Appendix D Changes in Distribution System Operation Significant Excursions Identified Using the " Maximum Concentration Approach" This page intentionally left blank. Significant Excursion Guidance Manual Proposal Draft July 2003 D 1 The first part of this appendix includes general system information and a summary of TTHM and HAA5 data that resulted in Elm City having to perform a significant excursion evaluation. This information is not required e as part of the documenntation of a significant excursion. Only the Significant Excursion Report is required to be completed by systems that experience a significant excursion.

This appendix is provided as an example of a system in which changes in distribution system operations led to a DBP Significant Excursion. Possible strategies to reduce excursions are presented in Chapter 4, but they are not to be included in the identification and documentation process. Appendices B, C, and E provide similar examples for systems in which changes in source water quality, changes in treatment plant operations, and multiple causes resulted in a significant excursion.

This example assumes the state has chosen to use 100 µ g/ L TTHM and 75 µ g/ L HAA5 as the trigger levels for determining that a significant excursion has occurred and that a significant excursion evaluation is required.

Background Information for this Example System Description:

General system characteristics: Service area: Elm City plus surrounding suburban areas Production: Annual average daily demand 15 MGD Source Water Information: Hardwood Lake ( surface water) pH: from 6.9 to 7.5 Alkalinity: from 82 to 98 mg/ L as CaCO 3 TOC: from 2.1 to 4.0 mg/ L as C Bromide: from 0.04 to 0.1 mg/ L Turbidity: 1 to 100 ntu Softwood River ( surface water) pH: from 6.8 to 7.9 Alkalinity: from 77 to 94 mg/ L as CaCO 3 TOC: from 1.6 to 9.4 mg/ L as C Bromide: from 0.03 to 0.1 mg/ L Turbidity: 2 to 115 ntu Significant Excursion Guidance Manual Proposal Draft July 2003 D 2 Treatment Provided: Hardwood, conventional ( 15 MGD design, 7.5 MGD average) Softwood River, conventional with GAC ( 20 MGD design, 7.5 MGD average) Primary and residual disinfection: Chlorine/ chlorine at both plants Summary of Stage 2 DBPR Monitoring Locations: Table D. 1 summarizes the Stage 2 DBPR monitoring locations used by Elm City. Sample locations are marked in the distribution system schematic presented in Figure D. 1.

Table D. 1 Stage 2 DBPR Monitoring Locations Location Description Location # 1 Hardwood Plant  average residence time Location # 2 Hardwood Plant  high TTHM Location # 3 Hardwood Plant  high HAA5 Location # 4 Hardwood/ Softwood Mix Zone  high TTHM Location # 5 Hardwood/ Softwood Mix Zone  high TTHM Location # 6 Hardwood/ Softwood Mix Zone  high TTHM Location # 7 Softwood Plant  average residence time Location # 8 Softwood Plant  high HAA5 Significant Excursion Guidance Manual Proposal Draft July 2003 D 3 Pineville MIXING ZONE Softwood River WTP Hardwood WTP Elevated Storage Tank Ground storage tank Booster disinfection 2 Oakville 1 3 Elmville 5 Downtown Appleville Weeping Willow Poplarville Cedarville Cypressville 6 7 4 8 Peak DBP site Figure D. 1 Schematic of Elm City Distribution System and Stage 2 DBPR Monitoring Locations Significant Excursion Guidance Manual Proposal Draft July 2003 D 4 DBP Excursion Investigation:

During the last sampling period which took place in September 2004, Elm City experienced unusually high TTHM values ( relative to the LRAA) at monitoring location # 2. DBP data from the previous year and most recent sampling period ( five quarters total) are presented in Table D. 2.

Table D. 2 TTHM and HAA5 Monitoring Data Loc atio n TTHM ( ug/ L) HAA5 ( ug/ L)

Quarterly Pre Sept 2004 Data1 LRAA Pre Sept 2004 Sept 2004 Data LRAA incl. Sept 2004 Quarterly Pre Sept 2004 Data1 LRAA Pre Sept 2004 Sept 2004 Data LRAA incl. Sept 2004 # 1 54, 67, 58, 75 65 72 68 52, 37, 30, 41 40 53 40 # 2 49, 39, 50, 76 52 122 72 43, 39, 41, 45 42 49 44 # 2 68, 68, 55, 69 63 69 65 38, 45, 28, 19 33 40 33 # 3 66, 52, 71, 72 64 76 68 41, 46, 45, 39 43 58 47 # 4 50, 55, 51, 61 55 82 60 42, 43, 38, 34 39 54 42 # 5 34, 48, 55, 50 44 68 48 32, 43, 55, 38 42 37 43 # 6 44, 62, 58, 60 49 70 63 45, 33, 41, 40 40 53 42 # 7 40, 41, 37, 46 41 58 46 21, 38, 28, 19 27 29 29 # 8 68, 68, 55, 69 63 69 65 38, 45, 28, 19 33 40 33 1Data for sampling conducted on September 2003, December 2003, March 2004 and June 2004. Data relevant to peak excursions are bold and underlined.

Unusually high TTHM concentrations were observed at location # 2. The results are significantly higher than both the LRAA at those locations for the previous 12 month period and the historic TTHM and HAA5 values at those locations for the years 1999 2003 ( see Significant Excursions Evaluation Report). Data for September 2004 meets the criteria of peak excursion. The city staff does not believe that treatment plant or source water quality changes caused the increase in the DBP level because such changes would likely impact all locations supplied by the treatment plant or source water, but only one location was affected by high DBP level. The city Significant Excursion Guidance Manual Proposal Draft July 2003 D 5 staff believes that distribution system operations in the vicinity of the location caused the increase in the DBP level.

Significant Excursion Report date: October 16th, 2004 Evaluation Report Report prepared by: Ronald Doe, P. E.

Page 1 System name: Elm City 1) When was the significant excursion sample( s) collected? What were the TTHM and HAA5 concentrations?

Location No. # 2 # ______ # ______ # ______

Location description Hardwood Plant  high TTHM Sample collection date Sept. 4, 2004 Sample collection time 2 p. m.

TTHM LRAA Concentration ( ug/ L) 72 TTHM Concentration ( ug/ L) 122 HAA5 LRAA Concentration ( ug/ L)

HAA5 Concentration ( ug/ L)

Note: Attach additional sheets if you observed more than four significant excursions during this round of sampling.

2) Where did the excursion( s) occur? Attach a schematic of your system, sketch your system in the space below, or have a schematic of your system available to review with your state at the time of your next sanitary survey. Indicate the location( s) of the significant excursion( s) on your schematic.

Location # 2 B Represents high residence time of water leaving the Hardwood Plant. It is located in the Pineville neighborhood. An elevated storage tank also supplies water to this subdivision.

The location of these sample locations is illustrated in Figure D. 1. Significant Excursion Guidance Manual Proposal Draft July 2003 D 6 Significant Excursion Evaluation Report Page 2 Report date: October 16th, 2004 3) Attach ( or provide in the Supplemental Data Form) all available water quality data for the round of sampling in which the significant excursion occurred. At a minimum, include all TTHM and HAA5 results from the sampling period. You should also consider including pH, temperature, alkalinity, TOC, disinfectant residual, and any other data that you think would be useful.

a) Were there any unusual circumstances associated with this round of sampling?

Yes No X If yes, please explain.

b) Were all analytical QA/ QC measures met?

Sample preservation Yes X No Sample holding time Yes X No Other If no, please explain.

4) Attach ( or provide in the Supplemental Data Form) historical TTHM and HAA5 data for the location( s) at which the significant excursion( s) occurred. Provide at least three years of data, if available. Significant Excursion Guidance Manual Proposal Draft July 2003 D 7 Significant Excursion Evaluation Report Page 3 Report date: October 16th, 2004 5) What caused your excursion( s) to occur?

Sections A through F starting on page 4 can help you determine the possible cause( s) of your excursion. Please note there may be more than one factor which resulted in your excursion.

Section A: Source water quality change Section B: Process upset at treatment plant Section C: Planned change or maintenance activities at plant Section D: Planned distribution system operations or maintenance activities Section E: Unplanned events in distribution system If you already suspect a cause, go directly to that section. If you read Sections A through E and are unable to determine a cause of your excursion, then complete Section F.

