[Federal Register Volume 76, Number 243 (Monday, December 19, 2011)]
[Notices]
[Page 78706]
[FR Doc No: 2011-32356]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65944; File No. SR-FINRA-2011-062]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Order Approving a Proposed Rule Change To Repeal
Incorporated NYSE Rule 2A (Jurisdiction)

December 13, 2011.

I. Introduction

    On October 20, 2011, the Financial Industry Regulatory Authority,
Inc. (``FINRA'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to repeal incorporated NYSE Rule 2A. The proposed
rule change was published for comment in the Federal Register on
November 3, 2011.\3\ The Commission received no comments on the
proposal. This order approves the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 65656 (November 3,
2011), 76 FR 68240 (``Notice'').
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II. Description of the Proposal and Discussion

    FINRA proposed to repeal incorporated NYSE Rule 2A (Jurisdiction)
as part of the process of developing a consolidated rulebook
(``Consolidated FINRA Rulebook''). NYSE Rule 2A generally addresses
jurisdictional authority with respect to, among other things,
rulemaking, examinations, disciplinary actions, and listing
applications. NYSE Rule 2A was adopted in 2006 as part of the merger
between the New York Stock Exchange LLC (``NYSE'') and Archipelago
Holdings, Inc. since the NYSE Constitution, which contained provisions
detailing the NYSE's jurisdiction, was eliminated in the merger.\4\
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    \4\ See Securities Exchange Act Release No. 53382 (February 27,
2006), 71 FR 11251 (March 6, 2006) (Order Approving File No. SR-
NYSE-2005-77).
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    FINRA, in its filing with the Commission, stated that the FINRA By-
Laws address the powers and authority of the FINRA Board of Governors
and, together with the Act, set forth FINRA's authority and
responsibilities as a registered securities association. FINRA further
stated that its authority to regulate those matters that are addressed
in NYSE Rule 2A and that are relevant to FINRA's role as a registered
securities association, such as its jurisdictional authority with
respect to: (i) Rulemaking; (ii) general supervisory powers over
members, member organizations and their offices, partnership and
corporate arrangements, their principal executives, employees and
approved persons in connection with their conduct of the business of
member organizations; (iii) ability to discipline members, member
organizations, principal executives, employees and approved persons in
connection with their conduct of the business of member organizations;
and (iv) any and all other functions of members, member organizations,
principal executives, employees and approved persons in connection with
the conduct of the business of member organizations, are contained in
the FINRA By-Laws.
    FINRA further noted that other matters addressed by NYSE Rule 2A
either are not applicable to the operations of a registered securities
association that does not operate a listing market or are otherwise
unique to the NYSE. FINRA stated that the transfer of NYSE Rule 2A to
the Consolidated FINRA Rulebook was unnecessary and proposed that it be
eliminated. FINRA advised that it would announce the implementation
date of the proposed rule change in a Regulatory Notice to be published
no later than 90 days following Commission approval of the proposed
rule change and that the operative date of the proposal would be no
later than 150 days following Commission approval.

III. Commission's Findings

    After carefully considering the proposed rule change, the
Commission finds that the proposal is consistent with the requirements
of the Act and the rules and regulations thereunder applicable to a
national securities association. In particular, the Commission finds
that the proposal is consistent with Section 15A(b)(6) of the Act,\5\
which requires, among other things, that FINRA rules be designed to
prevent fraudulent and manipulative acts and practices, to promote just
and equitable principles of trade and, in general, to protect investors
and the public interest.\6\
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    \5\ 15 U.S.C. 78o-3(b)(6).
    \6\ In approving this proposal, the Commission has considered
the proposed rule's impact on efficiency, competition, and capital
formation. See 15 U.S.C. 78c(f).
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    The Commission believes that the proposal will streamline FINRA's
rulebook by eliminating a rule that is duplicative of provisions of
FINRA's By-Laws that already are in place for FINRA members and govern
jurisdictional matters. The Commission notes that NYSE Rule 2A remains
in NYSE's own rulebook and will continue to apply to NYSE-only members.

IV. Conclusion

    It Is Therefore Ordered, pursuant to Section 19(b)(2) of the
Act,\7\ that the proposed rule change (SR-FINRA-2011-062), be, and it
hereby is, approved.
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    \7\ 15 U.S.C. 78s(b)(2).
    \8\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2011-32356 Filed 12-16-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 34 (Tuesday, February 21, 2012)]
[Notices]
[Pages 9945-9946]
[FR Doc No: 2012-3956]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0097]

Draft Guidance for Industry on Providing Submissions in
Electronic Format--Standardized Study Data; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Providing
Submissions in Electronic Format--Standardized Study Data.'' This draft
guidance establishes FDA's recommendation that sponsors and applicants
submit nonclinical and clinical study data in a standardized electronic
format. The draft guidance recognizes that standardized study data
promotes the efficient review of this information. The purpose of this
draft guidance is to promote the use of data standards for study data,
and increase the number of standardized study data submissions to the
Center for Drug Evaluation and Research, the Center for Biologics
Evaluation and Research, and the Center for Devices and Radiological
Health.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 23, 2012.

ADDRESSES: 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, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002 or the
Office of Communication, Outreach and Development (HFM-40), Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. The guidance
may also be obtained by mail by calling CBER at 1-800-835-4709 or 301-
827-1800. 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.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kieu Pham, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 21, Rm. 4677, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, or

Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17),
Food and Drug Administration, 1401 Rockville Pike, Suite 200N,
Rockville, MD 20852-1448,<PHONE_NUMBER>, or

Terrie Reed, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3324, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Providing Submissions in Electronic Format--Standardized
Study Data.'' FDA routinely receives submissions of the results of
scientific studies, including clinical trials and animal studies. For
many years, FDA has requested that clinical study data be submitted
electronically because paper case report tabulations (CRTs) are
universally recognized as being highly inefficient to support analysis
and review. The data in paper CRTs are not machine-readable and
therefore cannot be easily analyzed using modern analytic software.
Although submission of clinical study data in electronic format has
become relatively routine, these data are often submitted using
nonstandard formats.
    FDA has long recognized the advantage of standardizing study data,
as have many sponsors and applicants. Data submitted in a standard
electronic format are easier to understand, analyze, and review.
    This draft guidance establishes FDA's recommendation that sponsors
and applicants submit clinical and nonclinical study data in a standard
electronic format. As sponsors and applicants move toward standardized
electronic study data submissions, there is a need to understand FDA's
expectations for such data submissions. This draft guidance provides
FDA's current thinking on the submission of study data in a standard
electronic format.
    The draft guidance refers submitters to FDA's Study Data Standards
Resource Web page at http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/default.htm, where there is useful information
describing which data standards to use and how to use them.
    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 Agency's current thinking on submitting
standardized study data in electronic format. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternative approach may be used if such approach
satisfies the

requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 314 and 21 CFR
part 312 have been approved under OMB control numbers 0910-0001 and
0910-0014, respectively. The collections of information in 21 CFR part
807, subpart E have been approved under 0910-0120; the collections of
information in 21 CFR part 812 have been approved under 0910-0078; and
the collections of information in 21 CFR part 814 have been approved
under 0910-0231.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: February 14, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-3956 Filed 2-17-12; 8:45 am]
BILLING CODE 4160-01-P


[ Federal Register: December 28, 2000 ( Volume 65, Number 250)] [ Notices] [ Page 82335 82345] From the Federal Register Online via GPO Access [ wais. access. gpo. gov] [ DOCID: fr28de00 81] [[ Page 82335]] =====================================================================

ENVIRONMENTAL PROTECTION AGENCY [ FRL 6923 9] Draft Public Involvement Policy AGENCY: Environmental Protection Agency. ACTION: Proposed policy.

