[Federal Register Volume 81, Number 126 (Thursday, June 30, 2016)]
[Proposed Rules]
[Pages 42597-42600]
[FR Doc No: 2016-15617]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2015-0522; FRL-9948-51-Region 5]

Air Plan Approval; Ohio; Removal of Stage II Gasoline Vapor
Recovery Requirements

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a State Implementation Plan (SIP) revision submitted by the
Ohio Environmental Protection Agency (Ohio EPA) on July 15, 2015 and
February 29, 2016, concerning the state's Stage II vapor recovery
(Stage II) program for the Cleveland, Cincinnati, and Dayton ozone
areas in Ohio. The revision removes Stage II requirements for the three
areas as a component of the Ohio ozone SIP. The submittal also includes
a demonstration as required by the Clean Air Act (CAA) that addresses
emissions impacts associated with the removal of the program.

DATES: Comments must be received on or before August 1, 2016.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2015-0522 at http://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the ``For Further Information Contact'' section. For the
full EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Francisco J. Acevedo, Mobile Source
Program Manager, Control Strategies Section, Air Programs Branch (AR-
18J), Environmental Protection Agency, Region 5, 77 West Jackson
Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This SUPPLEMENTARY INFORMATION
section is arranged as follows:

    I. Background
    II. What changes have been made to the Ohio Stage II vapor
recovery program?
    III. What is EPA's analysis of the state's submittal?
    IV. What action is EPA proposing to take?
    V. Incorporation by Reference
    VI. Statutory and Executive Order Reviews

I. Background

    Stage II and onboard refueling vapor recovery systems (ORVR) are
two types of emission control systems that capture fuel vapors from
vehicle gas tanks during refueling. Stage II systems are specifically
installed at gasoline dispensing facilities (GDF) and capture the
refueling fuel vapors at the gasoline pump nozzle. The system carries
the vapors back to the underground storage tank at the GDF to prevent
the vapors from escaping to the atmosphere. ORVR systems are carbon
canisters installed directly on automobiles to capture the fuel vapors
evacuated from the gasoline tank before they reach the nozzle. The fuel
vapors captured in the carbon canisters are then combusted in the
engine when the automobile is in operation. Stage II and vehicle ORVR
were initially both required by the 1990 Amendments to the CAA under
sections 182(b)(3) and 202(a)(6), respectively. In some areas Stage II
has been in place for over 25 years, but Stage II was not widely
implemented by the states until the early to mid-1990s as a result of
the CAA requirements for moderate, serious, severe, and extreme ozone
nonattainment areas, and for states in the Northeast Ozone Transport
Region (OTR) under CAA section 184(b)(2).
    CAA section 202(a)(6) required EPA to promulgate regulations for
ORVR for light-duty vehicles (passenger cars). EPA adopted these
requirements in 1994, at which point moderate ozone nonattainment areas
were no longer subject to the section 182(b)(3) Stage II requirement.
However, some moderate areas retained Stage II requirements to provide
a control method to comply with rate-of-progress emission reduction
targets. ORVR equipment has been phased in for new passenger vehicles
beginning with model year 1998, and starting in 2001 for light-duty
trucks and most heavy-duty gasoline-powered vehicles. ORVR equipment
has been installed on nearly all new gasoline-powered light-duty
vehicles, light-duty trucks and heavy-duty vehicles since 2006.
    During the phase-in of ORVR controls, Stage II has provided
volatile organic compound (VOC) reductions in ozone nonattainment areas
and certain attainment areas of the OTR. Congress recognized that ORVR
and Stage II would eventually become largely redundant technologies,
and provided authority to EPA to allow states to remove Stage II from
their SIPs after EPA finds that ORVR is in widespread use.
    Effective May 16, 2012 (77 FR 28772), EPA determined that ORVR is
in widespread nationwide use for control of gasoline emissions during
refueling of vehicles at GDFs. Currently, more than 75 percent of
gasoline refueling nationwide occurs with ORVR-equipped vehicles, so
Stage II programs have become largely redundant control

systems and Stage II systems achieve an ever declining emissions
benefit as more ORVR-equipped vehicles continue to enter the on-road
motor vehicle fleet.\1\
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    \1\ In areas where certain types of vacuum-assist Stage II
systems are used, the differences in operational design
characteristics between ORVR and some configurations of these Stage
II systems result in the reduction of overall control system
efficiency compared to what could have been achieved relative to the
individual control efficiencies of either ORVR or Stage II emissions
from the vehicle fuel tank.
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    EPA also exercised its authority under CAA section 202(a)(6) to
waive certain Federal statutory requirements for Stage II gasoline
vapor recovery at GDFs. This decision exempts all new ozone
nonattainment areas classified serious or above from the requirement to
adopt Stage II control programs. Similarly, any state currently
implementing Stage II programs may submit SIP revisions that, once
approved by EPA, would allow for the phase out of Stage II control
systems. To assist states in the development of SIP revisions to remove
Stage II requirements from their SIPs, EPA released its ``Guidance on
Removing Stage II Gasoline Vapor Control Programs from State
Implementation Plans and Assessing Comparable Measures'' (EPA-457/B-12-
001) on August 7, 2012.

II. What changes have been made to the Ohio Stage II vapor recovery
program?

    The Ohio EPA originally submitted a SIP revision to EPA on June 7,
1993, to satisfy the requirement of section 182(b)(3) of the CAA. The
revision applied to the Cleveland (Ashtabula, Cuyahoga, Geauga, Lake,
Lorain, Medina, Portage and Summit counties), Cincinnati (Butler,
Clermont, Hamilton and Warren counties), and Dayton (Clark, Greene,
Miami and Montgomery counties) ozone nonattainment areas in Ohio. EPA
partially approved Ohio's Stage II program on October 20, 1994 (59 FR
52911), including the program's legal authority and administrative
requirements found in the Ohio Administrative Code (OAC) rules 3745-21-
09 (DDD)(1)-(4).
    As a result of EPA's May 16, 2012 determination that ORVR is in
widespread nationwide use for control of gasoline emissions during
refueling of vehicles at GDFs, Ohio EPA initiated a rulemaking process
to revise its SIP to remove Stage II requirements for all facilities in
the Cleveland, Cincinnati and Dayton areas. As part of that rulemaking
process, an Ohio-specific analysis following EPA's recommended
methodology was also completed. The analysis concluded that, starting
in calendar year 2017, ORVR would be in widespread use in Ohio and that
there would be no remaining emissions reduction benefit from Stage II
requirements beyond the benefits from ORVR.
    On July 15, 2015, and February 29, 2016, the Ohio EPA submitted a
SIP revision requesting EPA approval of amendments to OAC 3745-21-09
(DDD) that removes Stage II requirements from the Ohio ozone SIP and
allows GDFs currently implementing Stage II in the Cleveland,
Cincinnati and Dayton areas to decommission their systems by 2017. To
support the removal of the Stage II requirements, the revision included
amended copies of OAC 3745-21-09 (DDD), as adopted on April 29, 2013,
and January 17, 2014; a summary of Ohio-specific calculations based on
EPA guidance used to calculate program benefits and demonstrate
widespread use of ORVR in Ohio; and a section 110(l) demonstration that
includes documentation that addresses the period, 2013-2017, when Stage
II requirements were waived in Ohio but widespread use of ORVR has not
yet occurred.

