From: Jim Tozzi<EMAIL_ADDRESS>Sent: Thursday, April 16, 2015 12:25 PM To: Page, Steve; Culligan, Kevin Subject: DOE Role in EPA's Proposed Regulation for New Coal Fired Plants

  Gentlemen:       The Department of Energy spends billions on the development emission control technologies. It is important that they participate actively in the formulation of EPA's  NSPS for new coal fired plants.   DOE participation in the rulemaking is virtually guaranteed if EPA were to conduct a peer review in accordance with the requirements of the Data Quality Act.   Failure to conduct such a peer review could result in the execution of the legal strategy contained  herein which provides a method for challenging a proposed rule because of non-compliance with the peer review requirements specific to the Data Quality Act.  The strategy is a result of a legal precedent established in the TRAC litigation.      A court is authorized to act before a final rule is issued when the public has been denied the opportunity to utilize the results of a DQA peer review in developing their  comments on a proposed rule. A judicial intervention is warranted to protect the right of the public to influence the contents of a final rule.      Please see the attachment hereto.   Respectfully,   Jim Tozzi      Center for  Regulatory Effectiveness


[Federal Register Volume 76, Number 178 (Wednesday, September 14, 2011)]
[Proposed Rules]
[Pages 56694-56701]
[FR Doc No: 2011-23544]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2011-0638; FRL-9463-9]

Approval and Promulgation of Air Quality Implementation Plans;
California; Determinations of Failure To Attain the One-Hour Ozone
Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The EPA is proposing to determine that three areas in
California, previously designated nonattainment for the one-hour ozone
national ambient air quality standard (NAAQS), did not attain that
standard by their applicable attainment dates: the Los Angeles-South
Coast Air Basin Area (``South Coast''), the San Joaquin Valley Area
(``San Joaquin Valley''), and the Southeast Desert Modified Air Quality
Maintenance Area (``Southeast Desert''). These proposed determinations
are based on three years of quality-assured and certified ambient air
quality monitoring data for the period preceding the applicable
attainment deadline.

DATES: Written comments must be received on or before October 14, 2011.

ADDRESSES: Submit your comments, identified by Docket No. EPA-R09-OAR-
2011-0638, by one of the following methods:
    1. Federal Rulemaking Portal: http://www.regulations.gov. Follow
the on-line instructions for submitting comments.
    2. E-mail: Doris Lo at<EMAIL_ADDRESS>    3. Fax: Doris Lo, Air Planning Office (AIR-2), at fax number 415-
947-3579.
    4. Mail: Doris Lo, Air Planning Office (AIR-2), U.S. Environmental
Protection Agency, Region IX, 75 Hawthorne, San Francisco, California
94105.
    5. Hand or Courier Delivery: Doris Lo, Air Planning Section (AIR-
2), U.S. Environmental Protection Agency, Region IX, 75 Hawthorne, San
Francisco, California 94105. Such deliveries are only accepted during
the Docket's normal hours of operation. Special arrangements should be
made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R09-OAR-
2011-0638. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless

the comment includes information claimed to be Confidential Business
Information (CBI) or other information the disclosure of which is
restricted by statute. Do not submit information through http://www.regulations.gov or e-mail that you consider to be CBI or otherwise
protected from disclosure. The http://www.regulations.gov Web site is
an anonymous access system, which means EPA will not know your identity
or contact information unless you provide it in the body of your
comment. If you send an e-mail comment directly to EPA without going
through http://www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Air Planning
Office (Air-2), U.S. Environmental Protection Agency, Region IX, 75
Hawthorne Street, San Francisco, California 94105. EPA requests that if
at all possible, you contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to schedule your inspection during normal
business hours.

FOR FURTHER INFORMATION CONTACT: Doris Lo,<PHONE_NUMBER>, or by e-mail
at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.

Table of Contents

I. What actions is EPA taking?
II. Background
III. What is EPA's analysis?
    A. South Coast One-Hour Ozone Nonattainment Area
    B. San Joaquin Valley One-Hour Ozone Nonattainment Area
    C. Southeast Desert One-Hour Ozone Nonattainment Area
IV. What is the effect of the proposed determinations?
V. Proposed Actions
VI. Statutory and Executive Order Reviews

I. What actions is EPA taking?

    EPA is proposing to determine, under the Clean Air Act (CAA or
``Act''), that three areas previously designated nonattainment for the
one-hour ozone NAAQS--the South Coast, the San Joaquin Valley, and the
Southeast Desert--failed to attain the NAAQS for one-hour ozone by
their applicable one-hour NAAQS attainment dates.

II. Background

Regulatory Context

    The Act requires us to establish NAAQS for certain widespread
pollutants that cause or contribute to air pollution that is reasonably
anticipated to endanger public health or welfare (sections 108 and 109
of the Act). In 1979, we promulgated the revised one-hour ozone
standard of 0.12 parts per million (ppm) (44 FR 8202, February 8,
1979).\1\
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    \1\ For ease of communication, many reports of ozone
concentrations are given in parts per billion (ppb); ppb = ppm x
1000. Thus, 0.12 ppm becomes 120 ppb (or between 120 to 124 ppb,
when rounding is considered).
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    An area is considered to have attained the one-hour ozone standard
if there are no violations of the standard, as determined in accordance
with the regulation codified at 40 CFR 50.9, based on three consecutive
calendar years of complete, quality-assured and certified monitoring
data. A violation occurs when the ambient ozone air quality monitoring
data show greater than one (1.0) ``expected number'' of exceedances per
year at any site in the area, when averaged over three consecutive
calendar years.\2\ An exceedance occurs when the maximum hourly ozone
concentration during any day exceeds 0.124 ppm. For more information,
please see ``National 1-hour primary and secondary ambient air quality
standards for ozone'' (40 CFR 50.9) and ``Interpretation of the 1-Hour
Primary and Secondary National Ambient Air Quality Standards for
Ozone'' (40 CFR part 50, appendix H).
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    \2\ An ``expected number'' of exceedances is a statistical term
that refers to an arithmetic average. An ``expected number'' of
exceedances may be equivalent to the number of observed exceedances
plus an increment that accounts for incomplete sampling. See, 40 CFR
part 50, appendix H. Because, in this context, the term
``exceedances'' refers to days (during which the daily maximum
hourly ozone concentration exceeded 0.124 ppm), the maximum possible
number of exceedances in a given year is 365 (or 366 in a leap
year).
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    The Act, as amended in 1990, required EPA to designate as
nonattainment any area that was violating the one-hour ozone standard,
generally based on air quality monitoring data from the 1987 through
1989 period (section 107(d)(4) of the Act; 56 FR 56694, November 6,
1991). The Act further classified these areas, based on the severity of
their nonattainment problem, as Marginal, Moderate, Serious, Severe, or
Extreme.
    The control requirements and date by which attainment of the one-
hour ozone standard was to be achieved varied with an area's
classification. Marginal areas were subject to the fewest mandated
control requirements and had the earliest attainment date, November 15,
1993, while Severe and Extreme areas were subject to more stringent
planning requirements and were provided more time to attain the
standard. Two measures that are triggered if a Severe or Extreme area
fails to attain the standard by the applicable attainment date are
contingency measures [section 172(c)(9)] and a major stationary source
fee provision [sections 182(d)(3) and 185)] (``major source fee
program'' or ``section 185 fee program'').

Designations and Classifications

    On November 6, 1991, EPA designated the South Coast \3\ as
``Extreme'' nonattainment for the one-hour ozone standard, with an
attainment date no later than November 15, 2010 (56 FR 56694). In its
November 6, 1991 final rule, EPA designated the San Joaquin Valley \4\
as ``Serious'' nonattainment for the one-hour ozone standard, but later
reclassified the valley as ``Severe'' (66 FR 56476, November 8, 2001),
and then as ``Extreme'' (69 FR 20550, April 16, 2004) for the one-hour
ozone standard, with the same attainment date (November 15, 2010) as
the South Coast. In its 1991 final rule, EPA designated the Southeast
Desert \5\ as ``Severe-17'' nonattainment for the one-hour ozone
standard, with an attainment date no later than November 15, 2007.
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    \3\ The South Coast includes Orange County, the southwestern
two-thirds of Los Angeles County, southwestern San Bernardino
County, and western Riverside County (see 40 CFR 81.305).
    \4\ San Joaquin Valley includes all of Fresno, Kings, Madera,
Merced, San Joaquin, Stanislaus, and Tulare counties, as well as the
western half of Kern County (see 40 CFR 81.305).
    \5\ The Southeast Desert covers the Victor Valley/Barstow region
in San Bernardino County, the Coachella Valley region in Riverside
County, and the Antelope Valley portion of Los Angeles County (see
40 CFR 81.305).

