[Federal Register Volume 81, Number 9 (Thursday, January 14, 2016)]
[Notices]
[Pages 1961-1962]
[FR Doc No: 2016-00543]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2015-0022; OMB No. 1660-0054]

Agency Information Collection Activities: Submission for OMB
Review; Comment Request; Assistance to Firefighters Grant Program and
Fire Prevention and Safety Grants--Grant Application Supplemental
Information

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: The Federal Emergency Management Agency (FEMA) will submit the
information collection abstracted below to the Office of Management and
Budget for review and clearance in accordance with the requirements of
the Paperwork Reduction Act of 1995. The submission will describe the
nature of the information collection, the categories of respondents,
the estimated burden (i.e., the time, effort and resources used by
respondents to respond) and cost, and the actual data collection
instruments FEMA will use.

DATES: Comments must be submitted on or before February 16, 2016.

ADDRESSES: Submit written comments on the proposed information
collection to the Office of Information and Regulatory Affairs, Office
of Management and Budget. Comments

should be addressed to the Desk Officer for the Department of Homeland
Security, Federal Emergency Management Agency, and sent via electronic
mail to<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Requests for additional information or
copies of the information collection should be made to Director,
Records Management Division, 500 C Street SW., Washington, DC 20472-
3100, or email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This proposed information collection
previously published in the Federal Register on October 6, 2015 at 80
FR 60398 with a 60 day public comment period. FEMA received one comment
requesting a copy of the proposed information collection, and a draft
of the proposed information collection was subsequently forwarded to
the requester. The Agency responded to this comment and provided the
most up-to-date copy of the proposed information collection to the
requester. The purpose of this notice is to notify the public that FEMA
will submit the information collection abstracted below to the Office
of Management and Budget for review and clearance.

Collection of Information

    Title: Assistance to Firefighters Grant Program and Fire Prevention
and Safety Grants--Grant Application Supplemental Information.
    Type of information collection: Revision of a currently approved
information collection.
    OMB Number: 1660-0054.
    Form Titles and Numbers: FEMA Form 080-0-2, Assistance to
Firefighters Grants (AFG) Application (General Questions and
Narrative); FEMA Form 080-0-2a, Activity Specific Questions for AFG
Vehicle Applicants; FEMA Form 080-0-2b, Activity Specific Questions for
AFG Operations and Safety Applications; FEMA Form 080-0-3, Activity
Specific Questions for Fire Prevention and Safety (FP&S) Applicants;
FEMA Form 080-0-3a, Fire Prevention and Safety; FEMA Form 080-0-3b,
Research and Development.
    Abstract: The FEMA forms for this collection are used to
objectively evaluate each of the anticipated applicants to determine
which applicants' submission in each of the AFG activities are close to
the established program priorities. FEMA also uses the information to
determine eligibility and whether the proposed use of funds meets the
requirements and intent of the Federal Fire Prevention and Control Act
of 1974, as amended.
    Affected Public: State, Local or Tribal Government; Not-for-profit
Institutions.
    Estimated Number of Respondents: 22,000.
    Estimated Total Annual Burden Hours: 158,590 hours.
    Estimated Cost: The estimated annual cost to respondents for the
hour burden is $7,849,130.00. There are no annual costs to respondents'
operations and maintenance costs for technical services. There are no
annual start-up or capital costs. The cost to the Federal Government is
$3,319,699.04.

    Dated: December 23, 2015.
Richard W. Mattison,
Records Management Program Chief, Mission Support, Federal Emergency
Management Agency, Department of Homeland Security.
[FR Doc. 2016-00543 Filed 1-13-16; 8:45 am]
 BILLING CODE 9111-78-P


[Federal Register Volume 86, Number 181 (Wednesday, September 22, 2021)]
[Notices]
[Pages 52709-52712]
[FR Doc No: 2021-20446]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-93021; File No. SR-MIAX-2021-39]

Self-Regulatory Organizations; Miami International Securities
Exchange, LLC; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Amend Its Fee Schedule With Respect to Open-
Close Report Data

September 16, 2021.
    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 September 2, 2021, Miami International Securities Exchange, LLC
(``MIAX'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') a proposed rule change as described in
Items I, II, and III 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 Substance
of the Proposed Rule Change

    The Exchange is filing a proposal to amend the MIAX Options Fee
Schedule (the ``Fee Schedule'') to provide historical Open-Close Report
data for free by amending the fees for the Open-Close Report to: (i)
Respond to ad hoc requests for end-of-day data free of charge; and (ii)
provide mid-month subscribers data for the entire month in which they
subscribe.
    The text of the proposed rule change is available on the Exchange's
website at http://www.miaxoptions.com/rule-filings, at MIAX's principal
office, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, 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 recently adopted a new data product for options known
as the Open-Close Report,\3\ which the Exchange made available for
purchase to Exchange Members \4\ and non-Members on June 1, 2021.\5\
The Open-Close Report is described under Exchange Rule 531(b)(1). The
Exchange now proposes to provide historical Open-Close Report data for
free by amending the fees for the Open-Close Report to: (i) Respond to
ad hoc requests for end-of-day data free of charge; and (ii) provide
mid-month subscribers data for the entire month in which they
subscribe.
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    \3\ See Securities Exchange Act Release No. 91965 (May 21,
2021), 86 FR 28665 (May 27, 2021) (SR-MIAX-2021-18) (Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change to
Adopt a New Historical Market Data Product To Be Known as the Open-
Close Report).
    \4\ The term ``Member'' means an individual or organization that
is registered with the Exchange pursuant to Chapter II of these
Rules for purposes of trading on the Exchange as an ``Electronic
Exchange Member'' or ``Market Maker.'' Members are deemed
``members'' under the Exchange Act. See Exchange Rule 100.
    \5\ See Securities Exchange Act Release No. 92135 (June 9,
2021), 86 FR 31751 (June 15, 2021) (SR-MIAX-2021-23) (Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To
Amend the MIAX Pearl [sic] Options Fee Schedule To Adopt Fees for
the Open-Close Report).
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General
    By way of background, the Exchange offers two versions of the Open-
Close Report, an end-of-day summary and intra-day report.\6\ The end-
of-day version is a volume summary of trading activity on the Exchange
at the option level by origin (Priority Customer, Non-Priority
Customer, Firm, Broker-Dealer, and Market Maker),\7\ side of the market
(buy or sell), contract volume, and transaction type (opening or
closing). The customer and professional customer volume is further
broken down into trade size buckets (less than 100 contracts, 100-199
contracts, greater than 199 contracts). The Open-Close Data is
proprietary Exchange trade data and does not include trade data from
any other exchange. It is also a historical data product and not a
real-time data feed.
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    \6\ The intraday Open-Close Report provides similar information
to that of Open-Close Data but will be produced and updated every 10
minutes during the trading day. Data is captured in ``snapshots''
taken every 10 minutes throughout the trading day and is available
to subscribers within five minutes of the conclusion of each 10-
minute period.
    \7\ See Exchange Rule 100.
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    Members and non-Members may purchase the Open-Close Report on a
monthly basis. The Exchange currently assess a monthly fee of $600 per
month for subscribing to the end-of-day summary Open-Close Report and
$2,000 per month for subscribing to the intra-day Open-Close Report.
For mid-month subscriptions, new subscribers are currently charged for
the full calendar month for which they subscribe and will be provided
Open-Close Report data for each trading day of the calendar month from
the day on which they subscribed.
End-of-Day Ad Hoc Request (Historical Data)
    The Exchange now proposes to provide Members and Non-Members who
request on an ad hoc basis historical end-of-day Open-Close Report data
free of charge.\8\ An ad hoc request may be for any number of months
beginning with June 2021, the month in which the Exchange first made
the Open-Close Report available. For

