[Federal Register: April 7, 2006 (Volume 71, Number 67)]
[Notices]
[Page 17932-17934]
[DOCID:fr07ap06-116]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53586; File No. SR-CBOE-2006-29]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change To Increase the Class Quoting Limit in the Option Class
Apple Computer

April 3, 2006.
    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 March 16, 2006, the Chicago Board Options Exchange, Incorporated
(``CBOE'' or ``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 CBOE. The
Exchange has designated this proposal as one constituting a stated
policy, practice, or interpretation with respect to the meaning,
administration, or enforcement of an existing rule under

Section 19(b)(3)(A)(i) of the Act,\3\ and Rule 19b-4(f)(1)
thereunder,\4\ which renders the proposal effective upon filing with
the Commission. 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.
    \3\ 15 U.S.C. 78s(b)(3)(A)(i).
    \4\ 17 CFR 240.19b-4(f)(1).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    CBOE proposes to increase the class quoting limit in the option
class Apple Computer (``AAPL''). The text of the proposed rule change
is available on CBOE's Web site (http://www.cboe.com), at the CBOE's

Office of the Secretary, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the CBOE 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 CBOE 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
    CBOE Rule 8.3A establishes class quoting limits (``CQLs'') for each
class traded on the Hybrid Trading System.\5\ A CQL is the maximum
number of quoters that may quote electronically in a given product and
the current levels are established from 25-40, depending on the trading
activity of the particular product.
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    \5\ See CBOE Rule 8.3A.01.
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    CBOE Rule 8.3A, Interpretation .01(c) provides a procedure by which
the President of the Exchange may increase the CQL for a particular
product. In this regard, the President of the Exchange may increase the
CQL in exceptional circumstances, which would include substantial
trading volume, whether actual or expected.\6\ The effect of an
increase in the CQL is procompetitive in that it increases the number
of market participants that may quote electronically in a product. The
purpose of this filing is to increase the CQL in the option class AAPL
from its current limit of 44 to 47.\7\
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    \6\ Any actions taken by the President of the Exchange pursuant
to this paragraph must be submitted to the Commission in a rule
filing pursuant to Section 19(b)(3)(A) of the Act. CBOE Rule
8.3A.01(c).
    \7\ CBOE previously increased the CQL in AAPL from 40 to 44 on
April 21, 2005. See Securities Exchange Act Release No. 51720 (May
19, 2005), 70 FR 30164 (May 25, 2005).
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    AAPL is one of the most active equity option classes traded on the
Exchange, and consistently ranks among the top classes in national
average daily trading volume. Increasing the CQL in AAPL options would
enable the Exchange to enhance the liquidity offered, thereby offering
deeper and more liquid markets.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Act and the rules and regulations under the Act applicable to a
national securities exchange and, in particular, the requirements of
Section 6(b) of the Act.\8\ Specifically, the Exchange believes the
proposed rule change is consistent with the requirements of Section
6(b)(5) \9\ that the rules of an exchange be designed to promote just
and equitable principles of trade, to prevent fraudulent and
manipulative acts and, in general, to protect investors and the public
interest.
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    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

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

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

    The Exchange neither received nor solicited written comments on the
proposal.

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

    The foregoing proposed rule change will take effect upon filing
with the Commission pursuant to Section 19(b)(3)(A)(i) of the Act \10\
and Rule 19b-4(f)(1) thereunder,\11\ because it constitutes a stated
policy, practice, or interpretation with respect to the meaning,
administration, or enforcement of an existing rule.
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    \10\ 15 U.S.C. 78s(b)(3)(A)(i).
    \11\ 17 CFR 240.19b-4(f)(1).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate 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 e-mail to<EMAIL_ADDRESS>Please include

File Number SR-CBOE-2006-29 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CBOE-2006-29. 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. Copies of such
filing also will be available for inspection and copying at the
principal office of the CBOE. 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-CBOE-2006-29 and should be submitted on or before April
28, 2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\12\
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    \12\ 17 CFR 200.30-3(a)(12).
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Nancy M. Morris,
Secretary.
[FR Doc. E6-5084 Filed 4-6-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: June 22, 2006 (Volume 71, Number 120)]
[Notices]
[Page 35888]
[DOCID:fr22jn06-67]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. ER06-944-001, et al.]

M-S-R Public Power Agency, et al.; Electric Rate and Corporate
Filings

June 16, 2006.
    The following filings have been made with the Commission. The
filings are listed in ascending order within each docket
classification.

1. City of Anaheim, California

[Docket No. ER06-944-001]

    Take notice that on May 18, 2006, City of Anaheim, California
tendered for filing a Certificate of Concurrence regarding the filing
by Public Service Company of New Mexico of the Amended and Restated San
Juan Project Participation Agreement.
    Comment Date: 5 p.m. Eastern Time on June 26, 2006.

2. Los Alamos County, New Mexico

[Docket No. ER06-944-001]

    Take notice that on May 23, 2006, Los Alamos County, New Mexico
tendered for filing a Certificate of Concurrence regarding the filing
by Public Service Company of New Mexico of the Amended and Restated San
Juan Project Participation Agreement.
    Comment Date: 5 p.m. Eastern Time on June 26, 2006.

3. M-S-R Public Power Agency, et al.

[Docket No. ER06-944-001]

    Take notice that on May 22, 2006, M-S-R Public power Agency,
tendered for filing a Certificate of Concurrence regarding the filing
by Public Service Company of New Mexico of the Amended and Restated San
Juan Project Participation Agreement.
    Comment Date: 5 p.m. Eastern Time on June 26, 2006.

4. Southern California Public Power Authority

[Docket No. ER06-944-001]

    Take notice that on June 1, 2006, Southern California Public Power
Authority tendered for filing a Certificate of Concurrence regarding
the filing by Public Service Company of New Mexico of the Amended and
Restated San Juan Project Participation Agreement.
    Comment Date: 5 p.m. Eastern Time on June 26, 2006.

Standard Paragraph

    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is 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>.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-9889 Filed 6-21-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 141 (Wednesday, July 23, 2014)]
[Notices]
[Pages 42867-42868]
[FR Doc No: 2014-17289]

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DEPARTMENT OF TRANSPORTATION

Connected Vehicle Reference Implementation Architecture Workshop;
Notice of Public Meeting

AGENCY: ITS Joint Program Office, Office of the Assistant Secretary for
Research and Technology, U.S. Department of Transportation.

ACTION: Notice.

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    The U.S. Department of Transportation (USDOT) Intelligent
Transportation System Joint Program Office (ITS JPO) will host a free
Connected Vehicle Reference Implementation Architecture (CVRIA) public
workshop meeting to present and seek input on the emerging results of
its Connected Vehicle interfaces and standards analysis. The public
meeting will take place August 20, 2014, 8:30 a.m.-5:00 p.m. PDT and
August 21, 2014, 8:30 a.m.-4:00 p.m. PDT at the Holiday Inn Golden
Gateway Hotel, 1500 Van Ness Ave, San Francisco, California 94109.
    To register for the CVRIA Workshop, please visit www.itsa.org/cvriaregistration.

