[Federal Register Volume 77, Number 114 (Wednesday, June 13, 2012)]
[Rules and Regulations]
[Pages 35279-35285]
[FR Doc No: 2012-14148]

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 ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2010-0717; FRL 9661-3]

Approval and Promulgation of Implementation Plans; Arizona;
Update to Stage II Gasoline Vapor Recovery Program; Change in the
Definition of ``Gasoline'' To Exclude ``E85''

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: Under the Clean Air Act, EPA is taking final action to approve
certain revisions to the Arizona State Implementation Plan submitted by
the Arizona Department of Environmental Quality. These revisions
concern amendments to the statutory and regulatory provisions adopted
by the State of Arizona to regulate volatile organic compound emissions
from the transfer of gasoline from storage tanks to motor vehicle fuel
tanks at gasoline dispensing sites, i.e., stage II vapor recovery. The
revisions also amend the definition of ``gasoline'' to explicitly
exclude E85 and thereby amend the requirements for fuels available for
use in the Phoenix metropolitan area as well as the requirements for
vapor recovery. In approving the revisions, EPA is taking final action
to waive the statutory stage II vapor recovery requirements at E85
dispensing pumps within the Phoenix metropolitan area. Lastly, EPA is
taking final action to correct an EPA rulemaking that approved a
previous version of the Arizona rules regulating these sources and to
thereby identify the appropriate regulatory agency and specific rules
that were previously approved and incorporated by reference into the
Arizona State Implementation Plan.

DATES: Effective Date: This rule is effective on July 13, 2012.

ADDRESSES: EPA has established docket number EPA-R09-OAR-2010-0717 for
this action. The index to the docket is available electronically at
www.regulations.gov and in hard copy at EPA Region IX, 75 Hawthorne
Street, San Francisco, California. While all documents in the docket
are listed in the index, some information may be publicly available
only at the hard copy location (e.g., copyrighted material), and some
may not be publicly available in either location (e.g., Confidential
Business Information). To inspect the hard copy materials, please
schedule an appointment during normal business hours with the contact
listed in the FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: For further information on the
revisions to the Arizona State Implementation Plan submitted by the
Arizona Department of Environmental Quality, contact Mr. Andrew
Steckel, EPA Region IX, 75 Hawthorne Street (AIR-4), San Francisco, CA
94105, phone number<PHONE_NUMBER>, fax number<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us,''
and ``our'' refer to EPA.

Table of Contents

I. EPA's Proposed Action
    A. The State's Submittal
    B. Regulatory Context
    C. EPA's Evaluation of SIP Submittal and Proposed Action
    D. Proposed Correction of Previous Rulemaking
II. Public Comments and EPA Responses
III. Final Action
IV. Statutory and Executive Order Reviews

I. EPA's Proposed Action

A. The State's Submittal

    On October 3, 2011 (76 FR 61062), we proposed to approve a revision
to the Arizona State Implementation Plan (SIP) submitted to EPA on
September 21, 2009 by the Arizona Department of Environmental Quality
(ADEQ). The purpose of the SIP revision is to update the gasoline vapor
recovery program that was originally submitted and approved by EPA in
1994 to meet certain applicable requirements of the Clean Air Act, as
amended in 1990 (CAA or ``Act'').\1\ The specific revisions include
statutory provisions and administrative rules regulating the emissions
of volatile organic compounds (VOC) due to the transfer of gasoline
from storage tanks (typically underground) to motor vehicle fuel tanks
at gasoline stations in the Phoenix metropolitan area. The statutory
provisions and administrative rules are contained in enclosures 3 and 4
of ADEQ's September 21, 2009 SIP revision submittal package.\2\
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    \1\ Gasoline dispensing pump vapor control devices, commonly
referred to as ``stage II'' vapor recovery, are systems that control
VOC vapor releases during the refueling of motor vehicles. This
process takes the vapors normally emitted directly into the
atmosphere when pumping gas and recycles them back into the fuel
storage tank, preventing them from polluting the air. For more
information on stage II vapor recovery systems, please see EPA's
proposed rule, ``Air Quality: Widespread Use for Onboard Refueling
Vapor Recovery and Stage II Waiver,'' 76 FR 41731, at 41734 (July
15, 2011).
    \2\ By letter dated April 12, 2011, ADEQ substituted the
statutes and rules in enclosures 3 and 4 as submitted on September
21, 2009 with official, published versions of the same statutes and
rules in keeping with the requirements. ADEQ did so in response to
an EPA request for the official, published versions of the statutes
and rules to comply with the requirements established by the Office
of the Federal Register for incorporating such materials by
reference into the Code of Federal Regulations.
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    ADEQ's submittal represents an update to the stage II requirements
but is comprehensive in that the submitted

statutory and regulatory provisions also address general requirements
related to stage I vapor recovery.\3\ While ADEQ's submittal relates
almost entirely to the State's vapor recovery program, it also amends
the State's fuels program by amending the definition of the term
``gasoline'' to exclude ``E85,'' \4\ a change that affects both the
gasoline fuels program established for the Phoenix metropolitan area
and the stage II vapor recovery program because both programs now rely
on that particular definition. In our October 3, 2011 proposed rule, we
concluded that ADEQ's September 21, 2009 SIP revision submittal
contains adequate documentation of public notice, opportunity for
comment, and a public hearing on the proposed SIP revision (see
enclosure 5 of the submittal) and that the public participation
materials submitted by ADEQ demonstrate compliance with the procedural
requirements set forth in section 110(l) of the CAA.
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    \3\ ``Stage I'' vapor recovery refers to the collection of VOC
emissions expelled from underground storage tanks at gasoline
stations when being refilled by tank trucks. The Maricopa County Air
Quality Department (MCAQD) implements its own stage I vapor recovery
regulation within the Phoenix metropolitan area, Regulation III,
Rule 353 (``Transfer of Gasoline into Stationary Storage Dispensing
Tanks''). EPA approved MCAQD rule 353 and incorporated it into the
Arizona SIP. See 61 FR 3578 (February 1, 1996). MCAQDM's stage I
vapor recovery program and related rule are not affected by today's
proposed action.
    \4\ E85 is a motor vehicle fuel that is a blend of as little as
15 percent gasoline and up to 85 percent ethanol. (In wintertime
applications, the ratio may be 30 percent gasoline and 70 percent
ethanol.) E85 can only be used in specially designed FFVs, which
have mostly been manufactured since 1998. Since these are newer
vehicles, most of them are equipped with ORVR, and every FFV built
today has ORVR. Thus, most vehicles refueling at E85 dispensing
pumps are already having their evaporative emissions captured, as in
the cases of late model rental cars refueling at rental car
facilities and newly manufactured cars being fueled for the first
time at automobile assembly plants.
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    Table 1 lists the statutory provisions, and Table 2 lists the
administrative rules, that were submitted by ADEQ on September 21, 2009
and that we are approving in today's action.

