[Federal Register Volume 85, Number 149 (Monday, August 3, 2020)]
[Notices]
[Pages 46651-46657]
[FR Doc No: 2020-16833]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1700]

Prescription Drug User Fee Rates for Fiscal Year 2021

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the rates
for prescription drug user fees for fiscal year (FY) 2021. The Federal
Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Prescription
Drug User Fee Amendments of 2017 (PDUFA VI), authorizes FDA to collect
application fees for certain applications for the review of human drug
and biological products, and prescription drug program fees for certain
approved products. This notice establishes the fee rates for FY 2021.

FOR FURTHER INFORMATION CONTACT: Melissa Hurley, Office of Financial
Management, Food and Drug Administration, 4041 Powder Mill Rd., Rm.
61075, Beltsville, MD 20705-4304,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Sections 735 and 736 of the FD&C Act (21 U.S.C. 379g and 379h,
respectively) establish two different kinds of user fees. Fees are
assessed as follows: (1) Application fees are assessed on certain types
of applications for the review of human drug and biological products
and (2) prescription drug program fees are assessed on certain approved
products (section 736(a) of the FD&C Act). When specific conditions are
met, FDA may waive or reduce fees (section 736(d) of the FD&C Act) or
exempt certain prescription drug products from fees (section 736(k) of
the FD&C Act).
    For FY 2018 through FY 2022, the base revenue amounts for the total
revenues from all PDUFA fees are established by PDUFA VI. The base
revenue amount for FY 2021 is $1,065,707,676. The FY 2021 base revenue
amount is adjusted for inflation and for the resource capacity needs
for the process for the review of human drug applications (the capacity
planning adjustment or CPA). An additional dollar amount specified in
the statute (see section 736(b)(1)(F) of the FD&C Act) is then added to
provide for additional full-time equivalent (FTE) positions to support
PDUFA VI initiatives. The FY 2021 revenue amount may be adjusted
further, if necessary, to provide for sufficient operating reserves of
carryover user fees. Finally, the amount is adjusted to provide for
additional direct costs to fund PDUFA VI initiatives. Fee amounts are
to be established each year so that revenues from application fees
provide 20 percent of the total revenue, and prescription drug program
fees provide 80 percent of the total revenue.
    This document provides fee rates for FY 2021 for an application
requiring clinical data ($2,875,842), for an application not requiring
clinical data ($1,437,921), and for the prescription drug program fee
($336,432). These fees are effective on October 1, 2020, and will
remain in effect through September 30, 2021. For applications that are
submitted on or after October 1, 2020, the new fee schedule must be
used.

II. Fee Revenue Amount for FY 2021

    The base revenue amount for FY 2021 is $1,065,707,676 prior to
adjustments for inflation, capacity planning, additional FTE, operating
reserve, and additional direct costs (see section 736(b)(1) of the FD&C
Act).

A. FY 2021 Statutory Fee Revenue Adjustments for Inflation

    PDUFA VI specifies that the $1,065,707,676 is to be adjusted for
inflation increases for FY 2021 using two separate adjustments--one for
personnel compensation and benefits (PC&B) and one for non-PC&B costs
(see section 736(c)(1) of the FD&C Act).
    The component of the inflation adjustment for payroll costs shall
be one plus the average annual percent change in the cost of all PC&B
paid per FTE positions at FDA for the first 3 of the preceding 4 FYs,
multiplied by the proportion of PC&B costs to total FDA costs of the
process for the review of human drug applications for the first 3 of
the preceding 4 FYs (see section 736(c)(1)(A) and (B) of the FD&C Act).
    Table 1 summarizes the actual cost and FTE data for the specified
FYs and provides the percent changes from the previous FYs and the
average percent changes over the first 3 of the 4 FYs preceding FY
2021. The 3-year average is 1.2644 percent.

              Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Changes
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              Fiscal year                       2017               2018               2019        3-Year average
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Total PC&B.............................     $2,581,551,000     $2,690,678,000     $2,620,052,000
Total FTE..............................             17,022             17,023             17,144
PC&B per FTE...........................           $151,660           $158,061           $152,826
Percent Change From Previous Year......            2.8845%            4.2206%           -3.3120%         1.2644%
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    The statute specifies that this 1.2644 percent be multiplied by the
proportion of PC&B costs to the total FDA costs of the process for the
review of human drug applications. Table 2 shows the PC&B and the total
obligations for the process for the review of human drug applications
for the first 3 of the preceding 4 FYs.

        Table 2--PC&B as a Percent of Total Cost of the Process for the Review of Human Drug Applications
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              Fiscal year                       2017               2018               2019        3-Year average
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Total PC&B.............................       $711,016,627       $792,900,647       $872,087,636
Total Costs............................     $1,206,657,269     $1,374,508,527     $1,430,338,888
PC&B Percent...........................           58.9245%           57.6861%           60.9707%        59.1938%
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    The payroll adjustment is 1.2644 percent from table 1 multiplied by
59.1938 percent (or 0.7484 percent).
    The statute specifies that the portion of the inflation adjustment
for non-payroll costs is the average annual percent change that
occurred in the Consumer Price Index (CPI) for urban consumers
(Washington-Baltimore, DC-MD-VA-WV; not seasonally adjusted; all items;
annual index) for the first 3 years of the preceding 4 years of
available data multiplied by the proportion of all costs other than
PC&B costs to total costs of the process for the review of human drug
applications for the first 3 years of the preceding 4 FYs (see section
736(c)(1)(B) of the FD&C Act). As a result of a geographical revision
made by the Bureau of Labor and Statistics in January 2018 \1\, the
``Washington-Baltimore, DC-MD-VA-WV'' index was discontinued and
replaced with two separate indices (i.e., ``Washington-Arlington-
Alexandria, DC-VA-MD-WV'' and ``Baltimore-Columbia-Towson, MD''). In
order to continue applying a CPI that best reflects the geographic
region in which FDA is headquartered and that provides the most current
data available, the Washington-Arlington-

Alexandria index will be used in calculating the relevant adjustment
factors for FY 2020 and subsequent years. Table 3 provides the summary
data for the percent changes in the specified CPI for the Washington-
Arlington-Alexandria area. The data are published by the Bureau of
Labor Statistics and can be found on its website at: https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURS35ASA0,CUUSS35ASA0.

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    \1\ For purpose of the capacity planning adjustment, this is
defined as an active commercial IND for which a document has been
received in the past 18 months.

        Table 3--Annual and 3-Year Average Percent Change in CPI for Washington-Arlington-Alexandria Area
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                  Year                          2017               2018               2019        3-year average
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Annual CPI.............................            256.221            261.445            264.777
Annual Percent Change..................            1.1045%            2.0389%            1.2745%         1.4726%
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    The statute specifies that this 1.4726 percent be multiplied by the
proportion of all costs other than PC&B to total costs of the process
for the review of human drug applications obligated. Because 59.1938
percent was obligated for PC&B (as shown in table 2), 40.8062 percent
is the portion of costs other than PC&B (100 percent minus 59.1938
percent equals 40.8062 percent). The non-payroll adjustment is 1.4726
percent times 40.8062 percent, or 0.6009 percent.
    Next, we add the payroll adjustment (0.7484 percent) to the non-
payroll adjustment (0.6009 percent), for a total inflation adjustment
of 1.3493 percent (rounded) for FY 2021.
    We then multiply the base revenue amount for FY 2021
($1,065,707,676) by 1.013493, yielding an inflation-adjusted amount of
$1,080,087,270.