    The results of an initial USDOT led analysis will be presented and
feedback will be sought during this public workshop. The agenda will
focus discussion on:
     Which interfaces have been identified as candidates for
standardization;
     The process used for the identification and prioritization
of these interfaces and associated information exchanges; and
     Results from the analysis which:
    [cir] Identify how standards that exist today may satisfy interface
and exchange needs or may require some level of modification; and
    [cir] Identify standards gaps that exist.
    It is expected that results from this analysis will inform USDOT
decision making regarding future support of specific standards
activities. The project is sponsored and led by the USDOT's ITS JPO as
part of the ITS Architecture and Standards Program and Systems
Engineering and Test Bed Program efforts.
    Updates will be available on the ITS Program Web site at: http://www.its.dot.gov/ under Press Room: Public Meetings and Events, and on
the ITS Standards Web site at: http://www.standards.its.dot.gov/DevelopmentActivities/CVReference.

SUPPLEMENTARY INFORMATION: As the results of the CVRIA, interface
analysis, and standardization efforts are expected to affect a wide
variety of public and private organizations, it is important that the
analyses incorporate, as appropriate, the needs and requirements of the
CV community. This workshop is an appropriate opportunity for external
stakeholders to engage in the standards discussion.
    For further information, please contact Carlos Alban,
Transportation Program Specialist, Intelligent Transportation Society
of America, 1100 New Jersey Ave. SE., Suite 850, Washington, DC 20003,
202-721-4223<EMAIL_ADDRESS>
    Issued in Washington, DC, on the 17th day of July 2014.
John Augustine,
Managing Director, ITS Joint Program Office.
[FR Doc. 2014-17289 Filed 7-22-14; 8:45 am]
BILLING CODE 4910-9X-P


      Clean Air Act Section 111(d) CO2 Reduction Compliance Pathways for the Pacific Northwest and Intermountain West States

                                    Angus Duncan
                      For the Natural Resources Defense Council
                                   March 31, 2014
                                     White Paper
      Clean Air Act Section 111(d) CO2 Reduction Compliance Pathways for the Pacific Northwest and Intermountain West States

      Abstract
      The paper describes the architecture of a regional electric grid extending across nine Intermountain West and Pacific Northwest states, characterized by coal-fired generation on the east and south serving loads across the region including states to the west with few or no coal facilities but with significant loads and energy efficiency opportunities.  This multi-state arrangement argues for an EPA Clean Air Act 111(d) strategy that calculates a Best System of Emissions Reduction (BSER) standard on a regional basis, then disaggregates and allocates reduction obligations to individual states and the emitting generating units therein.  Voluntary State-to-State agreements could then identify least-cost compliance strategies involving single or multiple shared facilities in one or more states. Such strategies might continue full plant operations at the most efficient plants in "producer" states, reduced output from or retirement of less efficient units, and replacement of lost generation with a least-cost portfolio of low-carbon resources in both "producer" and "consumer" states.  The desired outcome is overall regional "system" emissions that are in compliance with an EPA-set emissions standard for the region overall.

Problem Statement
      The Obama Administration proposes to regulate greenhouse gas (GHG) emissions from existing power plants with the objective of reducing those emissions over time consistent with the nation achieving an overall GHG emissions reduction goal of 17% below 2005 levels by 2020.  The Environmental Protection Agency (EPA) plans to use Section 111(d) of the Clean Air Act (CAA) to develop a rule by mid-2015, and require state compliance plans one year later.  Those plans will either adopt EPA-issued "best system of emissions reduction" (BSER) guidelines, or gain EPA approval of State plans as resulting in equal or greater reductions.
	EPA is likely to afford substantial flexibility to States and plant owners in developing compliance plans, including allowing a "systems-based" approach under which emissions from two or more plants can be aggregated and averaged across the system counted for compliance.  EPA is also considering how new, low-carbon supply- and demand-side replacement resources can count toward compliance [to the extent they displace real emissions within the system subject to compliance requirements].
	Interstate electricity sales will complicate this regulatory structure.  It is not clear what compliance pathways will be workable for states whose utilities import significant quantities of power from coal-fired generation; and for states containing significant coal-fired generation that export to loads in other states.  Reconciling state-by-state compliance plans with this utility architecture  -  which is especially typical in the Pacific Northwest and Intermountain West states  -  will be challenging.
      At its most basic, the task is simply stated:
            (1) What emissions reduction trajectory for existing thermal power plants serving this region is consistent with the requirements of the Clean Air Act (including cost consequences); and,
            (2) How will the costs of compliance be allocated among plant owners and power consumers?
      EPA can perform the calculations to arrive at the first; and utility regulators have tools to achieve the second (not without some wrangling), including in circumstances where plants and loads are distributed among two or more states.  An EPA 111(d) rulemaking process could choose to stop here.
      The harder, third task is not a legal requirement, but it is essential to undertake if the outcome, for the the region, is the appropriate emissions reduction that is also politically achievable:
            (3) What's a least-cost compliance pathway for customers of affected utilities, and for affected states facing community, employment and tax effects of potential plant cutbacks or closures?
	A lower cost pathway would rely on wider portfolio of energy efficiency, renewable resources and integrating resources outside the plant fenceline as replacement resources for reduced or terminated coal-fired generation.  The compliance role for such resources is to replace such generation and its associated emissions.
	EPA's summer 2014 draft rule needs to be written with the flexibility to allow such least-cost pathways, and with a framework that encourages states and utilities to devise and propose them.
	While the CAA does not contain a direct legal obligation to seek a least cost path, there are reasons to do so that should be compelling to all parties.  The first reason is that EPA is obliged to consider cost when setting a performance standard (in effect, the benefits of the regulation must outweigh the costs imposed by the regulation; see "111(d) Regulatory Process," below).  That test is expansive, allowing EPA to include both immediate and downstream societal costs and benefits, not just the transactional costs to the plant owners and their customers.  But it can mean only minor emissions reductions are obtained, especially from technical fixes at the power plants themselves.  In contrast, EPA guidelines that  -  by virtue of their wider choice of allowable compliance paths  -  result in lower costs to plant owners and their power customers, are more likely to invite cooperative efforts among producer states, consumer states and utilities to devise cooperative compliance strategies.
      The optimum outcome, toward which EPA and those supporting an effective rule must bend their efforts, is the one that achieves material emissions reductions at costs that stay carefully within CAA limitations.

The Pacific Northwest / Intermountain West Electricity System
	This challenge is especially complicated in the Pacific Northwest and Intermountain West, where a substantial part of the load lies along the I-5 corridor (the Seattle and Portland metro areas), while most of the coal-fired generation imported to serve these loads is located in Montana, Wyoming Nevada and Utah; and most of this generation in at least Montana and Wyoming is committed to out-of-state loads.  The respective coal-generation capacities are:

	Montana	2717 MW
	Nevada	  521 MW
	Oregon	  585 MW
	Utah		5204 MW
	Washington	1460 MW
	Wyoming	4627 MW
	Arizona	414 MW