SUMMARY: The Environmental Protection Agency is revising its 1981 Public Participation Policy. The revised policy is being issued as the Draft 2000 Public Involvement Policy for 120 day public comment. The Draft Policy was updated to reflect changes over the past nineteen years such as additional Agency responsibilities, new regulations, expanded public involvement techniques, and the changed nature of public access due to the Internet. The Policy will provide guidance and direction to EPA officials on reasonable and effective means to involve the public in its regulatory and program decisions.

DATES: Comments will be accepted until April 27, 2001.

ADDRESSES: Submit comments to Patricia A. Bonner, United States Environmental Protection Agency, Office of Policy, Economics and Innovation ( MC 1802), 1200 Pennsylvania Ave, NW, Washington, DC 20460, by facsimile at 202 260 4903 or by electronic mail to bonner. patricia@ epa. gov.

FOR FURTHER INFORMATION CONTACT: Patricia Bonner at 202 260 0599. In addition to sending comments by mail, interested parties may file comments electronically to: stakeholders@ epa. gov. The Draft Public Involvement Policy may be downloaded from http:// www. epa. gov/ stakeholders. Any additional opportunities for public involvement on the Draft Policy will also be posted on the same web site. EPA particularly seeks comments on how the Agency can improve involvement opportunities for minority, low income and underserved populations and how it can encourage involvement opportunities in programs delegated or authorized to states, tribes and local governments.

SUPPLEMENTARY INFORMATION:

Background On January 19, 1981, the EPA published its first Agency wide Public Participation Policy    to ensure that managers plan in advance needed public involvement in their programs, that they consult with the public on issues where public comment can be truly helpful, that they use methods of consultation that will be effective both for program purposes and for the members of the public who take part, and finally that they are able to apply what they have learned from the public in their final program decisions.'' ( 46 FR 5736, Jan. 19, 1981)

The 1981 Policy complemented regulations on    Public Participation in Programs Under the Resource Conservation and Recovery Act, the Safe Drinking Water Act, and the Clean Water Act,'' 40 CFR Part 25 ( 2000) which EPA promulgated in 1979. Part 25 covers procedures that the Agency ( or state, tribe, etc.) should or must follow. Like the 1981 Policy, these procedures include matters associated with information, notification, consultation responsibilities, public hearings, public meetings, advisory committees, responsiveness summaries, permit enforcement, rulemakings, and work elements in financial assistance agreements.

In the nearly two decades following issuance of the 1981 Policy, Congress and three Presidents added to EPA's responsibilities, EPA promulgated many new regulations, public involvement techniques expanded, and the Internet revolutionized the nature of public access. EPA also developed and extended its methods of ensuring compliance with environmental regulations through partnerships, technical assistance, information and data access, and public involvement under the laws it implements. Legislation and executive orders established new government wide administrative procedures and public involvement requirements. Since many EPA programs are authorized or delegated to the states, tribes and in some instances, local governments, many of these organizations developed their own public policies and procedures for public involvement.

Most importantly, EPA itself made public involvement an increasingly important part of its decisionmaking at all levels, ranging from advisory committees for national rules to local involvement in permitting, cleanups, and a host of other initiatives. Further, the Agency developed tools to assist EPA staff and regulatory partners to conduct public involvement and consultation, such as the    RCRA Public Involvement Manual'' ( EPA530 R 96 007, September 1996),    Public Involvement in Environmental Permits: A Reference Guide ( EPA599 R00 007, August 2000), the Model Plan for Public Participation'' ( EPA300 K 96 003, November 1996),    Environmental Justice in the Permitting Process'' ( EPA/ 300 R 00 004, December 1999), and the Office of Pesticide Program's    How to Participate in EPA Decision making'' ( 63 FR 58038, October, 1998). .

It was in that context that EPA stated in its July 1999 publication    Aiming for Excellence: Actions to Encourage Stewardship and Accelerate Environmental Progress'' ( EPA 100 R 99 006) that the Agency would evaluate and update EPA's public involvement requirements and assess how well its regulations and policies ensure public involvement in decision making. In November 1999 the Agency sought the public's opinion on whether the 1981 Policy needed to be revised and updated ( 64 FR 66906, November 30, 1999). EPA collected, analyzed, and posted public comments on the Internet http:// www. epa. gov/ stakeholders.

Based on the comments received, EPA believes that, while the 1981 Policy required updating, it is basically sound and workable. Therefore, EPA is issuing today this Draft 2000 Public Involvement Policy ( hereinafter called the Draft Policy) which updates and strengthens ( but does not fundamentally change) the 1981 Policy. It incorporates many comments submitted in response to the 1999 Federal Register notice. After comments are received on this Draft Policy, EPA will issue a Final Public Involvement Policy.

Many of the 1999 comments can be grouped into several themes which are reflected in this Draft Policy. They suggest that the Agency should:

( a) increase efforts to identify groups or individuals interested in or affected by an issue and who represent a balance of views;

( b) provide notices and outreach materials in    plain English,'' and in other languages when appropriate;

( c) listen to, seek to understand, and involve stakeholders in issues of critical importance to them; ( d) select the most appropriate level of effort and mechanisms for public involvement in any specific circumstance;

( e) incorporate Environmental Justice ( EJ) considerations;

( f) inform and involve the public earlier; and ( g) evaluate EPA public involvement policies and practices.

Certain other suggestions were not fully reflected in this Draft Policy, for the following reasons: ( a) Expand the length of public comment periods. The Agency's response: Some comment periods are set in regulations and statutes, and Executive Orders in some instances. EPA managers already choose the length of a specific comment period based on the complexity and [[ Page 82336]]

other aspects of the rule or other proposed actions. Because the Draft Policy is meant to enhance public involvement, its implementation should ensure better planning and enable managers to engage the public in discussions during the development of proposals, prior to opening a formal comment period on proposals, and to set the length of comment periods that give the public adequate time to develop comments.

( b) Require a public notice for every meeting of EPA with others outside the Executive branch of government.