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    Outside of Indian country,\6\ the South Coast lies within the
jurisdiction of the South Coast Air Quality Management District
(SCAQMD). Similarly, with the exception of Indian country, San Joaquin
Valley lies within the San Joaquin Valley Unified Air Pollution Control
District (SJVUAPCD). Likewise, excluding Indian country, the Los
Angeles portion of the Southeast Desert lies within the Antelope Valley
Air Quality Management District (AVAQMD), the San Bernardino County
portion of the Southeast Desert lies within the Mojave Desert Air
Quality Management District (MDAQMD), and the Riverside County portion
of the Southeast Desert lies within the SCAQMD.
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    \6\ ``Indian country'' as defined at 18 U.S.C. 1151 refers to:
``(a) all land within the limits of any Indian reservation under the
jurisdiction of the United States Government, notwithstanding the
issuance of any patent, and, including rights-of-way running through
the reservation, (b) all dependent Indian communities within the
borders of the United States whether within the original or
subsequently acquired territory thereof, and whether within or
without the limits of a state, and (c) all Indian allotments, the
Indian titles to which have not been extinguished, including rights-
of-way running through the same.''
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    Under California law, each air district is responsible for adopting
and implementing stationary source rules, such as the fee program rules
required under CAA section 185, while the California Air Resources
Board (CARB) adopts and implements consumer products and mobile source
rules. The district and state rules are submitted to EPA by CARB.

Transition From One-Hour Ozone Standard to Eight-Hour Ozone Standard

    In 1997, EPA promulgated a new, more protective standard for ozone
based on an eight-hour average concentration (the 1997 eight-hour ozone
standard). In 2004, EPA published the 1997 eight-hour ozone
designations and classifications and a rule governing certain facets of
implementation of the eight-hour ozone standard (Phase 1 Rule) (69 FR
23858 and 69 FR 23951, respectively, April 30, 2004).
    Although EPA revoked the one-hour ozone standard (effective June
15, 2005), to comply with anti-backsliding requirements of the Act,
eight-hour ozone nonattainment areas remain subject to certain
requirements based on their one-hour ozone classification. Initially,
in our rules to address the transition from the one-hour to the eight-
hour ozone standard, EPA did not include contingency measures or the
section 185 fee program among the measures retained as one-hour ozone
anti-backsliding requirements.\7\ However, on December 23, 2006, the
United States Court of Appeals for the District of Columbia Circuit
determined that EPA should not have excluded these requirements from
its anti-backsliding requirements. South Coast Air Quality Management
District v. EPA, 472 F.3d 882 (D.C. Cir. 2006) reh'g denied 489 F.3d
1245 (clarifying that the vacatur was limited to the issues on which
the court granted the petitions for review).
---------------------------------------------------------------------------

    \7\ Final Rule to Implement the 8-Hour Ozone National Ambient
Air Quality Standard--Phase 1, 69 FR 23951 (April 30, 2004).
---------------------------------------------------------------------------

    Thus, the Court vacated the provisions that excluded these
requirements. As a result, States must continue to meet the obligations
for one-hour ozone NAAQS contingency measures and, for Severe and
Extreme areas, major source fee programs. EPA has issued a proposed
rule that would remove the vacated provisions of 40 CFR 51.905(e), and
that addresses contingency measures for failure to attain or make
reasonable further progress toward attainment of the one-hour standard.
See 74 FR 2936, January 16, 2009 (proposed rule); 74 FR 7027, February
12, 2009 (notice of public hearing and extension of comment period).

Rationale for Today's Proposed Action

    After revocation of the one-hour ozone standard, EPA must continue
to provide a mechanism to give effect to the one-hour anti-backsliding
requirements. See SCAQMD v. EPA, 47 F.3d 882, at 903. In keeping with
this responsibility with respect to one-hour anti-backsliding
contingency measures and section 185 fee programs for these three
California areas, EPA proposes to determine that each area failed to
attain the one-hour ozone standard by its applicable attainment date.

III. What is EPA's analysis?

    A determination of whether an area's air quality meets the one-hour
ozone standard is generally based upon three years of complete,\8\
quality-assured and certified air quality monitoring data gathered at
established State and Local Air Monitoring Stations (``SLAMS'') in the
nonattainment area and entered into the EPA's Air Quality System (AQS)
database. Data from air monitors operated by state/local agencies in
compliance with EPA monitoring requirements must be submitted to the
AQS database. Monitoring agencies annually certify that these data are
accurate to the best of their knowledge. Accordingly, EPA relies
primarily on data in its AQS database when determining the attainment
status of an area. See 40 CFR 50.9; 40 CFR part 50, appendix H; 40 CFR
part 53; 40 CFR part 58, appendices A, C, D and E. All data are
reviewed to determine the area's air quality status in accordance with
40 CFR part 50, appendix H.
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    \8\ Generally, a ``complete'' data set for determining
attainment of the ozone is one that includes three years of data
with an average percent of days with valid monitoring data greater
than 90% with no single year less than 75%. See 40 CFR part 50,
appendix I. There are less stringent data requirements for showing
that a monitor has failed an attainment test and thus has recorded a
violation of the standard.
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    Under EPA regulations at 40 CFR 50.9, the one-hour ozone standard
is attained at a monitoring site when the expected number of days per
calendar year with maximum hourly average concentrations above 0.12
parts per million (235 micrograms per cubic meter) is equal to or less
than 1, as determined by 40 CFR part 50, appendix H.\9\
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    \9\ The average number of expected exceedances is determined by
averaging the expected exceedances of the one-hour ozone standard
over a consecutive three calendar year period. See 40 CFR part 50
appendix H.
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    EPA proposes to determine that the South Coast, the San Joaquin
Valley, and the Southeast Desert failed to attain the one-hour ozone
standard by their applicable attainment dates; that is, the number of
expected exceedances at sites in each of the three nonattainment areas
was greater than one per year in the period prior to the applicable
attainment date. These proposed determinations are based on three years
of quality-assured and certified ambient air quality monitoring data in
AQS for the 2008-2010 monitoring period for the South Coast and the San
Joaquin Valley, and quality-assured and certified data in AQS for 2005-
2007 for the Southeast Desert.

A. South Coast One-Hour Ozone Nonattainment Area

    In the South Coast, the South Coast Air Quality Management District
(SCAQMD) is responsible for assuring that the area meets air quality
monitoring requirements. SCAQMD Annual Network Plans describe the air
monitoring network and discuss its status, as required under 40 CFR
58.10.
    Since 2007, EPA has regularly reviewed these annual plans for
compliance with the applicable reporting requirements in 40 CFR part
58. With respect to ozone, EPA has found that the area's network plans
meet the applicable requirements under 40 CFR part 58.\10\ Furthermore,
we