B. FY 2021 Statutory Fee Revenue Adjustments for Capacity Planning

    The statute specifies that after $1,065,707,676 has been adjusted
for inflation, the inflation-adjusted amount shall be further adjusted
to reflect changes in the resource capacity needs for the process of
human drug application reviews (see section 736(c)(2) of the FD&C Act).
The statute directed FDA to utilize an interim capacity planning
adjustment until a new methodology could be developed and made
effective.
    As a first step toward the new methodology, FDA committed to
establish modernized time reporting and a resource capacity planning
capability. Modernized time reporting was implemented in the Center for
Biologics Evaluation and Research (CBER) in 2018 and in the Center for
Drug Evaluation and Research (CDER) in 2019. A resource capacity
planning capability was established in both CDER and CBER in 2020. In
the statute, FDA was directed to commission an independent report
evaluating options and recommendations for a new methodology to
accurately assess changes in the resource and capacity needs of the
process for the review of human drug applications, informed by
personnel time reporting data as an input, and to publish the report
for public comment. The evaluation was conducted by Booz Allen Hamilton
and published on the FDA website in April 2020.\2\ A docket was then
opened to receive public comment.\3\ After having reviewed the
evaluation and the public comment, FDA is establishing and implementing
the new CPA methodology for the setting of FY 2021 fee amounts.
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    \2\ See: https://www.fda.gov/media/136606/download.
    \3\ See: https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2020-N-0989.
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    The new CPA methodology is intended to resolve issues with the
previous interim methodology.\4\ First, the interim methodology was a
lagging indicator as it utilized changes in average workload volumes
during prior years--specifically, the adjustment was based on the
change in the 3-year average ending in the most recent year for which
data is available over the 3-year average for the previous year. The
new methodology replaces the comparison of prior 3-year averages with
predictive models to forecast future workload volumes, where feasible.
Second, the interim CPA methodology did not convert the volume of
workload into resource demands; its adjustments simply reflected
changes in average number of workload units. The new methodology
translates the expected workload volumes into forecasted staffing needs
in terms of FTEs, facilitating a more straightforward calculation of
both future resource and funding needs.
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    \4\ Under the interim methodology, the capacity planning
adjustment for a fiscal year was based on the product of the annual
base revenue for the year, as adjusted for inflation, and an
adjustment percentage. The adjustment percentage was a weighted
change in the 3-year average ending in the most recent year for
which data are available, over the 3-year average in the previous
year, for: (1) The total number of human drug applications, efficacy
supplements, and manufacturing supplements submitted to FDA; (2) the
total number of active commercial investigational new drug
applications; and (3) the total number of formal meetings scheduled
by FDA and written responses issued by the Agency in lieu of such
formal meetings, as set forth in section 1.H. of the PDUFA
commitment letter.
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    The new CPA methodology includes four steps:
    (1) Forecast workload volumes: Predictive models estimate the
volume of workload for the upcoming fiscal year. Workload categories in
the CPA for PDUFA include original new drug applications (NDAs)/
biologics license applications (BLAs), commercial investigational new
drug applications (INDs) with activity, supplements (efficacy, labeling
and manufacturing), and formal industry meetings scheduled (Type A-C
meetings ,\5\ including written-response only (WRO) meetings)
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    \5\ The PDUFA VI commitment letter defines these meeting types
in section 1.H.: https://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm511438.pdf.
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    (2) Forecast the resource needs: Forecast algorithms are generated
utilizing time reporting data. These algorithms estimate the required
demand in FTEs for direct review-related effort. This is then compared
to current available resources for the direct review workload.
    (3) Assess the resource forecast in the context of additional
internal factors: Program leadership examines operational, financial,
and resourcing data to assess whether FDA will be able to utilize
additional funds during the fiscal year, and the funds are required to
support additional review capacity. FTE amounts are adjusted, if
needed.
    (4) Convert the FTE need to dollars: Utilizing the FDA's fully
loaded FTE cost model, the final feasible FTEs are converted to an
equivalent dollar amount.
    Further, FDA is adopting an iterative, continuous improvement
approach as part of its new CPA methodology. For FY 2021, FDA is
applying the new methodology to core review activities, for which
significant data collection and analysis has been completed. Going
forward, the Agency intends to refine its

data and estimates for the core review activities to improve their
accuracy, and also, as feasible, to apply the new methodology to all
major activities that impact the resource needs of the process for the
review of human drug applications under PDUFA, potentially including,
for example, postmarket safety activities and some subsets of policy
and guidance development. This iterative, continuous improvement
approach to the CPA methodology was recommended by the independent
evaluation and in the public comments. FDA believes that its estimates
will be continuously improved over time as more robust data becomes
available to more fully account for total PDUFA program resource needs,
and that this new methodology represents a significant improvement over
the previous CPA methodology.
    To determine the FY 2021 capacity planning adjustment, FDA
calculated a PDUFA CPA for CDER and CBER individually. The final
Center-level results were then combined to determine the total FY 2021
PDUFA CPA. The following section outlines the major components of each
Center's FY 2021 PDUFA CPA.
    Table 4 summarizes the forecasted workload volumes for CDER in FY
2021 based on predictive models, as well as historical actuals from FY
2019 for comparison.

   Table 4--CDER Actual FY 2019 Workload Volumes and Predicted FY 2021
                            Workload Volumes
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                                              FY 2019         FY 2021
            Workload category                 actuals       predictions
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Efficacy Supplements....................             287             322
Labeling Supplements....................           1,320           1,584
Manufacturing Supplements...............           2,024           2,187
NDA/BLA Original........................             156             171
PDUFA Industry Meetings Scheduled and              3,186           3,249
 WROs...................................
Active Commercial INDs \1\..............           8,233           8,565
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\1\ The Bureau of Labor Statistics' announcement of the geographical
  revision can be viewed at https://www.bls.gov/cpi/additional-resources/geographic-revision-2018.htm.

    \1\ For purpose of the capacity planning adjustment, this is
defined as an active commercial IND for which a document has been
received in the past 18 months.
    Utilizing the resource forecast algorithms, the forecasted workload
volumes for FY 2021 were then converted into estimated FTE needs for
CDER's PDUFA direct review-related work. The resulting expected FY 2021
FTE need for CDER was compared to current onboard capacity for direct
review related work to determine the FY 2021 resource delta, as
summarized in table 5.

                                     Table 5--CDER FY21 PDUFA Resource Delta
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                                                                   Current          FY 2021
                            Center                                 resource         resource       Predicted FY
                                                                   capacity         forecast      2021 FTE delta
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CDER.........................................................         1,594.1          1,859.7            265.6
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    The projected 265.6 FTE delta was then assessed by FDA in the
context of additional operational and internal factors to ensure that a
fee adjustment is only made for resources that can be utilized in the
fiscal year and for which funds are required to support additional
review capacity. After accounting for the range of recent years
historical net FTE gains within CDER and subtracting previously funded
PDUFA vacancies, a range of 6 to 59 FTEs was established as a realistic
adjustment for FY 2021. CDER adjusted to the lower portion of this
range until the pace of net gains increases and is sustained. CDER also
recognized that some resources may be required to sustain increases in
PDUFA workload resulting from the impacts of the COVID-19 pandemic. In
summary, after accounting for these internal factors, FDA determined
that an adjustment for $3,922,113 to fund an equivalent of 13 FTEs in
FY 2021 was needed and realistic.

                                         Table 6--CDER FY 2021 PDUFA CPA
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                                                               Additional FTEs   Cost for each   CDER FY21 PDUFA
                            Center                               for FY 2021     additional FTE        CPA
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CDER.........................................................              13         $301,701       $3,922,113
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    To calculate the FY 2021 PDUFA CPA for CBER, FDA followed the same
approach outlined above. Table 7 summarizes the forecasted workload
volumes for CBER in FY 2021 as well as the corresponding historical
actuals from FY 2019 for comparison.