                 Table 1--Submitted Statutory Provisions
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    Arizona revised statutes            Title             Submitted
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Title 41, chapter 15, article    Definitions:        09/21/09
 1, section 41-2051.              subsection 6
                                  (``Certification'
                                  '), subsection 10
                                  (``Department''),
                                  subsection 11
                                  (``Diesel
                                  fuel''),
                                  subsection 12
                                  (``Director''),
                                  and subsection 13
                                  (``E85'').
Title 41, chapter 15, article    Definitions:        09/21/09
 6, section 41-2121.              subsection 5
                                  (``Gasoline'').
Title 41, chapter 15, article    Definitions:        09/21/09
 7, section 41-2131.              subsection 1
                                  (``Annual
                                  throughput''),
                                  subsection 2
                                  (``Clean air
                                  act''),
                                  subsection 3
                                  (``Gasoline
                                  dispensing
                                  site''),
                                  subsection 4
                                  (``Stage I vapor
                                  collection
                                  system''),
                                  subsection 5
                                  (``Stage II vapor
                                  collection
                                  system''), and
                                  subsection 6
                                  (``Vapor control
                                  system'').
Title 41, chapter 15, article    Stage I and stage   09/21/09
 7, section 41-2132.              II vapor recovery
                                  systems.
Title 41, chapter 15, article    Compliance          09/21/09
 7, section 41-2133.              schedules.
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                                            Table 2--Submitted Rules
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                                                                 Effective date  (for
     Arizona administrative code             Rule title             state purposes)             Submitted
----------------------------------------------------------------------------------------------------------------
Title 20, chapter 2, article 1,       Definitions............  06/05/04................  09/21/09
 section R20-2-101.
Title 20, chapter 2, article 9,       Material Incorporated    06/05/04................  09/21/09
 section R20-2-901.                    by Reference.
Title 20, chapter 2, article 9,       Exemptions.............  06/05/04................  09/21/09
 section R20-2-902.
Title 20, chapter 2, article 9,       Equipment and            06/05/04................  09/21/09
 section R20-2-903.                    Installation.
Title 20, chapter 2, article 9,       Application              06/05/04................  09/21/09
 section R20-2-904.                    Requirements and
                                       Process for Authority
                                       to Construct Plan
                                       Approval.
Title 20, chapter 2, article 9,       Initial Inspection and   06/05/04................  09/21/09
 section R20-2-905.                    Testing.
Title 20, chapter 2, article 9,       Operation..............  10/08/98................  09/21/09
 section R20-2-907.
Title 20, chapter 2, article 9,       Training and Public      10/08/98................  09/21/09
 section R20-2-908.                    Education.
Title 20, chapter 2, article 9,       Recordkeeping and        10/08/98................  09/21/09
 section R20-2-909.                    Reporting.
Title 20, chapter 2, article 9,       Annual Inspection and    06/05/04................  09/21/09
 section R20-2-910.                    Testing.
Title 20, chapter 2, article 9,       Compliance Inspections.  06/05/04................  09/21/09
 section R20-2-911.
Title 20, chapter 2, article 9,       Enforcement............  06/05/04................  09/21/09
 section R20-2-912.
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    Under Arizona law, the principal stage II vapor recovery
requirements are found in Arizona Revised Statutes (ARS) section 41-
2132 (``Stage I and stage II vapor recovery systems''), which requires
gasoline dispensing sites to be equipped with a stage II vapor
collection system within ``an ozone nonattainment area designated as
moderate, serious, severe or extreme by the United States environmental
protection agency under Sec.  107(d) of the clean air act, area A or
other geographical area * * *.'' ARS section 41-2132(C). ``Area A'' is
defined in ARS section 49-541 and it includes all of the metropolitan
Phoenix former 1-hour ozone nonattainment area plus additional areas in
Maricopa County to the north, east, and west, as well as small portions
of Yavapai County and Pinal County.
    ARS 41-2132 also provides an exemption for gasoline dispensing
sites with a throughput of less than 10,000 gallons per month or less
than 50,000 gallons per month in the case of an independent small
business marketer as defined in section 324 of the CAA, and for
gasoline dispensing sites that are located on a manufacturer's proving
ground. ARS 41-2133 sets forth certain compliance schedules related to
the stage II vapor recovery requirements in ARS 41-2132.

    The stage II vapor recovery requirements in ARS 41-2132 rely upon
the definitions of certain terms, such as ``gasoline,'' ``stage II
vapor collection system,'' and ``E85,'' among others, which are
codified in ARS sections 41-2015, 41-2121, and 41-2131, and ADEQ
included the relevant definitions, along with ARS sections 41-2132 and
41-2133, in the SIP revision submittal dated September 21, 2009. See
table 1 of this document. The definition of ``gasoline,'' which is
codified in paragraph (5) of ARS 41-2121, specifically excludes
``diesel fuel'' and ``E85.''
    ARS section 41-2132(G) directs the Arizona Department of Weights
and Measures (ADWM) to adopt rules that establish standards for the
installation and operation of stage I and stage II vapor recovery
systems. In 1994, EPA approved an earlier version of ADWM's rules for
stage II vapor recovery. See 59 FR 54521 (November 1, 1994). Since
then, in addition to renumbering and recodifying the rules, ADWM has
amended the vapor recovery rules to delete, modify, and add certain
definitions; to approve use of certain new test procedures developed by
the California Air Resources Board (CARB); to include general
requirements for stage I vapor recovery systems; to add exemptions for
motor raceways, motor vehicle proving grounds, and marine and aircraft
refueling facilities; to clarify and expand application requirements;
and to enhance compliance-related provisions.
    ADWM's rules for such systems are now codified at title 20, chapter
2, article 9 (``Gasoline Vapor Recovery''), of the Arizona
Administrative Code (AAC). These rules rely upon certain definitions in
AAC, title 20, chapter 2, article 1 (``Administration and
Procedures''), section R20-2-101 (``Definitions''). ADEQ submitted
these rules and definitions to EPA as part of the stage II SIP revision
dated September 21, 2009--see table 2 of this document.
    In our October 3, 2011 proposed rule, we also explained that in our
1994 final rule approving an earlier version of ADWM's vapor recovery
rules, we made an error in how we codified the stage II vapor recovery
rules into the Arizona SIP, and were thus proposing to correct that
error. Please see our October 3, 2011 proposed rule at pages 61063 and
61064 for additional information on these topics.

