[Federal Register: May 28, 2008 (Volume 73, Number 103)]
[Notices]
[Page 30619-30621]
[DOCID:fr28my08-53]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0280]

Potential for a Registry of Breast Cancer Treatment Using Thermal
Ablation Devices; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is requesting comments
on whether a registry could facilitate standardization of feasibility
trials studying local treatment of small breast cancers with different
thermal ablation devices and therapies (i.e. cryoablation, focused
ultrasound, interstitial laser, microwave, radiofrequency ablation).
FDA is specifically interested in understanding how breast cancer
ablation feasibility trials can be constructed so that there exists
standardized evaluation of tissue biopsy pathology, selection of tumors
amenable to ablation, image guidance for ablation, post-ablation
imaging and assessment, and tissue pathology of ablated specimens. The
agency seeks to facilitate its understanding of local treatment for
breast cancer using thermal ablation devices.

DATES: Submit written or electronic comments by November 24, 2008.

ADDRESSES: Submit written comments concerning this document to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to http://www.regulations.gov. To ensure timelier processing
of comments, FDA is no longer accepting comments submitted to the
agency by e-mail.

FOR FURTHER INFORMATION CONTACT: Binita Ashar or Long Chen, Center for
Devices and Radiological Health (HFZ-500), Food and Drug
Administration, 1350 Piccard Dr., Rockville, MD 20850,<PHONE_NUMBER>, e-
mail<EMAIL_ADDRESS>or<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On July 24, 2003, FDA's General and Plastic Surgery Devices
Advisory Panel discussed issues pertaining to the use of thermal
ablation devices to percutaneously or non-invasively treat breast
cancer by causing coagulation necrosis of the tumor. The panel
discussed clinical trial issues pertaining to the local treatment of
breast cancer using thermal ablation versus operative resection.
    The panel addressed the following topics: (1) The level of evidence
that would be required, in initial studies of treatment of primary
breast cancer by minimally invasive ablation followed by immediate
lumpectomy for pathologic examination of margins (i.e. ablate and
resect studies), to permit initiation of studies that use minimally
invasive ablation to definitively treat the cancer without followup
resection (i.e., ablate and follow studies); (2) the type of pivotal
study that could demonstrate the efficacy of a thermal ablation device
to provide local breast cancer treatment in lieu of lumpectomy; (3) how
to mitigate concerns regarding the effect of thermal ablation on
surrounding breast tissue and radio/chemosensitivity; and (4) the
limitations of breast imaging and its effect on patient selection and
treatment followup. This panel's discussion of these issues has
significantly affected FDA's regulation of these technologies.
    Investigators studying the feasibility of thermal ablation devices
for the treatment of breast cancers have refined their techniques. In
fact, there have been small studies demonstrating nearly 100 percent
ablation accuracy.

Unfortunately, the lack of uniformity among different feasibility study
protocols has resulted in various study results that cannot be easily
compared. Uniformity with respect to standardized evaluation of tissue
biopsy pathology, selection of tumors amenable to ablation, image
guidance for ablation, timing of ablation (with respect to lymph node
biopsy, radiation therapy and chemotherapy), post-ablation imaging and
assessment, and tissue pathology of ablated specimens would facilitate
the assembly of results across both studies and ablation modalities and
better allow the formulation of science-based hypotheses regarding best
practices for breast cancer ablation therapy. The purpose of this
critical path effort is to motivate the breast cancer ablation industry
to standardize its feasibility study protocols so that data emerging
are comparable in all respects except for the specific ablation
modality. Such data could be used to hypothesize best practices and
potentially serve as the basis for larger prospective clinical trials.

II. Registry Development and Implementation

    FDA seeks comments on the possible role that a registry of breast
cancer treatment using thermal ablation devices could have on advancing
the development of thermal ablation devices. FDA is interested
specifically on the role of such a registry on establishing standard
imaging, pathological evaluation, and ablation timing protocols. In
addition, FDA is interested in receiving comments on the feasibility,
utility, benefits, and costs involved in the development and
implementation of such standardization and on FDA's role in such a
process.

A. Development of a Registry of Breast Cancer Treatment Using Thermal
Ablation Devices

    The agency believes that a registry for breast cancer treatments
using thermal ablation devices would motivate the development and
implementation of standardized protocols for pathology and imaging
assessments for diagnosis and treatment of breast cancers, and followup
of thermally ablated breast cancers. In addition, there would be a
central place for information regarding patient selection factors,
device attributes, device treatment settings and strategy, and device
use integration into the multimodality treatment plan for patients with
breast cancer. The patient selection, device attributes, device
treatment settings and strategy, and patient treatment regimen
information could include the following:
Patient Selection
    Demographics;
    Tumor imaging characteristics;
    Tumor size;
    Tumor nodal status;
    Tumor metastases;
    Tumor histology; and
    Tumor markers
Device Attributes
    Manufacturer, make, and model; and
    Unique device attributes (e.g., size, length, configuration,
software version)
Device Treatment Settings and Strategy
    Thermal ablation modality;
    Tumor imaging modality for treatment localization;
    Treatment settings used to achieve ablation (relevant to modality
used); and
    Treatment strategy (e.g. method for overlapping treatments, target
ablation volume, method of catheter positioning)
Treatment Regimen
    Care path (i.e. timing of ablation with respect to chemotherapy,
operative therapy and/or radiation therapy);
    Device application (e.g. time, target temperature, impedance,
temperature achieved);
    Anesthesia;
    Chemotherapy treatment;
    Operative treatment;
    Radiation treatment; and
    Image guidance.
Patient Followup
    Duration;
    Imaging (e.g. MRI field, name of contrast agent, dose, pulse
sequence used, post processing);
    Pathology assessment protocol of the ablated specimen;
    Adverse events; and
    Long term patient outcomes (i.e. overall survival, disease free
survival, local recurrence).

B. Primary Benefits of Implementing a Registry of Breast Cancer
Treatment Using Thermal Ablation Devices

    We believe that the registry could be used to share experience.
Practitioners could then refine best practices for imaging and
pathologic assessment of breast cancers treated using thermal ablation.
Such uniformity could identify conditions under which imaging might be
a good surrogate for pathology and might serve to identify genotypes of
responders versus nonresponders. This information could help our
understanding of the safety and effectiveness associated with thermal
ablation device use for breast cancer treatment and could better inform
the decisions made by study investigators who are considering expanding
their study into pivotal trials.

C. Ancillary Benefits

    There may also be secondary or ancillary benefits from the use of a
registry for thermal device ablation treatments for breast cancer.
These benefits include improved data management across the industry of
thermal ablation devices and associated healthcare cost savings. A
registry could also facilitate the automatic capture of important
information about the learning curve associated with thermal device use
and patient factors affecting thermal ablation device use. This
registry could also be used to help validate imaging findings with long
term pathological assessments and patient outcomes.

