16. Section 60.46b is amended by revising paragraphs (a) and (b) and
adding paragraphs (i) and (j) to read as follows:
* * * * *

Sec.  60.46b  Compliance and performance test methods and procedures
for particulate matter and nitrogen oxides.

    (a) The particulate matter emission standards and opacity limits
under Sec.  60.43b apply at all times except during periods of startup,
shutdown, or malfunction, and as specified in paragraphs (i) and (j) of
this section. The nitrogen oxides emission standards under Sec.  60.44b
apply at all times.
    (b) Compliance with the particulate matter emission standards under
Sec.  60.43b shall be determined through performance testing as
described in paragraph (d) of this section, except as provided in
paragraph (i) and (j).
* * * * *
    (i) Units burning only oil that contains no more than 0.3 weight
percent sulfur or liquid or gaseous fuels with a potential sulfur
dioxide emission rates of 140 ng/J (0.32 lb/MMBtu) heat input or less
may demonstrate compliance by maintaining fuel supplier certifications
of the sulfur content of the fuels burned.
    (j) In place of particulate matter testing with EPA Reference
Method 5, 5B, or 17, an owner or operator may elect to install,
calibrate, maintain, and operate a continuous emission monitoring
system for monitoring particulate matter emissions discharged to the
atmosphere and record the output of the system. The owner or operator
of an affected facility who elects to continuously monitor particulate
matter emissions instead of conducting performance testing using EPA
Method 5, 5B, or 17 shall comply with the requirements specified in
paragraphs (j)(1) through (j)(13) of this section.
    (1) Notify the Administrator one month before starting use of the
system.
    (2) Notify the Administrator one month before stopping use of the
system.
    (3) The monitor shall be installed, evaluated, and operated in
accordance with Sec.  60.13 of subpart A of this part.
    (4) The initial performance evaluation shall be completed no later
than 180 days after the date of initial startup of the affected
facility, as specified under Sec.  60.8 of subpart A of this part or
within 180 days of notification to the Administrator of use of the
continuous monitoring system if the owner or operator was previously
determining compliance by Method 5, 5B, or 17 performance tests,
whichever is later.
    (5) The owner or operator of an affected facility shall conduct an
initial performance test for particulate matter emissions as required
under Sec.  60.8 of subpart A of this part. Compliance with the
particulate matter emission limit shall be determined by using the
continuous emission monitoring system specified in paragraph (j) of
this section to measure particulate matter and calculating a 24-hour
block arithmetic average emission concentration using EPA Reference
Method 19, section 4.1.
    (6) Compliance with the particulate matter emission limit shall be
determined based on the 24-hour daily (block) average of the hourly
arithmetic average emission concentrations using continuous emission
monitoring system outlet data.
    (7) At a minimum, valid continuous monitoring system hourly
averages shall be obtained as specified in paragraphs (j)(7)(i) of this
section for 75 percent of the total operating hours per 30-day rolling
average.
    (i) At least two data points per hour shall be used to calculate
each 1-hour arithmetic average.
    (8) The 1-hour arithmetic averages required under paragraph (j)(7)
of this section shall be expressed in ng/J or lb/MMBtu heat input and
shall be used to calculate the boiler operating day daily arithmetic
average emission concentrations. The 1-hour arithmetic averages shall
be calculated using the data points required under Sec.  60.13(e)(2) of
subpart A of this part.
    (9) All valid continuous emission monitoring system data shall be
used in calculating average emission concentrations even if the minimum
continuous emission monitoring system data requirements of paragraph
(j)(7) of this section are not met.
    (10) The continuous emission monitoring system shall be operated
according to Performance Specification 11 in appendix B of this part.
    (11) During the correlation testing runs of the continuous emission
monitoring system required by Performance Specification 11 in appendix
B of this part, particulate matter and oxygen (or carbon dioxide) data
shall be collected concurrently (or within a 30- to 60-minute period)
by both the continuous emission monitors and the test methods specified
in paragraphs (j)(7)(i) of this section.
    (i) For particulate matter, EPA Reference Method 5, 5B, or 17 shall
be used.
    (ii) For oxygen (or carbon dioxide), EPA reference Method 3, 3A, or
3B, as applicable shall be used.
    (12) Quarterly accuracy determinations and daily calibration drift
tests shall be performed in accordance with procedure 2 in appendix F
of this part. Relative Response Audit's must be performed annually and
Response Correlation Audits must be performed every 3 years.
    (13) When particulate matter emissions data are not obtained
because of continuous emission monitoring system breakdowns, repairs,
calibration checks, and zero and span adjustments, emissions data shall
be obtained by using other monitoring systems as approved by the
Administrator or EPA Reference Method 19 to provide, as necessary,
valid emissions data for a minimum of 75 percent of total operating
hours per 30-day rolling average.

0
17. Section Sec.  60.47b is amended by revising paragraphs (a) and (d),
and adding paragraph (g) to read as follows:

Sec.  60.47b  Emission monitoring for sulfur dioxide.

    (a) Except as provided in paragraphs (b),(f), and (g) of this
section, the owner or operator of an affected facility subject to the
sulfur dioxide standards under Sec.  60.42b shall install, calibrate,
maintain, and operate continuous emission monitoring systems (CEMS)

for measuring sulfur dioxide concentrations and either oxygen
(O2) or carbon dioxide (CO2) concentrations and
shall record the output of the systems. The sulfur dioxide and either
oxygen or carbon dioxide concentrations shall both be monitored at the
inlet and outlet of the sulfur dioxide control device.
* * * * *
    (d) The 1-hour average sulfur dioxide emission rates measured by
the CEMS required by paragraph (a) of this section and required under
Sec.  60.13(h) is expressed in ng/J or lb/MMBtu heat input and is used
to calculate the average emission rates under Sec.  60.42(b). Each 1-
hour average sulfur dioxide emission rate must be based on 30 or more
minutes of steam generating unit operation. The hourly averages shall
be calculated according to Sec.  60.13(h)(2). Hourly sulfur dioxide
emission rates are not calculated if the affected facility is operated
less than 30 minutes in a given clock hour and are not counted toward
determination of a steam generating unit operating day.
* * * * *
    (g) Units burning any fuel with a potential sulfur dioxide emission
rate of 140 ng/J (0.32 lb/MMBtu) heat input or less are not required to
conduct emissions monitoring if they maintain fuel supplier
certifications of the sulfur content of the fuels burned.

0
18. Section 60.48b is amended by revising paragraphs (a), (b)
introductory text, (d), and adding paragraphs (j) and (k) to read as
follows:

Sec.  60.48b  Emission monitoring for particulate matter and nitrogen
oxides.

    (a) The owner or operator of an affected facility subject to the
opacity standard under Sec.  60.43b shall install, calibrate, maintain,
and operate a continuous monitoring system for measuring the opacity of
emissions discharged to the atmosphere and record the output of the
system, except as provided in paragraphs (j) and (k) of this section.
    (b) Except as provided under paragraphs (g), (h), and (i) of this
section, the owner or operator of an affected facility subject to a
nitrogen oxides standard under Sec.  60.44b shall comply with either
paragraphs (b)(1) or (b)(2) of this section.
* * * * *
    (d) The 1-hour average nitrogen oxides emission rates measured by
the continuous nitrogen oxides monitor required by paragraph (b) of
this section and required under Sec.  60.13(h) shall be expressed in
ng/J or lb/MMBtu heat input and shall be used to calculate the average
emission rates under Sec.  60.44b. The 1-hour averages shall be
calculated using the data points required under Sec.  60.13(h)(2).
* * * * *
    (j) Units that burn only oil that contains no more than 0.3 weight
percent sulfur or liquid or gaseous fuels with potential sulfur dioxide
emission rates of 140 ng/J (0.32 lb/MMBtu) heat input or less are not
required to conduct PM emissions monitoring if they maintain fuel
supplier certifications of the sulfur content of the fuels burned.
    (k) Owners or operators complying with the PM emission limit by
using a PM CEMs monitor instead of monitoring opacity must calibrate,
maintain, and operate a continuous monitoring system, and record the
output of the system, for PM emissions discharged to the atmosphere as
specified in Sec.  60.46b(j). The continuous monitoring systems
specified in paragraph Sec.  60.46b(j) shall be operated and data
recorded during all periods of operation of the affected facility
except for continuous monitoring system breakdowns and repairs. Data is
recorded during calibration checks, and zero and span adjustments.

Subpart Dc--[Amended]

0
19. Section 60.40c is amended by adding paragraphs (e), (f), and (g) to
read as follows:

Sec.  60.40c  Applicability and delegation of authority.

* * * * *
    (e) Heat recovery steam generators that are associated with
combined cycle gas turbines and meet the applicability requirements of
subpart KKKK of this part are not subject to this subpart. This subpart
will continue to apply to all other heat recovery steam generators that
are capable of combusting more than or equal to 2.9 MW (10 MMBtu/h)
heat input of fossil fuel but less than or equal to 29 MW (100 MMBtu/h)
heat input of fossil fuel. If the heat recovery steam generator is
subject to this subpart, only emissions resulting from combustion of
fuels in the steam generating unit are subject to this subpart. (The
gas turbine emissions are subject to subpart GG or KKKK, as applicable,
of this part).
    (f) Any facility covered by subpart AAAA of this part is not
covered by this subpart.
    (g) Any facility covered by an EPA approved State or Federal
section 111(d)/129 plan implementing subpart BBBB of this part is not
covered by this subpart.

0
20. Section 60.41c is amended by revising the definition of coal to
read as follows:

Sec.  60.41c  Definitions.

* * * * *
    Coal means all solid fuels classified as anthracite, bituminous,
subbituminous, or lignite by the American Society of Testing and
Materials in ASTM D388-77, 90, 91, 95, or 98a, Standard Specification
for Classification of Coals by Rank (IBR--see Sec.  60.17), coal
refuse, and petroleum coke. Coal-derived synthetic fuels derived from
coal for the purposes of creating useful heat, including but not
limited to solvent refined coal, gasified coal, coal-oil mixtures, and
coal-water mixtures, are also included in this definition for the
purposes of this subpart.
* * * * *

0
21. Section 60.42c is amended by revising paragraphs (a), (b)
introductory text, and (b)(1) to read as follows:

Sec.  60.42c  Standard for sulfur dioxide.