concluded in our Technical System Audit of the SCAQMD network conducted
during April 2010, that the ambient air monitoring network operated by
SCAQMD network currently meets or exceeds the requirements for the
minimum number of SLAMS monitoring sites for all criteria pollutants,
and that all of the required ozone monitoring sites are properly
located with respect to monitoring objectives, spatial scales and other
site criteria, as required by 40 CFR part 58, appendix D.\11\ Also,
SCAQMD annually certifies that the data it submits to AQS are quality-
assured.\12\
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    \10\ See, e.g., letter from Matthew Lakin, Manager, Air Quality
Analysis Office, Air Division, EPA Region IX, to Dr. Chung S. Liu,
Deputy Executive Officer, Science and Technology Advancement,
SCAQMD, dated November 1, 2010, approving SCAQMD's 2009 Annual Air
Quality Monitoring Network Plan.
    \11\ See letter from Deborah Jordan, Director, Air Division,
U.S. EPA Region IX, to Barry Wallerstein, Executive Officer, SCAQMD,
dated March 14, 2011, and enclosure titled, ``Technical System Audit
Report, South Coast Air Quality Management District, April 13-April
16, 2010.''
    \12\ See, e.g., letter from Chung S. Liu, Deputy Executive
Office, Science and Technology Advancement, SCAQMD, to Jared
Blumenfeld, Regional Administrator, U.S. EPA Region IX, certifying
2009 ozone data.
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    There were 29 ozone monitoring sites located throughout the South
Coast in calendar years 2008 through 2010: 13 within Los Angeles
County, four within Orange County, seven within Riverside County, and
five within San Bernardino County.\13\ All SCAQMD sites monitor ozone
concentrations on a continuous basis using ultraviolet absorption
monitors.\14\ SCAQMD administered 28 of the 29 sites, and one was
administered by the Morongo Band of Mission Indians. Table 1 summarizes
the ozone monitoring data from the various monitoring sites in the
South Coast Air Basin by showing the expected exceedances per year and
as an average over the 2008-2010 period. The data summarized in Table 1
are considered complete for the purposes of determining if the standard
is met.\15\
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    \13\ See figure 1 in appendix A to SCAQMD's Annual Air Quality
Monitoring Network Plan (July 2010) for a map of SCAQMD's ozone
monitors in the South Coast.
    \14\ SCAQMD operates federal equivalent method (FEM) monitors
for ozone, specifically, Thermo Electron model 49i and Teledyne/API
400 series ultraviolet absorption monitors. See SCAQMD's Annual Air
Quality Monitoring Network Plan (July 2010). These monitoring
devices have an EPA designation number EQOA-0880-047 and EQOA-0992-
087, respectively. See EPA ``List of Designated Reference and
Equivalent Methods, page 27 (February 1, 2011), available on the
Internet at: http://www.epa.gov/ttn/amtic/criteria.html.
    \15\ The criteria for data completeness are met at most of the
ozone monitors over the 2008-2010 period, but are not met for the
ozone monitors at certain stations over the 2008-2010 period:
Pomona, Morongo Reservation, Mira Loma (Jurupa High School), and
Fontana. However, with respect to these four monitors, the failure
to meet the completeness criteria does not bear on the question of
whether the data is complete for the purposes of this determination
because there are sufficient observed exceedances during the
relevant three-year period to establish that the standard was not
met by the applicable attainment date at those sites. See 40 CFR
part 50, appendix H, section 3, first paragraph.

               Table 1--One-Hour Ozone Data for the South Coast One-Hour Ozone Nonattainment Area
----------------------------------------------------------------------------------------------------------------
                                                                      Expected  exceedances  by      Expected
                                                                                year              exceedances 3-
         General location                    Site (AQS ID)         ------------------------------   yr average
                                                                                ---------------
                                                                      2008      2009      2010       2008-2010
----------------------------------------------------------------------------------------------------------------
LOS ANGELES COUNTY:
    East San Gabriel Valley.......  Azusa (06-037-0002)...........       7.0       4.0       0.0             3.6
    East San Fernando Valley......  Burbank (06-037-1002).........       1.0       1.0       0.0             0.7
    South Central Los Angeles       Lynwood/Compton (06-037-1301/        0.0       0.0       0.0             0.0
     County \a\.                     06-037-1302).
    East San Gabriel Valley.......  Glendora (06-037-0016)........      12.0       7.4       0.0             6.5
    Southwest Coastal LA County...  Los Angeles--LAX (06-037-5005)       0.0       0.0       0.0             0.0
    South Coastal LA County.......  North Long Beach (06-037-4002)       0.0       0.0       0.0             0.0
    Central Los Angeles...........  Los Angeles-N. Main Street (06-      0.0       1.0       0.0             0.3
                                     037-1103).
    West San Gabriel Valley.......  Pasadena (06-037-2005)........       0.0       3.0       0.0             1.0
    South San Gabriel Valley......  Pico Rivera (06-037-1602).....       0.0       1.0       0.0             0.3
    Pomona/Walnut Valley..........  Pomona (06-037-1701)..........       5.0       1.0       0.0             2.0
    West San Fernando Valley......  Reseda (06-037-1201)..........       0.0       1.0       0.0             0.3
    Santa Clarita Valley..........  Santa Clarita (06-037-6012)...       8.1       5.1       1.1             4.8
    Northwest Coastal LA County...  West Los Angeles (06-037-0113)       0.0       1.0       0.0             0.3
ORANGE COUNTY:
    Central Orange County.........  Anaheim (06-059-0007).........       0.0       0.0       0.0             0.0
    North Coastal Orange County...  Costa Mesa (06-059-1003)......       0.0       0.0       0.0             0.0
    North Orange County...........  La Habra (06-059-5001)........       0.0       0.0       0.0             0.0
    Saddleback Valley.............  Mission Viejo (06-059-2022)...       0.0       0.0       0.0             0.0
RIVERSIDE COUNTY:
    Banning Airport...............  Banning (06-065-0012).........      10.0       1.0       0.0             3.7
    Banning Airport \b\...........  Morongo Reservation (06-065-        12.1       2.7       4.0             6.3
                                     1016).
    Lake Elsinore.................  Lake Elsinore (06-065-9001)...       6.1       1.0       0.0             2.4
    Mira Loma.....................  Mira Loma--Jurupa High School        6.9       1.1       0.0             2.7
                                     (06-065-0004).
    Mira Loma.....................  Mira Loma--Van Buren (06-065-        4.0       0.0       0.0             1.3
                                     8005).
    Perris Valley.................  Perris (06-065-6001)..........       4.0       1.0       0.0             1.7
    Metropolitan Riverside County.  Rubidoux (06-065-8001)........       8.0       0.0       1.0             3.0
SAN BERNARDINO COUNTY:
    Central San Bernardino          Crestline (06-071-0005).......      16.2       7.0       8.0            10.4
     Mountains.
    Central San Bernardino Valley.  Fontana (06-071-2002).........       8.1       3.0       2.8             4.6
    East San Bernardino Valley....  Redlands (06-071-4003)........      12.0       1.0       1.0             4.7
    Central San Bernardino Valley.  San Bernardino (06-071-9004)..      11.1       2.0       1.0             4.7
    Northwest San Bernardino        Upland (06-071-1004)..........       9.1       3.0       1.0             4.4
     Valley.
----------------------------------------------------------------------------------------------------------------
\a\ Data for year 2008 is from the Lynwood monitor, which was relocated to Compton in late 2008.
\b\ This site is run by the Morongo Tribe of Mission Indians on the Morongo Reservation. It is not part of the
  SCAQMD monitoring network.
Source: Quicklook Report, June 16, 2011 (in the docket to this proposed action).

    Generally, the highest ozone concentrations in the South Coast
occur in the northern and eastern portions of the area. As shown in
Table 1, the highest three-year average of expected exceedances at any
site in the South Coast Air Basin for 2008-2010 is 10.4 (at Crestline,
a site located at 4,500 feet elevation in the San Bernardino
Mountains). The calculated exceedance rate of 10.4 represents a
violation of the one-hour ozone standard (a three-year average of
expected exceedances less than or equal to 1). For more information,
please see ``National 1-hour primary and secondary ambient air quality
standards for ozone'' (40 CFR 50.9) and ``Interpretation of the 1-Hour
Primary and Secondary National Ambient Air Quality Standards for
Ozone'' (40 CFR part 50, appendix H). Table 1 also shows that, while
the most frequent violations occur in the San Bernardino Mountains,
violations are widespread in eastern Riverside County and southwestern
San Bernardino County as well as the Santa Clarita and east San Gabriel
valleys in Los Angeles County.
    Taking into account the extent and reliability of the applicable
ozone monitoring network, and the data collected therefrom and
summarized in Table 1, we propose to determine that the South Coast Air
Basin failed to attain the one-hour ozone standard (as defined in 40
CFR part 50, appendix H) by the applicable attainment date (i.e.,
November 15, 2010).