III. Agency Request for Information

    In light of the potential benefits highlighted previously, FDA is
interested in gathering information about the feasibility, utility,
benefits, and costs associated with the development and implementation
of a registry of breast cancer treatment using thermal ablation
devices. We are also interested in obtaining information about existing
registries that may be modified to include breast cancer thermal
ablation information and parties that would be interested in
collaborating with the agency on this effort. Therefore, we invite
comments and available data on the following questions:
Stakeholder Role and Involvement for Developing a Registry of Breast
Cancer Treatment Using Thermal Ablation Devices
    1. What should be the role, if any, of FDA in the development and
implementation of a registry for breast cancer treatments using thermal
ablation devices?
    2. What are the incentives for establishing uniform, standardized
imaging and pathological assessment techniques for such a registry?
    3. What are the barriers for establishing a registry for breast
cancer thermal ablation treatments? What suggestions would you have for
overcoming these barriers?
    4. Are there academic groups, industry groups, professional
societies, or other organizations that would be interested in
partnering with FDA and/or other entities to develop or implement a
registry for breast cancer treatments using thermal ablation devices?
    5. What existing databases could be feasibly modified to serve as
the repository of a registry for breast cancer treatments using thermal
ablation and meet the needs of all involved stakeholders?
Developing a Registry of Breast Cancer Treatments Using Thermal
Ablation Devices

    6. How should a registry for breast cancer treatments using thermal
ablation devices be developed? What data analysis methods need to be
considered when developing the registry data set?
    7. Have you implemented some form of a registry for breast cancer
thermal ablation treatments already? Please describe the extent of
implementation, and type of data being collected.
    8. Should a registry be considered for all thermal ablation device
applications for cancer treatment? If yes, why? If not, what thermal
ablation device uses should be considered for data capture in a
registry?
    9. What solutions have you developed or do you think could be
developed for addressing the various technical use, pathological,
imaging and other treatment assessment problems that might arise in
developing and implementing a registry for breast cancer or other
cancer treatments using thermal ablation devices?
Criteria for Data Inclusion from Breast Cancer Treatments Using Thermal
Ablation Devices
    10. What is the minimum data set that should be associated with a
device use session? Would this minimum data set differ for different
devices? If so, how?
    11. How would the data in the minimum data set be used to improve
patient safety? What other data would improve patient safety?
    12. How and by whom should the registry and its associated minimum
data set be obtained and maintained?
    13. What information should be accessible by the public, healthcare
providers, professional organizations, FDA, other Federal Agencies, the
industry, and individual manufacturers? How would the information be
accessible?
    14. What type of proprietary information needs to be excluded?
    15. Should data from all thermal ablation device investigators be
included or should the data be limited to include only investigators
that have received a certain level of training for device use?
Registry Benefits and Costs
    16. From your perspective, how could a registry be best used among
competing manufacturers of similar product lines? What obstacles do you
see in using such an approach for justifying marketing claims?
    17. From your perspective, should data previously collected or
currently being collected be incorporated by investigators studying the
effects of thermal ablation treatment for breast cancer be included in
the registry? If so, why, and under what circumstances? If not, why
not?
    18. From your perspective, what specific public health and patient
safety benefits could be gained from having a standardized registry for
breast cancer treatments using thermal ablation devices? In addition,
how would such a system contribute to meeting device recall and adverse
event reporting requirements, and to reducing medical error? Please
submit detailed data to support benefits you identify.
    19. From your perspective, what are the startup costs measured in
time and other resources associated with the development,
implementation, and use of a registry for breast cancer treatments
using thermal ablation devices? Please submit detailed data to support
these cost estimates.
    20. If you have already implemented a form of a registry for breast
or other cancer treatments using thermal ablation devices, what
investments in equipment, training, and other human and physical
resources were necessary to implement the use of such a database? What
factors influenced your decision to implement such a system?
    21. From your perspective, what are the obstacles to implementing
or using a registry for breast cancer treatments using thermal ablation
devices?

IV. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic copies or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified 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.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

V. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen between
9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the Web
site address, but is not responsible for subsequent changes to the Web
site after this document publishes in the Federal Register.)
    1. Panel transcript and questions regarding percutaneous and
thermal ablation treatment of breast cancer in lieu of operative
resection (see http://www.fda.gov/OHRMS/DOCKETS/AC/03/questions/
3973q1_Breast%20ca%20Questions.htm and http://www.fda.gov/OHRMS/
DOCKETS/AC/03/transcripts/3973t1.htm.
    2. Gliklich, R.E., N.A Dreyer, eds. ``Registries for Evaluating
Patient Outcomes: A User's Guide.'' (Prepared by Outcome DEcIDE
Center [Outcome Sciences, Inc. dba Outcome] under Contract No.
HHSA29020050035I TO1.) AHRQ Publication No. 07-EHC001-1. Rockville,
MD: Agency for Healthcare Research and Quality. April 2007.
    3. Goldberg, S.N., et al. ``Image Guided Tumor Ablation:
Proposal for Standardization of Terms and Reporting Criteria,''
Radiology 2003; 228: 335-345.
    4. Goldberg, S.N., et al. ``Image Guided Tumor Ablation:
Standardization of Terminology and Reporting Criteria,'' Journal of
Vascular and Interventional Radiology 2005; 16: 765-778.

    Dated: May 19, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy and Planning.
[FR Doc. E8-11899 Filed 5-27-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 78, Number 29 (Tuesday, February 12, 2013)]
[Notices]
[Pages 9988-9989]
[FR Doc No: 2013-03141]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Noise Exposure Map Notice Nashville Interntional Airport,
Nashville, TN

AGENCY: Federal Aviation Administration, DOT.

ACTION: Notice.

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SUMMARY: The Federal Aviation Administration (FAA) announces its
determination that the Noise Exposure Maps submitted by Metropolitan
Nashville Airport Authority for Nashville International Airport under
the provisions of 49 U.S.C. 47501 et seq. (Aviation Safety and Noise
Abatement Act) and 14 CFR part 150 are in compliance with applicable
requirements.

DATES: Effective Date: The effective date of the FAA's determination on
the noise exposure maps is February 4, 2013.

FOR FURTHER INFORMATION CONTACT: Phillip J. Braden, Federal Aviation
Administration, Memphis Airports District Office, 2862 Business Park
Drive, Building G, Memphis, Tennessee 38118,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This notice announces that the FAA finds
that the Noise Exposure Maps submitted for Nashville International
Airport are in compliance with applicable requirements of Title 14 Code
of Federal Regulations (CFR) Part 150, effective February 4, 2013.
Under 49 U.S.C. section 47503 of the Aviation Safety and Noise
Abatement Act (the Act), an airport operator may submit to the FAA
Noise Exposure Maps which meet applicable regulations and which depict
noncompatible land uses as of the date of submission of such maps, a
description of projected aircraft operations, and the ways in which
such operations will affect such maps. The Act requires such maps to be
developed in consultation with interested and affected parties in the
local community, government agencies, and persons using the airport. An
airport operator who has submitted Noise Exposure Maps that are found
by FAA to be in compliance with the requirements of 14 CFR part 150,
promulgated pursuant to the Act, may submit a Noise Compatibility
Program for FAA approval which sets forth the measures the airport
operator has taken or proposes to take to reduce existing noncompatible
uses and prevent the introduction of additional noncompatible uses.
    The FAA has completed its review of the Noise Exposure Maps and
accompanying documentation submitted by Metropolitan Nashville Airport
Authority. The documentation that constitutes the ``Noise Exposure
Maps'' as defined in Section 150.7 of 14 CFR part 150 includes:
``Figure 2, Nashville International Airport Surrounding Communities
p.7; Figure 3, Existing Conditions (2012) Noise Exposure Map; Forecast
Condition (2017) Noise Exposure Map; Figure 5, Comparison of Existing
(2012) and Forecast (2017) Noise Exposure Maps; Table 4, Runway Details
p. 42; Table 5, Modeled Average Daily Aircraft Operations for 2012 p.
45; Table 6, Modeled Average Daily Aircraft Operations for 2017 p. 48;
Table 7, Designated Runup Locations and Use Guidance p. 50; Table 8,
Modeled Average Daily Runup Operations for

