[Federal Register Volume 79, Number 131 (Wednesday, July 9, 2014)]
[Notices]
[Page 38908]
[FR Doc No: 2014-15991]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0852]

Draft Guidance for Industry: Design and Analysis of Shedding
Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic
Products; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft document entitled ``Guidance for Industry:
Design and Analysis of Shedding Studies for Virus or Bacteria-Based
Gene Therapy and Oncolytic Products'' dated July 2014. The draft
guidance document provides sponsors of virus or bacteria-based gene
therapy products (VBGT products) and oncolytic viruses or bacteria
(oncolytic products) with recommendations on how to conduct shedding
studies during preclinical and clinical development.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by November 19, 2014.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Outreach and Development,
Center for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
the office in processing your requests. The draft guidance may also be
obtained by mail by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Tami Belouin, 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:

I. Background

    FDA is announcing the availability of a draft document entitled
``Guidance for Industry: Design and Analysis of Shedding Studies for
Virus or Bacteria-Based Gene Therapy and Oncolytic Products'' dated
July 2014. The draft guidance document provides sponsors of oncolytic
and VBGT products with recommendations on how to conduct shedding
studies during preclinical and clinical development. Oncolytic and VBGT
products are derived from infectious viruses or bacteria. In general,
these product-based viruses and bacteria are not as infectious or as
virulent as the parent strain of virus or bacterium. Nonetheless, FDA
is issuing this guidance because the possibility that infectious
product-based viruses and bacteria may be shed by a patient raises
safety concerns related to the risk of transmission to untreated
individuals. To understand the risk associated with product shedding,
sponsors should collect data in the target patient population in
clinical trials before licensure.
    The draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent FDA's current thinking on this topic. It does
not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirement of the applicable statutes
and regulations.

II. Paperwork Reduction Act of 1995

    The draft guidance 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 part 312 have been approved under
OMB control number 0910-0014; the collections of information in 21 CFR
part 600 have been approved under OMB control number 0910-0308; the
collections of information in 21 CFR part 601 have been approved under
OMB control number 0910-0338; and the collections of information in 21
CFR part 50 have been approved under OMB control number 0910-0755.

III. Comments

    The draft guidance is being distributed for comment purposes only
and is not intended for implementation at this time. Interested persons
may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets
Management (see ADDRESSES). It is only necessary to send one set of
comments. Identify comments with the docket number found in brackets in
the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: July 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-15991 Filed 7-8-14; 8:45 am]
BILLING CODE 4164-01-P


