[Federal Register Volume 85, Number 150 (Tuesday, August 4, 2020)]
[Notices]
[Pages 47220-47225]
[FR Doc No: 2020-16858]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3560]

Biosimilar 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 biosimilar user fees for fiscal year (FY) 2021. The Federal Food,
Drug, and Cosmetic Act (FD&C Act), as amended by the Biosimilar User
Fee Amendments of 2017 (BsUFA II), authorizes FDA to assess and collect
user fees for certain activities in connection with biosimilar
biological product development; review of certain applications for
approval of biosimilar biological products; and each biosimilar
biological product approved in a biosimilar biological product
application. BsUFA II directs FDA to establish, before the beginning of
each fiscal year, the amount of initial and annual biosimilar
biological product development (BPD) fees, the reactivation fee, and
the biosimilar biological product application and program fees for such
year. These fees apply to the period from October 1, 2020, through
September 30, 2021.

FOR FURTHER INFORMATION CONTACT: Andrew Bank, Office of Financial

Management, Food and Drug Administration, 4041 Powder Mill Rd., Rm.
62019A, Beltsville, MD 20705-4304,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Sections 744G, 744H, and 744I of the FD&C Act (21 U.S.C. 379j-51,
379j-52, and 379j-53), as amended by BsUFA II (title IV of the FDA
Reauthorization Act of 2017, Pub. L. 115-52), authorize the collection
of fees for biosimilar biological products. Under section 744H(a)(1)(A)
of the FD&C Act, the initial BPD fee for a product is due when the
sponsor submits an investigational new drug (IND) application that FDA
determines is intended to support a biosimilar biological product
application or within 5 calendar days after FDA grants the first BPD
meeting, whichever occurs first. A sponsor who has paid the initial BPD
fee is considered to be participating in FDA's BPD program for that
product.
    Under section 744H(a)(1)(B) of the FD&C Act, once a sponsor has
paid the initial BPD fee for a product, the annual BPD fee is assessed
beginning with the next fiscal year. The annual BPD fee is assessed for
the product each fiscal year until the sponsor submits a marketing
application for the product that is accepted for filing or the sponsor
discontinues participation in FDA's BPD program for the product.
    Under section 744H(a)(1)(D) of the FD&C Act, if a sponsor has
discontinued participation in FDA's BPD program and wants to re-engage
with FDA on development of the product, the sponsor must pay a
reactivation fee to resume participation in the program. The sponsor
must pay the reactivation fee by the earlier of the following dates: No
later than 5 calendar days after FDA grants the sponsor's request for a
BPD meeting for that product or upon the date of submission by the
sponsor of an IND describing an investigation that FDA determines is
intended to support a biosimilar biological product application for
that product. The sponsor will be assessed an annual BPD fee beginning
with the first fiscal year after payment of the reactivation fee.
    BsUFA II also authorizes fees for certain biosimilar biological
product applications and for each biosimilar biological product
identified in an approved biosimilar biological product application
(section 744H(a)(2) and (3) of the FD&C Act). Under certain conditions,
FDA will grant a small business a waiver from its first biosimilar
biological product application fee (section 744H(d)(1) of the FD&C
Act).
    For FY 2018 through FY 2022, the base revenue amounts for the total
revenues from all BsUFA fees are established by BsUFA II. For FY 2021,
the base revenue amount is the FY 2020 inflation adjusted fee revenue
amount of $41,922,873. The FY 2021 base revenue amount is to be
adjusted for inflation and may be reduced, as appropriate, for long-
term financial planning purposes. Beginning in FY 2021, the inflation-
adjusted base revenue amount is also adjusted to reflect changes in the
resource capacity needs for the process for the review of biosimilar
biological product applications.
    This document provides fee rates for FY 2021 for the initial and
annual BPD fee ($102,494), for the reactivation fee ($204,988), for an
application requiring clinical data ($1,746,745), for an application
not requiring clinical data ($873,373), and for the program fee
($304,162). 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 $41,922,873 prior to
adjustments for inflation, resource capacity, and operating reserves
(see section 744H(c)(1), (c)(2), and (c)(3) of the FD&C Act).

A. FY 2021 Statutory Fee Revenue Adjustments for Inflation

    BsUFA II specifies that the $41,922,873 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 744H(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 full-time equivalent (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 biosimilar biological
product applications for the first 3 of the preceding 4 FYs (see
section 744H(c)(1)(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 PC&B Each Year and Percent Changes
----------------------------------------------------------------------------------------------------------------
               Fiscal year                      2017              2018              2019         3-Year average
----------------------------------------------------------------------------------------------------------------
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%
----------------------------------------------------------------------------------------------------------------

    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 biosimilar biological product applications. Table 2 shows the
PC&B and the total obligations for the process for the review of
biosimilar biological product 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 Biosimilar Biological Product
                                                  Applications
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               Fiscal year                      2017              2018              2019         3-Year average
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Total PC&B..............................       $30,707,050       $35,477,032       $32,946,252  ................
Total Costs.............................       $55,814,043       $62,604,122       $65,210,467  ................

PC&B Percent............................          55.0167%          56.6688%          50.5230%          54.0695%
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    The payroll adjustment is 1.2644 percent from Table 1 multiplied by
54.0695 percent (or 0.6837 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 biosimilar
biological product applications for the first 3 years of the preceding
4 FYs (see section 744H(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 which best
reflects the geographic region in which FDA is headquartered and which
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\ 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.

      Table 3--Annual and Three-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 biosimilar biological product applications obligated.
Since 54.0695 percent was obligated for PC&B (as shown in Table 2),
45.9305 percent is the portion of costs other than PC&B (100 percent
minus 54.0695 percent equals 45.9305 percent). The non-payroll
adjustment is 1.4726 percent times 45.9305 percent, 0.6764 percent.
    Next, we add the payroll adjustment (0.6837 percent) to the non-
payroll adjustment (0.6764 percent), for a total inflation adjustment
of 1.3601 percent (rounded) for FY 2021.
    We then multiply the base revenue amount for FY 2021 ($41,922,873)
by one plus the inflation adjustment (1.013601), yielding an inflation-
adjusted amount of $42,493,000 (rounded to the nearest thousand).

B. FY 2021 Statutory Fee Revenue Adjustments for Capacity Planning

    The statute specifies a process to establish and implement a
capacity planning adjustment (CPA) to adjust the total revenue amount
to reflect changes in the resource capacity needs for the process for
the review of biosimilar biological product applications (see section
744H(c)(2) of the FD&C Act).
    As a first step toward implementing the new methodology, FDA
committed to establish modernized time reporting and a resource
capacity planning capability. Modernized time reporting was implemented
in CBER in 2018 and in 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 methodology to accurately
assess changes in the resource and capacity needs of the process for
the review of biosimilar biological product 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 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 consists of four steps:
    1. Forecast workload volumes: Predictive models estimate the volume
of workload for the upcoming fiscal year. Workload categories for BsUFA
include biosimilar biological product applications, participating BPD
programs, supplements, and formal industry meetings scheduled
(biosimilar initial advisory (BIA) and BPD Type 1-4 meetings,\4\
including BIA and BPD Type 2 written-response only meetings)
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    \4\ The BsUFA II commitment letter defines these meeting types
in section 1.I.: https://www.fda.gov/media/100573/download.
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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 efforts. 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 the 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 CPA methodology. For FY 2021, FDA is applying
the 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 biosimilar biological product
applications under BsUFA, potentially including, for example, post-
market 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 BsUFA program resource needs.
    The following section outlines the major components of the FY 2021
BsUFA CPA. Table 4 summarizes the forecasted workload volumes for BsUFA
in FY 2021 based on predictive models, as well as historical actuals
from FY 2019 for comparison.