      This difference becomes greater still in 2020 (when coal combustion ends at Boardman and one Centralia plant) and 2025 (the other Centralia plant is retired).  Neither Oregon nor Washington will then have any coal combustion remaining within their borders; and Idaho already is coal-free.   Yet all three will remain in significant degree dependent on imported coal generation to meet loads.
	The largest share of the remaining coal plants in the region is owned by PacifiCorp (PAC), but substantial shares in certain plants are divided up among multiple owners and serve loads in multiple states, complicating decision-making.  The plants also have different useful life designations.  All regional coal plants 40 years and older belong to PAC.  The selection of a baseline from which coal emissions reductions are measured, and the level of reductions required in each state under the rule, will affect plant owners differently, but PAC stands to be most challenged because of the makeup and age of its fleet, and because it operates (generates and serves loads) in multiple states.
	While this discussion centers on the coal assets of investor-owned PNW/IW utilities, there are also some 130 consumer-owned utilities in the PNW and more in the IW.  Most COU's are served from their own resources or from the federal hydropower system through the Bonneville Power Administration or Western Area Power Authority, and are unlikely to be significantly affected by an EPA carbon rule.  In addition there are both merchant coal plants (e.g., Centralia) and coal units owned and operated by other utilities but delivering power into the PNW grid, which will be accounted for in an EPA rulemaking.  To make this already complex subject slightly less complicated, this paper excludes these facilities.  State air regulators will need to deal with them however, and it is possible they could be wrapped into a system compliance strategy to collective benefit.
	Planning is further complicated by other Clean Air Act regulatory proceedings underway to which different plants have different exposures; and by price pressure from growing new sources of natural gas and declining cost curves for renewable technologies.
	Much of the region's long-distance transmission mileage is dedicated to east-to-west movement of power from these coal plants, and the economics of this transmission is substantially intertwined with the destinies of these facilities as well as with any replacement resource strategies for displaced coal generation.  How interstate sales and deliveries of energy are treated with respect to emissions liabilities will be critical to the calculations for each state and utility involved in these transactions, and their effects on utility determination of least-cost replacement resources, future energy contracts, and transmission investments and management of existing assets.

Dramatis Personae
      	The Power Plants:  There are thirty coal-fired power units at fourteen plant sites across eight states, with a combined nameplate capacity of 15,528 megawatts (see attached table), in part or fully committed to serve loads in the Intermountain West and Pacific Northwest.  After coal combustion ends at the Boardman, Centralia and Carbon facilities, and another plant (Naughton 3) is converted to gas combustion, some 12,968 megawatts of coal-fired generation will, under current plans, continue to operate.  Eight units, all owned by PAC and comprising almost 1400 megawatts , are now 40 years or older and relatively inefficient (with heat rates well above 11,000 BTU/kWh).  Most of the region's older units will require additional pollution controls to comply with the CAA before CO2 emissions come into play, but the extent of their obligations vary with each plant.
      	The Utilities:  Two-thirds of the residual (post-2025) regional coal capacity is owned and operated by PAC, making it by far the largest owner and operator of these facilities.  Puget Sound Energy (PSE) follows with around 8%.  Portland General Electric (PGE), Avista, Idaho Power, Northwestern, Sierra Pacific and PPL share ownership in the balance of the aggregated plant capacity.  Some utility service territories are wholly contained within a state (e.g., PSE, PGE) while others may have territories and customers across two or more states (e.g., PAC; Avista; Idaho Power).
      	The Air Regulators:  EPA regulates emissions at power plants, generally operating through State air and water quality regulatory agencies and requiring State rules to be equal to or more rigorous than EPA guidelines.  Prevailing federal regulation for these plants include: ozone, SO2/Nox, water, particulate, ash waste, mercury, and the air transport rule (for downwind effects of plant emissions).  Depending on when plants were built or underwent major modification, and whether an owner has systematically installed emissions control systems or was able to defer certain retrofits under "new source" exemptions, different rules will apply differently.  EPA either approves state compliance plans or, if necessary, will develop and impose a federal compliance plan.
      	The Utility Regulators:  Each State has a public utility regulatory commission that authorizes rates of return, customer tariffs, and terms of recovery of capital investment for each investor-owned utility with an assigned service territory.  These commissions also review the resource planning and capital investments made by their regulated utilities, including investments made to comply with Clean Air Act and other regulatory requirements. Utility regulators have no air quality regulatory authority but must address cost allocation resulting from rules set by air regulators, so they are likely to be closely consulted on cost implications of different emissions regulatory approaches.  They oversee cost recovery on utility capital investments; and measurement of energy efficiency gains, a critical task in the process of capturing least-cost emissons reductions.  They also oversee utility Integrated Resource Planning (IRP's) where each utility will need to describe its 111(d) compliance strategy and the effects on its generating facilities and costs.  PacifiCorp has customers in six states, making for an especially challenging utility regulatory task as each regulatory body has authority to make decisions independent of the other five.  The states have over time developed tools for allocating PacifiCorp costs among them, although each may allow or disallow recovery of different costs.  The formulas demand regular review among the utility and the six commissions, to work through disagreements that may advantage or disadvantage one state and the customers therein.  The good news is that much of the necessary allocation methodology and mechanisms exists; the challenge is that allocating the costs and emissions reduction responsibilities from 111(d) compliance can be expected to place new stresses on these arrangements.

The 111(d) Regulatory Process
There are extensive writeups (and differing interpretations) of the contents and meaning of the CAA Section 111(d) and how it may be applied to GHG emissions from existing power plants, which will not be repeated here.  But a brief introduction to 111(d) will serve to delineate some of the critical choices facing utilities, regulators and citizens of the Pacific Northwest and Intermountain West.  From a September 2013 EPA memorandum on the subject (critical terms underlined):
      "[President Obama's June 25, 2013] Memorandum directs EPA to issue proposed carbon pollution standards and guidelines, as appropriate, for modified and existing power plants by no later than June 1, 2014, and to issue final standards and guidelines, as appropriate, by no later than June 1, 2015. In addition, it directs EPA to include a requirement for state submittal of the implementation plans required under section 111(d) of the Clean Air Act by no later than June 1, 2016.
      Under section 111(d) EPA issues guidelines for states to use in developing plans implementing standards of performance for the affected sources.
      "Section 111(d) of the Clean Air Act is broad and allows for collaboration between EPA and states to address pollutants that endanger the public health and welfare. Moving forward, there are different options available for addressing carbon pollution from existing power plants such as a "source-based approach" and a "system-based approach." A source based approach evaluates emission reduction measures that could be taken directly at the affected sources -- in this case, the power plants. A system-based approach evaluates a broader portfolio of measures including those that could be taken beyond the affected sources but still reduce emissions at the source.
      "EPA believes that its guidelines should identify for sources and states the required level(s) of performance prior to plan submittal. Under section 111:
           "Standard of performance" means "a standard for emissions of air pollutants which reflects the degree of emission limitation achievable through the application of the best system of emission reduction which (taking into account the cost of achieving such reduction and any nonair quality health and environmental impact and energy requirements) the Administrator determines has been adequately demonstrated."
      "There are a number of ways to reduce CO2 emissions from existing power plants that might be included in an evaluation of the best system of emission reduction (BSER), including:
*             Onsite actions at individual affected section 111(d) sources.
      o                   Supply-side energy efficiency improvements ("heat rate improvements").
      o                   Fuel switching or co-firing of lower-carbon fuel.
*             Shifts in electricity generation among sources regulated under section 111(d) (e.g., shifts
            from higher- to lower-emitting affected fossil units).
*             Offsite actions that reduce or avoid emissions at affected section 111(d) sources.
      o                   Shifts from fossil generation to non-emitting generation.
      o                   Reduction in fossil generation due to increases in end-use energy efficiency and demand-side management."