2012 p. 51; Table 9, Modeled Average Daily Runup Operations for 2017 p.
51; Table 10, Modeled Average Daily Runway Use for 2012 and 2017 p. 53;
Table 11 RNAV Aircraft List p. 56; Figure 7, Existing North Flow Flight
Tracks for Conventional Departures, and Conventional and RNP Arrivals;
Figure 8, Existing South Flow Tracks for Conventional Departures, and
Conventional and RNP Arrivals; Figure 9, RNAV/RNP North Flow Arrival
and Departure Flight Tracks; Figure 10, RNAV/RNP South Flow Arrival and
Departure Flight Tracks; Table 12 Modeled Track Utilization for 2012 p.
67; Table 13 Modeled Track Utilization for 2017 p. 74; Appendix A,
Noise Terminology; Appendix B, FAA Acceptance of Previous Noise
Exposure Maps; Appendix C, May 23, 1989 FAA Record of Approval for 1989
Noise Compatibility Program Submission; Appendix D, Original 2011 and
2016 Noise Exposure Map Forecast Document and FAA Approval; Appendix E,
MNAA Submission to FAA and Associated FAA Approval for Revised 2012 and
2017 Forecasts; Appendix F, Request to FAA Regarding Non-Standard
Aircraft Type Modeling Substitutions and FAA Response; Appendix G,
Documentation Related to Draft Noise Exposure Map Notice, Review, and
Comment Opportunities; Appendix H, Documentation Related to September
18, 2012 Public Workshop; Appendix I, Written Comment Received During
Consultation''. The FAA has determined that these Noise Exposure Maps
and accompanying documentation are in compliance with applicable
requirements. This determination is effective on February 4, 2013.
    FAA's determination on the airport operator's Noise Exposure Maps
is limited to a finding that the maps were developed in accordance with
the procedures contained in Appendix A of 14 CFR part 150. Such
determination does not constitute approval of the airport operator's
data, information or plans, or a commitment to approve a Noise
Compatibility Program or to fund the implementation of that Program. If
questions arise concerning the precise relationship of specific
properties to noise exposure contours depicted on a Noise Exposure Map
submitted under Section 47503 of the Act, it should be noted that the
FAA is not involved in any way in determining the relative locations of
specific properties with regard to the depicted noise exposure
contours, or in interpreting the Noise Exposure Maps to resolve
questions concerning, for example, which properties should be covered
by the provisions of Section 47506 of the Act. These functions are
inseparable from the ultimate land use control and planning
responsibilities of local government. These local responsibilities are
not changed in any way under 14 CFR part 150 or through FAA's review of
Noise Exposure Maps. Therefore, the responsibility for the detailed
overlaying of noise exposure contours onto the map depicting properties
on the surface rests exclusively with the airport operator that
submitted those maps, or with those public agencies and planning
agencies with which consultation is required under Section 47503 of the
Act. The FAA has relied on the certification by the airport operator,
under Section 150.21 of 14 CFR part 150, that the statutorily required
consultation has been accomplished.
    Copies of the full Noise Exposure Maps documentation and of the
FAA's evaluation of the maps are available for examination at the
following locations: Federal Aviation Administration, Memphis Airports
District Office, 2862 Business Park Drive, Building G, Memphis,
Tennessee 38118.
    Questions may be directed to the individual named above under the
heading, FOR FURTHER INFORMATION CONTACT.

    Issued in Memphis, Tennessee on February 4, 2013.
Phillip J. Braden,
Manager, Memphis Airports District Office.
[FR Doc. 2013-03141 Filed 2-11-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 78 (Monday, April 23, 2018)]
[Notices]
[Pages 17691-17694]
[FR Doc No: 2018-08355]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83058; File No. SR-DTC-2018-003]

Self-Regulatory Organizations; The Depository Trust Company;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend the DTC Redemptions Service Guide and the DTC Reorganizations
Service Guide To Add Clarifying Text Relating to the Processing of MMI
Securities

April 17, 2018.
    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 April 16, 2018, The Depository Trust Company (``DTC'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I, II and III below, which Items have
been prepared by the clearing agency. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    The proposed rule change \3\ consists of proposed modifications to
the DTC Reorganizations Service Guide (``Reorganizations Guide'') \4\
and the DTC Redemptions Service Guide (``Redemptions Guide'') \5\ to
make clarifying changes and provide enhanced transparency within DTC's
Procedures \6\ relating to the processing of transactions in money
market instruments (``Money Market Securities'') in DTC's MMI
Program,\7\ as described below.
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    \3\ Each capitalized term not otherwise defined herein has its
respective meaning as set forth in the Rules, By-Laws and
Organization Certificate of The Depository Trust Company
(``Rules''), available at http://www.dtcc.com/legal/rules-and-procedures.aspx and the DTC Settlement Service Guide (``Settlement
Guide''), available at http://www.dtcc.com/~/media/Files/Downloads/
legal/service-guides/Settlement.pdf.
    \4\ Available at http://www.dtcc.com/~/media/Files/Downloads/
legal/service-guides/Reorganization-Service-Guide.pdf.
    \5\ Available at http://www.dtcc.com/~/media/Files/Downloads/
legal/service-guides/Redemptions.pdf.
    \6\ Pursuant to the Rules, the term ``Procedures'' means the
Procedures, service guides, and regulations of DTC adopted pursuant
to Rule 27, as amended from time to time. See Rule 1, Section 1,
supra note 3, at 13.
    \7\ Pursuant to the Rules, the term MMI Program means the
Program for transactions in MMI Securities, as provided in Rule 9(C)
and as specified in the Procedures. See Rule 1, Section 1, supra
note 3, at 10. Eligibility for inclusion in the MMI Program covers
MMI Securities, which are short-term debt Securities that generally
mature 1 to 270 days from their original issuance date. MMI
Securities include, but are not limited to, commercial paper,
banker's acceptances and short-term bank notes and are issued by
financial institutions, large corporations, or state and local
governments. Most MMI Securities trade in large denominations
(typically, $250,000 to $50 million) and are purchased by
institutional investors. Eligibility for inclusion in the MMI
Program also covers medium term notes that mature over a longer
term.

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II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

    In its filing with the Commission, the clearing agency 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 clearing agency has prepared summaries,
set forth in sections A, B, and C below, of the most significant
aspects of such statements.

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

1. Purpose
    The proposed rule change consists of proposed modifications to the
DTC Reorganizations Guide and the DTC Redemptions Guide to make
clarifying changes and provide enhanced transparency within DTC's
Procedures relating to the processing of transactions in MMI Securities
in DTC's MMI Program, as discussed below.