             SUMMARY OF SEPT. 14, 2016 PUBLIC LISTENING SESSION:
   PUBLIC NOTIFICATION OF COMBINED SEWER OVERFLOWS (CSOS) IN THE GREAT LAKES
Overview
The Environmental Protection Agency (EPA) held a public "listening session" on September 14, 2016 in Chicago, Illinois to obtain information from the public to help inform development of a new regulation establishing requirements for public notification of combined sewer overflow (CSO) discharges in the Great Lakes. This rulemaking is in response to Section 425 of the 2016 Consolidated Appropriations Act. EPA requested input from the public regarding potential approaches for these new public notification requirements through participation in the public listening session and by submitting information to EPA in writing either at the listening session or directly to the Public Docket. The agency is undertaking this outreach to help it shape a future regulatory proposal intended to provide the affected public with information that will help better protect public health. This public listening session was announced in a Federal Register Notice published on August 1, 2016.
PresentationS
John Wiemhoff, EPA Region 5 Water Division:
 Introduced the speakers.
 Notified attendees of the general agenda and Senator Kirk's presentation.
Barry Tonning, Tetra Tech:
 Introduced Kevin Weiss and indicated that comments would follow his presentation.
Kevin Weiss, EPA Office of Wastewater Management:
 Provided a basic introduction and introduced the key terms CSO, Clean Water Act (CWA) (the main source of authority for this rule), and the National Pollutant Discharge Elimination System (NPDES) permit program under CWA.
 Discussed history of combined sewer systems and impacts of CSOs on water quality and public health.
 Overview of CSO regulations  -  CSOs are point sources and require an NPDES permit. Each CSO discharge has an NPDES permit with specific requirements. CWA 402(q)  -  Permits and enforcement orders need to conform to the 1994 CSO Control Policy.  The 1994 CSO Control Policy provides that:
 CSO permittees are to implement nine minimum controls (NMCs).
 CSO permittees develop and implement long term control plans (LTCPs) that describe a comprehensive effort to comply with CWA requirements.
 One of the NMCs is the requirement that CSO permittees provide public notification to ensure the public receives adequate notification of CSO occurrences and impacts. The public notification requirement has been in CSO permits since the 1990s; what has changed is the technology and circumstances, as well as public expectations.
 LTCP process includes monitoring and modeling of the system at beginning, during, and end.  This information can support the public notification process.
 2016 EPA report on CSO discharges to Great Lakes:  Identified 184 communities in the Great Lakes Basin with CSOs, but EPA recently found out that the number is greater than 184 and will be updating the information.  The report provides information collected from 2014 on the volume and number of treated and untreated CSO discharge events. Numbers for Ohio are low because data from a number of communities was not available at the time of the report.
 Section 425 of the 2016 Consolidated Appropriations Act mandates that EPA is to work with Great Lakes states to create public notice requirements for CSO discharges to the Great Lakes.
 Section 425 states that public notice requirements shall provide method of notice, contents of notice, and how it will be made publicly available. Section 425 also states the minimum notice requirements including the volume of discharge, date and time and a description of public access areas affected by CSOs. Minimum notice requirements are to be consistent between all Great Lakes states.  The public notice requirements are to provide follow up notice requirements and annual publication requirements to list each treatment works that submits a notice.
 Notification requirements are to be implemented no later than December 18, 2017.  EPA may extend this date for individual communities to avoid undue economic hardship.
 States can choose to have more stringent requirements.
 The Great Lake states have provided EPA with a description of their existing public notification requirements.  Some of the key themes that have emerged from the state requirements are: (1) signage at outfalls, (2) consultation with local public health departments and drinking water suppliers, (3) immediate notification to the public, public health department and other affected municipalities, and (4) periodic (e.g., annual or quarterly) notification. In addition, there is a requirement to notify the NPDES agency within 24 hours of certain CSO events.
Senator Mark Kirk:
 Co-chair of Great Lakes task force of the bipartisan commission of the Senate.
 Senator Kirk is the main author of and introduced Section 425 of the 2016 Appropriations Act.  The provision was endorsed by six major environmental organizations.
 The provision brings us one step closer to significant ecological protection of one of the greatest ecosystems by banning sewage dumping in the Great Lakes.
 The Great Lakes ecosystem provides over 30 million Americans with safe drinking water, and supports over 40,000 fishing related jobs and a 7-billion-dollar recreational industry.
 Over 24 billion gallons of untreated sewage and industrial wastewater are dumped into the Great Lakes each year, jeopardizing public health and contributing to beach closures.
 In 2014, there were reports of over 1,400 events of untreated sewage dumping in the Great Lakes.  This happened without adequate public knowledge.
 Senator Kirk urged EPA to swiftly finalize its work on Section 425 and provide for immediate notice in local newspapers, online and other programming which will actually ensure the public knows about each CSO event so that families can plan accordingly.
Summary of Public CommentS
 Catherine Morley (consultant):  EPA's notice indicates that the goal is that CSOs don't occur.  For some communities that report CSOs, you can only get so far in reduction of CSOs.  While fully on board with the goal, there isn't always the recognition that this is difficult for many communities.
