Written by Nonroad interface at 1/9/2008 9:53:09 AM
This is the options file for the NONROAD program.
The data is sperated into "packets" bases on common
information.  Each packet is specified by an
identifier and a terminator. Any notes or descriptions
can be placed between the data packets.

9/2005 epa: Add growth & tech years to OPTIONS packet
  and Counties & Retrofit files to RUNFILES packet.

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

                  PERIOD PACKET

This is the packet that defines the period for
which emissions are to be estimated.  The order of the
records matter.  The selection of certain parameters
will cause some of the record that follow to be ignored.
The order of the records is as follows:

1  - Char 10  - Period type for this simulation.
                  Valid responses are: ANNUAL, SEASONAL, and MONTHLY
2  - Char 10  - Type of inventory produced.
                  Valid responses are: TYPICAL DAY and PERIOD TOTAL
3  - Integer  - year of episode (4 digit year)
4  - Char 10  - Month of episode (use complete name of month)
5  - Char 10  - Type of day
                  Valid responses are: WEEKDAY and WEEKEND
------------------------------------------------------
/PERIOD/
Period type        : Seasonal
Summation type     : Typical day
Year of episode    : 2008
Season of year     : Summer
Month of year      :
Weekday or weekend : Weekday
Year of growth calc:
Year of tech sel   :
/END/

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

                  OPTIONS PACKET

This is the packet that defines some of the user
options that drive the model.  Most parameters are
used to make episode specific emission factor
adjustments. The order of the records is fixed.
The order is as follows.

1  -  Char 80  - First title on reports
2  -  Char 80  - Second title on reports
3  -  Real 10  - Fuel RVP of gasoline for this simulation
4  -  Real 10  - Oxygen weight percent of gasoline for simulation
5  -  Real 10  - Percent sulfur for gasoline
6  -  Real 10  - Percent sulfur for diesel
7  -  Real 10  - Percent sulfur for LPG/CNG
8  -  Real 10  - Minimum daily temperature (deg. F)
9  -  Real 10  - maximum daily temperature (deg. F)
10 -  Real 10  - Representative average daily temperature (deg. F)
11 -  Char 10  - Flag to determine if region is high altitude
                      Valid responses are: HIGH and LOW
12 -  Char 10  - Flag to determine if RFG adjustments are made
                      Valid responses are: YES and NO
------------------------------------------------------
/OPTIONS/
Title 1            : RHODE ISLAND
Title 2            : 2008
Fuel RVP for gas   : 6.8
Oxygen Weight %    : 2.0
Gas sulfur %       : 0.030
Diesel sulfur %    : 0.33
Marine Dsl sulfur %: 0.2637
CNG/LPG sulfur %   : 0.003
Minimum temper. (F): 60
Maximum temper. (F): 88
Average temper. (F): 75
Altitude of region : LOW
/END/

------------------------------------------------------
                  REGION PACKET

This is the packet that defines the region for which
emissions are to be estimated.

The first record tells the type of region and
allocation to perform.

Valid responses are:
US TOTAL   -  emissions are for entire USA without state
              breakout.

50STATE    -  emissions are for all 50 states
              and Washington D.C., by state.

STATE      -  emissions are for a select group of states
              and are state-level estimates

COUNTY     -  emissions are for a select group of counties
              and are county level estimates.  If necessary,
              allocation from state to county will be performed.

SUBCOUNTY  -  emissions are for the specified sub counties
              and are subcounty level estimates.  If necessary,
              county to subcounty allocation will be performed.

The remaining records define the regions to be included.
The type of data which must be specified depends on the
region level.

US TOTAL   -  Nothing needs to be specified.  The FIPS
              code 00000 is used automatically.

50STATE    -  Nothing needs to be specified.  The FIPS
              code 00000 is used automatically.

STATE      -  state FIPS codes

COUNTY     -  state or county FIPS codes.  State FIPS
              code means include all counties in the
              state.

SUBCOUNTY  -  county FIPS code and subregion code.
------------------------------------------------------
/REGION/
Region Level       : COUNTY
The State of Rho RI: 44000
/END/

or use -
Region Level       : STATE
Michigan           : 26000
------------------------------------------------------

                  SOURCE CATEGORY PACKET

This packet is used to tell the model which source
categories are to be processed.  It is optional.
If used, only those source categories list will
appear in the output data file.  If the packet is
not found, the model will process all source
categories in the population files.
------------------------------------------------------

Diesel Only -
                   :2270000000
                   :2282020000
                   :2285002015
Spark Ignition Only -
                   :2260000000
                   :2265000000
                   :2267000000
                   :2268000000
                   :2282005010
                   :2282005015
                   :2282010005
                   :2285004015
                   :2285006015
------------------------------------------------------
 This is the packet that lists the names of output files
 and some of the input data files read by the model.  If
 a drive:\path\ is not given, the location of the
 NONROAD.EXE file itself is assumed.  You will probably
 want to change the names of the Output and Message files
 to match that of the OPTion file, e.g., MICH-97.OPT,
 MICH-97.OUT, MICH-97.MSG, and if used MICH-97.AMS.
------------------------------------------------------
/RUNFILES/
ALLOC XREF         : data\allocate\allocate.xrf
ACTIVITY           : data\activity\activity.dat
EXH TECHNOLOGY     : data\tech\tech-exh.dat
EVP TECHNOLOGY     : data\tech\tech-evp.dat
SEASONALITY        : data\season\season.dat
REGIONS            : data\season\season.dat
MESSAGE            : c:\nonroad\outputs\ri2008a.msg
OUTPUT DATA        : c:\nonroad\outputs\ri2008a.out
EPS2 AMS           :
US COUNTIES FIPS   : data\allocate\fips.dat
RETROFIT           :
/END/

------------------------------------------------------
This is the packet that defines the equipment population
files read by the model.
------------------------------------------------------
/POP FILES/
Population File    : c:\nonroad\data\pop\ri.pop
/END/

POPULATION FILE    : c:\nonroad\data\POP\MI.POP

------------------------------------------------------
This is the packet that defines the growth files
files read by the model.
------------------------------------------------------
/GROWTH FILES/
National defaults  : data\growth\nation.grw
/END/

/ALLOC FILES/
Air trans. empl.   :c:\nonroad\data\allocate\ri_airtr.alo
Undergrnd coal prod:c:\nonroad\data\allocate\ri_coal.alo
Construction cost  :c:\nonroad\data\allocate\ri_const.alo
Harvested acres    :c:\nonroad\data\allocate\ri_farms.alo
Golf course estab. :c:\nonroad\data\allocate\ri_golf.alo
Wholesale estab.   :c:\nonroad\data\allocate\ri_holsl.alo
Family housing     :c:\nonroad\data\allocate\ri_house.alo
Logging employees  :c:\nonroad\data\allocate\ri_loggn.alo
Landscaping empl.  :c:\nonroad\data\allocate\ri_lscap.alo
Manufacturing empl.:c:\nonroad\data\allocate\ri_mnfg.alo
Oil & gas employees:c:\nonroad\data\allocate\ri_oil.alo
Census population  :c:\nonroad\data\allocate\ri_pop.alo
Allocation File    :c:\nonroad\data\allocate\ri_rail.alo
RV Park establish. :c:\nonroad\data\allocate\ri_rvprk.alo
Snowblowers comm.  :c:\nonroad\data\allocate\ri_sbc.alo
Snowblowers res.   :c:\nonroad\data\allocate\ri_sbr.alo
Snowmobiles        :c:\nonroad\data\allocate\ri_snowm.alo
Rec marine inboard :c:\nonroad\data\allocate\ri_wib.alo
Rec marine outboard:c:\nonroad\data\allocate\ri_wob.alo
/END/
------------------------------------------------------
This is the packet that defines the emssions factors
files read by the model.
------------------------------------------------------
/EMFAC FILES/
THC exhaust        : data\emsfac\exhthc.emf
CO exhaust         : data\emsfac\exhco.emf
NOX exhaust        : data\emsfac\exhnox.emf
PM exhaust         : data\emsfac\exhpm.emf
BSFC               : data\emsfac\bsfc.emf
Crankcase          : data\emsfac\crank.emf
Spillage           : data\emsfac\spillage.emf
Diurnal            : data\emsfac\evdiu.emf
TANK PERM          : data\emsfac\evtank.emf
NON-RM HOSE PERM   : data\emsfac\evhose.emf
RM FILL NECK PERM  : data\emsfac\evneck.emf
RM SUPPLY/RETURN   : data\emsfac\evsupret.emf
RM VENT PERM       : data\emsfac\evvent.emf
HOT SOAKS          : data\emsfac\evhotsk.emf
RUNINGLOSS         : data\emsfac\evrunls.emf
/END/