Consecutive systems should also contact their wholesaler to identify the cause( s) of the significant excursion( s).

6) List steps taken or planned to reduce DBP peak levels.

Considering modifications to configuration of inflow piping at the Pineville tank to improve mixing. Significant Excursion Guidance Manual Proposal Draft July 2003 D 8 Significant Excursion Guidance Manual Proposal Draft July 2003 D 9 Significant Excursion Evaluation Report Page 4 Report date: October 16th, 2004 A. Source Water Quality Changes ° Did any of the events listed below take place before the DBP excursion to cause TOC levels to increase?   Heavy rain fall   Flooding   Spring snow melt/ runoff   Significant decrease in rainfall or source flow   Algae bloom ° Did any of the events listed below take place before the DBP excursion to cause bromide levels to increase?   Significant decrease in rainfall or source flow   Brackish or seawater intrusion ° Did pH and/ or alkalinity significantly change?

° If two or more supplies are used, was a greater portion of water drawn from the one with higher TOC?

° Was raw water stored for an unusually long period of time resulting in a significant increase in water temperature?

Conclusions:

Did source water quality changes cause or contribute to your significant excursion( s)?

Yes No X If yes, please explain:

Attach all supporting operational or other data which led you to conclude this was the cause of your excursion( s) or make sure this data is available during your sanitary survey. Significant Excursion Guidance Manual Proposal Draft July 2003 D 10 Significant Excursion Evaluation Report Page 5 Report date: October 16th, 2004 B. Process Upset at Treatment Plant ° Was raw water stored for an unusually long time, providing additional contact time for DBP formation after prechlorination?

° Were there changes in coagulation practices?

S Were there any changes or malfunctions of the coagulation process in the days leading to the excursion?

S Were the coagulant dose and pH properly adjusted for incoming source water conditions?

° Were there changes in chlorination practices?   Were there any changes in chlorine dose at any location in the plant?   Were there changes in plant flow that may have resulted in longer than normal residence time at any location in the plant?

S Did the pH change at the point of chlorine addition?

° Were there changes in settling practices?

S Was there excess sludge build up in the settling basin that may have carried over to the point of disinfectant addition?

S Was there any disruption in the sludge blanket that may have resulted in carryover to the point of disinfection?

° Were there changes in filtration practices?

S Have filter run times been changed to meet raw water quality changes?

S Were there any spikes in individual filter effluent turbidity ( which may indicate particulate or colloidal TOC breakthrough) in the days leading to the excursion?

S Did chlorinated water sit in the filter for an extended period of time?

S Were all filters run in a filter to waste mode during initial filter ripening?

S Were any filters operated beyond their normal filter run time?

S If GAC filters are used: Is it possible the adsorptive capacity of the GAC bed was reached before reactivation occurred?

S If biological filtration is used: Were there any process upsets that may have resulted in breakthrough of TOC ( particularly biodegradable TOC)?

° Were there changes in plant flow that may have resulted in an unusually high residence time in the clearwell on the days prior to the excursion?

S For example, a temporary plant shutdown.

Continued on next page Significant Excursion Guidance Manual Proposal Draft July 2003 D 11 Significant Excursion Evaluation Report Page 6 Report date: October 16th, 2004 B. Process Upset at Treatment Plant ( Continued)

Conclusions:

Did a process upset in the treatment plant cause or contribute to your significant excursion( s)?

Yes No X If yes, please explain:

Attach all supporting operational or other data which led you to conclude this was the cause of your excursion( s) or make sure this data is available during your sanitary survey. Significant Excursion Guidance Manual Proposal Draft July 2003 D 12 Significant Excursion Evaluation Report Page 7 Report date: October 16th, 2004 C. Planned Change or Maintenance Activities for the Treatment Plant ° Was there a recent change ( or addition) of pre oxidant?

° Was there any maintenance in the basin that may have stirred sludge from the bottom of the basin and caused it to carry over to the point of disinfectant addition?

° Did you change the type or manufacturer of the coagulant?

° Were there any changes in disinfection practices in the days prior to the excursion?

S For example, a switch from chloramines to free chlorine for burnout period.

S Discontinuation of ozone which forms very little TTHM.

° Was a filter( s) taken off line for an extended period of time that caused the other filters to operate near maximum design capacity and creating the conditions for possible breakthrough?

° Were any pumps shut down for maintenance, leading to changes in flow patterns or hydraulic surges?

Conclusions:

Did a planned maintenance or operational activity in the treatment plant cause or contribute to your significant excursion( s)?

Yes No X If yes, please explain:

Attach all supporting operational or other data which led you to conclude this was the cause of your excursion( s) or make sure this data is available during your sanitary survey. Significant Excursion Guidance Manual Proposal Draft July 2003 D 13 Significant Excursion Evaluation Report Page 8 Report date: October 16th, 2004 D. Planned Distribution System Operations or Maintenance Activities ° Was a tank drained for cleaning or other maintenance?

S Was the tank drained to waste or to the distribution system?

S Was a larger volume than normal drained to the distribution system?

° If booster disinfection is used, was the booster disinfectant dose higher than the normal booster disinfectant dose for that season?

° Were there any system maintenance activities in the days prior to DBP excursion? Including:   Repairing mains or installing new mains   Closure of valves to isolate sections of pipes ° Were the pipes flushed properly or were the appropriate valves re opened after work was completed?

° Did any pump or pipeline maintenance occur that would have changed the flow pattern in the area the sample was drawn from?

S Change in flow can cause water in stagnant areas to be drawn into another area.

° Did any pipeline replacement occur?

S Disinfecting piping in contact with drinking water could result in a high concentration of chlorine entering the distribution system and thus increase DBPs.

Conclusions:

Did a planned distribution system maintenance or operational activity cause or contribute to your significant excursion( s)?

Yes X No If yes, please explain:

Refer to the explanation following Section E.

Attach all supporting operational or other data which led you to conclude this was the cause of your excursion( s) or make sure this data is available during your sanitary survey. Significant Excursion Guidance Manual Proposal Draft July 2003 D 14 Significant Excursion Evaluation Report Page 9 Report date: October 16th, 2004 E. Unplanned Distribution System Events ° Were there increases in demand that caused older water in storage tanks to be drawn into the system?

S Were there any major fire events?

S Did one or more storage tank have greater than average drawdown preceding the time of DBP peak excursion?

° Were there decreases in demand that resulted in longer than normal system residence times?

S Were there any large customers off line?

° Did any main breaks occur causing changes in flow patterns in the influence area of the sample location?

° If you collect water temperature inside storage tanks, was the temperature inside the tank higher than normal for the season?

° Were any storage tanks hydraulically locked out of the system for an extended period and then used preceding the time of DBP peak excursion?

° Did changes in overall water demand cause a change in water demand patterns in the vicinity of dead ends and/ or stagnant zones in the system?

° Were there large variations in localized system pressures that were different from the normal pressure range that could have caused a change in water demand patterns in the vicinity of dead ends and/ or stagnant zones in the system?

Conclusions:

Did an unplanned distribution system maintenance or operational activity cause or contribute to your significant excursion( s)?

Yes X No If yes, please explain:

The city staff believes distribution system operations caused the peak THM excursion. Therefore, the likelihood that distribution issues contributed to the peak THM excursion has been explored first. To determine the cause of the THM peak excursion, the city staff reviewed the following information for a period of two weeks prior to the occurrence of peak THM excursion:

° System maintenance activities ° Main breaks ° System pressure fluctuations ° Overall system demand ° Water level in storage tanks ° Boost disinfection operation Attach all supporting operational or other data which led you to conclude this was the cause of your excursion( s) or make sure this data is available during your sanitary survey. Significant Excursion Guidance Manual Proposal Draft July 2003 D 15 System maintenance activities: Installation of a new 12 inch main for a new development in Elmville subdivision was completed. The city staff reviewed the main disinfection logbook which indicated that the new main was flushed properly, and chlorine residual in the pipe was 1 mg/ L before it was connected to the rest of the water system. Three valves were closed to isolate sections of pipes from the rest of the water system. during installation of the new main. These valves were checked to make sure that they were all opened after installation of the new main was completed. One valve was found to be inadvertently left in the closed position. However, the closure of this valve did not affect the water quality in Pineville subdivision where the peak THM concentration occurred. The city's hydraulic model indicated that water does not flow from Elmville to Pineville and closing the valve in the pipe in Elmville does not alter the water flow patters in Pineville.