B. Regulatory Context

    Under CAA section 182(b)(3), stage II vapor recovery systems are
required to be used at larger gasoline dispensing facilities located in
Serious, Severe, and Extreme nonattainment areas for ozone.\5\ More
specifically, the Act specifies that such systems be installed at any
facility that dispenses more than 10,000 gallons of gasoline per month,
or, in the case of an independent small business marketer (as defined
in CAA section 324), any facility that dispenses more than 50,000
gallons of gasoline per month. Based on deadlines established in the
Act, within 24 months from the effective date of the initial area
designation and classification, states must adopt a stage II program
into their SIPs, and the controls must be installed according to
specified deadlines following state rule adoption. For existing
facilities the installation deadlines depend on the date the facilities
were built and the monthly volume of gasoline dispensed. See CAA
sections 182(b)(3)(A)-(B), and 324(a)-(c).\6\
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    \5\ See CAA section 182(b)(3), 42 U.S.C. 7511a(b)(3).
Originally, the section 182(b)(3) stage II requirement also applied
in all Moderate ozone nonattainment areas. However, under section
202(a)(6) of the CAA, 42 U.S.C. 7521(a)(6), the requirements of
section 182(b)(3) no longer apply in Moderate ozone nonattainment
areas after EPA promulgated ORVR standards on April 6, 1994, 59 FR
16262, codified at 40 CFR parts 86 (including 86.098-8), 88 and 600.
Under implementation rules issued in 2004 for the 1997 8-hour ozone
standard, EPA retained the stage II-related requirements under
section 182(b)(3) as they applied for the 1-hour ozone standard. 40
CFR 51.900(f)(5).
    \6\ Section 182(b)(3)(B) has the following effective date
requirements for implementation of stage II after the adoption date
by a state of a stage II rule: 6 months after adoption of the state
rule, for gas stations built after the enactment date (which for
newly designated areas would be the designation date); 1 year after
adoption date, for gas stations pumping at least 100,000 gal/month
based on average monthly sales over 2-year period before adoption
date; 2 years after adoption, for all others.
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    However, the CAA provides discretionary authority to the EPA
Administrator to, by rule, revise or waive the section 182(b)(3) stage
II requirement after the Administrator determines that On-Board
Refueling Vapor Recovery (ORVR) is in widespread use throughout the
motor vehicle fleet. See CAA section 202(a)(6). ORVR consists of an
activated carbon canister installed in the vehicle into which vapors
being expelled from the vehicle fuel tanks are forced to flow. There
the vapors are captured by the activated carbon in the canister. When
the engine is started, the vapors are drawn off of the activated carbon
and into the engine where they are burned as fuel. EPA promulgated ORVR
standards on April 6, 1994, 59 FR 16262.
    EPA first began the phase-in of ORVR by requiring that 40 percent
of passenger cars manufactured in model year 1998 be equipped with
ORVR. The ORVR requirement for passenger cars was increased to 100
percent by model year 2000. Phase-in continued for other vehicle types
and ORVR has been a requirement on virtually all new gasoline-powered
motor vehicles (passenger cars, light trucks, and complete \7\ heavy-
duty gasoline powered vehicles under 10,000 lbs gross vehicle weight
rating (GVWR)) sold since model year 2006. See 40 CFR part 86.
Currently, ORVR-equipped vehicles comprise approximately 67 percent of
the in-service vehicle fleet nationwide, and account for around 76
percent of the vehicle miles traveled (VMT) in the nationwide fleet.
The percentage of non-ORVR vehicles and the percentage of VMT driven by
those vehicles declines each year as these older vehicles wear out and
are removed from service. Since certain vehicles are not required to
have ORVR, including motorcycles and incomplete heavy-duty gasoline
powered trucks chassis, under current requirements the nationwide motor
vehicle fleet would never be entirely equipped with ORVR but these
vehicles account for less than 2 percent of national annual highway
gasoline consumption.
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    \7\ For purposes of ORVR applicability, a ``complete'' vehicle
means a vehicle that leaves the primary manufacturer's control with
its primary load carrying device or container attached.
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    The CAA anticipates that, over the long-term, ORVR will reduce the
benefit from, and the need for, stage II vapor recovery systems at
gasoline dispensing sites in ozone nonattainment areas, and as noted
above, section 202(a)(6) of the CAA allows EPA to revise or waive the
application of stage II vapor recovery requirements for areas
classified as Serious, Severe, or Extreme for ozone, as appropriate,
after such time as EPA determines that ORVR systems are in widespread
use throughout the motor vehicle fleet. CAA section 202(a)(6) does not
specify which motor vehicle fleet must be the subject of a widespread
use determination before EPA may revise or waive the section 182(b)(3)
stage II requirement. Nor does the CAA identify what level of ORVR use
in the motor vehicle fleet must be reached before it is ``widespread.''
To date, EPA has issued two memoranda addressing when ORVR widespread
use might be found for particular fleets.\8\
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    \8\ ``Removal of Stage II Vapor Recovery in Situations Where
Widespread Use of Onboard Vapor Recovery is Demonstrated,''
memorandum from Stephen D. Page, Director, EPA Office of Air Quality
Planning and Standards, and Margo Tsirigotis Oge, Director, EPA
Office of Transportation and Air Quality, to Regional Air Division
Directors, dated December 12, 2006 (``2006 Page/Oge Memorandum'');
and ``Removal of Stage II Vapor Recovery from Refueling of Corporate
Fleets,'' memorandum from Stephen D. Page, Director, EPA Office of
Air Quality Planning and Standards, and Margo Tsirigotis Oge,
Director, EPA Office of Transportation and Air Quality, to Regional
Air Division Directors, dated November 28, 2007 (``2007 Page/Oge
Memorandum'').

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    EPA expects the possibility of different rates of implementation of
ORVR across different geographic regions and among different types of
motor vehicle fleets within any region. Given this, EPA does not
believe that CAA section 202(a)(6) must be read narrowly to allow a
widespread use determination and waiver of the stage II requirement for
a given area or area's fleet only if ORVR use has become widespread
through the entire United States, or only if ORVR use has reached a
definite level in each area. Rather, EPA believes that section
202(a)(6) allows the Agency to apply the widespread use criterion to
either the entire motor vehicle fleet in a State or nonattainment area,
or to special segments of the overall fleet for which ORVR use is shown
to be sufficiently high, and to base widespread use determinations on
differing levels of ORVR use, as appropriate. EPA also believes that
the Act allows the Agency to use an area-specific rulemaking approving
a SIP revision to issue the section 202(a)(6) waiver for a relevant
fleet in a nonattainment area.
    One metric that EPA has considered in determining whether ORVR use
is widespread within a given motor vehicle fleet considers when VOC
emissions resulting from the application of ORVR controls alone equal
the VOC emissions when both stage II vapor recovery systems and ORVR
controls are used, after accounting for incompatibility excess
emissions. The incompatibility excess emissions factor relates to
losses in control efficiency when certain types of stage II and ORVR
are used together. One metric previously discussed by EPA for
widespread use in distinct and unique situations was that widespread
use will likely have been reached when the percentage of motor vehicles
in service with ORVR, the vehicle miles traveled (VMT) by ORVR-equipped
vehicles, or the gasoline dispensed to ORVR-equipped vehicles reaches
95 percent. See the 2006 Page/Oge Memorandum, page 2. Application of
the 95 percent criterion could lead to, for example, waiver of stage II
vapor recovery requirements at gasoline dispensing sites that
exclusively fuel new automobiles at assembly plants and rental cars at
rental car facilities given the high percentage (essentially 100%) of
ORVR-equipped vehicles associated with such facilities.
    Recently, EPA proposed criteria for determining whether ORVR is in
``widespread use'' for purposes of controlling motor vehicle refueling
emissions throughout the motor vehicle fleet. See 76 FR 41731 (July 15,
2011). In EPA's July 15, 2011 action, EPA also proposed criteria that
would establish June 30, 2013 as the date on with ``widespread use''
will occur nationally, and the date on which a nationwide waiver of
stage II gasoline vapor recovery systems will be effective.
    EPA, after considering public comments, intends to take final
action regarding the July 15, 2011 proposal to establish a nationwide
date for determining when ORVR is in ``widespread use'' and for waiving
the stage II requirement. In the proposed rule, EPA stated that it
intends to provide that individual states may submit SIP revisions that
demonstrate that ORVR widespread use has occurred (or will occur) on a
date earlier than the date identified in the final rule for areas in
their states, and to request that the EPA revise or waive the section
182(b) (3) requirement as it applies to only those areas. See 76 FR at
41733. Consistent with EPA's July 15, 2011 proposal to allow states to
submit such SIP revisions, EPA is taking final action today to approve
an area-specific revision to the Arizona SIP and to approve a waiver
for a specific portion of the motor vehicle fleet, namely flexible fuel
vehicles refueled with E85 gasoline blend, in the Phoenix metropolitan
area.
    As explained in our October 3, 2011 proposed rule, the ``Phoenix
area,'' defined by the Maricopa Association of Governments' (MAGs')
urban planning area boundary (but later revised to exclude the Gila
River Indian Community at 70 FR 68339 (November 10, 2005)), was
classified as a ``Moderate'' nonattainment area for the 1-hour ozone
national ambient air quality standard (NAAQS) and later reclassified as
``Serious'' for the 1-hour ozone standard. See 56 FR 56694, at 56717
(November 6, 1991) and 62 FR 60001 (November 6, 1997). As noted above,
section 182(b)(3) of the Act required States with ozone nonattainment
areas such as the Phoenix area to adopt and submit a SIP revision
requiring gasoline dispensing facilities to install and operate stage
II vapor recovery equipment, and in response, ADEQ submitted the
statutory provisions and rules establishing stage II vapor recovery
requirements in the Phoenix area. EPA approved the stage II vapor
recovery rules as a revision to the Arizona SIP. See 59 FR 54521
(November 1, 1994). We are taking final action today to approve a SIP
revision that updates the stage II vapor recovery requirements for the
Phoenix metropolitan area and that waives stage II vapor recovery
requirements at E85 dispensing pumps.