Critical Terms for a Regional Compliance Strategy
How the following terms are defined in practice by EPA will be critical to the design of an effective regional compliance strategy.  It should be understood that the definitions are likely to be the subject of legal actions by both regulated parties and other stakeholders.
      	"rate-based / mass-based emissions values":  There are indications EPA is likely to propose a rate-based standard  -  pollutant quantity emitted by a facility per unit of output (lbs/MWh)  -  for application in each state, and apply this at the point of plant emissions.    On a system (state or utility) basis, it is possible for a rate-based value to be converted to a mass-based value (total lbs. GHG emissions within a state, or from a utility system of plants) allocated among plants or accountable parties.  EPA would need to determine the mass-based reduction amounts, then convert back to a rate-based value to compare outcomes and ensure compliance.
      "source-based approach / system-based approach":  A source-based approach is generally understood as a strategy that controls emissions at a single source, e.g., a single power plant.  While there are often efficiencies that can reduce GHG emissions at the margin, in many cases they may be of limited effectiveness or more costly than available alternatives.  A source-based approach may struggle to bring significant reductions at costs consistent with EPA guidelines.  A system-based approach, on the other hand, may permit a state or utility to aggregate multiple power plants (e.g., all power plants within a state; all power plants within a utility across a state, or across multiple states) within a plan, backing off power production (and emissions) at some plants and averaging these with other plants that continue to operate at higher capacity factors.  A system-based approach might permit a multi-state emissions management structure like an ISO, or like RGGI, to aggregate and average emissions across multiple plants owned by multiple operators.  The advantage of a system-based approach, of course, is that by being selective about which plant operations will be reduced and replaced by lower-carbon options, and which may continue to be operated at higher capacities, facilities can be managed to optimize power operations for CAA compliance at the least cost.
      "Standard of Performance; Best System of Emissions Reduction (BSER)":  EPA is expected to establish a Standard of Performance either for individual plants (source-based) or an aggregation of plants (system-based).  In either case it has an obligation to identify a BSER and issue guidelines for State implementation of the Standard that employs the BSER or another approach that yields equal or better emissions outcomes.  Given the complex and interacting architecture of the power system, it is arguable that a BSER could require a systems-based approach, since a source-based approach is highly likely to result in substantially higher emissions and costs both.
      "State Implementation Plan":  EPA is expected to issue its Standard of Performance and compliance guidelines for States in mid-2015.  States will develop implementation plans for submission to EPA by mid-2016.  For states that fail to submit plans or fail to get them approved, EPA will develop a Federal Implementation Plan and require the state to adopt and execute it.  For a systems-based approach that involves more than one state, it is likely that EPA will require approved implementation plans from all involved states.

A Systems-Based Strategy for the Pacific Northwest/Intermountain West
	Given the dispersed nature of the regional electricity system, and the geographical separation of generation and loads across nine states, EPA's rule-writing options are complicated.  While generation and load are spread across what is truly a regional electrical system, there is no regional transmission authority or independent system operator (e.g., CAISO or PJM).  A region-wide, multi-state pact like a RGGI is unlikely given the limited time for developing state compliance submissions to EPA, and the highly divergent views among the PNW and IW states on the threshold question whether GHG reductions are even necessary.
	Still, options exist for a least-cost system-based approach that the states and utilities may see in their best interests, albeit for different reasons.
	When devising a least-cost reduction strategy, bear in mind that there are three categories of costs to be evaluated:
   1.          Cost of emissions reduction retrofits at plants subject to compliance, if proposed.  These may be as costly as carbon-capture-and-storage (CCS), or as relatively modest as efficiency improvements in plant and transmission operations.
   2.          Cost of replacement resource for the reduced or terminated output of a power plant subject to the regulation.  Resources may include generation (e.g.  wind or other renewable resources, baseload gas turbine, peaking/integrating gas turbine), storage (e.g., utility-scale batteries, underground compressed air storage), and demand-side resources (e.g., energy efficiency, and demand-response integrating resources such as electric vehicle batteries).  Generally, energy efficiency has been the region's lowest cost resource, but it is unlikely to be the only resource selected to replace coal combustion.  Capturing energy efficiency in one state and using it to reduce plant operations and emissions in another state will require some deft agreement-writing and EPA oversight flexibility, or the development of a tradable allowance system.
   3.          Cost to communities of impacts attributable to reduction in coal plant operations or plant shutdown.  These may include lost jobs (and related multiplier effects on local businesses), and lost tax revenues.
      Of course there are real and potential offsetting benefits that may be realized under a well-designed compliance approach.  States that are net importers of coal-generated power, like ID, OR and WA, should see a reduction in dollars exported out of state to pay for those imports (e.g., over $300mm annually in fuel and operations costs alone for OR alone).  Substituting efficiency and renewable generating resources for coal generation will result in new jobs, additional environmental benefits, potentially lower electricity costs long-term (as hydropower has delivered over the last century) and an accelerated transition to the more flexible and distributed power (and electric vehicle transportation) systems of the future.
      There are many possible combinations of state compliance plans and utility actions, within a single state's boundaries or involving more than one state.  The most often discussed may be summarized as follows:
      1. Plant-by-plant emissions reduction:  EPA may simply begin by allocating emissions reductions (or maximum allowed emissions) for each power plant subject to regulation.  Enforcement at the plant would be direct and straightforward, but limited options for such direct reductions are likely to result in higher costs and therefore lower reductions.

      2. State-by-State emissions reduction:  For each state, EPA could aggregate rate-based, plant-specific reductions, convert to a mass-based value, and allow (or require) a State to propose a strategy for achieving the indicated reductions.  The State could then develop with in-state plant owners a strategy for allocating reductions among the plants according to a least-cost or other methodology (that includes replacement resources and their associated emissions).  .For the PNW, this approach leaves unclear the relationships between producer and consumer states.  On the one hand, customers in consumer states would have an obligation to pay for replacement costs, but limited access to the emissions reduction levels and the resource replacement assumptions used by the air regulators in the producer states as the basis for setting emissions reduction levels and compliance determinations.  On the other hand, the producer states may have difficulty accessing lower cost efficiency resources for a replacement strategy since loads (and thus efficiency opportunities) would be in another state not bound by EPA to perform.  Together, a producer state and a consumer state can jointly shape a single least-cost strategy to which each contributes, and for which the range and extent of compliance options is wider than would be available to either alone.

      3. Regional Agreement:  A regional agreement for the PNW states might be similar to RGGI.  It could involve power plants and customer loads across the nine state area.  It could convert EPA rate-based values  -  calculated assuming, as a BSER, an efficient regional system acting to capture maximum obtainable reductions -- to an aggregate regional mass-based value.  The States could then use an allocation agreement or allowance system to assign reduction (and resource replacement) responsibilities.  For compliance, reductions would be totaled and disaggregated among the states, who would then report separately to EPA.  So long as the total reductions matched EPA's requirements, the states would be in compliance.  Issues with this approach include:  the short time period between when an EPA rule is published and when state compliance plans need to be in place, including any such regional arrangements; institutional and political differences among the nine states; absence of a regional ISO or other institution that could help manage transactions.

      4. Bilateral or Multilateral State-to-State Agreements:  An alternative to trying to assemble a regional approach up front, that could capture much of the least-cost value of collective regional action, might be a series of bilateral State-to State agreements developed around a single plant or multi-plant facility.  As above, EPA would calculate a BSER value for the region, develop plant-specific rate-based values, and provide the methodology for converting to plant- or unit-specific mass-based values.  Regulators in the producer and consumer states, together with the unit's owner, could negotiate a strategy for that unit's compliance that might include both complementary arrangements with other plants and owners and/or reductions in plant operations coupled with development of lower-carbon replacement resources.  Such bilateral agreements could work off a common model agreement that is replicable state to state, and that subsequently could be rolled up into more comprehensive multi-plant agreements (and, logically, a voluntary regional agreement over time).