    (a) Except as provided in paragraphs (b), (c), and (e) of this
section, on and after the date on which the performance test is
completed or required to be completed under Sec.  60.8 of this part,
whichever date comes first, the owner or operator of an affected
facility that combusts only coal shall neither: Cause to be discharged
into the atmosphere from the affected facility any gases that contain
SO2 in excess of 87 ng/J (0.20 lb/MMBtu) heat input or 10
percent (0.10) of the potential SO2 emission rate (90
percent reduction), nor cause to be discharged into the atmosphere from
the affected facility any gases that contain SO2 in excess
of 520 ng/J (1.2 lb/MMBtu) heat input. If coal is combusted with other
fuels, the affected facility is subject to the 90 percent
SO2 reduction requirement specified in this paragraph and
the emission limit is determined pursuant to paragraph (e)(2) of this
section.
    (b) Except as provided in paragraphs (c) and (e) of this section,
on and after the date on which the performance test is completed or
required to be completed under Sec.  60.8 of this part, whichever date
comes first, the owner or operator of an affected facility that:
    (1) Combusts only coal refuse alone in a fluidized bed combustion
steam generating unit shall neither:
    (i) Cause to be discharged into the atmosphere from that affected
facility any gases that contain SO2 in excess of 87 ng/J
(0.20 lb/MMBtu) heat input or 20 percent (0.20) of the potential
SO2 emission rate (80 percent reduction), nor

    (ii) Cause to be discharged into the atmosphere from that affected
facility any gases that contain SO2 in excess of
SO2 in excess of 520 ng/J (1.2 lb/MMBtu) heat input. If coal
is fired with coal refuse, the affected facility subject to paragraph
(a) of this section. If oil or any other fuel (except coal) is fired
with coal refuse, the affected facility is subject to the 90 percent
SO2 reduction requirement specified in paragraph (a) of this
section and the emission limit is determined pursuant to paragraph
(e)(2) of this section.
* * * * *

0
22. Section 60.43c is amended by adding paragraph (e) to read as
follows:

Sec.  60.43c  Standard for particulate matter.

* * * * *
    (e)(1) On or after the date on which the initial performance test
is completed or is required to be completed under Sec.  60.8, whichever
date comes first, no owner or operator of an affected facility that
commences construction, reconstruction, or modification after February
28, 2005, and that combusts coal, oil, gas, wood, a mixture of these
fuels, or a mixture of these fuels with any other fuels and has a heat
input capacity of 8.7 MW (30 MMBtu/h) or greater shall cause to be
discharged into the atmosphere from that affected facility any gases
that contain particulate matter emissions in excess of 13 ng/J (0.030
lb/MMBtu) heat input, except as provided in paragraphs (e)(2) and
(e)(3) of this section. Affected facilities subject to this paragraph,
are also subject to the requirements of paragraphs (c) and (d) of this
section.
    (2) As an alternative to meeting the requirements of paragraph
(e)(1) of this section, the owner or operator of an affected facility
for which modification commenced after February 28, 2005, may elect to
meet the requirements of this paragraph. On and after the date on which
the performance test required to be conducted under Sec.  60.8 is
completed, the owner or operator subject to the provisions of this
subpart shall not cause to be discharged into the atmosphere from any
affected facility for which modification commenced after February 28,
2005, any gases that contain particulate matter in excess of:
    (i) 22 ng/J (0.051 lb/MMBtu) heat input derived from the combustion
of coal, oil, gas, wood, a mixture of these fuels, or a mixture of
these fuels with any other fuels, and
    (ii) 0.2 percent of the combustion concentration (99.8 percent
reduction) when combusting coal, oil, gas, wood, a mixture of these
fuels, or a mixture of these fuels with any other fuels.
    (3) On or after the date on which the initial performance test is
completed or is required to be completed under Sec.  60.8, whichever
date comes first, no owner or operator of an affected facility that
commences modification after February 28, 2005, and that combusts over
30 percent wood (by heat input) on an annual basis and has a heat input
capacity of 8.7 MW (30 MMBtu/h) or greater shall cause to be discharged
into the atmosphere from that affected facility any gases that contain
particulate matter emissions in excess of 43 ng/J (0.10 lb/MMBtu) heat
input.

0
23. Section 60.45c is amended by revising the introductory text in
paragraph (a) and adding paragraphs (c) and (d) to read as follows:

Sec.  60.45c  Compliance and performance test methods and procedures
for particulate matter.

    (a) The owner or operator of an affected facility subject to the PM
and/or opacity standards under Sec.  60.43c shall conduct an initial
performance test as required under Sec.  60.8, and shall conduct
subsequent performance tests as requested by the Administrator, to
determine compliance with the standards using the following procedures
and reference methods, except as specified in paragraph (c) and (d) of
this section.
* * * * *
    (c) Units that burn only oil containing no more than 0.5 weight
percent sulfur or liquid or gaseous fuels with potential sulfur dioxide
emission rates of 230 ng/J (0.54 lb/MMBtu) heat input or less are not
required to conduct emissions monitoring if they maintain fuel supplier
certifications of the sulfur content of the fuels burned.
    (d) In place of particulate matter testing with EPA Reference
Method 5, 5B, or 17, an owner or operator may elect to install,
calibrate, maintain, and operate a continuous emission monitoring
system for monitoring particulate matter emissions discharged to the
atmosphere and record the output of the system. The owner or operator
of an affected facility who elects to continuously monitor particulate
matter emissions instead of conducting performance testing using EPA
Method 5, 5B, or 17 shall install, calibrate, maintain, and operate a
continuous emission monitoring system and shall comply with the
requirements specified in paragraphs (d)(1) through (d)(13) of this
section.
    (1) Notify the Administrator 1 month before starting use of the
system.
    (2) Notify the Administrator 1 month before stopping use of the
system.
    (3) The monitor shall be installed, evaluated, and operated in
accordance with Sec.  60.13 of subpart A of this part.
    (4) The initial performance evaluation shall be completed no later
than 180 days after the date of initial startup of the affected
facility, as specified under Sec.  60.8 of subpart A of this part or
within 180 days of notification to the Administrator of use of the
continuous monitoring system if the owner or operator was previously
determining compliance by Method 5, 5B, or 17 performance tests,
whichever is later.
    (5) The owner or operator of an affected facility shall conduct an
initial performance test for particulate matter emissions as required
under Sec.  60.8 of subpart A of this part. Compliance with the
particulate matter emission limit shall be determined by using the
continuous emission monitoring system specified in paragraph (d) of
this section to measure particulate matter and calculating a 24-hour
block arithmetic average emission concentration using EPA Reference
Method 19, section 4.1.
    (6) Compliance with the particulate matter emission limit shall be
determined based on the 24-hour daily (block) average of the hourly
arithmetic average emission concentrations using continuous emission
monitoring system outlet data.
    (7) At a minimum, valid continuous monitoring system hourly
averages shall be obtained as specified in paragraph (d)(7)(i) of this
section for 75 percent of the total operating hours per 30-day rolling
average.
    (i) At least two data points per hour shall be used to calculate
each 1-hour arithmetic average.
    (ii) [Reserved]
    (8) The 1-hour arithmetic averages required under paragraph (d)(7)
of this section shall be expressed in ng/J or lb/MMBtu heat input and
shall be used to calculate the boiler operating day daily arithmetic
average emission concentrations. The 1-hour arithmetic averages shall
be calculated using the data points required under Sec.  60.13(e)(2) of
subpart A of this part.
    (9) All valid continuous emission monitoring system data shall be
used in calculating average emission concentrations even if the minimum
continuous emission monitoring system data requirements of paragraph
(d)(7) of this section are not met.
    (10) The continuous emission monitoring system shall be operated
according to Performance Specification 11 in appendix B of this part.
    (11) During the correlation testing runs of the continuous emission
monitoring system required by Performance Specification 11 in

appendix B of this part, particulate matter and oxygen (or carbon
dioxide) data shall be collected concurrently (or within a 30- to 60-
minute period) by both the continuous emission monitors and the test
methods specified in paragraph (d)(7)(i) of this section.
    (i) For particulate matter, EPA Reference Method 5, 5B, or 17 shall
be used.
    (ii) For oxygen (or carbon dioxide), EPA reference Method 3, 3A, or
3B, as applicable shall be used.
    (12) Quarterly accuracy determinations and daily calibration drift
tests shall be performed in accordance with procedure 2 in appendix F
of this part. Relative Response Audit's must be performed annually and
Response Correlation Audits must be performed every 3 years.
    (13) When particulate matter emissions data are not obtained
because of continuous emission monitoring system breakdowns, repairs,
calibration checks, and zero and span adjustments, emissions data shall
be obtained by using other monitoring systems as approved by the
Administrator or EPA Reference Method 19 to provide, as necessary,
valid emissions data for a minimum of 75 percent of total operating
hours on a 30-day rolling average.

0
24. Section 60.47c is amended by revising paragraph (a) and adding
paragraphs (c) and (d) to read as follows:

Sec.  60.47c  Emission monitoring for particulate matter.