III. What is EPA's analysis of the state's submittal?

    EPA's primary consideration for determining the approvability of
Ohio's request is whether this requested action complies with section
110(l) of the CAA.\2\
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    \2\ CAA section 193 is not relevant because Ohio's Stage II rule
was not included in the SIP before the 1990 CAA amendments.
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    Section 110(l) requires that a revision to the SIP not interfere
with any applicable requirement concerning attainment and reasonable
further progress (as defined in section 171), or any other applicable
requirement of the Act. EPA evaluates each section 110(l)
noninterference demonstration on a case-by-case basis considering the
circumstances of each SIP revision. EPA interprets 110(l) as applying
to all national ambient air quality standards (NAAQS) that are in
effect, including those that have been promulgated but for which EPA
has not yet made designations. The degree of the analysis focused on
any particular NAAQS in a noninterference demonstration varies
depending on the nature of the emissions associated with the proposed
SIP revision.
    In its July 15, 2015, and February 29, 2016, SIP revision, the Ohio
EPA used EPA's guidance to conduct a series of calculations to
determine the potential impact of removing the Stage II program on air
quality.\3\ Ohio EPA's analysis focused on VOC emissions because, as
mentioned previously, Stage II requirements affect VOC emissions and
because VOCs are a precursor for ground-level ozone formation.\4\
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    \3\ EPA, Guidance on Removing Stage II Gasoline Vapor Control
Program from State Implementation Plans and Assessing Comparable
Measure, EPA-457/B-12-001 (August 7, 2012), available at: http://www.epa.gov/groundlevelozone/pdfs/20120807guidance.pdf. This
guidance document notes that ``the potential emission control losses
from removing Stage II vapor recovery systems (VRS) are transitional
and relatively small. ORVR-equipped vehicles will continue to phase
in to the fleet over the coming years and will exceed 80 percent for
all highway gasoline vehicles and 85 percent of all gasoline
dispensed during 2015. As the number of these ORVE-equipped vehicles
increase, the control of attributed to Stage II VRS will decrease
even further, and the potential foregone Stage II VOC emission
reductions are generally expected to be no more than one percent of
the VOC inventory in the area.''
    \4\ Cleveland is currently designated nonattainment for the 2012
Annual fine particulate matter (PM2.5) NAAQS. While VOC
is one of the precursors for PM2.5 formation, a study
(Journal of Environmental Engineering--Qualifying the sources of
ozone, fine particulate matter, and regional haze in the
Southeastern United States, June 24, 2009, available at: http://www.journals.elsevier.com/journal-ofenvironmental-management)
indicates that in portions the Midwest (including portions of Ohio)
where Stage II has been implemented, emissions of PM2.5
and the precursor sulfur dioxide (SO2) are more
significant to ambient PM2.5 concentrations than nitrogen
oxides (NOx) and VOC. Specifically, PM2.5 sensitivities
to anthropogenic VOC emissions are near zero for the entire region,
including the Cincinnati region. This study also indicated that the
impact of SO2 emission, especially from electric
generating units, was most significant in the Cincinnati area due to
SO2 emissions in the entire mid-west region (Wisconsin,
Illinois, Indiana, Michigan, and Ohio). In fact, emissions from the
mid-west had the largest effect in the Cleveland and Dayton areas.
The technical analysis has met EPA's guidance and demonstrates
anthropogenic VOCs are insignificant to the formation of
PM2.5 in these areas. Currently, the Cleveland area is
also designated nonattainment for sulfur dioxide (Lake Co.) and lead
(Cuyahoga Co.) and those pollutants are not affected by the removal
of Stage II requirements.
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    Ohio EPA has calculated that beginning in 2017, ORVR will be in
widespread use in all three program areas and the absence of the Ohio
Stage II program starting in 2017 would not result in a net VOC
emissions increase compared to the continued utilization of this
emissions control technology. The emission reduction losses resulting
from removing Stage II before 2017 are transitional and relatively
small since ORVR-equipped vehicles will continue to phase into the
fleet over the coming years. Ohio EPA's calculation indicates a maximum
potential loss of 1.858 tons per summer day (tpsd) in Cleveland, 0.914
tpsd in Cincinnati, and 0.655 tpsd in Dayton from 2013 through 2016. In
2013, the year with the highest level of emission increases, these
summer day emissions increases are only 0.21 percent to 0.26 percent of
the typical summer day VOC emissions rate in the three areas. These
emissions increases

are insignificant with respect to the total summer day VOC emission
rates of all sectors in these areas. Also it is important to note that
the minimal emissions increase significantly decreases over the next
two years (2014 and 2015) and becomes an emissions decrease in 2017 and
all years thereafter.
    To help offset the initial emissions increases during the Stage II
phase out period, Ohio EPA is requiring the installation of low
permeation hoses at GDFs. Ohio EPA has calculated that low permeation
hoses will provide 42.9 tons of VOC emission reductions each year
during the ozone seasons (21.4 tons for Cleveland area, 13.6 tons for
Cincinnati area, and 7.9 for Dayton area) starting in 2013. Table 1
shows the increase of emissions associated with the phase out of State
II systems at facilities in all program areas in Ohio starting in 2013,
as well as offset emissions associated with the requirement of low
permeation hoses at GDFs.

                                   Table 1--VOC Emissions During Ozone Season
                                                 [Tons per day]
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                                       2013            2014            2015            2016            2017
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                                                 Cleveland Area
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Stage II Phase-out..............           0.910           0.580           0.300           0.068          -0.116
Low Permeation Hoses............           -0.14           -0.14           -0.14           -0.14           -0.14
                                 -------------------------------------------------------------------------------
Daily Total.....................            0.77            0.44            0.16          -0.072           -0.26
Typical Summer Day..............          367.17          367.17          367.17          367.17          367.17
% of Summer Day.................           0.21%           0.12%          0.043%         -0.019%          -0.26%
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                                                 Cincinnati Area
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Stage II Phase-out..............           0.440           0.284           0.151           0.039          -0.053
Low Permeation Hoses............          -0.089          -0.089          -0.089          -0.089          -0.089
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Daily Total.....................            0.35            0.20           0.062          -0.050           -0.14
Typical Summer Day..............          147.05          147.05          147.05          147.05          147.05
% of Summer Day.................           0.24%           0.13%          0.042%         -0.034%         -0.096%
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                                                   Dayton Area
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2013............................            2014            2015            2016            2017
Stage II Phase-out..............           0.310           0.201           0.110           0.034          -0.027
Low Permeation Hoses............          -0.052          -0.052          -0.052          -0.052          -0.052
                                 -------------------------------------------------------------------------------
Daily Total.....................            0.26            0.15           0.058          -0.018          -0.079
Typical Summer Day..............           99.66           99.66           99.66           99.66           99.66
% of Summer Day.................           0.26%           0.15%          0.058%         -0.018%         -0.079%
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    As illustrated in Table 1, and documented in Ohio's SIP revision,
for each year prior to the widespread use of ORVR in Ohio (2017)
starting in 2013, the VOC emissions increase associated with the
removal of Stage II systems is eventually offset by the VOC emission
reductions attributed to ORVR being in widespread use in Ohio and the
requirement of low permeation hoses at GDFs.
    EPA believes that the removal of the Ohio Stage II program does not
interfere with Ohio's ability to demonstrate compliance with the 8-hour
ozone NAAQS in all three areas. This is based on the use of permanent,
enforceable, contemporaneous, surplus emissions reductions achieved
through the requirement of low permeation hoses at GDFs, and the fact
that the small emissions increase is both temporary and insignificant
with respect to the total summer day emission rates for sectors in
these areas.
    EPA also examined whether the removal of Stage II program
requirements in all three areas will interfere with attainment of other
air quality standards. All the counties in the Dayton area are
designated attainment for all standards, including sulfur dioxide and
nitrogen dioxide. Cincinnati is designated attainment for all standards
other than ozone and sulfur dioxide. The Cleveland area is designated
attainment for all standards other than ozone, lead (Cuyahoga Co.),
sulfur dioxide (Lake Co.) and particulate matter (Cuyahoga and Lorain
Counties). Based on Ohio EPA's 110(l) analysis, EPA has no reason to
believe that the removal of the Stage II program in Ohio will cause the
areas to become nonattainment for any of these pollutants. In addition,
EPA believes that removing the Stage II program requirements in Ohio
will not interfere with the areas' ability to meet any other CAA
requirement.
    Based on the above discussion and the state's section 110(l)
demonstration, EPA believes that removal of the Stage II program would
not interfere with attainment or maintenance of any of the NAAQS in the
Cleveland, Cincinnati, and Dayton areas and would not interfere with
any other applicable requirement of the CAA, and thus, are approvable
under CAA section 110(l).