Example:  A PNW/IW Multi-lateral Compliance Agreement
      For illustrative purposes, the following describes how one such multi-lateral arrangement might be structured to involve three parties collectively seeking to devise a least cost compliance strategy:  (a) a "producer state" with 111(d) compliance responsibilities (e.g., MT; WY); (b) a "consumer state" (e.g., OR, WA); and, (c) a utility with a power plant in the first state and much of its load in the second.  Thus . . .
      	Step One:  After consultation  -  and optimally -- EPA develops a BSER based on obtaining emissions reductions from the PNW utility system considered as a single system involving nine states, then disaggregates the required reductions by state and plant unit.  Some states are primarily consumer states (OR; WA; ID), some primarily producer states (MT;WY), and some (UT) mixed.   This analysis assumes that, once a BSER is established, it is to all parties' advantage to seek a least-cost compliance solution and that costs can be allocated equitably within the system.  EPA would establish how reductions would be measured and verified.  EPA would then invite but not obligate states and utilities to find cooperative means to achieve the reductions, develop replacement resource plans, and allocate costs.  The states and utilities could use the system modeled by EPA in setting the trajectory, or select an alternative strategy  -  including options that traded emissions reductions among utilities and within or across state lines  -  so long as the overall regional reduction trajectory is realized.
      	Step Two  -  Example A:  Two states enter into a bilateral agreement that involves a producer state and a consumer state, linking the plant(s) and loads of a utility that owns and operates plants in the producer state.  Thus, WA and MT enter into an agreement, to which Puget Sound Energy (PSE) is party as the implementing utility, by which PSE's share of allowable emissions at the Colstrip powerplant (four generating units) is set consistent with the EPA rule (and proportionate to PSE's share of the required Colstrip reduction).  The lost resource is replaced with a least-cost combination of load-center energy efficiency measures (in WA, where the PSE load is), plus wind energy and wind-integrating resurces/storage in WA, MT or elsewhere.  If other utilities that also have shares of the Colstrip units also propose to reduce plant output (or close one or more units of the facility), Montana may seek to negotiate agreements with all involved states and utilities to ensure that a substantial share of the replacement resource is sited in Montana to offset employment and tax revenue losses, and resulting community impacts, as well as use otherwise-orphaned east-to-west transmission assets.
      	Step Two  -  Example B:  For a utility such as PacifiCorp (PAC), with multiple plants across two or more states, a system least-cost pathway may involve backing down or shutting down the least efficient plants and continuing to operate the most efficient, across state boundaries.  If this results in disproportionate reductions in one state (e.g., the least efficient plants are disproportionately in one state), an emissions liability sharing agreement could be negotiated among two producer states (MT; WY) and, a consumer state (OR), allocating costs across utility (PAC) customers, that supports a least-cost resource replacement  strategy.
      Step Three:  Compliance plans, emissions reduction allocations and cost allocations are reported by each plant owner (or partial owner) to its state air and utility regulators.  State air regulators validate the emissions reductions achieved (or proposed to be achieved) in each state, and report to EPA which reaggregates and compares to its adopted trajectory (BSER.  Utility regulators would review and acknowledge the proposed replacement resource plans consistent with existing practices.   Cost allocations among the states would be handled, as now, in separate proceedings.
In each of these cases, EPA has calculated system emissions reductions across a system, then disaggregated these emissions reductions and allocated them by state. The states and utilities are then enabled to find least-cost compliance solutions that permit and encourage, but do not require, re-aggregation into "systems" through a series of manageably-sized, mostly trilateral agreements (two states, one utility-owned power plant) that allow costs of resource replacement and local impacts to be negotiated among the direct parties.
   The three tasks set out at the beginning of this paper have been addressed:
*       Task 1, setting the BSER emission outcomes, by EPA;
*       Task 2, identifying and negotiating a system-based least-cost compliance strategy;  and,
*       Task 3, allocating compliance costs among states and utility customers through a series of manageably-scaled agreements ("manageable" in comparison to negotiating a single regional agreement).
	If the utilities and states fail in any case to arrive at an agreement for any one plant, EPA has the authority and obligation to devise a Federal Implementation Plan to address this failure in the state where the plant is located.
	Two or more such agreements could subsequently be rolled up into a larger PNW/IW regional operating agreement if the parties were to identify benefits from such a consolidation.  Alternately a regional or westwide voluntary reduction "credits" trading mechanism might be deployed to widen the market for least-cost emissions reductions among plants and states; or states might elect to affiliate with California's AB 32 trading system or the Northeast states RGGI trading mechanism.

Attachment A:  Clean Air Act Section 111(d)
(d)	Standards of performance for existing sources; remaining useful life of source
      (1) The Administrator shall prescribe regulations which shall establish a procedure similar to that provided by section 7410 of this title under which each State shall submit to the Administrator a plan which
      (A) establishes standards of performance for any existing source for any air pollutant
                  (i) for which air quality criteria have not been issued or which is not included on a list published under section 7408(a) of this title or emitted from a source category which is regulated under section 7412 of this title but
                  (ii) to whch a standard of performance under this section would apply if such an existing source were a new source, and
            (B) provides for the implementation and enforcement of such standards of performance.  Regulations of the Administrator under this paragraph shall permit the State in applying a standard of performance to any particular source under a plan submitted under this paragraph to take into consideration, among other factors, the remaining useful life of the existing source to which such standard applies.
	(2) The Administrator shall have the same authority --

            (A) to prescribe a plan for a State in cases where the State fails to submit a satisfactory plan as he would have under section 7410 (c) of this title in the case of failure to submit an implementation plan, and

            (B) to enforce the provisions of such plan in cases where the State fails to enforce them as he would have under sections 7413 and 7414 of this title with respect to an implementation plan.

      In promulgating a standard of performance under a plan prescribed under this paragraph, the Administrator shall take into consideration, among other factors, remaining useful lives of the sources in the category of sources to which such standard applies.

Attachment B:  PNW Regional Coal Plants

From "The War on Coal" BPA memo January 25, 2011; note that average age is calculated to 2011, and that emissions control data are out of date.  These are units that deliver from Intermountain states to utility loads in the four Northwest states; other coal-fired generation may serve local loads .  Notes: (a) the 521 MW North Valmy facility in Nevada, not in this table, is 50% owned by Idaho Power which imports the power to its Idaho loads; (b)  Idaho Power also owns one-third of the Jim Bridger units and 10% of Boardman; (c) PGE now owns 80% of Boardman, not the 100% shown in the table.

Attachment C:  Ten Criteria for EPA 111(d) Existing Plant Carbon Rule
   * Should collectively reduce emissions by more than 25-30 percent below current levels (2012) by 2020 (this is equivalent to 35-40% below 2005 levels)* and make further reductions thereafter.

   * Require that emission reductions in state plans must be measurable, verifiable and enforceable.

   * Should require that state plans include enforceable requirements for each individual covered source that collectively achieve the state target.

   * Should cover all fossil fuel sources that generate electricity for the grid and are currently required to report their emissions.

   * Should recognize for compliance all measures that quantifiably reduce emissions from the covered sources, including energy efficiency and renewable energy.