    (a) The owner or operator of an affected facility combusting coal,
oil, gas, or wood that is subject to the opacity standards under Sec.
60.43c shall install, calibrate, maintain, and operate a COMS for
measuring the opacity of the emissions discharged to the atmosphere and
record the output of the system, except as specified in paragraphs (c)
and (d) of this section.
* * * * *
    (c) Units that burn only oil that contains no more than 0.5 weight
percent sulfur or liquid or gaseous fuels with potential sulfur dioxide
emission rates of 230 ng/J (0.54 lb/MMBtu) heat input or less are not
required to conduct PM emissions monitoring if they maintain fuel
supplier certifications of the sulfur content of the fuels burned.
    (d) Owners or operators complying with the PM emission limit by
using a PM CEMS monitor instead of monitoring opacity must calibrate,
maintain, and operate a continuous monitoring system, and record the
output of the system, for PM emissions discharged to the atmosphere as
specified in Sec.  60.45c(d). The continuous monitoring systems
specified in paragraph Sec.  60.45c(d) shall be operated and data
recorded during all periods of operation of the affected facility
except for continuous monitoring system breakdowns and repairs. Data is
recorded during calibration checks, and zero and span adjustments.

0
25. Section 60.48c is amended by revising paragraph (g) to read as
follows:

Sec.  60.48c  Reporting and recordkeeping requirements.

* * * * *
    (g) The owner or operator of each affected facility shall record
and maintain records of the amounts of each fuel combusted during each
day. The owner or operator of an affected facility that only burns very
low sulfur fuel oil or other liquid or gaseous fuels with potential
sulfur dioxide emissions rate of 140 ng/J (0.32 lb/MMBtu) heat input or
less shall record and maintain records of the fuels combusted during
each calendar month.
* * * * *
[FR Doc. 06-1460 Filed 2-24-06; 8:45 am]

BILLING CODE 6560-50-P


MEMORANDUM

Date:	August 9, 2011

Subject:	Estimated Cost Impact for Mineral Wool Production Industry to Comply with Proposed Residual Risk and Technology Review (RTR) Amendments

Mineral Wool Production  RTR

RTI Project No. 0210426.010

From:	Dave Reeves, RTI International

To:	Susan Fairchild

OAQPS/SPPD/NRG (D243-02)

U.S. Environmental Protection Agency

The purpose of this memorandum is to present the estimated costs related to the mineral wool production source category for their processes and facilities to comply with the proposed RTR amendments and associated emission limits.

BACKGROUND

Based on the information provided by the mineral wool production industry and their primary trade association, North American Insulation Manufacturers Association (NAIMA), there are currently 7 facilities in the U.S. producing mineral wool. We estimate that all 7 of those facilities will incur additional testing cost to demonstrate compliance with the new (proposed) carbonyl sulfide (COS), hydrogen fluoride (HF), and hydrogen chloride (HCl) emission limits for cupolas.  One facility will also incur additional annual costs to purchase low-sulfur raw materials in order to comply with the proposed COS emission limit for cupolas.  We also estimate that the 3 facilities with bonded product lines will incur additional testing cost to demonstrate compliance with the revised formaldehyde and new (proposed) phenol and methanol emission limits that will apply to collection and curing operations combined.  Table 1 summarizes the above information and the associated cost impacts.

Table 1.  Summary of Mineral Wool Production Facilities Costs to Comply with RTR Amendments

	Cupolasa

Total  Facility Costs

Low-Sulfur Mat'ls	#	Testing	Collection/Curing

Facility	Location	Incremental Cost	Cupolas	Costb	# Bonded Lines	Test Costc

Industrial Insulation Group (IIG)	Phenix City, AL

0	1	18,000	1	14,000

32,000

Thermafiber	Wabash IN

0	2	34,000	1	14,000

48,000

USG Interiors	Red Wing, MN

0	2	34,000	0	0

34,000

USG Interiors	Walworth, WI

0	1	18,000	0	0

18,000

Amerrock Products	Nolanville, TX

0	2	34,000	0	0

34,000

Isolatek Int’l	Huntington, IN

0	2	34,000	0	0

34,000

Rock Wool Mfg	Leeds, AL

360,000	1	18,000	1	14,000

392,000

	SubTotal  	$360,000	11	$190,000	3	$42,000

$592,000

a – 6 of the 11 cupolas currently have incineration control (RTOs); Rock Wool is the only facility that is not currently meeting the proposed COS limit based on emission testing results provided by industry.  Low-sulfur material incremental cost based on an estimated 50% increase (per ton) of slag costs.  No other facility is expected to have any additional equipment or material cost impacts.

b – Cupola testing costs reflect incremental costs for COS, HF, and HCl testing; current test requirements for PM not included.

c – Collection/curing costs reflect incremental costs for phenol and methanol testing; current test requirements for formaldehyde not included.

COMPLIANCE TESTING COSTS

Mr. Stef Johnson of EPA’s Measurement Policy Group provided the following estimates for compliance testing based on the test methods being proposed in the RTR amendments:

Emission Source	HAP	Test Method	Test Cost	Comment

Cupola	COS	318	$14,000	$12,000 for each additional test

	HF and HCl	320

(add-on to M318 FTIR)	$4,000 (combined HF/HCl)	In addition to COS

testing cost

Collection/ Curing  (combined)	Phenol and Methanol (already testing for formaldehyde)	318	$14,000 (combined Phenol & Methanol)	$12,000 for each additional test

III.	LOW- SULFUR RAW MATERIAL COSTS

Based on the emission test data provided in the ICR responses, we estimate that only one facility (Rock Wool Manufacturing) is not currently meeting the proposed COS emission limit for cupolas.  We assumed that the least costly compliance option would be for the facility to switch to low-sulfur raw materials to reduce the amount of COS generated in the cupolas.

Rock Wool reported that slag comprises approximately 90% of the raw material going into their cupola.  Since there is no readily available source of low-sulfur slag, we estimated an incremental cost of 50% more (per ton) for switching to other low-sulfur raw materials.  No raw material cost information was provided by any of the companies, so we assumed a 50% cost increase per ton and then used Rock Wool’s reported annual slag usage to calculate an annual raw material cost increase of $360,000. (Production data and raw material usage and costs are considered confidential business information).

  PAGE  4

  PAGE   \* MERGEFORMAT  3


From<EMAIL_ADDRESS>Sent:	Wednesday, June 10, 2009 11:54 AM To:	Schaffner, Karen S. Cc<EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS>   Karen     Dr. Erickson has asked me to review the paragraph on the Delta Wing mixers.  I have added my  comments.  Please call me if you have any questions.     Thank you for your help.             The Delta Wing mixers have several functions in an SCR. One application is as static  mixers installed in the duct just prior to the SCR reactor and sometimes after the  reactors, there mixers are used to straighten and  homogenize the flue gas  (temperature, NOx, and dust)   The mixer plates are made of carbon steel and the cost  for installation of the Delta Wing includes the capital cost of the equipment and the  modeling to determine its location to maximize its mixing effect. A second application is  for mixing and injecting ammonia.   Because each application of the Delta Wing mixer is  different, it is difficult to cite a cost and Babcock Power typically does not have a  breakout cost for the Delta Wing mixer.  A cost for installing the mixer and conducting  the modeling would typically be less than $500,000, although for an SCR that was  originally installed without a static mixer, the cost to retrofit the SCR with a mixer could  be up to $1,000,000 to account for the capital, the modeling, and any other retrofit  issues.

Tony  Licat a   Vice  Presid ent   Babco ck  Power  Envir onme ntal  Inc.   5  Nepo nset  Street   Worc ester,  MA  01606       T:  508- 854- 3853  F:  508- 853- 2572   M:  508- 615- 0317       tlicata @bab cockp ower. com   http:// www. babco ckpo wer.c om     ********************* Think Before You Print ******************************  This e-mail and any attachments are intended only for the named  recipient(s) and may contain information that is legally privileged,   confidential and/or exempt from disclosure under applicable law. If you   have received this message in error and are not the intended recipient(s),   you may not retain, copy or use this e-mail or any attachment for any   purpose or disclose all or any part of the contents to any other person or   entity. Any such dissemination, distribution or copying of this e-mail or   its attachments is strictly prohibited. If you are not the intended   recipient(s), please immediately notify the sender and permanently delete   this e-mail and any attachments from your computer.   http://www.babcockpower.com  ***************************************************************************


[Federal Register: March 21, 2006 (Volume 71, Number 54)]
[Notices]
[Page 14268-14272]
[DOCID:fr21mr06-129]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53484; File No. SR-ISE-2005-25]

Self-Regulatory Organizations; International Securities Exchange,
Inc.; Notice of Filing and Order Granting Accelerated Approval to a
Proposed Rule Change and Amendment No. 1 Thereto Relating to Trading
Options on Full and Reduced Values of the FTSE 100 Index and the FTSE
250 Index, Including Long-Term Options

March 14, 2006.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on May 16, 2005, the International Securities Exchange, Inc. (the
``Exchange'' or the ``ISE'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I and II below, which Items have been prepared by the ISE. On
February 22, 2006, the Exchange filed Amendment No. 1 to the proposed
rule change.\3\ The Commission is publishing this notice to solicit
comments on the proposed rule change, as amended, from interested
persons. In addition, the Commission is granting accelerated approval
of the proposed rule change, as amended.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Form 19b-4 dated February 22, 2006. (``Amendment No.
1''). In Amendment No. 1, which replaced the original filing in its
entirety, the Exchange: (1) Expanded the ``purpose'' section to
include additional information about the components, and calculation
and maintenance of the FTSE Indexes; and (2) obtained a
representation by the FTSE regarding FTSE's insider trading and non-
disclosure policies as they pertain to broker-dealer members of the
FTSE committees that determine the composition of the indexes.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The ISE is proposing to amend its rules to trade options on full
and reduced values of the FTSE 100 Index and the FTSE 250 Index. The
Exchange also proposes to list and trade long-term options on full and
reduced values of the FTSE 100 Index and the FTSE 250 Index. Options on
these indexes will be a.m. cash-settled and will have European-style
exercise provisions. The text of this proposed rule change is available
on the Exchange's Web site at http://www.iseoptions.com/legal/proposed_rule_changes.asp
, the Exchange's principal office, and in