C. EPA's Evaluation of SIP Submittal and Proposed Action

Relevant Statutes, Rules, Policies, and Guidance
    In our October 3, 2011 proposed rule, we explained how we evaluated
the statutory provisions and administrative rules that ADEQ submitted
to update the Arizona SIP with respect to the stage II vapor recovery
program in the Phoenix metropolitan area. To summarize that
information, we evaluated ADEQ's stage II vapor recovery SIP update
revision based on the Phoenix metropolitan area's designations and
classifications for the now-revoked one-hour ozone standard and the
current eight-hour ozone standard to ensure Arizona's stage II program
complies with section 182(b)(3) of the Act (which is described in
section I.B. of this document), to ensure that the requirements of the
program are enforceable (see CAA section 110(a)(2)), and that the
changes would not interfere with reasonable further progress or
attainment of the NAAQS (see CAA section 110(l)).
    In doing so, we relied on a number of guidance and policy documents
including, but not limited to the 2006 Page/Oge Memorandum \9\ and the
2007 Page/Oge Memorandum (see footnote 7 of this document for the full
references to these memoranda). Please see our October 3, 2011 proposed
rule at page 61065 for a complete list of the guidance and policy
documents upon which we relied.
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    \9\ In EPA's recent national rulemaking regarding waiver of
stage II requirements, we indicate that the Agency continues to
believe the 2006 Page/Oge Memorandum is sound guidance in areas
where stage II is currently being implemented, and is unaffected by
the proposed national widespread use determination. See 76 FR 41731,
at 41737 (July 15, 2011). In today's action, we rely primarily on
the principles and rationale set forth in the 2006 Page/Oge
Memorandum rather than those set forth in EPA's July 15, 2011
proposed rule.
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Compliance With CAA Section 182(b)(3) Stage II Requirements
    In our October 3, 2011 proposed rule, we concluded that the
statutory provisions meet the CAA section 182(b)(3) stage II
requirements for the following reasons:
     The State is requiring stage II vapor recovery controls in
an area that encompasses all of the 1-hour ozone ``serious''
nonattainment area consistent

with compliance schedules set forth in the Act and the State provides
low-volume throughput exemptions that are consistent with those allowed
for in CAA section 182(b)(3); and
     The State law exemption for a ``gasoline dispensing site
that is located on a manufacturer's proving ground'' in ARS 41-2132(C)
does not apply to any facility within the nonattainment area, and,
assuming that the fuel throughput at the facility to which it had
applied is representative of the throughput of any such facility that
might locate within the nonattainment area, the exemption would be
consistent with the low-volume throughput exemptions allowed for in CAA
section 182(b)(3).
    Further, in our October 3, 2011 proposed rule, we evaluated whether
the exclusion of ``E85'' from the State law definition of gasoline
comports with section 182(b)(3) vapor recovery requirements. Based on
this evaluation, we concluded that, given how close the ORVR-equipped
percentage for flexible fuel vehicles (FFVs) in the Phoenix
metropolitan area (87 percent in 2008 and climbing) is to the ORVR
widespread use threshold based on comparable VOC emissions (95 percent)
and because the change in emissions due to use of E85 would not
interfere with attainment and RFP of any of the NAAQS, ORVR is in
widespread use in the FFV vehicle fleet in the Phoenix metropolitan
area for the purposes of CAA section 202(a)(6). Based on the finding of
``widespread use,'' in our October 3, 2011 proposed rule, we proposed
to waive the stage II vapor recovery requirements for E85 dispensing
pumps in the Phoenix metropolitan area under section 202(a)(6).
    Third, in our October 3, 2011 proposed rule, we noted that changes
in ADWM's vapor recovery rules would generally serve to clarify and
improve the existing stage II vapor recovery rules that we approved
into the SIP in 1994, and that the only significant changes potentially
affecting approvability with respect to CAA section 182(b) (3) would be
the new exemptions for motor raceways, and for marine and aircraft
refueling facilities. We evaluated the new exemptions and concluded
that they would be acceptable under section 182(b)(3) because the fuel
throughput at the one motor raceway facility to which the exemption
applies is far below the 10,000-gallon per month low-throughput
threshold exemption allowed under CAA section 182(b)(3) and because the
exemptions as applied to the race cars themselves and to marine and
aircraft refueling facilities do not apply to apply to ``motor
vehicles'' as defined in CAA section 216(2) and thus are not required
to be subject to stage II vapor recovery requirements under section
182(b)(3). Please see our October 3, 2011 proposed rule at pages 61066
and 61067 for more information about our evaluation of the submitted
statutory provisions and rules for compliance with section 182(b)(3)
and for more information about our proposed waiver under section
202(a)(6).
Compliance With CAA Section 110(l)
    In our October 3, 2011 proposed rule, we also evaluated the
statutory provisions and administrative rules submitted by ADEQ as part
of the September 21, 2009 SIP revision under CAA section 110(l) for
possible interference with any applicable requirement concerning
reasonable further progress (RFP) and attainment of any of the NAAQS or
any other applicable requirement under the Act. With respect to this
SIP revision, we found that the only potentially significant adverse
effect on emissions and, thus, potential for interference would stem
from the exclusion of E85 from the definition of ``gasoline'' in ARS
41-2121. The exclusion of E85 from ``gasoline'' would allow for
increased use of E85 (by FFVs) as a motor fuel in the Phoenix
metropolitan area and would result in corresponding change in emissions
from FFVs using E85 relative to the same vehicles using the specially
formulated gasoline (referred to as ``Arizona Cleaner Burning
Gasoline,'' or ``Arizona CBG'') otherwise required.\10\ (Arizona CBG is
a boutique fuel established to reduce vehicle emissions in the Phoenix
metropolitan area and to help meet CAA air quality planning
requirements.) The gasoline portion of E85 must continue to meet the
specifications for Arizona CBG pursuant to AAC R20-2-718(B).
---------------------------------------------------------------------------