IV. What action is EPA proposing to take?

    EPA is proposing to approve the revision to the Ohio ozone SIP
submitted by Ohio EPA on July 15, 2015, and February 26, 2016, because
we find that the revision meets all applicable requirements and it
would not interfere with reasonable further progress or attainment of
any of the NAAQS.

V. Incorporation by Reference

    In this rule, EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, EPA is proposing to incorporate by
reference Ohio rule 3745-21-09 ``Control of emissions of volatile
organic

compounds from stationary sources and perchloroethylene from dry
cleaning facilities.'' effective January 17, 2014. EPA has made, and
will continue to make, these documents generally available through
www.regulations.gov and/or at the EPA Region 5 Office (please contact
the person identified in the ``For Further Information Contact''
section of this preamble for more information).

VI. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the 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 EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where 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).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen oxides, Ozone,
Volatile organic compounds.

    Dated: June 27, 2016.
Robert Kaplan,
Acting Regional Administrator, Region 5.
[FR Doc. 2016-15617 Filed 6-29-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: March 16, 2009 (Volume 74, Number 49)]
[Proposed Rules]
[Page 11043-11045]
[DOCID:fr16mr09-18]

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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-0018; Directorate Identifier 2009-NE-01-AD]
RIN 2120-AA64

Airworthiness Directives; General Electric Company CF6-80C2
Series Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for General Electric Company (GE) CF6-80C2 series turbofan engines with
certain thrust reverser ballscrew gearbox assembly adjustable-length
end actuators installed. This proposed AD would require initial visual
inspections and repetitive replacements of the \3/8\-inch rod-ends
installed on the thrust reverser ballscrew gearbox assembly adjustable-
length end actuators, along with optional terminating action to those
repetitive replacements. This proposed AD would also require initial
visual inspections and replacements, if necessary, of the other
hardware connecting the thrust reverser transcowls to the engine. This
proposed AD results from reports of four failures of rod-ends on
certain thrust reverser ballscrew gearbox assembly adjustable-length
end actuators, leading to partial or complete separation of the
transcowl from the engine and airplane during thrust reversal. We are
proposing this AD to prevent loss of thrust control, asymmetric thrust,
increased stopping distance, and possibly hazardous debris on the
runway, which could result in unsafe landings.

DATES: We must receive any comments on this proposed AD by May 15,
2009.

ADDRESSES: Use one of the following addresses to comment on this
proposed AD.
     Federal eRulemaking Portal: Go to http://
www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Christopher J. Richards, Aerospace
Engineer, Engine Certification Office, FAA, Engine & Propeller
Directorate, 12 New England Executive Park, Burlington, MA 01803; e-
mail<EMAIL_ADDRESS>telephone<PHONE_NUMBER>; fax
(781) 238-7199.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send us any written relevant data, views, or
arguments regarding this proposal. Send your comments to an address
listed under ADDRESSES. Include ``Docket No. FAA-2009-0018; Directorate
Identifier 2009-NE-01-AD'' in the subject line of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of the proposed AD. We will consider
all comments received by the closing date and may amend the proposed AD
in light of those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact
with FAA personnel concerning this proposed AD. Using the search
function of the Web site, anyone can find and read the comments in any
of our dockets, including, if provided, the name of the individual who
sent the comment (or signed the comment on behalf of an association,
business, labor union, etc.). You may review the DOT's complete Privacy
Act Statement in the Federal Register published on April 11, 2000 (65
FR 19477-78).

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
the same as the Mail address provided in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

Discussion

    Since January 2007, we received reports of four GE CF6-80C2 series
turbofan engine thrust reverser transcowls separating from the engine
and airplane during thrust reverser deployment while landing.
Investigation has revealed that the \3/8\-inch adjustable rod-ends on
the adjustable-length end actuators can fail in fatigue. When a rod-end
fails, additional load is put on the thrust reverser system center
drive unit (CDU). This additional load can cause the CDU clevis bracket
fasteners to fail or the CDU clevis pin to lose its retaining
capability, both causing separation of the transcowl from the engine
and airplane. This condition, if not corrected, could result in loss of
thrust control, asymmetric thrust, increased stopping distance, and
possibly hazardous debris on the runway, which could result in unsafe
landings.

Relevant Service Information

    We have reviewed and approved the technical contents of Middle
River Aircraft Systems Alert Service Bulletin (ASB) No. CF6-80C2 S/B
78A1162, Revision 1, dated February 13, 2009. That ASB describes
procedures for inspecting ballscrew gearbox assembly adjustable-length
end actuator \3/8\-inch rod-ends and torsion arms, clevis fasteners,
clevis pins, and clevis pin retaining clips. That ASB also describes
procedures for replacing broken rod-ends, worn, damaged, or deformed
torsion arms, loose clevis fasteners, clevis pins that do not meet wear
limits, and loose clip retainer nuts and bolts.

FAA's Determination and Requirements of the Proposed AD

    We have evaluated all pertinent information and identified an
unsafe condition that is likely to exist or develop on other products
of this same type design. We are proposing this AD, which would require
initial and repetitive replacements of the \3/8\-inch rod-ends
installed on the thrust reverser ballscrew gearbox assembly adjustable-
length end actuators, along with optional terminating action to those
repetitive replacements. The proposed AD would also require an initial
visual inspection and replacement if necessary, of the other hardware
that connects the thrust reverser transcowl to the engine. The proposed
AD would require you to use the service information described
previously to perform these actions.

Costs of Compliance

    We estimate that this proposed AD would affect 750 GE CF6-80C2
series turbofan engines installed on airplanes of U.S. registry. We
also estimate that it would take about 1.5 work-hours per engine to
perform the proposed inspection, 0.8 work-hour per engine to perform
the proposed rod-end replacement, and 24 work-hours per engine to
perform the proposed clevis bracket replacement. The average labor rate
is $80 per work-hour. Required rod-ends would cost about $168 per
engine. We estimate that 75 engines would require clevis bracket
replacement. Required replacement clevis brackets and associated labor
would cost about $826,500. Based on these figures, we estimate the
total cost of the proposed AD to U.S. operators to be $1,090,500.

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.
    We are 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.

Regulatory Findings

    We have determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 the proposed AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD. You may get a copy of this summary at the
address listed under ADDRESSES.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

    Under the authority delegated to me by the Administrator, the
Federal Aviation Administration proposes to amend 14 CFR part 39 as
follows:

PART 39--AIRWORTHINESS DIRECTIVES

    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]

    2. The FAA amends Sec.  39.13 by adding the following new
airworthiness directive:

General Electric Company: Docket No. FAA-2009-0018; Directorate
Identifier 2009-NE-01-AD.