Background

    When an issuer of MMI Securities (``Issuer'') issues MMI Securities
at DTC, the Issuing and Paying Agent (``IPA'') for that Issuer sends
issuance instructions to DTC electronically, which results in crediting
the applicable MMI Securities to the DTC Account of the IPA. These MMI
Securities are then Delivered to the Accounts of applicable
Participants that are purchasing the issuance of MMI Securities in
accordance with their purchase amounts. These purchasing Participants
typically include broker/dealers or banks, acting as custodians for
institutional investors. The IPA Delivery instructions may be free of
payment or, most often, Delivery Versus Payment. Deliveries of MMI
Securities are processed pursuant to the same Rules and the applicable
Procedures set forth in the Settlement Guide, as are Deliveries
generally, whether free or versus payment. Delivery Versus Payment
transactions are subject to risk management controls of the IPA and
Receiving Participants for Net Debit Cap and Collateral Monitor
sufficiency,\8\ and payment for Delivery Versus Payment transactions is
due from the receiving Participants through DTC's net settlement
process. To the extent, if any, that the Participant has a Net Debit
Balance in its Settlement Account at end-of-day, payment of that amount
is due to DTC.
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    \8\ Delivery Versus Payment transfers at DTC are structured so
that the completion of Delivery of Securities to a Participant in
end-of-day settlement is contingent on the receiving Participant
satisfying its end-of-day net settlement obligation, if any. The
risk of Participant failure to settle is managed through risk
management controls, structured so that DTC may complete settlement
despite the failure to settle of the Participant, or Affiliated
Family of Participants, with the largest net settlement obligation.
The two principal controls are the Net Debit Cap and Collateral
Monitor. The largest net settlement obligation of a Participant or
Affiliated Family of Participants cannot exceed DTC liquidity
resources, based on the Net Debit Cap, and must be fully
collateralized, based on the Collateral Monitor. This structure is
designed so that DTC may pledge or liquidate Collateral of the
defaulting Participant in order to fund settlement among non-
defaulting Participants. Liquidity resources, including the
Participants Fund and a committed line of credit with a consortium
of lenders, are available to complete settlement among non-
defaulting Participants.
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    In 2017, DTC implemented rule changes (``2017 Changes'') relating
to the processing of MMI Securities to improve the efficiency and
reduce risks associated with the processing of transactions in MMI
Securities, as described in the rule filing pursuant to which the 2017
Changes were implemented.\9\ The 2017 Changes included amendments to
the Rules, Settlement Guide \10\ and DTC Distributions Service Guide
(``Distributions Guide'') \11\ in this regard.
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    \9\ Securities Exchange Act Release No. 34-79764 (January 9,
2017), 82 FR 4434 (January 13, 2018) (SR-DTC-2016-008).
    \10\ Supra note 3.
    \11\ Available at http://www.dtcc.com/~/media/Files/Downloads/
legal/service-guides/Service%20Guide%20Distributions.pdf.
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    While the Rules and Procedures governing the processing of
transactions in MMI Securities are primarily contained in the Rules
\12\ and the Settlement Guide,\13\ the Distributions Guide was amended
pursuant to the 2017 Changes to make clarifying changes to text
relating to the processing of Income Presentments,\14\ so that it is
consistent with the Settlement Guide in that regard.
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    \12\ See Rule 9(A), Rule 9(B) and Rule 9(C), supra note 3.
    \13\ See supra note 3 at 45-47.
    \14\ Pursuant to the Rules, the term ``Income Presentment''
means an instruction initiated by DTC to credit the Account of DTC
with an amount of interest or dividend income payable to DTC by an
issuer in respect of MMI Securities (other than an amount of
interest or dividend income or other distribution of cash or
property payable to DTC by the issuer in connection with a Maturity
Presentment or a Reorganization Presentment) and to debit the
designated Paying Agent Account for that issue with the same amount,
as provided in Rule 9(C) and as specified in the Procedures. See
Rule 1, Section 1, supra note 1, at 7.
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    The proposed rule change would make clarifying changes to the
Reorganizations Guide and Redemptions Guide to add text similar to that
included in the Distributions Guide \15\ pursuant to the 2017 Changes
and clarify certain aspects of processing relating more specifically to
Reorganization Presentments and Maturity Presentments, as described
below.
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    \15\ See supra note 11 at 28.
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Proposed Changes to the Redemptions Guide

    As mentioned above, provisions governing the processing of
transactions in MMI Securities are primarily contained in the Rules and
Settlement Guide. The Redemptions Guide currently contains provisions
relating to the processing of maturity events for non-MMI Securities
and does not contain text relating to the processing of maturities of
MMI Securities. In order to provide (i) enhanced clarity for
Participants, and (ii) a point of reference within the Redemptions
Guide, with respect to processing of transactions in maturing MMI
Securities, the proposed rule change would amend the Redemptions Guide
to (a) add a brief description of Maturity Presentments and the
processing of transactions relating to them, (b) add a brief
description of the ``Settlement User Interface,'' which is used by
Participants to submit input and inquiries relating to the processing
of transactions in MMI Securities in accordance with the Settlement
Guide,\16\ and (c) provide a cross-reference to the Settlement Guide
for Procedures relating to processing of transactions in MMI
Securities.
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    \16\ See supra note 3 at 5.
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    In this regard, the following text would be added to a new section
of the Redemptions Guide that would be titled ``Maturity Presentments
for MMI Issues,'' as follows:
    A ``Maturity Presentment'' is a Delivery Versus Payment (as defined
in Rule 1) of matured money market instruments (MMI Securities) from
the account of a presenting Participant to a designated paying agent
account for that issue and is subject to, and is processed in
accordance with, Rule 9(A), Rule 9(B), Rule 9(C) of DTC and the
Procedures set forth in the DTC Settlement Service Guide. Maturity

Presentments are not attempted for processing until the issuer's
issuing and paying agent (IPA) makes a funding decision in the form of
an ``MMI Funding Acknowledgment.'' Once a funding decision is made
items will be processed subject to risk controls and the sufficient
inventory of the relevant Participants. IPAs and other Participants may
submit input and inquiries relating to MMI Securities processing
through the Settlement User Interface. See the DTC Settlement Service
Guide, available at http://www.dtcc.com/~/media/Files/Downloads/legal/
service-guides/Settlement.pdf, for the DTC Procedures relating to the
processing of transactions in MMI Securities.

Proposed Changes to the Reorganizations Guide

    As mentioned above, provisions governing the processing of
transactions in MMI Securities are primarily contained in the Rules
\17\ and Settlement Guide.\18\ The Reorganizations Guide currently
contains provisions relating to the processing of reorganizations for
non-MMI Securities and does not contain text relating to the processing
of Reorganization Presentments. In order to provide (i) enhanced
clarity and transparency for Participants, and (ii) a point of
reference within the Reorganizations Guide, with respect to processing
of Reorganization Presentments, the proposed rule change would amend
the Reorganizations Guide to (a) add a brief description of
Reorganization Presentments and the processing of transactions relating
to them, (b) add a brief description of the ``Settlement User
Interface,'' which is used by Participants to submit input and
inquiries relating to processing of transactions in MMI Securities in
accordance with the Settlement Guide,\19\ and (c) provide a cross-
reference to the Settlement Guide for Procedures relating to the
processing of transactions in MMI Securities.
---------------------------------------------------------------------------

    \17\ See supra note 12.
    \18\ See supra note 13.
    \19\ See supra note 16.
---------------------------------------------------------------------------