------------------------------------------------------
This is the packet that defines the deterioration factors
files read by the model.
------------------------------------------------------
/DETERIORATE FILES/
THC exhaust        : data\detfac\exhthc.det
CO exhaust         : data\detfac\exhco.det
NOX exhaust        : data\detfac\exhnox.det
PM exhaust         : data\detfac\exhpm.det
Diurnal            : data\detfac\evdiu.det
/END/

Optional Packets - Add initial slash "/" to activate

/STAGE II/
Control Factor     : 85.0
/END/
Enter percent control: 95 = 95% control = 0.05 x uncontrolled
Default should be zero control.

/MODELYEAR OUT/
EXHAUST BMY OUT    :
EVAP BMY OUT       :
/END/

SI REPORT/
SI report file-CSV :OUTPUTS\NRPOLLUT.CSV
/END/

/DAILY FILES/
DAILY TEMPS/RVP    :
/END/

PM Base Sulfur
 cols 1-10: dsl tech type;
 11-20: base sulfur wt%; or '1.0' means no-adjust (cert= in-use)
/PM BASE SULFUR/
T2        0.2000    0.02247
T3        0.2000    0.02247
T3B       0.0500    0.02247
T4A       0.0500    0.02247
T4B       0.0015    0.02247
T4        0.0015    0.30
T4N       0.0015    0.30
/END/


[Federal Register: July 23, 2009 (Volume 74, Number 140)]
[Notices]
[Page 36483]
[DOCID:fr23jy09-33]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER09-1412-000]

US Energy Partners LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

July 16, 2009.
    This is a supplemental notice in the above-referenced proceeding of
US Energy Partners LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR Part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR Part 34, of future issuances of securities and assumptions of
liability, is August 5, 2009.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-17501 Filed 7-22-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 150 (Tuesday, August 4, 2020)]
[Notices]
[Pages 47280-47283]
[FR Doc No: 2020-16873]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-89421; File No. SR-ISE-2020-30]

Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend Options 7,
Sections 1, 3, and 6

July 29, 2020.
    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 July 20, 2020, Nasdaq ISE, LLC (``ISE'' or ``Exchange'') filed with
the Securities and Exchange Commission (``SEC'' or ``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to amend Options 7, Section 6, Other Options
Fees and Rebates. The Exchange also proposes an amendment to Options 7,
Section 1, General Provisions, and Options 7, Section 3, Regular Order
Fees and Rebates.
    The Exchange originally filed the proposed pricing change on July
9, 2020 (SR-ISE-2020-29). On July 20, 2020, the Exchange withdrew that
filing and submitted this filing.
    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/ise/rules, at the
principal office of the Exchange, 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 proposes to amend Options 7, Section 6, Other Options
Fees and Rebates. Specifically, the Exchange proposes to eliminate a
discount in Options 7, Section 6H related to the Crossing Fee Cap. The
Exchange also proposes an amendment to Options 7, Section 1, General
Provisions, and Options 7, Section 3, Regular Order Fees and Rebates.
Each change will be described below.
Options 7, Section 6
    Today, the Exchange offers a Crossing Fee Cap of $90,000 per month,
per Member on all Firm Proprietary \3\ transactions that are part of
the originating or contra-side of a Crossing Order \4\ within Options
7, Section 6H. Members that elect, prior to the start of the month, to
pay $65,000 per month, per Member are entitled to have their crossing
fees capped at that level instead.
---------------------------------------------------------------------------

    \3\ A ``Firm Proprietary'' order is an order submitted by a
member for its own proprietary account. See Options 7, Section 1.
    \4\ Crossing Orders are contracts that are submitted as part of
a Facilitation, Solicitation, PIM, Block or Qualified Contingent
Cross order. All eligible volume from affiliated Members is
aggregated for purposes of the Crossing Fee Cap, provided there is
at least 75% common ownership between the Members as reflected on
each Member's Form BD, Schedule A.
---------------------------------------------------------------------------

    By way of background regarding the Crossing Fee Cap, today, fees
charged by the Exchange for Responses to Crossing Orders are not
included in the calculation of the monthly fee cap. Surcharge fees
charged by the Exchange for licensed products and the fees for index
options are set forth in Options 7, Section 5 and are not included in
the calculation of the monthly fee cap. A service fee of $0.00 per side
will apply to all order types that are eligible for the fee cap.\5\
Once the fee cap is reached, the service fee shall apply to eligible
Firm Proprietary orders in all Nasdaq ISE products. The service fee is
not calculated in reaching the cap. For purposes of the Crossing Fee
Cap the Exchange will attribute eligible volume to the ISE Member on
whose behalf the Crossing Order was executed.
---------------------------------------------------------------------------

    \5\ The service fee shall apply once a member reaches the fee
cap level and shall apply to every contract side above the fee cap.
A member who does not reach the monthly fee cap will not be charged
the service fee.
---------------------------------------------------------------------------

    At this time, the Exchange is proposing to eliminate the
opportunity for Members to elect, prior to the start of the month, to
pay $65,000 per month, per Member to have their crossing fees capped at
that level, instead of the current cap of $90,000 per month, per
Member. The Exchange has offered this reduced cap since 2015, provided
Members pay prior to the start of the month. While some Members did
elect this option in prior years, and continued to elect this option
through 2020, no new Member initially elected this option in 2020. The
Exchange does not believe this discount incentivizes Members to bring
Crossing Order flow to the Exchange as originally intended. With this
proposal, the Exchange would not accept elections from Members to have
their crossing fees capped at $65,000 for the month of July 2020 and
moving forward. Finally, the Exchange notes that all Members remain
eligible to have their fees capped at $90,000 per month, per Member.
    The Exchange proposes several technical amendments to Options 7,
Section 6H including: (1) Adding punctuation; (2) capitalizing the term
``member'' in several places; and (3) updating a citation from
``Section III'' to ``Section 5.''
Options 7, Section 1
    The Exchange proposes an amendment to Options 7, Section 1, General
Provisions. The Exchange proposes to amend the description of Penny
Symbols to replace the term ``Penny Pilot Program'' with ``Penny
Interval Program.'' On April 1, 2020 the Commission approved the
amendment to the OLPP to make permanent the Pilot Program (the ``OLPP
Program'').\6\ The Exchange recently filed a proposal to amend ISE
Options 3, Section 3 to conform the rule to Section 3.1 of the Plan for
the Purpose of Developing and Implementing Procedures Designed to
Facilitate the Listing and Trading of Standardized Options (the
``OLPP'').\7\ The Exchange's proposal amended ISE Options 3, Section 3
to refer to a Penny Interval Program instead of a Penny Pilot Program.
This proposed change to Options 7, Section 1 conforms the name of the
program.
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release No. 88532 (April 1,
2020), 85 FR 19545 (April 7, 2020) (File No. 4-443) (``Approval
Order'').
    \7\ See SR-ISE-2020-24 (not yet published).
---------------------------------------------------------------------------

Options 7, Section 3
    The Exchange proposes to update an incorrect reference within
Options 7, Section 3 to the Crossing Fee Cap to change the reference
from ``Section IV.H'' to ``Options 7, Section 6.H.''