Comments Due Date

    (a) The Federal Aviation Administration (FAA) must receive
comments on this airworthiness directive (AD) action by May 15,
2009.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to General Electric Company (GE) CF6-80C2
series turbofan engines with thrust reverser ballscrew gearbox
assembly adjustable-length end actuators having \3/8\-inch rod-end,
part number (P/N) KBE6-59, MS21242S06, M81935/1-6, B15946-13, or
15946000-13, installed. These engines are installed on, but not
limited to, Airbus A300-600/R/F and A310-200/300, and Boeing 747-
200B/300/400/400D/400F, 767-200/300/300F/400ER, and MD-11 airplanes.

Exemption

    (d) GE CF6-80C2 series turbofan engines that have completed the
initial compliance actions in Middle River Aircraft Systems (MRAS)
Alert Service Bulletin (ASB) No. CF6-80C2 S/B 78A1162, dated
December 30, 2008, or ASB No. CF6-80C2 S/B 78A1162, Revision 1,
dated February 13, 2009:
    (1) Are allowed to take credit for accomplishing paragraphs (g)
and (h) of this AD; however
    (2) All \3/8\-inch rod-ends, including those on engines which
satisfy paragraph (d) of this AD, are subject to the replacement
requirements in paragraph (i) of this AD.

Unsafe Condition

    (e) This AD results from reports of four failures of rod-ends on
certain thrust reverser ballscrew gearbox assembly adjustable-length
end actuators, leading to partial or complete separation of the
transcowl from the engine and airplane during thrust reversal. We
are issuing this AD to prevent loss of thrust control, asymmetric
thrust, increased stopping distance, and possibly hazardous debris
on the runway, which could result in unsafe landings.

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Visual Inspection and Fastening Hardware Replacements

    (g) Within 500 flight cycles after the effective date of this
AD, do the following:
    (1) Inspect all translating cowl clevis pin retaining clips and
associated fastening hardware, including those on the center drive
unit (CDU), to ensure they are properly assembled and securely
fastened in place. If a retaining clip is not completely covering
the clevis pin and firmly attached to the clevis, remove and replace
the fastening hardware. Use paragraphs 3.B.(2)(b) and 3.B.(2)(c) of
MRAS ASB No. CF6-80C2 S/B 78A1162, Revision 1, dated February 13,
2009, to do the inspections.
    (2) Remove and inspect all clevis pins for physical damage or
significant corrosion. Use paragraphs 3.C.(1) through 3.C.(3) of
MRAS ASB No. CF6-80C2 S/B 78A1162, Revision 1, dated February 13,
2009, to do the removals, inspections, and part disposition as
necessary.
    (3) Inspect the clevis brackets and four clevis fasteners at
each of the clevis brackets (upper, center, and lower) for
structural integrity. Use paragraphs 3.F.(1)(a) and 3.F.(1)(b) of
MRAS ASB No. CF6-80C2 S/B 78A1162, Revision 1, dated February 13,
2009, to do the inspections.
    (4) If loose or missing clevis fasteners are found, remove and
replace the clevis

fasteners. Use paragraphs 3.F.(2)(a) through 3.F(2)(c) of MRAS ASB
No. CF6-80C2 S/B 78A1162, Revision 1, dated February 13, 2009, to do
the replacements.

Initial Rod-End Replacements

    (h) For all \3/8\-inch translating cowl adjustable-length
actuator rod-ends, P/N KBE6-59, MS21242S06, B15946-13, 15946000-13,
or M81935/1-6 having more than 600 flight cycles-since-new on the
effective date of this AD, replace them with P/N M81935/1-6, zero
time rod-ends within 500 flight cycles after the effective date of
this AD. Use paragraphs 3.E.(2) through 3.E.(7) of MRAS ASB No. CF6-
80C2 S/B 78A1162, Revision 1, dated February 13, 2009, to do the
replacements.

Repetitive \3/8\-inch Rod-End Replacements

    (i) Repetitively replace \3/8\-inch translating cowl adjustable-
length actuator rod-ends, P/N M81935/1-6, that were installed as
specified in paragraph (h) of this AD, before they accumulate 11,000
flight cycles, with a zero time \3/8\-inch adjustable-length rod-
end, P/N M81935/1-6. Use paragraphs 3.E.(2) through 3.E.(7) of MRAS
ASB No. CF6-80C2 S/B 78A1162, Revision 1, dated February 13, 2009,
to do the replacements.

Optional Terminating Action

    (j) As an optional terminating action to the repetitive \3/8\-
inch rod-end replacements required by this AD, replace the \3/8\-
inch adjustable rod-ends with either a fixed length rod-end, P/N
3238726-1, -2, or MS9560-08, or a 7/16-inch adjustable rod-end, P/N
3238729-1. Use paragraph 3.E.(1) of MRAS ASB No. CF6-80C2 S/B
78A1162, Revision 1, dated February 13, 2009, to do the
replacements.

Installation Prohibition

    (k) Rod-ends removed to comply with this AD are not eligible for
installation on any aircraft.

Previous Credit

    (l) Inspections and replacements and optional terminating action
performed before the effective date of this AD using MRAS ASB No.
CF6-80C2 S/B 78A1162, dated December 30, 2008, satisfy the required
initial actions and optional terminating action of this AD.

Alternative Methods of Compliance

    (m) The Manager, Engine Certification Office, has the authority
to approve alternative methods of compliance for this AD if
requested using the procedures found in 14 CFR 39.19.

Related Information

    (n) Contact Christopher J. Richards, Aerospace Engineer, Engine
Certification Office, FAA, Engine & Propeller Directorate, 12 New
England Executive Park, Burlington, MA 01803; e-mail:
<EMAIL_ADDRESS>telephone<PHONE_NUMBER>; fax (781)
238-7199, for more information about this AD.
    (o) Contact Middle River Aircraft Systems, Mail Point 46, 103
Chesapeake Park Plaza, Baltimore, MD 21220, attn: Warranty Support;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>, for a copy of the
service information identified in this AD.

    Issued in Burlington, Massachusetts, on March 9, 2009.
Francis A. Favara,
Manager, Engine and Propeller Directorate, Aircraft Certification
Service.
[FR Doc. E9-5575 Filed 3-13-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 187 (Tuesday, September 27, 2016)]
[Notices]
[Pages 66266-66267]
[FR Doc No: 2016-23238]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL16-117-000]

Vote Solar and Montana Environmental Information Center; Notice
of Petition for Enforcement

    Take notice that on September 19, 2016, Vote Solar and Montana
Environment Information Center (collectively, Vote Solar) filed a
petition for enforcement pursuant to section 210 of Public Utility
Regulatory Policies Act of 1978 (PURPA), 16 U.S.C. 824a-3. Vote Solar
asserts that Montana Public Service Commission violated PURPA by
suspending the standard rate for solar qualifying facilities with a
nameplate capacity between 100 kW and 3 MW, all as more fully explained
in the petition.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or

protests must be filed on or before the comment date. On or before the
comment date, it is not necessary to serve motions to intervene or
protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on October 11, 2016.

    Dated: September 20, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-23238 Filed 9-26-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 76 (Thursday, April 22, 2021)]
[Notices]
[Pages 21316-21317]
[FR Doc No: 2021-08372]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[FRL-10022-40-Region 5]

Clean Air Act Operating Permit Program; Petition for Objection to
State Operating Permit for AK Steel Dearborn Works, Wayne County,
Michigan

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of final order on petition for objection to a Clean Air
Act title V operating permit.