The Agency's response: Implementing this suggestion would create unnecessary barriers rather than expand public access to staff and managers. Its effect would be to lessen public involvement in Agency activities and to greatly expand the administrative procedures and costs. The public would be overwhelmed with notices to review to find specific events of interest to them. Staff and managers meet with individuals and groups all across the nation every day to explain programs, learn their needs and ideas, and to give and receive information. If every such session were subject to public notice, the administrative burdens created would interfere with the environmental protection and public health functions of the Agency, and the public would not be well served.

( c) Think broadly about the environmental issues in an area ( e. g., a watershed) and how all stakeholders can work together to identify:

( 1) Their information needs and how they prefer to obtain information;

( 2) issues that concern them; and ( 3) reach joint solutions, whenever possible; and ( d) Advance the concept of stewardship.

The Agency's response on ( c) and ( d): EPA's environmental education programs, community based and watershed focused activities, pollution prevention activities, and related outreach and public access activities are attempting to promote and provide opportunities for holistic approaches to environmental problems. Though the stewardship philosophy is not stated in the Draft Policy, the Agency strongly supports such efforts. EPA has encouraged and actively participated in several industry stewardship programs and sustainability efforts, and in June 2000, EPA launched the National Environmental Performance Track. This new program rewards facilities that do more to protect the environment than they are legally required to do, and motivates them to become environmental stewards. Program participants are also required to share environmental information with their communities and involve them in relevant decisions.

In requesting public input on today's Draft Policy, EPA is particularly interested in comment on the following topics:

What EPA can do to encourage, promote and ensure effective public involvement in programs that have been delegated to states, tribes and local governments;

How EPA can improve involvement opportunities for minority, low income and underserved populations; and How EPA can more fully address the comments received earlier regarding place based approaches.

The Draft 2000 Public Involvement Policy builds upon the 1981 Policy on Public Participation, not fundamentally changing its message. The strongest advice we received in response to the 1999 Federal Register notice was not to make major changes, but to place a high priority on carrying out the Draft Policy consistently at EPA national and regional levels. Therefore, the Administrator is directing that EPA staff and managers implement the Draft Policy while the Agency receives and considers public comments, and that they continue to implement other statutory and regulatory public involvement requirements. This directive is appropriate because in most respects this Draft Policy simply formalizes what has been the Agency's intent and widespread practice in recent years.

The Administrator also is charging the Agency's Reinvention Action Council, through a cross Agency work group for public involvement, with developing a Draft Strategic Plan for Public Involvement during 2001. This group will design the plan to: Ensure full implementation of the Final Policy ( when released); enhance Agency wide public involvement; increase access to environmental information and involvement processes for under served communities; and track and report progress on efforts to improve public involvement to the Agency and to the public. EPA will solicit input on the Plan from stakeholders and request public comments. The workgroup will also review EPA's Part 25 regulations and, if necessary, other regulations relating to public participation, to ensure consistency with Part 25.

The Administrator is further directing the Agency to develop the means to measure progress in implementing public involvement, evaluate the effectiveness of public involvement activities, and encourage our regulatory partners to implement the intent of this Draft Policy and other statutory and regulatory public involvement requirements.

Richard T. Farrell,

Associate Administrator, Office of Policy, Economics and Innovation.

EPA Draft Agency wide 2000 Public Involvement Policy Introduction This Draft 2000 Public Involvement Policy ( hereinafter called the Draft Policy) addresses public involvement in all of the Environmental Protection Agency's ( EPA) decision making, rulemaking, and program implementation activities. The fundamental premise of this Draft Policy is that, in all its programs, EPA should provide for meaningful public involvement. This requires that everyone at EPA remain open to receive all points of view and extend every effort to solicit input from those who will be affected by decisions. This openness to the public furthers our mission to protect public health and safeguard the natural environment by increasing our credibility and improving our decision making. Our willingness to remain open to new ideas from our constituents, and to incorporate them where appropriate, is absolutely essential to the execution of our mission. At the same time, we should not accord privileged status to any special interest, nor accept any recommendation or proposal without careful, critical examination.

Definitions The term the public is used in the Draft Policy in the broadest sense, meaning the general population of the United States. Many segments of    the public'' may have a particular interest or may be affected by Agency programs and decisions. In addition to private individuals,    the public'' includes, but is not limited to, representatives of consumer, environmental and other advocacy groups; environmental justice groups; indigenous people; minority and ethnic groups; business and industrial interests, including small businesses; elected and appointed public officials; the media; trade, industrial, agricultural, and labor organizations; public health, scientific, and professional representatives and societies; civic and community associations; faith based organizations; research, university, education, and governmental organizations and associations, and governments and agencies at all levels. Public agencies that serve as co regulators may have a dual role; they can be beneficiaries of [[ Page 82337]]

public involvement in their decision making processes as well as stakeholders who provide input into EPA's decisions.

The term public involvement is used in this document to encompass the full range of actions and processes that EPA uses to engage the public in the Agency's work, and means that the Agency considers public concerns, values, and preferences when making decisions. Public involvement enables the public to work with the Agency and hold it accountable for its decisions. Though every person living in the United States is an ultimate beneficiary of EPA actions to protect public health and the environment, a relatively small number of individuals directly participate in Agency activities. Individuals and organizations who have a strong interest in the Agency's work and policies are referred to as stakeholders. Stakeholders also may interact with EPA on behalf of another person or group that seeks to influence the Agency's future direction. Some stakeholders are, or believe they are, affected parties, that is, individuals or groups who will be impacted by EPA policies or decisions.

What Are the Purposes, Goals and Objectives of This Draft Policy?

The purposes of this Draft Policy are to:

Reaffirm EPA's commitment to early and meaningful public involvement;

Ensure that environmental decisions are made with an understanding of the interests and concerns of affected people and entities;

Promote the use of a wide variety of techniques to create early and, when appropriate, continuing opportunity for public involvement in Agency decisions; and Establish clear and effective procedures for conducting public involvement activities in EPA's decisionmaking processes.

Implementing a strong policy and consistent procedures will make it easier for the public to become involved and to affect the Agency's decisions. This in turn will assist the EPA in carrying out its mission by providing the Agency with a better understanding of the public's viewpoints, concerns, and preferences. Full implementation of this Draft Policy also should build public trust and make the Agency's decisions more likely to be accepted and implemented by those who are most concerned with and affected by them. Finally, implementing this policy will support EPA in meeting statutory requirements regarding public participation, particularly in environmental permitting programs and enforcement activities.

Decision makers are sometimes concerned about delays associated with public involvement. In some circumstances, a compelling need for immediate action may make it appropriate to limit public involvement. However, issues that are not resolved to the satisfaction of the concerned public may ultimately face time consuming review. Achievement of EPA's public involvement objectives may reduce delays caused by litigation or other adversarial activities.