2. Statutory Basis

    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\8\ in general, and furthers the objectives of Sections
6(b)(4) and 6(b)(5) of the Act,\9\ in particular, in that it provides
for the equitable allocation of reasonable dues, fees and other charges
among members and issuers and other persons using any facility, and is
not designed to permit unfair discrimination between customers,
issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The Commission and the courts have repeatedly expressed their
preference for competition over regulatory

intervention in determining prices, products, and services in the
securities markets. In Regulation NMS, while adopting a series of steps
to improve the current market model, 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.'' \10\
---------------------------------------------------------------------------

    \10\ Securities Exchange Act Release No. 51808 (June 9, 2005),
70 FR 37496, 37499 (June 29, 2005) (``Regulation NMS Adopting
Release'').
---------------------------------------------------------------------------

    Likewise, in NetCoalition v. Securities and Exchange Commission
\11\ (``NetCoalition'') the D.C. Circuit upheld the Commission's use of
a market-based approach in evaluating the fairness of market data fees
against a challenge claiming that Congress mandated a cost-based
approach.\12\ As the court emphasized, the Commission ``intended in
Regulation NMS that `market forces, rather than regulatory
requirements' play a role in determining the market data . . . to be
made available to investors and at what cost.'' \13\
---------------------------------------------------------------------------

    \11\ NetCoalition v. SEC, 615 F.3d 525 (D.C. Cir. 2010).
    \12\ See NetCoalition, at 534-535.
    \13\ Id. at 537.
---------------------------------------------------------------------------

    Further, ``[n]o one disputes that competition for order flow is
`fierce.' . . . As the SEC explained, `[i]n the U.S. national market
system, buyers and sellers of securities, and the broker-dealers that
act as their order-routing agents, have a wide range of choices of
where to route orders for execution'; [and] `no exchange can afford to
take its market share percentages for granted' because `no exchange
possesses a monopoly, regulatory or otherwise, in the execution of
order flow from broker dealers' . . . .'' \14\ Although the court and
the SEC were discussing the cash equities markets, the Exchange
believes that these views apply with equal force to the options
markets.
---------------------------------------------------------------------------

    \14\ Id. at 539 (quoting Securities Exchange Act Release No.
59039 (December 2, 2008), 73 FR 74770, 74782-83 (December 9, 2008)
(SR-NYSEArca-2006-21)).
---------------------------------------------------------------------------

Options 7, Section 6
    The Exchange believes that it is reasonable to amend Options 7,
Section 6H to eliminate the opportunity for Members to elect, prior to
the start of the month, to pay $65,000 per month, per Member to have
their crossing fees capped at that level instead of at $90,000 per
month, per Member. This discount was intended to incentivize members to
bring Crossing Order flow to the Exchange. While some Members did elect
this option in prior years, and continued to elect this option through
2020, no new Member initially elected this option in 2020. The Exchange
notes that only a small percentage of ISE Members elected this discount
and, therefore, would no longer receive the discount going forward. The
Exchange does not believe this discount incentivizes Members to bring
Crossing Order flow to the Exchange as originally intended and,
therefore, proposes to eliminate this discount. The Exchange was unable
to incentivize any new Member to elect the discount in 2020 and,
therefore, attract additional Crossing Order flow. The Exchange would
continue to cap all Firm Proprietary transactions that are part of the
originating or contra side of a Crossing Order at $90,000 per month,
per Member.
    The Exchange believes that it is equitable and not unreasonably
discriminatory to amend Options 7, Section 6H to eliminate the
opportunity for Members to elect, prior to the start of the month, to
pay $65,000 per month, per Member to have their crossing fees capped at
that level instead of at $90,000 per month, per Member. The Exchange
would not accept elections from any Member to have their crossing fees
capped at $65,000 per month, per Member for the month of July 2020 and
moving forward. Also, all Members remain eligible to have their fees
capped at $90,000 per month, per Member. Specifically, with respect to
the small percentage of ISE Members, who elected this discount and
would no longer receive the discount, the Exchange notes that those
Members would continue to be offered the opportunity to cap their
crossing fees at $90,000. Also, the Exchange notes that it offers
Members discounts and rebates to attract order flow to ISE. Depending
on the amount of order flow attracted to the Exchange, certain
discounts or rebates may be discontinued in favor of other discounts or
rebates. For example, as of July 1, 2020, the Exchange began offering a
Facilitation and Solicitation Break-up Rebate for Non-Select Symbols to
encourage increased originating regular and complex Non-Nasdaq ISE
Market Maker, Firm Proprietary/Broker-Dealer, Professional Customer,
and Priority Customer order flow to the Facilitation and Solicited
Order Mechanisms, thereby potentially increasing the initiation of and
volume executed through such auctions. Additional auction order flow
provides market participants with additional trading opportunities at
potentially improved prices.\15\
---------------------------------------------------------------------------

    \15\ See Securities Exchange Act Release No. 89321 (July 15,
2020) (SR-ISE-2020-26).
---------------------------------------------------------------------------

    The Exchange's proposed technical amendments to Options 7, Section
6H are reasonable, equitable and not unfairly discriminatory. These
amendments are non-substantive and clarify the current rule text.
Options 7, Section 1
    The Exchange's proposal to amend Options 7, Section 1 to replace
the term ``Penny Pilot Program'' with ``Penny Interval Program'' is
reasonable, equitable and not unfairly discriminatory. This amendment
seeks to conform the name of the program, which governs the listing of
certain standardized options.
Options 7, Section 3
    The Exchange's proposal to update an incorrect reference within
Options 7, Section 3 to the Crossing Fee Cap is reasonable, equitable
and not unfairly discriminatory. This change will bring clarity to the
Pricing Schedule.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act.
Intermarket Competition
    The proposal does not impose an undue burden on intermarket
competition. The Exchange believes its proposal remains competitive
with other options markets and will offer market participants with
another choice of where to transact options. The Exchange notes that it
operates in a highly competitive market in which market participants
can readily favor competing venues if they deem fee levels at a
particular venue to be excessive, or rebate opportunities available at
other venues to be more favorable. In such an environment, the Exchange
must continually adjust its fees to remain competitive with other
exchanges that have been exempted from compliance with the statutory
standards applicable to exchanges. Because competitors are free to
modify their own fees in response, and because market participants may
readily adjust their order routing practices, the Exchange believes
that the degree to which fee changes in this market may impose any
burden on competition is extremely limited.

Intramarket Competition
    The proposed amendments do not impose an undue burden on
intramarket competition.
Options 7, Section 6
    The Exchange believes that it does not impose an undue burden on
competition to amend Options 7, Section 6H to eliminate the opportunity
for Members to elect, prior to the start of the month, to pay $65,000
per month, per Member to have their crossing fees capped at that level
instead of at $90,000 per month, per Member. The Exchange has offered
this opportunity to all Members. While some Members did elect this
option in prior years, and continued to elect this option through 2020,
no new Member initially elected this option in 2020. Therefore, the
Exchange believes that eliminating the opportunity for Members to
elect, prior to the start of the month, to pay the discounted fee does
not impose an undue burden on competition, as there was no new interest
from Members, who had not previously elected this opportunity, in 2020
to pay the lower fee. The Exchange would not accept elections from any
Member to have their crossing fees capped at $65,000 per month, per
Member for the month of July 2020 and moving forward. Also, all Members
remain eligible to have their fees capped at $90,000 per month, per
Member.
    The Exchange's proposed technical amendments to Options 7, Section
6H are non-substantive and do not impose a burden on competition.
Options 7, Section 1
    The Exchange's proposal to amend Options 7, Section 1 to replace
the term ``Penny Pilot Program'' with ``Penny Interval Program'' does
not impose an undue burden on competition. This amendment seeks to
conform the name of the program, which governs the listing of certain
standardized options.
Options 7, Section 3
    The Exchange's proposal to update an incorrect reference within
Options 7, Section 3 to the Crossing Fee Cap does not impose an undue
burden on competition. This change will bring clarity to the Pricing
Schedule.