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 ISE 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 III 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 its Rules 2001, 2004 and 2009 to
provide for the listing and trading on the Exchange of a.m. cash-
settled, European-style, index options on the FTSE 100 Index and the
FTSE 250 Index (collectively, the ``FTSE Indexes''). Specifically, the
Exchange proposes to list options based upon (i) full value of the FTSE
Indexes, (ii) one-tenth of the value of the FTSE Indexes (``Mini FTSE
Indexes''), and (iii) one one-hundredth of the value of the FTSE
Indexes (``Micro FTSE Indexes''). In addition to regular options on the
FTSE Indexes, the Exchange may list long-term options on the FTSE
Indexes, the Mini FTSE Indexes, and the Micro FTSE Indexes (``FTSE
LEAPS'').\4\
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    \4\ Under ISE Rule 2009(b), ``Long-Term Index Options Series,''
the Exchange may list long-term options that expire from 12 to 60
months from the date of issuance.
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    The Exchange states that the FTSE 100 Index and the FTSE 250 Index
are internationally recognized, capitalization-weighted indexes based
on the prices of the most highly capitalized British stocks traded on
the London Stock Exchange (``LSE''), a Recognized Investment Exchange
under the Financial Services and Markets Act 2000 of the U.K and
regulated by the Financial Services Authority (``FSA'') of the U.K. The
LSE's Stock Exchange Electronic Trading Service (``SETS'') is a fully
electronic order book trading service. SETS is the central price
formation and trading service for the securities comprising the FTSE
100 Index, the most liquid FTSE 250 securities, and equities that
underlie Euronext.LIFFE (``LIFFE'') traded equity options. SETS market
maker (``SETSmm'') is the LSE's trading service for, among others, the
FTSE 250 securities that are not traded on SETS.
    Currently, LIFFE lists equity options on the FTSE 100 Index and
futures and futures options on the FTSE 250 Index. The Exchange notes
that the Commission previously approved for the Chicago Board Options
Exchange (``CBOE'') to list reduced-value options on the FTSE 100
Index, and for the American Stock Exchange (``Amex''), the CBOE, the
Midwest Stock Exchange (``MSE'') n/k/a the Chicago Stock Exchange, the
New York Stock Exchange (``NYSE''), and the Pacific Stock Exchange
(``PSE'') to trade warrants on the FTSE 100 Index.\5\
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    \5\  See Securities Exchange Act Release Nos. 29722 (September
23, 1991), 56 FR 49807 (October 1, 1991) (order approving File No.
SR-CBOE-91-07); 27769 (March 6, 1990), 55 FR 9380 (March 13, 1990)
(order approving File No. SR-Amex-90-03); 28634 (November 20, 1990),
55 FR 49729 (November 30, 1990) (order approving File No. SR-MSE-90-
12); 28399 (August 30, 1990), 55 FR 37390 (September 11, 1990)
(order approving File No. SR-NYSE-90-37); and 28106 (June 12, 1990),
55 FR 24955 (June 19, 1990) (order approving File No. SR-PSE-90-15).
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Index Design and Composition

    The FTSE 100 and 250 Indexes were created in the 1980's by the
International Stock Exchange of the United Kingdom and the Republic of
Ireland (the predecessor to the LSE) in conjunction with the Financial
Times and a committee of U.K. financial institutions, including LIFFE.
The Indexes are administered and maintained by FTSE International
Limited (``FTSE'').\6\ To qualify for inclusion in a FTSE Index, a
company must satisfy, among others, the following conditions: (1) It
must have a full listing on the London Stock Exchange; (2) it must not
be a subsidiary of another FTSE Index constituent; and (3) it must be
sufficiently liquid to be traded.\7\ The FTSE 100 Index consists of the
largest 100 UK companies ranked by unadjusted market value, and the
FTSE 250 consists of the next 250 UK companies ranked by unadjusted
market value.\8\ The FTSE EMEA Committee

conducts a quarterly review of the FTSE Indexes to ensure that its
component stocks are representative of the state of the equity market
for the largest U.K. companies.
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    \6\ The FTSE Europe, Middle East and Africa ( ``EMEA'')
Committee is responsible for, among other things, establishing rules
to determine, review, and modify the composition of the FTSE
Indexes, as well as how the FTSE Indexes are calculated. The FTSE
EMEA Committee is comprised of representatives from various
financial institutions including, among others, FTSE, Barclays
Global Investors, Goldman Sachs, and LIFFE.
    \7\ See ``Ground Rules for the Management of the UK Series of
the FTSE Actuaries Share Indices,'' at http://www.ftse.com for

complete eligibility criteria.
    \8\ Unadjusted market capitalization (as opposed to a ``free-
float'' index methodology) refers to the total number of shares
outstanding multiplied by the share price. A ``free-float'' index
methodology usually excludes shares held by strategic investors by
way of cross ownership, government ownership, private ownership, and
restricted share ownership. Telephone conversation between Samir
Patel, Assistant General Counsel, ISE, and Raymond Lombardo, Special
Counsel, Division, Commission, on February 27, 2006.
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    As of February 14, 2005, following are the characteristics of the
FTSE 100 Index: (i) The total capitalization of all of the components
in the Index is [pound]1.23 trillion; (ii) regarding component
capitalization, (a) the highest capitalization of a component is
[pound]119.14 billion (BP Plc), (b) the lowest capitalization of a
component is [pound]516.80 million (Schroders NV), (c) the mean
capitalization of the components is [pound]12.07 billion, and (d) the
median capitalization of the components is [pound]5.20 billion; (iii)
regarding component price per share, (a) the highest price per share of
a component is [pound]31.56 (Carnival), (b) the lowest price per share
of a component is 60 pence (Corus Group), (c) the mean price per share
of a component is [pound]6.91, and (d) the median price per share of a
component is [pound]6.06; (iv) regarding component weightings, (a) the
highest weighting of a component is 9.82% (BP Plc), (b) the lowest
weighting of a component is 0.04% (Schroders NV), (c) the mean
weighting of the components is 0.98%, (d) the median weighting of the
components is 0.43%, and (e) the total weighting of the top five
highest weighted components is 36.52% (BP Plc, HSBC Holdings, Vodafone
Group, GlaxoSmithKline, Royal Bank of Scotland); (v) regarding
component available shares, (a) the most available shares of a
component is 65.28 billion (Vodafone Group), (b) the least available
shares of a component is 70.94 million (Schroders NV), (c) the mean
available shares of the components is 2.72 billion, and (d) the median
available shares of the components is 1.11 billion; (vi) regarding the
six month average daily volumes of the components, (a) the highest six
month average daily volume of a component is 224.20 million (Vodafone
Group), (b) the lowest six month average daily volume of a component is
117,669 (Schroders NV), (c) the mean six month average daily volume of
the components is 13.69 million, (d) the median six month average daily
volume of the components is 7.56 million, (e) the average of six month
average daily volumes of the five most heavily traded components is
441.02 million (Vodafone Group, BP Plc, Corus Group, BT Group, Shell
Transport and Trading Co.), and (f) 100% of the components had a six
month average daily volume of at least 50,000.
    As of February 14, 2005, following are the characteristics of the
FTSE 250 Index: (i) The total capitalization of all of the components
in the Index is [pound]220.24 billion; (ii) regarding component
capitalization, (a) the highest capitalization of a component is
[pound]2.69 billion (BPB), (b) the lowest capitalization of a component
is [pound]212.30 million (PZ Cussons PLC), (c) the mean capitalization
of the components is [pound]877.46 million, and (d) the median
capitalization of the components is [pound]693.41 million; (iii)
regarding component price per share, (a) the highest price per share of
a component is [pound]43.72 (Greggs PLC), (b) the lowest price per
share of a component is 20 pence (Invensys), (c) the mean price per
share of a component is [pound]4.91, and (d) the median price per share
of a component is [pound]3.47; (iv) regarding component weightings, (a)
the highest weighting of a component is 1.30% (BPB), (b) the lowest
weighting of a component is 0.06% (Euromoney Institutional Investor
PLC), (c) the mean weighting of the components is 0.40%, (d) the median
weighting of the components is 0.31%, and (e) the total weighting of
the top five highest weighted components is 6.04% (BPB, International
Power, Hammerson PLC, Kelda Group, Peninsular & Oriental Steam PLC);
(v) regarding component available shares, (a) the most available shares
of a component is 5.69 billion (Invensys), (b) the least available
shares of a component is 12.14 million (Greggs PLC), (c) the mean
available shares of the components is 345.10 million, and (d) the
median available shares of the components is 201.60 million; (vi)
regarding the six month average daily volumes of the components, (a)
the highest six month average daily volume of a component is 40.89
million (Invensys), (b) the lowest six month average daily volume of a
component is 4,139 (PZ Cussons PLC), (c) the mean six month average
daily volume of the components is 1.95 million, (d) the median six
month average daily volume of the components is 702,801, (e) the
average of six month average daily volumes of the five most heavily
traded components is 104.75 million (Invensys, ARM Holdings PLC,
Cookson Group, Woolworths Group, EMI Group), and (f) 97% of the
components had a six month average daily volume of at least 50,000.