EPA has the following goals for public involvement processes:

To foster a spirit of mutual trust, confidence, and openness between the Agency and the public; To fulfill legal requirements imposed by various environmental statutes;

To ensure that the Agency consults with interested or affected segments of the public and takes public viewpoints into consideration when making decisions; To ensure that the Agency provides the public with information at a time and in a form that it needs to participate in a meaningful way;

To ensure that the public understands official programs and the implications of potential alternative courses of action;

To learn from the public the information it is uniquely able to provide ( community values, concerns, practices, local norms, and relevant history, such as locations of past contaminant sources, or potential impacts on small businesses, etc.);

To solicit assistance from the public in understanding potential consequences of technical issues, identifying alternatives to be studied, and selecting among the alternatives considered;

To keep the public informed about significant issues and changes in proposed programs or projects;

To foster, to the extent possible, equal and open access to the regulatory process for all interested and affected parties;

To ensure that the government understands public goals and concerns, and is responsive to them; To anticipate conflicts and encourage early discussions of differences among affected parties;

To promote the public's involvement in implementing environmental protection laws; and To ensure that the Agency communicates to the public how its input affected the Agency's decision.

To achieve the purposes and goals, while also recognizing resource constraints, Agency officials will strive to provide for, encourage, and assist public involvement in the following ways:

Beginning public involvement early in the decision making process and continuing it throughout the process as necessary to provide the best information possible;

Striving to identify, communicate with and listen to all affected sectors of the public. The role of Agency officials is to plan and conduct public involvement activities that provide equal opportunity for all individuals and groups to be heard. Where appropriate, implementation of this Draft Policy will require Agency officials to give extra encouragement and consider providing assistance to some sectors, such as minorities and low income populations, or small businesses, which may have fewer opportunities or resources to participate;

Involving members of the public in developing options and alternatives ( when possible) and, before making decisions, seeking the public's opinion on options or alternatives. Agency officials must avoid advocacy and pre commitment to any particular alternative or option prior to decision making, unless statutory or regulatory requirements dictate otherwise ( e. g. when EPA proposes a Plan for a Superfund site);

Actively developing options that address the conflicts in underlying issues expressed by disagreeing stakeholders, thereby seeking to facilitate discussion; and Making every effort to match the design of public involvement programs with the complexity and potential for controversy surrounding the issue being addressed, the segments of the public affected, the time frame for decision making, and the overall desired outcome of the public involvement process.

When Does This Draft Policy Apply? This Draft Policy applies to all EPA programs conducted under the laws and Executive Orders that EPA implements. Appendix 1 contains a list of these laws and orders.

The activities covered by this Draft Policy include:

EPA rulemaking, when the regulations are classified as significant ( under the terms of Executive Order 12866);

The issuance or significant modification of permits or licenses;

[[ Page 82338]]

EPA activities in support of programs that are authorized, approved, or delegated by EPA that are funded by EPA financial assistance ( grants and cooperative agreements) to States, tribes, interstate agencies, intertribal consortia, and local governments;

Selection of plans for cleanup, remediation, or restoration of hazardous waste sites, or Brownfields properties;

The process leading to a determination of approval of state, tribal or local government administration of a program;

All other policy decisions that are determined by the Administrator, Deputy Administrator, or appropriate Assistant, Regional, or Associate Administrator to warrant application of the Draft Policy in view of EPA's responsibility to involve the public in important decisions. [ Note: Science based decisions prompt application of the Agency's policy on peer review.]

Many of the activities covered by this Draft Policy have their own public involvement requirements established by statute, rule, or Executive Order. Those provisions should be considered the minimum level of public involvement that EPA will provide. This Draft Policy should be used to determine the appropriate nature and extent of public involvement above the basic requirements. While it is important for the Agency to consider the interests of the public and take steps to effectively involve the communities or constituencies that will be most impacted by EPA's decisions, it is not necessary to have extensive involvement for all public participation or stakeholder involvement activities. However, lack of adequate participation or lack of effective means for participation can result in agreements or policies that do not necessarily reflect the interests of communities or constituencies that will be most impacted by them.

Major national rules and policy decisions will generally involve the most extensive public involvement, but more localized decisions such as individual permits and cleanups sometimes engender a high degree of public interest and warrant a more extensive involvement process as well. This Draft Policy does not limit the degree of public involvement provided, or preclude developing new tools for public involvement.

This Draft Policy relies heavily on the sound use of discretion by Agency officials, although always with a bias in favor of public involvement. The Agency should make all reasonable efforts to ensure that the public is informed and given appropriate opportunities for involvement. Those opportunities should not be judged solely by their quantity; but also by whether they are designed to improve the quality of EPA's decisions. The Agency will always provide opportunity for public involvement in rulemaking that requires public notice and comment, but not every document or decision requires public involvement. Every involvement opportunity does not call for the inclusion of all potentially interested persons; including legitimate representatives of the various interests may be sufficient. Agency officials must have the flexibility to determine appropriate public involvement, and will be accountable for those decisions. Agency officials must recognize that agreement among all parties, while valuable, is not always needed, and that the Agency must retain the discretion to make decisions or take actions to preserve and protect the environment and public health.

The Draft Policy is not a rule, is not legally enforceable, and does not confer legal rights or impose legal obligations upon any member of the public, EPA or any other agency. It is, however, EPA's statement of its strong commitment to full and meaningful public involvement in Agency activities. As a policy, the Draft Policy is not binding upon states, tribes and local governments that implement federally delegated, authorized or approved programs. However, EPA encourages those entities to adopt similar policies and will discuss public involvement among other issues in its periodic joint planning efforts with states, tribes and local governments that implement these programs.

What Should EPA Do to Ensure Full and Meaningful Public Involvement?

Each Assistant Administrator, Associate Administrator, Office Director, or Regional Administrator should ensure that the Agency fully carries out this Draft Policy and all public involvement provisions of the laws that they are responsible for implementing. They should ensure that, to the greatest extent possible, authorized and delegated program partners provide opportunities for the public to participate in decision making related to implementing their EPA related programs. EPA officials are responsible for determining forthcoming decisions or activities to which this Draft Policy and applicable laws and Executive Orders should be applied, and taking the steps needed to ensure that adequate public involvement processes are developed and implemented.

This Draft Policy identifies six key functions that should be considered when planning for public involvement. Agency officials must exercise judgment and take into consideration the particular circumstances of each situation in determining how those functions will be carried out. Agency employees should strive to provide the most meaningful public involvement opportunities appropriate to each situation. The issues, locations, potential environmental and public health consequences of the activities, potential for controversy, specific needs of the public and the Agency, and other circumstances will influence the design of public involvement processes. The Draft Policy recognizes the Agency's need to set priorities for its use of resources. It also emphasizes involvement by the public in decisions where options are available and alternatives must be weighed, or where EPA is seeking substantial agreement from the public to carry out a program.