   Table 7--CBER Actual FY 2019 Workload Volumes and Predicted FY 2021
                            Workload Volumes
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                                              FY 2019         FY 2021
            Workload category                 Actuals       predictions
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Efficacy Supplements....................              12              15
Labeling Supplements....................              66              64
Manufacturing Supplements...............             541             576
NDA/BLA Original........................               7               7
PDUFA Industry Meetings Scheduled and                541             738
 WROs...................................
Active Commercial INDs\1\...............           1,361           1,571
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    The forecasted CBER PDUFA workload for FY 2021 was then converted
into expected FTE resources and compared to current onboard capacity
for PDUFA direct review work, as summarized in table 8.

                                   Table 8--CBER FY 2021 PDUFA Resource Delta
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                                                                   Current          FY 2021
                            Center                                 resource         resource       Predicted FY
                                                                   capacity         forecast      2021 FTE delta
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CBER.........................................................           322.7            385.1             62.4
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    The projected 62.4 FTE delta for CBER was also assessed in the
context of other operational and financial factors that may impact the
need and/or feasibility of obtaining the additional resources. After
accounting for historical net FTE gains within CBER and subtracting
previously funded PDUFA vacancies, an adjustment of 29 additional FTEs
within CBER for FY 2021 was determined to be both needed and realistic
to support significant growth in some PDUFA products and PDUFA workload
stemming from the COVID-19 pandemic. The FY 2021 PDUFA CPA for CBER is
therefore $8,641,681, as summarized in table 9.

                                         Table 9--CBER FY 2021 PDUFA CPA
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                                                               Additional FTEs   Cost for each     CBER FY 2021
                            Center                               for FY 2021     additional FTE     PDUFA CPA
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CBER.........................................................              29         $297,989       $8,641,681
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    The CDER and CBER CPA amounts were then added together to determine
the PDUFA CPA for FY 2021 of $12,563,794, as outlined in table 10.

                       Table 10--FY 2021 PDUFA CPA
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                                                           FY 2021 PDUFA
                         Center                                 CPA
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CDER....................................................      $3,922,113
CBER....................................................      $8,641,681
Total...................................................     $12,563,794
------------------------------------------------------------------------

    Table 11 shows the calculation of the inflation and capacity
planning adjusted amount for FY 2021. The FY 2021 base revenue amount,
$1,065,707,676, shown on line 1 is multiplied by the inflation
adjustment factor of 1.013493, resulting in the inflation-adjusted
amount of $1,080,087,270 shown on line 3. The FY 2021 CPA of
$12,563,794 is then added on line 4, resulting in the inflation and
capacity planning adjusted amount of $1,092,651,064 shown on line 5.

 Table 11.--PDUFA Inflation and Capacity Planning Adjusted Amount for FY
                        2021, Summary Calculation
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------------------------------------------------------------------------
FY 2021 Revenue Amount..........     $1,065,707,676  Line 1
Inflation Adjustment Factor for            1.013493  Line 2
 FY 2021 (1 plus 1.3493 percent).
Inflation-Adjusted Amount.......     $1,080,087,270  Line 3
Capacity Planning Adjustment for        $12,563,794  Line 4
 FY 2021.
Inflation and Capacity Planning      $1,092,651,064  Line 5
 Adjusted Amount.
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    Per the commitments made in PDUFA VI, this increase in the revenue
amount will be allocated to and used by organizational review
components engaged in direct review work to enhance resources and
expand staff capacity and capability (see II.A.4 on p. 37 of the PDUFA
VI commitment letter \6\).
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    \6\ The PDUFA VI commitment letter can be viewed at https://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm511438.pdf.
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C. FY 2021 Statutory Fee Revenue Adjustments for Additional Dollar
Amounts

    PDUFA VI provides an additional dollar amount for each of the 5
fiscal years covered by PDUFA VI for additional FTE to support PDUFA VI

enhancements outlined in the PDUFA VI commitment letter. The amount for
FY 2021 is $5,426,896 (see section 736(b)(1)(F) of the FD&C Act).
Adding this amount to the inflation and capacity planning adjusted
revenue amount, $1,092,651,064, equals $1,098,077,960.

D. FY 2021 Statutory Fee Revenue Adjustments for Operating Reserve

    PDUFA VI provides for an operating reserve adjustment to allow FDA
to increase the fee revenue and fees for any given fiscal year during
PDUFA VI to maintain up to 14 weeks of operating reserve of carryover
user fees. If the carryover balance exceeds 14 weeks of operating
reserves, FDA is required to decrease fees to provide for not more than
14 weeks of operating reserves of carryover user fees.
    To determine the 14-week operating reserve amount, the FY 2021
annual base revenue adjusted for inflation, capacity planning, and
additional dollar amounts, $1,098,077,960 is divided by 52, and then
multiplied by 14. The 14-week operating reserve amount for FY 2021 is
$295,636,374.
    To determine the end of year operating reserve amount, the Agency
must assess actual operating reserve at the end of the third quarter of
FY 2020 and forecast collections and obligations in the fourth quarter
of FY 2020. The estimated end of year FY 2020 operating reserve is
$217,070,092.
    Because the estimated end of year FY 2021 PDUFA operating reserve
does not exceed the 14-week operating reserve for FY 2021, FDA will not
reduce the FY 2021 PDUFA fee revenue in FY 2021.

E. FY 2021 Statutory Fee Revenue Adjustments for Additional Direct Cost

    PDUFA VI specifies that $8,730,000, adjusted for inflation, be
added in addition to the operating reserve adjustment to account for
additional direct costs in FY 2021. This additional direct cost
adjustment is adjusted for inflation by multiplying $8,730,000 by the
Consumer Price Index for urban consumers (Washington-Baltimore, DC-MD-
VA-WV; Not Seasonally Adjusted; All Items; Annual Index) for the most
recent year of available data, divided by such index for 2016 (see
section 736(c)(4)(B) of the FD&C Act). Because of the geographical
revision made by the Bureau of Labor and Statistics, the Washington-
Arlington-Alexandria index will be used in calculating the direct cost
adjustment inflation factor for FY 2020 and subsequent years. The
annual index for 2019, 264.777, divided by such index for 2016,
253.422, results in an adjustment factor of 1.044807, making the
additional direct cost adjustment equal to $9,121,165.
    The final FY 2021 PDUFA target revenue is $1,107,199,000 (rounded
to the nearest thousand dollars).

III. Application Fee Calculations

A. Application Fee Revenues and Application Fees

    Application fees will be set to generate 20 percent of the total
target revenue amount, or $221,439,800 in FY 2021.

B. Estimate of the Number of Fee-Paying Applications and Setting the
Application Fees

    FDA will estimate the total number of fee-paying full application
equivalents (FAEs) it expects to receive during the next FY by
averaging the number of fee-paying FAEs received in the 3 most recently
completed FYs. Prior year FAE totals are updated annually to reflect
refunds and waivers processed after the close of the FY.
    In estimating the number of fee-paying FAEs, a full application
requiring clinical data counts as one FAE. An application not requiring
clinical data counts as one-half of an FAE. An application that is
withdrawn before filing, or refused for filing, counts as one-fourth of
an FAE if the applicant initially paid a full application fee, or one-
eighth of an FAE if the applicant initially paid one-half of the full
application fee amount. Prior to PDUFA VI, the FAE amount also included
supplements; supplements have been removed from the FAE calculation as
the supplement fee has been discontinued in PDUFA VI.
    As table 12 shows, the average number of fee-paying FAEs received
annually in the most recent 3-year period is 77 FAEs. FDA will set fees
for FY 2021 based on this estimate as the number of full application
equivalents that will pay fees.