    \10\ EPA's guidance for States in developing their stage II SIPs
in the early 1990s suggested that States use the same definition of
``gasoline'' as the one found in EPA's Standard of Performance for
Bulk Gasoline Terminals at 40 CFR 60.501, which includes ``any
petroleum distillate or petroleum distillate/alcohol blend having a
Reid vapor pressure of 27.6 kilopascals or greater which is used as
a fuel for internal combustion engines.'' EPA recommended using this
definition to most broadly reach situations in which refueling of
motor vehicles results in evaporative VOC emissions that contribute
to ozone nonattainment concentrations, and to avoid a narrow
interpretation of what is ``gasoline'' that would allow significant
VOC emissions from motor vehicle refueling activities in
nonattainment areas to go uncontrolled.
    In the existing SIP, Arizona includes a definition of
``gasoline,'' AAC R4-31-901(5), that is consistent with the NSPS
definition. The SIP revision that we are approving today would
replace the existing SIP definition of ``gasoline'' from Arizona's
rules for gasoline vapor recovery (AAC title 20, chapter 2, article
9) with the definition of ``gasoline'' from Arizona's statutes
governing motor fuel (ARS section 41-2121(5)). The definition of
``gasoline'' in ARS section 41-2121(5) is as inclusive as the
existing SIP definition in AAC R4-31-901(5), except for the explicit
exclusion of E85. Given that E85 can only be used by FFVs, and based
on our proposed ``widespread use'' determination with respect to the
FFV fleet in the Phoenix area that would be fueled at E85 dispensing
pumps, we find the exception for E85 from the definition of
``gasoline'' acceptable under CAA section 182(b)(3). Moreover, to
allow for the distribution and sale of E85 in the Phoenix area, a
change in the term of ``gasoline'' (to exclude E85) for stage II
vapor recovery purposes alone would not have sufficed. Because of
the boutique fuel requirements of Arizona CBG that have been
approved into the Arizona SIP, a change in the definition of
``gasoline'' as a motor fuel (to exclude E85) was also necessary.
---------------------------------------------------------------------------

    To evaluate the change in emissions, we reviewed a recently
published study from the Journal of the Air & Waste Management
Association titled ``Effect of E85 on Tailpipe Emissions from Light-
Duty Vehicles \11\'' (herein, the ``E85 Vehicle Emissions Study''),
which compiled the results from previous published studies but also
analyzed a significantly larger database compiled by EPA for vehicle
certification purposes. As described in our October 3, 2011 proposed
rule, though the results vary by pollutant and between ``tier 1''
(i.e., model year (MY) 1994-2003) and ``tier 2'' (MY 2004-2008)
vehicles, in general, the study suggests that FFVs using E85 emit fewer
oxides of nitrogen (NOX), carbon monoxide, and particulate
matter (PM) relative to the same FFVs using gasoline. However, with
respect to VOCs, FFVs may well emit greater VOCs than the same FFVs
using gasoline [based on the measurement results for non-methane
organic gases (NMOGs)].\12\
---------------------------------------------------------------------------

    \11\ Janet Yanowitz and Robert L. McCormick, ``Effect of E85 on
Tailpipe Emissions from Light-Duty Vehicles,'' Journal of the Air &
Waste Management Association, Volume 59, February 2009, pages 172-
182.
    \12\ Ethanol itself contains no lead (Pb) or sulfur, but the
ethanol portion of E85 does contain some Pb and sulfur due to the
addition of a denaturant, which can comprise up to 5% of the ethanol
portion of E85. The denaturant used by ethanol producers is
typically gasoline (either RFG or conventional gasoline, depending
on where the ethanol plant is located), which has sulfur and Pb
specifications similar to those for CBG. Therefore, a gallon of E85
would have less sulfur and Pb than a gallon of CBG (due to the
dilution provided by the ethanol), and thus the emissions of sulfur
dioxide and Pb from use of E85 in FFVs would be less than the
corresponding emissions from use of CBG in those vehicles.
Therefore, there would be no interference with RFP or attainment of
the Pb and sulfur dioxide NAAQS.
---------------------------------------------------------------------------

    Thus, with respect to nitrogen dioxide, carbon monoxide and
particulate matter, because emissions using E85 would be lower than
those using CBG, we concluded that the incremental substitution of CBG
with E85 would not interfere with RFP or

attainment of the ambient standards for those pollutants.
    We also concluded that the net effect on ozone conditions in the
Phoenix 8-hour ozone nonattainment area would be beneficial despite the
potential higher VOC emission rate by E85-fueled FFVs (relative to CBG-
fueled FFVs) because of the offsetting effect of NOX
emissions reductions (from use of E85 relative to Arizona CBG) and
because of the extension of stage II vapor recovery requirements to
``Area A,'' an area that is larger than the area formerly designated as
nonattainment for the 1-hour ozone standard and that includes the fast-
growing region west of the City of Phoenix.\13\
---------------------------------------------------------------------------

    \13\ As submitted in 1993, ARS section 41-2132(C) established
the stage II vapor recovery requirement within the ozone
nonattainment area, but the current version of this statute, which
is included in today's final approval action, extends the
requirement to ``Area A.''
---------------------------------------------------------------------------

    On the basis of the above rationale, we determined in our October
3, 2011 proposed rule that this SIP revision, including the change in
the definition of ``gasoline'' to exclude ``E85,'' would not interfere
with RFP and attainment for any of the NAAQS. Please see our October 3,
2011 proposed rule at pages 61067 and 61068 for more information about
our evaluation of the submitted statutory provisions and rules for
compliance with section 110(l) of the CAA.

D. Proposed Correction of Previous Rulemaking

    Lastly, in our October 3, 2011 proposed rule, we described our
direct final action (59 FR 54521, November 1, 1994) to approve the
administrative rules adopted by ADWM to provide for the installation
and operation of stage II vapor recovery systems, and in which we
included erroneous references and failed to identify the specific rules
being incorporated by reference into the SIP. To address this issue, we
proposed, under section 110(k)(6) and 301(a) of the CAA,\14\ to correct
our previous codification of our approval of the stage II vapor
recovery rules to identify the appropriate regulatory agency and to
identify the specific rules that were being approved and incorporated
by reference into the Arizona SIP. Please see our October 3, 2011
proposed rule at page 61068 for more information about our proposed
error correction under CAA section 110(k)(6).
---------------------------------------------------------------------------

    \14\ Section 110(k)(6) of the CAA provides that, whenever EPA
determines that the Agency's action approving, disapproving, or
promulgating any plan or plan revision, area designation,
redesignation, classification, or reclassification was in error, EPA
may in the same manner as the approval, disapproval, or promulgation
revise such action as appropriate without requiring any further
submission from the State. Section 301(a) of the CAA authorizes EPA
to prescribe such regulations as are necessary to carry out the
Agency's functions under the CAA.
---------------------------------------------------------------------------

II. Public Comments and EPA Responses

    Our October 3, 2011 proposed rule provided a 60-day comment period.
During this period, we received no comments on our proposed action.