example, as of the date of this filing, a market participant may
request end-of-day Open-Close Report data for the month of June 2021 or
July 2021, or may request such data for both June and July 2021 and
would not be charged a fee for such request(s). The Exchange notes that
other exchanges that provide similar data products allow for ad hoc
requests of their end-of-day data for a fee \9\ and, like the Exchange
proposes herein, allow for ad hoc requests back to a certain month.\10\
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    \8\ The Exchange does not propose to allow for ad hoc requests
for intra-day Open-Close Report data.
    \9\ See Price List--U.S. Derivatives Data for Nasdaq PHLX, LLC
(``PHLX''), The Nasdaq Stock Market, LLC (``Nasdaq''), Nasdaq ISE,
LLC (``ISE''), and Nasdaq GEMX, LLC (``GEMX''), available at http://www.nasdaqtrader.com/Trader.aspx?id=DPPriceListOptions#web.
Particularly, PHLX offers ``Nasdaq PHLX Options Trade Outline
(PHOTO)'' and assesses $400 for historical end-of-day data; Nasdaq
offers the ``Nasdaq Options Trade Outline (NOTO)'' and assesses $250
for historical end-of-day data; ISE offers the ``Nasdaq ISE Open/
Close Trade Profile'' and assesses $600 per month for historical
end-of-day data and $27,500 for complete history; and GEMX offers
the ``Nasdaq GEMX Open/Close Trade Profile'' and assesses $400 for
historical end-of-day data.
    Cboe EDGX Exchange, Inc. (``EDGX'') and Cboe BZX Exchange, Inc.
(``BZX'') both assess $400 for historical end-of-day data per
request per month. See the EDGX fee schedule available at http://markets.cboe.com/us/options/membership/fee_schedule/edgx/ and the
BZX fee schedule available at http://markets.cboe.com/us/options/membership/fee_schedule/bzx/. Both EDGX and BZX allow for ad-hoc
requests to be for any number of months beginning with January 2018
for which the data is available.
    \10\ Both EDGX and BZX allow for ad-hoc requests to be for any
number of months beginning with January 2018 for which the data is
available. See the EDGX fee schedule available at http://markets.cboe.com/us/options/membership/fee_schedule/edgx/ and the
BZX fee schedule available at http://markets.cboe.com/us/options/membership/fee_schedule/bzx/.
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    The Exchange also proposes to make the historical monthly data
available fifteen (15) days after the end of the month for which it is
requested. The Exchange proposes this delay because it is making
historical end-of-day Open-Close Report data free of charge and seeks
to not encourage subscribers to request historical end-of-day Open-
Close Report data over a paid subscription.
Mid-Month Subscriptions
    The Exchange also proposes to amend the data range of Open-Close
Report data it provides to mid-month subscribers. As noted above, the
Exchange currently charges new mid-month subscribers for the full
calendar month for which they subscribe, but only provides Open-Close
Report data for each trading day of the calendar month from the day on
which they subscribed. The Exchange now proposes to provide new mid-
month subscribers data for each trading day of the calendar month prior
to the day on which they subscribe. In other words, those that
subscribe mid-month will be provided Open-Close Data retroactively for
each trading day of the month in which they subscribed and
prospectively for each trading day for the remainder of that calendar
month pursuant to either the end-of-day or intra-day subscription they
chose. This is identical to how the Exchange provides data to mid-month
subscribers of the Exchange's Liquidity Taker Event report.\11\
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    \11\ See the Exchange's fee schedule available at https://www.miaxoptions.com/sites/default/files/fee_schedule-files/MIAX_Pearl_Options_Fee_Schedule_08122021.pdf [sic] (providing that
``[n]ew subscribers will be charged for the full calendar month for
which they subscribe and will be provided Liquidity Taker Event
Report data for each trading day of the calendar month prior to the
day on which they subscribed.'').
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Implementation Date
    The Exchange intends to provide historical Open-Close Report data
for free pursuant this proposal immediately.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\12\ in general, and furthers the
objectives of Section 6(b)(5) of the Act,\13\ in particular, in that it
is designed to prevent fraudulent and manipulative acts and practices,
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 to protect investors and the public
interest, and that it is not designed to permit unfair discrimination
among customers, brokers, or dealers. The Exchange also believes that
its proposed changes to its Fee Schedule concerning fees for the Open-
Close Report is consistent with Section 6(b) of the Act \14\ in
general, and furthers the objectives of Section 6(b)(4) of the Act \15\
in particular, in that it is an equitable allocation of dues, fees and
other charges among its members and other recipients of Exchange data.
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    \12\ 15 U.S.C. 78f(b).
    \13\ 15 U.S.C. 78f(b)(5).
    \14\ 15 U.S.C. 78f(b).
    \15\ 15 U.S.C. 78f(b)(4).
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    In adopting Regulation NMS, the Commission granted self-regulatory
organizations (``SROs'') and broker-dealers increased authority and
flexibility to offer new and unique market data to the public. It was
believed that this authority would expand the amount of data available
to consumers, and also spur innovation and competition for the
provision of market data. Particularly, the Open-Close Report further
broadens the availability of U.S. option market data to investors
consistent with the principles of Regulation NMS. The data product also
promotes increased transparency through the dissemination of the Open-
Close Report. Particularly, information regarding opening and closing
activity across different option series during the trading day may
indicate investor sentiment, which may allow market participants to
make better informed trading decisions throughout the day. Subscribers
to the data may also be able to enhance their ability to analyze option
trade and volume data and create and test trading models and analytical
strategies. The Exchange believes the Open-Close Report provides a
valuable tool that subscribers can use to gain comprehensive insight
into the trading activity in a particular series, but also emphasizes
such data is not necessary for trading. Moreover, other exchanges offer
a similar data product.\16\ This proposal simply and solely seeks to
provide historical Open-Close Report data to market participants for
free by amending the fees for the Open-Close Report to: (i) Respond to
ad hoc requests for end-of-day data free of charge; and (ii) provide
mid-month subscribers data for the entire month in which they
subscribe.
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    \16\ See supra notes 9 and 10.
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    The Exchange operates in a highly competitive environment. Indeed,
there are currently 16 registered options exchanges that trade options.
Based on publicly available information, no single options exchange has
more than 15% of the market share and currently the Exchange represents
only approximately 6.23% of the market share.\17\ The Commission has
repeatedly expressed its preference for competition over regulatory
intervention in determining prices, products, and services in the
securities markets. Particularly, in Regulation NMS, the Commission
highlighted the importance of market forces in determining prices and
SRO revenues and, also, recognized that current regulation of the
market system ``has been remarkably successful in promoting market
competition in its broader forms that are most important to investors
and listed companies.'' \18\ Making similar data products available to
market participants fosters competition in the marketplace, and
constrains the ability of exchanges to charge supra-competitive fees.
In the