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

SUMMARY: The Environmental Protection Agency (EPA) Administrator signed
an Order dated January 15, 2021, denying a Petition dated September 27,
2017 from the Sierra Club, the South Dearborn Environmental Improvement
Association, and the Great Lakes Environmental Law Center (the
Petitioners). The Petition requested that EPA object to a Clean Air Act
(CAA) title V operating permit issued by the Michigan Department of
Environment, Great Lakes and Energy (EGLE), to AK Steel Dearborn Works
(AK Steel), located in Wayne County, Michigan.

ADDRESSES: The final order, the Petition, and other supporting
information are available for public inspection during normal business
hours at the following address: U.S. Environmental Protection Agency,
Region 5, Air and Radiation Division, 77 West Jackson Boulevard,
Chicago, Illinois 60604. This facility is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding Federal holidays and facility
closures due to COVID-19. We recommend that you telephone Susan Kraj,
Environmental Engineer, at<PHONE_NUMBER> before visiting the Region 5
office. Additionally, the final Order and Petition are available
electronically at: https://www.epa.gov/title-v-operating-permits/title-v-petition-database.

FOR FURTHER INFORMATION CONTACT: Susan Kraj, Environmental Engineer,
Air Permits Section, Air Programs Branch (AR-18J), Environmental
Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago,
Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The CAA affords EPA a 45-day period to
review and object to, as appropriate, operating permits proposed by
state permitting authorities under title V of the CAA. Section
505(b)(2) of the CAA authorizes any person to petition the EPA
Administrator to object to a title V operating permit within 60 days
after the expiration of EPA's 45-day review period if EPA has not
objected on its own initiative. Petitions must be based only on
objections to the permit that were raised with reasonable specificity
during the public comment period provided by the state, unless the
petitioner demonstrates that it was impracticable to raise these issues
during the comment period or unless the grounds for the issues arose
after this period.
    EPA received the September 27, 2016 Petition from the Petitioners
requesting that EPA object to the issuance of operating permit no. MI-
ROP-A8640.2016a issued by Michigan EGLE to AK Steel. The Petition
alleged: (1) The incorporation of a construction permit into the
operating permit was unlawful because the it allowed emissions
increases without applying current standards, that is, EGLE evaluated
the Sulphur Dioxide regulations as they existed in 2007 rather than
applying the regulations in effect at the time the construction permit
was issued in 2014; (2) that any future operation or rebuild of the B
Blast Furnace (which is not operational due to catastrophic failure)
should require a new construction permit and that the title V permit
cannot authorize the operation of this Blast Furnace; and, (3) that
EGLE was required to address environmental justice concerns in the
permit.
    On January 15, 2021, the EPA Administrator issued an Order denying
the Petition. The order explains the basis for EPA's decision.
    Sections 307(b) and 505(b)(2) of the CAA provide that a petitioner
may request judicial review of those portions of an order that deny
issues in a petition. Any petition for review of the Administrator's
January 15, 2021 Order shall be filed in the United States Court

of Appeals for the appropriate circuit no later than June 21, 2021.

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

    Dated: April 8, 2021.
Cheryl Newton,
Acting Regional Administrator, Region 5.
[FR Doc. 2021-08372 Filed 4-21-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 31 (Thursday, February 14, 2019)]
[Notices]
[Page 4057]
[FR Doc No: 2019-02336]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2790-072]

Boott Hydropower, LLC; Notice of Comment Period Extension

    On January 28, 2019, Boot Hydropower, LLC filed a revised study
plan in support of the re-licensing process for the Lowell
Hydroelectric Project No. 2790. Pursuant to 18 CFR 5.13(b),
participants may file comments within 15 days of the date the potential
applicant files the revised study plan; and pursuant to 18 CFR 5.13(c),
the Director of Energy Projects will issue a study plan determination
within 30 days of the date the potential applicant files its revised
study plan. Due to the funding lapse at certain federal agencies
between December 22, 2018 and January 25, 2019, the Commission is
extending the comment period on the revised study plan to February 27,
2019, and the issuance date for the Director's study plan determination
to March 14, 2019.

    Dated: February 8, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-02336 Filed 2-13-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 21 (Tuesday, February 1, 2011)]
[Notices]
[Pages 5572-5574]
[FR Doc No: 2011-2151]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

January 21, 2011.
    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER99-1522-007; ER02-723-006; ER04-359-005; ER06-
796-005; ER07-553-004; ER07-554-

004; ER07-555-004; ER07-556-004; ER07-557-004.
    Applicants: Emera Energy Services Inc., Emera Energy Services
Subsidiary No. 1 LLC, Emera Energy Services Subsidiary No. 2 LLC, Emera
Energy Services Subsidiary No. 3 LLC, Emera Energy Services Subsidiary
No. 4 LLC, Emera Energy Services Subsidiary No. 5 LLC, Emera Energy
U.S. Subsidiary No. 1, Inc., Emera Energy U.S. Subsidiary No. 2, Inc.,
Bangor Hydro Electric Company, Emera Energy Services Subsidiary No. 3
LLC.
    Description: Change in Status Report of the Emera Entities.
    Filed Date: 01/20/2011.
    Accession Number: 20110120-5186.
    Comment Date: 5 p.m. Eastern Time on Thursday, February 10, 2011.

    Docket Numbers: ER00-586-009.
    Applicants: Madison Gas and Electric Company.
    Description: Notification of Change in Facts under Market-Based
Rate Authority.
    Filed Date: 01/20/2011.
    Accession Number: 20110120-5182.
    Comment Date: 5 p.m. Eastern Time on Thursday, February 10, 2011.

    Docket Numbers: ER10-3124-001; ER10-3127-001; ER10-3129-001; ER10-
3130-001; ER10-3132-001; ER10-3134-001; ER10-3135-001; ER10-3137-001.
    Applicants: Noble Wethersfield Windpark, LLC, Noble Chateaugay
Windpark, LLC, Noble Bellmont Windpark, LLC, Noble Ellenburg Windpark,
LLC, Noble Bliss Windpark, LLC, Noble Clinton Windpark I, LLC, Noble
Altona Windpark, LLC, Noble Great Plains Windpark, LLC.
    Description: Notice of Non-Material Change in Status of Noble
Altona Windpark, LLC.
    Filed Date: 01/21/2011.
    Accession Number: 20110121-5020.
    Comment Date: 5 p.m. Eastern Time on Friday, February 11, 2011.

    Docket Numbers: ER11-2128-001.
    Applicants: California Independent System Operator Corporation.
    Description: California Independent System Operator Corporation
submits tariff filing per 35: 2010-12-03 CAISO's Convergence Bidding
Compliance Filing Errata to be effective 2/1/2011.
    Filed Date: 12/03/2010.
    Accession Number: 20101203-5187.
    Comment Date: 5 p.m. Eastern Time on Thursday, January 27, 2011.

    Docket Numbers: ER11-2715-000.
    Applicants: Interstate Power and Light Company.
    Description: Interstate Power and Light Company submits tariff
filing per 35.13(a)(2)(iii): IPL O & T Agreement with ITCM and CIPCO to
be effective 3/21/2011.
    Filed Date: 01/20/2011.
    Accession Number: 20110120-5144.
    Comment Date: 5 p.m. Eastern Time on Thursday, February 10, 2011.