                                            Table 12--Fee-Paying FAEs
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                     FY                             2017             2018             2019        3-year average
----------------------------------------------------------------------------------------------------------------
Fee-Paying FAEs.............................           79.75            68.87            82.38            77.00
----------------------------------------------------------------------------------------------------------------
Note: Prior year FAE totals are updated annually to reflect refunds and waivers processed after the close of the
  FY.

    The FY 2021 application fee is estimated by dividing the average
number of full applications that paid fees over the latest 3 years, 77,
into the fee revenue amount to be derived from application fees in FY
2021, $221,439,800. The result is a fee of $2,875,842 per full
application requiring clinical data, and $1,437,921 per application not
requiring clinical data.

IV. Fee Calculations for Prescription Drug Program Fees

    PDUFA VI assesses prescription drug program fees for certain
prescription drug products; in addition, an applicant will not be
assessed more than five program fees for a fiscal year for prescription
drug products identified in a single approved NDA or BLA (see section
736(a)(2)(C) of the FD&C Act). Applicants are assessed a program fee
for a fiscal year only for user fee eligible prescription drug products
identified in a human drug application approved as of October 1 of such
fiscal year.
    FDA estimates 2,793 program fees will be invoiced in FY 2021 before
factoring in waivers, refunds, and exemptions. FDA approximates that
there will be 124 waivers and refunds granted. In addition, FDA
approximates that another 36.2 program fees will be exempted in FY 2021
based on the orphan drug exemption in section 736(k) of the FD&C Act.
FDA estimates 2,632.8 program fees in FY 2021, after allowing for an
estimated 160.2 waivers and reductions, including the orphan drug
exemptions. The FY 2021 prescription drug program fee rate is
calculated by dividing the adjusted total revenue from program fees
($885,759,200) by the estimated 2,632.8 program fees, for a FY 2021
program fee of $336,432 (rounded to the nearest dollar).

V. Fee Schedule for FY 2021

    The fee rates for FY 2021 are displayed in table 13.

                   Table 13--Fee Schedule for FY 2021
------------------------------------------------------------------------
                                                           Fee rates for
                      Fee Category                            FY 2021
------------------------------------------------------------------------
Application:
Requiring clinical data.................................      $2,875,842
Not requiring clinical data.............................      $1,437,921
Program.................................................        $336,432
------------------------------------------------------------------------

VI. Fee Payment Options and Procedures

A. Application Fees

    The appropriate application fee established in the new fee schedule
must be paid for any application subject to fees under PDUFA that is
submitted on or after October 1, 2020. Payment must be made in U.S.
currency by electronic check, check, bank draft, wire transfer, or U.S.
postal money order payable to the order of the Food and Drug
Administration. The preferred payment method is online using electronic
check (Automated Clearing House (ACH) also known as eCheck) or credit
card (Discover, VISA, MasterCard, American Express).
    FDA has partnered with the U.S. Department of the Treasury to use
Pay.gov, a web-based payment application, for online electronic
payment. The Pay.gov feature is available on the FDA website after
completing the Prescription Drug User Fee Cover Sheet and generating
the user fee ID number. Secure electronic payments can be submitted
using the User Fees Payment Portal at https://userfees.fda.gov/pay
(Note: only full payments are accepted. No partial payments can be made
online). Once an invoice is located, ``Pay Now'' should be selected to
be redirected to Pay.gov. Electronic payment options are based on the
balance due. Payment by credit card is available for balances that are
less than $25,000. If the balance exceeds this amount, only the ACH
option is available. Payments must be made using U.S bank accounts as
well as U.S. credit cards.
    If a check, bank draft, or postal money order is submitted, make it
payable to the order of the Food and Drug Administration and include
the user fee ID number to ensure that the payment is applied to the
correct fee(s). Payments can be mailed to: Food and Drug
Administration, P.O. Box 979107, St. Louis, MO 63197-9000. If a check,
bank draft, or money order is to be sent by a courier that requests a
street address, the courier should deliver your payment to: U.S. Bank,
Attention: Government Lockbox 979107, 1005 Convention Plaza, St. Louis,
MO 63101. (Note: This U.S. Bank address is for courier delivery only.
If you have any questions concerning courier delivery, contact the U.S.
Bank at<PHONE_NUMBER>. This telephone number is only for questions about
courier delivery). Please make sure that the FDA post office box number
(P.O. Box 979107) is written on the check, bank draft, or postal money
order.
    For payments made by wire transfer, include the unique user fee ID
number to ensure that the payment is applied to the correct fee(s).
Without the unique user fee ID number, the payment may not be applied,
which could result in FDA not filing an application and other
penalties. The originating financial institution may charge a wire
transfer fee. Applicable wire transfer fees must be included with
payment to ensure fees are fully paid. Questions about wire transfer
fees should be addressed to the financial institution. The account
information for wire transfers is as follows: U.S. Department of the
Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Acct. No.:
75060099, Routing No.: 021030004, SWIFT: FRNYUS33. If needed, FDA's tax
identification number is 53-0196965.

B. Prescription Drug Program Fees

    FDA will issue invoices and payment instructions for FY 2021
program fees under the new fee schedule in August 2020. Payment will be
due on October 1, 2020. FDA will issue invoices in December 2020 for FY
2021 program fees that qualify for fee assessments after the August
2020 billing.

    Dated: July 29, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.

[FR Doc. 2020-16833 Filed 7-29-20; 4:15 pm]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 164 (Friday, August 25, 2023)]
[Rules and Regulations]
[Pages 58110-58112]
[FR Doc No: 2023-18374]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2023-0707]
RIN 1625-AA00

Safety Zone; Ohio River, Mile Markers 322.5 to 323, Ashland, KY

AGENCY: Coast Guard, Department of Homeland Security (DHS).

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for a
fireworks display occurring on September 12, 2023, on the Ohio River,
Ashland, KY. The safety zone will cover all navigable waters between
mile marker 322.5 and 323 to protect personnel, vessels, and the marine
environment from potential hazards associated with a fireworks event.
Entry of vessels or persons into this zone is prohibited unless
specifically authorized by the Captain of the Port Sector Ohio Valley
(COTP) or a designated representative.

DATES: This rule is effective from 7:30 p.m. through 8:15 p.m. on
September 12, 2023.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2023-0707 in the search box and click ``Search.'' Next, in the Document
Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Petty Officer Chelsea Zimmerman, Marine Safety Unit
Huntington, U.S. Coast Guard, telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

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

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule

without prior notice and opportunity to comment when the agency for
good cause finds that those procedures are ``impracticable,
unnecessary, or contrary to the public interest.'' Under 5 U.S.C.
553(b)(B), the Coast Guard finds that good cause exists for not
publishing a notice of proposed rulemaking (NPRM) with respect to this
rule because publishing an NPRM would be impracticable. A safety zone
is needed to alleviate safety concerns associated with a fireworks
display that is being launched from two barges in the Ohio River. It is
impracticable to publish an NPRM because we must establish this safety
zone by September 12, 2023, and lack sufficient time to provide a
reasonable comment period and then consider those comments before
issuing the rule.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impracticable and contrary to the public interest
because we must establish the safety zone by September 12, 2023, in
order to protect personnel, vessels, and the marine environment from
the potential safety hazards associated with a fireworks display that
is being launched from two barges in the Ohio River.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034. The Captain of the Port Sector Ohio Valley (COTP) has determined
that safety needs associated with a fireworks display on September 12,
2023, present a safety concern. The purpose of this rulemaking is to
ensure the safety of the public surrounding the regulated area before,
during, and after the fireworks event.