 Ramont Bell (Faith in Place  -  an interfaith environmental group):  Provided a series of questions including the following:  (1) How will notifications be issued? (2) How soon after an event and how many times will notification be sent to public? (3) How will the effectiveness of the notice be measured? (4) What will be the content of the notification and how will it be? (5) Will notification be sent to community groups and how will the community be involved in planning the notifications? (6) Will there be corrective actions after discharge and will there be notifications of any corrective actions?  (7) Will any potential side effects or warnings be provided about the discharge; (8) Will notifications be plant-by-plant or overall? (9) Will there be any water qualify information provided before and after discharge?
 Cynthia Finley (National Association of Clean Water Agencies (NACWA))  -  represents nearly 300 public wastewater facilities):  Purpose of notification needs to be carefully considered.  If it is to protect public health, then it probably should happen before rain starts to notify public to stay out of water.  If it is to collect data to track the number and volume of CSOs, then time should be given for utilities to collect and analyze the data to provide accurate reports. Use of the word "immediate" in the Federal Register notice is concerning. In the law, "immediate" was not used.  It was in the legislative proposal but was not included in the law. There should be a reasonable timeframe, not an arbitrary number of hours assigned.  CSO utilities vary in size and staffing and this can create difficulties if a short reporting time is required.  During wet weather, utility staff is busy managing a high flow situation, and this should be taken into consideration.  Real-time monitoring versus modeling is an important consideration.  Real-time monitoring can be a useful tool but can be difficult to implement in high flow situations and might not yield accurate results.  Real-time monitoring does not make sense for utilities that are working to eliminate their CSOs.  Models can be difficult to maintain, upgrade and calibrate.  Utilities need to be given flexibility to provide the right solution for each facility.
 Fred Andes (Barnes & Thornburg LLP):  (1) Requirements should not be expanded outside of the Great Lakes basin. Congress spoke only to the Great Lakes basin.  Expanding outside of the basin would be viewed as problematic and an illegal action.  (2) Inside the Great Lakes basin  - consider whether resources should be spent monitoring or otherwise providing information on every CSO discharge when communities could be spending time and effort focusing on reducing CSOs.  Monitoring during rain events tells nothing about water quality impacts and notification of every event would not provide perspective on public health impacts. (3) Many communities have developed notification procedures that should be allowed to remain in place. (4) There is no authority in the statute to require immediate notification. (5) Use perspective when negotiating LTCPs and consent decrees  -  for example, one consent decree required signs posted next to the river that can be read from 50 yards away, which was far from anyone that would be in the stream. (6) Do not impose requirements well beyond what is required to notify the public that would divert resources from CSO control.
 Kevin Shafer (Milwaukee Metropolitan Sewerage District (MMSD)):  CSOs are events every community strives to avoid.  We all understand they are not good for public health and environment but allowing overflows can help to prevent a greater public health risk, which is basement backups.  To protect the ecosystem, we need to talk about polluted stormwater, both urban and rural as the cause.  CSOs are a problem and will get worse unless the country develops a sustainable funding source to help utilities address the problem.  Need to take steps to inform public when they happen  -  in Milwaukee, MMSD reports to regulators and the public and go beyond the requirements of Section 425. Milwaukee has a deep tunnel system that has been successful and has collected 98% of water into the sewer system.  When an overflow will occur  -  operators close tunnel  -  send mass email, post notification on website stating that a CSO has occurred, media monitors website and puts it out on TV and radio, MMSD verbally notifies WDNR. Then MMSD contacts the newspaper, and within 5 days, notifies DNR and media of estimated CSO volume.  These meet all requirements of the Kirk Bill and MMSD thinks it's the right approach.  EPA should consider that other utilities are not the same.  Should notify location and number immediately, as soon as possible after the event; should be on websites, emails and to media.  Permitted CSO utilities should be given at least 5 days to calculate volume.  Utilities should report a summary of CSOs annually.  The proposed rule should not be limited to the Great Lakes because it would economically disadvantage Great Lakes communities compared to other communities nationwide.  Public health departments, not sewer operators, should evaluate and respond to health risks at public access sites. Operators monitor and report overflows, public health departments should monitor public health risks.
 Catherine Boyd-Michaud (Great Lakes and St Lawrence Cities Initiative; (GLSLCI)):  Public health is of utmost importance to municipalities. Members have been working to reduce the number and severity of CSOs and have made great progress but they still occur.  It is important to educate the general public on CSOs to reduce public health risk and the discharge of waters into sewers during heavy rainfalls.  Notify health officials and state agencies but also need measures to inform citizens.  The following points should be considered: (1) Notification of CSO events can be based on monitoring at CSO outfalls or modeling approaches based on rainfall data.  Public notification should be made as soon as data are available in a form that can be distributed.  (2) Public notification should be available in a form accessible to public; for example, through alerts by email or texts, social media posts or online. Data should be presented in a way that is understandable; for example, categorize CSO events into small, medium or big events. Social media postings should refer to online sites for more details on CSO events.
