Regulation
FD was adopted due to a concern that the practice of selective
disclosure leads to a loss of investor confidence in the integrity of
our capital markets. All information is provided to the public for
review. The information required is filed on occasion and is mandatory.
We estimate that approximately 13,000 issuers make Regulation FD
disclosures approximately five times a year for a total of 58,000
submissions annually, not including an estimated 7,000 issuers who file
Form 8-K to comply with Regulation FD. We estimate that it takes
approximately 5 hours per response (58,000 responses x 5 hours) for a
total burden of 290,000 hours annually. In addition, we estimate that
25% of the 5 hours (1.25 hours) is prepared by the filer for an annual
reporting burden of 72,500 hours (1.25 hours per response x 58,000
responses).
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    The public may view background documentation for this information
collection at the following website: www.reginfo.gov. Find this
particular information collection by selecting ``Currently under 30-day
Review--Open for Public Comments'' or by using the search function.
Written comments and recommendations for the proposed information
collection should be sent within 30 days of publication of this notice
to (i) www.reginfo.gov/public/do/PRAMain and (ii) David Bottom,
Director/Chief Information Officer, Securities and Exchange Commission,
c/o John Pezzullo, 100 F Street NE, Washington, DC 20549, or by sending
an email to: [email protected].

    Dated: December 28, 2021.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-28422 Filed 12-30-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 131 (Wednesday, July 9, 2014)]
[Notices]
[Pages 38909-38910]
[FR Doc No: 2014-15990]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0851]

Public Meeting on Patient-Focused Drug Development for Hemophilia
A, Hemophilia B, von Willebrand Disease, and Other Heritable Bleeding
Disorders

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

    The Food and Drug Administration (FDA) is announcing a public
meeting and an opportunity for public comment on Patient-Focused Drug
Development for Hemophilia A, Hemophilia B, von Willebrand Disease, and
other heritable bleeding disorders such as other factor deficiencies
(including I, V, VII, X, XI) and platelet disorders. Patient-Focused
Drug Development is an FDA performance commitment under the fifth
authorization of the Prescription Drug User Fee Act (PDUFA V). The
public meeting is intended to provide FDA with patients' perspectives
on the impact on daily life of Hemophilia A, Hemophilia B, von
Willebrand Disease, and other heritable bleeding disorders. FDA also is
seeking patients' perspectives on the available therapies for these
disorders.
    Dates and Time: The public meeting will be held on September 22,
2014, from 9 a.m. to 5 p.m. Registration to attend the meeting must be
received by September 12, 2014. Registration from those individuals
interested in presenting comments as part of the panel discussions must
be received by August 22, 2014 (see the SUPPLEMENTARY INFORMATION for
instructions).
    Location: The meeting will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503 B and C), Silver Spring, MD 20993. Entrance for public
meeting participants (non-FDA employees) is through Building 1, where
routine security checks will be performed. For more information on
parking and security procedures, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Submit either electronic or written comments by November 28, 2014.
Submit electronic comments to http://www.regulations.gov. Submit
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852. All comments should be identified with the docket number found
in brackets in the heading of this document.
    FDA will post the agenda approximately 5 days before the workshop
at: http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm401758.htm.
    Contact Person: Henry Allen, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 1125, Silver Spring, MD 20993,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>,
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background on Patient-Focused Drug Development

    FDA has selected Hemophilia A, Hemophilia B, von Willebrand
Disease, and other heritable bleeding disorders as the focus of a
public meeting under the Patient-Focused Drug Development initiative.
This initiative involves obtaining a better understanding of patients'
perspectives on the challenges posed by these disorders, and the impact
of therapies for these disorders. The Patient-Focused Drug Development
initiative is being conducted to fulfill FDA performance commitments
that are part of the PDUFA reauthorization under Title I of the Food
and Drug Safety and Innovation Act (Pub. L. 112-144). The full set of
performance commitments is available on the FDA Web site at http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf.
    FDA has committed to obtaining the patient perspective on 20
disease areas during the course of PDUFA V. For each disease area, the
Agency will conduct a public meeting to discuss the disease and its
impact on patients' daily lives, the types of treatment benefits that
matter most to patients, and patients' perspectives on the adequacy of
the available therapies. These meetings will include participation of
FDA review divisions, the relevant patient communities, and other
interested stakeholders.
    On April 11, 2013, FDA published a notice in the Federal Register
(78 FR 21613) that announced the disease areas for meetings in fiscal
years (FY) 2013-2015, the first 3 years of the 5-year PDUFA V
timeframe. The Agency used several criteria outlined in the April 11,
2013, notice to develop the list of disease areas. FDA obtained public
comment on the Agency's proposed criteria and potential disease areas
through a public docket and a public meeting that was convened on
October 25, 2012. In selecting the set of disease areas, FDA carefully
considered the public comments received and the perspectives of review
divisions at FDA. By the end of FY 2015, FDA will initiate a second
public process for determining the disease areas for meetings in FY
2016-2017. More information, including the list of disease areas and a
general schedule of meetings, is posted on FDA's Web site at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm326192.htm.