IV. Discussion of the Rule

    This rule establishes a safety zone that will be enforced from 7:30
p.m. until 8:15 p.m. on September 12, 2023. The safety zone will cover
all navigable waters between mile markers 322.5 to 323 on the Ohio
River. The duration of the zone is intended to protect personnel,
vessels, and the marine environment in these navigable waters during
the fireworks display. No vessel or person will be permitted to enter
the safety zone without obtaining permission from the COTP or a
designated representative. A designated representative means a Coast
Guard Patrol Commander, including a Coast Guard coxswain, petty
officer, or other officer operating a Coast Guard vessel and a Federal,
State, and local officer designated by or assisting the COTP in the
enforcement of the safety zone.
    Persons or vessels seeking to enter the safety zone must request
permission from the COTP on VHF-FM channel 16 or by telephone at 1-502-
779-5424. If permission is granted, all persons and vessels shall
comply with the instructions of the COTP or designated representative.
    The COTP or a designated representative will inform the public of
the enforcement times and date for this safety zone through Broadcast
Notices to Mariners, Local Notices to Mariners, and/or Safety Marine
Information Broadcasts as appropriate.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action,'' under section 3(f) of Executive Order 12866, as
amended by Executive Order 14094 (Modernizing Regulatory Review).
Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB).
    This regulatory action determination is based on the size,
location, duration, and time-of-day of the regulated area. This rule is
limited to the Ohio River from mile 322.5 to 323 on September 12, 2023,
and will be enforced only for a forty-five-minute duration. Moreover,
the Coast Guard will issue Broadcast Notice to Mariners via VHF-FM
marine channel 16 about the regulated area and the rule allows vessels
to seek permission to enter the area.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the National Government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes,

or on the distribution of power and responsibilities between the
Federal Government and Indian tribes.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves
establishing a temporary safety zone lasting only forty-five minutes on
the Ohio River at mile 322.5 to 323 on September 12, 2023. It is
categorically excluded from further review under paragraph L60(a) of
Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A
Record of Environmental Consideration supporting this determination is
available in the docket. For instructions on locating the docket, see
the ADDRESSES section of this preamble.

G. Protest Activities

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

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  46 U.S.C. 70034, 70051, 70124; 33 CFR 1.05-1, 6.04-
1, 6.04-6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.3.

0
2. Add Sec.  165.T08-0707 to read as follows:

Sec.  165.T08-0707  Safety Zone; Ohio River, Mile Markers 322.5 to 323,
Ashland, KY.

    (a) Location. The following area is a safety zone: all navigable
waters of the Ohio River from mile marker 317 to mile marker 317.5,
extending the entire width of the river.
    (b) Definitions. Designated representative means a Coast Guard
Patrol Commander (PATCOM), including a Coast Guard coxswain, petty
officer, or other officer operating a Coast Guard vessel and a Federal,
State, and local officer designated by or assisting the Captain of the
Port Ohio Valley (COTP) in the enforcement of the regulations in this
section.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative. The Coast Guard may patrol the event
area under the direction of a designated Coast Guard Patrol Commander.
    (2) To seek permission to enter, the COTP or the COTP's
representative may be contacted on Channel 16 VHF-FM (156.8 MHz) by the
call sign ``PATCOM'', or phone at 1-606-923-4884. Those in the safety
zone must comply with all lawful orders or directions given to them by
the COTP or the COTP's designated representative.
    (3) The Patrol Commander may forbid and control the movement of all
vessels in the regulated area. When hailed or signaled by an official
patrol vessel, a vessel shall come to an immediate stop and comply with
the directions given. Failure to do so may result in expulsion from the
area, citation for failure to comply, or both.
    (4) The Patrol Commander may terminate the event or the operation
of any vessel at any time it is deemed necessary for the protection of
life or property.
    (5) The COTP will provide notice of the regulated area through
advanced notice via local notice to mariners and broadcast notice to
mariners and by on-scene designated representatives.
    (d) Enforcement period. This section will be enforced from 7:30
p.m. to 8:15 p.m. on September 12, 2023.

    Dated: August 17, 2023.
H.R. Mattern,
Captain, U.S. Coast Guard, Captain of the Port Sector Ohio Valley.
[FR Doc. 2023-18374 Filed 8-24-23; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 77, Number 50 (Wednesday, March 14, 2012)]
[Proposed Rules]
[Pages 15012-15015]
[FR Doc No: 2012-6056]

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

40 CFR Part 180

[EPA-HQ-OPP-2012-0001; FRL-9335-9]

Receipt of Several Pesticide Petitions Filed for Residues of
Pesticide Chemicals in or on Various Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of filing of petitions and request for comment.

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SUMMARY: This document announces the Agency's receipt of several
initial filings of pesticide petitions requesting the establishment or
modification of regulations for residues of pesticide chemicals in or
on various commodities.

DATES: Comments must be received on or before April 13, 2012.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number and the pesticide petition number (PP) of interest as shown
in the body of this document, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to the docket ID number and the
pesticide petition number of interest as shown in the body of this
document. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line 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 whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or
email. The 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 email
comment directly to EPA without going through regulations.gov, your
email address will be automatically captured and included as part of
the comment that is placed in the 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 docket index
available at http://www.regulations.gov. 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, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: A contact person, with telephone
number and email address, is listed at the end of each pesticide
petition summary. You may also reach each contact person by mail at
Antimicrobials Division (7510P), Biopesticides and Pollution Prevention
Division (7511P), or Registration Division (7505P), Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially

affected entities may include, but are not limited to:
    [emsp14]Crop production (NAICS code 111).
    [emsp14]Animal production (NAICS code 112).
    [emsp14]Food manufacturing (NAICS code 311).
    [emsp14]Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed at the end of the pesticide petition
summary of interest.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low-income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticides
discussed in this document, compared to the general population.

II. What action is the agency taking?

    EPA is announcing its receipt of several pesticide petitions filed
under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA),
21 U.S.C. 346a, requesting the establishment or modification of
regulations in 40 CFR part 174 or part 180 for residues of pesticide
chemicals in or on various food commodities. The Agency is taking
public comment on the requests before responding to the petitioners.
EPA is not proposing any particular action at this time. EPA has
determined that the pesticide petitions described in this document
contain the data or information prescribed in FFDCA section 408(d)(2);
however, EPA has not fully evaluated the sufficiency of the submitted
data at this time or whether the data support granting of the pesticide
petitions. After considering the public comments, EPA intends to
evaluate whether and what action may be warranted. Additional data may
be needed before EPA can make a final determination on these pesticide
petitions.
    Pursuant to 40 CFR 180.7(f), a summary of each of the petitions
that are the subject of this document, prepared by the petitioner, is
included in a docket EPA has created for each rulemaking. The docket
for each of the petitions is available on-line at http://www.regulations.gov.
    As specified in FFDCA section 408(d)(3), (21 U.S.C. 346a(d)(3)),
EPA is publishing notice of the petition so that the public has an
opportunity to comment on this request for the establishment or
modification of regulations for residues of pesticides in or on food
commodities. Further information on the petition may be obtained
through the petition summary referenced in this unit.