event that a market participant views one exchange's data product as
more or less attractive than the competition they can and do switch
between similar products. The proposed fees are a result of the
competitive environment, as the Exchange seeks to adopt fees to attract
purchasers of the recently introduced Open-Close Data product.
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    \17\ See the Exchange's ``The market at a glance'', available at
https://www.miaxoptions.com/ (last visited September 1, 2021).
    \18\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496, 37499 (June 29, 2005) (``Regulation NMS Adopting
Release'').
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    The Exchange believes its proposal to provide Open-Close data in
response to ad hoc request for end-of-day data free of charge is
reasonable as the proposed rate is lower than the fees assessed by
other exchanges that provide data in response to ad hoc request for
their similar data products.\19\ In fact, the Exchange understands that
no other exchange provides such data free of charge.\20\ Indeed,
proposing fees that are excessively higher than established fees for
similar data products would simply serve to reduce demand for the
Exchange's data product, which as noted, is entirely optional. Like the
Exchange's Open-Close Report, other exchanges offer similar data
products that each provide insight into trading on those markets and
may likewise aid in assessing investor sentiment. Although each of
these similar Open-Close data products provide only proprietary trade
data and not trade data from other exchanges, it is possible investors
are still able to gauge overall investor sentiment across different
option series based on open and closing interest on any one
exchange.\21\ Similarly, market participants may be able to analyze
option trade and volume data, and create and test trading models and
analytical strategies using only Open-Close data relating to trading
activity on one or more of the other markets that provide similar data
products. As such, if a market participant views another exchange's
Open-Close data as more attractive than its proposed Open-Close Report,
then such market participant can merely choose not to subscribe to the
Exchange's Open-Close Report and instead purchase another exchange's
Open-Close data product, which offer similar data points, albeit based
on that other market's trading activity.
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    \19\ See supra notes 9 and 10.
    \20\ See supra note 9.
    \21\ The exchange notes that its Open-Close Report data product
does not include data on any exclusive, singly-listed option series.
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    The Exchange also believes its proposal to amend the fees for the
Open-Close Report to: (i) Provide historical end-of-day data free of
charge and (ii) provide mid-month subscribers data for the entire month
in which they subscribe, is reasonable as it would further support its
recent introduction of the Open-Close Report, which is designed to aid
investors by providing insight into trading on the Exchange. Providing
market data, such as the Open-Close Report, is also a means by which
exchanges compete to attract business. Subscribers that receive end-of-
day Open-Close data for free in response to an ad hoc request may use
such data to evaluate the usefulness of the Exchange's Open-Close
Report and decide, based on that data, whether to subscribe to the
Open-Close Report on a monthly basis. In addition, providing new mid-
month subscribers data for the entire calendar month would further
enhance the value of the Open-Close Report and encourage mid-month
subscriptions market participants that seek to subscribe to the Open-
Close Report not having to wait to the first of the next month to
subscribe and receive a full month of Open-Close Report Data for the
current monthly fee. To the extent that the Exchange is successful in
attracting subscribers for the Open-Close Report through this proposal,
it may earn trading revenues and further enhance the value of its data
products. The Exchange also believes it proposal to make historical
end-of-day Open-Close Report data on a delayed basis is a reasonable
means to not encourage subscribers to request historical end-of-day
Open-Close Report data over a paid subscription. If the market deems
the proposal to be unfair or inequitable, firms can diminish or
discontinue their use of the data and/or avail themselves of similar
products offered by other exchanges.\22\ The Exchange therefore
believes that its proposal reflects the competitive environment and
would be properly assessed on Member or non-Member users. The Exchange
also believes the proposal is equitable and not unfairly discriminatory
as it would apply equally to all users who choose to purchase or
receive such data.
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    \22\ See supra notes 9 and 10.
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    As noted above, a wide variety of market participants to subscribe
to the Open-Close Report, including but not limited to individual
customers, buy-side investors and investment banks. The Exchange
reiterates that the decision as to whether or not to subscribe to the
Open-Close Report is entirely optional for all potential subscribers.
Indeed, no market participant is required to subscribe to the Open-
Close Report, and the Exchange is not required to make the Open-Close
Report available to all investors. Rather, the Exchange is voluntarily
making additional Open-Close Report data available via ad hoc requests
for end-of-day data and to mid-month subscribers under this proposal at
the request of customers, and market participants may choose to receive
this data based on their own business needs. Potential subscribe to or
request the data at any time if they believe it to be valuable or may
decline to subscribe such data.

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. Rather, the
Exchange believes that the proposal will promote competition by
permitting the Exchange to enhance the value of a data product that is
similar to those offered by other competitor options exchanges.\23\ The
Exchange made Open-Close Data available in order to keep pace with
changes in the industry and evolving customer needs, and believes the
data product will continue to contribute to robust competition among
national securities exchanges. At least eight other U.S. options
exchanges offer a market data product that is substantially similar to
the Open-Close Report. As a result, the Exchange believes this proposed
rule change permits fair competition among national securities
exchanges.
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    \23\ See supra note 9.
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    Furthermore, the Exchange operates in a highly competitive
environment, and its ability to price the Open-Close Report is
constrained by competition among exchanges that offer similar data
products to their customers. As discussed, there are currently a number
of similar products available to market participants and investors. At
least eight other U.S. options exchanges offer a market data product
that is substantially similar to the Open-Close Report, which the
Exchange must consider in its pricing discipline in order to compete
for the market data.\24\ For example, proposing fees that are
excessively higher than established fees for similar data products
would simply serve to reduce demand for the Exchange's data product,
which as discussed, market participants are under no obligation to
utilize. In this competitive environment, potential purchasers are free
to choose which, if any, similar product to purchase to satisfy their
need for market information. As a result, the Exchange believes this
proposed rule change

permits fair competition among national securities exchanges.
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    \24\ See, e.g., Cboe Options Fees Schedule, Livevol Fees, Open-
Close Data. See also Nasdaq ISE Options 7 Pricing Schedule, Section
10.A and Nasdaq PHLX Options 7 Pricing Schedule, Section 10, PHLX
Options Trade Outline (``PHOTO'').
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    The Exchange also does not believe the proposal would cause any
unnecessary or in appropriate burden on intermarket competition as
other exchanges are free to introduce their own comparable data product
and lower their prices to better compete with the Exchange's offering.
The Exchange does not believe the proposed rule change would cause any
unnecessary or inappropriate burden on intramarket competition.
Particularly, the proposal would apply uniformly to any market
participant, in that it does not differentiate between subscribers to
the Open-Close Report. The proposal is modest and would allow any
interested Member or non-Member to subscribe to or request such data
based on their business needs.