   * The stringency of the performance standards set in EPA's guideline must reflect the full set of measures that can be used to comply.

   * Should provide for approval of alternative state plans if they result in total carbon dioxide emissions from the power sector that are no higher than allowed by the performance standard in the guideline.

   * States may adopt plans that are more stringent than the EPA guideline.

   * So that states would have adequate notice of what the federal plan would be, EPA should propose a standby Federal Plan by June 2015 and promulgate it by June 2016 for states that choose not to submit an acceptable State Plan by that deadline.

   * Should be reviewed and updated at least every eight years along with the new source standard.

   * 35-40% below 2005 levels = 25-30% below 2012 emission levels = 500-600 million metric tons below 2012 levels = 850-950 million metric tons below 2005 levels.


[Federal Register Volume 87, Number 23 (Thursday, February 3, 2022)]
[Notices]
[Page 6186]
[FR Doc No: 2022-02224]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3569-EM; Docket ID FEMA-2022-0001]

Mississippi; Amendment No. 4 to Notice of an Emergency
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of an emergency declaration for
the State of Mississippi (FEMA-3569-EM), dated August 28, 2021, and
related determinations.

DATES: This change occurred on January 14, 2022.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, James R.
Stephenson, of FEMA is appointed to act as the Federal Coordinating
Officer for this disaster.
    This action terminates the appointment of Brett H. Howard as
Federal Coordinating Officer for this disaster.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2022-02224 Filed 2-2-22; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 85, Number 126 (Tuesday, June 30, 2020)]
[Notices]
[Pages 39193-39194]
[FR Doc No: 2020-14085]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1518]

Development of Anti-Infective Drug Products for the Pediatric
Population; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Development of Anti-Infective Drug Products for the Pediatric
Population.'' The purpose of this guidance is to provide general
recommendations on the development of anti-infective drug products for
pediatric patients. The guidance addresses initiation of pediatric
clinical studies, enrollment strategies, extrapolation of efficacy, and
other considerations to help facilitate pediatric anti-infective drug
product development.

DATES: Submit either electronic or written comments on the draft
guidance by August 31, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a

third party may not wish to be posted, such as medical information,
your or anyone else's Social Security number, or confidential business
information, such as a manufacturing process. Please note that if you
include your name, contact information, or other information that
identifies you in the body of your comments, that information will be
posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-D-1518 for ``Development of Anti-Infective Drug Products for
the Pediatric Population.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or the
Office of Communication, Outreach, and Development, Center for
Biologics Evaluation and Research, 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 that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Hiwot Hiruy, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6395, Silver Spring, MD 20993-0002, 240-
402-0872; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Development of Anti-Infective Drug Products for the
Pediatric Population.'' The purpose of this guidance is to provide
general recommendations on the development of anti-infective drug
products for pediatric patients. The guidance addresses initiation of
pediatric clinical trials, enrollment strategies, extrapolation of
efficacy, and other considerations to help facilitate pediatric anti-
infective drug development.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Development
of Anti-Infective Drug Products for the Pediatric Population.'' It does
not establish any rights for any person and is not binding on FDA or
the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved FDA collections
of information. 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. 3501-3521). The collections of
information in 21 CFR parts 50, 312, and 314, and in 21 CFR 201.56 and
201.57 have been approved under OMB control numbers 0910-0755, 0910-
0014, 0910-0001, and 0910-0572, respectively.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.

    Dated: June 25, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14085 Filed 6-29-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: July 18, 2007 (Volume 72, Number 137)]
[Notices]
[Page 39395]
[DOCID:fr18jy07-47]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 [Docket No. RP07-502-001]

Texas Eastern Transmission, LP; Notice of Compliance Filing

July 10, 2007.
    Take notice that on July 5, 2007, Texas Eastern Transmission, LP
(Texas Eastern) tendered for filing as part of its FERC Gas Tariff,
Seventh Revised Volume No. 1, substitute revised tariff sheets, as
listed on Appendix B to the filing, to become effective August 1, 2007.
    Texas Eastern states that these substitute revised tariff sheets
are being filed in substitution for those corresponding tariff sheets
filed on June 29, 2007 as a part of Texas Eastern's semi-annual
Electric Power Cost tracking filing to be effective August 1, 2007, in
order to correct an inadvertency which occurred in the preparation of
the originally filed tariff sheets.
    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing will be considered by the
Commission in determining the appropriate action to be taken, but will
not serve to make protestants parties to the proceeding. Such protests
must be filed in accordance with the provisions of Section 154.210 of
the Commission's regulations (18 CFR 154.210). Anyone filing a protest
must serve a copy of that document on all the parties to the
proceeding.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons

unable to file electronically should submit an original and 14 copies
of the protest to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-13865 Filed 7-17-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 135 (Monday, July 15, 2013)]
[Notices]
[Pages 42135-42138]
[FR Doc No: 2013-16820]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-69952; File No. SR-NYSEMKT-2013-61]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and
Immediate Effectiveness of Proposed Rule Change Amending NYSE MKT Rules
504 and 509--Equities With Respect to DMM Quoting Requirements
Applicable to Nasdaq Stock Market Securities Traded on the Exchange
Pursuant to A Grant of Unlisted Trading Privileges

July 9, 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 26, 2013, NYSE MKT LLC (the ``Exchange'' or ``NYSE MKT'')
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 Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend NYSE MKT Rules 504 and 509--Equities
with respect to DMM quoting requirements applicable to Nasdaq Stock
Market (``Nasdaq'') securities traded on the Exchange pursuant to a
grant of unlisted trading privileges. The text of the proposed rule
change is available on the Exchange's Web site at www.nyse.com, at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

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

    In its filing with the Commission, the 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 those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