New Tolerances

    1. PP 1E7942. (EPA-HQ-OPP-2011-0985). Interregional Research
Project Number 4 (IR-4), IR-4 Project Headquarters, 500 College Road
East, Suite 201 W, Princeton, New Jersey, 08540, requests to establish
tolerances in 40 CFR part 180 for the combined residues of the
insecticide flonicamid [N-(cyanomethyl)-4-(trifluoromethyl)-3-
pyridinecarboxamide] and its metabolites TFNA [4-
trifluoromethylnicotinic acid], TFNA-AM [4-trifluoromethylnicotinamide]
TFNG [N-(4-trifluoromethylnicotinoyl) glycine], in or on berry, low
growing, subgroup 13-07G at 1.4 parts per million (ppm); cucumber at
1.3 ppm; and rapeseed, subgroup 20A at 1.5 ppm. Analytical methodology
has been developed to determine the residues of flonicamid and its
three major plant metabolites, TFNA, TFNG, and TFNA-AM in various
crops. The residue analytical method for the majority of crops includes
an initial extraction with acetonitrile (ACN)/deionized (DI) water,
followed by a liquid-liquid partition with ethyl acetate. The residue
method for wheat straw is similar, except that a C18 solid
phase extraction (SPE) is added prior to the liquid-liquid partition.
The final sample solution is quantitated using a liquid chromatography
(LC) equipped with a reverse phase column and a triple quadruple mass
spectrometer (MS/MS). Contact: Sidney Jackson, Registration Division
(7505P),<PHONE_NUMBER>, email address<EMAIL_ADDRESS>    2. PP 1E7950. (EPA-HQ-OPP-2011-1012). Interregional Research
Project Number 4 (IR-4), IR-4 Project Headquarters, 500 College Road
East, Suite 201 W, Princeton, NJ 08540, requests to establish
tolerances in 40 CFR part 180 for residues of the insecticide
pyriproxyfen, 2-[1-methyl-2-(4-phenoxyphenoxy)ethoxypyridine, in or on
vegetable, bulb, group 3-07 at 0.70 ppm; vegetable, fruiting, group 8-
10 at 0.20 ppm; fruit, citrus, group 10-10 at 0.30 ppm; fruit, pome,
group 11-10 at 0.20 ppm; caneberry subgroup 13-07A at 1.0 ppm;
bushberry subgroup 13-07B at 1.0 ppm; berry, low growing, except
strawberry, subgroup 13-07H at 1.0 ppm; and herb subgroup 19A at 50
ppm. Practical analytical methods for detecting and measuring levels of
pyriproxyfen (and relevant metabolites)

have been developed and validated in/on all appropriate agricultural
commodities, respective processing fractions, milk, animal tissues, and
environmental samples. The extraction methodology has been validated
using aged radiochemical residue samples from metabolism studies. The
methods have been validated in cottonseed, apples, soil, and oranges at
independent laboratories. EPA has successfully validated the analytical
methods for analysis of cottonseed, pome fruit, nutmeats, almond hulls,
and fruiting vegetables. The limit of detection of pyriproxyfen in the
methods is 0.01 ppm which will allow monitoring of food with residues
at the levels proposed for the tolerances. Contact: Andrew Ertman,
Registration Division (7505P),<PHONE_NUMBER>, email address:
<EMAIL_ADDRESS>    3. PP 1E7959. (EPA-HQ-OPP-2012-0009). Interregional Research
Project Number 4 (IR-4), IR-4 Project Headquarters, 500 College Road
East, Suite 201 W, Princeton, NJ 08540, requests to establish a
tolerance in 40 CFR part 180 for residues of the fungicide fluazinam,
in or on fruiting vegetables group, pepper/eggplant subgroup 8-10B at
0.10 ppm and cucurbit vegetables, melon subgroup 9A at 0.08 ppm. This
notice includes information from a separate petition submitted by ISK
Biosciences Corporation, 7470 Auburn Road, Suite A, Concord, OH 44057.
An analytical method using LC/MS/MS for the determination of fluazinam
and AMGT residues on cantaloupe and pepper has been developed and
validated. The method involves solvent extraction followed by liquid-
liquid partitioning and concentration prior to a final purification.
The method has been successfully validated by an independent laboratory
using peanut nutmeat as the matrix. The limit of quantitation (LOQ) of
the method is 0.01 ppm for both fluazinam and AMGT in both crops.
Contact: Andrew Ertman, Registration Division (7505P),<PHONE_NUMBER>,
email address<EMAIL_ADDRESS>    4. PP 1F7934. (EPA-HQ-OPP-2010-0916). Gowan Company, LLC, P.O. Box
556, Yuma, AZ 85366, requests to establish tolerances in 40 CFR part
180 for residues of the insecticide hexythiazox (trans-5-(4-
chlorophenyll)-N-cyclohexyl-4-methyl-2-oxothiazolidine-3-carboxamide),
in or on wheat, forage at 3.0 ppm; wheat, hay at 30 ppm; wheat, grain
at 0.02 ppm; wheat, straw at 7.0 ppm; alfalfa, forage at 7.0 ppm;
alfalfa, hay at 14 ppm; timothy, forage at 35 ppm; and timothy, hay at
17 ppm. A practical analytical method, high pressure liquid
chromatography (HPLC) with an ultraviolet (UV) detector, which detects
and measures residues of hexythiazox and its metabolites as a common
moiety, is available for enforcement purposes with a limit of detection
that allows monitoring of food with residues at or above the levels set
in this tolerance. Contact: Olga Odiott, Registration Division (7505P),
(703) 308-9369, email address<EMAIL_ADDRESS>    5. PP 1F7944. (EPA-HQ-OPP-2011-1002). Nichino America, Inc., 4550
New Linden Hill Road, Suite 501, Wilmington, DE 19808, requests to
establish a tolerance in 40 CFR part 180 for residues of the herbicide
pyraflufen-ethyl, ethyl 2-chloro-5-(4-chloro-5-difluoromethoxy-1-
methyl-1H-pyrazol-3-yl)-4-fluorophenoxyacetate and its acid metabolite,
E-1, 2-chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-pyrazol-3-yl)-
4-fluorophenoxyacetic acid, expressed in terms of the parent, in or on
hop, dried cone at 0.01 ppm; peanut at 0.01 ppm; peanut, hay at 0.07
ppm; peanut, meal at 0.01 ppm; and peanut, refined oil at 0.01 ppm.
Aqueous organic solvent extraction, column clean up, and quantitation
by gas chromatography with mass spectrometry (GC/MS) is used to measure
and evaluate the chemical residues. Contact: Tracy T. White,
Registration Division (7505P),<PHONE_NUMBER>, email address:
<EMAIL_ADDRESS>
Amended Tolerance

    PP 1E7950. (EPA-HQ-OPP-2011-1012). Interregional Research Project
Number 4 (IR-4), IR-4 Project Headquarters, Rutgers, The State
University of New Jersey, 500 College Road East, Suite 201 W,
Princeton, NJ 08540, requests to amend the tolerances in 40 CFR 180.510
by revocation of the existing tolerances for residues of the
insecticide pyriproxyfen, 2-[1-methyl-2-(4-
phenoxyphenoxy)ethoxypyridine, in or on vegetable, bulb, group 3,
except onion, bulb; onion, bulb; vegetable, fruiting, group 8; okra;
fruit, citrus; fruit, pome; caneberry subgroup 13-A; bushberry subgroup
13-B; cranberry; loganberry; Juneberry; lingonberry; and salal, because
tolerances for the revised groupings are being requested under ``New
Tolerances''. Contact: Andrew Ertman, Registration Division (7505P),
(703) 308-9367, email address<EMAIL_ADDRESS>
New Tolerance Exemptions