   Table 4--BsUFA Actual FY 2019 Workload Volumes & Predicted FY 2021
                            Workload Volumes
------------------------------------------------------------------------
                                              FY 2019         FY 2021
            Workload category                 actuals       predictions
------------------------------------------------------------------------
Efficacy Supplements....................              12               8
Labeling Supplements....................              10               7
Manufacturing Supplements...............              58              90
Biosimilar Biological Product                          6               8
 Applications...........................
BsUFA Industry Meetings (BIA, BPD Type 1-            114             102
 4).....................................
Participating BPD Programs..............              95             119
------------------------------------------------------------------------

    Utilizing the resource forecast algorithms, the forecasted workload
volumes for FY 2021 were then converted into estimated FTE needs for
FDA's BsUFA direct review-related work. The resulting expected FY 2021
FTE need for BsUFA was compared to current onboard capacity for BsUFA
direct review-related work to determine the FY 2021 resource delta, as
summarized in Table 5.

                                      Table 5--FY 2021 BsUFA Resource Delta
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      Current resource capacity            FY 2021  resource forecast           Predicted FY 2021  FTE delta
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                            61.7                                  88.3                                  26.5
----------------------------------------------------------------------------------------------------------------

    The projected 26.5 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 which 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 and one remaining previously funded BsUFA
vacancy, FDA determined that the realistic expected net FTE gains could
be funded through the expected FY 2021 collections amount without a
further adjustment from the CPA. In summary, after accounting for these
internal factors, FDA determined that in FY 2021 the BsUFA fee amounts
did not need adjustment from the CPA to provide funds for the realistic
estimated net FTE gains.

                                           Table 6--FY 2021 BsUFA CPA
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    Additional FTEs for  FY 2021          Cost for each  additional FTE              FY 2021  BsUFA CPA
----------------------------------------------------------------------------------------------------------------
                            26.5                              $301,701                                    $0
----------------------------------------------------------------------------------------------------------------

    Although an adjustment to the fee amounts for resource needs by the
CPA will not be made in FY 2021, FDA will evaluate the need for a fee
adjustment from the CPA in future fiscal years and will make
adjustments as warranted.

C. FY 2021 Statutory Fee Revenue Adjustments for Operating Reserve

    BsUFA II provides for an operating reserve adjustment to allow FDA
to adjust the fee revenue and fees for any given fiscal year during
BsUFA II, after FY 2018, to maintain an appropriate operating reserve
of carryover user fees. Beginning in FY 2019, FDA may reduce the fee
revenue and fees for long-term financial planning purposes. Once the
capacity planning adjustment is effective, FDA also may, if necessary,
increase the fee revenue and fees to maintain not more than 21 weeks of
operating reserve of carryover user fees.
    As described in the BsUFA II commitment letter, Biosimilar
Biological Product Reauthorization Goals and Procedures Fiscal Years
2018 Through 2022,\5\ FDA is committed to reducing the BsUFA carryover
reserve to an

amount no greater than 21 weeks of operating reserve of carryover user
fees by the end of FY 2022. FDA has determined that it shall not apply
an operating reserve adjustment to lower the FY 2021 target revenue
amount as FDA appears on track to reduce the carryover reserve to the
committed level.
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    \5\ See: https://www.fda.gov/media/100573/download.
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III. Fee Amounts for FY 2021

    Under section 744H(b)(3)(A) of the FD&C Act, FDA must determine the
percentage of the total revenue amount for a fiscal year to be derived
from: (1) Initial and annual BPD fees and reactivation fees; (2)
biosimilar biological product application fees; and (3) biosimilar
biological product program fees. In establishing the fee amounts for
the fourth year of BsUFA II, FDA considered how best to balance the fee
allocation to provide stable funding and reasonable fee amounts. In
future years, FDA will consider the most appropriate means of
allocating the fee amounts to collect the adjusted target revenue
amount, subject to the relevant statutory provisions.

A. Application Fees

    In establishing the biosimilar biological product application fee
amount for FY 2021, FDA utilized an average of the 3 most recently
completed fiscal years (i.e., fiscal years 2017-2019) of biosimilar
biological product application submissions. Based on the available
information, FDA estimates it will receive 8 biosimilar biological
product applications requiring clinical data for approval in FY 2021.
    FDA will maintain the biosimilar biological product application fee
for FY 2021 at the same level as FY 2020, which is $1,746,745. This is
estimated to provide a total of $13,973,960 representing 33 percent
(rounded to the nearest whole number) of the FY 2021 target revenue
amount.

B. Biosimilar Biological Product Program Fee

    Under BsUFA II, FDA assesses biosimilar biological product program
fees (``program fees''). An applicant in a biosimilar biological
product application shall not be assessed more than five program fees
for a fiscal year for biosimilar biological products identified in a
single biosimilar biological product application (see FD&C Act section
744H(a)(3)(D)). Applicants are assessed a program fee for a fiscal year
only for biosimilar biological products identified in a biosimilar
biological product application approved as of October 1 of such fiscal
year.
    Based on available information, FDA estimates that 54 program fees
will be invoiced for FY 2021, including currently approved products and
products with the potential to be approved in pending applications with
goal dates in FY 2020. For products invoiced in the FY 2021 regular
billing cycle, FDA anticipates that zero program fees will be refunded.
    FDA will maintain the biosimilar biological product program fee for
FY 2021 at the same level as FY 2020, which is $304,162. This is
estimated to provide a total of $16,424,748, representing 39 percent
(rounded to the nearest whole number) of the FY 2021 target revenue
amount.

C. Initial and Annual BPD Fees, Reactivation Fees

    To estimate the number of BPD fees to be paid in FY 2021, FDA must
consider the number of new BPD programs, the number of current BPD
programs, and the number of BPD programs that will be reactivated.
These estimates provide information that, when aggregated, allows FDA
to set BPD fees (initial BPD fees, annual BPD fees, reactivation fees).
    FDA uses internal data and a survey of BPD sponsors to estimate the
total number of BPD programs for FY 2021. In FY 2021, FDA estimates 32
new BPD programs, no reactivations (a single reactivation is weighted
as two BPD fees), and 86 BPD programs to be invoiced for the annual BPD
fee, for a total equivalent of 118 BPD fees assessed in FY 2021.
    The remainder of the target revenue of $12,094,292, or 28 percent
(rounded to the nearest whole number), is to be collected from the BPD
fees. Dividing this amount by the estimated 118 BPD fees to be paid
equals an initial BPD and annual BPD fee amount of $102,494. The
reactivation fee is set at twice the initial/annual BPD amount at
$204,988. This represents a reduction of the BPD fees from the FY 2020
levels.