Main breaks: A road repair worker in Pineville subdivision damaged a 12 inch water main that runs along that road. The broken section of the water main was isolated and shut off within two hours. However, it is anticipated that there was significant loss of water during those two hours. Hydraulic analyses using the city's hydraulic model have indicated that the piping network in Pineville does not have any stagnant zones with high residence time. Also, using the city's hydraulic model to simulate the main break by creating artificial demand at the location of the main break indicated that the influence of the main break did not draw water from any stagnant zones towards the sample location where peak THM excursion occurred.

System pressure fluctuations: The distribution system pressure in the Pineville subdivision was generally within the normal range expected for the month of September, approximately 52 65 psi. However, the pressure was about 10 psi lower at the location of the main break for about two hours. As soon as the damaged section of the main was isolated, the pressure at that location returned to the normal pressure range generally expected for the month of September. The piping network in Pineville does not have any stagnant zones. There may be stagnant zones outside the Pineville subdivision, but the lower pressure in the vicinity of the peak THM occurrence did not impact water flow patterns outside the Pineville subdivision, as verified by the city's hydraulic model.

Overall system demand: The total hourly distribution system demand was checked using treatment plant production figures and tank level data. The hourly total system demand during September 2004 ranged between 14 17 mgd, which was also the general range for the system demand during the month of September for 1999 2003. An unusual increase or decrease in the total system demand was not observed two weeks prior to the peak THM occurrence. The loss of water due to the main break did not cause a significant change in the overall system demand. Therefore, there was not any unusual shift in the water demand patterns and water flow patterns in the vicinity of stagnant zones and thus did not contribute to the peak THM occurrence.

Water level in storage tanks: The hourly water level for all the tank in Elm City was plotted using the SCADA system data. The water levels fluctuated within the normal range for all the tanks except for the elevated tank located in Pineville. The water level in the Pineville tank generally fluctuates approximately 20 feet to 35 feet above the bottom of the tank. The water level in this tank dropped to about 12 feet above the bottom of the tank at the time of the main break and then rose to normal levels once the broken section of the main was isolated. The increased water demand and pressure drop at the location of the main break was responsible for the unusual drop in the water level of the Pineville tank. The proximity of Sample Location 2 to the main break also decreased the pressure at the sampling location, this allowing the water from the top portion of the tank to reach that location during the main break. The SCADA data indicated that the average inflow rate into the tank is 1000 gpm and the inlet diameter is 36 inches. This inflow rate and inlet diameter may not provide adequate momentum to mix the water near the top portion of the tank where the water came from during the main break. Therefore, the water age in the top portion of the tank was higher and may have caused the peak DBP level at Sample Site 2. Significant Excursion Guidance Manual Proposal Draft July 2003 D 16 Significant Excursion Guidance Manual Proposal Draft July 2003 D 17 Booster disinfection operation:

There is a booster disinfection station located in the Polarville subdivision. The disinfectant residual leaving this booster station was within the normal range of 1 2 mg/ L. Pineville subdivision receives all the water either from the treatment plant directly or from the Pineville tank. It does not receive any portion of its water from the booster station. Thus, the disinfectant residuals at the booster station did not contribute to peak THM occurrence at Location 2. Significant Excursion Guidance Manual Proposal Draft July 2003 D 18 Significant Excursion Evaluation Report Page 10 Report date: October 16th, 2004 F. If you were unable to identify the cause of your significant excursion( s) after reviewing Sections A through E, are you able to identify another potential cause of your increase in DBP concentrations? Explain.

Note: If you are unable to determine the cause of your excursion you may wish to consider:

° More frequent raw water temperature monitoring. ° More frequent raw water TOC monitoring. ° Increased disinfectant residual monitoring in the distribution system. ° Tracer studies to characterize distribution system water age. ° Development of a hydraulic model to characterize the distribution system.

Attach all supporting operational or other data which led you to conclude this was the cause of your excursion( s) or make sure this data is available during your sanitary survey. Significant Excursion Guidance Manual Proposal Draft July 2003 D 19 Significant Excursion Guidance Manual Proposal Draft July 2003 D 20 Supplemental Data Form for the Significant Excursion Evaluation Report Report date: October 16th, 2004 Report prepared by: Ronald Doe, P. E.

System name: Elm City 1) Water quality data from significant excursion sampling period.

Location No. # 1 # 2 # 3 # 4 # 5 # 6 # 7 # 8 Location Name TTHM ( ug/ L) 72 122 82 68 68 70 58 69 HAA5 ( ug/ L) 53 38 58 54 37 53 29 40 Free Chlorine ( mg/ L) 1.5 0.1 NA 0.5 0.8 1.1 NA 0.9 Total Chlorine ( mg/ L) 1.7 0.2 NA 0.7 1.1 1.5 NA 1.2 pH 7.9 8.0 8.3 8.1 7.8 8.3 7.5 8.2 Significant Excursion Guidance Manual Proposal Draft July 2003 D 21 2) Supplemental data from each treatment facility:

Plant # 1: Hardwood Plant Plant # 2: Softwood Plant Raw Water Temperature: NA Raw Water Temperature: NA Plant Effluent Water Temperature: 20

C Plant Effluent Water Temperature: 20

C Raw Water TOC: 2.2 mg/ L ( Avg.  2.0mg/ L) Raw Water TOC: 1.8 mg/ L ( Avg.  2.0mg/ L)

Other Data: Other Data: Inf. turb.: 25 ntu ( Avg  20 ntu)

3) Historical TTHM and HAA5 data at significant excursion sampling locations.

TTHM Data ( ug/ L) HAA5 Data ( ug/ L)

Monitoring Location # 2 #_____ #_____ #_____ Monitoring Location # 2 #_____ #_____ #_____

Date  1998 61 Date  1998 32 Date  1999 55 Date  1999 29 Date  2000 70 Date  2000 48 Date  2001 64 Date  2001 36 Date  2002 49 Date  2002 43 Avg. 98 02 60 Avg. 98 02 49 Attach additional sheets if necessary


[Federal Register: July 18, 2007 (Volume 72, Number 137)]
[Notices]
[Page 39476-39477]
[DOCID:fr18jy07-123]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56058; File No. SR-NYSEArca-2006-83]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
of Proposed Rule Change Relating to Amendments to NYSE Arca Rules 2.17
and 4.5 Relating to Certain OTP Holder and OTP Firm Administrative
Procedures

July 12, 2007.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Exchange Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby
given that on November 7, 2006, NYSE Arca, Inc. (``NYSE Arca'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'' or ``SEC'') the proposed rule change as described in
Items I, II and III below, which Items have been substantially prepared
by the Exchange. The Commission is publishing this notice to solicit
comment on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend NYSE Arca Rules 2.17 and 4.5(c) and
(d). The text of the proposed rule change is set forth below.
Italicized text indicates additions; brackets indicate deletions.
* * * * *

Rule 2.17 Amendments to OTP Firm or OTP Holder Documents

    (a) All formation documents for OTP Firms for which NYSE Arca, Inc.
is the Designated Examining Authority, such as articles of
incorporation, by-laws, partnership agreements, limited liability
company agreements, and all amendments thereto, now in effect or
adopted in the future, shall be filed with the Exchange and shall be
subject to Exchange approval.
* * * * *

Rule 4.5(c) Part II Quarterly Reports

    [Two manually signed copies of] Part II of SEC Form X-17A-5 shall
be filed electronically with, and in a manner prescribed by, the
Exchange for each calendar quarter by any OTP Holder or OTP Firm which
carries or clears accounts for customers. Such report shall be due by
the seventeenth business day following the end of the calendar quarter
being reported upon. Original copies of such reports with manual
signatures shall be maintained by the OTP Holder or OTP Firm, as
applicable, in accordance with NYSE Arca Rule 11.16(a).
* * * * *