    Docket Numbers: ER11-2716-000.
    Applicants: NorthWestern Corporation.
    Description: NorthWestern Corporation submits tariff filing per
35.13(a)(2)(iii): NorthWestern (MT) Service Agreement No. 576-LGIA with
WKN Montana II, LLC to be effective 12/29/2010.
    Filed Date: 01/20/2011.
    Accession Number: 20110120-5155.
    Comment Date: 5 p.m. Eastern Time on Thursday, February 10, 2011.

    Docket Numbers: ER11-2717-000.
    Applicants: Entergy Arkansas, Inc.
    Description: Entergy Arkansas, Inc. submits tariff filing per
35.13(a)(2)(iii): Grand Gulf Nuclear Station LGIA to be effective 3/20/
2011.
    Filed Date: 01/20/2011.
    Accession Number: 20110120-5160.
    Comment Date: 5 p.m. Eastern Time on Thursday, February 10, 2011.

    Docket Numbers: ER11-2718-000.
    Applicants: Dow Pipeline Company.
    Description: Dow Pipeline Company submits tariff filing per 35: MBR
Tariff Compliance Filing to be effective 10/18/2010.
    Filed Date: 01/21/2011.
    Accession Number: 20110121-5022.
    Comment Date: 5 p.m. Eastern Time on Friday, February 11, 2011.

    Docket Numbers: ER11-2719-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc. submits tariff filing per
35.13(a)(2)(iii): 2141 Buffalo Point Wind LLC GIA to be effective 12/
22/2010.
    Filed Date: 01/21/2011.
    Accession Number: 20110121-5045.
    Comment Date: 5 p.m. Eastern Time on Friday, February 11, 2011.

    Docket Numbers: ER11-2720-000.
    Applicants: California Independent System Operator Corporation.
    Description: California Independent System Operator Corporation
submits tariff filing per 35.13(a)(2)(iii): 2011-01-21 CAISO's
Convergence Bidding Amendment to Section <IP_ADDRESS> to be effective 2/1/
2011.
    Filed Date: 01/21/2011.
    Accession Number: 20110121-5054.
    Comment Date: 5 p.m. Eastern Time on Thursday, January 27, 2011.

    Take notice that the Commission received the following open access
transmission tariff filings:

    Docket Numbers: OA11-4-000.
    Applicants: Willmar Municipal Utilities.
    Description: Petition of Willmar Municipal Utilities for Waiver of
Standards of Conduct and Oasis Reciprocity Conditions.
    Filed Date: 01/20/2011.
    Accession Number: 20110120-5185.
    Comment Date: 5 p.m. Eastern Time on Thursday, February 10, 2011.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    As it relates to any qualifying facility filings, the notices of
self-certification [or self-recertification] listed above, do not
institute a proceeding regarding qualifying facility status. A notice
of self-certification [or self-recertification] simply provides
notification that the entity making the filing has determined the
facility named in the notice meets the applicable criteria to be a
qualifying facility. Intervention and/or protest do not lie in dockets
that are qualifying facility self-certifications or self-
recertifications. Any person seeking to challenge such qualifying
facility status may do so by filing a motion pursuant to 18 CFR
292.207(d)(iii). Intervention and protests may be filed in response to
notices of qualifying facility dockets other than self-certifications
and self-recertifications.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies

of the intervention or protest to the Federal Energy Regulatory
Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-2151 Filed 1-31-11; 8:45 am]
BILLING CODE 6717-01-P


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ÃÃSubject: ÄÄÁØ	Ø	ÁY2001 and Y2002 TRI data

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Ð (#€%Ø'0*ˆ,à.813è5@8˜:ð<H? AøCPF¨HKXM°OR`T¸VYh[À]`°ÐÐ

Betsy,

The attached charts provide the calculated TWPE for dioxins and furans from
SICC 2491 facilities based on the 2001 and 2002 TRI reports, adjusted to
reflect the recent TM-17 distribution information.  I am forwarding this
directly to you as you requested after our meeting yesterday.

 <<2001 dioxin.xls>>  <<2002 dioxin.xls>>

Herbert Estreicher, J.D., Ph.D.
Keller and Heckman LLP
1001 G Street, N.W. Suite 500W
Washington, DC 20001
(202)-434-4334 (tel)
(202) 434-4646 (fax)
<EMAIL_ADDRESS>Resident in the District of Columbia and Admitted to
Practice in the District of Columbia

**********************************************************
This electronic mail transmission contains confidential information
intended only for the person(s) named.  It may be protected by
Attorney-Client, Work Product and other legal privileges.  Any use,
distribution, copying or disclosure by another person is strictly
prohibited without the consent of the sender.  If this transmission has
been received in error, you are requested to delete it from your system and
to contact the undersigned immediately.

ÐÐØ	ÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿ°ÐÐ
ÃÃCC:ÄÄÁØ	Ø<EMAIL_ADDRESS><EMAIL_ADDRESS>


[Federal Register Volume 78, Number 59 (Wednesday, March 27, 2013)]
[Notices]
[Pages 18585-18586]
[FR Doc No: 2013-06920]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2012-0442; FRL-9382-5]

FIFRA Pesticide Registration Review and ESA Consultation
Processes; Stakeholder Input; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA is announcing the availability of the final paper
describing enhanced opportunities for stakeholder input during its
review of pesticide registrations under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) and associated consultations
under the Endangered Species Act (ESA). The paper was jointly prepared
by EPA, the U.S. Department of Agriculture (USDA), and the National
Marine Fisheries Service (NMFS) in the U.S. Department of Commerce and
the U.S. Fish and Wildlife Service (USFWS) in the Department of
Interior (collectively, the Services). The paper describes significant
changes to EPA's registration review process intended to facilitate ESA
pesticide consultations and coordination across these Federal agencies,
and calls for a greater role for USDA. EPA accepted public comment on
the proposed changes for 60 days, and then reviewed the comments
received. Subsequently, EPA, USDA, and the Services revised the paper
to outline specific roles and responsibilities for each agency, and to
provide clarifying information on focus meetings and the timing for
public input.

FOR FURTHER INFORMATION CONTACT: Richard P. Keigwin, Jr., Pesticide Re-
evaluation Division (7501P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture,
buy, sell, distribute, or use pesticide products.

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPP-2012-0442, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

II. Background

    EPA is announcing the availability of a document titled,
``Enhancing Stakeholder Input in the Pesticide Registration Review and
ESA Consultation Processes and Development of Economically and
Technologically Feasible Reasonable and Prudent Alternatives.'' A copy
of this document is available in the docket at http://www.regulations.gov under docket ID number EPA-HQ-OPP-2012-0442. The
document describes changes to EPA's pesticide registration review
program and how it conducts consultation with the Services under
section 7 of the ESA. In an effort to be responsive to stakeholders'
desires for a mechanism to get information into the registration review
process as early as possible, EPA is holding ``focus'' meetings at the
start of registration review for each active ingredient. In response to
stakeholders' desires for a more open, reliable, and transparent
pesticide consultation process, EPA will initiate any needed formal ESA
consultations at a later stage in the review process. Consulting later
in the registration review process allows EPA to develop more refined
ecological risk assessments and to engage affected stakeholders in
discussions that should result in more focused consultation packages
inclusive of mitigation for listed species. There is a consensus that
EPA and the Services should engage informally and early in the
consultation process, but that formal consultation

should be reserved until EPA's ecological risk assessment and proposed
decision are more fully formed. This approach has the potential to
maximize the opportunity to effect changes that provide protections for
species and their designated critical habitat, lessen the impacts on
agriculture, and narrow the scope of the Federal action.
    Additionally, the document describes EPA's plans to reach out to
pesticide users potentially affected to discuss the technological and
economic feasibility of reasonable and prudent alternatives (RPAs)
intended to avoid jeopardy to threatened and/or endangered species. The
USDA's relationships with the agricultural community provide a critical
link between EPA's expertise on pesticides and the Services' expertise
on listed species' locations, status and biology.
    Finally, the document describes the process by which public
comments received on RPAs will be summarized and organized by EPA and
provided to the Services, who will prepare a document to be included in
the administrative record of the consultation explaining how comments
were considered, and if appropriate, how the final biological opinion
was modified to address the comments. The Services will provide the
document to EPA, and both the Services and EPA will make the document
available to the public upon request. These process changes are
intended to provide clarity and transparency to the ESA section 7
consultation process for pesticides.