IV. Fee Schedule for FY 2021

    The fee rates for FY 2021 are displayed in Table 7.

                    Table 7--Fee Schedule for FY 2021
------------------------------------------------------------------------
                                                          Fee rates  for
                      Fee category                            FY 2021
------------------------------------------------------------------------
Initial BPD.............................................        $102,494
Annual BPD..............................................         102,494
Reactivation............................................         204,988
Applications:
  Requiring clinical data...............................       1,746,745
  Not requiring clinical data...........................         873,373
Program.................................................         304,162
------------------------------------------------------------------------

V. Fee Payment Options and Procedures

A. Initial BPD, Reactivation, and Application Fees

    The fees established in the new fee schedule apply to FY 2021,
i.e., the period from October 1, 2020, through September 30, 2021. The
initial BPD fee for a product is due when the sponsor submits an IND
that FDA determines is intended to support a biosimilar biological
product application for the product or within five calendar days after
FDA grants the first BPD meeting for the product, whichever occurs
first. Sponsors who have discontinued participation in the BPD program
for a product and seek to resume participation in such program must pay
the reactivation fee by the earlier of the following dates: No later
than five calendar days after FDA grants the sponsor's request for a
BPD meeting for that product or upon the date of submission by the
sponsor of an IND describing an investigation that FDA determines is
intended to support a biosimilar biological product application for
that product.
    The application fee for a biosimilar biological product is due upon
submission of the application (see section 744H(a)(2)(C) of the FD&C
Act).
    To make a payment of the initial BPD, reactivation, or application
fee, complete the Biosimilar User Fee Cover Sheet, available on FDA's
website (https://www.fda.gov/bsufa) and generate a user fee
identification (ID) number. Payment must be made in U.S. currency by
electronic check, check, bank draft, U.S. postal money order, or wire
transfer. 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 the user fee ID number is generated.
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

you search for your invoice, click ``Pay Now'' 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 979108, 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 979108, 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 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 979108) and ID number 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.
The originating financial institution may charge a wire transfer fee.
Include applicable wire transfer fees with payment to ensure fees are
fully paid. Questions about wire transfer fees should be addressed to
the financial institution. The following account information should be
used to send payments by wire transfer: U.S. Department of the
Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Acct. No.:
75060099, Routing No.: 021030004, SWIFT: FRNYUS33. FDA's tax
identification number is 53-0196965.

B. Annual BPD and Program Fees

    FDA will issue invoices with payment instructions for FY 2021
annual BPD and program fees under the new fee schedule in August 2020.
Payment will be due on October 1, 2020. If sponsors join the BPD
program after the annual BPD invoices have been issued in August 2020,
FDA will issue invoices in December 2020 to firms subject to fees for
FY 2021 that qualify for the annual BPD fee after the August 2020
billing. FDA will issue invoices in December 2020 for any annual
program fees for FY 2021 that qualify for fee assessments and were not
issued in August 2020.

    Dated: July 29, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-16858 Filed 7-30-20; 4:15 pm]
BILLING CODE 4164-01-P


STANDARD REVIEW EXPOSURE REPORT

This assessment is based on CEB Staff Draft dated 10/2/2012.

	Chemical ID:   P-12-0539                                              Reviewer: Kwon/SS

Results Table: Dose, Concentration, and Days Exceeded Results Summary

Exposure Scenario1

	Water

	Landfill	Stack Air	Fugitive Air

Drinking Water	Fish Ingestion

ADR	LADD	ADR	LADD	7Q104

CC = 1	PDM Days Exceeded	LADD	ADR	LADD	ADR	LADD

Release activity(ies)2; exposure calculation(s)3	mg/kg/day	mg/kg/day mg/kg/day	mg/kg/day	µg/l	# Days	mg/kg/day	mg/kg/day	mg/kg/day	mg/kg/day mg/kg/day

MFG: Max acute eco	---	---	---	---	73.94	---	---	---	---	---	---

PROC: Max acute eco	---	---	---	---	6.70	---	---	---	---	---	---

PROC: PDM	---	---	---	---	1.80	36	---	---	---	---	---

USE1: PDM1	---	---	---	---	9.64	98	---	---	---	---	---

USE1: PDM2	---	---	---	---	9.28	108	---	---	---	---	---

USE2: Max acute eco	---	---	---	---	14.25	---	---	---	---	---	---

USE2: PDM	---	---	---	---	9.35	195	---	---	---	---	---

1 Exposure scenario titles consist of release activity followed by exposure calculation abbreviation.

2 Release activities are from engineering report's Manufacturing (Mfg), Processing (Proc) and Use release activity labels. Multiple release activities are combined in one exposure scenario if their releases occur at same location.

3 Exposure calculations are Acute Dose Rate (ADR), Lifetime Average Daily Dose (LADD), and Probabilistic Dilution Model (PDM).  There may be one, two, or all three exposure calculations per exposure scenario. CC is the aquatic concentration of concern.

4 This column displays concentration values for the 7Q10 streamflow, which is defined as the average daily streamflow of the seven consecutive days of lowest flow within a ten year period.

Remarks:   Run B – using 1% of total releases.

Fate test recommendations?: (default is NA) 1  STANDARD REVIEW EXPOSURE REPORT

Chemical ID: P-12-0539B	       Assessor:

ENVIRONMENTAL RELEASES

 Scenario#:1	       Number of Release Sites: 1.

 Release Activity:	MFG: Max acute eco

 Release Description:	WATER	LANDFILL

Non-sludge/Sludge 	STACK	FUGITIVE

Total Releases:	4.00	N/A	N/A	N/A

	(kg/yr)	(kg/yr)	(kg/yr)	(kg/yr)

Non-sludge/Sludge

Release Days/yr:	1.00	 ADVANCE \D 4.95 0.00/0.00	N/A	N/A

Per Site Release:	4.00	N/A/0.00	N/A	N/A

	(kg/site/day)	(kg/site/day)	(kg/site/day)	(kg/site/day)

Remarks:

STANDARD REVIEW EXPOSURE REPORT

               Chemical ID: P-12-0539B

SIC-CODE BASED  HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 1	Number of Sites: 1	RELEASE ACTIVITY:MFG: Max acute eco

SIC-CODE DESCRIPTION: Organic Chemicals Manufacture

SIC-CODE (S): 2865,2869	EXPOSED POPULATION: Adult

WWT

REMOVAL

(%)

RELEASE

DAYS	PRETREATMENT RELEASE (kg/site/day)	POSTTREATMENT RELEASE (kg/site/day)	DWT

(%)

BCF

(L/kg)