    In this regard, the following text would be added to a new section
of the Reorganizations Guide that would be titled ``Reorganization
Presentments for MMI Issues,'' as follows:
    A ``Reorganization Presentment'' is a Delivery Versus Payment (as
defined in Rule 1) of money market instruments (MMI Securities) in
response to a reorganization action from the account of a presenting
Participant to a designated paying agent account for that issue, and is
subject to, and is processed in accordance with Rule 9(A), Rule 9(B),
Rule 9(C) of DTC and the Procedures set forth in the Settlement Service
Guide. Reorganization Presentments are not attempted for processing
until the issuer's issuing and paying agent (IPA) makes a funding
decision in the form of an ``MMI Funding Acknowledgment.'' Once a
funding decision is made items will be processed subject to risk
controls and the sufficient inventory of the relevant Participants.
IPAs and other Participants may submit input and inquiries relating to
processing of transactions in MMI Securities through the Settlement
User Interface. See the DTC Settlement Service Guide, available at
http://www.dtcc.com/~/media/Files/Downloads/legal/service-guides/
Settlement.pdf, for the DTC Procedures relating to the processing of
transactions in MMI Securities.

Effective Date

    The proposed rule change would become effective upon filing with
the Commission.
2. Statutory Basis
    Section 17A(b)(3)(F) of the Act \20\ requires that the rules of the
clearing agency be designed, inter alia, to promote the prompt and
accurate clearance and settlement of securities transactions. DTC
believes that the proposed rule change is consistent with this
provision of the Act because by adding text within the Procedures set
forth in the Redemptions Guide and Reorganizations Guide regarding the
processing of MMI Securities, the proposed rule change would provide
enhanced clarity and transparency for Participants with respect to the
Rules and Procedures relating to the processing of Maturity
Presentments and Reorganization Presentments, as described above.
Therefore, by providing Participants with enhanced clarity and
transparency with regard to the Procedures relating to the processing
of Maturity Presentments and Reorganizations Presentments, DTC believes
that the proposed rule change would promote the prompt and accurate
clearance and settlement of securities transactions consistent with the
Act.
---------------------------------------------------------------------------

    \20\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

(B) Clearing Agency's Statement on Burden on Competition

    DTC does not believe that the proposed rule change would have any
impact, or impose any burden, on competition. The proposed rule change
would merely clarify and provide enhanced transparency with respect to
the processing of transactions in MMI Securities by adding text to the
Redemptions Service Guide and the Reorganizations Service Guide that is
consistent with existing provisions set forth in the Rules and the
Settlement Guide, as described above.

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants, or Others

    Written comments relating to this proposed rule change have not
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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \21\ and paragraph (f) of Rule 19b-4
thereunder.\22\ 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.
---------------------------------------------------------------------------

    \21\ 15 U.S.C. 78s(b)(3)(A).
    \22\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

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 protected]. Please include
File Number SR-DTC-2018-003 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-DTC-2018-003. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent

amendments, all written statements with respect to the proposed rule
change that are filed with the Commission, and all written
communications relating to the proposed rule change between the
Commission and any person, other than those that may be withheld from
the public in accordance with the provisions of 5 U.S.C. 552, will be
available for website viewing and printing in the Commission's Public
Reference Room, 100 F Street, NE, Washington, DC 20549 on official
business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of
the filing also will be available for inspection and copying at the
principal office of DTC and on DTCC's website (http://dtcc.com/legal/sec-rule-filings.aspx). All comments received will be posted without
change. Persons submitting comments are cautioned that we do not redact
or edit personal identifying information from comment submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-DTC-2018-003
and should be submitted on or before May 14, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\23\
---------------------------------------------------------------------------

    \23\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-08355 Filed 4-20-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: August 4, 2008 (Volume 73, Number 150)]
[Proposed Rules]
[Page 45184]
[DOCID:fr04au08-13]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2006-0003; FRL-8696-4]

Approval and Promulgation of Air Quality Implementation Plans;
Illinois

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing to approve a revision to the Illinois State
Implementation Plan (SIP) for ozone. The state is incorporating
revisions EPA made to its definition of volatile organic compound
(VOC). This SIP revision adds one compound to the list of compounds
that are exempt from being considered a VOC. This is because it was
determined that the listed compound does not contribute to ozone
formation.

DATES: Comments must be received on or before September 3, 2008.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2006-0003, by one of the following methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: John M. Mooney, Chief, Criteria Pollutant Section, Air
Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West
Jackson Boulevard, Chicago, Illinois 60604.
    5. Hand Delivery: John M. Mooney, Chief, Criteria Pollutant
Section, Air Programs Branch (AR-18J), U.S. Environmental Protection
Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604. Such
deliveries are only accepted during the Regional Office normal hours of
operation, and special arrangements should be made for deliveries of
boxed information. The Regional Office official hours of business are
Monday through Friday, 8:30 a.m. to 4:30 p.m. excluding Federal
holidays.
    Please see the direct final rule which is located in the Rules
section of this Federal Register for detailed instructions on how to
submit comments.

FOR FURTHER INFORMATION CONTACT: Matt Rau, Environmental Engineer,
Criteria Pollutant Section, Air Programs Branch (AR-18J), Environmental
Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago,
Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Final Rules section of this Federal
Register, EPA is approving the State's SIP submittal as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no adverse comments are received in response to this rule, no
further activity is contemplated. If EPA receives adverse comments, the
direct final rule will be withdrawn and all public comments received
will be addressed in a subsequent final rule based on this proposed
rule. EPA will not institute a second comment period. Any parties
interested in commenting on this action should do so at this time.
Please note that, if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment. For
additional information, see the direct final rule which is located in
the Rules section of this Federal Register.

    Dated: July 14, 2008.
Walter W. Kovalick Jr.,
Acting Regional Administrator, Region 5.
 [FR Doc. E8-17698 Filed 8-1-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: September 13, 2006 (Volume 71, Number 177)]
[Notices]
[Page 54033-54034]
[DOCID:fr13se06-41]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Effectiveness of Holding Company and Transaction
Exemptions and Waivers

August 29, 2006.

------------------------------------------------------------------------
                                                           Docket No.
------------------------------------------------------------------------
ALLETE, Inc..........................................        PH06-49-000
AOG Corporation......................................        PH06-50-000
American States Water Company........................        PH06-51-000
Consolidated Edison, Inc.............................        PH06-52-000
CH Energy Group......................................        PH06-53-000
Energy East Corporation..............................        PH06-54-000
RGS Energy Group, Inc................................        PH06-55-000
Energen Corporation..................................        PH06-56-000
UGI Corporation......................................        PH06-57-000
Puget Energy, Inc....................................        PH06-58-000
HH-SU Investments L.L.C..............................        PH06-59-000

Cap Rock Energy Corporation..........................        PH06-60-000
Peoples Energy Corporation...........................        PH06-61-000
Peoples Energy Corporation...........................        PH06-62-000
Duquesne Light Holdings, Inc.........................        PH06-63-000
Milliken & Company...................................        PH06-64-000
Intermountain Industries, Inc........................        PH06-65-000
TXU Corp.............................................        PH06-66-000
Cleco Corporation....................................        PH06-67-000
KeySpan Energy Corporation...........................        PH06-68-000
KeySpan New England, LLC.............................        PH06-69-000
WPS Resources Corporation............................        PH06-70-000
------------------------------------------------------------------------

    Take notice that in July 2006 the holding company and transaction
exemptions and waivers requested in the above-captioned proceedings are
deemed to have been granted by operation of law pursuant to 18 CFR
366.4.