B. San Joaquin Valley One-Hour Ozone Nonattainment Area

    In the San Joaquin Valley, CARB and San Joaquin Valley Unified Air
Pollution Control District (SJVUAPCD) are the agencies responsible for
assuring that the area meets air quality monitoring requirements. The
SLAMS network of ozone monitors in the valley includes monitors
operated by SJVUAPCD and monitors operated by CARB. SJVUAPCD submits
annual monitoring network plans to EPA. SJVUAPCD Network Plans describe
the various monitoring sites operated by SJVUAPCD as well as those
operated by CARB. These plans discuss the status of the air monitoring
network, as required under 40 CFR 58.10. See SJVUAPCD's Air Monitoring
Network Plan, dated June 30, 2010.
    As noted above for the South Coast, EPA regularly reviews these
annual plans for compliance with the applicable reporting requirements
in 40 CFR part 58. With respect to ozone, EPA has found that the area's
network plans meet the applicable requirements under 40 CFR part
58.\16\ Furthermore, we concluded in our Technical System Audit of the
CARB Primary Quality Assurance Organization (PQAO),\17\ conducted
during summer 2007, that, with one exception, the combined ambient air
monitoring network operated by CARB and SJVUAPCD in the San Joaquin
Valley currently meets or exceeds the requirements for the minimum
number of SLAMS monitoring sites for ozone. In our audit, we found that
our regulations required an additional ozone monitor in the Visalia-
Porterville Metropolitan Statistical Area (MSA) to meet the minimum
SLAMS monitoring requirements. In response, SJVUAPCD opened an ozone
monitoring station in Porterville. The new station began reporting
ozone data in March 2010. CARB annually certifies that the data the
agency submits to AQS are quality-assured, including data collected by
CARB at monitoring sites in San Joaquin Valley.\18\ SJVUAPCD does the
same for monitors operated by the District.\19\
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    \16\ See, e.g., letter from Matthew Lakin, Manager, Air Quality
Analysis Office, Air Division, EPA Region IX, to Scott Nester,
Planning Director, SJVUAPCD, dated November 1, 2010, approving
SJVUAPCD's 2009 Ambient Air Monitoring Network Plan.
    \17\ A primary quality assurance organization is responsible for
a group of monitoring stations for which data quality assessments
can be pooled. See 40 CFR 58.1. CARB is the lead PQAO for all the
air districts in the Sacramento Metro Area.
    \18\ See, e.g., letter from Karen Magliano, Chief, Air Quality
Data Branch, Planning and Technical Support Division, CARB, to Jared
Blumenfeld, Regional Administrator, U.S. EPA Region IX, certifying
calendar year 2010 ambient air quality data and quality assurance
data, dated April 28, 2011.
    \19\ See, e.g., letter from Seyed Sadredin, Executive Director/
Air Pollution Control Officer, letter to Jared Blumenfeld, Regional
Administrator, U.S. EPA Region IX, certifying in part calendar year
2010 ambient air quality data and quality assurance data, dated June
13, 2011. The District's 2010 partial certification dated June 13,
2011 covered ozone data.
---------------------------------------------------------------------------

    There were 22 ozone monitoring sites located throughout the San
Joaquin Valley in calendar years 2008 through 2010: six within Kern
County, five within Fresno County, three within Tulare County, two
within Kings, San Joaquin and Stanislaus counties, and one each in
Madera and Merced counties.\20\ All of the sites monitor ozone
concentrations on a continuous basis using ultraviolet absorption
monitors. CARB or SJVUAPCD operate 19 of the 22 ozone monitoring sites;
the National Park Service operates two ozone monitoring sites in
Sequoia National Park in Tulare County; and the Tachi-Yokut Tribe
operates an ozone monitor at the Santa Rosa Rancheria in Kings County.
---------------------------------------------------------------------------

    \20\ See figure 1 in SJVUAPCD's Air Monitoring Network Plan
(June 30, 2010) for a map of the ozone monitors in the San Joaquin
Valley.
---------------------------------------------------------------------------

    Table 2 summarizes the ozone monitoring data from the various
monitoring sites in the San Joaquin Valley by showing the expected
exceedances per year and as an average over the 2008-2010 period. The
data summarized in Table 2 are considered complete for the purposes of
determining if the standard is met.\21\
---------------------------------------------------------------------------

    \21\ The criteria for data completeness are met at most of the
ozone monitors over the 2008-2010 period, but are not met for the
ozone monitors at certain stations over the 2008-2010 period: Fresno
(Drummond Street), Clovis, Hanford/Corcoran, and Sequoia National
Park (06-017-0009). However, with respect to all of these monitors
except for Fresno (Drummond Street), the failure to meet the
completeness criteria does not bear on the question of whether the
data is complete for the purposes of this determination because
there are sufficient observed exceedances during the relevant three-
year period to establish that the standard was not met by the
applicable attainment date at those sites. See 40 CFR part 50,
appendix H, section 3, first paragraph. Moreover, despite the lack
of complete data from Fresno (Drummond Street), sufficient data from
the network as a whole exist to support the proposed determination
of failure to attain the one-hour ozone NAAQS by the applicable
attainment date within the San Joaquin Valley.

            Table 2--One-Hour Ozone Data for the San Joaquin Valley One-Hour Ozone Nonattainment Area
----------------------------------------------------------------------------------------------------------------
                                                                      Expected  exceedances  by      Expected
                                                                                year              exceedances 3-
                           Site (AQS ID)                           ------------------------------   yr average
                                                                                ---------------
                                                                      2008      2009      2010       2008-2010
----------------------------------------------------------------------------------------------------------------
FRESNO COUNTY:
    Clovis (06-019-5001)..........................................       8.3       0.0       3.0             3.8
    Fresno--Drummond Street (06-019-0007).........................       0.0       0.0       0.0             0.0
    Fresno--North First Street (06-019-0008)......................       7.1       0.0       2.0             3.0
    Fresno--Sierra Skypark 2 (06-019-0242)...............       2.1       0.0       2.4             1.5
    Parlier (06-019-4001).........................................       2.0       0.0       1.1             1.0
KERN COUNTY:
    Arvin (06-029-5001)...........................................      14.3       3.1       2.4             6.6
    Bakersfield (06-029-0014).....................................       1.0       0.0       0.0             0.3
    Edison (06-029-0007)..........................................       5.0       2.0       1.0             2.7
    Maricopa (06-029-0008)........................................       0.0       0.0       0.0             0.0
    Oildale (06-029-0232).........................................       0.0       0.0       0.0             0.0
    Shafter (06-029-6001).........................................       1.0       0.0       0.0             0.3
KINGS COUNTY:
    Hanford/Corcoran \a\ (06-031-1004/06-031-0004)................       4.4       0.0       2.7             2.4
    Santa Rosa Rancheria (06-031-0500)............................       2.2       0.0       0.0             0.7
MADERA COUNTY:
    Madera (06-039-0004)..........................................       0.0       0.0       0.0             0.0
MERCED COUNTY:
    Merced (06-047-0003)..........................................       3.1       0.0       0.0             1.0
SAN JOAQUIN COUNTY:
    Stockton (06-077-1002)........................................       0.0       0.0       0.0             0.0
    Tracy (06-077-3005)...........................................       0.0       0.0       0.0             0.0
STANISLAUS COUNTY:
    Modesto (06-099-0005).........................................       1.0       0.0       0.0             0.3
    Turlock (06-099-0006).........................................       3.0       1.0       0.0             1.3
TULARE COUNTY:
    Sequoia National Park--Lower Kaweah (06-107-0006).............       1.0       0.0       0.0             0.3
    Sequoia National Park--Sequoia and Kings Canyon Nat'l Park (06-      6.9       0.0       0.0             2.3
     107-0009)....................................................
    Visalia (06-107-2002).........................................       3.0       0.0       0.0             1.0
----------------------------------------------------------------------------------------------------------------
\a\ The data reflect the combined data from the Corcoran site (2008 and 2009) and the Hanford site (2010). The
  Hanford site was closed due to renovation during 2008 and 2009, and an ozone monitor was added to the Corcoran
  site to serve as a temporary replacement during the renovation.
Source: Quicklook Report, May 19, 2011 (in the docket to this proposed action).

    It should be noted that CARB and SJVUAPCD have flagged certain
ozone exceedances in years 2008 and 2010 as exceptional events,\22\ but
because EPA has not yet concurred on, or determined to exclude, any of
the flagged events, Table 2 includes the flagged data. Generally, the
highest ozone concentrations in San Joaquin Valley occur in the central
(i.e., in and around the city of Fresno) and the southern portions
(i.e., southeast of Bakersfield) of the area. As shown in Table 2, the
highest three-year average of expected exceedances at any site in the
San Joaquin Valley for 2008-2010 is 6.6 at Arvin, a site located with
mountains to the east, west, and south. The calculated exceedance rate
of 6.6 represents a violation of the one-hour ozone standard (a three-
year average of expected exceedances less than or equal to 1). Even if
EPA were to concur on all of the flagged exceedances and determine that
they qualify for exclusion for the purpose of determining attainment,
the calculated exceedance rate at Arvin would be 3.9, which still
constitutes a violation of the standard.
---------------------------------------------------------------------------

    \22\ Under CAA section 319(b)(1)(A), the term ``exceptional
event'' means an event that--(i) Affects air quality; (ii) is not
reasonably controllable or preventable; (iii) is an event caused by
human activity that is unlikely to recur at a particular location or
a natural event; and (iv) is determined by the Administrator through
the process established in the regulations promulgated under
paragraph (2) to be an exceptional event. Under CAA section
319(b)(1)(B), the term ``exceptional event'' does not include--(i)
Stagnation of air masses or meteorological inversions; (ii) a
meteorological event involving high temperatures or lack of
precipitation; or (iii) air pollution relating to source
noncompliance. EPA's regulations referred to in CAA section
309(b)(1)(A) were promulgated at 40 CFR 50.14.
---------------------------------------------------------------------------

    Taking into account the extent and reliability of the applicable
ozone monitoring network, and the data collected therefrom and
summarized in Table 2, we propose to determine that the San Joaquin
Valley failed to attain the one-hour ozone standard (as defined in 40
CFR part 50, appendix H) by the applicable attainment date (i.e.,
November 15, 2010).