90.00	1.          	4.          	0.40	0.00	0.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

PLANT TYPE	% ILE

STREAM CONC. (μg/l)

Harmonic Mean

30Q5

7Q10

1Q10	Harmonic Mean

30Q5

7Q10

1Q10

ALL	50	2825.61	935.49	634.16	514.20	0.14	0.43	0.63	0.78

ALL	10	50.57	9.38	5.41	4.53	7.91	42.64	73.94	88.30

DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES

Exposure Units	Drinking Water Results	Drinking Water Units

Fish Ingestion Results	Fish Ingestion Units

	50%	10%

50%	10%

	Cancer

LADDpot 	3.02E-09	1.69E-07	mg/kg/day	0.00	0.00	mg/kg/day

LADCpot 	1.55E-07	8.67E-06	mg/L	0.00	0.00	mg/kg

Acute

ADRpot 	3.57E-05	3.56E-03	mg/kg/day	0.00	0.00	mg/kg/day

SIC Code Comments:

  STANDARD REVIEW EXPOSURE REPORT

Chemical ID: P-12-0539B	       Assessor:

ENVIRONMENTAL RELEASES

 Scenario#:2	       Number of Release Sites: 6.

 Release Activity:	PROC: Max acute eco

 Release Description:	WATER	LANDFILL

Non-sludge/Sludge 	STACK	FUGITIVE

Total Releases:	3.12	N/A	N/A	N/A

	(kg/yr)	(kg/yr)	(kg/yr)	(kg/yr)

Non-sludge/Sludge

Release Days/yr:	1.00	 ADVANCE \D 4.95 0.00/0.00	N/A	N/A

Per Site Release:	0.52	N/A/0.00	N/A	N/A

	(kg/site/day)	(kg/site/day)	(kg/site/day)	(kg/site/day)

Remarks:

STANDARD REVIEW EXPOSURE REPORT

               Chemical ID: P-12-0539B

SIC-CODE BASED  HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 2	Number of Sites: 6	RELEASE ACTIVITY:PROC: Max acute eco

SIC-CODE DESCRIPTION: POTW (Indust., includes POTWs which receive ind. disch.)

SIC-CODE (S): Subset of 4952	EXPOSED POPULATION: Adult

WWT

REMOVAL

(%)

RELEASE

DAYS	PRETREATMENT RELEASE (kg/site/day)	POSTTREATMENT RELEASE (kg/site/day)	DWT

(%)

BCF

(L/kg)

90.00	1.          	0.52        	5.20E-02	0.00	0.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

PLANT TYPE	% ILE

STREAM CONC. (μg/l)

Harmonic Mean

30Q5

7Q10

1Q10	Harmonic Mean

30Q5

7Q10

1Q10

ALL	50	288.00	123.84	78.18	66.05	0.18	0.42	0.67	0.79

ALL	10	39.60	13.29	7.76	7.57	1.31	3.91	6.70	6.87

DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES

Exposure Units	Drinking Water Results	Drinking Water Units

Fish Ingestion Results	Fish Ingestion Units

	50%	10%

50%	10%

	Cancer

LADDpot 	3.86E-09	2.81E-08	mg/kg/day	0.00	0.00	mg/kg/day

LADCpot 	1.98E-07	1.44E-06	mg/L	0.00	0.00	mg/kg

Acute

ADRpot 	3.51E-05	3.27E-04	mg/kg/day	0.00	0.00	mg/kg/day

SIC Code Comments:

  STANDARD REVIEW EXPOSURE REPORT

Chemical ID: P-12-0539B	       Assessor:

ENVIRONMENTAL RELEASES

 Scenario#:3	       Number of Release Sites: 6.

 Release Activity:	PROC: PDM

 Release Description:	WATER	LANDFILL

Non-sludge/Sludge 	STACK	FUGITIVE

Total Releases:	100.80	N/A	N/A	N/A

	(kg/yr)	(kg/yr)	(kg/yr)	(kg/yr)

Non-sludge/Sludge

Release Days/yr:	120.00	 ADVANCE \D 4.95 0.00/0.00	N/A	N/A

Per Site Release:	0.14	N/A/0.00	N/A	N/A

	(kg/site/day)	(kg/site/day)	(kg/site/day)	(kg/site/day)

Remarks:

STANDARD REVIEW EXPOSURE REPORT

               Chemical ID: P-12-0539B

SIC-CODE BASED  HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 3	Number of Sites: 6	RELEASE ACTIVITY:PROC: PDM

SIC-CODE DESCRIPTION: POTW (Indust., includes POTWs which receive ind. disch.)

SIC-CODE (S): Subset of 4952	EXPOSED POPULATION: Adult

WWT

REMOVAL

(%)

RELEASE

DAYS	PRETREATMENT RELEASE (kg/site/day)	POSTTREATMENT RELEASE (kg/site/day)	DWT

(%)

BCF

(L/kg)

90.00	120.        	0.14        	1.40E-02	0.00	0.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

PLANT TYPE	% ILE

STREAM CONC. (μg/l)

Harmonic Mean

30Q5

7Q10

1Q10	Harmonic Mean

30Q5

7Q10

1Q10

ALL	50	288.00	123.84	78.18	66.05	4.86E-02	0.11	0.18	0.21

ALL	10	39.60	13.29	7.76	7.57	0.35	1.05	1.80	1.85

DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES

Exposure Units	Drinking Water Results	Drinking Water Units

Fish Ingestion Results	Fish Ingestion Units

	50%	10%

50%	10%

	Cancer

LADDpot 	1.25E-07	9.07E-07	mg/kg/day	0.00	0.00	mg/kg/day

LADCpot 	6.39E-06	4.65E-05	mg/L	0.00	0.00	mg/kg

Acute

ADRpot 	9.45E-06	8.80E-05	mg/kg/day	0.00	0.00	mg/kg/day

SIC Code Comments:

STANDARD REVIEW EXPOSURE REPORT

               Chemical ID:  P-12-0539B

SIC CODE EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 3	RELEASE ACTIVITY: PROC: PDM

SIC CODE DESCRIPTION: POTW (Indust., includes POTWs which receive ind. disch.)

ASSOCIATED SIC CODES: Subset of 4952

SIC CODE RESULTS

COC (μg/L)	Percent of Year COC Exceeded	Number of Days COC Exceeded Release days/year	Loading (kg/site/day)	Waste Water

Treatment (%)	High/Avg

Analysis

1.00	10	36	120.00	0.14	90.00	High

  STANDARD REVIEW EXPOSURE REPORT

Chemical ID: P-12-0539B	       Assessor:

ENVIRONMENTAL RELEASES

 Scenario#:4	       Number of Release Sites: 73.