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

    No written comments were either solicited or 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 \16\ and Rule 19b-4(f)(2) \17\ 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: (i) Necessary or
appropriate in the public interest; (ii) for the protection of
investors; or (iii) 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.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \17\ 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 email to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2020-30 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-ISE-2020-30. 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-ISE-2020-30 and should be submitted on
or before August 25, 2020.
---------------------------------------------------------------------------

    \18\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-16873 Filed 8-3-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 170 (Wednesday, September 2, 2015)]
[Rules and Regulations]
[Pages 52935-52937]
[FR Doc No: 2015-21475]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

========================================================================

Federal Register / Vol. 80, No. 170 / Wednesday, September 2, 2015 /
Rules and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-0085; Directorate Identifier 2014-NM-078-AD;
Amendment 39-18255; AD 2015-17-22]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for all
Airbus Model A330-243, A330-243F, A330-341, A330-342, and A330-343
airplanes. This AD was prompted by reports indicating that certain
hinge sleeves on the cowl doors of the thrust reverser units (TRUs)
were not heat treated. This AD requires replacing the sleeves of
certain hinges on the cowl doors of the TRUs with new parts. We are
issuing this AD to prevent, in the event of a fan-blade-off event due
to high vibration, in-flight loss of TRU heavy components, which might
damage airplane structure or control surfaces and consequently reduce
controllability of the airplane.

DATES: This AD becomes effective October 7, 2015.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of October 7,
2015.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2015-0085 or in person at the
Docket Management Facility, U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC.
    For Airbus service information identified in this AD, contact
Airbus SAS, Airworthiness Office--EAL, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61
93 45 80; email<EMAIL_ADDRESS>Internet http://www.airbus.com. For Aircelle service information identified in this AD,
contact Aircelle Customer support Center, BP 50042, 50, rue Pierre
Curie, 78371 Plaisir Cedex, France: telephone +33 (0)1 64 14 80 33; fax
+33 (0)1 64 14 84 10. You may view this referenced service information
at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW.,
Renton, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
0085.

FOR FURTHER INFORMATION CONTACT: Vladimir Ulyanov, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to all Airbus Model A330-243,
A330-243F, A330-341, A330-342, and A330-343 airplanes. The NPRM
published in the Federal Register on February 13, 2015 (80 FR 7986).
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive 2014-0062, dated March 11, 2014 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for all Airbus Model
A330-243, A330-243F, A330-341, A330-342, and A330-343 airplanes. The
MCAI states:

    A manufacturing discrepancy (lack of heat treatment) on a batch
of the N[deg]3 and N[deg]4 hinge sleeves installed on [a] Thrust
Reverser Unit (TRU) was identified. Those parts are only installed
on A330 aeroplanes equipped with Rolls-Royce (RR) Trent 700 engines.
    This condition, if not corrected, in case of a Fan Blade Off
event due to high vibration level, could cause in-flight loss of
some heavy components of the TRU, possibly resulting in injury to
persons on the ground [or damage to airplane structure or control
surfaces, and consequent reduced controllability of the airplane].
    As current hinge sleeves are not serialized, it is not possible
to identify the TRU hinge sleeves which did not receive the heat
treatment. The part supplier has developed an identification
procedure for these TRU hinge sleeves in order to identify the
affected hinge sleeves, and to allow a better part traceability in
the future.
    For the reason described above, this [EASA] AD requires
identification and replacement of the affected TRU hinge sleeves.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2015-0085-0002.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (80 FR 7986, February 13,
2015) or on the determination of the cost to the public.

Conclusion

    We reviewed the relevant data and determined that air safety and
the public interest require adopting this AD as proposed except for
minor editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (80 FR 7986, February 13, 2015) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (80 FR 7986, February 13, 2015).

Related Service Information Under 1 CFR Part 51

    Airbus has issued Service Bulletin A330-78-3021, Revision 03, dated
October 15, 2014. Aircelle has issued Service Bulletin 78-AG924, dated
September 26, 2012. This service information describes procedures for
modifying and marking the sleeves for hinges number 3 and number 4 on
the cowl doors of Rolls-Royce Trent 700 engines. 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 of this AD.

Costs of Compliance

    We estimate that this AD affects 24 airplanes of U.S. registry.
    We also estimate that it will take about 29 work-hours per product
to comply with the basic requirements of this AD. The average labor
rate is $85 per work-hour. Required parts will cost about $0 per
product. Based on these figures, we estimate the cost of this AD on
U.S. operators to be $59,160, or $2,465 per product.
    In addition, we estimate that any necessary follow-on action will
take up to 1 work-hour and require parts costing $0, for a cost of $85
per product. We have no way of determining the number of aircraft that
might need this action.

Authority for This Rulemaking

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

Regulatory Findings

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

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-015-0085; or in person at the
Docket Management Facility between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays. The AD docket contains this AD, the
regulatory evaluation, any comments received, and other information.
The street address for the Docket Operations office (telephone 800-647-
5527) is in the ADDRESSES section.

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):

2015-17-22 Airbus: Amendment 39-18255. Docket No. FAA-2015-0085;
Directorate Identifier 2014-NM-078-AD.

(a) Effective Date

    This AD becomes effective October 7, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Airbus Model A330-243, A330-243F, A330-
341, A330-342, and A330-343 airplanes, certificated in any category,
all manufacturer serial numbers.

(d) Subject

    Air Transport Association (ATA) of America Code 78, Exhaust.

(e) Reason

    This AD was prompted by reports indicating that certain hinge
sleeves on the cowl doors of the thrust reverser units (TRUs) were
not heat treated. We are issuing this AD to prevent, in the event of
a fan-blade-off event due to high vibration, in-flight loss of TRU
heavy components, which might damage airplane structure or control
surfaces and consequently reduce controllability of the airplane.

(f) Compliance

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

(g) Identification of TRU Part Number

    Within 12 months after the effective date of this AD: Identify
the part number of the TRUs, in accordance with the information in
Aircelle Service Bulletin 78-AG924, dated September 26, 2012.

(h) Replacement of TRU Hinge Sleeves

    If the results of the part identification required by paragraph
(g) of this AD reveal that the TRUs are affected: Within the
compliance time defined in paragraph (g) of this AD, replace hinge
sleeves numbers 3 and 4 of each TRU cowl door, in accordance with
the Accomplishment Instructions of Airbus Service Bulletin A330-78-
3021, Revision 03, dated October 15, 2014.

    Note 1 to paragraph (h) of this AD: Rolls-Royce Alert Service
Bulletin RB.211-78-AG924, dated September 26, 2012, is an additional
source of guidance for replacing the TRUs and is not incorporated by
reference in this AD.

(i) Optional Terminating Action for Paragraphs (g) and (h) of this AD

    Modifying an airplane by incorporating Airbus Modification
202463 in production terminates the requirements specified in
paragraphs (g) and (h) of this AD for that airplane.

(j) Parts Installation Limitation

    As of the effective date of this AD, no person may install a TRU
on any airplane unless it has been determined, using Aircelle
Service Bulletin 78-AG924, dated September 26, 2012, that the cowl
door hinge sleeves installed on the TRU are not affected by the
requirements of this AD.