Index Calculation and Index Maintenance

    The base index value of the FTSE 100 Index and the FTSE 250 Index,
was 1000, as of December 31, 1983, and 1412.60, as of December 31,
1985, respectively. On February 14, 2005, the index value of the FTSE
100 Index and the FTSE 250 Index was 5041.80 and 7370.10, respectively.
The Exchange believes that these levels are too high for successful
options trading. As a result, the premiums for options on the full
values of the FTSE Indexes are high, which may deter retail investors.
Accordingly, the Exchange proposes to base trading in options on both
full size FTSE Indexes and on fractions of full size FTSE Indexes. In
particular, the Exchange proposes to list (i) Mini FTSE Index options
that are based on one-tenth of the value of each of the FTSE Indexes,
and (ii) Micro FTSE Index options that are based on one one-hundredth
of each of the FTSE Indexes.\9\ The Exchange believes that listing
options on reduced values will attract a greater source of customer
business than if options were based only on the full value of the FTSE
Indexes. The Exchange further believes that listing options on reduced
values will provide an opportunity for investors to hedge, or speculate
on, the market risk associated with the stocks comprising the FTSE
Indexes. Additionally, by reducing the values of the FTSE Indexes,
investors will be able to use this trading vehicle while extending a
smaller outlay of capital. The Exchange believes that this should
attract additional investors, and, in turn, create a more active and
liquid trading environment.\10\
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    \9\ As noted above, the Exchange also proposes to list LEAPS on
all FTSE Indexes.
    \10\ The concept of listing reduced value options on an index is
not a novel one. For example, the Commission has previously approved
the listing of reduced value options on the S&P 500 Index, the
Nasdaq 100 Index, and the NYSE Composite Index. See Securities
Exchange Act Release Nos. 32893 (September 14, 1993), 58 FR 49070
(September 21, 1993) (S&P 500 Index); 43000 (June 30, 2000), 65 FR
42409 (July 10, 2000) (Nasdaq 100 Index); 48681 (October 22, 2003),
68 FR 62337 (November 3, 2003) (NYSE Composite Index).
---------------------------------------------------------------------------

    Index levels for options on the full size FTSE Indexes, the Mini
FTSE Indexes and the Micro FTSE Indexes shall each be calculated by
FTSE, and shall be disseminated by ISE every 15 seconds during the
Exchange's regular trading hours to market information vendors via the
Options Price Reporting Authority (``OPRA'').\11\ The methodology used
to calculate the value of the FTSE Indexes is similar to the
methodology used to calculate the value of other well-known market-
capitalization weighted indexes. The level of each FTSE Index reflects
the total market value of the component

stocks relative to a particular base period and is computed by dividing
the total market value of the companies in each index by its respective
index divisor.\12\
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    \11\ The Exchange shall also disseminate these values to its
members. The FTSE Indexes will be published daily through major
quotation vendors, such as Reuters.
    \12\ A divisor is an arbitrary number chosen at the starting
date of an index to fix the index starting value. The divisor is
adjusted periodically when capitalization amendments are made to the
constituents of the index in order to allow the index value to
remain comparable over time. Without a divisor the index value would
change when corporate actions took place and would not reflect the
true value of an underlying portfolio based upon the index.
---------------------------------------------------------------------------

    The FTSE Indexes are updated on a real-time basis from 8 a.m. to
4:30 p.m. (London time), which corresponds to 3 a.m. to 11:30 a.m. (New
York time). After 11:30 a.m. (New York time), the Exchange will
disseminate a static value of the FTSE Indexes via OPRA until the close
of trading each day. The FTSE Indexes are calculated using the last
traded price of the component securities. If a component security does
not open for trading, the price of that security at the close or the
index on the previous day is used in the calculation.\13\
---------------------------------------------------------------------------

    \13\ The FTSE Indexes are published daily in the Financial Times
and are available real-time on Reuters, Bloomberg, and other market
information systems which disseminate information on a real-time
basis.
---------------------------------------------------------------------------

    The FTSE Indexes will be monitored and maintained by FTSE. FTSE
will be responsible for making all necessary adjustments to the indexes
to reflect component deletions, share changes, stock splits, stock
dividends (other than an ordinary cash dividend), and stock price
adjustments due to restructuring, mergers, or spin-offs involving the
underlying components. Some corporate actions, such as stock splits and
stock dividends, require simple changes to the available shares
outstanding and the stock prices of the underlying components. Other
corporate actions, such as share issuances, that change the market
value would require changing the index divisor to effect adjustments.
    The FTSE Indexes are reviewed each quarter in March, June,
September, and December based on market capitalization. Based on
information submitted by FTSE, the FTSE EMEA Committee approves the new
index components and a reserve list of six companies for the FTSE 100
Index. If a company is deleted from the FTSE 100 Index between reviews
as a result of a merger, takeover, or other corporate action, the
highest ranking company from the reserve list will replace it in the
index.
    Although the Exchange is not involved in the maintenance of any of
the FTSE Indexes, the Exchange represents that it will monitor each
FTSE Index on a quarterly basis, at which point the Exchange will
notify the staff of the Market Regulation Division of the Commission by
filing a proposed rule change pursuant to Rule 19b-4, if, with respect
to any FTSE Index: (i) The number of securities in a FTSE Index drops
by \1/3\rd or more; (ii) 10% or more of the weight of a FTSE Index is
represented by component securities having a market value of less than
50 million; (iii) 10% or more of the weight of a FTSE Index is
represented by component securities trading less than 20,000 shares per
day; or (iv) the largest component security accounts for more than 15%
of the weight of a FTSE Index or the largest five components in the
aggregate account for more than 50% of the weight of a FTSE Index.
    The Exchange will also notify the staff of the Market Regulation
Division of the Commission immediately in the event FTSE ceases to
maintain and calculate the FTSE Indexes, or in the event values of the
FTSE Indexes are not disseminated every 15 seconds by a widely
available source. In the event the FTSE Indexes cease to be maintained
or calculated, or its values are not disseminated every 15 seconds by a
widely available source, the Exchange will not list any additional
series for trading and will limit all transactions in such options to
closing transactions only for the purpose of maintaining a fair and
orderly market and protecting investors.

Exercise and Settlement Value

    Options on the FTSE Indexes will expire on the Saturday following
the third Friday of the expiration month. Trading in the FTSE Indexes
will normally cease at 4:15 p.m. (New York time) on the Thursday
preceding an expiration Saturday. The index value for exercise of the
FTSE Index options will be calculated based on the LSE's Exchange
Delivery Settlement Price (``EDSP'') intra-day auction, which was
introduced by LSE in November of 2004. The EDSP is a settlement value
calculated by Euronext-LIFFE for FTSE index futures and options
contracts traded on its exchange. The EDSP value is calculated using an
intra-day auction process administered by the LSE for all the component
stocks of the FTSE 100 Index and the FTSE 250 Index. The intra-day
auction occurs between 10:10 a.m. and 10:29 a.m. (London time) for the
FTSE 100 Index, and between 10:10 a.m. and 10:31 a.m. (London time) for
the FTSE 250 Index on the third Friday of the expiration month.
Therefore, because trading in the expiring contract months will
normally cease on a Thursday at 4:15 p.m. (New York time), the EDSP for
exercise will be determined the day after trading has ceased, i.e.,
during the Friday morning LSE trading session, by 5:31 a.m. (New York
time). The last automated traded price prior to the EDSP auction or the
previous day's closing price will be used to calculate the final EDSP
if a security did not participate in the auction. During the auction
process, indications of the settlement price for each index are widely
disseminated every 15 seconds via special indexes called Expiry
Indexes. The purpose of the Expiry Indexes is to disseminate expected
settlement values as the auction progresses. When the auction is
finished, the final values of the Expiry Indexes are disseminated as
the EDSP values. The Expiry Indexes and subsequent EDSP values are
widely disseminated through major market data vendors including
Reuters, Bloomberg, and Thomson.
    If the LSE is closed on the Friday before expiration, but the ISE
remains open, then the last trading day for expiring FTSE Index options
will be moved earlier to Wednesday as if the ISE had had a Friday
holiday. The settlement index value used for exercise will be
calculated during LSE's EDSP intra-day auction on Thursday morning.

Contract Specifications

    The contract specifications for options on the FTSE 100 Index and
the FTSE 250 Index are set forth in Exhibits 3-2 and 3-4, respectively,
to the proposed rule change filed by the Exchange. The FTSE Indexes are
broad-based indexes, as defined in Exchange Rule 2001(j). Options on
the FTSE Indexes are European-style and a.m. cash-settled. The
Exchange's standard trading hours for broad-based index options (9:30
a.m. to 4:15 p.m., New York time), as set forth in Rule 2008(a), will
apply to the FTSE Indexes. Exchange rules that are applicable to the
trading of options on broad-based indexes will apply to both full and
reduced values of the FTSE Indexes.\14\ Specifically, the trading of
full and reduced values of the FTSE Indexes will be subject to, among
others, Exchange rules governing margin requirements and trading halt
procedures for index options. Options shall be quoted and traded in
U.S. dollars.
---------------------------------------------------------------------------

    \14\ See ISE Rules 2000 through 2012.
---------------------------------------------------------------------------

    For options on the full value FTSE Indexes, the Exchange proposes
to establish aggregate position limits at 25,000 contracts on the same
side of the market, provided no more than 15,000 of such contracts are
in the nearest

expiration month series. Mini FTSE Index option contracts and Micro
FTSE Index option contracts shall be aggregated with full value FTSE
Index option contracts, where ten (10) Mini FTSE Index option contracts
and one-hundred (100) Micro FTSE Index option contracts equal one (1)
full value FTSE Index option contracts. These limits are identical to
the limits that were approved for options on the FTSE Indexes
previously listed for trading at the CBOE.\15\ Additionally, under ISE
Rule 2006, an index option hedge exemption for public customers may be
available which may expand the position limit up to an additional
75,000 contracts.\16\ Furthermore, proprietary accounts of members may
receive an exemption of up to 50,000 contracts for the purpose of
facilitating public customer orders.\17\
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    \15\ See supra note 5.
    \16\ The same limits that apply to position limits shall apply
to exercise limits for these products.
    \17\ See ISE Rule 413(c).
---------------------------------------------------------------------------

    The Exchange proposes to apply broad-based index margin
requirements for the purchase and sale of options on the FTSE Indexes.
Accordingly, purchases of put or call options with 9 months or less
until expiration must be paid for in full. Writers of uncovered put or
call options must deposit/maintain 100% of the option proceeds, plus
15% of the aggregate contract value (current index level x $100), less
any out-of-the-money amount, subject to a minimum of the option
proceeds plus 10% of the aggregate contract value for call options and
a minimum of the option proceeds plus 10% of the aggregate exercise
price amount for put options.
    The Exchange proposes to set strike price intervals at least 2\1/2\
points for certain near-the-money series in near-term expiration months
when the index level of the FTSE Indexes is below 200, and 5 point
strike price intervals for other options series with expirations up to
one year, and at least 10 point strike price intervals for longer-term
options. The minimum tick size for series trading below $3 shall be
$0.05, and for series trading at or above $3 shall be $0.10.
    The Exchange proposes to list options on full and reduced values of
the FTSE Indexes in the three consecutive near-term expiration months
plus up to three successive expiration months in the March cycle. For
example, consecutive expirations of January, February, March, plus
June, September, and December expirations would be listed.\18\ In
addition, long-term option series having up to sixty months to
expiration may be traded.\19\ The trading of long-term FTSE Indexes
shall be subject to the same rules that govern the trading of all the
Exchange's index options, including sales practice rules, margin
requirements, and trading rules.
---------------------------------------------------------------------------

    \18\ See Rule 2009(a)(3).
    \19\ See Rule 2009(b)(1). The Exchange is not listing reduced
value LEAPS on the FTSE Indexes pursuan to Rule 2009(b)(2).
---------------------------------------------------------------------------

    Except for the further reduced value given to the FTSE Indexes, all
of the specifications and calculations for the reduced value FTSE
Indexes shall be the same as those used for the full value FTSE
Indexes. The reduced value FTSE Indexes will trade independently of and
in addition to the full value FTSE Indexes, and all the FTSE Indexes
shall be subject to the same rules that presently govern the trading of
Exchange index options, including sales practice rules, margin
requirements, trading rules, and position and exercise limits.