List of Subjects

    Environmental protection, Endangered species, Pesticide
registration review, Section 7 ESA consultation.

    Dated: March 19, 2013.
Steven Bradbury,
 Director, Office of Pesticide Programs.
[FR Doc. 2013-06920 Filed 3-26-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 53 (Thursday, March 19, 2015)]
[Rules and Regulations]
[Pages 14305-14307]
[FR Doc No: 2015-06357]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2014-0436]
RIN 1625-AA09

Drawbridge Operation Regulation; Gulf Intracoastal Waterway, St.
Petersburg Beach, FL

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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

SUMMARY: The Coast Guard is modifying the operating schedule that
governs the Pinellas Bayway Structure ``E'' (SR 679) Bridge, Gulf
Intracoastal Waterway mile 113.0, St. Petersburg Beach, FL. This will
extend the time period when the bridge is subject to periodic closings.
During this extended time period the bridge will not open on demand.

DATES: This rule is effective April 20, 2015.

ADDRESSES: Documents mentioned in this preamble are part of docket
[USCG-2014-0436]. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking. You may also
visit the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Mr. Robert Glassman, Seventh Coast Guard District, Bridge
Branch,<PHONE_NUMBER>, email<EMAIL_ADDRESS>If you have
questions on viewing the docket, call Cheryl Collins, Program Manager,
Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
Sec.  Section Symbol
U.S.C. United States Code

A. Regulatory History and Information

    On August 11, 2014, we published a notice of proposed rulemaking
(NPRM) entitled, ``Drawbridge Operation Regulations; Gulf Intracoastal
Waterway, St Petersburg Beach, FL'' in the Federal Register (79 FR
46740). We received 173 comments on the proposed rule. No public
meeting was requested, and none was held.

B. Basis and Purpose

    The Pinellas Bayway Structure ``E'' Bridge provides a vertical
clearance of 25 feet at mean high water in the closed position and a
horizontal clearance of 89 feet. Vessels with a height of less than 25
feet may pass through the bridge at any time. The current regulation,
33 CFR 117.287(d)(4), states Pinellas

Bayway Structure ``E'' (SR 679) bridge, mile 113.0 at St. Petersburg
Beach ``shall open on signal, except that from 9 a.m. to 7 p.m. the
draw need open only on the hour and 30 minutes past the hour.'' This
modification will extend the time by two hours in the morning and two
hours in the evening, allowing this Bridge to open on the hour and
half-hour from 7 a.m. to 9 p.m., seven days a week and continue to open
on demand all other times.

C. Discussion of Comments, Changes and the Final Rule

    Of the 173 comments received, 171 were in favor of extending the
half-hour schedule by two hours in the morning and two hours in the
evening. Two comments opposed extending the scheduled opening period.
    Two commenters asked if afternoon scheduled openings should end
prior to 9 p.m. Vehicles exiting Fort de Soto Park to the mainland must
use Pinellas Bayway Structure ``E'' Bridge. Fort de Soto Park closes at
8:30 p.m. Extending scheduled openings until 9 p.m. will reduce traffic
for departing park visitors.
    One commenter indicated that one hour is too long to wait for a
bridge opening. This rule will provide for passage two times in an hour
during the period of scheduled openings. From 7 a.m. to 9 p.m. the
bridge will open on the hour and on the half hour.
    One commenter voiced concern for the safety of vessels transiting
to a dock or marina in a storm. Other comments recommended extending
scheduled openings for the entire day, in part because it serves as a
means of ingress and egress for emergency vehicles. Under Title 33 Code
of Federal Regulations, Section 117.31, drawtenders are required to
make reasonable efforts to have drawspans closed for emergency vehicles
and opened for vessels in distress or seeking shelter from severe
weather.
    One commenter asked for an exception for boat parades. If an
extended closure period is necessary for a special event, the bridge
owner may request a temporary change to the drawbridge operating
schedule.
    No changes were made to the proposed regulatory text as a result of
the comments. Therefore, paragraph (d)(4) of 33 CFR 117.287 will be
revised to require opening on signal, except that from 7 a.m. to 9 p.m.
the draw need open only on the hour and 30 minutes past the hour.
    This rule will not unreasonably impact navigation. Both vehicle
traffic and vessel traffic may need to adjust schedules to ensure that
they are not unreasonably delayed.

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on these statutes or executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Order 12866 or under
section 1 of Executive Order 13563. The Office of Management and Budget
has not reviewed it under those Orders.
    This rule is not a significant regulatory action because vessels
may still transit the Bridge at scheduled intervals and these changes
will continue to meet the reasonable needs of navigation. Therefore,
the rule will only have a minor impact on vessels transiting the Gulf
Intracoastal Waterway in the vicinity of St. Petersburg Beach, Florida.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard received no comments from the Small Business
Administration on this rule. The Coast Guard certifies under 5 U.S.C.
605(b) that this rule will not have a significant economic impact on a
substantial number of small entities.
    This rule would affect the following entities, some of which might
be small entities: The owners or operators of vessels transiting the
Gulf Intracoastal Waterway. However, this action will not have a
significant economic impact on a substantial number of small entities
for the following reasons: Vessels that can safely transit under the
Bridge may do so at any time. Vessels unable to transit under the
Bridge will be able to transit the Bridge at specific intervals which
can be taken into account by vessel owners and operators.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Public Law 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT,
above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We analyzed this rule under that Order and determined that
it does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or

more in any one year. Though this rule will not result in such an
expenditure, we do discuss the effects of this rule elsewhere in this
preamble.

8. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that might
disproportionately affect children.

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination With Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

12. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards; therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guides the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have concluded
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule is categorically excluded, under figure 2-1,
paragraph (32)(e), of the Instruction.
    Under figure 2-1, paragraph (32)(e), of the Instruction, an
environmental analysis checklist and a categorical exclusion
determination are not required for this rule.

List of Subjects in 33 CFR Part 117

    Bridges.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

0
1. The authority citation for part 117 continues to read as follows:

    Authority: 33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland
Security Delegation No. 0170.1.

0
2. In Sec.  117.287, revise paragraph (d)(4) to read as follows:

Sec.  117.287  Gulf Intracoastal Waterway.