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

    Written comments were neither solicited nor received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act,\25\ and Rule 19b-4(f)(2) \26\ thereunder.
At any time within 60 days of the filing of the 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. If the Commission takes such
action, the Commission shall institute proceedings to determine whether
the proposed rule should be approved or disapproved.
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    \25\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \26\ 17 CFR 240.19b-4(f)(2).
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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 email to<EMAIL_ADDRESS>Please include
File Number SR-MIAX-2021-39 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-MIAX-2021-39. This file
number should be included on the subject line if email 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 website (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 website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-MIAX-2021-39 and should be submitted on
or before October 13, 2021.
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    \27\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\27\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-20446 Filed 9-21-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 144 (Monday, July 27, 2020)]
[Rules and Regulations]
[Pages 45062-45066]
[FR Doc No: 2020-16122]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0967; Project Identifier 2017-NE-35-AD; Amendment
39-21167; AD 2020-15-04]
RIN 2120-AA64

Airworthiness Directives; GE Aviation Czech s.r.o. Turboprop
Engines (Type Certificate Previously Held by WALTER Engines a.s.,
Walter a.s., and MOTORLET a.s.)

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for all
GE Aviation Czech s.r.o. M601D-11, M601E-11, M601E-11A, M601E-11AS,
M601E-11S, M601F, H80, H80-100, H80-200, H75-100, H75-200, H85-100, and
H85-200 model turboprop engines. This AD was prompted by a review by
the manufacturer that identified the possibility of a power turbine
(PT) rotor overspeed and the uncontained release of PT blades. This AD
requires installing a modified engine outlet system. The FAA is issuing
this AD to address the unsafe condition on these products.

DATES: This AD is effective August 31, 2020.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of August 31,
2020.

ADDRESSES: For service information identified in this final rule,
contact GE Aviation Czech s.r.o., Beranov[yacute]ch 65, 199 02 Praha
9--Let[ncaron]any, Czech Republic; phone: +420 222 538 111; fax: +420
222 538 222. You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 1200
District Avenue, Burlington, MA, 01803. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. It is also
available on the internet at https://www.regulations.gov by searching
for and locating Docket No. FAA-2017-0967.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0967; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, the mandatory continuing airworthiness information
(MCAI), the regulatory evaluation, any comments received, and other
information. The address for Docket Operations is U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Barbara Caufield, Aerospace Engineer,
ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone:
781-238-7146; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    The FAA issued a supplemental notice of proposed rulemaking (SNPRM)
to amend 14 CFR part 39 by adding an AD that would apply to all GE
Aviation Czech s.r.o. M601D-11, M601E-11, M601E-11A, M601E-11AS, M601E-
11S, M601F, H80, H80-100, H80-200, H75-100, H75-200, H85-100, and H85-
200 model turboprop engines. The SNPRM published in the Federal
Register on February 4, 2020 (85 FR 6110) (``the SNPRM''). The FAA
preceded the SNPRM with a notice of proposed rulemaking (NPRM) that
published in the Federal Register on January 24, 2018 (83 FR 3287)
(``the NPRM''). The NPRM proposed to require installing a modified
engine outlet system. The NPRM was prompted by a review by the
manufacturer that identified the possibility of a PT rotor overspeed
and the uncontained release of PT blades. The FAA is issuing this AD to
address the unsafe condition on these products.
    The European Union Aviation Safety Agency (EASA), which is the
Technical Agent for the Member States of the European Community, has
issued EASA AD 2017-0151, dated August 18, 2017 (referred to after this
as ``the MCAI''), to address the unsafe condition on these products.
The MCAI states:

    A recent design review identified the possibility of failure of
the power turbine (PT) or quill shaft splines.
    This condition, if not corrected, could lead to a PT rotor
overspeed, with consequent release of PT blade(s), possibly
resulting in high energy debris and damage to, and/or reduced
control of, the aeroplane.
    To address this potential unsafe condition, GE Aviation Czech
(GEAC) designed a modification (mod) of the engine outlet system and
issued Alert Service Bulletins (ASB) ASB-M601E-72-00-00-0070, ASB-
M601D-72-00-00-0053, ASB-M601F-72-00-00-0036, ASB-M601T-72-00-00-
0029, ASB-M601Z-72-00-00-0039, ASB-H75-72-00-00-0011, ASB-H80-72-00-
00-0025 and ASB-H85-72-00-00-0007 (single document, hereafter
referred to as ``the ASB'' in this AD), providing instructions for
modification of engines in service.
    For the reason described above, this AD requires modification of
the affected engines, and prohibits installation of pre-mod parts.

    You may obtain further information by examining the MCAI in the AD
docket on the internet at https://www.regulations.gov by searching for
and locating Docket No. FAA-2017-0967.

Comments

    The FAA gave the public the opportunity to participate in
developing this final rule. The FAA received no comments on the SNPRM,
on the determination of the cost to the public, or the impact of the
proposed rule on small entities.

Conclusion

    The FAA reviewed the relevant data and determined that air safety
and the public interest require adopting this final rule as proposed.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed GE Aviation ASB ASB-M601E-72-00-00-0070[03], ASB-
M601D-72-00-00-0053[03], ASB-M601F-72-00-00-0036[03], ASB-M601T-72-00-
00-0029[03], ASB-M601Z-72-00-00-0039[03], ASB-H75-72-00-00-0011[03],
ASB-H80-72-00-00-0025[03], and ASB-H85-72-00-00-0007[03] (single
document; formatted as service bulletin identifier[revision number]),
dated July 24, 2018. The ASB describes procedures for removal and
replacement of the engine outlet system hardware. This service
information is reasonably available because the interested parties have
access to it through their normal course of business or by the means
identified in the ADDRESSES section.

Costs of Compliance

    The FAA estimates that this AD affects 42 engines installed on
airplanes of U.S. registry.
    The FAA estimates the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Replace exhaust system parts..........  64 work-hours x $85 per          $63,000         $68,440      $2,874,480
                                         hour = $5,440.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Flexibility Determination

    The Regulatory Flexibility Act of 1980 (Pub. L. 96-354, codified as
amended at 5 U.S.C. 601-612) (RFA) establishes ``as a principle of
regulatory issuance that agencies shall endeavor, consistent with the
objectives of the rule and of applicable statutes, to fit regulatory
and informational requirements to the scale of the businesses,
organizations, and governmental jurisdictions subject to regulation. To
achieve this principle, agencies are required to solicit and consider
flexible regulatory proposals and to explain the rationale for their
actions to assure that such proposals are given serious
consideration.'' Public Law 96-354, 2(b), Sept. 19, 1980. The RFA
covers a wide-range of small entities, including small businesses, not-
for-profit organizations, and small governmental jurisdictions.
Agencies must perform a review to determine whether a rule will have a
significant economic impact on a substantial number of small entities.
If the agency determines that it will, the agency must prepare a
regulatory flexibility analysis as described in the RFA.
    The FAA published an Initial Regulatory Flexibility Analysis (IRFA)
in the proposed rule to aid the public in commenting on the potential
impacts to small entities. The FAA considered the public comments in
developing the final rule and this Final Regulatory Flexibility
Analysis (FRFA). A FRFA must contain the following:
    (1) A statement of the need for, and objectives of, the rule;
    (2) A statement of the significant issues raised by the public
comments in response to the IRFA, a statement of the assessment of the
agency of such issues, and a statement of any changes made in the
proposed rule as a result of such comments;
    (3) The response of the agency to any comments filed by the Chief
Counsel for Advocacy of the Small Business Administration (SBA) in
response to the proposed rule, and a detailed statement of any change
made to the proposed rule in the final rule as a result of the
comments;
    (4) A description of and an estimate of the number of small
entities to which the rule will apply or an explanation of why no such
estimate is available;
    (5) A description of the projected reporting, recordkeeping, and
other compliance requirements of the proposed rule, including an
estimate of the classes of small entities which will be subject to the
requirement and the type of professional skills necessary for
preparation of the report or record;
    (6) A description of the steps the agency has taken to minimize the
significant economic impact on small entities consistent with the
stated objectives of applicable statutes, including a statement of the
factual, policy, and legal reasons for selecting the alternative
adopted in the final rule and why each of the other significant
alternatives to the rule considered by the agency which affect the
impact on small entities was rejected.