II. Public Meeting Information

A. Purpose and Scope of the Meeting

    The purpose of this Patient-Focused Drug Development meeting is to
obtain input on the symptoms and other impacts that matter most to
patients with Hemophilia A, Hemophilia B, von Willebrand Disease, and
other heritable bleeding disorders. FDA also intends to seek patients'
perspectives on current approaches to treating these disorders. FDA
expects that this information will come directly from patients,
caregivers, and patient advocates.
    Heritable bleeding disorders are a diverse group of diseases and
some involve lifelong defects in the clotting mechanism of the blood.
The most frequently occurring of these disorders include Hemophilia A,
Hemophilia B, and von Willebrand Disease. Less frequent yet also
serious heritable bleeding disorders include Factor VII deficiency,
Factor XIII deficiency, [alpha]2-antiplasmin deficiency and platelet
disorders such as Gray platelet syndrome. Symptoms of heritable
bleeding disorders include frequent nose bleed; prolonged and heavy
menstrual bleeding; prolonged bleeding from cuts, trauma, dental
extractions, and surgical procedures as well as bleeding into internal
organs, muscles, and joints. Intracranial hemorrhage is a particularly
serious and life-threatening manifestation. Specific treatment
recommendations are determined by the type and severity of the
disorder; but in general, therapies such as factor replacement,
platelet transfusion, fresh frozen plasma, and cryoprecipitate are
utilized.
    The questions that will be asked of patients and patient
stakeholders at the meeting are provided in this document. For each
topic, a brief patient panel discussion will begin the dialogue. This
will be followed by a facilitated discussion inviting comments from
other patient and patient stakeholder

participants. In addition to input generated through this public
meeting, FDA is interested in receiving patient input addressing these
questions through electronic or written comments, which can be
submitted to the Division of Dockets Management (see Location). For
context, please indicate if you are commenting as a patient with a
heritable bleeding disorder or on behalf of a child or loved one.
Topic 1: The effects of your bleeding disorder that matter most to you
     Of all of the symptoms that you experience because of your
condition, which one to three symptoms (bleeding or non-bleeding) have
the most significant impact on your life? (Examples may include joint
damage/pain, infections, prolonged and heavy bleeding with
menstruation, fatigue, etc.)
     Are there specific activities that are important to you,
but that you cannot do at all, or as well as you would like, because of
your condition? Please describe, using specific examples. (Examples may
include participating in physical activities, attending work/school,
and family/social activities, etc.)
     How have your condition and its symptoms changed over
time?
     What worries you most about your condition?
Topic 2: Perspectives on current approaches to treatment
     What are you currently doing to treat your condition or
its symptoms? (Examples may include blood transfusions, replacement
therapies, over-the-counter products, and/or other therapies).
    [cir] How well do these treatments work for you?
    [cir] What are the most significant disadvantages or complications
of your current treatments, and how do they affect your daily life?
    [cir] How has your treatment changed over time and why?
    [cir] What aspects of your condition are not improved by your
current treatment regimen?
    [cir] What treatment has had the most positive impact on your life?
     If you could create your ideal treatment, what would it do
for you (i.e., what specific things would you look for in an ideal
treatment)?
     If you had the opportunity to consider participating in a
clinical trial studying experimental treatments, what things would you
consider when deciding whether or not to participate?

B. Attendance and/or Participation in the Meeting

    If you wish to attend this meeting, visit https://www.eventbrite.com/e/patient-focused-public-meeting-on-heritable-bleeding-disorders-registration-11996980291. Please register by
September 12, 2014. Those who are unable to attend the meeting in
person can register to view a live Webcast of the meeting. You will be
asked to indicate in your registration if you plan to attend in person
or via the Webcast. Your registration will also contain your complete
contact information, including name, title, affiliation, address, email
address, and phone number. Seating will be limited, so early
registration is recommended. Registration is free and will be on a
first-come, first-served basis. However, FDA may limit the number of
participants from each organization based on space limitations.
Registrants will receive confirmation once they have been accepted.
Onsite registration on the day of the meeting will be based on space
availability. If you need special accommodations because of disability,
please contact Henry Allen (see Contact Person) at least 7 days before
the meeting.
    Patients and patient stakeholders who are interested in presenting
comments as part of the initial panel discussions should register by
August 22, 2014. You will be asked to indicate in your registration
which topic(s) you wish to address. You will be asked to send a brief
summary of responses to the topic questions to<EMAIL_ADDRESS>Panelists will be notified of their selection soon
after August 22, 2014. FDA will try to accommodate all patients and
patient advocate participants who wish to speak, either through the
panel discussion or audience participation; however, the duration of
comments may be limited by time constraints.
    Comments: Interested members of the public, including those who
attend the meeting in person or via the Webcast, are invited to provide
electronic or written responses to any or all of the questions
pertaining to topics 1 and 2 to the Division of Dockets Management (see
Location). Comments may be submitted until November 28, 2014. Received
comments may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday, and will be posted to the
docket at http://www.regulations.gov.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm401761.htm and at http://www.regulations.gov. It may be viewed at
the Division of Dockets Management (see Location). A transcript will
also be available in either hardcopy or on CD-ROM, after submission of
a Freedom of Information request. Written requests are to be sent to
the Division of Freedom of Information (ELEM-1029), Food and Drug
Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.

    Dated: July 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-15990 Filed 7-8-14; 8:45 am]
BILLING CODE 4164-01-P