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

1. Purpose
    The Exchange proposes to amend NYSE MKT Rules 504 and 509--Equities
with respect to DMM quoting requirements applicable to Nasdaq
securities traded on the Exchange pursuant to a grant of unlisted
trading privileges. NYSE MKT Rules 500-525--Equities, as a pilot
program, govern the trading of any Nasdaq-listed security on the
Exchange pursuant to unlisted trading privileges (``UTP Pilot
Program'').\3\ The UTP Pilot Program includes any security listed on
Nasdaq that (i) is designated as an ``eligible security'' under the
Joint Self-Regulatory Organization Plan Governing the Collection,
Consolidation and Dissemination of Quotation and Transaction
Information for Nasdaq-Listed Securities Traded on Exchanges on an
Unlisted Trading Privilege Basis, as amended (``UTP Plan''),\4\ and
(ii) has been admitted to dealings on the Exchange pursuant to a grant
of unlisted trading privileges in accordance with Section 12(f) of the
Act \5\ (collectively, ``Nasdaq Securities'').\6\
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    \3\ The UTP Pilot Program is currently scheduled to expire on
the earlier of Commission approval to make such pilot permanent or
January 31, 2014. See Securities Exchange Act Release No. 69814
(June 20, 2013) (SR-NYSEMKT-2013-53) (Notice of Filing and Immediate
Effectiveness of Proposed Rule Change Amending NYSE MKT Rule 500--
Equities to Extend the Operation of the Pilot Program that Allows
Nasdaq Stock Market (``Nasdaq'') Securities to be Traded on the
Exchange Pursuant to a Grant of Unlisted Trading Privileges). See
also Securities Exchange Act Release No. 62479 (July 9, 2010), 75 FR
41264 (July 15, 2010) (SR-NYSEAmex-2010-31). See also Securities
Exchange Act Release Nos. 62857 (September 7, 2010), 75 FR 55837
(September 14, 2010) (SR-NYSEAmex-2010-89); 63601 (December 22,
2010), 75 FR 82117 (December 29, 2010) (SR-NYSEAmex-2010-124); 64746
(June 24, 2011), 76 FR 38446 (June 30, 2011) (SR-NYSEAmex-2011-45);
66040 (December 23, 2011), 76 FR 82324 (December 30, 2011) (SR-
NYSEAmex-2011-104); 67497 (July 25, 2012), 77 FR 45404 (July 31,
2012) (SR-NYSEMKT-2012-25); and 68561 (January 2, 2013), 78 FR 1290
(January 8, 2013) (SR-NYSEMKT-2012-86).
    \4\ See Securities Exchange Act Release No. 58863 (October 27,
2008), 73 FR 65417 (November 3, 2008) (File No. S7-24-89). The
Exchange's predecessor, the American Stock Exchange LLC, joined the
UTP Plan in 2001. See Securities Exchange Act Release No. 55647
(April 19, 2007), 72 FR 20891 (April 26, 2007) (S7-24-89). In March
2009, the Exchange changed its name to NYSE Amex LLC, and in May
2012, the Exchange subsequently changed its name to NYSE MKT LLC.
See Securities Exchange Act Release Nos. 59575 (March 13, 2009), 74
FR 11803 (March 19, 2009) (SR-NYSEALTR-2009-24) and 67037 (May 21,
2012), 77 FR 31415 (May 25, 2012 (SR-NYSE Amex-2012-32),
    \5\ 15 U.S.C. 781.
    \6\ ``Nasdaq Securities'' is included within the definition of
``security'' as that term is used in the NYSE MKT Rules--Equities.
See NYSE MKT Rule 3--Equities. In accordance with this definition,
Nasdaq Securities are admitted to dealings on the Exchange on an
``issued,'' ``when issued,'' or ``when distributed'' basis. See NYSE
MKT Rule 501--Equities.
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    Designated Market Maker units (``DMM units'') \7\ registered in one
or more Nasdaq Securities must comply with all ``DMM rules,'' as
defined in NYSE MKT Rule 98--Equities,\8\ and the

obligations and benefits of DMMs in Nasdaq Securities closely track
those applicable to DMMs in Exchange-listed equities, subject to
certain modifications enumerated in NYSE MKT Rule 509--Equities. As is
the case with DMMs in Exchange-listed equities, a DMM unit in Nasdaq
Securities has an affirmative obligation to engage in a course of
dealings for its own account to assist in the maintenance of a fair and
orderly market insofar as reasonably practicable, including maintaining
price continuity with reasonable depth and quoting and trading with
reference to Exchange-provided Depth Guidelines.\9\ In addition, a DMM
in Nasdaq Securities is required to facilitate trading when a ``gap''
quote procedure is being used and when a manual block trade is being
executed.\10\
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    \7\ See NYSE MKT Rule 103--Equities--Registration and Capital
Requirements of DMMs and DMM Units. ``DMM unit'' means any member
organization, aggregation unit within a member organization, or
division or department within an integrated proprietary aggregation
unit of a member organization that (i) has been approved by NYSE
Regulation pursuant to section (c) of this Rule 103, (ii) is
eligible for allocations under NYSE MKT Rule 103B--Equities as a DMM
unit in a security listed or traded on the Exchange, and (iii) has
met all registration and qualification requirements for DMM units
assigned to such unit. See NYSE MKT Rule 98(b)(2)--Equities.
    \8\ ``DMM rules'' means any rules that govern DMM conduct or
trading. See NYSE MKT Rule 98(b)(5)--Equities.
    \9\ See NYSE MKT Rule 104(a), (f)(ii) and (f)(iii)--Equities.
    \10\ See NYSE MKT Rule 104(a)(5)--Equities.
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    The obligations of DMM units registered to trade Nasdaq Securities
are, however, slightly different from those that apply to DMMs in
Exchange-listed securities. First, the rules that apply to trading in
Nasdaq Securities on the Exchange do not provide for opening and
closing auctions in Nasdaq Securities, so DMMs in Nasdaq Securities are
not responsible for facilitating openings and closings, as DMMs in
listed equities are. Second, NYSE MKT Rule 509(a)(1)--Equities states
that in lieu of NYSE MKT Rule 104(a)(1)(A)--Equities, with respect to
maintaining a continuous two-sided quote with reasonable size, a DMM
unit registered in Nasdaq Securities must maintain a quote at the
National Best Bid or Offer (``inside'') in each assigned Nasdaq
Security an average of at least 10% of the time during the regular
business hours of the Exchange for each calendar month for Nasdaq
Securities with a consolidated average daily volume (``CADV'') of less
than one million shares per calendar month and an average of at least
5% of the time during the regular business hours of the Exchange for
each calendar month for Nasdaq Securities with a CADV equal to or
greater than one million shares per calendar month. As such, a DMM in a
Nasdaq Security is required to meet these quoting requirements on a
stock-by-stock basis.
    The Exchange proposes to amend NYSE MKT Rule 509(a)(1)--Equities to
require that DMM units maintain a bid or offer at the NBBO for a
certain percentage of the trading day on a portfolio basis. The
percentage required would depend on whether the stock is a ``More
Active Security'' or ``Less Active Security'' security, as defined in
Rule 103B(II)(B) and (C)--Equities. As proposed, a DMM unit would be
required to maintain a bid or offer at the NBBO for at least 15% of the
trading day for Nasdaq Securities in which the DMM unit is registered
with a CADV of less than one million shares (i.e., Less Active
Securities), and at least 10% of the trading day for Nasdaq Securities
in which the DMM unit is registered with a CADV equal to or greater
than one million shares (i.e., More Active Securities).
    The requirements of proposed NYSE MKT Rule 509(a)(1)(A) are modeled
on the DMM unit quoting requirements in New York Stock Exchange LLC
(``NYSE'') Rule 104(a)(1)(A), which requires that DMM units maintain a
bid or offer at the NBBO for a certain percentage of the trading day on
a portfolio basis. Specifically, NYSE Rule 104(a)(1)(A) requires that
DMM units maintain a bid or offer at the NBBO for at least 15% of the
trading day for NYSE-listed securities in which the DMM unit is
registered with a CADV of less than one million shares, and at least
10% for securities for NYSE-listed securities in which the DMM unit is
registered with a CADV equal to or greater than one million shares.
    The Exchange notes that the NYSE requirement for NYSE-listed
securities is greater than the DMM unit quoting requirement for
Exchange-listed securities. NYSE MKT Rule 104(a)(1)(A)--Equities
requires that DMM units maintain a bid or offer at the NBBO for a
certain percentage of the trading day for all Exchange-listed
securities in which the DMM unit is registered, specifically, at least
10% of the trading day for the Exchange-listed securities in which the
DMM unit is registered with a CADV of less than one million shares, and
at least 5% for securities in which the DMM unit is registered with a
CADV equal to or greater than one million shares.
    Accordingly, under the proposed change, DMM units would be required
to meet a quoting requirement for Nasdaq Securities that is greater
than the quoting requirement for Exchange-listed securities.
    The Exchange believes the proposed change is appropriate in light
of the low volume of trading of Nasdaq Securities occurring on the
Exchange. The Exchange believes that basing the quoting requirements on
quoting in the portfolio of securities in which the DMM unit is
registered rather than on a security-by security basis will encourage
quoting activity in a broader number of Nasdaq Securities, including
less active securities. Because, in part, of the difficulty DMM units
have in meeting the current stock-by-stock quoting obligation, DMM
units have declined to participate in the UTP Pilot Program, and
trading in Nasdaq Securities on NYSE MKT is minimal, with only 135 of
the approximately 2,600 Nasdaq Securities trading at the Exchange as of
May 21, 2013. Specifically, meeting the security-by-security quoting
requirement on a daily basis has been sufficiently difficult to
discourage DMM units from participating in the UTP program. The
Exchange believes that the portfolio approach will give DMM units more
flexibility in meeting the quoting requirements, thus encouraging DMM
participation in the UTP Pilot Program. The Exchange notes that while
there may be more or less quoting in individual securities in the
portfolio in any particular trading session, as with the portfolio
quoting requirement for NYSE and the Exchange, the Exchange believes
that over time, quoting across all of the assigned Nasdaq Securities
will even out as the requirement to meet the portfolio requirement
would discourage an imbalance in quoting any one security. The Exchange
therefore seeks to adopt an obligation that is both meaningful and
attainable to encourage increased participation by DMM units in the UTP
Pilot Program, which would result in more liquidity providing and
quoting in a higher number of Nasdaq Securities trading on the
Exchange.
    The Exchange also notes that the proposed quoting requirement is
higher than the quoting requirement applicable to Exchange-listed
securities, and therefore the obligation associated with the quoting
requirement for DMMs in Nasdaq Securities would still be greater than
the similar obligation for Exchange-listed securities. The Exchange
believes that this is appropriate given the Commission's prior finding
that the obligations and benefits for DMMs that trade Nasdaq Securities
differ from the obligations and benefits for DMMs that trade Exchange-
listed securities.\11\ The Exchange believes that the proposed change
strikes the appropriate balance between setting a meaningful obligation
to the market that is tailored to the volume levels of Nasdaq
Securities that trade in the UTP Pilot Program while at the same time
recognizing that the obligations for DMM units must be meaningful as
compared to the benefits they receive.
---------------------------------------------------------------------------