The six basic functions for effective public involvement in any decision or activity are:

1. Plan and budget for public involvement activities;

2. Identify the interested and affected public;

3. Consider providing technical or financial assistance to the public to facilitate involvement;

4. Provide information and outreach to the public;

5. Conduct public consultation and involvement activities; and 6. Assimilate information and provide feedback to the public. The goals( s) and recommended actions for each of these functions are described below.

1. Plan and budget for public involvement activities Goal: To ensure effective public involvement processes through advance planning, early notice to stakeholders, adequate time and resources, and evaluation.

a. Recommended actions: When preparing budgetary documents for programs affecting the public, Agency officials should include resources for conducting and evaluating public involvement activities. These may be included as an element of regulatory development plans, analytic blueprints, program plans, or EPA's plans for complying with the Government Performance and Results Act. Programs also should plan for complying with the Unfunded Mandates Reform Act, the Regulatory Flexibility Act, as amended by the Small Business Regulatory Enforcement Fairness Act, Executive [[ Page 82339]]

Order 13132 ( Federalism), and Executive Order 13175 ( Consultation and Coordination with Indian Tribal Governments).

Such planning documents should set forth, at a minimum:

Key decisions subject to public involvement; Staff contacts and budget resources to be allocated to public involvement;

Segments of the public targeted for involvement and plans for identifying organizations and individuals, consistent with the Paperwork Reduction Act if the plans involve the collection of information;

Proposed schedule for public involvement activities consistent with the Federal Advisory Committee Act; Mechanisms to apply the six basic functions Planning and Budgeting, Identification, Providing Assistance, Information and Outreach, Public Consultation and Involvement, and Assimilation and Feedback outlined above; and Measures or methods to evaluate the effectiveness of public involvement.

When identified in an approved grant work plan, grant funds may be used, subject to any statutory or regulatory limitations, to support reasonable costs of public involvement incurred by assisted agencies, including advisory group expenses.

Assistant Administrators, Associate Administrators and Regional Administrators should ensure that program and activity planning documents include public involvement activities and that they are developed in a timely manner for use in the annual budget planning process.

2. Identify the interested and affected public Goal: To identify groups or members of the public who may have expressed an interest in, or may by the nature of their location, purposes or activities be affected by or have an interest in an upcoming activity or action.

a. Recommended actions: The responsible official should develop a contact list for each program, activity or project, and add to the list those members of the public who request to be added. Each list should be updated frequently, and will be most useful if subdivided by category of interest or geographic area. The nature and intensity of the involvement activities will drive the updating frequency. Pro active efforts should be made to ensure that all points of view are represented on the lists. The contact lists should be used to send announcements of involvement opportunities; notices of meetings, hearings, field trips, and other events; notices of available information, reports and documents; and to identify members of the public who may be considered for advisory group membership and other activities. Where circumstances (   lesser actions'' such as minor program guidance or minor amendments to a permit) do not warrant identifying individual interested parties to this extent, Agency officials should, at a minimum, be aware of who the interested parties are and how best to provide them notice.

b. Methods: Construction of this list of contacts may be accomplished by any number of activities, including, but not limited to the following [ Note: Where the above activities involve the collection of information from non agency parties, they may be subject to the Paperwork Reduction Act ( PRA). For advice, staff should consult with the Office of General Counsel]:

Requesting the names of interested and affected individuals from others in the Agency; from facilities/ companies; state, tribal, regional and local governments; or from key non governmental forprofit and not for profit groups;

Using questionnaires or surveys to find out levels of awareness;

Reviewing dockets, depositories, research papers or other publications for previous similar or related activities; I ncluding an EPA point of contact on EPA documents ( fact sheets, public notices, sign up sheets at meetings, etc.) so that individuals may ask to be placed on lists;

Soliciting interest through notices in the Federal Register; trade and trade association publications; local print, radio, cable and television outlets; not for profit secular and religious publications; or through the Internet or other electronic means;

Asking those who attend events what, if any, interests or key individuals are missing; and yy using other comprehensive or creative means that consider the community structure, languages spoken, local communications preferences and the locations ( such as libraries and other centers) where the community regularly congregates.

3. Consider Providing Technical or Financial Assistance to the Public to Facilitate Involvement. Goal: To assist stakeholder groups and members of the public who may not have resources to obtain the technical assistance or funding that would enable them to contribute effectively and in a timely manner.

a. Recommended actions: EPA recognizes that responsible involvement by the various elements of the public in some of the highly technical and complex issues addressed by the Agency requires substantial commitments of time, study, research, analysis, and discussion. Where it is possible to provide technical or financial assistance, doing so can improve the quality of public involvement.

In some circumstances, direct financial assistance may be available. For example, depending on annual budget authorizations, Assistant and Associate Administrators, Regional Administrators and Office Directors may have authority to provide funds to outside organizations and individuals for public involvement activities associated with rules under development that they, as EPA managers, deem appropriate and essential for achieving program goals. However, funds for such purposes are generally very limited. When funding is provided, the primary purpose must be consistent with the Federal Grant and Cooperative Agreement Act, and appropriate authority for the funded activities must be provided in one or more of EPA's statutes. In other cases, assistance in forms other than direct financial support can be provided. Examples of such assistance are provided below.

b. Methods: There are numerous ways to provide assistance to members of the public who lack the ability to participate in an effective or timely manner in Agency public consultation or involvement activities. Agency managers should consult with knowledgeable staff to determine the most feasible and legal methods to follow. Methods may include staff resources or funding for:

Access to Agency experts or contractors to obtain information and analyses as resources allow; Access to technical personnel through grants to universities ( e. g.: The Superfund Program's Technical Outreach Services to Communities project has provided independent university based scientific and engineering expertise to 115 communities dealing with hazardous substance contamination questions);

Travel and per diem to consult and provide advice directly to Agency officials;

Compensation for time spent on Federal Advisory Committee meetings;

Technical Assistance Grants ( TAGs) under Section 117 of CERCLA awarded to groups of individuals who may be affected by a release or a threatened release at Superfund sites to obtain assistance in interpreting and [[ Page 82340]]

disseminating data and information related to site activities;

Task specific technical assistance to help stakeholders address issues either in project negotiation or implementation phases of XL ( Excellence and Leadership) projects;

Collection and dissemination of information on outside sources of funding or technical assistance;

Collaboration with non governmental organizations and other information brokers;

Provision of surplussed computer equipment to parties who need access to the Internet, following Agency requirements for this activity ( under EPA's policy in response to Executive Order 12999 Educational Technology Ensuring Opportunity for all Children in the Next Century that directs special attention be given to schools and nonprofit organizations, including community based educational organizations located in minority, low income and underserved communities).

c. Public involvement funding criteria: Currently the Agency does not have Agency wide criteria for providing formal assistance to facilitate public involvement. Any criteria that the Agency may develop in the future for the award of financial assistance by the Agency for public involvement should be based on the following criteria:

( 1) whether the proposed activity is allowable under applicable statutory authority;

( 2) whether the activity proposed will involve interests not adequately represented;

( 3) whether the applicant does not otherwise have adequate resources to participate;

( 4) whether the applicant is qualified to accomplish the work;

( 5) whether the proposed activity will be undertaken by those with a direct and genuine stake in the local community; and, ( 6) whether the activity proposed will further the objectives of this Draft Policy that benefit the public.