(k) Credit for Previous Actions

    This paragraph provides credit for the actions required by
paragraph (h) of this AD if those actions were performed before the
effective date of this AD using the service information identified
in paragraphs (k)(1), (k)(2), or (k)(3) of this AD, which are not
incorporated by reference in this AD.
    (1) Airbus Service Bulletin A330-78-3021, dated October 17,
2012.
    (2) Airbus Service Bulletin A330-78-3021, Revision 01, dated
July 30, 2013.
    (3) Airbus Service Bulletin A330-78-3021, Revision 02, dated
April 17, 2014.

(l) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, 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 International Branch, send it to ATTN: Vladimir
Ulyanov, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
WA 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information
may be emailed to: 9-ANM-116-

<EMAIL_ADDRESS>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. The AMOC approval letter must
specifically reference this AD.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or the
European Aviation Safety Agency (EASA); or Airbus's EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.
    (3) Required for Compliance (RC): Where Airbus Service Bulletin
A330-78-3021, Revision 03, dated October 15, 2014, contains
procedures or tests that are identified as RC, those procedures and
tests must be done to comply with this AD; any procedures and tests
that are not identified as RC are recommended. Those procedures and
tests that are not identified as RC may be deviated from using
accepted methods in accordance with the operators' maintenance or
inspection program without obtaining approval of an AMOC, provided
the procedures and tests identified as RC can be done and the
airplane can be put back in a serviceable condition. Any
substitutions or changes to procedures or tests identified as RC
require approval of an AMOC.

(m) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA AD 2014-0062, dated March 11, 2014, for related
information. This MCAI may be found in the AD docket on the Internet
at http://www.regulations.gov/#!documentDetail;D=FAA-2015-0085-0002.
    (2) Airbus service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (n)(3) and (n)(5) of this AD.
    (3) Rolls-Royce service information identified in this AD that
is not incorporated by reference is available at Rolls-Royce plc,
P.O. Box 31, Derby, DE24 8BJ, England; phone: 011-44-1332-242424;
fax:<PHONE_NUMBER>-249936; email: http://www.rolls-royce.com/contact/civil_team.jsp; Internet: https://www.aeromanager.com.

(n) 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 this AD specifies otherwise.
    (i) Airbus Service Bulletin A330-78-3021, Revision 03, dated
October 15, 2014.
    (ii) Aircelle Service Bulletin 78-AG924, dated September 26,
2012.
    (3) For Airbus service information identified in this AD,
contact Airbus SAS, Airworthiness Office--EAL, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96;
fax +33 5 61 93 45 80; email<EMAIL_ADDRESS>
Internet http://www.airbus.com.
    (4) For Aircelle service information identified in this AD,
contact Aircelle Customer support Center, BP 50042, 50, rue Pierre
Curie, 78371 Plaisir Cedex, France: telephone +33 (0)1 64 14 80 33;
fax +33 (0)1 64 14 84 10.
    (5) You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (6) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on August 21, 2015.
Kevin Hull,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-21475 Filed 9-1-15; 8:45 am]
BILLING CODE 4910-13-P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on August 7, 2003

NOTICE OF ACTION TAKEN -- DOCKET OST 1999-5615

________________________________________________________________________
________________________________________________________

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:  AEROVIAS de MEXICO, S.A. de C.V.
                               Date Filed:  July 15, 2003

Relief requested:  Exemption from 49 USC section 41301 to permit the
applicant to continue to conduct scheduled, combination services between
Guadalajara, Mexico, and Atlanta, Georgia.

If renewal, date and citation of last action:  August 22, 2002, in this
Docket.

Applicant representative(s):  William C. Evans,<PHONE_NUMBER>
DOT analyst:  Allen F. Brown,<PHONE_NUMBER>

Responsive pleadings:  None.

	DISPOSITION

Action:  Approved.			       			                        Action date:
August 7, 2003

Effective dates of authority granted:  August 7, 2003, through August
22, 2004.

Basis for approval:  United States-Mexico Air Transport Services
Agreement

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

Special conditions/Remarks:

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) our action was consistent with Department
policy; (2) the applicant was qualified to perform its proposed
operations; (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:

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


[Federal Register Volume 88, Number 51 (Thursday, March 16, 2023)]
[Notices]
[Pages 16272-16274]
[FR Doc No: 2023-05357]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0583]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Radioactive Drug Research Committees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on information collection requirements
contained in regulations governing the use of radioactive drugs for
basic informational research.

DATES: Either electronic or written comments on the collection of
information must be submitted by May 15, 2023.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 15, 2023. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.

     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2010-N-0583 for ``Radioactive Drug Research Committees.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Radioactive Drug Research Committees--21 CFR 361.1

OMB Control Number 0910-0053--Extension

    This information collection request supports regulations and
associated Agency forms. Sections 201, 505, and 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 355, and 371) establish
provisions under which FDA issues regulations governing the use of
radioactive drugs for basic scientific research. Specifically, section
Sec.  361.1 (21 CFR 361.1) sets forth specific regulations about
establishing and composing radioactive drug research committees (RDRCs)
and their role in approving and monitoring basic research studies using
radiopharmaceuticals. No basic research study involving any
administration of a radioactive drug to research subjects is permitted
without the authorization of an FDA-approved RDRC (Sec.  361.1(d)(7)).
The type of research that may be undertaken with a radiopharmaceutical
drug must be intended to obtain basic information and not to carry out
a clinical trial for safety or efficacy. The types of basic research
permitted are specified in the regulations and include studies of
metabolism, human physiology, pathophysiology, or biochemistry.
    Section 361.1(c)(2) requires that each RDRC will select a chairman,
who will sign all applications, minutes, and reports of the committee.
Each committee will meet at least once each quarter in which research
activity has been authorized or conducted. Minutes will be kept and
will include the numerical results of votes on protocols involving use
in human subjects. Under Sec.  361.1(c)(3), each RDRC will submit an
annual report to FDA. The annual report will include the names and
qualifications of the members of, and of any consultants used by, the
RDRC, using Form FDA 2914 (Report on Research Use of Radioactive
Drugs--Membership Summary). The annual report will also include a
summary of each study conducted during the preceding year, using Form
FDA 2915 (Report on Research Use of Radioactive Drugs--Study Summary).
    We developed the guidance document entitled ``Radioactive Drug
Research Committee: Human Research Without An Investigational New Drug
Application'' (August 2010), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/radioactive-drug-research-committee-human-research-without-investigational-new-drug-application, which provides information to help