 Robin Halperin (Northeast Ohio Regional Sewer District (NEORSD)):  NEORSD is a large publically owned wastewater utility that operates three (3) large wastewater treatment plants and 122 CSO outfalls in the greater Cleveland area, working to significantly reduce the amount of CSOs to the Great Lakes. The current volume of overflows is 4.5 billion gallons per year but this amount will be reduced to 0.5 billion gallons per year within 25 years. The purpose of the CSO notification requirement is to alert the public to CSO discharges to mitigate risks to public health.  Greatest risk is in recreational areas during recreation season.  The best solution is monitoring water quality in these areas and in public education. The district monitors beach areas daily during recreation season, does predictive modeling and source tracking in conjunction with the Ohio Department of Public Health.  Sources of bacteria also include stormwater, failing septic systems, pet waste, illegal sanitary sewer connections among others.  Just because a CSO has not occurred does not mean that bacteria is not present. Benefits to public health can be achieved through a public education system.  It is well known that when it rains in Cleveland CSOs occur.  Have posted large warning signs at each outfall that warns the public to avoid contact with water during and after a rain.  We have a phone number on the signs and get no phone calls.  This is a very visible and direct communication.  If a more intensive public notification process was required for all 122 CSOs, it would place a burden on staff and overwhelm press.  Most CSOs have multiple regulators, each contributes flow to a common outfall making it difficult to monitor at a single point.  Sewers have other inputs, making it difficult to determine when a CSO has occurred.  Would have to place, maintain, and replace flow monitors in an inhospitable environment.  Sensors can be clogged or dislodged after any rain event.  Financial and staff resources would be diverted from the goal to reduce CSOs.  Propose to use extensive computer models already in place instead of field monitoring instruments.  It is not a fast or immediate notification  -  would be run on a monthly basis, but would not be reasonable to run on a daily basis.  Don't lose sight of the real goal  -  eliminate risk and reduce CSOs.  Communicating and educating public with signage and monitoring recreation areas would go a long way to address the requirements.
 David St. Pierre (Metropolitan Water Reclamation District (MWRD); Chicago):  Previous commenters have different approaches for notification  -  recommend caution from EPA to make guidelines broad enough so good ideas can be perpetuated and not so restrictive that nobody can meet the requirement.  Since 2005 MWRD has had a CSO notification plan.  Developed based on feedback from stakeholders  -  civic groups, recreational groups and interested citizens.  The majority of CSOs [in Chicago] do not discharge to Great Lakes but away from Lake Michigan. Two CSO outfalls discharge to Lake Michigan  -  only three events in the last decade. The district reverses flow only when needed to protect public health and safety. Since 2003, only reversed to the lake 12 times. The Notification system is available on the website. Anyone can sign up for CSO notification and will receive a text or email in real time. They can click on a website link for an interactive map showing the exact location of the CSO. The district maintains a database of stakeholder email addresses, including the media, for email notification.  MWRD will be submitting written comments that include its notification plans and comments and offers assistance for providing further information to answer any questions or provide lessons learned.
 Katrina Phillips (Illinois Chapter of Sierra Club):  Happy to see a recent increase in public use of Chicago's waterways for kayaking and rowing but are concerned about health and safety of these users given pollution from CSOs that introduce bacteria and pathogens.  Look forward to stronger requirements.  Note that the only way to fully allow safe enjoyment is elimination of CSOs and hope to see further progress. Notification requirements are currently insufficient  -  public notification programs could be improved. There is a lack of coordination of agencies that operate different parts of the system.  MWRD owns and operates the system but they are not known by the general public and not the first place people go for information.  Need coordination with agencies so city can rely on agencies other than MWRD for notification.  Public notice of CSOs should be provided through mass media: radio, online, social media, and opt-in system for text or emails.  Alerts should not be delayed while waiting for information that is not immediately available.  Monitoring at all outfalls or modeling should be used to alert the public as to when CSOs are likely to occur. The CSO map on MWRD's website only shows CSOs at outfalls with monitors and don't provide notice on outfalls without monitoring equipment.  Concerned that the enforcement of new requirements will be limited by long delays in issuance of NPDES permits if they are solely enforced by these permits.  Recommend that EPA incorporate new requirements into some other framework that doesn't rely on state agencies issuing permits.  Should not be limited to only cover permit violations but should include discharges that are covered in permits and not considered violations but could still pose public health threats.  All CSO discharges should be reported.
 Andrew Donakowski (Friends of Chicago River):  Advocate for increased recreation on Chicago River.  CSOs are concern; currently there is a severe lack of public notification on CSOs.  Outfall owners rely on MWRD notification, owner's websites contain no information on how to receive notifications of CSO discharges.  Accurate, timely, and accessible notifications are important.  Hope that the result of the listening session results in standards that require municipal organizations, including the city, MWRD, and municipalities to work together to provide sufficient information to the public regarding CSO events and waterway conditions  -  should be on municipal websites, text or email notifications.
 Timothy Schaefer (Alliance of Great Lakes):  Clear rules and standardized public notification of CSOs will maximize public protection.  Facilities can only effectively reach public using multiple forms of notification.  Should be immediate  -  before two (2) hours after CSO  -  this reflects current practices in New York State.  Should include media, internet, web app, and on-site notice.  On-site notice should tell people how to opt in for immediate notification.  Annual notice should contain data to analyze CSOs region-wide and be compiled for Great Lakes region.  Notification should contain info to help people stay safe  -  treatment status of discharge and duration of discharge because we understand that volume is difficult to calculate.
Questions for Discussion