Rule 4.5(d) Part IIA Quarterly Reports

    [Two manually signed copies of] Part IIA of SEC Form X-17A-5 shall
be filed electronically with, and in a manner prescribed by, the
Exchange for each calendar quarter by any OTP Holder or OTP Firm which
does not carry or clear accounts for customers. Such report shall be
due by the seventeenth business day following the end of the calendar
quarter being reported upon. Original copies of such reports with
manual signatures shall be maintained by the OTP Holder or OTP Firm, as
applicable, in accordance with NYSE Arca Rule 11.16(a).
* * * * *

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 self-regulatory organization
included statements concerning the purpose of and basis for the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of these statements may be examined at
the places specified in Item IV below. The self-regulatory organization
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 NYSE Arca Rules 2.17 and 4.5(c) and
(d) in order to simplify the administrative procedures that Options
Trading Permit (``OTP'') Holders \3\ and OTP Firms \4\ must follow. The
Exchange believes that such amendments will not compromise the
Exchange's ability to regulate its OTP Holders and OTP Firms.
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    \3\ See NYSE Arca Rule 1.1(q).
    \4\ See NYSE Arca Rule 1.1(r).
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    NYSE Arca Rule 2.17 currently provides that all OTP Firms must file
their formation documents with the Exchange. The Exchange proposes to
amend NYSE Arca Rule 2.17 in order to provide that only those OTP Firms
for which the Exchange is the Designated Examining Authority must
submit such formation documents to the Exchange. The Exchange believes
that it is duplicative and unnecessary for an OTP Firm to submit
documentation relating to its organizational structure to more than one
SRO for review. Further, to the extent an OTP Firm is required to send
organizational documents only to one SRO for review, NYSE Arca believes
that the most appropriate SRO to perform that review is the OTP Firm's
Designated Examining Authority.
    NYSE Arca Rule 4.5(c) currently requires OTP Holders and OTP Firms
that carry or clear accounts for customers to file two manually signed
copies of Part II of SEC Form X-17A-5 with the Exchange on a quarterly
basis. The Exchange proposes to amend NYSE Arca Rule 4.5(c) to provide
that such reports shall be filed electronically with the Exchange,
rather than manually, and that the OTP Holder or OTP Firm, as
applicable, shall maintain original copies of such reports with manual
signatures in accordance with NYSE Arca Rule 11.16(a).\5\
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    \5\ NYSE Arca Rule 11.16(a) provides that each OTP Holder and
OTP Firm must make, keep current and preserve such books and records
as the Exchange may prescribe and as may be prescribed by the
Securities Exchange Act of 1934 (the ``Exchange Act'') and the rules
and regulations thereunder (including any interpretation relating
thereto) as though such OTP Holder or OTP Firm were a broker or
dealer registered with the SEC pursuant to Section 15 of the
Exchange Act.
---------------------------------------------------------------------------

    NYSE Arca Rule 4.5(d) currently requires OTP Holders and OTP Firms
that do not carry or clear accounts for customers to file two manually
signed copies of Part IIA of SEC Form X-17A-5 with the Exchange on a
quarterly basis. The Exchange proposes to amend NYSE Arca Rule 4.5(d)
to provide that such reports shall be filed electronically with the
Exchange, rather than manually, and that the OTP Holder or OTP Firm, as
applicable, shall maintain original copies of such reports with manual
signatures in accordance with NYSE Arca Rule 11.16(a).\6\
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    \6\ Id.
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    The Exchange proposes amending NYSE Arca Rule 4.5(c) and (d) to
codify procedural changes that have been implemented by the Exchange
and to be consistent with guidance that has been provided previously to
OTP Holders and OTP Firms.
(2) Statutory Basis
    The Exchange believes the proposed rule change is consistent with
section 6(b) of the Exchange Act,\7\ in general, and furthers the
objectives of section 6(b)(5) \8\ in particular in that it is designed
to prevent fraudulent and manipulative acts and practices, to

promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in facilitating transactions in
securities, and to remove impediments to and perfect the mechanism of a
free and open market and a national market system.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

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

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

    Written comments on the proposed rule change were neither solicited
nor received.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve the proposed modifications, or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

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

File Number SR-NYSEArca-2006-83 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-NYSEArca-2006-83. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site: (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments,

all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room, 100 F Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of NYSE Arca. 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-NYSEArca-2006-83 and should
be submitted on or before August 8, 2007.

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

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

 [FR Doc. E7-13880 Filed 7-17-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 79, Number 104 (Friday, May 30, 2014)]
[Rules and Regulations]
[Pages 31023-31028]
[FR Doc No: 2014-12544]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2013-N-0544]

Microbiology Devices; Reclassification of Nucleic Acid-Based
Systems for Mycobacterium tuberculosis Complex in Respiratory Specimens

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is reclassifying
nucleic acid-based in vitro diagnostic devices for the detection of
Mycobacterium tuberculosis complex in respiratory specimens from class
III (premarket approval) into class II (special controls). FDA is also
issuing the special controls guideline entitled ``Class II Special
Controls Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for
the Detection of Mycobacterium tuberculosis Complex in Respiratory
Specimens.'' These devices are intended to be used as an aid in the
diagnosis of pulmonary tuberculosis.

DATES: This rule is effective June 30, 2014.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2013-
N-0544, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-2013-N-0544 for this rulemaking. All comments
received may be posted without change to http://www.regulations.gov,
including any personal information provided. For additional information
on submitting comments, see the ``Comments'' heading of the
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Janice A. Washington, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5554, Silver Spring, MD 20993-0002,
301-796-6207.

SUPPLEMENTARY INFORMATION:

I. Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended
by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L.
94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the
Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-
115), the Medical Device User Fee and Modernization Act of 2002 (Pub.
L. 107-250), the Medical Devices Technical Corrections Act (Pub. L.
108-214), the Food and Drug Administration Amendments Act of 2007 (Pub.
L. 110-85), and the Food and Drug Administration Safety and Innovation
Act (Pub. L. 112-144) establish a comprehensive system for the
regulation of medical devices intended for human use. Section 513 of
the FD&C Act (21 U.S.C. 360c) establishes three categories (classes) of
devices, reflecting the regulatory controls needed to provide
reasonable assurance of their safety and effectiveness. The three
categories of devices are class I (general controls), class II (special
controls), and class III (premarket approval).
    Under the FD&C Act, FDA clears or approves the three classes of
medical devices for commercial distribution in the United States
through three

regulatory processes: Premarket approval (PMA), product development
protocol, and premarket notification (a premarket notification is
generally referred to as a ``510(k)'' after the section of the FD&C Act
where the requirement is found). The purpose of a premarket
notification is to demonstrate that the new device is substantially
equivalent to a legally marketed predicate device. Under section 513(i)
of the FD&C Act, a device is substantially equivalent if it has the
same intended use and technological characteristics as a predicate
device, or has different technological characteristics but data
demonstrate that the new device is as safe and effective as the
predicate device and does not raise different issues of safety or
effectiveness.
    FDA determines whether new devices are substantially equivalent to
previously offered devices by means of premarket notification
procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and
part 807 of the regulations (21 CFR part 807). Section 510(k) of the
FD&C Act and the implementing regulations in part 807, subpart E,
require a person who intends to market a medical device to submit a
premarket notification submission to FDA before proposing to begin the
introduction, or delivery for introduction into interstate commerce,
for commercial distribution of a device intended for human use.
    In accordance with section 513(f)(1) of the FD&C Act, devices that
were not in commercial distribution before May 28, 1976, the date of
enactment of the 1976 amendments, generally referred to as
postamendment devices, are classified automatically by statute into
class III without any FDA rulemaking process. These devices remain in
class III and require premarket approval, unless FDA classifies the
device into class I or class II by issuing an order finding the device
to be substantially equivalent, in accordance with section 513(i) of
the FD&C Act, to a predicate device that does not require premarket
approval or the device is reclassified into class I or class II. The
Agency determines whether new devices are substantially equivalent to
predicate devices by means of premarket notification procedures in
section 510(k) of the FD&C Act and part 807 of FDA's regulations.
    Section 513(f)(2) of the FD&C Act establishes procedures for ``de
novo'' risk-based review and classification of postamendment devices
automatically classified into class III by section 513(f)(1). Under
these procedures, any person whose device is automatically classified
into class III by section 513(f)(1) of the FD&C Act may seek
reclassification into class I or II, either after receipt of an order
finding the device to be not substantially equivalent, in accordance
with section 513(i), to a predicate device that does not require
premarket approval, or at any time after determining there is no
legally marketed device upon which to base a determination of
substantial equivalence. In addition, under section 513(f)(3) of the
FD&C Act, FDA may initiate, or the manufacturer or importer of a device
may petition for, the reclassification of a device classified into
class III under section 513(f)(1).