Surveillance and Capacity

    The Exchange represents that it has an adequate surveillance
program in place for options traded on the FTSE Indexes and intends to
apply those same program procedures that it applies to the Exchange's
other index options. Additionally, the Exchange has provided the
Commission, on a confidential basis, a representation made by FTSE to
the Exchange regarding FTSE's insider trading policies, as they pertain
to the broker-dealer members of FTSE's EMEA Committee who are charged
with the selection of component securities that comprise the FTSE
Indexes. The FTSE EMEA Committee members are also required to maintain
in confidence, including non-disclosure to another party, any
information that they may be given by virtue of their membership of the
FTSE EMEA Committee, unless such information is already in the public
domain or where disclosure is required by law. The Exchange is also a
member of the Intermarket Surveillance Group (ISG) under the
Intermarket Surveillance Group Agreement, dated June 20, 1994. The
members of the ISG include all of the U.S. registered stock and options
markets: the American Stock Exchange, the Boston Stock Exchange, the
Chicago Board Options Exchange, the Chicago Stock Exchange, the
National Stock Exchange, the National Association of Securities
Dealers, the New York Stock Exchange, the Pacific Stock Exchange and
the Philadelphia Stock Exchange. In addition, the LSE and LIFFE are
affiliate members of ISG.\20\ The ISG members work together to
coordinate surveillance and investigative information sharing in the
stock and options markets. In addition, the major futures exchanges are
affiliated members of the ISG, which allows for the sharing of
surveillance information for potential intermarket trading abuses. \
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    \20\ Telephone conversation between Samir Patel, Assistant
General counsel, ISE, and Raymond Lombardo, Special Counsel,
Division, Commission, on February 28, 2006.
---------------------------------------------------------------------------

    The Exchange has the necessary systems capacity to support new
options series that will result from the introduction of both full and
reduced values of the FTSE Indexes, including LEAPS. The Exchange has
provided the Commission system capacity information that supports its
system capacity representations.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\21\ in general, and furthers the
objectives of Section 6(b)(5),\22\ in particular, in that it is
designed to promote just and equitable principles of trade, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system, and, in general, to protect investors and the
public interest.
---------------------------------------------------------------------------

    \21\ 15 U.S.C. 78f(b).
    \22\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change imposes
any burden on competition.

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. Solicitation of Comments

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

Electronic Comments

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

File No. SR-ISE-2005-25 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2005-25. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commissions Internet Web site (http://www.sec.gov/rules/sro.shtml).

Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for inspection and copying in the
Commission's Public Reference Room. Copies of such filing also will be
available for inspection and copying at the principal office of the
ISE. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-ISE-
2005-25 and should be submitted by April 11, 2006.

IV. Commission's Findings and Order Granting Accelerated Approval of
Proposed Rule Change

    After careful consideration, the Commission finds that the proposed
rule change, as amended, is consistent with the requirements of the Act
and the rules and regulations thereunder applicable to a national
securities exchange.\23\ In particular, the Commission finds that the
proposed rule change is consistent with Section 6(b) of the Act,\24\ in
general, and furthers the objectives of Section 6(b)(5),\25\ in
particular, in that it is designed to promote just and equitable
principles of trade, to remove impediments to and perfect the mechanism
of a free and open market and a national market system, and, in
general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \23\ In approving this proposal, the Commission has considered
its impact on efficiency, competition and capital formation. 15
U.S.C. 78c(f).
    \24\ 15 U.S.C. 78f(b).
    \25\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    Because the FTSE 100 and FTSE 250 Indexes are broad-based indexes
of actively traded, well-capitalized stocks, the trading of the
proposed Index options on the Exchange does not raise unique regulatory
concerns. The options on the FTSE Indexes will be traded under ISE's
existing regulatory regime for index options, which include, among
other things, position and exercise limits and margin requirements.
Additionally, the Exchange has represented that it has adequate systems
capacity and surveillance for these Index options and that the index
value will be disseminated at least every 15 seconds.
    Under Section 19(b)(2) of the Act,\26\ the Commission may not
approve any proposed rule change prior to the thirtieth day after
publication of the notice of the filing thereof, unless the Commission
finds good cause for so doing and publishes its reasons for so finding.
The Commission believes that the proposed rule filing does not raise
any new, unique or substantive issues from those raised in a filing
previously approved by the Commission \27\ allowing the CBOE to list
and trade reduced value index options on the FTSE 100 Index.
Accordingly, The Commission hereby finds good cause for approving the
proposed rule change and Amendment No. 1 thereto prior to the thirtieth
day after the date of publication of notice of filing thereof in the
Federal Register.
---------------------------------------------------------------------------

    \26\ 15 U.S.C. 78s(b)(2).
    \27\ See Securities Exchange Act Release No. 29722 (September
23, 1991), 56 FR 49807 (October 1, 1991) (order approving SR-CBOE-
91-07).
---------------------------------------------------------------------------

V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\28\ that the proposed rule change (SR-ISE-2005-25), as amended,
be, and hereby is, approved on an accelerated basis.
---------------------------------------------------------------------------

    \28\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\29\
---------------------------------------------------------------------------

    \29\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Nancy M. Morris,
Secretary.
 [FR Doc. E6-4056 Filed 3-20-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 85, Number 136 (Wednesday, July 15, 2020)]
[Notices]
[Pages 42883-42887]
[FR Doc No: 2020-15252]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0567]

Designating Additions to the Current List of Tropical Diseases in
the Federal Food, Drug, and Cosmetic Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes
the Food and Drug Administration (FDA or Agency) to award priority
review vouchers (PRVs) to tropical disease product applicants when the
applications meet certain criteria. The FD&C Act lists the diseases
that are considered tropical diseases for purposes of obtaining PRVs
and provides for Agency expansion of that list to include other
diseases that satisfy the definition of ``tropical diseases'' eligible
for PRVs as set forth in the FD&C Act. The Agency has determined that
two foodborne trematode infections, opisthorchiasis and paragonimiasis,
satisfy this definition, and is therefore adding them to the list of
designated tropical diseases whose product applications may result in
the award of PRVs. Sponsors submitting certain drug or biological
product applications for the prevention or treatment of opisthorchiasis
or paragonimiasis infections may be eligible to receive a PRV if such
applications are approved by FDA.

DATES: This order is issued on July 15, 2020.

ADDRESSES: Submit electronic comments on additional diseases suggested
for designation to https://www.regulations.gov. Submit written comments
on additional diseases suggested for designation to the Dockets
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified
with the docket number found in brackets in the heading of this
document.

FOR FURTHER INFORMATION CONTACT: Katherine Schumann, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6242, Silver Spring, MD 20993-0002, 301-
796-1300<EMAIL_ADDRESS>or Stephen Ripley, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background: Priority Review Voucher Program
II. Diseases Being Designated
    A. Opisthorchiasis
    B. Paragonimiasis
III. Process for Requesting Additional Diseases To Be Added to the
List
IV. Paperwork Reduction Act
V. References

I. Background: Priority Review Voucher Program

    Section 524 of the FD&C Act (21 U.S.C. 360n), which was added by
section 1102 of the Food and Drug Administration Amendments Act of 2007
(Pub. L. 110-85), uses a PRV incentive to encourage the development of
new drugs, including biological products, for prevention and treatment
of certain diseases that, in the aggregate, affect millions of people
throughout the world. To be eligible to receive a tropical disease PRV,
a drug must be for prevention or treatment of a ``tropical disease'' as
listed under section 524(a)(3) of the FD&C Act. This list can be
expanded by the Agency under section 524(a)(3)(S) of the FD&C Act,
which authorizes FDA to designate by order ``[a]ny other infectious
disease for which there is no significant market in developed nations
and that disproportionately affects poor and marginalized populations''
as an addition to the list of tropical diseases, approved drug
applications for which may be eligible to receive a PRV. Further
information about the tropical disease PRV program can be found in the
October 6, 2016 (81 FR 69537), guidance for industry ``Tropical Disease
Priority Review Vouchers,'' available at https://www.fda.gov/media/72569/download.
    On August 20, 2015, FDA published a final order (80 FR 50559)
(August 2015 final order) designating Chagas disease and
neurocysticercosis as additions to the list of tropical diseases under
section 524 of the FD&C Act. The August 2015 final order also sets
forth FDA's interpretation of the statutory criteria for tropical
disease designation and expands the list of tropical diseases under
section 524(a)(3)(R) of the FD&C Act (redesignated as section
524(a)(3)(S) of the FD&C Act). Additions by order to the statutory list
of PRV-eligible tropical diseases published in the Federal Register can
be accessed at https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm534162.htm.
    In this document, FDA has applied its August 2015 final order
criteria to analyze whether the foodborne

trematode infections opisthorchiasis and paragonimiasis meet the
statutory criteria for addition to the tropical diseases list under
section 524 of the FD&C Act.