C. Southeast Desert One-Hour Ozone Nonattainment Area

    In the Southeast Desert, CARB is the agency responsible for
assuring that the area meets air quality monitoring requirements. The
Antelope Valley Air Quality Management District (AVAQMD) operates
monitors in the Los Angeles County portion of the Southeast Desert; the
Mojave Desert Air Quality Management District (MDAQMD) operates
monitors in the San Bernardino County portion of the Southeast Desert;
and SCAQMD operate monitors in the Riverside County portion of the
Southeast Desert. All three agencies submit annual monitoring network
plans to EPA. These plans discuss the status of the air monitoring
network, as required under 40 CFR 58.10.
    SCAQMD's annual network plans and data certifications, as well as
EPA's TSA of SCAQMD's ambient air monitoring program, are discussed
above in connection with the South Coast Air Basin. With respect to the
annual network plans submitted by AVAQMD

and MDAQMD, we have reviewed these plans and found that they meet the
applicable requirements for such plans.\23\ The TSA we conducted in
2007 of the CARB PQAO included a review of the network requirements in
AVAQMD and MDAQMD. In the TSA, we concluded that the combined ambient
air monitoring networks operated by CARB and the air districts
currently meet or exceed the requirements for the minimum number of
SLAMS monitoring sites for ozone in the Southeast Desert. Also, AVAQMD
and MDAQMD annually certify that the data submitted to AQS are quality-
assured.\24\
---------------------------------------------------------------------------

    \23\ See, e.g., letter dated April 30, 2008 from Sean P. Hogan,
Manager, Air Quality Analysis Office, EPA Region IX, to Eldon
Heaston, Executive Director, MDAQMD.
    \24\ See, e.g., letter dated June 27, 2007 from Chris Collins,
A/Q Supervisor, MDAQMD, to Wayne Nastri, Regional Administrator, EPA
Region IX, certifying calendar year 2006 ambient air quality data in
both MDAQMD and AVAQMD.
---------------------------------------------------------------------------

    There were nine ozone monitoring sites located throughout the
Southeast Desert in calendar years 2005 through 2007: one in Los
Angeles County, three in Riverside County, and five in San Bernardino
County.\25\ All of the sites monitor ozone concentrations on a
continuous basis using ultraviolet absorption monitors.\26\ AVAQMD
operates the one monitor in Los Angeles County. SCAQMD operates two of
the three monitors in Riverside County; the third monitor is operated
by the National Park Service at Joshua Tree National Park. MDAQMD
operates four of the five sites in San Bernardino County; the fifth
monitor is operated by the National Park Service at Joshua Tree
National Park.
---------------------------------------------------------------------------

    \25\ See figures 5 and 11 from CARB's State and Local Air
Monitoring Network Plan (June 2009) for illustrations of the
locations of the ozone monitors within the Southeast Desert.
    \26\ AVAQMD and MDAQMD operate Federal Equivalent Method (FEM)
monitors for ozone, specifically, Teledyne/API 400 series
ultraviolet absorption monitors.
---------------------------------------------------------------------------

    Table 3 summarizes the ozone monitoring data from the various
monitoring sites in the Southeast Desert, showing the expected
exceedances per year and as an average over the 2005-2007 period. The
data summarized in Table 3 are considered complete for the purposes of
determining if the standard is met.\27\
---------------------------------------------------------------------------

    \27\ The criteria for data completeness are met at all of the
ozone monitors in the Southeast Desert over the 2005-2007 period
except for the ozone monitor at the Joshua Tree National Park (06-
065-0008). Despite the lack of complete data from that one monitor,
sufficient data from the network as a whole exist to support the
proposed determination of failure to attain the one-hour ozone NAAQS
by the applicable attainment date within the Southeast Desert.

             Table 3--One-Hour Ozone Data for the Southeast Desert One-Hour Ozone Nonattainment Area
----------------------------------------------------------------------------------------------------------------
                                                                    Expected exceedances by year     Expected
                                                                   ------------------------------ exceedances 3-
          General location                    Site (AWS ID)                                         yr average
                                                                      2005      2006      2007   ---------------
                                                                                2005-2007
----------------------------------------------------------------------------------------------------------------
Antelope Valley.....................  Lancaster (06-037-9033).....       1.0       2.0       0.0             1.0
Coachella Valley....................  Indio (06-065-2002).........       0.0       0.0       0.0             0.0
Joshua Tree National Park...........  Cottonwood Visitor Center           NA       0.0       0.0             0.0
                                       (06-065-0008).
Coachella Valley....................  Palm Springs (06-065-5001)..       4.0       2.0       1.0             2.3
Northern portion of SE Desert AQMA..  Barstow (06-071-0001).......       0.0       0.0       0.0             0.0
SW portion of SE Desert AQMA........  Hesperia (06-071-4001)......       3.0       2.0       2.0             2.3
SW portion of SE Desert AQMA........  Phelan (06-071-0012)........       2.0       2.0       0.0             1.3
SW portion of SE Desert AQMA........  Victorville (06-071-0306)...       2.0       1.0       0.0             1.0
Joshua Tree National Park...........  Yucca Valley (06-071-9002)..       2.0       1.0       1.0            1.3
----------------------------------------------------------------------------------------------------------------
NA = No data is available.
Source: Quicklook Report, May 11, 2011 (in the docket to this proposed action).

    Generally, the highest ozone concentrations in the Southeast Desert
occur in the far southwestern portion of the area, near mountain passes
through which pollutants are transported to the Southeast Desert from
the South Coast Air Basin. As shown in Table 3, the highest three-year
average of expected exceedances at any site in the Southeast Desert for
2005-2007 is 2.3 at Palm Springs in Riverside County and Hesperia in
San Bernardino County. The calculated exceedance rate of 2.3 represents
a violation of the one-hour ozone standard (a three-year average of
expected exceedances less than or equal to 1).\28\
---------------------------------------------------------------------------

    \28\ A preliminary review of more recent data (2008-2010) for
the Southeast Desert suggests that only one monitoring site (the
site in Phelan, San Bernardino County) remains in violation of the
one-hour ozone standard with a calculated expected annual exceedance
rate of 1.7. However, due to the four exceedances recorded in 2010,
the soonest that the Phelan site could be determined to be attaining
the one-hour ozone standard will be in 2014 (assuming such a
determination is supported by 2011-2013 data).
---------------------------------------------------------------------------

    Taking into account the extent and reliability of the applicable
ozone monitoring network, and the data collected therefrom and
summarized in Table 3, we propose to determine that the Southeast
Desert failed to attain the one-hour ozone standard (as defined in 40
CFR part 50, appendix H) by the applicable attainment date (i.e.,
November 15, 2007).