III. Final Action

    As authorized in section 110(k)(3) of the Act and for the reasons
provided in our October 3, 2011 proposed rule and summarized herein,
EPA is taking final action to approve the statutory provisions and
updated administrative rules establishing certain vapor recovery
requirements in the Phoenix metropolitan area as a revision to the
Arizona SIP. Specifically, we are taking final action to approve
Arizona Revised Statutes (ARS) sections listed in table 1 of this
document and the Arizona Administrative Code (AAC) sections listed in
table 2 of this document.\15\ Second, as authorized under CAA section
202(a)(6), we are taking final action to waive the stage II vapor
recovery requirements at E85 dispensing pumps in the Phoenix area under
CAA section 202(a)(6) based on our conclusion that ORVR is in
widespread use among the FFVs that use such facilities.
---------------------------------------------------------------------------

    \15\ Our approval of the statutory provisions and administrative
rules in tables 1 and 2 of this document supersedes the previously
approved versions of the administrative rules in the Arizona SIP
(i.e., AAC Article 9 (``Gasoline Vapor Control''), Rules R4-31-901
through R4-31-910, adopted by the Arizona Department of Weights and
Measures on August 27, 1993, submitted on May 27, 1994, and approved
on November 1, 1994 (59 FR 54521)).
---------------------------------------------------------------------------

    In so doing, we conclude that the submitted statutory provisions
and updated administrative rules meet the related requirements for
stage II vapor recovery under CAA section 182(b)(3) and will not
interfere with attainment and RFP of any of the NAAQS or any other CAA
applicable requirement, consistent with the requirements of CAA section
110(l). Final EPA approval of the updated statutory provisions and
rules and incorporation of them into the Arizona SIP makes them
federally enforceable.
    Lastly, under section 110(k)(6) and 301(a) of the CAA, we are
taking final action to correct and clarify the incorporation of the
previous version of ADWM's vapor recovery related administrative rules
into the Arizona SIP.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 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 Order
12866 (58 FR 51735, October 4, 1993) given the limited nature of this
SIP revision (as to geographic scope and vehicle applicability);
     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 disproportionate human health or environmental effects with
practical, appropriate, and legally permissible methods under Executive
Order 12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have tribal implications as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000), because the
SIP is not approved to apply in Indian country located in the State,
and EPA notes that

it will not impose substantial direct costs on tribal governments or
preempt tribal law.

    The Congressional Review Act, 5 U.S.C. section 801 et seq., as
added by the Small Business Regulatory Enforcement Fairness Act of
1996, generally provides that before a rule may take effect, the agency
promulgating the rule must submit a rule report, which includes a copy
of the rule, to each House of the Congress and to the Comptroller
General of the United States. EPA will submit a report containing this
rule and other required information to the U.S. Senate, the U.S. House
of Representatives, and the Comptroller General of the United States
prior to publication of the rule in the Federal Register. A major rule
cannot take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
section 804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by August 13, 2012. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this rule for the purposes of judicial review nor does
it extend the time within which a petition for judicial review may be
filed, and shall not postpone the effectiveness of such rule or action.
This action may not be challenged later in proceedings to enforce its
requirements (See section 307(b)(2)).

List of Subjects in 40 CFR Parts 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Reporting and
recordkeeping requirements, Volatile organic compounds.

    Dated: April 11, 2012.
Lisa P. Jackson,
Administrator.

    Part 52, chapter I, title 40 of the Code of Federal Regulations is
amended as follows:

PART 52--[AMENDED]

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

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

Subpart D--Arizona

0
2. Section 52.120 is amended by revising paragraph (c)(69)(i)(A) and
adding paragraph (c)(148) to read as follows:

Sec.  52.120  Identification of plan.

* * * * *
    (c) * * *
    (69) * * *
    (i) * * *
    (A) Arizona Department of Weights and Measures. (1) Letter from
Grant Woods, Attorney General, State of Arizona, to John U. Hays,
Director, Department of Weights and Measures, dated August 31, 1993,
and enclosed Form R102 (``Certification of Rules and Order of Rule
Adoption'').
    (2) Arizona Administrative Code, Article 9 (``Gasoline Vapor
Control''), Rules R4-31-901 through R4-31-910, adopted August 27, 1993,
effective (for state purposes) on August 31, 1993.
* * * * *
    (148) The following plan revision was submitted on September 21,
2009 by the Governor's designee.
    (i) Incorporation by reference. (A) Arizona Department of Weights
and Measures. (1) Arizona Revised Statutes, title 41 (State
Government), chapter 15 (Department of Weights and Measures), as
amended and supplemented by the general and permanent laws enacted
through the First Special Session, and legislation effective January
11, 2011 of the First Regular Session of the Fiftieth Legislature
(2011):
    (i) Article 1 (General Provisions), section 41-2051
(``Definitions''), subsections (6) (``Certification''), (10)
(``Department''), (11) (``Diesel fuel''), (12) (``Director''), and (13)
(``E85''), amended by Laws 2008, Ch. 254, Sec.  2;
    (ii) Article 6 (Motor Fuel), section 41-2121 (``Definitions''),
subsection (5) (``Gasoline'') amended by Laws 2007, Ch. 292, Sec.  11;
and
    (iii) Article 7 (Gasoline Vapor Control), section 41-2131
(``Definitions''), added by Laws 1992, Ch. 299, Sec.  6; section 41-
2132 (``Stage I and stage II vapor recovery systems''), amended by Laws
2010, Ch. 181, Sec.  2; and section 41-2133 (``Compliance schedules''),
amended by Laws 1999, Ch. 295, Sec.  17.
    (2) Arizona Administrative Code, title 20, chapter 2, article 1
(Administration and Procedures), section R20-2-101 (``Definitions''),
effective (for state purposes) on June 5, 2004.
    (3) Arizona Administrative Code, title 20, chapter 2, article 9
(Gasoline Vapor Control):
    (i) Sections R20-2-901 (``Material Incorporated by Reference''),
R20-2-902 (``Exemptions''), R20-2-903 (``Equipment and Installation''),
R20-2-904 (``Application Requirements and Process for Authority to
Construct Plan Approval''), R20-2-905 (``Initial Inspection and
Testing''), R20-2-910 (``Annual Inspection and Testing''), R20-2-911
(``Compliance Inspections''), and R20-2-912 (``Enforcement''),
effective (for state purposes) on June 5, 2004.
    (ii) Sections R20-2-907 (``Operation''), R20-2-908 (``Training and
Public Education''), and R20-2-909 (``Recordkeeping and Reporting''),
effective (for state purposes) on October 8, 1998.

[FR Doc. 2012-14148 Filed 6-12-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 143 (Friday, July 25, 2014)]
[Notices]
[Pages 43494-43496]
[FR Doc No: 2014-17588]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1006]

Revised Draft Guidance for Industry on Providing Regulatory
Submissions in Electronic Format--Certain Human Pharmaceutical Product
Applications and Related Submissions Using the Electronic Common
Technical Document Specifications; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a revised draft guidance for industry entitled
``Providing Regulatory Submissions in Electronic Format--Certain Human
Pharmaceutical Product Applications and Related Submissions Using the
eCTD Specifications.'' The draft guidance announced in this notice is
being issued in accordance with the Food and Drug Administration Safety
and Innovation Act (FDASIA), which amended the Federal Food, Drug, and
Cosmetic Act (FD&C Act) to require that certain submissions under the
FD&C Act and Public Health Service Act (PHS Act) be submitted in
electronic format, beginning no earlier than 24 months after issuance
of the final version of the guidance on that topic. The draft guidance
outlines Electronic Common Technical Document (eCTD) specification
requirements for certain submissions to new drug applications (NDAs),
abbreviated new drug applications (ANDAs), biologics license
applications (BLAs), and investigational new drug applications (INDs)
and is being issued for public comment. This draft guidance revises and
replaces a previous draft guidance entitled ``Providing Regulatory
Submissions in Electronic Format--Certain Human Pharmaceutical Product
Applications and Related Submissions Using the eCTD Specifications''
that was issued in January 2013 (2013 draft guidance on eCTD
Specifications). When finalized, this revised draft guidance will
supersede the guidance for industry entitled ``Providing Regulatory
Submissions in Electronic Format--Human Pharmaceutical Product
Applications and Related Submissions Using the eCTD Specifications''
that was issued in June 2008.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 23, 2014.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002, or
the Office of Communication, Outreach and Development, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance.
    Submit electronic comments on the draft guidance 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.