These criteria should be the primary tests used for public involvement financial assistance. From among those who meet these tests, the Agency would make special efforts to provide assistance to groups that may have fewer opportunities or insufficient resources to participate.

4. Provide information and outreach to the public.

Goals: To provide the public with accurate, understandable, pertinent and timely information in accessible places so that the public can contribute effectively to Agency program decisions. To ensure that the public understands the legal requirements for Agency action and the significance of the related technical data so that the public can provide meaningful comments that assist the Agency in its decisionmaking

a. Recommended actions: Agency officials should:

Ensure that adequate, timely information concerning a forthcoming action or decision reaches the public;

Provide policy, program, and technical information to the affected public and interested parties at the earliest practicable times, to enable those potentially affected or interested persons to make informed and constructive contributions to decision making;

Ensure that information is provided at places easily accessible to interested and affected persons and organizations;

Fully implement the goals of the Agency's Public Access Strategy when released ( to provide the public with integrated, online, user friendly access to environmental data and information) and, to the extent practicable, enable communities, including minority, low income, and underserved populations, to have access to relevant data and information;

To the extent practicable, direct that information and educational programs be developed so that all levels of government and the public have an opportunity to become familiar with the issues and the technical data from which they emerge;

Ensure that informational materials clearly identify the role of the public in the specific decisions to be made;

Highlight significant issues that will be the subject of decision making;

Make special efforts to summarize complex technical materials for the public;

Write documents in plain language that the public will easily understand; and Consider whether EPA should provide documents in languages in addition to English in order to reach the affected public or interested parties.

b. Methods: Information and outreach programs require the use of appropriate communication tools, and should be tailored to accommodate the public's level of familiarity with the subject. The following, among many other approaches, may be used for this purpose:

( 1) Publications, fact sheets, technical summaries, bibliographies, resource guides and other printed materials which may be made available through the mail and at information depositories ( e. g., EPA regional and field offices, federal repository libraries and local public libraries, and state/ tribal/ local agencies);

( 2) Videos and CD ROMs;

( 3) Questionnaires, surveys, and interviews, subject to approval by the Office of Management and Budget under the Paperwork Reduction Act;

( 4) Public service announcements and news releases;

( 5) Educational publications, programs or activities;

( 6) Electronic communications such as Web pages, chat rooms, on line dialogues, and list servers;

( 7) Participation in conferences, workshops, or meetings;

( 8) Telephone communications such as hotlines, clearinghouses and toll free comment lines;

( 9) Video conferences and satellite downlinks; and ( 10) Participation at public events, such as fairs and festivals c. Content. Outreach materials may include:

Background information ( e. g. statutory basis, rationale, specific goal( s) of involvement activities, or the triggering event of the action);

A timetable of proposed actions; Summaries of lengthy documents or technical material if relevant;

A delineation of issues and the interests that they may affect;

Alternative courses of action or tentative determinations that the Agency may have made; Information on whether an Environmental Impact Statement or Environmental Assessment is, or will be, available;

Specific encouragement to stimulate active involvement by the public, including describing the nature of its influence, roles, and potential impact on the decisions;

The name and contact information ( address, e mail address, telephone and telefax numbers) to reach an individual for further information;

Whenever possible, the social, economic, and environmental consequences of proposed decisions and alternatives; and Technical evidence and research methodology explained in non technical language. ( Summaries of technical documents should be footnoted to refer to the original data.)

Fact sheets, news releases, summaries, and similar publications in print and on the Internet may be used to provide notice of availability of materials and to facilitate public understanding of more complex documents, but should not be a substitute for public access to the complete documents. When practicable,

[[ Page 82341]]

information should be provided in formats and locations that match the public's needs. Some information ( e. g., Confidential Business Information) is not available for public review and the Agency cannot release it.

d. Notification. Responsible officials should seek to ensure that parties on the contact list and the media are aware of the outreach materials available and that they have adequate time and opportunity to receive and review the information before any additional public involvement activities are conducted. Notices should include information about the repository ( address, hours of operation, etc.) or other information relating to access to all documents referred to in the notice, including the name of a contact person when appropriate.

e. Timing. To enable effective and meaningful public involvement, outreach materials that make the public aware of the planned activity and that outline the issue( s) should be distributed as early as such information is available. The more complex the issue and greater the potential for controversy or misunderstanding, the earlier the materials should be distributed. When the Agency holds a formal public comment process, notification should take place as soon as possible when the Agency takes an action to permit the public to obtain and review the materials, and prepare responses in a timely and meaningful way. Minimum public comment periods are often specified in statutes or rules. Generally, materials for public comment should be provided as soon as they are available and should allow for not less than 30 days for the public review and comment ( or longer, as specified in program specific requirements), or 45 days in the case of public hearings.

When unusually complex issues or lengthy documents are presented for public review this period generally should be no less than 60 days. ( For Superfund actions, regardless of complexity, the public is provided 30 days to submit comments on proposed remedies. Upon a timely request, the public comment period can be extended by a minimum of 30 additional days.)

f. Fees for Copying: Whenever possible, the Agency should provide copies of relevant documents, free of charge. Free copies may be reserved for private citizens, public interest organizations, or small businesses with limited funds. Any charges must be consistent with requirements under the Freedom of Information Act as set forth in 40 CFR Part 2.

g. Depositories or dockets: The Agency should provide one or more central collections of documents, reports, studies, plans, etc. relating to controversial issues or significant decisions in a location or locations convenient to the public. Suitable locations will depend on the nature of the action; for national rules a single central docket is generally appropriate whereas local repositories may be preferable when decisions relate to individual facilities or sites. RCRA authorizes EPA to require a facility to set up and maintain a repository. In all other instances, for actions at local facilities or sites, Agency officials should work with community representatives and the facility to determine the most accessible repository site( s) within the community. Consideration should be given to accessibility, travel time, parking, transit, and availability during off work hours. Copying facilities, at reasonable charges, should be available at depositories. Agency officials are encouraged to determine the accessibility to the interested public and feasibility of electronic depositories that take advantage of the Internet to reach directly into homes, libraries and other facilities throughout a community and across the nation. If the public has reasonably convenient, well advertised electronic repositories, this can achieve significantly enhanced accessibility at a very modest cost.