IV. What is the effect of the proposed determinations?

    A final determination of a Severe or Extreme area's failure to
attain by its one-hour ozone NAAQS attainment date would trigger the
obligation to implement one-hour contingency measures for failure to
attain under section 172(c)(9) and fee programs under sections
182(d)(3), 182(f), and 185. Section 172(c)(9) requires one-hour ozone
SIPs, other than for ``Marginal'' areas, to provide for implementation
of specific measures (referred to herein as ``contingency measures'')
to be undertaken if the area fails to attain the NAAQS by the
attainment date. The effect of the proposed determinations would be to
give effect to any one-hour ozone contingency measures that are not
already in effect within the three subject California nonattainment
areas.
    Section 182(d)(3) requires SIPs to include the provisions required
under section 185, and section 185 requires one-hour ozone SIPs in
areas classified as ``Severe'' or ``Extreme'' to provide that, if the
area has failed to attain the standard by the applicable attainment
date, each major stationary source of ozone precursors located in the
area must begin paying a fee [computed in accordance with section
185(b)] to the State. Section 182(f) extends the section 185
requirements, among others, that apply to major stationary sources of
VOCs to major stationary sources of NOX unless EPA has
waived such

requirements for NOX sources in the particular nonattainment
area.
    The three subject ozone nonattainment areas, the South Coast, the
San Joaquin Valley, and the Southeast Desert, lie within the
jurisdictions of four California air districts: The SCAQMD, the
SJVUAPCD, the AVAQMD, and the MDAQMD. Each of the four air districts
has adopted rules intended to comply with sections 182(d)(3) and 185 of
the Act and CARB has submitted them to EPA for approval into the SIP.
EPA has taken action on one of the rules, SJVUAPCD Rule 3170. See 75 FR
1716 (January 13, 2010). Since then, SJVUAPCD Rule 3170 has been
revised, and EPA has recently proposed approval of the amended rule.
See 76 FR 45212 (July 28, 2011). EPA has not yet taken action on the
rules developed by the other three districts (SCAQMD Rule 317, AVAQMD
Rule 315, and MDAQMD Rule 315, all of which were submitted on April 22,
2011). Another effect of the proposed determinations of failure to
attain the 1-hour ozone standard by the applicable attainment dates
would be to give effect to the section 185 requirements to the extent
they are not already in effect within the three subject California
nonattainment areas.

V. Proposed Actions

    Under EPA's authority under CAA section 301(a) to ensure
implementation of one-hour ozone anti-backsliding requirements, EPA is
proposing to determine that the South Coast, the San Joaquin Valley,
and the Southeast Desert failed to attain the one-hour ozone standard
by the applicable attainment dates. For South Coast and San Joaquin
Valley, quality-assured and certified data collected during 2008-2010
show that these two ``Extreme'' one-hour ozone nonattainment areas
failed to attain the standard by November 15, 2010. For Southeast
Desert, a ``Severe-17'' one-hour ozone nonattainment area, quality-
assured and certified data for 2005-2007 show that the area failed to
attain the standard by November 15, 2007.
    These proposed determinations, if finalized, would bear on the
areas' obligations with respect to certain one-hour standard anti-
backsliding requirements whose implementation is triggered by a failure
to attain by the applicable attainment date: section 172(c)(9)
contingency measures for failure to attain and sections 182(d)(3) and
185 major stationary source fee programs. Through this proposed rule,
EPA is soliciting comments on the above determinations.

VI. Statutory and Executive Order Reviews

    These actions propose to make determinations that certain areas did
not attain the applicable standard based on air quality, and do not
impose any requirements beyond those required by statute. For that
reason, these proposed actions:
     Are 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);
     Do not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Are 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.);
     Do 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);
     Do not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Are not economically significant regulatory actions based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Are not significant regulatory actions subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Are not subject to the requirements of Section 12(d) of
the National Technology Transfer and Advancement Act of 1995 (15 U.S.C.
272 note) because application of those requirements would be
inconsistent with the Clean Air Act; and
     Do 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 proposed 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.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Intergovernmental
relations, Oxides of nitrogen, Ozone, Reporting and recordkeeping
requirements, Volatile organic compounds.

    Dated: September 1, 2011.
Jared Blumenfeld,
Regional Administrator, Region IX.
[FR Doc. 2011-23544 Filed 9-13-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 57 (Monday, March 27, 2017)]
[Rules and Regulations]
[Pages 15126-15128]
[FR Doc No: 2017-05233]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-9300; Directorate Identifier 2016-NM-124-AD;
Amendment 39-18829; AD 2017-06-05]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for all The
Boeing Company Model DC-6, DC-6A, C-118A, R6D-1, DC-6B, and R6D-1Z
airplanes. This AD was prompted by a report of a fuel leak in a Model
C-118A airplane that resulted from a crack in the wing lower skin. This
AD requires repetitive radiographic, electromagnetic testing high
frequency (ETHF), and electromagnetic testing low frequency (ETLF)
inspections for cracking of the wing lower skin, and repairs if
necessary. We are issuing this AD to address the unsafe condition on
these products.

DATES: This AD is effective May 1, 2017.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of May 1, 2017.

ADDRESSES: For service information identified in this final rule,
contact Boeing Commercial Airplanes, Attention: Contractual & Data
Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA
90740-5600; telephone<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may view this referenced service information
at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW.,
Renton, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
9300.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
9300; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The address for the Docket Office (phone: 800-647-
5527) is Docket Management Facility, U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: George Garrido, Aerospace Engineer,
Airframe Branch, ANM-120L, FAA, Los Angeles Aircraft Certification
Office (ACO), 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone:
562-627-5232; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to all The Boeing Company
Model DC-6, DC-6A, C-118A, R6D-1, DC-6B, and R6D-1Z airplanes. The NPRM
published in the Federal Register on October 26, 2016 (81 FR 74352).
The NPRM was prompted by a report of a fuel leak in a Model C-118A
airplane that resulted from a crack in the wing lower skin. The NPRM
proposed to require repetitive radiographic, ETHF, and ETLF inspections
for cracking of the wing lower skin just inboard of the number 2
nacelle attach angle at wing station 175, and repairs if necessary. We
are issuing this AD to detect and correct fatigue cracking in the wing
lower skin, which could adversely affect the structural integrity of
the wing.

Comments

    We gave the public the opportunity to participate in developing
this AD. We have considered the comments received. The National
Transportation Safety Board, Boeing, and Ms. Ana Maria expressed their
support for the NPRM.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this AD as proposed, except for minor editorial changes. We have
determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Service Bulletin DC6-57A001, dated April
28, 2016. The service information describes procedures for
radiographic, ETHF, and ETLF inspections for cracking of the wing lower
skin at wing station 175, and repairs. This service information is
reasonably available because the interested parties have access to it
through their normal course of business or by the means identified in
the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 36 airplanes of U.S. registry. We
estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
           Action                    Labor cost           Parts cost      Cost per product        operators
----------------------------------------------------------------------------------------------------------------
Inspections.................  17 work-hours x $85 per               $0  $1,445 per           $52,020 per
                               hour = $1,445 per                         inspection cycle.    inspection cycle.
                               inspection cycle.
----------------------------------------------------------------------------------------------------------------

    We have received no definitive data that would enable us to provide
cost estimates for the on-condition actions specified in this AD.

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

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

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

2017-06-05 The Boeing Company: Amendment 39-18829; Docket No. FAA-
2016-9300; Directorate Identifier 2016-NM-124-AD.

(a) Effective Date

    This AD is effective May 1, 2017.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all The Boeing Company Model DC-6, DC-6A, DC-
6B, C-118A, R6D-1, and R6D-1Z airplanes, certificated in any
category.

(d) Subject

    Air Transport Association (ATA) of America Code 57, Wings.

(e) Unsafe Condition

    This AD was prompted by a report of a fuel leak in a Model C-
118A airplane that resulted from a crack in the wing lower skin just
inboard of the number 2 nacelle attach angle at wing station 175. We
are issuing this AD to detect and correct fatigue cracking in the
wing lower skin, which could adversely affect the structural
integrity of the wing.

(f) Compliance

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

(g) Repetitive Inspections

    Except as specified in paragraph (i) of this AD: At the
applicable time specified in paragraph 1.E., ``Compliance,'' of
Boeing Alert Service Bulletin DC6-57A001, dated April 28, 2016, do
radiographic, electromagnetic testing high frequency (ETHF), and
electromagnetic testing low frequency (ETLF) inspections for
cracking of the wing lower skin at station 175, in accordance with
the Accomplishment Instructions of Boeing Alert Service Bulletin
DC6-57A001, dated April 28, 2016. Repeat the radiographic, ETHF, and
ETLF inspections of any unrepaired areas thereafter at the
applicable intervals specified in paragraph 1.E., ``Compliance,'' of
Boeing Alert Service Bulletin DC6-57A001, dated April 28, 2016.

(h) Repairs

    If any cracking is found during any inspection required by this
AD: Before further flight, repair the cracking using a method
approved in accordance with the procedures specified in paragraph
(j) of this AD.