 Release Activity:	USE1: PDM1

 Release Description:	WATER	LANDFILL

Non-sludge/Sludge 	STACK	FUGITIVE

Total Releases:	4067.09	N/A	N/A	N/A

	(kg/yr)	(kg/yr)	(kg/yr)	(kg/yr)

Non-sludge/Sludge

Release Days/yr:	219.00	 ADVANCE \D 4.95 0.00/0.00	N/A	N/A

Per Site Release:	0.25	N/A/0.00	N/A	N/A

	(kg/site/day)	(kg/site/day)	(kg/site/day)	(kg/site/day)

Remarks:

STANDARD REVIEW EXPOSURE REPORT

               Chemical ID: P-12-0539B

SIC-CODE BASED  HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 4	Number of Sites: 73	RELEASE ACTIVITY:USE1: PDM1

SIC-CODE DESCRIPTION: Metal Finishing

SIC-CODE (S): 34xx - 39xx	EXPOSED POPULATION: Adult

WWT

REMOVAL

(%)

RELEASE

DAYS	PRETREATMENT RELEASE (kg/site/day)	POSTTREATMENT RELEASE (kg/site/day)	DWT

(%)

BCF

(L/kg)

90.00	219.        	0.2544      	2.54E-02	0.00	0.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

PLANT TYPE	% ILE

FACILITY	STREAM FLOW (MLD)	STREAM CONC. (μg/l)

Harmonic Mean

30Q5

7Q10

1Q10	Harmonic Mean

30Q5

7Q10

1Q10

ALL	50	300.46	107.45	67.50	55.59	8.47E-02	0.24	0.38	0.46

ALL	10	23.74	4.69	2.64	2.27	1.07	5.42	9.64	11.21

DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES

Exposure Units	Drinking Water Results	Drinking Water Units

Fish Ingestion Results	Fish Ingestion Units

	50%	10%

50%	10%

	Cancer

LADDpot 	3.96E-07	5.01E-06	mg/kg/day	0.00	0.00	mg/kg/day

LADCpot 	2.03E-05	2.57E-04	mg/L	0.00	0.00	mg/kg

Acute

ADRpot 	1.98E-05	4.53E-04	mg/kg/day	0.00	0.00	mg/kg/day

SIC Code Comments:

STANDARD REVIEW EXPOSURE REPORT

               Chemical ID:  P-12-0539B

SIC CODE EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 4	RELEASE ACTIVITY: USE1: PDM1

SIC CODE DESCRIPTION: Metal Finishing

ASSOCIATED SIC CODES: 34xx - 39xx

SIC CODE RESULTS

COC (μg/L)	Percent of Year COC Exceeded	Number of Days COC Exceeded Release days/year	Loading (kg/site/day)	Waste Water

Treatment (%)	High/Avg

Analysis

1.00	27	98	219.00	0.25	90.00	High

  STANDARD REVIEW EXPOSURE REPORT

Chemical ID: P-12-0539B	       Assessor:

ENVIRONMENTAL RELEASES

 Scenario#:5	       Number of Release Sites: 73.

 Release Activity:	USE1: PDM2

 Release Description:	WATER	LANDFILL

Non-sludge/Sludge 	STACK	FUGITIVE

Total Releases:	4417.60	N/A	N/A	N/A

	(kg/yr)	(kg/yr)	(kg/yr)	(kg/yr)

Non-sludge/Sludge

Release Days/yr:	247.00	 ADVANCE \D 4.95 0.00/0.00	N/A	N/A

Per Site Release:	0.24	N/A/0.00	N/A	N/A

	(kg/site/day)	(kg/site/day)	(kg/site/day)	(kg/site/day)

Remarks:

STANDARD REVIEW EXPOSURE REPORT

               Chemical ID: P-12-0539B

SIC-CODE BASED  HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 5	Number of Sites: 73	RELEASE ACTIVITY:USE1: PDM2

SIC-CODE DESCRIPTION: Metal Finishing

SIC-CODE (S): 34xx - 39xx	EXPOSED POPULATION: Adult

WWT

REMOVAL

(%)

RELEASE

DAYS	PRETREATMENT RELEASE (kg/site/day)	POSTTREATMENT RELEASE (kg/site/day)	DWT

(%)

BCF

(L/kg)

90.00	247.        	0.245       	2.45E-02	0.00	0.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

PLANT TYPE	% ILE

FACILITY	STREAM FLOW (MLD)	STREAM CONC. (μg/l)

Harmonic Mean

30Q5

7Q10

1Q10	Harmonic Mean

30Q5

7Q10

1Q10

ALL	50	300.46	107.45	67.50	55.59	8.15E-02	0.23	0.36	0.44

ALL	10	23.74	4.69	2.64	2.27	1.03	5.22	9.28	10.79

DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES

Exposure Units	Drinking Water Results	Drinking Water Units

Fish Ingestion Results	Fish Ingestion Units

	50%	10%

50%	10%

	Cancer

LADDpot 	4.30E-07	5.45E-06	mg/kg/day	0.00	0.00	mg/kg/day

LADCpot 	2.21E-05	2.79E-04	mg/L	0.00	0.00	mg/kg

Acute

ADRpot 	1.91E-05	4.37E-04	mg/kg/day	0.00	0.00	mg/kg/day

SIC Code Comments:

STANDARD REVIEW EXPOSURE REPORT

               Chemical ID:  P-12-0539B

SIC CODE EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 5	RELEASE ACTIVITY: USE1: PDM2

SIC CODE DESCRIPTION: Metal Finishing

ASSOCIATED SIC CODES: 34xx - 39硸܇䥓⁃佃䕄删卅䱕協܇

COC (μg/L)	Percent of Year COC Exceeded	Number of Days COC Exceeded Release days/year	Loading (kg/site/day)	Waste Water

Treatment (%)	High/Avg

Analysis

1.00	30	108	247.00	0.24	90.00	High

  STANDARD REVIEW EXPOSURE REPORT

Chemical ID: P-12-0539B	       Assessor:

ENVIRONMENTAL RELEASES

 Scenario#:6	       Number of Release Sites: 5.

 Release Activity:	USE2: Max acute eco

 Release Description:	WATER	LANDFILL

Non-sludge/Sludge 	STACK	FUGITIVE

Total Releases:	5.53	N/A	N/A	N/A

	(kg/yr)	(kg/yr)	(kg/yr)	(kg/yr)

Non-sludge/Sludge

Release Days/yr:	1.00	 ADVANCE \D 4.95 0.00/0.00	N/A	N/A

Per Site Release:	1.11	N/A/0.00	N/A	N/A

	(kg/site/day)	(kg/site/day)	(kg/site/day)	(kg/site/day)

Remarks:

STANDARD REVIEW EXPOSURE REPORT

               Chemical ID: P-12-0539B

SIC-CODE BASED  HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 6	Number of Sites: 5	RELEASE ACTIVITY:USE2: Max acute eco

SIC-CODE DESCRIPTION: POTW (Indust., includes POTWs which receive ind. disch.)