5. Conduct public consultation and involvement activities.

Goals: To understand the interests and needs of the affected public. To provide for the exchange of information and views and open exploration of issues, alternatives and consequences between interested and affected members of the public and officials responsible for the forthcoming action or decision.

a. Recommended actions: Agency officials should: Ensure that public consultation and involvement are preceded by timely outreach activities, including timely distribution of information;

Notify the public of potential consultation and involvement activities early enough to ensure that the public has adequate time to obtain and evaluate information; conduct any additional data gathering; consult experts and formulate their opinions, options, and suggestions prior to Agency action;

Conduct public consultation and involvement activities at times and places which, to the maximum extent feasible, facilitate attendance or involvement by the affected public. Whenever possible, public meetings concerning local facilities or sites should be held during non work hours, such as evenings or weekends, and at locations accessible to public transportation;

Identify and select the public consultation or involvement process appropriate to the decision being made, and the time frame and resources available. When possible, consult or involve the affected public in identifying and selecting appropriate public involvement processes. This ensures that the approaches selected consider and, if appropriate, accommodate the potentially affected parties' needs, preferences, schedules and resources, as well as the Agency's needs;

Provide guidance, resources, training, and professional assistance to Agency staff, interested delegated program partners, and the public to assist them in conducting or participating in public consultation and involvement activities in an effective and credible manner. ( EPA invites comment on how best this can be accomplished, particularly with respect to including those from minority, low income, and other underserved communities);

Consider the appropriate use of third parties in the development and implementation of programs, projects and activities; and Be knowledgeable of and comply with provisions of open meetings laws and regulations, such as the Federal Advisory Committee Act, whenever they apply to the public involvement process being conducted.

b. Methods: Consultation and involvement processes may take a variety of forms, depending upon the issues to be addressed, the timing of the decision making action, and the needs and resources of the public whose involvement is sought. Public hearings and public meetings are two familiar forms of consultation and often are legally required, but their use should not serve as the only forum for citizen input. When required, public hearings and meetings should be held at the end of a process that has previously given the public more informal and interactive opportunities for becoming informed and involved. Alternative Dispute Resolution ( ADR) is another tool that the Agency uses to consider and seek to resolve differences among various stakeholders. ADR is a consensual resolution of disputes and issues in controversy. ADR allows EPA to obtain the services of neutral parties on an expedited basis to manage a public dialogue in which neighbors, business interests, environmental groups, and [[ Page 82342]]

other interested parties have an opportunity to raise concerns to the parties involved in the enforcement action or other controversy.

EPA and other public agencies employ a wide variety of consultation techniques that can be divided into three categories based upon the outcomes of the process:

( 1) Information Exchange;

( 2) Recommendations; and ( 3) Agreements.

Information exchange involves EPA staff and management sharing data, options, issues and ideas with the public in a way that encourages dialogue. Information exchange activities include workshops, forums, joint fact finding, interactive public meetings, focus groups, surveys ( subject to provisions of the Paperwork Reduction Act), roundtables and informal consultation such as meetings with interest groups, attendance at conferences, and other opportunities for informal dialogue. These activities are not meant to reach agreement or consensus on future action. Their purpose is to compile a mutually developed knowledge base of everyone's interests, ideas and needs. Though not a fully interactive method, the notice and comment process also serves as a limited form of information exchange.

Recommendations activities involve a number of stakeholder representatives collaborating with each other and with Agency staff to develop recommendations. The Agency may accord significant deference to the recommendations, but is generally not bound to implement the recommendations, nor are the parties bound to accept them. ( See Appendix 2 for FACA requirements.) Examples of recommendations activities include FACA committees established by EPA, external technical committees ( such as those conducted with the American Society for Testing and Materials), peer review panels, and various technical advisory groups, citizens advisory groups, or panels. Agreement activities involve EPA management and representatives of stakeholders who reach an agreement by consensus.

Agreement activities include negotiated rulemaking committees and other mediated agreements. If the agreement activity used does not produce a legally binding agreement, the desired outcome of such an activity is a commitment on the part of the participants to full implementation.

The list above is not exhaustive but it indicates the need for program officials to be flexible and choose the right techniques for the right occasion. These activities are not mutually exclusive; they form a progression. They can and should be used as part of a thorough, well planned system of consultation and public involvement. Successful agreement or recommendation processes occur only with significant information exchange and outreach. However, progressing to a recommendation process or agreement process is not necessary, practical or affordable in all decision making processes.

c. Content Agency officials should clearly identify issues to be discussed, negotiated or decided prior to and throughout the engagement process so that the public understands which decisions are subject to its input. The type of process to be conducted, the schedule, and the assumptions and expectations for the outcomes of the process also should be clearly stated so that the public and its representatives understand whether they are being invited to an information exchange or a negotiation and can set their expectations accordingly. If possible, the public should be involved in determining the design of the processes. The Agency will comply with all applicable open meeting requirements, such as FACA and all information gathering requirements, such as the Paperwork Reduction Act, in the design of its public outreach processes.

d. Notification The Agency should ensure that all parties on the contact list and the media are notified of opportunities to participate and provided with appropriate information. Agency officials should not assume that the general public reads printed legal notices or Federal Register notices which are often required by statute or regulation. Although these methods serve as legal notice to the public, they can be augmented by broader notice to the media or interested persons on the contact list, and other tailored notifications. Notification should give the time, date and location of the consultation process, a general description of the topics or agenda, a contact person and contact information, and a general description of the nature of the process to be conducted, as well as the role of the public. Agency officials should consider the use of multilingual notices of upcoming activities and/ or translator services, when appropriate.

e. Timing Agency officials should provide early advance notice of public involvement processes so that the public can obtain background information, obtain and evaluate additional data, formulate their needs and interests, and obtain expert assistance, if necessary. Generally, notice should be given not less than 15 days in advance of an impending meeting or consultation process. If the issues are unusually complex or involve review of lengthy documents this period generally should be no less than 60 days. Program specific notice requirements should be consulted; for example, for Superfund actions, regardless of complexity, the public is provided 30 days to submit comments on proposed remedies. Upon a timely request, the public comment period can be extended by a minimum of 30 additional days.

f. Summaries: Detailed summaries of advisory committee meetings under FACA are required by law. [ Appendix 2 contains requirements for formation and use of EPA advisory committees.] In addition, some statutes also require minutes of public meetings. Even when not required, when possible and appropriate, Agency officials should make summaries of public hearings and public meetings available to participants and other interested parties. When possible and appropriate, Agency officials should be open to participants' comments that might correct or add to the summary. In rulemaking proceedings under the Administrative Procedure Act, a memorandum summarizing any significant new factual data or information likely to affect the final decision received during an informal meeting or other conversations should be placed in the public docket for the rule. In other situations, it may be helpful to document discussions that contribute information useful to decision making and make that information available to participants and interested parties.

6. Assimilate information and provide feedback to the public.

Goal: To consistently earn and retain the public's trust and credibility for EPA consultation processes, by evaluating and assimilating public viewpoints and preferences into final decisions, where appropriate and possible, and communicating to the public the decisions made and how their input affected those decisions.