    1. PP 1E7936. (EPA-HQ-OPP-2011-0951). Ecolab, Inc., EPA Company No.
1677, 370 N. Wabasha Street, St. Paul, MN 55102, requests to establish
an exemption from the requirement of tolerances for residues of the
sodium xylene sulfonate (SXS) (CAS No. 1300-72-7) under 40 CFR
180.940(a) when used as a pesticide inert ingredient in antimicrobial
pesticide formulations applied to food-contact surfaces in public
eating places, dairy-processing equipment, and food-processing
equipment and utensils at 500 ppm. The petitioner believes no
analytical method is needed because it is not required for the
establishment of a tolerance exemption for inert ingredients. Contact:
John Redden, Registration Division (7505P),<PHONE_NUMBER>, email
address<EMAIL_ADDRESS>    2. PP 1F7901. (EPA-HQ-OPP-2011-1018). Wagner Regulatory Associates,
Inc., (on behalf of Bedoukan Research, Inc., 21 Finance Drive, Danbury,
CT 06810), requests to establish an exemption from the requirement of
tolerances for residues of the biochemical pesticide ethyl-2E, 4Z-
decadienoate (Pear Ester) for pre-harvest uses, in or on all
agricultural commodities. Pear Ester is the naturally occurring
compound responsible for the characteristic aroma of pears and other
fruits. Researchers have estimated that mature, ripening fruit releases
up to 3,712 grams of Pear Ester per acre per month. It is estimated
that the potential residue amounts from application of formulated
products would be virtually indistinguishable from natural background
levels. For this reason, and due to its low toxicity, it is proposed to
exempt Pear Ester from the requirement to establish a finite tolerance
for residues on food commodities. Therefore, an analytical method for
determination of residues is not needed. Contact: Gina M. Burnett,
Biopesticides and Pollution Prevention Division (7511P), (703) 605-
0513, email address<EMAIL_ADDRESS>    3. PP 1F7914. (EPA-HQ-OPP-2011-1033). Albemarle Corporation, 451
Florida Street, Baton Rouge, LA 70801, requests to establish an
exemption from the requirement of tolerances for residues of the
antimicrobial 1,3-dibromo-5,5-dimethylhydantoin, in or on all raw
agricultural commodities, when such residues result from the use of
1,3-dibromo-5,5-dimethylhydantoin as an antimicrobial treatment in
solutions containing a diluted end-use concentration of all bromide-
producing chemicals in the solution not to exceed 900 ppm of total
bromine. The petitioner believes no analytical method is needed because
it is not necessary since 1,3-dibromo-5,5-dimethylhydantoin residues
are exempted from the requirements of a tolerance. Contact: Tom
Luminello,

Antimicrobials Division (7510P),<PHONE_NUMBER>, email address:
<EMAIL_ADDRESS>    4. PP 1F7917. (EPA-HQ-OPP-2011-1026). Bert Volger, Ceres
International LLC., 1087 Heartsease Drive, West Chester, PA 19382 (on
behalf of Consumo Em Verde S.A., Biotecnologia De Plantas, Parque
Tecnol[oacute]gico de Cantanhede, N[uacute]cleo 04, Lote 2, 3060-197
Cantanhede, Portugal), requests to establish an exemption from the
requirement of tolerances for residues of the biofungicide BLAD, a
naturally occurring polypeptide from the catabolism of a seed storage
protein of sweet lupines (Lupinus albus), in or on various crops and
ornamentals. The petitioner believes no analytical method is needed
because the requirements of an analytical method are not applicable to
a request to establish an exemption from the requirement of a
tolerance. Contact: Menyon Adams, Biopesticides and Pollution
Prevention Division (7511P),<PHONE_NUMBER>, email address:
<EMAIL_ADDRESS>    5. PP 9F7670. (EPA-HQ-OPP-2010-0065). Technology Sciences Group,
Inc., 1150 18th Street, NW., Suite 1000, Washington, DC 20036, (on
behalf of AMVAC Chemical Corporation, 4695 MacArthur Court, Suite 1250,
Newport Beach, CA 90660), requests to establish an exemption from the
requirement of a tolerance for residues of the biochemical potato
sprout inhibitor, 3-decen-2-one, as a post-harvest treatment, in or on
stored potatoes. An analytical method for residues is not applicable.
It is expected that, when used as proposed, 3-decen-2-one would not
result in residues that are of toxicological concern. The Agency is re-
issuing this notice of filing (NOF) of a pesticide petition for 3-
decen-2-one (PP 9F7670) because the petitioner revised the pending
petition. Instead of proposing an exemption from the requirement of a
tolerance for residues of the potato sprout inhibitor, 3-decen-2-one,
in or on all food commodities, the petitioner is now requesting the
tolerance exemption for use of 3-decen-2-one as a post-harvest
treatment on stored potatoes only. The original NOF published in the
Federal Register for comment on March 10, 2010 (75 FR 11171)(FRL-8810-
8), with a 30 day comment period. One comment was received in response
to this NOF. The Agency will respond to this comment in the final rule
but notes that the comment was not germane to the active ingredient
described herein, and focused on concerns that were not specific to
dietary exposure. Contact: Colin G. Walsh, Biopesticides and Pollution
Prevention Division (7511P),<PHONE_NUMBER>, email address:
<EMAIL_ADDRESS>
Amended Tolerance Exemptions

    1. PP 1E7931. (EPA-HQ-OPP-2011-0949). BASF Corporation, 100 Campus
Drive, Florham Park, NJ 07932, requests to amend an exemption from the
requirement of a tolerance for residues of N,N-Bis-[alpha]-ethyl-
[omega]-hydroxypoly(oxy-1,2-ethanediyl) C8-C18
saturated and unsaturated alkylamines; the poly(oxy-1,2-ethanediyl)
content is 2-60 moles; herein referred to as Alkyl Amines
Polyalkoxylates under 40 CFR 180.920 and 180.930 to include CAS No.
1266162-49-5 when used as a pesticide inert ingredient in pesticide
formulations. An analytical method is not required for enforcement
purposes since the Agency has established an exemption from the
requirement of a tolerance without any numerical limitation. Contact:
Elizabeth Fertich, Registration Division (7505P),<PHONE_NUMBER>, email
address<EMAIL_ADDRESS>    2. PP 1F7914. (EPA-HQ-OPP-2011-1033). Albemarle Corporation, 451
Florida Street, Baton Rouge, LA 70801, requests to amend 40 CFR
180.940(a) by establishing an exemption from the requirement of a
tolerance for the residues of the antimicrobial 1,2-dibromo-5,5-
dimethylhyadantoin (CAS Reg. No. 77-48-5) in antimicrobial
formulations, in or on food contact surface sanitizing solutions. May
be applied to: Food contact surfaces in public eating places, dairy
processing equipment, and food-processing equipment and utensils. When
ready for use, end-use concentration of all bromine-producing chemicals
in solution is not to exceed 500 ppm of total bromine. Analytical
method is not necessary since 1,3-dibromo-5,5-dimethylhydantoin
residues are exempted from the requirements of a tolerance. Contact:
Tom Luminello, Antimicrobials Division (7510P),<PHONE_NUMBER>, email
address<EMAIL_ADDRESS>    3. PP 1F7920. (EPA-HQ-OPP-2011-1029). D-I-1-4, Inc., a Division of
1,4 Group, Inc., P.O. Box 680, Meridian, ID 83680, requests to amend an
exemption from the requirement of a tolerance in 40 CFR 180.1142 for
residues of the plant growth regulator 1,4-Dimethylnaphthalene (1,4-
DMN) when applied post-harvest to potatoes and other sprouting root,
tuber and bulb crops in accordance with good agricultural practices. An
analytical method for residues is not applicable. It is expected that,
when used as proposed, 1,4-Dimethylnaphthalene would not result in
residues that are of toxicological concern. Contact: Colin G. Walsh,
Biopesticides and Pollution Prevention Division (7511P), (703) 308-
0298, email address<EMAIL_ADDRESS>    4. PP 1F7940. (EPA-HQ-OPP-2011-1028). Kaken Pharmaceutical Co.,
Ltd., c/o Conn & Smith, Inc., Agent, 6713 Catskill Road, Lorton, VA
22079, requests to amend an existing exemption from the requirement of
tolerances in 40 CFR 180.1285 for residues of the biochemical pesticide
polyoxin D zinc salt when used as a fungicide for pre-harvest and post-
harvest uses in accordance with good agricultural practices, in or on
all agricultural commodities. A tolerance exemption is proposed.
Therefore, no tolerance enforcement method is proposed. Contact: Colin
G. Walsh, Biopesticides and Pollution Prevention Division (7511P),
(703) 308-0298, email address<EMAIL_ADDRESS>
List of Subjects

    Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.