SIC-CODE (S): Subset of 4952	EXPOSED POPULATION: Adult

WWT

REMOVAL

(%)

RELEASE

DAYS	PRETREATMENT RELEASE (kg/site/day)	POSTTREATMENT RELEASE (kg/site/day)	DWT

(%)

BCF

(L/kg)

90.00	1.          	1.1         	0.11	0.00	0.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

PLANT TYPE	% ILE

FACILITY	STREAM FLOW (MLD)	STREAM CONC. (μg/l)

Harmonic Mean

30Q5

7Q10

1Q10	Harmonic Mean

30Q5

7Q10

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DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES

Exposure Units	Drinking Water Results	Drinking Water Units

Fish Ingestion Results	Fish Ingestion Units

	50%	10%

50%	10%

	Cancer

LADDpot 	8.20E-09	5.97E-08	mg/kg/day	0.00	0.00	mg/kg/day

LADCpot 	4.21E-07	3.06E-06	mg/L	0.00	0.00	mg/kg

Acute

ADRpot 	7.46E-05	6.95E-04	mg/kg/day	0.00	0.00	mg/kg/day

SIC Code Comments:

  STANDARD REVIEW EXPOSURE REPORT

Chemical ID: P-12-0539B	       Assessor:

ENVIRONMENTAL RELEASES

 Scenario#:7	       Number of Release Sites: 5.

 Release Activity:	USE2: PDM

 Release Description:	WATER	LANDFILL

Non-sludge/Sludge 	STACK	FUGITIVE

Total Releases:	907.00	N/A	N/A	N/A

	(kg/yr)	(kg/yr)	(kg/yr)	(kg/yr)

Non-sludge/Sludge

Release Days/yr:	250.00	 ADVANCE \D 4.95 0.00/0.00	N/A	N/A

Per Site Release:	0.73	N/A/0.00	N/A	N/A

	(kg/site/day)	(kg/site/day)	(kg/site/day)	(kg/site/day)

Remarks:

STANDARD REVIEW EXPOSURE REPORT

               Chemical ID: P-12-0539B

SIC-CODE BASED  HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 7	Number of Sites: 5	RELEASE ACTIVITY:USE2: PDM

SIC-CODE DESCRIPTION: POTW (Indust., includes POTWs which receive ind. disch.)

SIC-CODE (S): Subset of 4952	EXPOSED POPULATION: Adult

WWT

REMOVAL

(%)

RELEASE

DAYS	PRETREATMENT RELEASE (kg/site/day)	POSTTREATMENT RELEASE (kg/site/day)	DWT

(%)

BCF

(L/kg)

90.00	250.        	0.7256      	7.26E-02	0.00	0.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

PLANT TYPE	% ILE

FACILITY	STREAM FLOW (MLD)	STREAM CONC. (μg/l)

Harmonic Mean

30Q5

7Q10

1Q10	Harmonic Mean

30Q5

7Q10

1Q10

ALL	50	288.00	123.84	78.18	66.05	0.25	0.59	0.93	1.10

ALL	10	39.60	13.29	7.76	7.57	1.83	5.46	9.35	9.59

DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES

Exposure Units	Drinking Water Results	Drinking Water Units

Fish Ingestion Results	Fish Ingestion Units

	50%	10%

50%	10%

	Cancer

LADDpot 	1.35E-06	9.79E-06	mg/kg/day	0.00	0.00	mg/kg/day

LADCpot 	6.90E-05	5.02E-04	mg/L	0.00	0.00	mg/kg

Acute

ADRpot 	4.90E-05	4.56E-04	mg/kg/day	0.00	0.00	mg/kg/day

SIC Code Comments:

STANDARD REVIEW EXPOSURE REPORT

               Chemical ID:  P-12-0539B

SIC CODE EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 7	RELEASE ACTIVITY: USE2: PDM

SIC CODE DESCRIPTION: POTW (Indust., includes POTWs which receive ind. disch.)

ASSOCIATED SIC CODES: Subset of 4952

SIC CODE RESULTS

COC (μg/L)	Percent of Year COC Exceeded	Number of Days COC Exceeded Release days/year	Loading (kg/site/day)	Waste Water

Treatment (%)	High/Avg

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1/9/13		page          of


[Federal Register: May 31, 2007 (Volume 72, Number 104)]
[Notices]
[Page 30409-30410]
[DOCID:fr31my07-109]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55807; File No. SR-NSX-2007-06]

Self-Regulatory Organizations; National Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Modify the Liquidity Provider Rebate Program for Transactions Executed
Through NSX BLADE in Which the Order Delivery Mode of Interaction Has
Been Selected

May 23, 2007.
    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 14, 2007, the National Stock Exchange, Inc. (``NSX'' or
``Exchange'') 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 substantially prepared by the
Exchange. NSX has filed the proposal pursuant to Section 19(b)(3)(A) of
the Act \3\ and Rule 19b-4(f)(2) thereunder,\4\ which renders the
proposal effective upon filing with the Commission. The Commission is
publishing this notice to solicit comments on the proposed rule change
from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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

    The Exchange is proposing a change to its liquidity provider rebate
program for transactions that are executed through NSX BLADE, the
Exchange's new trading platform. The Exchange wishes to modify its
liquidity provider rebate program for only those orders in which the
User effecting such order has chosen the order delivery mode of order
interaction as set forth in NSX Rule 11.13(b)(2) (``Order Delivery'').
The text of the proposed rule change is available at NSX, the
Commission's Public Reference Room, and http://www.nsx.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, NSX 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. NSX 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 has created a new state of the art trading platform,
known as NSX BLADE, which utilizes a strict price/time priority system.
Pursuant to Exchange Rule 16.1(a), the Exchange maintains a Fee
Schedule that contains its current fees, dues, and other charges
applicable to transactions in NSX BLADE (``NSX BLADE Fee Schedule'').
    Currently, the NSX BLADE Fee Schedule provides for an execution fee
of $0.0030 per share for removing liquidity from NSX BLADE (in other
words, a charge for taking liquidity against an order in NSX BLADE),
and a rebate of $0.0030 per share executed for adding liquidity into
NSX BLADE (in other words, a rebate for the addition of liquidity to
NSX BLADE, provided that it results in an execution through NSX BLADE)
regardless of the mode of order interaction chosen by an ETP Holder.
Thus, ETP Holders taking liquidity against an order in NSX BLADE are
currently charged a fee of $0.0030 per share executed, and ETP Holders
providing liquidity into NSX BLADE are currently paid a rebate of
$0.0030 per share executed. Similarly, orders executed at less than
$1.00 per share will result in either a rebate or an execution fee for
a dollar amount equal to 0.3% of the price per share, multiplied by the
number of shares executed.
    NSX Rule 11.13(b) establishes two separate modes of order
interaction from which ETP Holders may choose: Automatic Execution and
Order Delivery. The Exchange is proposing that the NSX BLADE Fee
Schedule be modified so that ETP Holders who have selected the
Automatic Execution mode of order interaction pursuant to NSX Rule
11.13(b)(1) be granted rebates at a different rate than ETP Holders who
have selected the Order Delivery mode of order interaction.
Specifically, the Exchange is proposing that the rebate for adding
liquidity for ETP Holders who have selected Order Delivery be reduced
to $0.0028 for orders executed at $1.00 or more per share. The rebate
for adding liquidity for ETP Holders who have selected Order Delivery
for orders executed at less than $1.00 per share will be reduced to
0.28% of the price per share, multiplied by the number of shares
executed. The Exchange believes this change in its liquidity provider
rebate is appropriate because the Order Delivery mode of order
interaction involves greater cost and regulatory burden for the
Exchange. All other liquidity taker fees and liquidity provider rebates
will remain unchanged.
    Pursuant to NSX Rule 16.1(c), the Exchange will ``provide ETP
Holders with notice of all relevant dues, fees, assessments and charges
of the Exchange.'' Accordingly, ETP Holders will, simultaneously with
this filing, be notified through the issuance of a Regulatory Circular
of the changes to the NSX BLADE Fee Schedule.
    The Exchange liquidity taker fees and liquidity provider rebates
have been designed in this manner in order to ensure that the Exchange
can continue to fulfill its obligations under the Act.
2. Statutory Basis
    NSX believes that the proposed rule change is consistent with the
provisions of Section 6 of the Act,\5\ in general, and with Sections
6(b)(4) of the Act,\6\ in particular, in that the proposal provides for
the equitable allocation of reasonable dues, fees, and other charges.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f.
    \6\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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