determine whether research studies may be conducted under an FDA-
approved RDRC, or whether research studies must be conducted under an
investigational new drug application. It also offers answers to
frequently asked questions on conducting research with radioactive
drugs, and provides information on the membership, functions, and
reporting requirements of an RDRC approved by FDA. All Agency guidance
documents are issued consistent with our good guidance practice
regulations at 21 CFR 10.115.
    Under Sec.  361.1(d)(5), each investigator will obtain the proper
consent required under the regulations. Each female research subject of
childbearing potential must state in writing that she is not pregnant
or, based on a pregnancy test, be confirmed as not pregnant.
    Under Sec.  361.1(d)(8), the investigator will immediately report
to the RDRC all adverse effects associated with use of the drug, and
the committee will then report to FDA all adverse reactions probably
attributed to the use of the radioactive drug.
    Section 361.1(f) sets forth labeling requirements for radioactive
drugs. These requirements are not in the reporting burden estimate
because they are information supplied by the Federal Government to the
recipient for the purposes of disclosure to the public (5 CFR
1320.3(c)(2)).
    Types of research studies not permitted under the regulations are
also specified and include those intended for immediate therapeutic,
diagnostic, or similar purposes or to determine the safety or
effectiveness of the drug in humans for such purposes (i.e., to carry
out a clinical trial for safety or efficacy). These studies require
filing of an investigational new drug application under 21 CFR part
312, and the associated information collections, are covered in OMB
control number 0910-0014.
    The primary purpose of this collection of information is to
determine whether the research studies are being conducted in
accordance with required regulations and that human subject safety is
assured. If these studies were not reviewed, human subjects could be
subjected to inappropriate radiation or pharmacologic risks.
Respondents to this information collection are the chairperson or
chairpersons of each individual RDRC, investigators, and participants
in the studies. The burden estimates are based on our experience with
these reporting and recordkeeping requirements and the number of
submissions we received under the regulations over the past 3 years.
    We estimate the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
         21 CFR section and FDA form              Number of     responses per   Total annual     Average burden per response (in hours)     Total hours
                                                 respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   361.1(c)(3) reports and (c)(4)                      56               1              56  1........................................              56
 approval (Form FDA 2914: Membership Summary)
 \2\.
Sec.   361.1(c)(3) reports (Form FDA 2915:                 37              10             370  3........................................           1,110
 Study Summary) \3\.
Sec.   361.1(d)(8) adverse events............              10               1              10  0.5 (30 minutes).........................               5
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............             436  .........................................           1,171
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM094979.pdf.
\3\ https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM074720.pdf.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
                21 CFR section                    Number of      records per    Total annual     Average burden per  recordkeeping  (in     Total hours
                                                recordkeepers   recordkeeper       records                       hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   361.1(c)(2) RDRC......................              56               4             224  10.......................................           2,240
Sec.   361.1(d)(5) human research subjects...              37              10             370  0.75 (45 minutes)........................             278
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............             594  .........................................           2,518
--------------------------------------------------------------------------------------------------------------------------------------------------------
 \1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We have adjusted our estimate for the information collection to
reflect an annual decrease of 703 hours and 158 responses since OMB's
last approval. We attribute this adjustment to a decrease from 3.5
hours to 3 hours per response for public reporting burden for Form FDA-
2915: Study Summary to match the burden hours reflected on the form. In
addition, this adjustment is also attributable to the Agency receiving
fewer submissions over the last few years.

    Dated: March 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-05357 Filed 3-15-23; 8:45 am]
BILLING CODE 4164-01-P


Approved Removal Credits list updated May 18, 2005 POTW Date Approved Pollutant( s) Affected Industries Type Number Hartland, Maine ME0101443 Permitted POTW flow: 1.5 MGD.

http:// www. epa. gov/ npdescan/ m e0101443fs. pdf http:// www. epa. gov/ npdescan/ m e0101443fp. pdf 10/ 31/ 95 Chromium  97% removal 40 CFR 425 Leather tannery Irving Tanning Company ( Only IU in town, contributing approx.

90% of POTW influent directly to POTW headworks.

IU provides no treatment. IU effluent approx. 4 x cat. std.) 1 Berwick, Maine ME0101397 POTW flow is ~ 1 MGD.

http:// www. epa. gov/ npdescan/ m e0101397fs. pdf http:// www. epa. gov/ npdescan/ m e0101397fp. pdf April 2005 Chromium  97% removal 40 CFR 425 Leather tannery Prime Tanning Company ( Only IU in town, contributing approx.

90% of POTW influent directly to POTW headworks.

IU provides no treatment. IU effluent approx. 4 x cat. std.) 1 Approved Removal Credits list updated May 18, 2005 POTW Date Approved Pollutant( s) Affected Industries Type Number Frank E. Van Lare Wastewater Treatment Plant

Monroe County, NY Pretreatment Program NY0028339 Permitted POTW Flow: 135 MGD Public noticed in October 2004;

Approval pending notification,

installation, and successful start up of autodialer at POTW.* Phenols 40 CFR 433, 464 Metal Molding & Casting ( combined with Metal Finishing) 0*

Linden Roselle Sewerage Authority Linden, NJ NJPDES# NJ0024953 8/ 8/ 2001 15 organic compounds originally approved within removal credit.

7/ 11/ 2003 revision to 40 CFR 439 deregulated one of the pollutants, so the removal credit now applies to 14 pollutants. 40 CFR 439.36 Pharmaceutical:

MERCK 1 Approved Removal Credits list updated May 18, 2005 POTW Date Approved Pollutant( s) Affected Industries Type Number City of Bethlehem Wastewater Treatment Plant Bethlehem, PA PA0026042 http:// www. epa. gov/ npdescan/ P A0026042FS. pdf http:// www. epa. gov/ npdescan/ P A0026042FP. pdf ( Removal credit is still recognized in the POTW NPDES permit, even though no CIU is currently using it.) 5/ 1998 Ammonia 40 CFR 420 Iron & Steel Bethlehem Steel industry operations closed May 1998 0 Red Wing WWTP

Red Wing, MN MN0024571 Permitted POTW flow: 4 MGD http:// www. epa. gov/ npdescan/ m n0024571fp. pdf http:// www. epa. gov/ npdescan/ m n0024571fs. pdf 7/ 18/ 2003 Chromium  91% removal 40 CFR 425 Leather tannery S B Foot Tanning Company http:// www. sbfoot. com 1 Approved Removal Credits list updated May 18, 2005 POTW Date Approved Pollutant( s) Affected Industries Type Number Joint American Bottoms Regional Treatment Facility

Sauget, IL IL0065145 http:// www. epa. state. il. us/

publicnotices 2003/ sauget/ draft permit . pdf ONP and PNP approved 7/ 24/ 97 PNP % removal revised 1/ 13/ 03 In 2004, industrial process generating these pollutants was discontinued ortho nitrophenol (" ONP")

97.19% removal para nitrophenol (" PNP")

98.22% removal 40 CFR 414 OCPSF:

Solutia, Inc./ Flexsys 0 Joint American Bottoms Regional Treatment Facility

Sauget, IL IL0065145 http:// www. epa. state. il. us/

publicnotices 2003/ sauget/ draft permit . pdf 5/ 4/ 98 Cadmium  57% removal Zinc  83% removal 40 CFR 421.85, 40 CFR 421.95 Nonferrous Metals Manufacturing Big River Zinc Corporation  produces 100,000 tons per year of zinc as refined zinc metal, zinc alloys,

zinc powders, zinc sulfate monohydrate and zinc oxide as an electrolytic zinc refinery.

 produces over 150,000 tons per year of electrolytic or commercial grade sulfuric acid and is also a producer of high quality cadmium oxide.

http:// www. bigriverzinc. com/ who. html 1 Approved Removal Credits list updated May 18, 2005 POTW Date Approved Pollutant( s) Affected Industries Type Number Ashland STP  Ashland, KY KY0022373 2/ 8/ 1994 Ammonia  66% removal 40 CFR 420 Iron & Steel A. K. Steel  Ashland Works ( formerly ARMCO Steel) 1 SUMMARY Approved Removal Credits list updated May 18, 2005 POTW Date Approved Pollutant( s) Affected Industries Type Number 6 POTWs currently using Removal Credits ( with 8 POTWs' NPDES permits recognizing the credits)

2 POTWs not currently using the Removal Credits listed in their NPDES permits:

 Frank E. Van Lare WWTP,

Monroe County, NY  awaiting installation of equipment at POTW;

 City of Bethlehem, PA

removal credit still in permit, but industry receiving credit has ceased operation.