II. Diseases Being Designated

    FDA has considered all diseases submitted to the public docket
(FDA-2008-N-0567) between June 20, 2018, and November 21, 2018, as
potential additions to the list of tropical diseases under section 524
of the FD&C Act, pursuant to the docket review process explained on the
Agency's web page at https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm534162.htm. Based on an
assessment using the criteria from its August 2015 final order, FDA has
determined that the following additional diseases will be designated as
additions to the list of tropical diseases for purposes of the tropical
disease PRV program under section 524 of the FD&C Act:

 Opisthorchiasis
 Paragonimiasis

    The four primary foodborne trematode infections identified by the
World Health Organization (WHO) include these two infections, as well
as fascioliasis, which was included in the original statutory list of
tropical diseases under section 524(a)(3) of the FD&C Act, and
clonorchiasis, which FDA has determined does not at this time meet the
requirements to be designated as an addition to the list of tropical
diseases, approved drug applications for which may be eligible for a
PRV under section 524 of the FD&C Act (see FDA's ``Notice of Decision
Not to Designate Clonorchiasis as an Addition to the Current List of
Tropical Diseases in the Federal Food, Drug, and Cosmetic Act,''
published elsewhere in this issue of the Federal Register).
    Foodborne trematode infections are caused by parasitic trematodes,
commonly known as flukes. Trematode infections are naturally
transmissible from vertebrate animals to people and back. People become
infected through the consumption of raw or undercooked food (e.g.,
fish, crustaceans, and vegetables), which harbor the minute larval
stages of the parasites.
    FDA's rationale for adding these diseases to the list is discussed
in the analyses that follow.

A. Opisthorchiasis

    Opisthorchiasis is caused by the trematodes Opisthorchis viverrini
or O. felineus, acquired by the consumption of raw or undercooked fish
(Ref. 1). The natural final hosts of these O. viverrini or O. felineus
flukes are cats and other fish-eating carnivores (Ref. 1). O. viverrini
flukes are reported in Thailand, Laos, Cambodia, and Vietnam while O.
felineus flukes are reported in Italy, Germany, Belarus, Russia,
Kazakhstan, and Ukraine (Ref. 2).
    The final location of adult O. viverrini and O. felineus is the
smaller bile ducts of the liver (Ref. 3). The symptoms caused by
opisthorchiasis are related to inflammation and fibrosis of the tissues
adjacent to bile ducts. While the majority of infected individuals are
asymptomatic, patients may develop cholangitis, intrahepatic calculi,
or cholangiohepatitis. Chronic infection is also associated with the
development of cholangiocarcinoma, a severe and fatal form of bile duct
cancer, and O. viverrini are recognized by the International Agency for
Research on Cancer as Group 1, which means that the agent is classified
as carcinogenic to humans (Refs. 4 and 5).
    There is one FDA-approved treatment for opisthorchiasis,
praziquantel, approved in 1982 and indicated for the treatment of
infections due to all species of schistosoma and infections due to the
liver flukes Clonorchis sinensis and O. viverrini (Ref. 6).
1. No Significant Market in Developed Nations
    No significant market exists for the treatment or prevention of
opisthorchiasis in developed nations. As stated above, opisthorchiasis
occurs as a result of O. viverrini and O. felineus (Ref. 7). O.
viverrini have been reported in Thailand, Laos, Cambodia, and Vietnam.
O. felineus have been reported in Italy, Germany, Belarus, Russia,
Kazakhstan, and Ukraine (Ref. 7). Since O. viverrini and O. felineus
have a limited geographic range, infections in other countries only
occur from movement of infected persons. O. viverrini and O. felineus
flukes have a life span of 25 to 30 years, meaning that opisthorchiasis
may persist long after a patient is initially infected, however, as
described below, these numbers are low in developed countries.
    Thailand, Laos, Cambodia, Vietnam, Belarus, Russia, Kazakhstan, and
Ukraine are not on the World Bank list of high-income economies, which,
as described in FDA's August 2015 final order, will be used as evidence
that the country should be considered a ``developed nation'' for
determination of additions to the PRV-eligible tropical diseases list
under section 524 of the FD&C Act (Ref. 8). Germany, Greece, and Italy,
however, are on the World Bank list of high-income economies, and
therefore are considered to be developed nations for the purposes of
this order (Ref. 8).
    In developed countries where O. viverrini and O. felineus are
found, the prevalence of opisthorchiasis is very low. There have only
been approximately five cases of human infections of O. felineus
reported in Germany since the 1980s, and two in Greece in the late
1990s and early 2000s (though one of those infections may have
originated elsewhere) (Ref. 9). Italy has seen an increase in reported
human infections due to the increased consumption of marinated fillets
of raw tench (Tinca tinca), infected with O. felineus (Ref. 9).
However, even with this rise in infection rates, the total number of
reported opisthorchiasis cases in Italy was only 211 from 2003 to 2011
(Ref. 9). As described in the August 2015 final order, FDA uses a
disease prevalence rate of 0.1 percent of the population of developed
countries for aiding in the determination of whether a ``significant
market'' may exist for a disease's treatment. In these three high-
income countries where O. viverrini and O. felineus have been reported,
the prevalence rates are significantly lower than that which FDA would
consider could offer a sufficient market incentive to drive the
development of new drug products to prevent or treat opisthorchiasis.
Therefore, in developed nations where opisthorchiasis occurs, the
prevalence rates of infection are not large enough to create a
significant market for treatment.
    There is currently no estimate of the number of individuals
infected with opisthorchiasis in the United States. The available
information concerning opisthorchiasis in the United States suggests
that the prevalence of opisthorchiasis is much lower than 0.1 percent
of the population. Of the infections that do occur in the United
States, foodborne trematode infections occur predominantly in
immigrants and travelers to and from endemic regions (Refs. 10 and 11).
For example, in a retrospective study in one U.S. travel medicine
clinic over 6 years, only 17 cases of Opisthorchis spp. and Clonorchis
spp. were identified through the review of medical records (Ref. 12).
All patients with identified cases were migrants from Laos, Cambodia,
Thailand, Vietnam, the former Soviet Union, and Ecuador (Ref. 12).
    There is evidence that U.S. military personnel were exposed to
Opisthorchis spp. and Clonorchis spp. during their service in the
Vietnam War (Ref. 13). In one study, there was evidence that veterans
were likely previously infected, but patients in the study did not have
evidence of ongoing infection, given

negative stool exams and negative imaging studies, and therefore would
not have ongoing infections requiring treatment at present (Ref. 13).
    As illustrated above, opisthorchiasis occurs rarely in developed
nations. The market for drugs for opisthorchiasis in developed nations
such as the United States would largely be comprised of immigrants and
travelers to and from endemic regions and military populations serving
in endemic regions. These markets are unlikely to provide sufficient
incentive to encourage development of products to treat or prevent
opisthorchiasis. At present, FDA is unaware of any significant funding
for opisthorchiasis drug development by the U.S government sources, and
opisthorchiasis is not among the Centers for Disease Control and
Prevention's (CDC) list of potential bioterrorism agents.
2. Opisthorchiasis Disproportionately Affects Poor and Marginalized
Populations
    Opisthorchiasis disproportionately affects poor and marginalized
populations around the world. Within countries where O. viverrini or O.
felineus are reported, opisthorchiasis predominantly occurs in
populations living in impoverished settings. For example, in rural
northeast Thailand, where the per capita gross domestic product (GDP)
is less than $4,000, reported opisthorchiasis prevalence typically
exceeds 30 percent of the population (Ref. 14). In contrast, in urban
Bangkok, where the per capita GDP is around $15,000, opisthorchiasis
prevalence is reported to be less than 5 percent of the population
(Refs. 14 and 15). Likewise, in Laos, in the poorer rural southern
provinces (poverty rates of 30 to 50 percent), reported opisthorchiasis
prevalence is the highest at 20 to 30 percent, whereas in the
relatively wealthier urban Vientiane region of Laos (poverty rate less
than 20 percent), opisthorchiasis prevalence is reportedly less than 5
percent (Refs. 15 and 16). In Cambodia, a similar trend is noted, where
the highest reported prevalence of opisthorchiasis (24 percent) can be
found in the rural Kampong Cham and Tak[eacute]o provinces, where
poverty rates exceed 50 percent (Refs. 15 and 17).
    Opisthorchiasis is also included in the WHO List of Neglected
Tropical Diseases (Ref. 18). The WHO Foodborne Disease Burden
Epidemiology Reference Group identified opisthorchiasis as an important
cause of disability, with an estimated annual incidence of over 16,315
infections and 1,498 deaths, resulting in a global disability-adjusted
life years (DALYs), which is calculated by adding the number of years
of life lost to mortality and the number of years lived with disability
due to morbidity due to the illness, of 188,346 (Refs. 19 and 20).
    Given the above information, FDA concludes that opisthorchiasis
disproportionately affects poor and marginalized populations.
3. FDA Determination
    Given the factors described above, FDA has determined that
opisthorchiasis meets both the statutory criteria of ``no significant
market in developed nations'' and ``disproportionately affects poor and
marginalized populations.'' Therefore, FDA is designating
opisthorchiasis as an addition to the tropical diseases list under
section 524 of the FD&C Act.