    The Exchange 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.

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

    The Exchange has neither solicited nor received written comments on
the proposed rule change.

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 \7\ and subparagraph (f)(2) of Rule 19b-4
thereunder \8\ because it establishes or changes a due, fee, or other
charge applicable only to a member imposed by the self-regulatory
organization. Accordingly, the proposal is effective upon Commission
receipt of the filing. At any time within 60 days of the filing of the
proposed rule change, the Commission may summarily abrogate 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.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \8\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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-NSX-2007-06 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-NSX-2007-06. 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 Room. Copies of the filing
also will be available for inspection and copying at the principal
office of NSX. 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-NSX-
2007-06 and should be submitted on or before June 21, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-10377 Filed 5-30-07; 8:45 am]

BILLING CODE 8010-01-P


November 5, 2007

Karl Simon

Acting Division Director

Compliance and Innovative Strategies Division

1200 Pennsylvania Avenue, N. W.

Mail Code: 6406J

Washington, DC 20460

RE:	CAA Section 211(b) Fuels and Fuel Additives Health Effects Testing
Regulation:  Second Draft Final Report Gasoline Ethanol Vapor Condensate
- A One-Generation Whole-Body Inhalation Reproduction Toxicity Study in
Rats (Study No. 00-4203)

Dear Mr. Karl Simon:

The American Petroleum Institute (API), on behalf of the Section 211(b)
Research Group (RG), is submitting the following information for EPA
review and approval as partial fulfillment of the CAA Section 211(b)
Alternative Tier 2 requirements of the testing regulation:

Second Draft Final Report: Gasoline Ethanol Vapor Condensate - A
One-Generation Whole-Body Inhalation Reproduction Toxicity Study in Rats
(Study No. 00-4203)

Reviewer Checklist

List of Final Revisions

The Second Draft Final Report addresses all EPA and independent reviewer
comments as indicated, with page citation, in the Reviewer Checklist.
Additionally, during the RG review of the second draft report, a few
minor items needing correction were noted as described in the List of
Final Revisions. These final revisions to be made to the report do not
affect the conclusions from the study.

The RG requests EPA approval of the report pending appropriate report
revision as specified in the List of Final Revisions.  The List of Final
Revisions will be sent to the laboratory after receipt of EPA’s
approval.

When the RG receives EPA’s approval of the second draft report, the
final study report will be submitted to you at the EPA Office of
Transportation and Air Quality, Transportation and Regional Programs
Division, as part of the requirements of Clean Air Act Section 211(b)(2)
and 211(e) (Docket No. A-90-07). If you require further information,
please contact Tom Gray by mail at this address.

Regards,

Thomas M. Gray

Encl (3):	Second draft final report: Gasoline Ethanol Vapor Condensate -
A One-Generation Whole-Body	Inhalation Reproduction Toxicity Study in
Rats (Study No. 00-4203)

	Reviewer Checklist

	List of Final Revisions

Cc:	Gary Hoffman, HLS Study Director (via email)

	211b RG Oversight and Technical Committees

	Joe Sopata, EPA (via email)

	Monica Alvarez, EPA (via email)

	Amanda Evans, EPA (via email)

	Dave Kortum, EPA (via email)

  FILENAME  \* MERGEFORMAT  2007_march20_ETHANOL_1gen_ cvrletter 		An
equal opportunity employer

Thomas M. Gray

211(b) Technical Manager

1220 L Street, Northwest

Washington, DC  20005-4070

Tel<PHONE_NUMBER>

Fax<PHONE_NUMBER>

E-mail<EMAIL_ADDRESS>


[Federal Register Volume 82, Number 54 (Wednesday, March 22, 2017)]
[Notices]
[Pages 14778-14779]
[FR Doc No: 2017-05609]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-80265; File No. SR-NYSEArca-2017-05]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of
Designation of a Longer Period for Commission Action on a Proposed Rule
Change Relating to the Listing and Trading of Shares of the Direxion
Daily Crude Oil Bull 3x Shares and Direxion Daily Crude Oil Bear 3x
Shares Under NYSE Arca Equities Rule 8.200

March 16, 2017.
    On January 23, 2017, NYSE Arca, Inc. (``Exchange'') filed with the
Securities and Exchange Commission (``Commission''), pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4 thereunder,\2\ a proposed rule change to list and trade
shares of the Direxion Daily Crude Oil Bull 3x Shares and Direxion
Daily Crude Oil Bear 3x Shares under NYSE Arca Equities Rule 8.200. The
proposed rule change was published for comment in the Federal Register
on February 7, 2017.\3\ The Commission received no comments on the
proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 79916 (February 1,
2017), 82 FR 9608.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \4\ provides that, within 45 days of
the publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
Commission is extending this 45-day time period.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission finds it appropriate to designate a longer period
within which to take action on the proposed rule change so that it has
sufficient time to consider the proposed rule change. Accordingly, the
Commission, pursuant to Section 19(b)(2) of the Act,\5\ designates May
8, 2017 as the date by which the Commission should either approve or
disapprove, or institute proceedings to determine whether to
disapprove, the proposed rule change (File No. SR-NYSEArca-2017-05).
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(2).

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

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
---------------------------------------------------------------------------

    \6\ 17 CFR 200.30-3(a)(31).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-05609 Filed 3-21-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 5 (Friday, January 7, 2022)]
[Notices]
[Pages 1001-1003]
[FR Doc No: 2022-00063]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2022-0002]

Agency Information Collection Activities; Emergency Approval of a
New Information Collection Request: Apprenticeship Pilot Program

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), Department
of Transportation (DOT).

ACTION: Notice of request for emergency OMB approval.