    Dated: February 28, 2012.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2012-6056 Filed 3-13-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 131 (Friday, July 8, 2011)]
[Notices]
[Pages 40413-40415]
[FR Doc No: 2011-17122]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64793; File No. SR-NYSE-2011-31]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Amending Exchange Rule 1000(a)(iv) To Provide for a Different Liquidity
Replenishment Point Value Range During the First Day of Trading of an
Initial Public Offering on the Exchange

July 1, 2011.
    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 June 28, 2011, New York Stock Exchange LLC (``NYSE'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The
Commission is publishing this notice 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.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange proposes to amend Exchange Rule 1000(a)(iv) to provide
for a different liquidity replenishment point (``LRP'') value range
during the first day of trading of an initial public offering (``IPO'')
on the Exchange. The text of the

proposed rule change is available at the Exchange, the Commission's
Public Reference Room, and http://www.nyse.com.

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

    In its filing with the Commission, the Exchange 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. The Exchange 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
    The Exchange proposes to amend Exchange Rule 1000(a)(iv) to provide
for a different LRP value range during the first day of trading of an
IPO on the Exchange. Specifically, the Exchange proposes to add
proposed Rule 1000(a)(iv)(E) to provide that on the first day of
trading of an IPO, the LRP value shall be the greater of $2.00 or the
LRP value range that would be applicable based on the offering price of
the IPO.
I. Background
    Pursuant to NYSE Rule 1000(a)(iv), LRPs are pre-determined price
points that function to moderate volatility in a particular security,
improve price continuity, and foster market quality by temporarily
converting the electronic market to an auction market and permitting
new trading interest to add liquidity.\3\
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    \3\ See also NYSE Rules 60(e)(i).
---------------------------------------------------------------------------

    Pursuant to Exchange Rule 60, Autoquote is suspended when an LRP is
reached, i.e., when the unfilled balance of an incoming automatically
executing order is able to trade at a price above (below) the LRP, or
if the incoming interest would create a locked or crossed market.
Autoquote resumes after a manual trade or when the lock or cross is
cleared.\4\
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    \4\ See NYSE Rule 60(d)(i)(C).
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    LRPs are calculated by adding and subtracting a value to the
security's last sale price. The LRP values are based on an examination
of trading data and vary based on the security's NYSE average daily
volume (``ADV''), price, and volatility. The values used to calculate
the LRPs' range do not change intraday and are disseminated daily by
the Exchange on its Web site.
II. Modification to LRP Value Ranges
    The Exchange proposes to amend NYSE Rule 1000(a)(iv) to provide for
a different LRP value range during the first day of trading of an IPO
on the Exchange. Specifically, the Exchange proposes to provide that
for the first day of trading of an IPO on the Exchange, the LRP value
will be the greater of $2.00 or the LRP value that would be applicable
based on the offering price.
    The Exchange currently uses the offering price of an IPO, as set by
the investment bank syndicate the night before the first day of
trading, to determine the LRP value range in that security. However,
trading prices on the first day of an IPO can often be volatile, both
compared to the offering price as well as intra-day. As a result, using
the offering price to determine the LRP value range may be inconsistent
with the actual trading prices, resulting in more frequent triggering
of LRPs than is typical on the Exchange, thus unnecessarily limiting
automatic execution of orders on the first day of trading.
    For example, for the May 19, 2011, IPO of LinkedIn Corp. (LNKD),
the offering price was set the night before at $45 per share and based
on that price and pursuant to Rule 1000(a)(iv)(C), the Exchange set the
LRP value for the security at $0.70 for the first day of trading.
Notwithstanding the offering price, the opening price for LNKD at the
Exchange was $83.00 and the stock reached a trading high of $122.70
during the first day of trading, closing at $94.25. LNKD therefore
traded at prices throughout the day that would have otherwise warranted
a higher LRP value and as a result, there was a greater occurrence of
LRPs being reached than would have otherwise occurred on a regular
trading day. The first day of trading in LNKD is illustrative of the
type of volatility and price fluctuations that can occur on the first
day of trading of an IPO.
    The Exchange proposes to widen the LRP values for the first day of
trading of an IPO in order to reflect that the first day of trading of
an IPO generally differs from regular trading days in that there is
often greater volume and volatility, with wider price fluctuations. As
proposed, the LRP value range would be the greater of $2.00 or the LRP
value range that would be applicable based on the IPO's offering price.
For example, if the IPO's offering price were priced above $150, the
LRP value range could be $4.00 rather than $2.00.
    The Exchange believes that widening the LRP value ranges for the
first day of trading of an IPO would allow for more continuous
automatic executions of securities before hitting an LRP. While the
purpose of the LRP is to dampen volatility and to provide market
participants with time to react, the Exchange believes that the
proposed amendment is necessary to lessen artificial limitations on
trading. If an LRP is triggered too frequently, such as when the price
of a security increases during the trading day well beyond the LRP
value that has been assigned to that security for the day, trading in
the security may be overly restrained. As such, the NYSE believes that
allowing for an expanded value range on the first day of trading of an
IPO will better facilitate the natural trading of a particular
security.
2. Statutory Basis
    The basis under the Act for these proposed rule changes are the
requirement under Section 6(b)(5) \5\ that an Exchange have rules that
are designed to promote just and equitable principles of trade, to
remove impediments to and perfect the mechanism of a free and open
market and a national market system and, in general, to protect
investors and the public interest. The proposed rule change also is
designed to support the principles of Section 11A(a)(1) \6\ in that it
seeks to assure economically efficient execution of securities
transactions, make it practicable for brokers to execute investors'
orders in the best market and provide an opportunity for investors'
orders to be executed without the participation of a dealer. The
Exchange's proposal to provide flexibility in setting the LRP range on
the first day of trading for an IPO is intended to provide for faster
executions of securities by limiting the amount of time automatic
executions are suspended when an LRP is triggered.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b)(5).
    \6\ 15 U.S.C. 78k-1(a)(1).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \7\ and Rule 19b 4(f)(6) thereunder.\8\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6)(iii) thereunder.\9\
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    \7\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \8\ 17 CFR 240.19b-4(f)(6).
    \9\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to provide the Commission
with written notice of its intent to file the proposed rule change,
along with a brief description and text of the proposed rule change,
at least five business days prior to the date of filing of the
proposed rule change, or such shorter time as designated by the
Commission. The Exchange has fulfilled this requirement.
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    A proposed rule change filed under Rule 19b-4(f)(6)\10\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\11\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest.
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    \10\ 17 CFR 240.19b-4(f)(6).
    \11\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    The Exchange has requested that the Commission waive the 30-day
operative delay so that the proposal may become operative upon filing.
The Commission hereby grants that request. The proposed wider LRP
values may facilitate trading by limiting the amount of time automatic
executions are suspended when an LRP is triggered. Waiving the 30-day
operative delay will enable this change to be implemented immediately
so that the wider LRP values will be available for the next IPO that
takes place on the Exchange. Therefore, the Commission believes it is
consistent with the protection of investors and the public interest to
waive the 30-day operative delay and designates the proposal as
operative upon filing.\12\
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    \12\ For purposes only of waiving the operative delay for this
proposal, the Commission has considered the proposed rule's impact
on efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change 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-NYSE-2011-31 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSE-2011-31. 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 Web site viewing and
printing in the Commission's Public Reference Room on official business
days between the hours of 10 a.m. and 3 p.m. Copies of such filing also
will be available for inspection and copying at the principal offices
of the Exchange. 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-
NYSE-2011-31, and should be submitted on or before July 29, 2011.
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    \13\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-17122 Filed 7-7-11; 8:45 am]
BILLING CODE 8011-01-P