POTW Locations:

2 in Maine ( tanneries)

1 in New York ( Metal Molding)

1 in New Jersey ( Pharmaceutical)

1 in Pennsylvania ( iron & steel)

1 in Minnesota ( tannery)

1 in Illinois ( OCPSF,

Nonferrous)

1 in Kentucky ( iron & steel) 22 different pollutants ( 19 pollutants currently credited  15 at 1 CIU):

° Chromium at 3 POTWs  the leather tanneries)

° Phenols at 1 POTW

Metal Molding & Casting ( credit pending installation of equipment at POTW)

° Ammonia at 2 POTWs

Iron & Steel ( 1 credit is in POTW but industry not discharging)

° 15 organic compounds at 1 POTW for 1 CIU

Pharmaceutical manufacturer ° ONP and PNP ( phenols)

at 1 POTW for 1 CIU

OCPSF, but industry no longer operates the contributing process line ° Cadmium & Zinc at 1 POTW for 1 CIU

Nonferrous metal manufacturer 6 different industrial sectors represented, but only 4 sectors actively using removal credits 6 CIUs currently using the credits:

° 3 Leather Tanning facilities;

° 1 Pharmaceutical facility;

° 1 Iron & Steel facilities;

° 1 Nonferrous Metals Manufacturing facility ______________________________

Other CIUs with approved removal credits in the POTW permit, but CIU not actively using the credit:

° 1 Metal Molding and Casting facility ( combined with Metal Finishing operation)  at Frank E. Van Lare WWTP, which is awaiting installation of equipment at POTW;

° 1 OCPSF facility  removal credit is still in POTW permit, but facility ceased operation of contribution process;

° 1 Iron & Steel facility  removal credit is still in POTW permit, but facility ceased operation Key: * Shaded rows indicate inactive Removal Credits


DISCUSSION QUESTIONS FOR MOSQUITO REPELLENT STUDIES

The Human Studies Review Board (HSRB or Board) has discussed and
provided advice to EPA on scientific and ethical issues related to the
conduct of field studies to evaluate the efficacy of mosquito repellent
products.  The HSRB has reviewed both proposals for new field studies
and the results of completed studies.  The HSRB has noted that, although
there are many similarities across studies, not all studies employ the
same study design.  The HSRB has identified several methodological
issues for which additional background information would assist the
Board in its evaluation of such studies.

BACKGROUND

Currently, EPA requires all pesticide products that claim to repel
mosquitoes to provide data on the duration of efficacy under field
conditions at two biologically distinct sites.  These data are derived
from human research with subjects who have been treated with the
repellent formulations in the field.  The Agency evaluates the duration
of repellent efficacy for a subject by calculating the time from
application of the repellent to the occurrence of an event indicating an
efficacy failure.  Historically, for field studies of mosquito
repellency, EPA has used the “first confirmed bite” as an indication
of efficacy failure on a test subject.  Several recent studies have
shifted to the “first confirmed landing with intent to bite;” EPA
has accepted this alternative endpoint.  A “confirmed landing” on a
test subject is a mosquito landing followed by a second landing on the
same subject within a specified period of time (usually 30 minutes)
after the initial landing.

Field studies typically involve 6 – 10 subjects who have been treated
with a defined amount of the test material.  Each subject is then
regularly and repeatedly exposed to ambient mosquito populations for a
fixed interval of time until the subject experiences an efficacy failure
followed by a confirmation with the specified period of time. Mosquito
landing pressure (representing intent to bite) at a site is monitored by
concurrently exposing untreated subjects to mosquito landings.  A study
is considered valid only if there are at least a specified minimum
number of mosquito landings on untreated subjects during each exposure
interval.

On October 25, 2007, the HSRB will discuss scientific aspects of the
design of field studies to assess the efficacy of mosquito repellents.
For this meeting the Board has requested consultants to provide
specialized information or assistance to the Board.   The Board is
particularly interested in the frequency, duration and timing of
exposure of subjects to potential mosquito landings.  The Board requests
each consultant to respond briefly to the series of questions below.
Please send the responses to the HSRB Chair and Designated Federal
Official (DFO) at least one week before the meeting—i.e., by no later
than October 18.  All responses will subsequently be provided to the
other consultants, the HSRB members, and EPA staff for their review, and
will be posted on   HYPERLINK "http://www.regulations.gov/"
www.regulations.gov  under docket ID number, EPA-HQ-ORD-2007-0942.  HSRB
consultants will be available at the meeting to discuss their responses
and address questions from the Board.  The questions for Board
consultant consideration are provided below:

DISCUSSION QUESTIONS

·	What do data show about the variability of the time intervals between
first and subsequent landings in mosquito repellent field trials?

The literature indicates that the time intervals between first and
subsequent bites/landing is quite variable and depends on several
factors such as skin temperature, blood content and circulation, hairs
on skin surface, and density of mosquito population.  Normally first
5-15 minutes is sufficient for a mosquito to find the host and land/bite

·	What is the current scientific understanding of how factors other
than repellent efficacy could affect the likelihood that an initial
event—a mosquito landing or mosquito bite—would be “confirmed”
by another similar event within 30 minutes?  Please address at least
these factors:

Characteristics of mosquito populations

The mosquito population densities vary widely and there is a lack of
coordination and agreement among investigators on mosquito population
sizes or landing/biting rates.  It has been shown that insect
populations of different density do not provide equivalent estimates of
protection time when the test method used depends on fixed endpoint for
protection time such as first (or second) observed bite.  This may be
because the first (or second) insect bite in a small test population
represents a less extreme position in the tolerance distribution than
the first (or second) bite in a large population.

o	Characteristics of test sites

Weather conditions, test site terrain, vegetation, and proximity to
human dwellings probably can affect the mosquito host seeking and
landing/biting behavior.  It has been shown that temperature plays an
important role on the effectiveness and persistence of repellents.
Protection periods of the repellents tested decreased by an average of
7.6 minutes for each increase of 1° C in ambient temperature.

o	Characteristics of test subjects

Dr Strickman has adequately address the test subject characteristics in
his response

o	Characteristics of test methods

In bioassay test methods the responses of the mosquito population to the
test material are determined over time/application.  Test method design
and observation/collection techniques have the potential of
significantly impacting the study results.  Factors such as test
exposure skin surface between control and treated subjects, restricting
exposure of control subject to beginning and end of the test, by
preventing actual bites and counting landings instead, and selective
application of treatments or selection of control subjects.  Such
shortcuts or substitutions inevitably lead to ambiguity in the data
obtained because the biting activity of a mosquito population is in a
constant state of flux in course of any repellent field test.

It is suggested that the ideal test methods incorporating or simulating
activities of the end user application/protection from mosquito
landing/bites may provide beneficial and relevant information.

·	Can the impact of such factors on the likelihood or timing of an
initial and confirming event be predicted?  Can it be quantified?

In repellent studies, procedures for recoding landing/bites may be
either continuous recording, meaning that the observer records the
occurrence and time of each landing/bite from the beginning to the end
of the method, or time sampling, meaning that the observer records the
occurrence of landing/biting periodically during the method.  In
repellent studies the initial and confirming event (landing/bites)
cannot be predicted.

10/04/07

	Col. Raj Gupta’s Responses to Discussion Questions


DRAFT GUIDANCE FOR INDUSTRY:  gUIDE TO MINIMIZE MICROBIAL FOOD SAFETY
HAZARDS OF Leafy greens

DOCKET NO.  FDA-2009-D-0348

(FDA has verified the Web site addresses, but FDA is not responsible for
any subsequent changes to the Web sites after this document publishes in
the FEDERAL REGISTER.)

DOCUMENTS LISTED IN “V. REFERENCES” OF FEDERAL REGISTER NOTICE

Gorny, J., et al., Eds., Commodity Specific Food Safety Guidelines for
the Lettuce and Leafy Greens Supply Chain (1st edition); International
Fresh-cut Produce Ass’n, Produce Marketing Ass’n, United Fresh Fruit
and Vegetable Ass’n, Western Growers Ass’n; April 25, 2006.
Accessed online at   HYPERLINK
"http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/FruitsVe
getablesJuices/GuidanceComplianceRegulatoryInformation/ucm168630.htm"
http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/FruitsVeg
etablesJuices/GuidanceComplianceRegulatoryInformation/ucm168630.htm .
(See Reference 7 below.)