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

SUMMARY: In compliance with the Paperwork Reduction Act (PRA) of 1995,
this notice announces that the new Information Collection Request (ICR)
discussed below has been forwarded to the Office of Management and
Budget (OMB) for review and emergency approval. FMCSA requests that OMB
approve this collection by January 13, 2021.

DATES: Comments must be submitted on or before January 12, 2022.

ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within by January 12, 2022 to
www.reginfo.gov/public/do/PRAMain. All comments received are part of
the public record. Comments will generally

be posted without change. Upon receiving the requested emergency
approval by OMB, FMCSA will follow the normal PRA procedures to renew
the information collection at its expiration date.

FOR FURTHER INFORMATION CONTACT: Nicole Michel, Mathematical
Statistician, Research Division, Department of Transportation, FMCSA,
West Building, 6th Floor, 1200 New Jersey Avenue SE, Washington, DC
20590-0001;<PHONE_NUMBER>; [email protected].

SUPPLEMENTARY INFORMATION:
    Title: Apprenticeship Pilot Program.
    OMB Control Number: N/A; this is a new ICR.
    Type of Request: Request for emergency approval of a new
information collection.
    Respondents: Motor carriers; drivers.
    Estimated Total Respondents: 44,945 total (4,500 motor carriers and
40,445 commercial motor vehicle (CMV) drivers); 16,482 annually (3,000
carriers and 13,482 CMV drivers).
    Estimated Total Responses: Applications: 44,945 total, or 14,982
annually; Data collection for participating carriers: 486,000 total, or
162,000 annually.
    Estimated Burden Hours: 571,047 total, or 190,349 annually (Motor
carriers: 557,250 hours total, or 185,750 hours annually; Drivers:
13,797 hours total, or 4,599 hours annually).
    Estimated Burden per Response: 20 minutes per response for carrier,
apprentice, and experienced driver application forms; 15 minutes per
response for safety benchmark certifications; 60 minutes per month per
driver for monthly driving and safety data; 90 minutes per month for
miscellaneous data submission.
    Frequency: Once for carrier, apprentice, and experienced driver
application forms; twice for safety benchmark certifications; monthly
per number of participating drivers for driving and safety data; and
monthly for miscellaneous monthly data.
    Background: Current regulations on driver qualifications (49 CFR
part 391.11(b)(1)) state that a driver must be 21 years of age or older
to operate a CMV in interstate commerce. Currently, drivers under the
age of 21 may operate CMVs only in intrastate commerce subject to State
laws and regulations.
    Section 23022 of the Infrastructure Investment and Jobs Act (IIJA),
requires the Secretary of Transportation to conduct a commercial driver
Apprenticeship Pilot Program. An ``apprentice'' is defined as a person
under the age of 21 who holds a commercial driver's license (CDL).
Under this program, these apprentices will complete two probationary
periods, during which they may operate in interstate commerce only
under the supervision of an experienced driver in the passenger seat.
An experienced driver is defined in Section 23022 as a driver who is
not younger than 26 years old, who has held a CDL and been employed for
at least the past 2 years, and who has at least 5 years of interstate
CMV experience and meets the other safety criteria defined in the IIJA.
    The first probationary period must include at least 120-hours of on
duty time, of which at least 80 hours are driving time in a CMV. To
complete this probationary period, the employer must determine
competency in:

    1. Interstate, city traffic, rural 2-lane, and evening driving;
    2. Safety awareness;
    3. Speed and space management;
    4. Lane control;
    5. Mirror scanning;
    6. Right and left turns; and
    7. Logging and complying with rules relating to hours of
service.

    The second probationary period must include at least 280 hours of
on-duty time, including not less than 160 hours driving time in a CMV.
To complete this probationary period, the employer must determine
competency in:

    1. Backing and maneuvering in close quarters;
    2. Pre-trip inspections;
    3. Fueling procedures;
    4. Weighing loads, weight distribution, and sliding tandems;
    5. Coupling and uncoupling procedures; and
    6. Trip planning, truck routes, map reading, navigation, and
permits.

    After completion of the second probationary period the apprentice
may begin operating CMVs in interstate commerce unaccompanied by an
experienced driver.
    In addition to data regarding successful completion of the
probationary periods, the IIJA requires data collection for data
relating to any incident in which a participating apprentice is
involved as well as other data relating to the safety of apprentices.
Additional data will include crash data (incident reports, police
reports, insurance reports), inspection data, citation data, safety
event data (as recorded by all safety systems installed on vehicles, to
include advanced driver assistance systems, automatic emergency braking
systems, onboard monitoring systems, and forward-facing and in-cab
video systems) as well as exposure data (record of duty status logs,
on-duty time, driving time, and time spent away from home terminal).
This data will be submitted monthly through participating motor
carriers.
    The data collected will be used to report on the following items,
as required by section 23022:

    1. The findings and conclusions on the ability of technologies
or training provided to apprentices as part of the pilot program to
successfully improve safety;
    2. An analysis of the safety record of participating apprentices
as compared to other CMV drivers;
    3. The number of drivers that discontinued participation in the
apprenticeship program before completion;
    4. A comparison of the safety records of participating drivers
before, during, and after each probationary period; and
    5. A comparison of each participating driver's average on-duty
time, driving time, and time spent away from home terminal before,
during, and after each probationary period.

    FMCSA will monitor the monthly data being reported by the motor
carriers and will identify drivers or carriers that may pose a risk to
public safety. While removing unsafe drivers or carriers may bias the
dataset, it is a necessary feature for FMCSA to comply with 49 CFR
381.505, which requires development of a monitoring plan to ensure
adequate safeguards to protect the health and safety of pilot program
participants and the general public. Knowing that a driver or carrier
was removed from the pilot program for safety reasons will help FMCSA
minimize bias in the final data analysis.
    FMCSA and the Department of Labor's Employment and Training Agency
(DOL/ETA) will be partnering in the implementation of the Safe Driver
Apprenticeship Pilot Program. All motor carriers who are approved for
the program by FMCSA will also be required to become Registered
Apprenticeships (RAs) under 29 CFR part 29 before they can submit
information on their experienced drivers and apprentices. The
information collection burden for the DOL/ETA RA Program can be found
in approved ICR 1205-0223.
    The statutory mandate for this pilot program is contained in
Section 23022 of the Infrastructure Investment and Jobs Act. FMCSA's
regulatory authority for initiation of a pilot program is 49 CFR
381.400. The Apprentice Pilot Program supports the USDOT strategic goal
of economic strength while maintaining USDOT and FMCSA's commitment to
safety.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including: (1) Whether the proposed
collection is necessary for FMCSA to perform its

functions; (2) the accuracy of the estimated burden; (3) ways for FMCSA
to enhance the quality, usefulness, and clarity of the collected
information; and (4) ways that the burden could be minimized without
reducing the quality of the collected information.

    Issued under the authority delegated in 49 CFR 1.87.
Thomas P. Keane,
Associate Administrator, Office of Research and Registration.
[FR Doc. 2022-00063 Filed 1-6-22; 8:45 am]
BILLING CODE 4910-EX-P