FOR FURTHER INFORMATION CONTACT: Virginia Hussong, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 1161, Silver Spring, MD 20993, email:
<EMAIL_ADDRESS>or Stephen Ripley, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New

Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-
7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Providing Regulatory Submissions in Electronic Format--
Certain Human Pharmaceutical Product Applications and Related
Submissions Using the eCTD Specifications.'' FDASIA (Public Law 112-
144), signed by the President on July 9, 2012, amended the FD&C Act to
add section 745A (21 U.S.C.379k-1) entitled ``Electronic Format for
Submissions.'' Section 745A(a)(1) of the FD&C Act requires that
submissions under section 505(b), (i), or (j) of the FD&C Act (21 U.S.C
355(b), (i), or (j)), and submissions under section 351(a) or (k) of
the PHS Act (42 U.S.C. 262(a) or (k)), be submitted to FDA in
electronic format no earlier than 24 months after FDA issues final
guidance on that topic.
    In accordance with section 745A(a)(1) of the FD&C Act, FDA is
issuing this draft guidance, announcing its determination that
submission types identified in this draft guidance must be submitted
electronically (except for submissions that are exempted), in the
format specified in this guidance.
    This guidance (and the technical specification documents it
incorporates by reference) describes how submissions under section
745A(a) of the FD&C Act \1\ must be organized and submitted in
electronic format using eCTD specifications version 3.2.2. The eCTD is
an International Conference on Harmonization (ICH) format based on
specifications developed by ICH and its member parties. FDA's Center
for Drug Evaluation and Research (CDER) and Center for Biologics
Evaluation and Research (CBER) have been receiving submissions in the
eCTD format since 2003, and eCTD has been the recommended format for
electronic submissions to CDER and CBER since January 1, 2008. The
majority of new electronic submissions are now received in eCTD format.
---------------------------------------------------------------------------

    \1\ For more information concerning how the FDA interprets
section 745(a), see the draft guidance for industry ``Providing
Regulatory Submissions in Electronic Format--Submissions Under
Section 745A(a) of the Federal Food, Drug, and Cosmetic Act''
(available at http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidances/default.htm).
---------------------------------------------------------------------------

    This guidance revises and replaces the previous 2013 draft guidance
on eCTD specifications. This revised version of the draft guidance,
when finalized, will supersede the guidance for industry titled
``Providing Regulatory Submissions in Electronic Format--Human
Pharmaceutical Product Applications and Related Submissions Using the
eCTD Specifications'' that was issued in June 2008. This revised draft
guidance, when finalized, will be applicable to all submissions within
the scope of section 745A(a) of the FD&C Act, i.e., certain NDAs,
ANDAs, BLAs, and INDs and all subsequent submissions, including
amendments, supplements, and reports, to these submission types.\2\
---------------------------------------------------------------------------

    \2\ See id.
---------------------------------------------------------------------------

    In general, this revised draft guidance contains the following
changes from the previous 2013 draft guidance on eCTD specifications:
     It is now explicit that certain master files are within
the scope of section 745A(a) of the FD&C Act.
     Similarly, it is now explicit that advertising and
promotional labeling materials are also within the scope of section
745A(a) of the FD&C Act.
     Use of the FDA Electronic Submissions Gateway (ESG) will
be required.
     Use of FDA fillable forms will be required with all eCTD
submissions.
     Specified file formats and software versions will be
required for submissions filed with the FDA.
    After publication of the Federal Register notice of availability of
the final version of the guidance, all submissions with a filing date
24 months after the Federal Register notice must use the appropriate
FDA-supported eCTD specifications for certain NDA, ANDA, and BLA
submissions. IND submissions must use the FDA-supported eCTD
specifications for electronic submissions filed 36 months after the
Federal Register notice of availability is published.
    In section 745A(a) of the FD&C Act, Congress granted explicit
authorization to FDA to implement the statutory electronic submission
requirements by specifying in a guidance document the format for the
submissions. Accordingly, to the extent that this draft guidance
provides the requirements under section 745A(a) of the FD&C Act,
indicated by the use of the words must or required, it is not subject
to the usual restrictions in FDA's good guidance practice regulations,
such as the requirement that guidances not establish legally
enforceable responsibilities (see 21 CFR 10.115(d)).

II. Paperwork Reduction Act of 1995

    The draft guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The draft guidance pertains to sponsors and applicants making
regulatory submissions to FDA in electronic format for NDAs, ANDAs,
BLAs, INDs, master files, and advertising and promotional labeling. The
information collection discussed in the draft guidance is contained in
our IND regulations (21 CFR part 312) and approved under OMB control
number 0910-0014, our NDA regulations (including ANDAs) (21 CFR part
314) and approved under OMB control number 0910-0001, and our BLA
regulations (21 CFR part 601) and approved under OMB control number
0910-0338.
    Sponsors and applicants have been submitting NDAs, ANDAs, BLAs,
INDs, and master files electronically since 2003, and the majority of
these submissions are already received in electronic format. Under
section 745A(a) of the FD&C Act, sponsors and applicants are required
to file most of these submissions electronically. These requirements
will be phased in over 2- and 3-year periods after the issuance of the
final version of the guidance.
    For some sponsors and applicants, there may be new costs, including
capital costs or operating and maintenance costs, which would result
from the requirements under FDASIA and the final version of the
guidance, because some sponsors and applicants may have to upgrade eCTD
specifications and/or change their method of submitting information to
the FDA. FDA estimates that for some sponsors and applicants the costs
may be as follows:
     eCTD Publishing Software: $25,000 to $150,000;
     Publishing Operations Support: $50,000 to $1,000,000; and
     Training: $5,000 to $50,000.

III. Comments

    Interested persons may submit either electronic comments to http://www.regulations.gov or written comments regarding this document to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
http://

www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/
default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
http://www.regulations.gov.