Magalie R. Salas,
Secretary.
[FR Doc. E6-15142 Filed 9-12-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 196 (Tuesday, October 11, 2011)]
[Notices]
[Pages 62890-62891]
[FR Doc No: 2011-26101]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65477; File No. SR-FINRA-2011-028]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Withdrawal of Proposed Rule Change To Adopt
Rules Regarding Supervision in the Consolidated FINRA Rulebook

October 4, 2011.
    On June 10, 2011, Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange

Commission (``Commission''), pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934 (``Exchange Act'' or ``Act'') \1\ and
Rule 19b-4 thereunder,\2\ a proposed rule change to adopt rules
regarding supervision in the consolidated FINRA rulebook. The proposed
rule change was published for comment in the Federal Register on June
29, 2011.\3\ The Commission received 12 comments on the proposal.\4\ On
July 26, 2011, FINRA extended the time period in which the Commission
must approve the proposed rule change, disapprove the proposed rule
change, or institute proceedings to determine whether to approve or
disapprove the proposed rule change, to September 27, 2011.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 64736 (June 26,
2011), 76 FR 38245 (June 29, 2011) (Notice of Filing of File No. SR-
FINRA-2011-028) (``Notice'').
    \4\ The comment period ended on July 20, 2011; all comments are
posted on the Commission's Web site, http://www.sec.gov/rules/sro.shtml.
---------------------------------------------------------------------------

    On September 27, 2011, FINRA withdrew the proposed rule change (SR-
FINRA-2011-028).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\5\
---------------------------------------------------------------------------

    \5\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-26101 Filed 10-7-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 180 (Friday, September 16, 2011)]
[Notices]
[Pages 57729-57730]
[FR Doc No: 2011-23796]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER11-4482-000]

Supplemental Notice That Initial Market-Based Rate Filing
Includes Request for Blanket Section 204 Authorization; Madstone Energy
Corp.

    This is a supplemental notice in the above-referenced proceeding of
Madstone Energy Corp.'s application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is October 3, 2011.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic

service, persons with Internet access who will eFile a document and/or
be listed as a contact for an intervenor must create and validate an
eRegistration account using the eRegistration link. Select the eFiling
link to log on and submit the intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: September 12, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-23796 Filed 9-15-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: December 1, 2005 (Volume 70, Number 230)]
[Rules and Regulations]
[Page 72078-72080]
[DOCID:fr01de05-11]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 64

[Docket No. FEMA-7903]

Suspension of Community Eligibility

AGENCY: Department of Homeland Security, Federal Emergency Management
Agency (FEMA), Mitigation Division.

ACTION: Final rule.

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

SUMMARY: This rule identifies communities, where the sale of flood
insurance has been authorized under the National Flood Insurance
Program (NFIP), that are scheduled for suspension on the effective
dates listed

within this rule because of noncompliance with the floodplain
management requirements of the program. If FEMA receives documentation
that the community has adopted the required floodplain management
measures prior to the effective suspension date given in this rule, the
suspension will not occur and a notice of this will be provided by
publication in the Federal Register on a subsequent date.

EFFECTIVE DATES: The effective date of each community's scheduled
suspension is the third date (``Susp.'') listed in the third column of
the following tables.

ADDRESSES: If you wish to determine whether a particular community was
suspended on the suspension date, contact the appropriate FEMA Regional
Office or the NFIP servicing contractor.

FOR FURTHER INFORMATION CONTACT: Michael M. Grimm, Mitigation Division,
500 C Street, SW., Room 412, Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The NFIP enables property owners to purchase
flood insurance which is generally not otherwise available. In return,
communities agree to adopt and administer local floodplain management
aimed at protecting lives and new construction from future flooding.
Section 1315 of the National Flood Insurance Act of 1968, as amended,
42 U.S.C. 4022, prohibits flood insurance coverage as authorized under
the NFIP, 42 U.S.C. 4001 et seq.; unless an appropriate public body
adopts adequate floodplain management measures with effective
enforcement measures. The communities listed in this document no longer
meet that statutory requirement for compliance with program
regulations, 44 CFR part 59 et seq. Accordingly, the communities will
be suspended on the effective date in the third column. As of that
date, flood insurance will no longer be available in the community.
However, some of these communities may adopt and submit the required
documentation of legally enforceable floodplain management measures
after this rule is published but prior to the actual suspension date.
These communities will not be suspended and will continue their
eligibility for the sale of insurance. A notice withdrawing the
suspension of the communities will be published in the Federal
Register.
    In addition, FEMA has identified the Special Flood Hazard Areas
(SFHAs) in these communities by publishing a Flood Insurance Rate Map
(FIRM). The date of the FIRM, if one has been published, is indicated
in the fourth column of the table. No direct Federal financial
assistance (except assistance pursuant to the Robert T. Stafford
Disaster Relief and Emergency Assistance Act not in connection with a
flood) may legally be provided for construction or acquisition of
buildings in identified SFHAs for communities not participating in the
NFIP and identified for more than a year, on FEMA's initial flood
insurance map of the community as having flood-prone areas (section
202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a),
as amended). This prohibition against certain types of Federal
assistance becomes effective for the communities listed on the date
shown in the last column. The Administrator finds that notice and
public comment under 5 U.S.C. 553(b) are impracticable and unnecessary
because communities listed in this final rule have been adequately
notified.
    Each community receives 6-month, 90-day, and 30-day notification
letters addressed to the Chief Executive Officer stating that the
community will be suspended unless the required floodplain management
measures are met prior to the effective suspension date. Since these
notifications were made, this final rule may take effect within less
than 30 days.

National Environmental Policy Act

    This rule is categorically excluded from the requirements of 44 CFR
part 10, Environmental Considerations. No environmental impact
assessment has been prepared.

Regulatory Flexibility Act

    The Administrator has determined that this rule is exempt from the
requirements of the Regulatory Flexibility Act because the National
Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits
flood insurance coverage unless an appropriate public body adopts
adequate floodplain management measures with effective enforcement
measures. The communities listed no longer comply with the statutory
requirements, and after the effective date, flood insurance will no
longer be available in the communities unless remedial action takes
place.

Regulatory Classification

    This final rule is not a significant regulatory action under the
criteria of section 3(f) of Executive Order 12866 of September 30,
1993, Regulatory Planning and Review, 58 FR 51735.

Paperwork Reduction Act

    This rule does not involve any collection of information for
purposes of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

List of Subjects in 44 CFR Part 64

    Flood insurance, Floodplains.

0
Accordingly, 44 CFR Part 64 is amended as follows:

PART 64--[AMENDED]

0
1. The authority citation for Part 64 continues to read as follows:

    Authority: 42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp.; p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp.; p. 376.