1. Need for and Objectives of the Rule

    This AD was prompted by a review by the manufacturer that
identified the possibility of a PT overspeed and the uncontained
release of PT blades. The FAA is issuing this AD to prevent uncontained
release of the PT blades. This AD requires installing a modified engine
outlet system. The unsafe condition, if not addressed, could result in
failure of the PT blades, uncontained release of the blades, damage to
the engine, and damage to the airplane.

2. Significant Issues Raised in Public Comments

    The FAA did not receive any public comments on the SNPRM.

3. Response to SBA Comments

    The Chief Counsel for Advocacy of the Small Business Administration
(SBA) did not file any comments in response to the proposed rule. Thus,
the FAA did not make any changes to the proposed rule in the final
rule.

4. Small Entities to Which the Rule Will Apply

    This AD applies to all GE Aviation Czech s.r.o. M601D-11, M601E-11,
M601E-11A, M601E-11AS, M601E-11S, M601F, H75-100, H75-200, H80, H80-
100, H80-200, H85-100, and H85-200 turboprop engines. These engines are
typically installed on airplanes that are owned and operated by aerial
application businesses, which is a small segment of the aviation
industry. These airplanes, also known as ``crop-dusters,'' spread
fertilizer, insecticides, fungicides, and weed killers.\1\
---------------------------------------------------------------------------

    \1\ ``Flying Low Is Flying High As Demand for Crop-Dusters
Soars'', by Jonathan Welsh, updated Aug. 14, 2009: https://www.wsj.com/articles/SB125020758399330769. Accessed on July 26,
2019.
---------------------------------------------------------------------------

    The FAA searched the 2018 Aircraft Registration database that
contains the records of all U.S. Civil Aircraft maintained by the FAA's
Aircraft Registration Branch and identified 42 airplanes with GE H80
series engines or equivalent turboprop engines installed. The Aircraft
Registration database shows that 38 companies own these 42 airplanes, 4
companies own 2 airplanes, while the remaining 34 companies own 1
airplane each. Based on these registration records, the FAA assumes
that approximately each entity or business owned one airplane.
    By using the Small Business Administration (SBA)'s size standards
and the North American Industry Classification System (NAICS) code
classifications, the FAA is able to determine whether a business is
small or not. These entities operate under NAICS code 115112, Soil
Preparation, Planting, and Cultivating. The size standards for this
NAICS code as provided by SBA's Size Standards

Table \2\ is $7.5 million in annual revenues. Therefore, entities
generating less than $7.5 million in annual revenues would be treated
as small businesses for the purposes of this analysis.
---------------------------------------------------------------------------

    \2\ https://www.sba.gov/sites/default/files/files/Size_Standards_Table.pdf Accessed on July 26, 2019.
---------------------------------------------------------------------------

    The FAA assumes that all 38 operators above that are affected by
this AD are small businesses because $700,000 annual revenue for a
first-class, used turbine agricultural aviation plane \3\ is a
reasonable industry estimate. On average, entities operating in the
aerial application industry generate approximately $700,000 each year
($700,000 x 1 crop-duster airplane), which is below $7.5 million
revenue size standards for NAICS code 115112. Therefore, the FAA
assumes all 38 registered company owners or operators to be small
entities.
---------------------------------------------------------------------------

    \3\ ``How much does it cost?'' by Bill Lavender, April 3, 2017.
https://agairupdate.com/how-much-does-it-cost/ Accessed on July 26,
2019.
---------------------------------------------------------------------------

5. Projected Reporting, Recordkeeping, and Other Compliance
Requirements

    There are no record-keeping costs or other compliance costs
associated with this final rule.

6. Significant Alternatives Considered

    There is no direct safety alternative to the modification of the
engine outlet system. The modification addresses a safety issue aimed
at preventing an uncontained release of the PT blades. Compliance cost
of this AD comes from the removal and replacement of the exhaust system
parts. Estimated compliance cost per engine is identified below.
    Labor cost = 64 repair hours per engine * $85 Mean Hourly Wage =
$5,440.
    Cost of Parts = $63,000 per engine (Source: GE Aviation Czech).
    $5,440 labor per engine + $63,000 parts per engine = $68,440
compliance cost per engine.
    To estimate the revenue impacts of the AD on these 38 small
operators, the FAA used the total estimated one-time costs of
compliance per each engine ($68,440) and divided it by the estimated
annual revenue of each entity ($700,000). The FAA determined all 38
small businesses that would be affected by this AD would experience
impacts of approximately 10 percent of their annual revenue during the
implementation of this AD ($68,440 / $700,000).
    Therefore, the FAA determined that this AD rule will have a
significant economic impact on a substantial number of small entities.

Regulatory Findings

    The FAA determined that this AD would not have federalism
implications under Executive Order 13132. This AD would not have a
substantial direct effect on the States, on the relationship between
the national Government and the States, or on the distribution of power
and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866, and
    (2) Will not affect intrastate aviation in Alaska.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

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

2020-15-04 GE Aviation Czech s.r.o. (Type Certificate previously
held by WALTER Engines a.s., Walter a.s., and MOTORLET a.s.):
Amendment 39-21167; Docket No. FAA-2017-0967; Project Identifier
2017-NE-35-AD.

(a) Effective Date

    This AD is effective August 31, 2020.

(b) Affected ADs

    None.

(c) Applicability

    (1) This AD applies to all GE Aviation Czech s.r.o. M601D-11,
M601E-11, M601E-11A, M601E-11AS, M601E-11S, M601F, H75-100, H75-200,
H80, H80-100, H80-200, H85-100, and H85-200 turboprop engines.
    (2) These engines are known to be installed on, but not limited
to, Thrush Aircraft, Inc. (formerly Quality, Ayres, Rockwell) S-2R,
PZL ``Warszawa-Ok[eogon]cie'' PZL-106 (Kruk), Air Tractor AT-300,
AT-400 and AT-500 series, Allied Ag Cat Productions, Inc. (formerly
Schweizer, Grumman American) G-164 series, RUAG (formerly Dornier)
Do 28 and Aircraft Industries (formerly LET) L-410 airplanes.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7810, Engine
Collector/Tailpipe/Nozzle.

(e) Unsafe Condition

    This AD was prompted by a review by the manufacturer that
identified the possibility of a power turbine (PT) overspeed and the
uncontained release of PT blades. The FAA is issuing this AD to
prevent uncontained release of the PT blades. The unsafe condition,
if not addressed, could result in failure of the PT blades,
uncontained release of the blades, damage to the engine, and damage
to the airplane.