II. Regulatory Background of the Device

    A nucleic acid-based in vitro diagnostic device for the detection
of M. tuberculosis complex in respiratory specimens is a postamendment
device classified into class III under section 513(f)(1) of the FD&C
Act in 1995. Consistent with the FD&C Act and FDA's regulations in 21
CFR 860.130(a), FDA is reclassifying these devices from class III into
class II because there is sufficient information from FDA's accumulated
experience with these devices to establish special controls that can
provide a reasonable assurance of the device's safety and
effectiveness.

III. Identification

    Nucleic acid-based in vitro diagnostic devices for the detection of
M. tuberculosis complex in respiratory specimens are qualitative
nucleic acid-based in vitro diagnostic devices intended to detect M.
tuberculosis complex nucleic acids extracted from human respiratory
specimens. These devices are non-multiplexed and intended to be used as
an aid in the diagnosis of pulmonary tuberculosis when used in
conjunction with clinical and other laboratory findings. These devices
do not include devices intended to detect the presence of organism
mutations associated with drug resistance. Respiratory specimens may
include sputum (induced or expectorated), bronchial specimens (e.g.,
bronchoalveolar lavage or bronchial aspirate), or tracheal aspirates.

IV. Background for Reclassification Decision

    At an FDA/Centers for Disease Control (CDC)/National Institute of
Allergy and Infectious Diseases public workshop entitled ``Advancing
the Development of Diagnostic Tests and Biomarkers for Tuberculosis,''
held in Silver Spring, MD, on June 7 and 8, 2010, the class III
designation for nucleic acid-based in vitro diagnostic devices for the
detection of M. tuberculosis complex in respiratory specimens was
raised as a barrier to advancing M. tuberculosis diagnostics (Ref. 1).
Based on discussion at the public workshop, FDA agreed to consider this
issue further and subsequently convened a meeting of the Microbiology
Devices Panel of the Medical Devices Advisory Committee on June 29,
2011. Panel members were asked to discuss if sufficient risk mitigation
was possible for FDA to initiate the reclassification process from
class III to class II devices for this intended use through the
drafting of a special controls guidance. All panel members expressed
the opinion that sufficient data and information exist such that the
risks of false positive and false negative results can be mitigated to
allow a special controls guidance to be created that would support
reclassification from class III to class II for nucleic acid-based in
vitro diagnostic devices for the detection of M. tuberculosis complex
in respiratory specimens (Ref. 2). All outside speakers at the open
public hearing session during the meeting also spoke in favor of
reclassification.
    No comments were received on the proposed rule issued on June 19,
2013.

V. Classification

    FDA is reclassifying nucleic acid-based in vitro diagnostic devices
for the detection of M. tuberculosis complex in respiratory specimens
from class III to class II. FDA believes that reclassifying this device
into class II with special controls (guideline document) provides
reasonable assurance of the safety and effectiveness of the device.
Section 510(m) of the FD&C Act provides that a class II device may be
exempt from the premarket notification requirements under section
510(k), if the Agency determines that premarket notification is not
necessary to provide reasonable assurance of the safety and
effectiveness of the device. For this device, FDA believes that
premarket notification is necessary to provide reasonable assurance of
safety and effectiveness and, therefore, is not exempting the device
from the premarket notification requirements.

VI. Risks to Health

    After considering the information discussed by the Microbiology
Devices Panel during the June 29, 2011, meeting, the published
literature, and the medical device reporting system reports, FDA
believes the following risks are associated with nucleic acid-based in
vitro diagnostic devices for the detection of M. tuberculosis complex
in respiratory specimens: (1) False positive test results may lead to
incorrect

treatment of the individual with possible adverse effects. The patient
may be subjected to unnecessary isolation and/or other human contact
limitations. Unnecessary contact investigations may also occur; (2)
false negative test results could result in disease progression and the
risk of transmitting disease to others; and (3) biosafety risks to
health care workers handling specimens and control materials with the
possibility of transmission of tuberculosis infection to health care
workers.

VII. Summary of the Reasons for Reclassification

    FDA, consistent with the opinions expressed by the Microbiology
Devices Panel of the Medical Devices Advisory Committee, believes that
the establishment of special controls, in addition to general controls,
provides reasonable assurance of the safety and effectiveness of
nucleic acid-based in vitro diagnostic devices for the detection of M.
tuberculosis complex in respiratory specimens.
    1. The safety and effectiveness of nucleic acid-based systems for
M. tuberculosis complex have become well-established since approval of
the first device for this use in 1995.
    2. The risk of false positive test results can be mitigated by
specifying minimum performance standards in the special controls
guideline and including information regarding patient populations
appropriate for testing in the device labeling. Additional risk
mitigation strategies include the indication for use that the device be
used as an aid to the diagnosis of pulmonary tuberculosis in
conjunction with other clinical and laboratory findings. The device
also should be accurately described and have labeling that addresses
issues specific to these types of devices.
    3. The risk of false negative test results can be mitigated by
specifying minimum performance standards for test sensitivity in the
special controls guideline and ensuring that different patient
populations are included in clinical trials. Additional risk mitigation
strategies include the indication for use that the device be used as an
aid to the diagnosis of pulmonary tuberculosis in conjunction with
other clinical and laboratory findings. The device also should be
accurately described and have appropriate labeling that addresses
issues specific to these types of devices.
    4. Biosafety risks to health care workers handling specimens and
control materials with the possibility of transmission of tuberculosis
infection to health care workers could be addressed similarly to
existing devices of this type that we have already approved. It is
believed there are no additional biosafety risks introduced by
reclassification from class III to class II. The need for appropriate
biosafety measures can be addressed in labeling recommendations that
are included in the special controls guideline and by adherence to
recognized laboratory biosafety procedures.
    Based on FDA's review of published literature, the information
presented by outside speakers invited to the Microbiology Devices
meeting, and the opinions of panel members expressed at that meeting,
FDA believes that there is a reasonable basis to determine that nucleic
acid-based in vitro diagnostic devices for the detection of M.
tuberculosis complex in respiratory specimens can provide the
significant benefit of rapid detection of infection in patients with
suspected tuberculosis as compared to traditional means of diagnosis.
For patients with acid-fast smear negative tuberculosis, nucleic acid-
based in vitro diagnostic devices for the detection of M. tuberculosis
complex in respiratory specimens are currently the only laboratory
tests available for rapid detection of active pulmonary tuberculosis.
Rapid identification of patients with active tuberculosis may have
significant benefits to the infected patient by earlier diagnosis and
management as well as potentially significant effects on the public
health by limiting disease spread.
    Nucleic acid-based in vitro diagnostic devices for the detection of
M. tuberculosis complex in respiratory specimens have been approved for
marketing by FDA for over 15 years. There is substantial scientific and
medical information available regarding the nature, complexity, and
problems associated with these devices. Revised public health
recommendations for use, published by CDC on January 16, 2009,
recommended the use of nucleic acid amplification testing in
conjunction with acid-fast microscopy and culture and specifically
states that ``Nucleic acid amplification testing should be performed on
at least one respiratory specimen from each patient with signs and
symptoms of pulmonary [tuberculosis] for whom a diagnosis of
[tuberculosis] is being considered but has not yet been established,
and for whom the test result would alter case management or
[tuberculosis] control activities'' (Ref. 3).