After attendees in the room and those who participated by phone were given an opportunity to provide public statements, EPA conducted a facilitated discussion with the public listening session participants. The discussion of the eight questions that had been identified in the August 1, 2016 Federal Register notice is summarized below.
 What means of receiving immediate notice of CSO discharge events are most helpful to the public?
Municipal government:  Would love to have the main media outlets pick up the notifications. Have tried for years to have them give notifications prior to storms but they don't think that's attractive news reporting.  Is there a way to coordinate that in a national way?
Municipal government:  We have one large CSO on a popular beach in Cleveland. When it discharges, we have media attention, public attention and signs posted.  If we have to do that for every CSO every time it rains, people will lose interest.  Not everybody has social media.  A lot of affected people don't have access to social media and other electronic tools.  Having these websites doesn't mean it will reach the right people and get the message out there.  We are a proponent of having a visible sign at the location saying that if it is raining or has rained recently, there is a potential risk.
Environmental group:  Agree not everybody is on social media. Would appreciate an app, website or text to know if kayaking/rowing groups can take a group out that day or if they should avoid an area.
Environmental group:  Emphasis on diverse means of notification so the most people are reached.  If only one method is used, it is likely that you will miss some people.  Need multiple methods to increase likelihood that people get it.
Municipal government:  Allow communities to tailor their notification systems.  Have opt in program for text and email alerts that is programmed to consolidate messages.
  What should immediate mean in the context of immediate public notification?
Municipal government: The New York approach is to provide notification within 2 hours.
Municipal government:  This is not a one size fits all situation. [We would] ask the agency for some flexibility.  At MWRD, we could probably meet a two hour notification but some others that don't operate 24/7 might not be able to meet that.
Municipal government:  Not all utilities are the same size or in the same stage in LTCP implementation.  Milwaukee is at 98% capture so it has fewer overflows per year.  In Northeast Ohio Sewer District  -  the volume and frequency of CSOs is larger.  If a system had monitors on every CSO and knows with accuracy when an event happened, then they could provide immediate notification but it's not easy.  Sometimes only stormwater discharges from the CSO outfall pipe so there might not be a CSO but there is flow that would be measured. Also if the river level is rising and water is coming in, it would still register as flow even though no CSO has occurred.  There would lead to false positives and false negatives.
Municipal government: Flexibility for size of utility and financial means of the utility should be considered.  As an operator, immediate is great if you can get there.  Have some very reliable outfalls but difficult or impossible for others.
  What additional information would be most appropriate for immediate notices?
Municipal government:  There's a conflict between immediate notification and providing volumes.  We can let you know when a CSO has started but can't provide volume immediately because it's ongoing.  MWRD has maps on its website but it might not be possible for every utility.
Municipal government:  Only want most useful information to the public in immediate notifications.  If volume would be confusing, don't want it included, but expected duration of event would give the public an idea of when it would be safe again and should be included.
Trade association:  You don't know duration until the event is finished.  The profile of storm event depends on the storm size and how big the watershed is from the discharge point.  Don't know duration until the storm is over and there is always a lag time, sometimes an hour or many hours, from water working its way through the system.  Have to go back to analyze after storm is done.  Can notify that there is potential for CSO to occur but be careful about false positives.
Municipal government: Sometimes have snowmelt and rain and can't predict when it will stop.  Several of us have mentioned using models instead of monitoring.  Using a model, it will tell you the rainfall intensity and duration and it will tell you the volume and duration.  It won't give you start and end times.  That would be a challenge for those planning to use a model.
Attorney:  During a storm, a CSO point might have intermittent short discharges.  How would you report that?  Would people get a text each time?  Also, some communities monitor each discharge to determine if it is activated, but they don't monitor the flow at each discharge.  If monitoring for flow and other indicators becomes a requirement, it would be incredibly costly, would not be helpful to the public and tells you nothing about impact to water quality.  If minimal and large events cause mass alerts, it wouldn't help people know potential risk.  Immediate is not the same as soon as possible.  They need to be carefully defined.
Environmental group:  In public notices, can we state general public health issues?  Side effects based on what was discharged at that time.
Trade association:  A tailored, flexible approach is needed.  Immediate is being used but is not a requirement and needs to be taken out of the language.  Need to look at what is required by the law and what is practical for utilities.
  What role should local public health agencies have in identifying immediate notification requirements?
Municipal government:  Public health agencies generally don't engage in this issue.  Utilities that are familiar with these issues should do it.
Environmental group:  Not specific to immediate notification but public health agencies should be involved because they have ideas of standards that should be met and when exceeded it would trigger warning to public.  They can help with explanations of warnings to public, risks of avoiding warnings should be put on the dischargers' websites.  They should also collect information when there are illnesses or infections that might have been caused by water from CSOs to assess extent of the problem and determine the effectiveness of public notification system.
Municipal government:  We have a voluntary beach monitoring program with the local and state health department.  When bacteria levels exceed limits, we notify the public health department and media.  We partner with the public health department because they will be fielding public calls with concerns.  People walk past the signs warning about swimming and go swim. Most people won't call the treatment plant but will call the public health department to ask if water is safe.
Trade association: General education to public and health department that CSOs are not the only threat to water quality.
 How should annual notices be made available to the public?
Environmental group:  They should go through the EPA process with a public comment period to facilitate ongoing input on public notification program.  If someone opted in, they should receive a notice when the annual notice is available for download, and it should be on the websites of all dischargers.  If sewer bills are sent to customers, a notice should be in with the bill.
Municipal government:  Our NPDES permit requires public notice for industrial users and violations.  The requirement is to place one public notice in a newspaper stating the report is available.  The annual notice is provided in a newspaper, on the website and is available at a state EPA location.
Municipal government:  Prefer a public comment period to encourage an ongoing discussion to find out if notification is working instead of implementing it and hoping for the best.
  What information should be included in annual notices and who should prepare annual notices?
Municipal government:  Most consent decrees detail this information, and requirements from a federal judge will trump anything else.  Caution EPA against including additional requirements when requirements are already in place.
Environmental group:  Provide summary of all information provided through immediate and follow-up notifications throughout the year, including a summary of when discharges occurred, volumes and impacts that they had on public health and the use of waterway, habitat degradation, etc. This is a good place to provide information on progress for eliminating CSOs, progress made toward LTCP, why CSOs are still occurring and any changes to the LTCP.  Allowing for a citizen complaint system where they can submit complaints about CSOs and allow the agency to summarize those in an annual notice. Subsection b(4)(b) is not clear and new requirements should clarify that permitting authority is responsible and should be available on website.
Municipal government:  A list of CSOs, how many times they had an event, volumes, dates and times that they had an event, and how public was notified.  Providing extra information is a waste of resources.
Trade association:  Not certain as to how you can hold the discharger responsible for determining whether the notification is working.  If the point of the notification is to keep people out of the water after a CSO, then a discharger would have to stand there and see if people are going into the water despite the notification.  If the notification is to determine whether you're influencing public opinion, it is not possible to make dischargers responsible for public opinion surveys.  There is a CSO policy in place that dischargers are complying with.  Congress can revisit the issue of eliminating CSOs but the standard is not elimination but is control and reduction.  Don't hold dischargers responsible for determining public's response to notification.
  Do EPA's requirements to notify NPDES permitting authorities under 40 CFR 122.41(l)4, (6) and (7) have a role in the new public notice requirements?
Municipal government:  We are concerned that tying this to the permit as a requirement will relieve some responsibility for some facilities.  Prefer an independent regulation that can be expressed through the permit not necessarily tied to the permit.
Municipal government:  Our public notification plan was required under our permit.  If independent, we don't want conflicts between the different rules. Consider consistency across different regulatory platforms.
Environmental group:  One of the issues with the requirements under this statute is that it only covers permit violations, but not all CSO discharges are violations.  The public wants to know about all CSOs, not just violations.  Require reporting if impacting the environment, which could allow for subjective judgement by dischargers.  Want to eliminate subjectivity in reporting requirements. While public should get this information, it should be in a different format that is easy to understand.  Immediate notification shouldn't be delayed to include what is submitted to permitting authority.
  What regulatory framework is most appropriate for immediate notification requirements?
Municipal government:  Just want clear rules.  Am open to the idea of smaller municipalities or sewer districts using a compliance schedule for immediate notification.  Understand that resources are different for different sizes of facilities.
Closing
EPA will produce an informal summary of this public meeting for the docket.  EPA encourages today's attendees to submit written comments by September 23.
Comment from Senator Kirk's office: EPA should consider all comments. Senator Kirk wants to advance the goals of water quality, public health, and the greatest ecosystem in the world.
EPA schedule  -  plans to publish a proposal by end of year for public comment.  Plans to finalize rule by December of 2017.  This dialogue is invaluable and we value your time and thoughts.