B. Paragonimiasis

    Paragonimiasis is caused by Paragonimus spp., which are trematodes
acquired through the consumption of raw or undercooked crustaceans
(crabs and crayfish) (Ref. 1). The natural final hosts of Paragonimus
spp. are cats, dogs, and other crustacean eating carnivores (Ref. 1).
Paragonimus spp. are reported in China, the Philippines, Japan,
Vietnam, the Republic of Korea (South Korea), Taiwan, Thailand, Central
and South America, Africa, and there have been rare reports of these
flukes being found in the midwestern United States (Ref. 21). The final
location in humans of adult Paragonimus spp. is in lung tissue (Ref.
1). The symptoms caused by paragonimiasis are chronic cough with blood-
stained sputum, chest pain, dyspnea, and fever (Ref. 1). Paragonimus
spp. can migrate to other parts of the body, e.g., to the brain, where
they can cause severe cerebral manifestations (Ref. 1). There are no
FDA-approved treatments for paragonimiasis.
1. No Significant Market in Developed Nations
    FDA is unaware of any significant market for the treatment or
prevention of paragonimiasis in the United States or other developed
nations. As stated above, paragonimiasis is caused by Paragonimus spp.
flukes that have been reported in China, the Philippines, Japan,
Vietnam, South Korea, Taiwan, Thailand, Central and South America,
Africa, and there have been rare reports of these flukes being found in
the midwestern United States. The limited range of Paragonimus spp.
means infections outside of these endemic countries only occur from the
movement of infected persons. From the countries and regions listed
above, South Korea, Taiwan, Uruguay, Chile, and Panama all are on the
World Bank's list of high-income economies (Ref. 8).
    In developed nations where Paragonimus spp. are found, the
prevalence of paragonimiasis is low, according to the published data
obtained by the Agency. For example, in Japan, there were 443 patients
who were referred to one academic institution and diagnosed as having
paragonimiasis from 2001 to 2012 (Ref. 22). The majority of native
Japanese patients with paragonimiasis were residents of one island;
while one quarter of the cases occurred in immigrants mostly from
China, Thailand, and Korea (Ref. 22). In South Korea, the prevalence of
paragonimiasis has precipitously dropped as the country has developed;
in the 1960s, at least 2 million people were estimated to be infected
with paragonimiasis based on intradermal testing; by the 1990s, the
prevalence was reduced to 1 percent of the previous estimate (Ref. 23).
In a relatively recent review of medical records at another large
referral medical center in Seoul, South Korea, only 36 patients were
diagnosed with pulmonary paragonimiasis over a 10-year period (1994 to
2004). FDA was unable to find published information about the
prevalence of paragonimiasis in humans in Uruguay, Chile, Argentina, or
Panama (there are rare reports in the midwestern United States). One
study reported 16 cases of paragonimiasis acquired in Missouri from
2008 to 2014, which were associated with consumption of raw crayfish
(Ref. 24).
    The market for drugs for paragonimiasis in most developed nations
would largely be comprised of immigrants and travelers from endemic
regions. These low prevalence rates in developed countries are unlikely
to provide sufficient incentive to encourage development of products to
treat or prevent paragonimiasis in developed countries.
2. Paragonimiasis Disproportionately Affects Poor and Marginalized
Populations
    Paragonimiasis disproportionately affects poor and marginalized
populations around the world. The true burden of paragonimiasis is
unclear given the population it impacts; under-reporting is likely,
particularly in African regions (Refs. 25 and 26). While epidemiologic
data for paragonimiasis are scant, transmission of foodborne trematodes
within countries is typically restricted to limited areas and reflects
behavioral and ecological patterns

which are related to socioeconomic status. This includes people's food
habits, methods of food production and preparation, and the
distribution of intermediate hosts. For example, food can be
contaminated through unhygienic preparation and storage. Furthermore,
the consumption of raw fish and crustaceans is a main risk factor for
contracting these parasites. The life cycle of the parasites is closely
linked with water and sanitation. In populations without access to
toilets, or without sewage system infrastructure, unprocessed human and
animal fecal waste may be found near water or used as manure or fish
feed. This can contaminate drinking water and aquatic vegetables,
leading to a continuous cycle of infections.
    Paragonimiasis is included in the WHO List of Neglected Tropical
Diseases (Ref. 18). The WHO Foodborne Disease Burden Epidemiology
Reference Group identified paragonimiasis as an important cause of
disability, with an estimated annual incidence rate of 139,238
infections and 250 deaths, resulting in global disability-adjusted life
years of 1,048,937 (Ref. 27). Given the above information, FDA has
concluded that paragonimiasis disproportionately affects poor and
marginalized populations.
3. FDA Determination
    Given the factors described above, FDA has determined that
paragonimiasis meets both the statutory criteria of ``no significant
market in developed nations,'' and ``disproportionately affects poor
and marginalized populations.'' Therefore, FDA is designating
paragonimiasis as an addition to the tropical diseases list under
section 524 of the FD&C Act.

III. Process for Requesting Additional Diseases To Be Added to the List

    The purpose of this order is to add diseases to the list of
tropical diseases that FDA has found to meet the criteria in section
524(a)(3)(S) of the FD&C Act. By expanding the list with this order,
FDA does not mean to preclude the addition of other diseases to this
list in the future. Interested persons may submit requests for
additional diseases to be added to the list to the public docket
established by FDA for this purpose (see https://www.regulations.gov,
Docket No. FDA-2008-N-0567). Such requests should be accompanied by
information to document that the disease meets the criteria set forth
in section 524(a)(3)(S) of the FD&C Act. FDA will periodically review
these requests, and, when appropriate, expand the list. For further
information, visit the Agency's web page at https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm534162.htm.

IV. Paperwork Reduction Act

    This final order reiterates the ``open'' status of the previously
established public docket through which interested persons may submit
requests for additional diseases to be added to the list of tropical
diseases that FDA has found to meet the criteria in section
524(a)(3)(S) of the FD&C Act. Such a request for information is exempt
from Office of Management and Budget review under 5 CFR 1320.3(h)(4) of
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).
Specifically, facts or opinions submitted in response to general
solicitations of comments from the public, published in the Federal
Register or other publications, regardless of the form or format
thereof are exempt, provided that no person is required to supply
specific information pertaining to the commenter, other than that
necessary for self-identification, as a condition of the Agency's full
consideration of the comment.

V. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.

1. * WHO, 2018, ``Fact Sheet on Foodborne Trematodiases,'' accessed
October 23, 2019, https://www.who.int/news-room/fact-sheets/detail/foodborne-trematodiases.
2. * CDC, 2018, ``Parasites--Opisthorchis Infection, Epidemiology &
Risk Factors,'' accessed February 20, 2018, https://www.cdc.gov/parasites/opisthorchis/epi.html.
3. * WHO, 2018, ``Fact Sheet on Foodborne Trematodiases,'' accessed
February 8, 2018, https://www.who.int/news-room/fact-sheets/detail/foodborne-trematodiases.
4. * WHO, International Agency for Research on Cancer (IARC), 2019,
``IARC Monographs on the Identification of Carcinogenic Hazards to
Humans, Agents Classified by the IARC Monographs,'' Vols. 1-124,
accessed October 23, 2019, https://monographs.iarc.fr/agents-classified-by-the-iarc/.
5. * WHO, IARC, 2012, ``IARC Monographs on the Evaluation of
Carcinogenic Risks in Humans, Opisthorchis Viverrini and Clonorchis
Sinensis,'' Vol. 100B, 341-370, accessed October 23, 2019, https://monographs.iarc.fr/wp-content/uploads/2018/06/mono100B-13.pdf.
6. U.S. National Library of Medicine, 2015, ``Label: Biltricide-
Praziquantel Tablet, Film Coated,'' DailyMed.
7. * CDC, 2018, ``Parasites--Opisthorchis Infection: Resources for
Health Professionals,'' accessed October 24, 2019, https://www.cdc.gov/parasites/opisthorchis/health_professionals/index.html.
8. The World Bank, 2018, ``World Bank Country and Lending Groups,''
accessed December 12, 2018, https://datahelpdesk.worldbank.org/knowledgebase/articles/906519-world-bank-country-and-lending-groups.
9. Pozio, E., O. Armignacco, F. Ferri, and M. Gomez, 2013,
``Opisthorchis Felineus, an Emerging Infection in Italy and its
Implication for the European Union,'' Acta Tropica, epub ahead of
print January 18, 2013, doi: 10.1016/j.actatropica.2013.01.005.
10. Furst, T., U. Duthaler, B. Sripa, et al., 2012, ``Trematode
Infections: Liver and Lung Flukes,'' Infectious Disease Clinics of
North America, 26(2):399-419.
11. Qian, M-B., Y-D. Chen, S. Liang, et al., 2012, ``The Global
Epidemiology of Clonorchiasis and Its Relation with
Cholangiocarcinoma,'' Infectious Diseases of Poverty, epub ahead of
print October 25, 2012, doi: 10.1186/2049-9957-1-4.
12. Stauffer, W.M., J.S. Sellman, and P.F. Walker, 2004, ``Billiary
Liver Flukes (Opisthorchiasis and Clonorchiasis) in Immigrants in
the United States: Often Subtle and Diagnosed Years After Arrival,''
Journal of Travel Medicine, 11(3):157-159.
13. Psevdos, G., F.M. Ford, and S.T. Hong, 2018, ``Screening U.S.
Vietnam Veterans for Liver Fluke Exposure 5 Decades After the End of
the War,'' Infectious Diseases in Clinical Practice, epub ahead of
print January 16, 2018, doi: 0.1097/IPC.0000000000000611.
14. * Office of the National Economic and Social Development Board
of Thailand, 2015, ``Gross Regional and Provincial Product, 2016
Edition,'' accessed October 25, 2019, https://www.nesdc.go.th/nesdb_en/ewt_w3c/ewt_dl_link.php?filename=national_account&nid=4317.
15. Sithithaworn, P., P. Yongvanit, K. Duenngai, et al., 2014,
``Roles of Liver Fluke Infection As Risk Factor for
Cholangiocarcinoma,'' Journal of Hepato-Biliary-Pancreatic Science,
epub ahead of print January 10, 2014, doi: 10.1002/jhbp.62.
16. Epprecht, M., N. Minot, R. Dewina, et al.,

and the International Food Policy Research Institute, 2008, ``The
Geography of Poverty and Inequality in the Lao PDR,'' Swiss National
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    Dated: July 8, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15252 Filed 7-14-20; 8:45 am]
BILLING CODE 4164-01-P