    \11\ See Securities Exchange Act Release Nos. 62479 (July 9,
2010), 75 FR 41264 (July 15, 2010) (SR-NYSEAmex-2010-31).

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

    Finally, the Exchange notes that using a similar structure for the
obligations for listed securities and for Nasdaq Securities would, for
the same DMM unit eliminate in large part the additional responsibility
and burden for DMM units to design, implement and maintain different
technology approaches and programming for their trading and internal
compliance applications relating to Nasdaq Securities only.
    The Exchange also proposes to delete from NYSE MKT Rule
504(b)(1)(A)--Equities, Nasdaq Security Assignment, the text setting
out the DMM quoting requirements of NYSE MKT Rule 509--Equities and to
replace the repetition of the text with a cross-reference to NYSE MKT
Rule 509--Equities.
    The Exchange proposes to implement the rule changes effective [sic]
August 1, 2013.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder applicable to a national securities exchange. In particular,
the Exchange believes that its proposal is consistent with: (i) Section
6(b) of the Act,\12\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\13\ in particular, in that it is designed to
prevent fraudulent and manipulative acts and practices, to promote just
and equitable principles of trade, to remove impediments to and perfect
the mechanism of a free and open market and a national market system,
and, in general, to protect investors and the public interest; (ii)
Section 11A(a)(1) of the Act,\14\ in that it seeks to ensure the
economically efficient execution of securities transactions and fair
competition among brokers and dealers and among exchange markets; and
(iii) Section 12(f) of the Act,\15\ which governs the trading of
securities pursuant to UTP consistent with the maintenance of fair and
orderly markets, the protection of investors and the public interest,
and the impact of extending the existing markets for such securities.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f(b).
    \13\ 15 U.S.C. 78f(b)(5).
    \14\ 15 U.S.C. 78k-1(a)(1).
    \15\ 15 U.S.C. 78l(f).
---------------------------------------------------------------------------

    Specifically, the Exchange believes that the proposed change would
remove impediments to and perfect the mechanism of a free and open
market and national market system because it would remove an obligation
that is virtually impossible for DMM units to meet and replace it with
a quoting obligation better tailored to the scope of the UTP Pilot
Program and how Nasdaq Securities trade at the Exchange. The Exchange
believes that the proposed change would promote fair competition among
broker dealers by encouraging more DMM units to quote Nasdaq
Securities, thereby increasing the available liquidity in such
securities, which would benefit investors and the public.

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

    The Exchange does not believe that the proposed rule changes will
impose any burden on competition that are not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange believes that
the proposed change is pro-competitive because it would remove an
overly burdensome obligation that places Exchange DMM units at a
disadvantage vis-[agrave]-vis market makers on other markets because
the Exchange DMM units are unable to meet the quoting obligations, and
therefore do not trade Nasdaq Securities at the Exchange. The Exchange
further believes that the proposed change will foster competition
because it will increase the number of DMM units that would be willing
to be registered in Nasdaq Securities, thereby increasing the potential
pool of liquidity in Nasdaq Securities in the market.

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

    No written comments were solicited or received with respect to 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 significantly
affect the protection of investors or the public interest, does not
impose any significant burden on competition, and, by its terms, does
not 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) of the Act \16\ and Rule 19b-
4(f)(6) thereunder.\17\
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78s(b)(3)(A).
    \17\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
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
Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such 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. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \18\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \18\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

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-NYSEMKT-2013-61 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-NYSEMKT-2013-61. 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, 100 F Street NE.,
Washington, DC 20549, on official

business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of
the filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change; 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-NYSEMKT-2013-61 and should be submitted on or before
August 5, 2013.

For the Commission, by the Division of Trading and Markets, pursuant
to delegated authority.\19\
---------------------------------------------------------------------------

    \19\ 17 CFR 200.30-3(a)(12).

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-16820 Filed 7-12-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 186 (Monday, September 26, 2011)]
[Notices]
[Pages 59405-59406]
[FR Doc No: 2011-24601]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

Anti-Infective Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Anti-Infective Drugs Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on November 4, 2011, from 8
a.m. to 5 p.m.
    Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD. The hotel telephone number is 301-
589-5200.
    Contact Person: Minh Doan, Center for Drug Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm.
2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, e-
mail<EMAIL_ADDRESS>or FDA Advisory Committee Information Line, 1-
800-741-8138<PHONE_NUMBER> in the Washington, DC area), and follow the
prompts to the desired center or product area. Please call the
Information Line for up-to-date information on this meeting. A notice
in the Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
    Agenda: On November 4, 2011, the committee will discuss clinical
trial design issues in the development of antibacterials for the
treatment of hospital-acquired bacterial pneumonia, including
ventilator-associated bacterial pneumonia, and the draft document
entitled ``Guidance for Industry: Hospital-Acquired Bacterial Pneumonia
and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for
Treatment,'' published November 2010 (see FDA Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064980.htm).
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
October 21, 2011. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before October 13, 2011. Time allotted
for each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by October 14, 2011.

    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Minh Doan at least 7
days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: September 20, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-24601 Filed 9-23-11; 8:45 am]
BILLING CODE 4160-01-P