    Dated: July 22, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-17588 Filed 7-24-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: January 25, 2008 (Volume 73, Number 17)]
[
Notices]
[Page 4580-4581]
[DOCID:fr25ja08-80]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Oncologic Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Oncologic Drugs Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on March 12, 2008, from 8
a.m. to 5 p.m. and on March 13, 2008, from 8 a.m. to 4 p.m.
    Location: Holiday Inn, The Ballrooms, 2 Montgomery Village Ave.,
Gaithersburg, MD,<PHONE_NUMBER>.
    Contact Person: Nicole Vesely, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane,
(for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD
20857,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, e-mail:

<EMAIL_ADDRESS>or FDA Advisory Committee Information Line,

1-800-741-8138<PHONE_NUMBER> in the Washington, DC area), code
3014512542. Please call the Information Line for up-to-date information
on this meeting. A notice in the Federal Register about last minute
modifications that impact a previously announced advisory committee
meeting cannot always be published quickly enough to provide timely
notice. Therefore, you should always check the agency's Web site and
call the appropriate advisory committee hot line/phone line to learn
about possible modifications before coming to the meeting.
    Agenda: On March 12, 2008, the committee will discuss: (1) Biologic
license application (BLA) 125268, proposed trade name NPLATE
(romiplostim), Amgen Inc., proposed indication for the treatment of
thrombocytopenia in adults with chronic immune (idiopathic)
thrombocytopenia purpura who are nonspelenectomized and have had an
inadequate response or are intolerant to corticosteroids and/or
immunoglobulins; or patients who are splenectomized and have an
inadequate response to splenectomy, and (2)

supplemental biologics license application (sBLA) 103949/5153,
PEGINTRON (peginterferon alfa-2b), Schering Corp., proposed indication
for adjuvant treatment of melanoma. On March 13, 2008, the committee
will discuss the cumulative data, including recent study results, on
the risks of erythropoeisis-stimulating agents when administered to
patients with cancer. Agents to be discussed include ARANESP
(darbepoetin alfa), EPOGEN (epoetin alfa), PROCRIT (epoetin alfa,
Amgen, Inc.), and MIRCERA (methoxy polyethylene glycol-epoetin beta,
Hoffman-La Roche Inc.). This is a followup to the May 10, 2007,
Oncologic Drugs Advisory Committee Meeting.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on

the year 2008 and scroll down to the appropriate advisory committee
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
February 27, 2008. Oral presentations from the public will be scheduled
between approximately 10:30 a.m. to 11 a.m., and 3:30 p.m. to 4 p.m. on
March 12, 2008, and between approximately 1 p.m. to 2 p.m. on March 13,
2008. Those desiring to make formal oral presentations should notify
the contact person and submit a brief statement of the general nature
of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
February 19, 2008. Time allotted for each presentation may be limited.
If the number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by February 20,
2008.
    Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Nicole Vesely at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/
default.htm
 for procedures on public conduct during advisory committee

meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: January 17, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-1295 Filed 1-24-08; 8:45 am]

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[Federal Register: February 19, 2009 (Volume 74, Number 32)]
[Rules and Regulations]
[Page 7646]
[DOCID:fr19fe09-4]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2009-0001; Airspace Docket No. 09-ASW-2]

Revocation of Class E Airspace; Altus AFB, OK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action removes the Class E airspace area designated as an
extension to a Class D surface area at Altus AFB, OK. This airspace has
been incorporated into the Altus AFB Class D airspace area under
separate rulemaking actions.

DATES: Effective Date: 0901 UTC, February 19, 2009. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR Part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Ft. Worth, TX 76193-0530; telephone (817)
321-7716.

SUPPLEMENTARY INFORMATION:

History

    On August 6, 2008, the FAA published in the Federal Register a
direct final rule to amend Class D and Class E airspace at Altus AFB,
OK (73 FR 45605, Docket No. FAA-2008-0339). This amendment extended the
Class D airspace, removing the need for Class E extensions to the Class
D airspace area. This airspace has been incorporated into the Altus
AFB, OK, Class D airspace area under a separate rulemaking action,
which was published on September 29, 2008 and became effective November
20, 2008 (73 FR 56473).
    Interested parties were invited to participate in this rulemaking
effort by submitting written comments on the proposal to the FAA. No
comments were received. Class E airspace designations are published in
paragraph 6004 of FAA Order 7400.9S signed October 3, 2008, and
effective October 31, 2008, which is incorporated by reference in 14
CFR Part 71.1. The Class E airspace designations listed in this
document will be published subsequently in that Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
Part 71 by revoking Class E airspace at Altus AFB, OK.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it revokes controlled airspace at Altus AFB, OK.
    Since this airspace area has been incorporated into Class D
airspace, and in consideration of the need to avoid confusion on the
part of pilots flying in the vicinity of Altus AFB, the FAA finds good
cause, pursuant to 5 U.S.C. 553(d), for making this amendment effective
in less than 30 days in order to promote the safe and efficient
handling of air traffic in the area.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of the Federal
Aviation Administration Order 7400.9S, Airspace Designations and
Reporting Points, signed October 3, 2008, and effective October 31,
2008, is amended as follows:

Paragraph 6004 Class E Airspace Designated as an Extension to a
Class D Surface Area.
* * * * *

ASW K E4 Altus, OK [Removed]

* * * * *

    Issued in Fort Worth, TX, on February 2, 2009.
Anthony D. Roetzel,
Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. E9-2987 Filed 2-18-09; 8:45 am]

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[Federal Register Volume 76, Number 77 (Thursday, April 21, 2011)]
[Notices]
[Page 22392]
[FR Doc No: 2011-9662]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER11-3336-000]

Command Power Corp.; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Command Power Corp.'s application for market-based rate authority, with
an accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is May 3, 2011.
    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 Street, NE., Washington, DC 20426.
    The filings in the above-referenced proceeding 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>.

    Dated: April 13, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-9662 Filed 4-20-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 37 (Friday, February 23, 2018)]
[Notices]
[Pages 8071-8072]
[FR Doc No: 2018-03717]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP18-80-000]

Notice of Request Under Blanket Authorization: National Fuel Gas
Supply Corporation

    Take notice that on February 7, 2018, National Fuel Gas Supply
Corporation (National Fuel), 6363 Main Street, Williamsville, New York
14221 filed a prior notice request pursuant to sections 157.205 and
157.216 of the Commission's regulations under the Natural Gas Act for
authorization to abandon two wells lines and convert the two associated
injection/withdrawal wells to observation wells in its Holland Storage
Field located in Erie County, New York. The abandonment will have no
effect on the service to any of National Fuel's customers, all as more
fully set forth in the application which is on file with the Commission
and open to public inspection. The filing may also be viewed on the web
at http://www.ferc.gov using the eLibrary link. Enter the docket number
excluding the last three digits in the docket number field to access
the document. For assistance, contact FERC at
[email protected] or call toll-free,<PHONE_NUMBER> or TTY,
(202) 502-8659.
    Any questions regarding this application should be directed to
Alice

A. Curtiss, Deputy General Counsel for National Fuel, 6363 Main Street,
Williamsville, New York 14221, by phone<PHONE_NUMBER>, by fax (716)
857-7206, or by email at [email protected].
    Any person may, within 60 days after the issuance of the instant
notice by the Commission, file pursuant to Rule 214 of the Commission's
Procedural Rules (18 CFR 385.214) a motion to intervene or notice of
intervention. Any person filing to intervene or the Commission's staff
may, pursuant to section 157.205 of the Commission's Regulations under
the NGA (18 CFR 157.205) file a protest to the request. If no protest
is filed within the time allowed therefor, the proposed activity shall
be deemed to be authorized effective the day after the time allowed for
protest. If a protest is filed and not withdrawn within 30 days after
the time allowed for filing a protest, the instant request shall be
treated as an application for authorization pursuant to section 7 of
the NGA.
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commentary will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the internet in lieu of paper. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
website (www.ferc.gov) under the e-Filing link. Persons unable to file
electronically should submit original and 5 copies of the protest or
intervention to the Federal Energy Regulatory Commission, 888 First
Street NE, Washington, DC 20426.

    Dated: February 16, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-03717 Filed 2-22-18; 8:45 am]
 BILLING CODE 6717-01-P