[Federal Register Volume 78, Number 126 (Monday, July 1, 2013)]
[Notices]
[Pages 39365-39367]
[FR Doc No: 2013-15622]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-69846; File No. SR-BOX-2013-33]

Self-Regulatory Organizations; BOX Options Exchange LLC; Notice
of Filing and Immediate Effectiveness of a Proposed Rule Change to
Amend Interpretive Material to Rule 7150 (Price Improvement Period
``PIP'') to Extend a Pilot Program that Permits the Exchange to Have no
Minimum Size Requirement for Orders Entered into the PIP (``PIP Pilot
Program'')

June 25, 2013.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934

(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on June 21, 2013, BOX Options Exchange LLC (the ``Exchange'') 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 self-regulatory organization. The Commission
is publishing this notice to solicit comments on the proposed rule from
interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to amend Interpretive Material to Rule 7150
(Price Improvement Period ``PIP'') to extend a pilot program that
permits the Exchange to have no minimum size requirement for orders
entered into the PIP (``PIP Pilot Program''). The text of the proposed
rule change is available from the principal office of the Exchange, at
the Commission's Public Reference Room and also on the Exchange's
Internet Web site at http://boxexchange.com.

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

    In its filing with the Commission, 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 purpose of the proposed rule change is to extend the PIP Pilot
Program for twelve additional months. The PIP Pilot Program allows the
Exchange to have no minimum size requirement for orders entered into
the PIP.\3\ The Exchange has committed to provide certain data to the
Commission during the PIP Pilot Program.\4\ The proposed rule change
retains the text of IM-7150-1 to Rule 7150 and seeks to extend the
operation of the PIP Pilot Program until July 18, 2014.
---------------------------------------------------------------------------

    \3\ The Pilot Program is currently set to expire on July 18,
2013. See Securities Exchange Act Release Nos. 66871 (April 27,
2012) 77 FR 26323 (May 3, 2012) (File No.10-206, In the Matter of
the Application of BOX Options Exchange LLC for Registration as a
National Securities Exchange Findings, Opinion, and Order of the
Commission) and 67255 (June 26, 2012) 77 FR 39315 (July 2, 2013)
(SR-BOX-2012-009) (Notice of Filing and Immediate Effectiveness of a
Proposal To Extend a Pilot Program That Permits BOX to Have No
Minimum Size Requirement for Orders Entered Into the Price
Improvement Period).
    \4\ Id. at 26334.
---------------------------------------------------------------------------

    The Exchange notes that the PIP Pilot Program guarantees
Participants the right to trade with their customer orders that are
less than 50 contracts. In particular, any order entered into the PIP
is guaranteed an execution at the end of the auction at a price at
least equal to the national best bid or offer. In further support of
this proposed rule change, the Exchange will submit to the Commission
monthly a PIP Pilot Program Report, offering detailed data from, and
analysis of, the PIP Pilot Program. Specifically, the Exchange believes
that, by extending the expiration of the PIP Pilot Program, the
proposed rule change will allow for further analysis of the PIP Pilot
Program and a determination of how the PIP Pilot Program shall be
structured in the future.
2. Statutory Basis
    The Exchange believes that the proposal is consistent with the
requirements of Section 6(b) of the Act,\5\ in general, and Section
6(b)(5) of the Act,\6\ in particular, in that it is designed to foster
cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to remove impediments to and
perfect the mechanism for a free and open market and a national market
system and, in general, to protect investors and the public interest.
The Exchange believes that the data demonstrates that there is
sufficient investor interest and demand to extend the PIP Pilot Program
for an additional twelve months. The Exchange represents that the Pilot
Program is designed to provide investors with real and significant
price improvement regardless of the size of the order.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b).
    \6\ 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 will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. Specifically, the Exchange
believes that, by extending the expiration of the PIP Pilot Program,
the proposed rule change will allow for further analysis of the PIP
Pilot Program and a determination of how the PIP Pilot Program shall be
structured in the future. In doing so, the proposed rule change will
also serve to promote regulatory clarity and consistency, thereby
reducing burdens on the marketplace and facilitating investor
protection.