(f) Compliance

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

(g) Required Actions

    (1) After the effective date of this AD, replace the parts
listed in Tables 2 through 5 to paragraph (g) of this AD with the
parts identified in Planning Information, Paragraph 1.5, Sections I
through IV, respectively in GE Aviation Alert Service Bulletin (ASB)
ASB-M601E-72-00-00-0070[03], ASB-M601D-72-00-00-0053[03], ASB-M601F-
72-00-00-0036[03], ASB-M601T-72-00-00-0029[03], ASB-M601Z-72-00-00-
0039[03], ASB-H75-72-00-00-0011[03], ASB-H80-72-00-00-0025[03], and
ASB-H85-72-00-00-0007[03] (single document; formatted as service
bulletin identifier[revision number]), dated July 24, 2018, using
the criteria below, whichever occurs first:
    (i) During the next engine shop visit,
    (ii) within the compliance time identified in the applicable
Airworthiness Limitations Section of the existing maintenance manual
for the affected engine model, or
    (iii) within the compliance time, in years after the effective
date of this AD, shown in Table 1 of this AD.
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BILLING CODE 4910-13-C
    (2) [Reserved]

(h) Installation Prohibition

    (1) Do not install any part with a P/N listed in Tables 2
through 5 to paragraph (g) of this AD on any engine after that
engine has been modified as required by paragraph (g)(1) of this AD.
    (2) After the effective date of this AD, do not install a part
with a P/N listed in Tables 2 through 5 of this AD on any engine
manufactured on or after September 1, 2017.

(i) Definition

    For the purpose of this AD, an engine shop visit is when the
engine is overhauled or rebuilt, or the PT is disassembled.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, ECO Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the manager of the
ECO Branch, send it to the attention of the person identified in
paragraph (k)(1) of this AD. You may email your request to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(k) Related Information

    (1) For more information about this AD, contact Barbara
Caufield, Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue,
Burlington, MA 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) Refer to European Union Aviation Safety Agency (EASA) AD
2017-0151R1, dated December 5, 2018, for more information. You may
examine the EASA AD in the AD docket on the internet at https://www.regulations.gov by searching for and locating it in Docket No.
FAA-2017-0967.

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) GE Aviation Alert Service Bulletin ASB-M601E-72-00-00-
0070[03], ASB-M601D-72-00-00-0053[03], ASB-M601F-72-00-00-0036[03],
ASB-M601T-72-00-00-0029[03], ASB-M601Z-72-00-00-0039[03], ASB-H75-
72-00-00-0011[03], ASB-H80-72-00-00-0025[03], and ASB-H85-72-00-00-
0007[03] (single document; formatted as service bulletin
identifier[revision number]), dated July 24, 2018.
    (ii) [Reserved]
    (3) For GE Aviation Czech service information identified in this
AD, contact GE Aviation Czech s.r.o., Beranov[yacute]ch 65, 199 02
Praha 9--Let[ncaron]any, Czech Republic; phone: +420 222 538 111;
fax: +420 222 538 222.
    (4) You may view this service information at FAA, Airworthiness
Products Section, Operational Safety Branch, 1200 District Avenue,
Burlington, MA, 01803. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on July 10, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2020-16122 Filed 7-24-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 168 (Tuesday, August 30, 2011)]
[Notices]
[Pages 53910-53912]
[FR Doc No: 2011-22062]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0594]

Fee for Using a Priority Review Voucher in Fiscal Year 2012

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the fee
rates for using a tropical disease priority review voucher for fiscal
year (FY) 2012. The Federal Food, Drug, and Cosmetic Act (the FD&C
Act), as amended by the Food and Drug Administration Amendments Act of
2007 (FDAAA), authorizes FDA to determine and collect priority review
user fees for certain applications for approval of drug or biological
products when those applications use a priority review voucher awarded
by the Secretary of Health and Human Services. These vouchers are
awarded to the sponsors of certain tropical disease product
applications, submitted after September 27, 2007, upon FDA approval of
such applications. The amount of the fee to be submitted to FDA with
applications using a priority review voucher is determined each FY
based on the average cost incurred by FDA in the review of a human drug
application subject to priority review in the previous FY. This notice
establishes the priority review fee rate for FY 2012.

FOR FURTHER INFORMATION CONTACT: David Miller, Office of Financial
Management (HFA-100), Food and Drug Administration, 1350 Picard Dr.,
Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 1102 (under title XI) of FDAAA (Pub. L. 110-85) added new
section 524 to the FD&C Act (21 U.S.C. 360n). In section 524, Congress
encouraged development of new drug and biological products for
prevention and treatment of certain tropical diseases by offering
additional incentives for obtaining FDA approval of such products.
Under section 524, the sponsor of an eligible human drug application
submitted after September 27, 2007, for a qualified tropical disease
(as defined in section 524(a)(3)), shall receive a priority review
voucher upon approval of the tropical disease product application. The
recipient of a priority review voucher may either use the voucher with
a future submission to FDA under section 505(b)(1) of the FD&C Act (21
U.S.C. 355(b)(1)) or section 351 of the Public Health Service Act (21
U.S.C. 262), or transfer (including by sale) the voucher to another
party that may then use it. A priority review is a review conducted
with a Prescription Drug User Fee Act (PDUFA) goal date of 6 months.
    The applicant that uses a priority review voucher is entitled to a
priority review but must pay FDA a priority review user fee in addition
to any other fee required by PDUFA. FDA has published a draft guidance
on its Web site about how this priority review voucher program will
operate (available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080599.pdf).
    This notice establishes the priority review fee rate for FY 2012 of
$5,280,000 and outlines FDA's process for implementing the collection
of the priority review user fees. This rate is effective on October 1,
2011, and will remain in effect through September 30, 2012, for
applications submitted with a priority review voucher. The payment of

this priority review user fee is required in addition to the payment of
any other fee that would normally apply to such an application under
PDUFA before FDA will consider the application complete and acceptable
for filing.