(i) Service Information Exception

    Where paragraph 1.E., ``Compliance,'' of Boeing Alert Service
Bulletin DC6-57A001, dated April 28, 2016, specifies a compliance
time ``after the original issue date of this service bulletin,''
this AD requires compliance within the specified compliance time
after the effective date of this AD.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Los Angeles Aircraft Certification Office
(ACO), FAA, has the authority to approve AMOCs for this AD, if
requested using the procedures found in 14 CFR 39.19. In accordance
with 14 CFR 39.19, send your request to your principal inspector or
local Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in paragraph (k) of this AD.
Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by the Boeing Commercial Airplanes Organization
Designation Authorization (ODA) that has been authorized by the
Manager, Los Angeles ACO, to make those findings. To be approved,
the repair method, modification deviation, or alteration deviation
must meet the certification basis of the airplane, and the approval
must specifically refer to this AD.
    (4) For service information that contains steps that are labeled
as Required for Compliance (RC), the provisions of paragraphs
(j)(4)(i) and (j)(4)(ii) of this AD apply.
    (i) The steps labeled as RC, including substeps under an RC step
and any figures identified in an RC step, must be done to comply
with the AD. If a step or substep is labeled ``RC Exempt,'' then the
RC requirement is removed from that step or substep. An AMOC is
required for any deviations to RC steps, including substeps and
identified figures.
    (ii) Steps not labeled as RC may be deviated from using accepted
methods in accordance with the operator's maintenance or inspection
program without obtaining approval of an AMOC, provided the RC
steps, including substeps and identified figures, can still be done
as specified, and the airplane can be put back in an airworthy
condition.

(k) Related Information

    For more information about this AD, contact George Garrido,
Aerospace Engineer, Airframe Branch, ANM-120L, Los Angeles ACO, FAA,
3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-
5232; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Boeing Alert Service Bulletin DC6-57A001, dated April 28,
2016.
    (ii) Reserved.
    (3) For Boeing service information identified in this AD,
contact Boeing Commercial Airplanes, Attention: Contractual & Data
Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA
90740-5600; telephone<PHONE_NUMBER>; Internet https://www.myboeingfleet.com.
    (4) You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on March 8, 2017.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2017-05233 Filed 3-24-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: July 27, 2006 (Volume 71, Number 144)]
[Notices]
[Page 42696-42698]
[DOCID:fr27jy06-91]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-54160; File No. SR-NASD-2006-057]

Self-Regulatory Organizations; National Association of Securities
Dealers, Inc.; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change and Amendment No. 1 Thereto Regarding the Pricing Schedule
for NASD Members Using the Nasdaq Market Center and Nasdaq's Brut and
INET Facilities

July 17, 2006.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on May 1, 2006, the National Association of Securities Dealers, Inc.
(``NASD''), through its subsidiary, The Nasdaq Stock Market, Inc.
(``Nasdaq''), filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by Nasdaq. On June 12,
2006, Nasdaq filed Amendment No. 1 to the proposed rule change.\3\
Pursuant to Section 19(b)(3)(A)(ii) of the Act \4\ and Rule 19b-4(f)(2)
thereunder,\5\ Nasdaq has designated this proposal as establishing or
changing a due, fee, or other charge, which renders the proposed rule
change effective immediately upon filing. The Commission is publishing
this notice, as amended, to solicit comments on the proposed rule
change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ In Amendment No. 1, Nasdaq amended proposed Rule 7010(i)(7)
to indicate that when a market participant enters an order into
Nasdaq's Brut or INET systems that is sent to a Nasdaq Market Center
market participant that charges an access fee to Brut or INET, the
market participant entering the order shall be charged (i) the
applicable execution fee of the Nasdaq Facilities, or (ii) in the
case of executions against Quotes/Orders at less than $1.00 per
share, a pass-through of the access fee charged to Brut or INET.
Nasdaq also made conforming changes to the description of the
proposed rule change.
    \4\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \5\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Nasdaq proposes to modify the pricing for NASD members using the
Nasdaq Market Center and Nasdaq's Brut and INET Facilities (the
``Nasdaq Facilities''). Nasdaq implemented the proposed rule change on
May 1, 2006.
    The text of the proposed rule change, as amended, is available on
the NASD's

Web site (http://www.nasd.com), at the NASD's Office of the Secretary,

and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, Nasdaq included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. Nasdaq has prepared summaries, set forth in Sections A,
B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    Nasdaq is proposing to reduce its fees for routing orders from its
three trading platforms--the Nasdaq Market Center, Brut, and INET--to
the American Stock Exchange (``Amex''). Specifically, whereas Nasdaq
now charges $0.01 per share executed for routing such orders, the fee
will be reduced to $0.003 per share executed. However, an additional
fee of $0.01 would be charged in cases where the Amex specialist
charges a fee to execute the order (which generally occurs when the
order remains on the specialist book for more than a certain amount of
time before being executed).
    Nasdaq is also broadening the conditions under which a member may
qualify for a reduced fee of $0.0028 per share executed to access
liquidity and route orders in Nasdaq-listed securities and exchange-
traded funds. Currently, members qualify for the $0.0028 fee (a
reduction from the otherwise applicable fee of $0.003 per share
executed) if they (i) provide an daily average of more than 30 million
shares of liquidity during a month and (ii) access and/or route a daily
average of more than 50 million shares of liquidity during a month.
With the proposed rule change, the reduced fee would also be available
to members that (i) provide a daily average of more than 20 million
shares of liquidity during a month and (ii) access and/or route a daily
average of more than 60 million shares of liquidity during a month.
Thus, the change will broaden the availability of the reduced fee to
members that provide comparatively less liquidity but access and/or
route comparatively more liquidity.
    Nasdaq is also adding rule text to clarify the fee to be charged
with respect to orders that are entered into Brut or INET and then sent
to a Nasdaq Market Center participant that charges an access fee to
Brut or INET. When the execution price of the stock is greater than
$1.00, Nasdaq charges its usual order execution fee of $0.0028 or
$0.003, which will generally approximate the access fee charged to Brut
or INET. In the case of stocks price at $1.00 or less, Nasdaq's order
execution fee of 0.1% of the total transaction cost would not allow it
to recoup the access fee charged to Brut or INET. Accordingly, in those
cases, Nasdaq passes through the ECN access fee to the market
participant that entered the order into Brut or INET.
2. Statutory Basis
    Nasdaq believes that the proposed rule change is consistent with
the provisions of Section 15A of the Act,\6\ in general, and with
Section 15A(b)(5) of the Act,\7\ in particular, in that it provides for
the equitable allocation of reasonable dues, fees and other charges
among members and issuers and other persons using any facility or
system which the NASD operates or controls. ``The proposed rule change
reduces fees for routing to Amex in most cases, broadens the
availability of a reduced fee to access liquidity and route orders, and
clarifies the fee charged with respect to orders entered into Brut or
INET and sent for execution to a Nasdaq Market Center participant that
charges an access fee.''
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78o-3.
    \7\ 15 U.S.C. 78o-3(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    Nasdaq does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act \8\ and subparagraph (f)(2) of Rule 19b-4
thereunder.\9\ At any time within 60 days of the filing of the proposed
rule change, the Commission could have summarily abrogated such rule
change if it appeared to the Commission that such action was necessary
or appropriate in the public interest, for the protection of investors,
or otherwise in furtherance of the purposes of the Act.\10\
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(a)(ii).
    \9\ 17 CFR 240.19b-4(f)(2).
    \10\ The effective date of the original proposed rule change is
May 1, 2006 and the effective date of the amendment is June 12,
2006. For purposes of calculating the 60-day period within which the
Commission may summarily abrogate the proposed rule change, as
amended, under Section 19(b)(3)(C) of the Act, the Commission
considers the period to commence on June 12, 2006, the date on which
the NASD submitted Amendment No. 1.  See 15 U.S.C. 78s(b)(3)(C).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change, as amended, is consistent with the Act. Comments may be
submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-NASD-2006-057 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NASD-2006-057. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Section, 100 F Street,
NE., Washington, DC 20549. Copies of such filing also will be available
for inspection and copying at the principal office of the NASD. All
comments received will be posted without change; the Commission does

not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NASD-2006-057 and should be
submitted on or before August 17, 2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
 [FR Doc. E6-11982 Filed 7-26-06; 8:45 am]

BILLING CODE 8010-01-P


Pollutant 2000 MGSP Benchmark Proposed 2005 MSGP Benchmark Total Sectors Affected (