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

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

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A)(ii) of the Act \7\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\8\
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \8\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires the Exchange to give the Commission written notice of the
Exchange's intent to file the proposed rule change along with a
brief description and text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission. The
Commission deems this requirement to have been met.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \9\ normally
does not become operative for 30 days after the date of filing.
However, pursuant to Rule 19b-4(f)(6)(iii) \10\ the Commission may
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange requested
that the Commission waive the 30-day operative delay. The Exchange
noted that such waiver will permit the PIP Pilot Program to continue
without interruption.
---------------------------------------------------------------------------

    \9\ 17 CFR 240.19b-4(f)(6).
    \10\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    The Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest, as
it will allow the pilot program to continue uninterrupted, thereby
avoiding any potential investor confusion that could result from a
temporary interruption in the pilot program. Further, the

Commission notes that, because the filing was submitted for immediate
effectiveness on June 21, 2013, the fact that the current rule
provision does not expire until July 18, 2013 will afford interested
parties the opportunity to comment on the proposal before the Exchange
requires it to become operative. For this reason, the Commission
designates the proposed rule change to be operative on July 18,
2013.\11\
---------------------------------------------------------------------------

    \11\ For purposes only of waiving the operative delay, the
Commission has considered the proposed rule's impact on efficiency,
competition, and capital formation. See 15 U.S.C. 78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-BOX-2013-33 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BOX-2013-33. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet 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 Web site viewing and
printing in the Commission's Public Reference Room, on official
business days between the hours of 10:00 a.m. and 3:00 p.m., located at
100 F Street NE., Washington, DC 20549. Copies of such filing also will
be available for inspection and copying at the principal office of the
Exchange. 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-BOX-
2013-33 and should be submitted on or before July 22, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

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

Kevin M. O'Neill,
Deputy Secretary .
[FR Doc. 2013-15622 Filed 6-28-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: February 17, 2006 (Volume 71, Number 33)]
[Notices]
[Page 8624-8625]
[DOCID:fr17fe06-120]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Filings and Information Services, Washington,
DC 20549.

Extension:
    Rule 11a1-1(T); OMB Control No. 3235-0478; SEC File No. 270-428.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget requests for extension of the previously approved collection
of information discussed below.

Rule 11a1-1(T)--Transactions Yielding Priority, Parity, and Precedence

    On January 27, 1976, the Commission adopted Rule 11a1-1(T) under
the Securities Exchange Act of 1934 (``Exchange Act'') to certain
exempt transactions of exchange members for their own accounts that
would otherwise be prohibited under Section 11(a) of the Exchange Act.
The rule provides that a member's proprietary order may be executed on
the exchange of which the trader is a member, if, among other things:
(1) The member discloses that a bid or offer for its account is for its
account to any member with whom such bid or offer is placed or to whom
it is communicated; (2) any such member through whom that bid or offer
is communicated discloses to others participating in effecting the
order that it is for account of a member; and (3) immediately before
executing the order, a member (other than a specialist in such
security) presenting any order for the account of a member on the
exchange clearly announces or otherwise indicates to the specialist and
to other members then present that he is presenting an order for the
account of a member.
    Without these requirements, it would not be possible for the
Commission to monitor its mandate under the Exchange Act to promote
fair and orderly markets and ensure that exchange members have, as the
principle purpose of their exchange memberships, the conduct of a
public securities business.
    There are approximately 1,000 respondents that require an aggregate
total of 333 hours to comply with this rule. Each of these
approximately 1,000 respondents makes an estimated 20 annual responses,
for an aggregate of 20,000 responses per year. Each response takes
approximately 1 minute to complete. Thus, the total compliance burden
per year is 333 hours (20,000 minutes/60 minutes per hour = 333 hours).
The approximate cost per hour is $100, resulting in a total cost of
    Compliance with Rule 11a1-1(T) is necessary for exchange members to
make transactions for their own accounts under a specific exemption
from the general prohibition of such transactions under Section 11(a)
of the Exchange Act. Compliance with Rule 11a1-1(T) does not involve
the collection of confidential information. Rule 11a1-1(T) does not
have a record retention requirement per se. However, responses made
pursuant to Rule 11a1-1(T) are subject to the recordkeeping
requirements of Rules 17a-3 and 17a-4. Please note that an agency may
not conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid control
number.
    Written comments regarding the above information should be directed
to the following persons: (i) Desk Officer for the Securities and
Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Building,
Washington DC 20503 or by sending an e-mail to
<EMAIL_ADDRESS>and (ii) R.

Corey Booth, Director/Chief Information Officer, Office of Information
Technology, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549. Comments must be submitted to OMB within 30 days
of this notice.

    Dated: February 7, 2006.
Nancy M. Morris,
Secretary.
[FR Doc. E6-2297 Filed 2-16-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 86, Number 238 (Wednesday, December 15, 2021)]
[Notices]
[Pages 71263-71264]
[FR Doc No: 2021-27151]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2816-0000]

North Hartland, LLC; Notice of Authorization for Continued
Project Operation

    On November 26, 2019, North Hartland, LLC, licensee for the North
Hartland Hydroelectric Project No. 2816, filed an Application for a New
Major License pursuant to the Federal Power Act (FPA) and the
Commission's regulations thereunder. The North Hartland Hydroelectric
Project is located on the Ottauquechee River in Windsor County,
Vermont.
    The license for Project No. 2816 was issued for a period ending
November 30,