Commodity Specific Food Safety Guidelines for the Production and Harvest
of Lettuce and Leafy Greens; Produce Marketing Ass’n, United Fresh
Fruit and Vegetable Ass’n, and Western Growers Ass’n; last revised
June 13, 2008.  Accessed online at    HYPERLINK
"http://www.caleafygreens.ca.gov/trade/documents/LGMAAcceptedGAPs06.13.0
8.pdf"
http://www.caleafygreens.ca.gov/trade/documents/LGMAAcceptedGAPs06.13.08
.pdf .  (See Reference 8 below.)

________________________

DOCUMENTS LISTED IN “X. REFERENCES” OF DRAFT GUIDANCE

1.         U.S. Food and Drug Administration (FDA), 1996-2008 Produce
Outbreaks (unpublished data).

2.         Institute of Food Technologists and FDA.    HYPERLINK
"http://www.cfsan.fda.gov/~comm/ift3-toc.html"  Analysis and Evaluation
of Preventative Control Measures for the Control and
Reduction/Elimination of Microbial Hazards on Fresh and Fresh-Cut
Produce . September 2001. (  HYPERLINK
"http://www.fda.gov/Food/ScienceResearch/ResearchAreas/SafePracticesforF
oodProcesses/ucm090977.htm"
http://www.fda.gov/Food/ScienceResearch/ResearchAreas/SafePracticesforFo
odProcesses/ucm090977.htm ) (accessed 7/14/09).

3.         Mead, P.S., et al, Food-Related Illness and Death in the
United States. Journal of Environmental Health, 2000. 62: 9-18.

4.         Allos, B.M., et al., Surveillance for Sporadic Foodborne
Disease in the 21st Century: The FoodNet Perspective. Clinical
Infectious Disease, 2004. 38(Suppl 3): S115-120.

5.         Lampel, K.A., Orlandi, P.A., and Kornegay, L., Improved
Template Preparations for PCR-Based Assays for Detection of Food-Borne
Bacterial Pathogens. Applied and Environmental Microbiology, 2000.
66(10): 4539-4542.

6.         Sivapalasingam, S., et al., Fresh Produce: A Growing Cause of
Outbreaks of Foodborne Illness in the United States, 1973 through 1997.
Journal of Food Protection, 2000. 67(10): 2342-2353.

7.         Gorny, J., et al., Eds. Commodity Specific Food Safety
Guidelines for the Lettuce and Leafy Greens Supply Chain (1st edition);
International Fresh-cut Produce Ass’n, Produce Marketing Ass’n,
United Fresh Fruit and Vegetable Ass’n, Western Growers Ass’n; April
25, 2006.   Accessed online at   HYPERLINK
"http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/FruitsVe
getablesJuices/GuidanceComplianceRegulatoryInformation/ucm168630.htm"
http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/FruitsVeg
etablesJuices/GuidanceComplianceRegulatoryInformation/ucm168630.htm .

8.	Commodity Specific Food Safety Guidelines for the Production and
Harvest of Lettuce and Leafy Greens; Produce Marketing Ass’n, United
Fresh Fruit and Vegetable Ass’n, and Western Growers Ass’n; last
revised June 13, 2008.    Accessed online at    HYPERLINK
"http://www.caleafygreens.ca.gov/trade/documents/LGMAAcceptedGAPs06.13.0
8.pdf"
http://www.caleafygreens.ca.gov/trade/documents/LGMAAcceptedGAPs06.13.08
.pdf .

9.	Solomon, E.B., Pang, H.J., and Matthews, K.R., Persistence of
Escherichia coli O157:H7 on Lettuce Plants following Spray Irrigation
with Contaminated Water. Journal of Food Protection, 2003.
66(12):2198-2202.

10.	Fukushima, H.K. Hoshina, and Goymoda, M., Long-term survival of
Shiga toxin-producing Eschericia coli O26, O111 and O157 in bovine
feces. Applied and Environmental Microbiology, 1999. 65:5177-5181.

11.	Gagliardi, J.V. and Karns, J.S., Leaching of Escherichia coli
O157:H7 in diverse soils under various agricultural management
practices. Applied and Environmental Microbiology, 2000. 66(3):877-883.

12.       Jiang, X., Morgan, J., and Doyle, M.P., Fate of Escherichia
coli O157:H7 in manure-amended soil. Applied and Environmental
Microbiology, 2002. 71:2221-2225.

13.       Franz, E., et al., Effects of cattle feeding regimen and soil
management type on the fate of    Escherichia coli  O157:H7 and
Salmonella enterica serovar typhimurium in manure, manure-amended soil,
and lettuce.  Applied and Environmental Microbiology, 2005.
71:6165-6177.

14.       Kudva, I.T., Blanch, K. and Hovde, C.J., Analysis of
Escherichia coli  O157:H7 survival in ovine or bovine manure and manure
slurry. Applied and Environmental Microbiology, 1998. 64:3166-3174.

15.       Jiang, X., Morgan, J., and Doyle, M.P., Fate of Escherichia
coli O157:H7 during composting of bovine manure in a laboratory-scale
bioreactor. Journal of Food Protection, 2003. 66(1):25-30.

16.       Jiang, X., Morgan, J., and Doyle, M.P., Thermal Inactivation
of Escherichia coli O157:H7 in cow manure compost. Journal of Food
Protection, 2003. 66(10):1771–1777.

17.       Islam, M., et al., Persistence of Enterohemorrhagic
Escherichia coli O157:H7 in Soil and on Leaf Lettuce and Parsley Grown
in Fields Treated with Contaminated Manure Composts or Irrigation Water.
Journal of Food Protection, 2004. 67(7):1365-1370.

18.       Van Elsas, J.D., et al., Survival of genetically marked
Escherichia coli O157:H7 in soil as affected by soil microbial community
shifts. The ISME journal, 2007. 1:204-214.

19.       Suslow, T.V., Assessment of indicator bacteria in lettuce
production environments.  California Lettuce Research Board, Annual
Report 2004 – 2005. Salinas, CA. p. 235–249, 2005.

20.       Suslow, T.V., et al., Production practices as risk factors in
microbial food safety of fresh  and fresh-cut produce.  Comprehensive
Reviews in Food Science and Food Safety.  2003. 2S:38-77.

21.      Takeuchi, K. and Frank, J.F. Expression of Red-Shifted Green
Fluorescent Protein by Escherichia coli O157:H7 as a Marker for the
Detection of Cells on Fresh Produce. Journal of Food Protection, 2001.
64(3):298-304.

22.       Wachtel, M.R., Whitehand, L.C., and Mandrell, R.E.,
Association of Escherichia coli O157:H7 with Preharvest Leaf Lettuce
upon Exposure to Contaminated Irrigation Water. Journal of Food
Protection, 2002. 65(1):18-25.

23.      Wachtel, M.R., Whitehand, L.C., and Mandrell, R.E., Prevalence
of Escherichia coli Associated with a Cabbage Crop Inadvertently
Irrigated with Partially Treated Sewage Wastewater. Journal of Food
Protection, 2002. 65(3)471-475.

24.      Wells, J.M. and Butterfield, J.E., Salmonella contamination
associated with bacterial soft rot of fresh fruits and vegetables in the
marketplace. Plant Disease, 1997. 81:867-872.

25.	Wachtel, M.R. and Charkowski, A.O., Cross-Contamination of Lettuce
with Escherichia coli O157:H7. Journal of Food Protection, 2002.
65(3)465-470.

________________________

 PAGE

 PAGE   3