Sec.  64.6  [Amended]

0
The tables published under the authority of Sec.  64.6 are amended as
follows:

----------------------------------------------------------------------------------------------------------------
                                                 Effective date
                                                 authorization/
                                   Community    cancellation of    Current effective map   Date certain Federal
         State/Location               No.        sale of flood             date            assistance no longer
                                                  insurance in                              available in SFHAs
                                                   community
----------------------------------------------------------------------------------------------------------------
           Region IV

North Carolina:
    Freemont, Town of, Wayne           370492  May 27, 1997,      12/02/2005............  12/02/2005.
     County.                                    Emerg; May 27,
                                                1997, Reg;
                                                December 2,
                                                2005, Susp.
    Smithfield, Town of                370140  January 20, 1975,  ......do..............   Do.
     Johnston County.                           Emerg; April 1,
                                                1982, Reg;
                                                December 2,
                                                2005, Susp.
    Walnut Creek, Village of,          370435  October 19, 1989,  ......do..............   Do.
     Wayne County.                              Emerg; October
                                                19, 1989, Reg;
                                                December 2,
                                                2005, Susp.
    Wayne County,                      370254  September 16,      ......do..............   Do.
     Unincorporated Areas.                      1991, Emerg;
                                                September 16,
                                                1991, Reg;
                                                December 2,
                                                2005, Susp.

           Region VII

Missouri:
    Cole County, Unincorporated        290107  January 21, 1982,  ......do..............   Do.
     Areas.                                     Emerg; January
                                                21, 1982, Reg;
                                                December 2,
                                                2005, Susp.
    Jefferson, City of, Cole           290108  April 23, 1971,    ......do..............   Do.
     County.                                    Emerg; April 15,
                                                1980, Reg;
                                                December 2,
                                                2005, Susp.
Nebraska:
    Bellevue, City of, Sarpy           310191  April 13, 1973,    ......do..............   Do.
     County.                                    Emerg; January
                                                16, 1980, Reg;
                                                December 2,
                                                2005, Susp.
    Bennington, City of,               310074  July 10, 1975,     ......do..............   Do.
     Douglas County.                            Emerg; December
                                                4, 1979, Reg;
                                                December 2,
                                                2005, Susp.
    Douglas County,                    310073  November 15,       ......do..............   Do.
     Unincorporated Areas.                      1974, Emerg;
                                                January 16,
                                                1981, Reg;
                                                December 2,
                                                2005, Susp.
    Elkhorn, City of, Douglas          310075  March 31, 1975,    ......do..............   Do.
     County.                                    Emerg; August
                                                15, 1979, Reg;
                                                December 2,
                                                2005, Susp.
    La Vista, City of, Sarpy           310192  April 23, 1974,    ......do..............   Do.
     County.                                    Emerg; January
                                                16, 1980, Reg;
                                                December 2,
                                                2005, Susp.
    Omaha, City of, Douglas            315274  November 6, 1970,  ......do..............   Do.
     County.                                    Emerg; May 7,
                                                1971, Reg;
                                                December 2,
                                                2005, Susp.
    Papillion, City of, Sarpy          315275  July 2, 1971,      ......do..............   Do.
     County.                                    Emerg; August
                                                18, 1972, Reg;
                                                December 2,
                                                2005, Susp.
    Ralston, City of, Douglas          310077  August 19, 1975,   ......do..............   Do.
     County.                                    Emerg; May 15,
                                                1980, Reg;
                                                December 2,
                                                2005, Susp.
    Sarpy County,                      310190  February 23,       ......do..............   Do.
     Unincorporated Areas.                      1973, Emerg;
                                                January 16,
                                                1981, Reg;
                                                December 2,
                                                2005, Susp.
    Valley, City of, Douglas           310078  May 1, 1975,       ......do..............   Do.
     County.                                    Emerg; March 18,
                                                1980, Reg;
                                                December 2,
                                                2005, Susp.
----------------------------------------------------------------------------------------------------------------
*......do = Ditto.
Code for reading third column: Emerg.-Emergency; Reg.-Regular; Susp.-Suspension.

    Dated: November 23, 2005.
Michael K. Buckley,
Deputy Director, Mitigation Division, Federal Emergency Management
Agency.
[FR Doc. 05-23528 Filed 11-30-05; 8:45 am]

BILLING CODE 9110-12-P


                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, D.C. 20460

              OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

MEMORANDUM

January 30, 2013
TXR # 0056527

SUBJECT:	Trifloxystrobin:  Summary of Hazard and Science Policy Council (HASPOC) Meeting of November 29, 2012:  Recommendations on waiver requests for a 28-day inhalation study

PC Code:  129112
DP Barcode:   405845
Decision No.: N/A
Registration No.: N/A
Petition No.: N/A
Regulatory Action: N/A
Risk Assessment Type: N/A
Case No.: N/A
TXR No.: 0056527
CAS No.: 141571-21-7
MRID No.: N/A
40 CFR: 180.555

FROM:	Kristin Rury, MPH
		Executive Secretary, HASPOC
		Health Effects Division (7509P)

THROUGH:	Jess Rowland, MS. Co-Chair
      Anna Lowit, Ph.D, Co-Chair
            HASPOC
		Health Effects Division (7509P)

TO:		Sheila Healy, Toxicologist
      Jeff Dawson, Acting Chief
		Registration Action Branch 3
		Health Effects Division (7509P)

MEETING ATTENDEES:

HASPOC Members:  Anna Lowit, Elizabeth Mendez, Jeff Evans, Jess Rowland, John Kough, Jonathan Chen, Julie Van Alstine, Kristin Rury, Michael Metzger, PV Shah, Ray Kent
Presenters:  Nancy Tsaur and Sheila Healy

Other Attendees:  Danette Drew, Kelly Lowe, Linda Taylor, Matthew Lloyd, William Irwin

I.	PURPOSE OF MEETING:

The Hazard and Science Policy Council (HASPOC) met initially on December 8, 2011 to discuss the need for a subchronic inhalation toxicity study; the study was required based on low margins of exposure (MOEs), including for handgun applications to turf (MOE = 190).  Since then the Risk Assessment Branch III (RAB III) has received an inhalation toxicity study waiver request from Bayer CropScience (Bayer) specifically addressing a need for updated exposure scenarios and exposure assumptions.  HASPOC met again on November 29, 2012 to discuss Bayer's subchronic inhalation toxicity study waiver request.

II.  	SUMMARY OF WAIVER REQUEST:

Bayer rebutted the previous HASPOC decision, noting that the lowest MOE was from an outdated assessment (S. Wang, DP258460, 08/09/1999).  The highest inhalation exposure and was from mixing/loading/applying with a handgun to turf and resulted in an MOE of 190.

III.  	SUMMARY OF USE PROFILE & PREVIOUS RISK ASSESSMENT:

Trifloxystrobin is a broad spectrum fungicide (oximinoacetate) of the strobilurin class.  Tolerances are currently established for the combined residues of trifloxystrobin and its metabolite(s) in/on various crop and livestock commodities ranging from 0.02 ppm (milk) to 38 ppm (citrus oil) [40 CFR §180.555(a)].  Trifloxystrobin is registered for use via several application methods, including groundboom, aerial, chemigation and airblast equipment.

In the most recent risk assessment (N. Tsaur, D385972, 08/02/11), a subchronic inhalation toxicity study in the rat was required as a condition of registration for further characterization of inhalation risk.  Due to the potential for repeated occupational inhalation exposure, including exposure in indoor environments during seed treatment, there is concern for toxicity by the inhalation route.