VIII. Special Controls

    FDA believes that the measures set forth in the special controls
guideline entitled ``Nucleic Acid-Based In Vitro Diagnostic Devices for
the Detection of Mycobacterium tuberculosis Complex in Respiratory
Specimens'' are necessary, in addition to general controls, to mitigate
the risks to health described in section VI. As seen in table 1, the
special controls set forth in the guideline for this device address
each of the identified risks.

            Table 1--Risks to Health and Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
False positive test results may lead to  Device description containing
 incorrect treatment of the individual    the information specified in
 with possible adverse effects. The       the special control guideline.
 patient may be subjected to             Performance studies.
 unnecessary isolation and/or other      Labeling.
 human contact limitations. Unnecessary
 contact investigations may also occur.
False negative test results could        Device description containing
 result in disease progression, and the   the information specified in
 risk of transmitting disease to others.  the special control guideline.
                                         Performance studies.
                                         Labeling.
Biosafety risks to health care workers   Labeling.
 handling specimens and control
 materials with the possibility of
 transmission of tuberculosis infection
 to health care workers.
------------------------------------------------------------------------

    As of the effective date of this rule, nucleic acid-based in vitro
diagnostic devices for the detection of M. tuberculosis complex in
respiratory specimens will be reclassified into class II. The
reclassification will be codified

in 21 CFR 866.3372. Firms submitting a 510(k) for a nucleic acid-based
in vitro diagnostic device for the detection of M. tuberculosis complex
in respiratory specimens will need either to: (1) Comply with the
particular mitigation measures set forth in the special controls
guideline or (2) use alternative mitigation measures, but demonstrate
to the Agency's satisfaction that alternative measures identified by
the firm will provide at least an equivalent assurance of safety and
effectiveness. Adherence to the criteria in the guideline, in addition
to the general controls, is necessary to provide a reasonable assurance
of the safety and effectiveness of the devices.

IX. Electronic Access to the Special Controls Guideline

    Persons interested in obtaining a copy of the guideline may do so
by using the Internet. A search capability for all Center for Devices
and Radiological Health guidelines and guidance documents is available
at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. The guideline is also available at
http://www.regulations.gov.
    To receive ``Class II Special Controls Guideline: Nucleic Acid-
Based In Vitro Diagnostic Devices for the Detection of Mycobacterium
tuberculosis Complex in Respiratory Specimens,'' you may either send an
email request to<EMAIL_ADDRESS>to receive an electronic copy of
the document or send a fax request to<PHONE_NUMBER> to receive a hard
copy. Please use the document number 1788 to identify the guideline you
are requesting.

X. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this
reclassification action is of a type that does not individually or
cumulatively have a significant effect on the human environment.
Therefore, neither an environmental assessment nor an environmental
impact statement is required.

XI. Federalism

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. Section 4(a) of the Executive order
requires Agencies to ``construe * * * a Federal statute to preempt
State law only where the statute contains an express preemption
provision or there is some other clear evidence that the Congress
intended preemption of State law, or where the exercise of State
authority conflicts with the exercise of Federal authority under the
Federal statute.'' Federal law includes an express preemption provision
that preempts certain state requirements ``different from or in
addition to'' certain Federal requirements applicable to devices. (See
section 521 of the FD&C Act (21 U.S.C. 360k); Medtronic v. Lohr, 518
U.S. 470 (1996); and Riegel v. Medtronic, 128 S. Ct. 999 (2008)). The
special controls established by this final rule create ``requirements''
for specific medical devices under 21 U.S.C. 360k, even though product
sponsors have some flexibility in how they meet those requirements.
(See Papike v. Tambrands, Inc., 107 F.3d 737, 740-42 (9th Cir. 1997)).

XII. Paperwork Reduction Act of 1995

    This rule refers to previously approved collections of information
found in FDA regulations. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections
of information in 21 CFR 56.115 have been approved under OMB control
number 0910-0130; the collections of information in 21 CFR part 807,
subpart E have been approved under OMB control number 0910-0120; the
collections of information in 21 CFR part 812 have been approved under
OMB control number 0910-0078; the collections of information in 21 CFR
part 820 have been approved under OMB control number 0910-0073; and the
collections of information in 21 CFR part 801 and 21 CFR 809.10 have
been approved under OMB control number 0910-0485.

XIII. Clarifications to Special Controls Guideline

    This special controls guideline reflects changes the Agency is
making to clarify its position on the binding nature of special
controls. The changes include referring to the document as a
``guideline,'' as that term is used in section 513(a) of the FD&C Act,
which the Secretary has developed and disseminated to provide a
reasonable assurance of safety and effectiveness for class II devices,
and not a ``guidance,'' as that term is used in 21 CFR 10.115. The
guideline clarifies that firms will need either to: (1) Comply with the
particular mitigation measures set forth in the special controls
guideline or (2) use alternative mitigation measures, but demonstrate
to the Agency's satisfaction that those alternative measures identified
by the firm will provide at least an equivalent assurance of safety and
effectiveness. Finally, the guideline uses mandatory language to
emphasize that firms must comply with special controls to legally
market their class II devices. These revisions do not represent a
change in FDA's position about the binding effect of special controls,
but rather are intended to address any possible confusion or
misunderstanding.

XIV. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The Agency believes that this rule is not a significant
regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because the reclassification relieves manufacturers
of premarket approval requirements of section 515 of the FD&C Act (21
U.S.C. 360e) it would not create new burdens. Thus, the Agency
certifies that the rule will not have a significant economic impact on
a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $141 million, using the most current (2013) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
rule to result in any 1-year expenditure that would meet or exceed this
amount.
    The proposed rule was issued on June 19, 2013 (78 FR 36698). The
comment period closed August 19, 2013, and FDA did not receive any
comments. We revise the analysis of impact presented in the proposed
rule with more current data, and adjust for inflation. Our estimate of
benefits annualized over 20 years is $12.34 million at a 3 percent
discount rate and $8.02 million at a 7

percent discount rate. The change in pre- and post-marketing
requirements between a 510(k) and a PMA lead to benefits in the form of
reduced submission costs, review-related activities, and inspections.
Another unquantifiable benefit from the rule is that a decrease in
entry could lead to further product innovation. FDA is unable to
quantify the costs that could arise if there is a change in risk which
could lead to adverse events, recalls, warning letters, or unlisted
letters. Table 2 summarizes the estimated costs and benefits.
    The full discussion of economic impacts is available in docket FDA-
2013-N-0544 at http://www.regulations.gov, and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm (Ref.
4).

                                      Table 2--Summary of Benefits, Costs and Distributional Effects of Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Units
                                                                                ---------------------------------
                    Category                       Primary       Low        High                Discount    Period                  Notes
                                                   estimate    estimate   estimate     Year       rate     covered
                                                                                dollars   (percent)   (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized.................................        $8.02  .........  .........       2012          7         20
    Monetized $millions/year...................       $12.34  .........  .........       2012          3         20
    Annualized.................................  ...........  .........  .........       2012          7         20
    Quantified.................................  ...........  .........  .........       2012          3         20
    Qualitative................................
Costs:
    Annualized.................................  ...........  .........  .........       2012          7         20
    Monetized $millions/year...................  ...........  .........  .........       2012          3         20
    Annualized.................................  ...........  .........  .........       2012          7         20
    Quantified.................................  ...........  .........  .........       2012          3         20
--------------------------------------------------------------------------------------------------------------------------------------------------------
    Qualitative................................    FDA is unable to quantify the
                                                  costs that could arise if there
                                                  is a change in risk which could
                                                  lead to adverse events, recalls,
                                                    warning letters, or unlisted
                                                              letters.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
    Federal....................................  ...........  .........  .........       2012          7         20
    Annualized.................................  ...........  .........  .........       2012          3         20
                                                --------------------------------------------------------------------------------------------------------
    Monetized $millions/year...................  From:
                                                 To:
                                                --------------------------------------------------------------------------------------------------------
    Other......................................  ...........  .........  .........       2012          7         20
    Annualized.................................  ...........  .........  .........       2012          3         20
                                                --------------------------------------------------------------------------------------------------------
    Monetized $millions/year...................  From:
                                                 To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government: None estimated...................................................................................................
    Small Business: The proposed rule will not have a significant impact on a substantial number of small entities......................................
    Wages: None estimated...............................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

XV. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov. (FDA
has verified all the Web site addresses in this reference section, but
we are not responsible for any subsequent changes to the Web sites
after this document publishes in the Federal Register.)