II. Priority Review User Fee for FY 2012

    Under section 524(c)(2) of the FD&C Act, the amount of the priority
review user fee is to be determined each FY based on the average cost
incurred by FDA in the review of a human drug application subject to
priority review in the previous FY.
    A priority review is a review conducted with a PDUFA goal date of 6
months. Normally, an application for a Center for Drug Evaluation and
Research (CDER) product will qualify for a priority review if FDA
determines that the product, if approved, would provide safe and
effective therapy where no satisfactory alternative therapy exists or
would be a significant improvement compared to marketed products,
including non-drug products and/or therapies, in the treatment,
diagnosis, or prevention of a disease. A Center for Biologics
Evaluation and Research (CBER) product will qualify for a priority
review if FDA determines that the product, if approved, would be a
significant improvement in the safety or effectiveness of the
treatment, diagnosis, or prevention of a serious or life-threatening
disease. FDA has committed to a goal to review and act on 90 percent of
the applications that have been granted priority review status no later
than 6 months after receipt. An application that does not receive a
priority designation will receive a standard review. Under the goals
identified in the letters referenced in section 101(c) of FDAAA, FDA
commits to a goal to review and act on 90 percent of standard
applications within 10 months of the date of receipt. A priority review
involves a more intensive level of effort and a higher level of
resources than a standard review.
    Section 524 of the FD&C Act specifies that the fee amount should be
based on the average cost incurred by the Agency for a priority review
in the previous FY. Because FDA has never tracked the cost of reviewing
applications that get priority review as a separate cost subset, FDA
estimated this cost based on other data that the Agency has tracked and
kept. FDA started by using data that the Agency estimates and publishes
on its Web site each year--standard costs for review. FDA does not
publish a standard cost for ``the review of a human drug application
subject to priority review in the previous fiscal year.'' However, we
expect all such applications would contain clinical data. The standard
cost application categories with clinical data that FDA does publish
each year are: (1) New drug applications (NDAs) for a new molecular
entity (NME) with clinical data, and (2) biologic license applications
(BLAs).
    The worksheets for standard costs for FY 2010, the latest year for
which standard cost data are available, show a standard cost of
$4,316,567 for an NDA with clinical data and $6,081,461 for a BLA.
Based on these standard costs, the total cost to review the 33
applications in these two categories in FY 2010 (9 BLAs and 24 NDAs
with clinical data) was $158,331,000, rounded to the nearest thousand
dollars. (Note: No investigational new drug (IND) review costs are
included in this amount; they will be calculated separately and added
in the next paragraph.) Records acquired from CDER and CBER by the
Office of Policy and Planning (OPP), Economics Staff, indicate that a
total of 13 of these applications (8 NDAs [excluding the President's
Emergency Plan for Aids Relief NDAs] and 5 BLAs) received priority
review, which would mean that the remaining 20 received standard
reviews. Because a priority review compresses a review that ordinarily
takes 10 months into 6 months, OPP estimates that a multiplier of 1.67
(10 months divided by 6 months) should be applied to non-priority
review costs in estimating the effort and cost of a priority review as
compared to a standard review. This multiplier is consistent with
published research on this subject. In the article ``Developing Drugs
for Developing Countries,'' published in Health Affairs, Volume 25,
Number 2, in 2006, the analysis by David B. Ridley, Henry G. Grabowski,
and Jeffrey L. Moe supports a priority review multiplier in the range
of 1.48 to 2.35. The multiplier derived by FDA falls well below the
mid-point of this range. Using FY 2010 figures, the costs of a priority
and standard review are estimated using the following formula:

(13 [alpha] * 1.67) + (20 [alpha]) = $158,331,000

where ``[alpha]'' is the cost of a standard review and ``[alpha] times
1.67'' is the cost of a priority review. Using this formula, the cost
of a standard review for NMEs is calculated to be $3,796,000 (rounded
to the nearest thousand dollars) and the cost of a priority review for
NMEs is 1.67 times that amount, or $6,339,000 (rounded to the nearest
thousand dollars).
    Next, the cost of the IND review phase for these applications is
calculated. The standard lifetime cost of reviewing a drug IND in FY
2010 was $362,102. The standard lifetime cost of a biologic IND review
in FY 2010 was $791,916. Because there were 8 priority NDAs and 5
priority BLAs received in FY 2010, the following formula below
estimates the average cost of the IND review phase of an application:

(8 NDA * $362,102) + (5 BLAs * $791,916) = $6,856,396

This is the full cost of the IND review associated with the 13 priority
review applications received in FY 2010. Dividing $6,856,000 (rounded
to the nearest thousand dollars) by 13 (the total number of priority
review applications received in FY 2010), yields an average IND review
phase cost of $527,000 (rounded to the nearest thousand dollars) per
priority review application.
    Adding the cost of the NDA/BLA priority review calculated above,
$6,339,000, to the cost of the IND review phase of $527,000, results in
an estimated average cost for priority review for an application
received in FY 2010 of $6,866,000.
    Section 524 of the FD&C Act specifies that the fee amount should be
based on the average cost incurred by the Agency for a priority review
in the previous FY. FDA is setting fees for FY 2012, and the previous
FY is FY 2011. However, the FY 2011 submission cohort has not been
closed out yet, and the cost data for FY 2011 are not complete. The
latest year for which FDA has data is FY 2010. Accordingly FDA will
adjust the FY 2010 cost figure above by the average amount by which
FDA's average salary and benefit costs increased in the 5 years prior
to FY 2011, to adjust the FY 2010 amount for cost increases in FY 2011.
That figure, also published in the Federal Register of August 1, 2011
(76 FR 45831), setting PDUFA fees for FY 2012, is 3.72 percent.
Increasing the FY 2010 average priority review cost figure of
$6,866,000 by 3.72 percent results in an estimated cost of $7,121,000
(rounded to the nearest thousand dollars).
    FDA will deduct from this amount the PDUFA fee that must also be
paid (in addition to the priority review fee) when an NDA or BLA with
clinical data is submitted in FY 2012. That amount, also published in
the Federal Register of August 1, 2011, is $1,841,500. The difference,
rounded to the nearest thousand dollars, is $5,280,000. This is the
priority review user fee amount for FY 2012 that must be submitted with
a priority review voucher in FY 2012, in addition to any PDUFA fee that
is required for such an application.

III. Priority Review Fee Schedule for FY 2012

    The fee rate for FY 2012 is set out in table 1 of this document:

              Table 1--Priority Review Schedule for FY 2012
------------------------------------------------------------------------
                                                               Fee rate
                        Fee category                         for FY 2012
------------------------------------------------------------------------
Applications Submitted With a Priority Review Voucher in      $5,280,000
 Addition to the Normal PDUFA Fee..........................
------------------------------------------------------------------------

IV. Implementation of Priority Review Fee

    Under section 524(c)(4)(A) of the FD&C Act, the priority review
user fee is due upon submission of the application for which the
priority review voucher is used. Section 524(c)(4)(B) specifies that
the application will be considered incomplete if the priority review
user fee and all other applicable user fees are not paid in accordance
with FDA payment procedures. FDA may not grant a waiver, exemption,
reduction, or refund of any fees due and payable under this section of
the FD&C Act, and FDA may not collect priority review voucher fees
prior to a relevant appropriation for fees for that FY. Beginning with
FDA's appropriation for FY 2009, the annual appropriation language
states specifically that ``priority review user fees authorized by 21
U.S.C. 360n (section 524 of the FD&C Act) may be credited to this
account, to remain available until expended.'' (Pub. L. 111-8, Section
5, Division A, Title VI).
    The priority review fee established in the new fee schedule must be
paid for any application that is received after September 30, 2011, and
submitted with a priority review voucher. This fee must be paid in
addition to any other fee due under PDUFA. Payment must be made in U.S.
currency by check, bank draft, or U.S. postal money order payable to
the order of the Food and Drug Administration. The user fee
identification (ID) number should be included on the check, followed by
the words ``Priority Review.'' Payments can be mailed to: Food and Drug
Administration, P.O. Box 979107, St. Louis, MO 63197-9000.
    If checks are sent by a courier that requests a street address, the
courier can deliver the checks 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.) The FDA post office
box number (P.O. Box 979107) must be written on the check. The tax
identification number of the Food and Drug Administration is 53-
0196965.
    Wire transfer payments may also be used. Please reference your
unique user fee ID number when completing your transfer. The
originating financial institution may charge a wire transfer fee.
Please ask your financial institution about the fee and include it with
your payment to ensure that your fee is fully paid. The account
information is as follows: New York Federal Reserve Bank, U.S. Dept. of
Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Acct. No.:
75060099, Routing No.: 021030004, Swift: FRNYUS33, Beneficiary: FDA,
1350 Piccard Dr., Rockville, MD 20850.