Using the oral point of departure (POD) from the last risk assessment (N. Tsaur, D396514, 09/19/2012), and updated exposure estimates, some short- and intermediate-term MOEs are near or below HED's level of concern (LOC) of 100.  The highest inhalation exposure is from occupational mixing/loading/applying with a mechanically pressurized handgun in a greenhouse to (MOE = 54).  The second highest inhalation exposure results from mixing/loading liquids for aerial application to high acreage crops (MOE = 180).  As a seed treatment, sweet corn represents the seed with the highest potential occupational inhalation exposure (based on application rate and seed treatment throughput).  Activities related to treating seed and planting treated seed at baseline (no respirator) result in inhalation MOEs ranging from 3,700 to 90,000 (LOC = 100).

Residential handler inhalation MOEs from application to turf and ornamentals range from 3,700 to 20,000,000.

III. STUDY WAIVER REQUESTS

   a. Inhalation Study
In the past, OPP has used a set of criteria when considering the scientific information available to waive (or not waive) an inhalation study including the chemical's: 1) severe irritation and corrosivity, 2) low volatility, 3) large aerosol particle size, and 4) Acute Toxicity Category IV and an extrapolated MOE (e.g., MOEs 10 times higher than the target).  In 2009, OPP developed an issue paper on risk assessment approaches for semi-volatile pesticides.  As part of that issue paper, an analysis was conducted on a comparison of oral and inhalation experimental toxicology studies.  In general, this analysis showed that the degree to which oral PODs were protective of potential inhalation toxicity varied.  In many cases the oral POD was protective but in some cases the inhalation PODs were significantly more sensitive.  At this time, OPP is currently developing a scientifically supportable approach for considering waiver requests for inhalation studies.  In the interim, OPP will be using a weight of the evidence (WOE) approach which builds upon experience using the previously used criteria listed above and informed by the 2009 SAP.

Inhalation exposure can be to vapors, droplets, and/or particles/dusts.  The form of this exposure is determined by a number of factors including physical-chemical properties, use pattern, and exposure scenario.  This interim WOE approach considers:

1) Physical-chemical properties:  Vapor pressure and Henry's law constant are key considerations with respect to the volatilization after sprays have settled. Trifloxystrobin (408.4 g/mol) has a low vapor pressure (3.4 x 10[-6] Pa at 25 C) and the Henry's law constant is 2.3 x 10-3 Pa m³ mol[-1] at 25°C.   However, low vapor pressure and/or Henry's law constant does not preclude exposure to aerosolized droplets or particles/dusts.

2) Use pattern & exposure scenarios:  Any application scenario that leads to inhalation exposure to droplets needs to be considered in the WOE analysis for an inhalation toxicology study waiver request.  It is, however, acknowledged that air blast and aerial applications are more likely to lead to higher occupational handler inhalation exposure, particularly to droplets, and may contribute to contribute to spray drift.  In the case of trifloxystrobin, mechanically pressurized handgun applications in greenhouses result in the highest inhalation exposure.

3) Margins of Exposure (MOEs):  The MOE estimates for inhalation scenarios were calculated using an oral toxicity study and should be considered in the WOE analysis for an inhalation toxicology study waiver request.  In the past, OPP has used MOEs of approximately 10 times higher than the level of concern as a benchmark for granting waiver requests.  The 2009 analysis suggests this approach is appropriate for most pesticides but not all.  Using this interim WOE approach MOEs from 10-100X over the level of concern will be considered in combination with other factors discussed here.
   HASPOC agrees with Bayer that the updated calculation for the handgun scenario to turf would result in an MOE of 4,300 (using a body weight of 80 kg).  However, RAB III has reassessed all inhalation MOEs for registered scenarios with the latest occupational exposure calculation spreadsheet.  The new screening assessment results in inhalation MOEs as low as 54 (handgun app to ornamentals, which is a use pattern not previously assessed) and 180 (mixing/loading for aerial application to high acreage crops).

4)  Toxicity:  Trifloxystrobin has relatively low acute toxicity via the oral (Toxicity Category IV), dermal (Toxicity Category IV), and inhalation (Toxicity Category IV) routes of exposure; it is a mild eye (Toxicity Category III) and dermal irritant (Toxicity Category IV), and is a dermal sensitizer.  With repeated dosing by either the oral or dermal route, the liver is consistently the target organ for trifloxystrobin.  Trifloxystrobin does not produce malformations in either rat or rabbit developmental toxicity studies and does not produce reproductive effects.  Trifloxystrobin was determined not to be carcinogenic in mice or rats following long-term dietary administration.  However, it is positive for mutagenicity in Chinese Hamster V79 cells at cytotoxic dose levels while testing negative in the remaining mutagenicity studies.
    For considering a waiver request for inhalation toxicity study, the Agency will evaluate other pesticides which share the same MOA and/or are in the same chemical class.  These pesticides may provide important information with respect to potential inhalation toxicity. Specifically, if other similar pesticides show inhalation toxicity studies to be more sensitive, and depending on the exposure profile, an inhalation toxicity study may be required regardless of MOE.  HASPOC has granted waivers for inhalation toxicity studies for two strobilurin fungicides, azoxystrobin and fluoxastrobin based on high MOEs.  However, for another strobilurin, pyraclostrobin, there were adverse respiratory effects observed in a 28 day inhalation study (i.e., alveolar histiocytosis and olfactory atrophy/necrosis in nasal tissue).  Thus, the HASPOC cannot rule out the potential concern for inhalation toxicity for this class of chemicals.

IV.  HASPOC RECOMMENDATIONS:

Based on a WOE approach considering all the available hazard and exposure information for trifloxystrobin, the HASPOC determined that a 28-day inhalation toxicity study in the rat is required at this time.  This approach considered all the available hazard and exposure information for trifloxystrobin, including: (1) the low vapor pressure of trifloxystrobin (3.4 x 10[-6] Pa at 25 C); (2) the low acute inhalation toxicity of trifloxystrobin (Toxicity Category IV); (3) a similar strobilurin chemical, pyraclostrobin, demonstrated adverse respiratory effects in a subchronic inhalation toxicity study in rats at 0.030 mg/L/day or 6.9 mg/kg/day; and (4) the use of an oral POD resulting in MOEs as low as 54 and 180.  Beyond the guideline requirements, the inhalation toxicity study should include nasal histopathology (serial sections of the nasal passages) because of the nasal effects seen in the pyraclostrobin subchronic inhalation toxicity study (olfactory atrophy and necrosis).  The Agency requests a study protocol be submitted prior to beginning the study. In the absence of a route-specific inhalation study, the HASPOC recommends that a 10X database uncertainty factor be applied only to assess risks for inhalation exposure scenarios.


[Federal Register Volume 80, Number 218 (Thursday, November 12, 2015)]
[Notices]
[Pages 69956-69957]
[FR Doc No: 2015-28641]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER16-256-000]

CEP&G LLC; Supplemental Notice That Initial Market-Based Rate
Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding
CEP&G LLC's application for market-based rate authority, with an
accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is November 24, 2015.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic

service, persons with Internet access who will eFile a document and/or
be listed as a contact for an intervenor must create and validate an
eRegistration account using the eRegistration link. Select the eFiling
link to log on and submit the intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
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    Dated: November 4, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-28641 Filed 11-10-15; 8:45 am]
 BILLING CODE 6717-01-P