2021. Section 15(a)(1) of the FPA, 16 U.S.C. 808(a)(1), requires the
Commission, at the expiration of a license term, to issue from year-to-
year an annual license to the then licensee(s) under the terms and
conditions of the prior license until a new license is issued, or the
project is otherwise disposed of as provided in section 15 or any other
applicable section of the FPA. If the project's prior license waived
the applicability of section 15 of the FPA, then, based on section 9(b)
of the Administrative Procedure Act, 5 U.S.C. 558(c), and as set forth
at 18 CFR 16.21(a), if the licensee of such project has filed an
application for a subsequent license, the licensee may continue to
operate the project in accordance with the terms and conditions of the
license after the minor or minor part license expires, until the
Commission acts on its application. If the licensee of such a project
has not filed an application for a subsequent license, then it may be
required, pursuant to 18 CFR 16.21(b), to continue project operations
until the Commission issues someone else a license for the project or
otherwise orders disposition of the project.
    If the project is subject to section 15 of the FPA, notice is
hereby given that an annual license for Project No. 2816 is issued to
North Hartland, LLC for a period effective December 1, 2021 through
November 30, 2022, or until the issuance of a new license for the
project or other disposition under the FPA, whichever comes first. If
issuance of a new license (or other disposition) does not take place on
or before November 30, 2022, notice is hereby given that, pursuant to
18 CFR 16.18(c), an annual license under section 15(a)(1) of the FPA is
renewed automatically without further order or notice by the
Commission, unless the Commission orders otherwise.
    If the project is not subject to section 15 of the FPA, notice is
hereby given that North Hartland, LLC is authorized to continue
operation of the North Hartland Hydroelectric Project, until such time
as the Commission acts on its application for a new major license.

    Dated: December 9, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-27151 Filed 12-14-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: February 20, 2009 (Volume 74, Number 33)]
[Notices]
[Page 7942-7943]
[DOCID:fr20fe09-113]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59409; File No. SR-DTC-2009-03]

Self-Regulatory Organizations; The Depository Trust Company;
Notice of Filing and Order Granting Accelerated Approval of Proposed
Rule Change To Revise Its Fee Schedule

February 13, 2009.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ notice is hereby given that on January 13, 2009, The
Depository Trust Company (``DTC'') filed with the Securities and
Exchange Commission (``Commission'') and on February 13, 2009, amended
the proposed rule change described in Items I, II, and III below, which
items have been prepared primarily by DTC. The Commission is publishing
this notice and order to solicit comments on the rule change from
interested parties and to grant accelerated approval of the proposal.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
---------------------------------------------------------------------------

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

    The purpose of the rule change is to revise fees for certain DTC
services.

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

    In its filing with the Commission, DTC 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. DTC has prepared summaries, set forth in sections (A),
(B), and (C) below, of the most significant aspects of these
statements.\2\
---------------------------------------------------------------------------

    \2\ The Commission has modified the text of the summaries
prepared by DTC.
---------------------------------------------------------------------------

(A) Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    DTC is proposing to revise fees for certain services. The revisions
include: (i) Decreases of Settlement Services fees to realign fees with
costs incurred in providing the services; (ii) decreases of Custody and
Dividend service fees to realign fees with costs scaled to reflect
processing complexity creating fee simplification and transparency;
(iii) increases of Reorganization services fees to realign fees with
costs incurred due to low volume tender offers which are subject to
extensive monitoring; and (iv) increases of Custody and Deposits fees
to realign fees with costs associated with intensive photocopy and
research requests.
    In addition, DTC will increase certain disincentive fees to
discourage activities that increase industry inefficiencies. These
revisions include: fee increases for underwriters who have incomplete,
inaccurate, or untimely submission of information in connection with
DTC's Underwriting services and fee increases for Withdrawals by
Transfer and Deposits (in connection with DTC's continuing efforts to
discourage continued traffic in physical securities and to discourage
erroneous requests).
    The proposed fee revisions are consistent with DTC's overall
pricing philosophy to align service fees with underlying costs,
discourage manual and exception processing, and encourage
immobilization and dematerialization of securities. Except as otherwise
noted above, the effective date for these fee adjustments is January 2,
2009.
    The proposed rule change is consistent with Section 17A of the
Act,\3\ as amended, because it clarifies and updates DTC's fee
schedule. As such, it provides for the equitable allocation of fees
among its participants.
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

(B) Self-Regulatory Organization's Statement on Burden on Competition

    DTC does not believe that the proposed rule change will have any
impact or impose any burden on competition.

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

    Written comments relating to the proposed rule change have not yet
been solicited or received. DTC will notify the Commission of any
written comments received by DTC.

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

    Section 17A(b)(3)(D) of the Act requires that the rules of a
clearing agency provide for the equitable allocation of reasonable
dues, fees, and other charges among its participants. The Commission
finds that DTC's proposed rule change is consistent with DTC's
obligation under the Act because it clarifies and updates DTC's fee
schedule.
    The Commission finds good cause for approving the proposed rule
change prior to the thirtieth day after the date of publication of
notice of filing in the Federal Register because the proposed rule
change originally was filed previously but had to be refiled due to a
technical issue.

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-DTC-2009-03 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-DTC-2009-03. 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 filings also will be available for inspection and
copying at the principal office of DTC and on DTC's Web site at http://
www.dtcc.com/downloads/legal/rule_filings/2009/dtc/2009-03.pdf . 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-DTC-2009-03 and should be
submitted on or before March 13, 2009.

V. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposal is consistent with the requirements of the Act and in
particular with the requirements of Section 17A of the Act \4\ and the
rules and regulations thereunder.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\5\ that the proposed rule change (File No. SR-DTC-2009-03) be, and
hereby is, approved.\6\
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(2).
    \6\ In approving the proposed rule change, the Commission
considered the proposal's impact on efficiency, competition, and
capital formation. 15 U.S.C. 78c(f).

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E9-3576 Filed 2-19-09; 8:45 am]

BILLING CODE 8011-01-P