    1. Transcript of the Tuberculosis Public Workshop, June 7. 2010.
(Available at: http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/CriticalPathInitiative/UpcomingEventsonCPI/UCM289182.doc.)
    2. Transcript of FDA's Microbiology Devices Panel Meeting, June
29, 2011. (Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/MicrobiologyDevicesPanel/UCM269469.pdf.)
    3. ``Updated Guidelines for the Use of Nucleic Acid
Amplification Tests in the Diagnosis of Tuberculosis,'' Morbidity
and Mortality Weekly Report (MMWR), vol. 58, pp. 7-10, January 16,
2009. (Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5801a3.htm.)
    4. Full Disclosure Final Regulatory Impact Analysis of the final
rule ``Microbiology Devices; Reclassification of Nucleic Acid-Based
Systems for Mycobacterium tuberculosis Complex in Respiratory
Specimens,'' Docket No. FDA-2013-N-0544. (Available at: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, Medical devices.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
866 is amended as follows:

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

0
1. The authority citation for part 866 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Add Sec.  866.3372 to subpart D to read as follows:

Sec.  866.3372  Nucleic acid-based in vitro diagnostic devices for the
detection of Mycobacterium tuberculosis complex in respiratory
specimens.

    (a) Identification. Nucleic acid-based in vitro diagnostic devices
for the detection of Mycobacterium tuberculosis complex in respiratory
specimens are qualitative nucleic acid-based in vitro diagnostic
devices intended to detect Mycobacterium tuberculosis complex nucleic
acids extracted from human respiratory specimens. These devices are
non-multiplexed and intended to be used as an aid in the diagnosis of
pulmonary tuberculosis when used in conjunction with clinical and other
laboratory findings. These devices do not include devices intended to
detect the presence of organism mutations associated with drug
resistance. Respiratory specimens may include sputum (induced or
expectorated), bronchial specimens (e.g., bronchoalveolar lavage or
bronchial aspirate), or tracheal aspirates.
    (b) Classification. Class II (special controls). The special
control for this device is the FDA document entitled ``Class II Special
Controls Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for
the Detection of Mycobacterium tuberculosis Complex in Respiratory
Specimens.'' For availability of the guideline document, see Sec.
866.1(e).

    Dated: May 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12544 Filed 5-29-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 81, Number 127 (Friday, July 1, 2016)]
[Notices]
[Pages 43194-43197]
[FR Doc No: 2016-15585]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AD16-17-000]

Reactive Supply Compensation in Markets Operated by Regional
Transmission Organizations and Independent System Operators;
Supplemental Notice of Workshop

    As announced in the Notice of Workshop issued on March 17, 2016,
and the Supplemental Notice of Workshop issued on May 19, 2016, in

the above-captioned proceeding,\1\ Federal Energy Regulatory Commission
(Commission) staff will convene a workshop on June 30, 2016, from 12:00
p.m. (EDT) to 4:00 p.m. (EDT) in the Commission Meeting Room at 888
First Street NE., Washington, DC 20426. The workshop will be open to
the public, and all interested parties are invited to attend and
participate. The workshop will be led by Commission staff, and may be
attended by one or more Commissioners.
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    \1\ Reactive Supply Compensation in Markets Operated by Regional
Transmission Organizations and Independent System Operators, Docket
No. AD16-17-000 (Mar. 17, 2016) (Notice of Workshop); Reactive
Supply Compensation in Markets Operated by Regional Transmission
Organizations and Independent System Operators, Docket No. AD16-17-
000 (May 19, 2016) (Supplemental Notice of Workshop).
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    The purpose of the workshop is to discuss compensation for Reactive
Supply and Voltage Control (Reactive Supply) within the Regional
Transmission Organizations (RTOs) and Independent System Operators
(ISOs). Specifically, the workshop will explore the types of costs
incurred by generators for providing Reactive Supply capability and
service; whether those costs are being recovered solely as compensation
for Reactive Supply or whether recovery is also through compensation
for other services; and different methods by which generators receive
compensation for Reactive Supply (e.g., Commission-approved revenue
requirements, market-wide rates, etc.). The workshop will also explore
potential adjustments in compensation methods based on changes in
Reactive Supply capability and potential mechanisms to prevent
overcompensation for Reactive Supply.
    Attached to this supplemental notice is an agenda for the workshop,
including Reactive Supply compensation topics to be considered for
discussion at the workshop. Questions that speakers should be prepared
to discuss are grouped by topic. This notice includes the list of
panelists for each of the three topic areas.
    Discussions at the workshop may involve issues raised in
proceedings that are pending before the Commission. These proceedings
include, but are not limited to:

------------------------------------------------------------------------
                                                 Docket No(s).
------------------------------------------------------------------------
ISO New England Inc..................  ER16-946-001, ER16-1789-000
Garrison Energy Center, LLC..........  ER15-2735-000
Newark Energy Center, LLC............  ER15-1706-001, EL15-97-000
Scrubgrass Generating Company, L.P...  ER15-2254-000, ER15-2254-001
CPV Shore, LLC.......................  ER15-2589-000, ER15-2589-001,
                                        EL16-4-000, EL16-4-001
C.P. Crane LLC.......................  ER16-259-000, ER16-332-000, EL16-
                                        21-000
GenOn Energy Management, LLC.........  ER15-2571-000, ER15-2572-000,
                                        ER15-2573-000
NRG Wholesale Generation LP..........  ER16-413-000, ER04-1164-001, EL16-
                                        28-000
Talen Energy Marketing, LLC..........  ER16-277-000, ER16-277-001, ER16-
                                        277-002, ER16-277-003, EL16-44-
                                        000, EL16-44-001, ER08-1462-001,
                                        EL16-32-000, ER16-1456-000
Constellation Power Source             ER16-746-001, EL16-57-000
 Generation, LLC.
New Covert Generating Company, LLC...  ER16-1226-000
Panda Liberty LLC....................  ER16-1256-001
Roundtop Energy LLC..................  ER16-1004-000, EL16-51-000
Beaver Dam Energy LLC................  ER16-1032-000, EL16-51-000
FirstEnergy Solutions Corp...........  ER15-1510-000, ER15-1510-001
Duke Energy Indiana, Inc.............  ER16-200-000, ER16-201-000, ER16-
                                        200-002
Wabash Valley Power Association, Inc.  ER16-435-001, ER16-444-001
Consumers Energy Company.............  ER16-1058-000, EL16-56-000
MidAmerican Energy Company...........  ER16-1062-000, EL16-59-000
Indiana Municipal Power Agency.......  EL16-14-000
BIF III Holtwood LLC.................  ER16-1530-000
Seward Generation, LLC...............  ER16-1344-000
Northampton Generating Company, L.P..  ER13-1431-001, EL16-65-000
Entergy Louisiana, LLC...............  ER16-1832-000
LWP Lessee, LLC......................  ER16-1923-000
Midcontinent Independent System        EL16-61-000
 Operator, Inc.
NRG Power Midwest, LP................  ER16-1443-000; EL16-72-000
Panda Patriot LLC....................  ER16-1958-000
Reactive Power Requirements for Non-   RM16-1-000
 Synchronous Generation.
Midwest Generation, LLC..............  EL16-66-000
------------------------------------------------------------------------

    This workshop will be transcribed and webcast. Transcripts of the
workshop will be available for a fee from Ace-Federal Reporters, Inc.
at<PHONE_NUMBER>. A free webcast of this event will be available
through www.ferc.gov. Anyone with internet access who wants to view
this event can do so by navigating to the Calendar of Events at
www.ferc.gov and locating this event in the Calendar. The event will
contain a link to its webcast. The Capitol Connection provides
technical support for webcasts and offers the option of listening to
the workshop via phone-bridge for a fee. If you have any questions,
visit www.CapitolConnection.org or call<PHONE_NUMBER>. Those
interested in attending the workshop or viewing the webcast are
encouraged to register at https://www.ferc.gov/whats-new/registration/06-30-16-form.asp.
    Commission workshops are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations, please
send an email to<EMAIL_ADDRESS>call<PHONE_NUMBER> (toll
free) or<PHONE_NUMBER> (TTY), or send a FAX to<PHONE_NUMBER> with the
required accommodations.
    Those who wish to file written comments may do so by July 28, 2016.
The Commission strongly encourages electronic filing. Please file
comments using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>(866) 208-3676 (toll free), or
(202) 502-8659

(TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426. The first page of any filing should include
docket number AD16-17-000.
    All comments will be placed in the Commission's public files and
will be available for review at the Commission in the Public Reference
Room or may be viewed on the Commission's Web site at www.ferc.gov
using the eLibrary link. Enter AD16-17-000 in the docket number field
to access documents. For assistance, please contact FERC Online
Support.
    For more information about this workshop, please contact:

Sam Wellborn (Technical Information), Office of Energy Market
Regulation--East, Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426,<PHONE_NUMBER>,
<EMAIL_ADDRESS>Sarah McKinley (Logistical Information), Office of External Affairs,
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426,<PHONE_NUMBER><EMAIL_ADDRESS>Gretchen Kershaw (Legal Information), Office of the General Counsel,
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426,<PHONE_NUMBER><EMAIL_ADDRESS>
    Dated: June 22, 2016.
Kimberly D. Bose,
Secretary.

Reactive Supply Compensation in Markets Operated by Regional
Transmission Organizations and Independent System Operators Workshop

Docket No. AD16-17-000

June 30, 2016, Washington, DC

Agenda

1. Introduction and Background 12:00 p.m. to 12:15 p.m.\1\
---------------------------------------------------------------------------

    \1\ All times are eastern daylight time.
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1.1 Introduction of Commission staff
1.2 Workshop procedures
1.3 Brief overview of Commission precedent on Reactive Supply
compensation

2. Costs Incurred by Synchronous Generators for Reactive Supply 12:15
p.m. to 1:15 p.m.

2.1 What costs do synchronous generators incur to install and maintain
Reactive Supply capability?
2.2 Is the equipment required for synchronous generators to maintain
Reactive Supply capability the same as that required to produce and
deliver real power, or must additional costs be incurred to provide
Reactive Supply capability?
2.3 Would synchronous generators be designed or operated differently
were it not for the Reactive Supply capability requirements of their
respective Interconnection Agreements or Reactive Supply reliability
requirements?
2.4 What costs do synchronous generators incur in real-time to provide
Reactive Supply service?
2.5 How are the costs required for synchronous generators to maintain
Reactive Supply capability and to provide Reactive Supply service
recovered?

Panelists:

 Dennis Bethel, Bethel Electric Rate Consulting, LLC
 Brook Knodel, Mott MacDonald
 Robert O'Connell, Main Line Electricity Market Consultants,
LLC, on behalf of Panda Power Funds
 Jason Sine, PSEG Services Corporation

3. Costs Incurred by Non-Synchronous Generators for Reactive Supply
1:15 p.m. to 2:15 p.m.

3.1 What costs do non-synchronous generators incur to install and
maintain Reactive Supply capability?
3.2 Is the equipment required for non-synchronous generators to
maintain Reactive Supply capability the same as that required to
produce and deliver real power, or must additional costs be incurred to
provide Reactive Supply capability?
3.3 Would non-synchronous generators be designed or operated
differently were it not for the Reactive Supply capability requirements
of their respective Interconnection Agreements or Reactive Supply
reliability requirements?
3.4 What costs do non-synchronous generators incur in real-time to
provide Reactive Supply service?
3.5 How are the costs required for non-synchronous generators to
maintain Reactive Supply capability and to provide Reactive Supply
service recovered?

Panelists:

 Ravi Bantu, RES America Developments Inc.
 Mason Emnett, NextEra Energy, Inc.
 Omar Martino, EDF Renewable Energy
 Nicholas Miller, GE Energy Consulting
 Robert Nelson, Siemens Wind Power

4. Compensation Methods for Reactive Supply in Regional Transmission
Organizations (RTOs) and Independent System Operators (ISOs) 2:15 p.m.
to 3:55 p.m.

4.1 How does each RTO and ISO currently compensate for Reactive Supply
capability and Reactive Supply service?
4.2 Is compensation for Reactive Supply capability and Reactive Supply
service in RTOs and ISOs commensurate with the associated costs?
4.3 How do the RTOs and ISOs monitor the availability and amount of
Reactive Supply capability, and is availability and amount of Reactive
Supply capability and Reactive Supply service linked to compensation?
4.4 How could RTOs and ISOs compensate for Reactive Supply based on the
actual provision of Reactive Supply service?
4.5 Are there compensation mechanisms other than those currently in
place that would be more commensurate with costs?
4.6 Should real power capacity compensation mechanisms (i.e.,
centralized capacity markets and other capacity constructs in RTOs/
ISOs) account for reactive power capital cost compensation, and, if so,
how?
4.7 Should Reactive Supply compensation be adjusted to account for
changes in Reactive Supply capability (e.g., capability that has
degraded or increased), and, if so, how? Should a degradation threshold
be considered?

Panelists:

 Joe Bowring, Monitoring Analytics, LLC
 Michael DeSocio, New York Independent System Operator, Inc.
 Keith Johnson, California Independent System Operator
Corporation
 Pallas LeeVanSchaick, Potomac Economics
 Neil Levy, King & Spalding LLP, on behalf of the Electric
Power Supply Association
 Alan McBride, ISO New England Inc.
 Robert A. Weishaar, Jr., McNees Wallace & Nurick LLC, on
behalf of the PJM Industrial Customer Coalition and the Coalition of
MISO Transmission Customers
 Stan Williams, PJM Interconnection, L.L.C.

6. Closing Comments and Next Steps 3:55 p.m. to 4:00 p.m.

[FR Doc. 2016-15585 Filed 6-30-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 61 (Friday, March 31, 2017)]
[Rules and Regulations]
[Page 15998]
[FR Doc No: 2017-06385]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2017-0246]

Drawbridge Operation Regulation; Willamette River at Portland, OR

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Hawthorne Bridge, mile 13, crossing
the Willamette River at Portland, OR. This deviation is necessary to
accommodate the Cinco de Mayo 5K event. The deviation allows the bridge
to remain in the closed-to-navigation position to allow safe roadway
movement of event participants.

DATES: This deviation is effective from 8 a.m. to 11:15 a.m. on May 7,
2017.

ADDRESSES: The docket for this deviation, USCG-2017-0246 is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH.'' Click on Open Docket Folder on the line
associated with this deviation.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Mr. Steven Fischer, Bridge
Administrator, Thirteenth Coast Guard District; telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Multnomah County has requested a temporary
deviation from the operating schedule for the Hawthorne Bridge, mile
13.1 crossing the Willamette River at Portland, OR. The requested
deviation is to accommodate the Cinco de Mayo 5K event. To facilitate
this event, the draw of this bridge will be allowed to be kept in the
closed-to-navigation position to marine traffic from 8 a.m. to 11:15
a.m. on May 7, 2017. The Hawthorne Bridge provides a vertical clearance
of 49 feet in the closed-to-navigation position referenced to the
vertical clearance above Columbia River Datum 0.0. The normal operating
schedule is in 33 CFR 117.897. Waterway usage on this part of the
Willamette River includes vessels ranging from commercial tug and barge
to small pleasure craft. The Coast Guard contacted all known users of
the Willamette River for comment, and we received no objections for
this deviation.
    Vessels able to pass through the bridge in the closed-to-navigation
position may do so at any time. The bridge will be able to open for
emergencies, and there is no immediate alternate route for vessels to
pass. The Coast Guard will inform the users of the waterway, through
our Local and Broadcast Notices to Mariners, of the change in operating
schedule for the bridges so that vessels can arrange their transits to
minimize any impact caused by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedules immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: March 27, 2017.
Steven M. Fischer,
Bridge Administrator, Thirteenth Coast Guard District.
[FR Doc. 2017-06385 Filed 3-30-17; 8:45 am]
 BILLING CODE 9110-04-P