    Dated: August 24, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-22062 Filed 8-29-11; 8:45 am]
BILLING CODE 4160-01-P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on March 15, 2006

NOTICE OF ACTION TAKEN -- DOCKET OST-2003-16581

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant:  Iberia Lineas Aereas de Espana, S.A. 					Date Filed:
February 21, 2006

Relief requested:  Renew exemption from 49 U.S.C. § 41301 to engage in
scheduled foreign air transportation of persons, property and mail,
between:  1) any point or points in Spain and Miami, via San Juan, and
beyond Miami to/from the ten coterminal points Cancun, Guatemala City,
San Salvador, Managua, San Jose, Panama City, Santo Domingo, Lima, San
Pedro Sula and Tegucigalpa (with local traffic rights between Miami and
these ten coterminal points); and 2) any point or points in Spain and
the six U.S. coterminal points Chicago, Houston, Los Angeles, Miami, New
Orleans, and New York.

If renewal, date and citation of last action:  March 1, 2005, in this
Docket

Applicant representative: William Karas & Carol Gosain<PHONE_NUMBER>

DOT Analyst:  Shelita A. Smith<PHONE_NUMBER>

Responsive pleadings:  None filed

DISPOSITION

Action:  Approved									Action date:  March 15, 2006

Effective dates of exemption authority granted:  March 15, 2006 –
March 15, 2007

Basis for approval (bilateral agreement/reciprocity): United
States-Spain Air Transport Agreement

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations indicated:

   X    Standard exemption conditions (attached)              X
Foreign air carrier permit   (Order 90-3-9)

Special conditions/Partial grant/Denial basis/Remarks:  In its foreign
air carrier permit issued by Order 90-3-9, Iberia holds authority, among
other things, to conduct scheduled services between Spain and the U.S.
points Miami (via San Juan), New York, Chicago and Los Angeles.  The
exemption granted here permits additional operations, authorizing the
carrier to serve:  the ten foreign points beyond Miami; Houston and New
Orleans; and the six U.S. points named in 2 (above) as coterminals.

Action taken by:  Paul L. Gretch, Director

		   Office of International Aviation

________________________________________________________________________
________________________________________________________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) the applicant is qualified to perform the
proposed operations; (2) our action was consistent with Department
policy; (3) grant of the authority was consistent with the public
interest; and (4) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted/deferred/dismissed, we denied

all requests in the referenced Docket.  We may amend, modify, or revoke
the authority granted in this Notice at any time without hearing at our
discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR §
385.30, may file their petitions within seven (7) days after the date of
issuance of this Notice.  This action was effective when taken, and the
filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

  HYPERLINK "http://dms.dot.gov//reports/reports_aviation.asp"
http://dms.dot.gov//reports/reports_aviation.asp

Foreign Carrier Exemption Conditions

In the conduct of the operations authorized, the foreign carrier
applicant(s) shall:

(1)  Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

(2)  Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security, including, but not limited to, 49 CFR Part 1546 or 1550, as
applicable.  To assure compliance with all applicable U.S. Government
requirements concerning security, the holder shall, before commencing
any new service (including charter flights) from a foreign airport that
would be the holder’s last point of departure for the United States,
contact its International Principal Security Inspector (IPSI) to advise
the IPSI of its plans and to find out whether the Transportation
Security Administration has determined that security is adequate to
allow such airport(s) to be served;

(3)  Comply with the requirements for minimum insurance coverage
contained in 14 CFR Part 205, and, prior to the commencement of any
operations under this authority, file evidence of such coverage, in the
form of a completed OST Form 6411, with the Federal Aviation
Administration’s Program Management Branch (AFS-260), Flight Standards
Service (any changes to, or termination of, insurance also shall be
filed with that office);

(4)  Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

(5)  Conform to the airworthiness and airman competency requirements of
its Government for international air services;

(6)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR Part 203,
concerning waiver of Warsaw Convention liability limits and defenses;

(7)  Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are: (a)  based on its
operations in international air transportation that, according to the
contract of carriage, include a point in the United States as a point of
origin, point of destination, or agreed stopping place, or for which the
contract of carriage was purchased in the United States; or (b)  based
on a claim under any international agreement or treaty cognizable in any
court or other tribunal of the United States.  In this condition, the
term "international air transportation" means "international
transportation" as defined by the Warsaw Convention, except that all
States shall be considered to be High Contracting Parties for the
purpose of this definition;

(8)  Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

(9)  Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

(10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department's rules
governing charters (including 14 CFR Parts 212 and 380); and

(11) Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department, with all applicable orders or regulations of other U.S.
agencies and courts, and with all applicable laws of the United States.

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code.

05/2004


[Federal Register Volume 77, Number 215 (Tuesday, November 6, 2012)]
[Notices]
[Page 66606]
[FR Doc No: 2012-27008]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 [Project No. 2769-041]

 Allegheny Electric Cooperative, Inc. and the Connecticut Bank
and Trust Company, National Association; Notice of Application for
Partial Transfer of License, and Soliciting Comments and Motions To
Intervene

    On June 22, 2012, Allegheny Electric Cooperative, Inc. (AECI) and
The U.S. Bank National Association, (as successor in interest to The
Connecticut Bank and Trust Company, National Association) (co-licensee)
filed an application for partial transfer of license for the Raystown
Lake Hydro Station Project No. 2769, located on the Raystown Branch of
the Juniata River in Huntingdon County, Pennsylvania.
    Applicants seek Commission approval to transfer the license for the
Raystown Lake Hydro Station from AECI and the U.S. Bank National
Association, (as successor in interest to The Connecticut Bank and
Trust Company, National Association) co-licensee to AECI as sole
licensee.
    Applicants' Contact: Mr. David Dulick, General Counsel, Allegheny
Electric Cooperative, Inc., 212 Locust Street, Harrisburg, PA 17101,
phone<PHONE_NUMBER>. Mr. Robert Weinberg and Joshua Adrian, Ducan,
Weinberg, Genzer & Pembroke, P.C., 1615 M Street NE., Washington, DC
20036, phone<PHONE_NUMBER>.
    FERC Contact: Patricia W. Gillis<PHONE_NUMBER>,
<EMAIL_ADDRESS>    Deadline for filing comments and motions to intervene: November 21,
2012. Comments and motions to intervene may be filed electronically via
the Internet. See 18 CFR 385.2001(a)(1) and the instructions on the
Commission's Web site under http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000
characters, without prior registration, using the eComment system at
http://www.ferc.gov/docs-filing/ecomment.asp. You must include your
name and contact information at the end of your comments. If unable to
be filed electronically, documents may be paper-filed. To paper-file,
an original plus seven copies should be mailed to: Kimberly D. Bose,
Secretary, Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426. More information about this project can be viewed
or printed on the eLibrary link of Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (P-2769)
in the docket number field to access the document. For assistance, call
toll-free 1-866-208-3372.

    Dated: October 31, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-27008 Filed 11-5-12; 8:45 am]
BILLING CODE 6717-01-P