Activities in Sector Affected/

Total Activities in Sector) Estimated Number of Facilities Affected**

Ammonia 19 mg/ L 19 mg/ L K 31 Biochemical Oxygen Demand ( 5 day) 30 mg/ L 30 mg/ L S, U ( 1/ 10) 467 Chemical Oxygen Demand 120 mg/ L 120 mg/ L A ( 8/ 11), B ( 1/ 5), G ( 1/ 2), K, N, S, U ( 1/ 10) 398 Total Suspended Solids 100 mg/ L 100 mg/ L ALL 3656 Turbidity 5 NTU above background 50 NTU G ( 1/ 2) 42 Nitrate + Nitrite Nitrogen 0.68 mg/ L 0.68 mg/ L C ( 3/ 10), G ( 1/ 2), J ( 1/ 7), U ( 1/ 10), AA 197 Total Phosphorus 2.0 mg/ L 2.0 mg/ L C ( 1/ 10) 11 pH 6.0  9.0 s. u. 6.0  9.0 s. u. G ( 1/ 2), S 442 Aluminum, Total ( pH 6.5  9) 0.75 mg/ L 0.75 mg/ L C ( 1/ 10), E ( 2/ 8), F ( 2/ 7), H, M, N, Q,

AA ( 1/ 2) 663 Antimony, Total Recoverable .636 mg/ L 0.64 mg/ L G ( 1/ 2) 42 Arsenic 0.16854 mg/ L 0.15 mg/ L A ( 1/ 11), G( 1/ 2), K 53 Beryllium, Total Recoverable 0.13 mg/ L 0.13 mg/ L G ( 1/ 2) 42 Cadmium, Total Recoverable 0.0159 mg/ L 0.0021 mg/ L G( 1/ 2), K 73 Chromium N/ A ( Effluent Guideline Only) 1.8 mg/ L A ( 1/ 11) 12 Copper, Total Recoverable 0.0636 mg/ L 0.014 mg/ L A ( 1/ 11), F( 3/ 7), G ( 1/ 2) 87 Cyanide 0.0636 mg/ L 0.022 mg/ L K 31 Iron, Total Recoverable 1.0 mg/ L 1.0 mg/ L C ( 2/ 10), E( 1/ 8), F( 1/ 7), G( 1/ 2), H, L,

M, N, O, Q, AA( 1/ 2) 806 Lead, Total Recoverable 0.0816 mg/ L 0.082 mg/ L C( 1/ 10), G( 1/ 2), K, M, N, Q 587 Magnesium, Total Recoverable 0.0636 mg/ L 0.064 mg/ L K 31 Manganese 1.0 mg/ L 0.050 mg/ L G ( 1/ 2) 42 Mercury, Total Recoverable 0.0024 mg/ L 0.0014 mg/ L G ( 1/ 2), K 73 Nickel, Total Recoverable 1.417 mg/ L 0.47 mg/ L G ( 1/ 2) 42 Phenols, Total N/ A ( Effluent Guideline Only) 0.016 mg/ L A ( 1/ 11) 12 Selenium, Total Recoverable .2385 mg/ L 0.005 mg/ L G ( 1/ 2), K 73 Silver, Total Recoverable 0.0318 mg/ L 0.0038 mg/ L G ( 1/ 2), K 73 Zinc, Total Recoverable 0.117 mg/ L 0.12 mg/ L A ( 1/ 11), C ( 4/ 10), F ( 4/ 7), G ( 1/ 2), N,

Q, Y ( 4/ 10), AA 531 ** Methodology is the same as that for estimating in Cost Analysis Draft 9/ 26/ 05 Sector Active Permits*

Total Activities A 130 11 B 95 5 C 106 10 D 146 3 E 232 9 F 78 7 G 83 2 H 11 1 I 196 4 J 268 7 K 31 1 L 123 1 M 262 1 N 205 1 O 68 1 P 470 5 Q 37 1 R 49 1 S 400 1 T 96 1 U 67 10 V 37 3 W 9 2 X 25 1 Y 111 10 Z 4 1 AA 104 2 AB 91 2 AC 110 3 AD 12 1


[Federal Register Volume 84, Number 234 (Thursday, December 5, 2019)]
[Notices]
[Pages 66682-66684]
[FR Doc No: 2019-26252]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-E-2596]

Determination of Regulatory Review Period for Purposes of Patent
Extension; LUXTURNA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for LUXTURNA and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human
biological product.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
February 3, 2020. Furthermore, any interested person may petition FDA
for a determination regarding whether the applicant for extension acted
with due diligence during the regulatory review period by June 2, 2020.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before February 3, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 3, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
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-E-2596 for ''Determination of Regulatory Review Period for
Purposes of Patent Extension; LUXTURNA.'' Received comments, those
filed in a timely manner (see ADDRESSES), 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 Sec.  10.20 (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: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human biological
product and continues until FDA grants permission to market the
biological product. Although only a portion of a regulatory review
period may count toward the actual amount of extension that the
Director of USPTO may award (for example, half the testing phase must
be subtracted as well as any time that may have occurred before the
patent was issued), FDA's determination of the length of a regulatory
review period for a human biological product will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(1)(B).
    FDA has approved for marketing the human biologic product LUXTURNA
(voretigene neparvovec-rzyl). LUXTURNA is indicated for treatment of
patients with confirmed biallelic RPE65 mutation-associated retinal
dystrophy. Subsequent to this approval, the USPTO received a patent
term restoration application for LUXTURNA (U.S. Patent No. 9,433,688)
from Trustees of the University of Pennsylvania, the University of
Florida Research Foundation, Inc., and Cornell Research Foundation,
Inc., and the USPTO requested FDA's assistance in determining this
patent's eligibility for patent term restoration. In a letter dated May
13, 2019, FDA advised the USPTO that this human biological product had
undergone a regulatory review period and that the approval of LUXTURNA
represented the first permitted commercial marketing or use of the
product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
LUXTURNA is 3,809 days. Of this time, 3,591 days occurred during the
testing phase of the regulatory review period, while 218 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: July 18,
2007. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on July 18,
2007.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): May 16, 2017. FDA has verified the
applicant's claim that the biologics license application (BLA) for
LUXTURNA (BLA 125610) was initially submitted on May 16, 2017.
    3. The date the application was approved: December 19, 2017. FDA
has verified the applicant's claim that BLA 125610 was approved on
December 19, 2017.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 344 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of

Sec.  60.30, including but not limited to: must be timely (see DATES),
must be filed in accordance with Sec.  10.20, must contain sufficient
facts to merit an FDA investigation, and must certify that a true and
complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: November 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-26252 Filed 12-4-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 60 (Monday, March 30, 2015)]
[Notices]
[Page 16727]
[FR Doc No: 2015-07098]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2014-0120]

Petition for Waiver of Compliance

    In accordance with part 211 of Title 49 Code of Federal Regulations
(CFR), this document provides the public notice that by a document
dated November 7, 2014, the Port Authority Trans-Hudson Corporation
(PATH) has petitioned the Federal Railroad Administration (FRA) for a
waiver of compliance from certain provisions of the Federal railroad
safety regulations contained at 49 CFR part 236--Rules, Standards, and
Instructions Governing the Installation, Inspection, Maintenance, and
Repair of Signal and Train Control Systems, Devices, and Appliances.
FRA assigned the petition Docket Number FRA-2014-0120.
    This request is for an extension of time from the requirements of
49 CFR 236.108(a), Insulation resistance tests, wires in trunking, and
cables, and the related 49 CFR 236.110, Results of tests. PATH is
seeking to extend the test time interval from 10 years to 13 years for
the approximately 840 local and express cables involved. These cables
would still be subject to all other rules and requirements under 49 CFR
part 236, subpart A.
    The referenced cables are scheduled to be replaced within the next
3 years under the PATH Automatic Train Control signal system
replacement project. Under this project, which started in 2010, PATH is
installing a communications-based train control/Positive Train Control
system in which all of the existing relay-based interlocking and
automatic block signal control equipment, internal bungalow wiring, and
cabling from the bungalow to the field devices is being replaced. The
requested extension of time will aid in the acceleration plans for the
new system as PATH staff who will be relieved from cable testing
requirements will be used for the installation of the new system.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey
Avenue SE., W12-140, Washington, DC 20590. The Docket Operations
Facility is open from 9 a.m. to 5 p.m., Monday through Friday, except
Federal Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Communications received by May 14, 2015 will be considered by FRA
before final action is taken. Comments received after that date will be
considered as far as practicable.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the document,
if submitted on behalf of an association, business, labor union, etc.).
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its processes. DOT posts these comments,
without edit, including any personal information the commenter
provides, to www.regulations.gov, as described in the system of records
notice (DOT/ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy.
See also http://www.regulations.gov/#!privacyNotice for the privacy
notice of regulations.gov or interested parties may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477).

    Issued in Washington, DC, on March 24, 2015.
Ron Hynes,
Director, Office of Technical Oversight.
[FR Doc. 2015-07098 Filed 3-27-15; 8:45 am]
 BILLING CODE 4910-06-P