* * * * *
    (d) * * *
    (4) Pinellas Bayway Structure ``E'' (SR 679) bridge, mile 113.0 at
St. Petersburg Beach. The draw shall open on signal, except that from 7
a.m. to 9 p.m. the draw need open only on the hour and 30 minutes past
the hour.
* * * * *

    Dated: February 27, 2015.
J. H. Korn,
Rear Admiral, U.S. Coast Guard, Commander, Seventh Coast Guard
District.
[FR Doc. 2015-06357 Filed 3-18-15; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 67 (Friday, April 6, 2018)]
[Notices]
[Pages 14859-14861]
[FR Doc No: 2018-07028]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0791]

Exposure-Response Analysis in Drug Development and Regulatory
Decision Making; Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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

SUMMARY: The Prescription Drug User Fee Act of 2017 (PDUFA VI), part of
the FDA Reauthorization Act of 2017 (FDARA, highlights the goal of
advancing model-informed drug development (MIDD). Exposure-response
analysis is a MIDD strategy that has been used in drug development and
regulatory decision making. The Food and Drug Administration (FDA or
Agency) is opening a docket to receive public comments on experience
leveraging exposure-response analysis since publishing the guidance for
industry (GFI) entitled ``Exposure-Response Relationships--Study
Design, Data Analysis, and Regulatory Applications,'' which was
announced in the Federal Register on May 6, 2003. Specifically, the
Agency wants to identify areas of scientific policy that may need
further clarity or elaboration, as well as any obstacles that prevent
use of exposure-response analyses in drug development and regulatory
review.

DATES: To ensure that the Agency considers your input, submit either
electronic or written comments by July 5, 2018.

ADDRESSES: You may submit comments as follows. Electronic comments must
be submitted on or before July 5, 2018. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery date service acceptance
receipt is on or before that date:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a

third party may not wish to be posted, such as medical information,
your or anyone else's Social Security number, or confidential business
information, such as a manufacturing process. Please note that if you
include your name, contact information, or other information that
identifies you in the body of your comments, that information will be
posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-N-0791 for ``Exposure-Response Analysis in Drug Development
and Regulatory Decision Making; Request for Comments.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kevin Krudys, Office of Clinical
Pharmacology, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3110, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On May 6, 2003, FDA issued a GFI entitled ``Exposure-Response
Relationships--Study Design, Data Analysis, and Regulatory
Applications'' (available at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072109.pdf) (68 FR
24004). This guidance provides recommendations for sponsors of
investigational new drugs (INDs) and applicants submitting new drug
applications (NDAs) or biologics license applications (BLAs) on the use
of exposure-response analyses in the development of drugs, including
therapeutic biologics. Since then, FDA and drug developers have gained
a wealth of experience performing exposure-response analyses and
leveraging the results to influence drug development and inform
regulatory review. Additionally, obstacles that limit the routine
application and acceptance of exposure-response analyses to address key
drug development and regulatory decisions have since been identified.
Given that PDUFA VI goals highlight advancing MIDD, FDA wants to
capture the public's experience to inform future efforts on providing
additional clarity, new insights, and updated recommendations for
employing exposure-response analyses in drug development. To achieve
these ends, FDA is opening the docket ``Exposure-Response Analysis in
Drug Development and Regulatory Decision Making: Request for Comments''
to give interested parties an opportunity to identify areas of
scientific policy that may need further clarity or elaboration, as well
as any obstacles preventing use of exposure-response analyses in drug
development and regulatory review.

II. Additional Issues for Consideration: Request for Information and
Comments

    Interested persons are invited to provide detailed information and
comments on the use of exposure-response analysis in drug development
and regulatory review. FDA is particularly interested in responses to
the following questions:
    1. In general, are there any aspects of the 2003 GFI entitled
``Exposure-Response Relationships--Study Design, Data Analysis, and
Regulatory Applications'' that merit further elaboration? Additionally,
are there any new topic areas that should be addressed?
    2. What are best practices for conducting exposure-response
analysis that can be generally applied across development programs and
regulatory submissions? Input on best practices can include any of the
following topic areas:
     Planning and design (e.g., data considerations, assumption
setting);
     Analytical approaches (e.g., exposure and response
metrics, choice and inclusion of predictors, methods for addressing
confounding factors);
     Model evaluation and qualification (e.g., goodness-of-fit,
assessment of model risk, impact on regulatory decisions); and
     Communication of results and impact on subsequent drug
development or regulatory decisions.
    3. What attributes of an exposure-response analysis are critical to
effectively inform a drug development or regulatory decision?
Additionally, what are the main obstacles preventing widespread
acceptance of exposure-response analyses?
    4. During which stages of drug development would it be most
productive to interact with the FDA regarding exposure-response
analysis planning? What type of feedback would be useful to inform
exposure-response analyses and to reduce uncertainty in regulatory
acceptance?
    FDA will consider all information and comments submitted.

III. Electronic Access

    Persons with access to the internet may obtain the 2003 GFI
entitled ``Exposure-Response Relationships--Study Design, Data
Analysis, and Regulatory Applications'' at either https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072109.pdf or https://www.fda.gov/Drugs/GuidancecomplianceRegulatoryInformation/Guidances/default.htm.

    Dated: April 2, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07028 Filed 4-5-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: April 13, 2010 (Volume 75, Number 70)]
[Rules and Regulations]
[Page 18751]
[DOCID:fr13ap10-1]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

========================================================================

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 118

[Docket No. FDA-2000-N-0190]

Prevention of Salmonella Enteritidis in Shell Eggs During
Production, Storage, and Transportation; Change of Registration Date,
Address, and Telephone Number; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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

SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations to correct the date by which producers must register their
farm with FDA, reflect a change in the address and telephone number for
requesting copies of Form No. 3733, and reflect a change in the address
to which producers must send their CD-ROM. This action is editorial in
nature and is intended to improve the accuracy of the agency's
regulations.

DATES: Effective on April 13, 2010.

FOR FURTHER INFORMATION CONTACT: John Sheehan, Center for Food Safety
and Applied Nutrition (HFS-315), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: FDA is amending its regulations in 21 CFR
part 118 to correct the following information: (1) The date by which
egg producers must register their farm with FDA, (2) the address and
telephone number for requesting copies of Form 3733, and (3) the
address to which egg producers must send their CD-ROM. Publication of
this document constitutes final action on this change under the
Administrative Procedure Act (5 U.S.C. 553). Notice and public
procedures are unnecessary because FDA is merely updating
nonsubstantive content.

List of Subjects in 21 CFR Part 118

    Eggs and egg products, Incorporation by reference, Recordkeeping
requirements, Safety.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
118 is amended as follows:

PART 118--PRODUCTION, STORAGE, AND TRANSPORTATION OF SHELL EGGS

0
1. The authority citation for 21 CFR part 118 continues to read as
follows:

    Authority: 21 U.S.C. 321, 331-334, 342, 371, 381, 393; 42 U.S.C.
243, 264, 271.

0
2. In Sec.  118.11, revise paragraphs (a), (b)(2)(i), and (b)(3)(vi) to
read as follows:

Sec.  118.11  Registration requirements for shell egg producers covered
by the requirements of this part.

    (a) Shell egg producers covered under Sec.  118.1(a) are required
to register their farms with FDA within 30 days of becoming an egg
producer or, if already an egg producer, by each farm's applicable
compliance date.
    (b) * * *
    (2) * * *
    (i) You must register using FDA Form No. 3733. You may obtain a
copy of this form by writing to the U.S. Food and Drug Administration,
5600 Fishers Lane (HFS-681), Rockville, MD 20857, or by requesting the
form by phone at 1-800-216-7331 or<PHONE_NUMBER>.
* * * * *
    (3) * * *
    (vi) You must mail the CD-ROM to the U.S. Food and Drug
Administration, 5600 Fishers Lane (HFS-681), Rockville, MD 20857.
* * * * *

    Dated: April 7, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-8358 Filed 4-12-10; 8:45 am]
BILLING CODE 4160-01-S