Assimilating public viewpoints and preferences into decisions and final actions involves examining and analyzing public input, considering if and how to incorporate that input into final program decisions, and making or modifying decisions according to carefully considered public views. The Agency should demonstrate, in its decisions and actions, that it has understood and fully considered public concerns. Finally, the Agency should communicate the decision and discuss [[ Page 82343]] the influence of the public's input in the final decision. a. Recommended actions:

( 1) Assimilate the information: Agency officials should briefly and clearly document consideration of the public's views in Responsiveness Summaries, regulatory preambles, EISs or other appropriate forms. This should be done at key decision points. Each Responsiveness Summary ( or similar document) should:

Include a statement of the action that was taken;

Explain briefly the type of public involvement activity that was conducted;

Identify or summarize those who participated and their affiliation;

Describe the matters on which the public was consulted;

Summarize the public's views, important comments, criticisms and suggestions;

Disclose the Agency's logic in developing decisions;

Indicate the effect the public's comments had on that action; and Discuss the Agency's specific responses to significant issues, in terms of modifying the proposed action, or explaining why the Agency rejected proposals made by the public.

( 2) Provide feedback to the public: For all major actions and whenever practicable for lesser actions, the Agency should provide feedback to participants and interested parties concerning the outcome of the public's involvement. The Agency should publish, post on a web site or in public places, distribute, mail, or e mail a Responsiveness Summary or similar document for those who participated in or observed the public involvement processes, those who provided public comments and to those on the contact list. In addition, where circumstances and resources permit, or where the number of participants was small, feedback may be in the form of personal letters. Feedback provided in meetings or through other means should be documented.

Who is responsible for ensuring that this Draft Policy is applied appropriately?

Public involvement is an integral part of any program. It should routinely be included in decision making and not be treated as an independent or secondary function. Managers should ensure that personnel are properly trained, supported and counseled, and that adequate funding needs are incorporated in their specific budgets.

Under the overall direction of the Administrator, the Assistant, Associate, and Regional Administrators are responsible and accountable for the adequacy of public involvement programs. They are ultimately responsible for making certain that, for the activities under their jurisdiction, all Agency staff implement the purpose of this Draft Policy. They are responsible for ensuring that the level of effort in public involvement is commensurate with the potential impact of the upcoming action or decision. The Regional, Assistant, or Associate Administrators will make certain that concerns about the adequacy of public involvement are heard and, where necessary, acted upon as resources allow. Citizens who have questions or objections about the substance of this Draft Policy or the appropriateness of applying it in a particular case should raise that issue with the Agency officials involved.

Although this Draft Policy is not binding on states, tribes and local governments, EPA encourages these entities to adopt similar policies where they administer federal programs authorized, approved or delegated by EPA. The Agency intends to include public involvement among the issues discussed during the annual reviews of state, tribal or local program( s), and during any other program audit or review.

1. The Administrator maintains overall direction and responsibility for the Agency's public involvement activities. Specifically, the Administrator will:

a. Establish policy direction and guidance for all EPA public involvement programs;

b. Provide incentives to Agency personnel to ensure commitment to and competence in implementing this Draft policy; and c. evaluate the adequacy of public involvement activities conducted under this Draft Policy, the appropriateness and results of public involvement expenditures, and the effectiveness of this Draft Policy.

2. Assistant Administrators and Associate Administrators have the following responsibilities:

a. Identify and address those activities and major decisions where application of this Draft Policy is appropriate;

b. Ensure that plans developed for these programs or activities include and provide adequate time and resources for effective public involvement;

c. Consider providing guidance and assistance to support regional office public involvement activities at the request of Regional Administrators;

d. Implement the public information and public involvement portions of approved plans;

e. Evaluate the effectiveness and appropriateness of public involvement expenditures and activities under their jurisdiction, revising and improving them as necessary;

f. Encourage coordination of public involvement activities;

g. Ensure that, as regulations for the programs cited in Appendix 1 of the Draft Policy are amended, they incorporate the Draft Policy's provisions;

h. Consider funding authorized pilot and/ or innovative demonstration projects;

i. Consider measures to ensure Draft Policy implementation in appropriate managers' performance standards;

j. Provide financial assistance, as appropriate and available, for authorized public involvement activities at the national level;

k. Coordinate public involvement funding to outside groups to ensure the most economical expenditures;

l. Provide guidance and technical assistance and training as appropriate to support authorized and delegated program activities of state, tribal, regional and local entities;

m. Develop guidance and training needed to ensure that program personnel are equipped to implement the Draft Policy;

n. Provide incentives to Agency staff to ensure commitment to and competence in implementing this Draft Policy;

o. Seek public involvement in decisions to modify or develop major national policies, at their discretion; and p. Ensure that applicable legal requirements associated with public involvement are adhered to, such as the Federal Advisory Committee Act and the Paperwork Reduction Act.

3. Regional Administrators have the following responsibilities:

a. Identify and address those EPA activities, policies, and programs where this Draft Policy should be applied;

b. Ensure that plans developed by the programs for activities, programs and policies subject to this Draft Policy provide for adequate public involvement;

c. Implement the public information and public involvement portions of approved Agency plans;

d. Provide information and technical assistance to staff and participants in delegated programs on the conduct of public involvement activities;

e. Discuss with state, tribal, regional and local entities the effectiveness and appropriateness of their public involvement activities during periodic meetings;

f. Encourage coordination of public involvement activities;

[[ Page 82344]]

g. Support and assist the public involvement activities of EPA Headquarters;

h. Ensure that Regional staff members are trained, and that resources are allocated for public involvement;

i. Incorporate measures to ensure Draft Policy implementation in managers' performance standards;

j. Provide small grants to representative public groups for needed public involvement work, where feasible and appropriate;

k. Evaluate the appropriateness of public involvement expenditures and activities, revising and improving them as necessary; and l. Ensure that applicable legal requirements associated with public involvement are adhered to, such as the Federal Advisory Committee Act and the Paperwork Reduction Act.

4. The Director, Office of Communication, Education, and Media Relations ( OCEMR) has an important role in the development and support of Agency public involvement activities. The Director will:

a. Assist EPA Headquarters and Regions in identifying interested and affected members of the public;

b. Support Headquarters and Regional programs in critiquing, developing and distributing outreach materials to inform and educate the public about Agency environmental programs and issues, and involvement opportunities; and c. Encourage, develop, and support Agency strategic communications plans to foster public awareness and complement public involvement plans. 5. The Associate Administrator, Office of Congressional and Intergovernmental Relations, has the responsibility to assist program offices in identifying:

a. State and local officials, both elected and appointed, to engage in public involvement activities; and,

b. Appropriate mechanisms and forums to reach these constituents.

Appendix 1: Laws, Executive Orders and Presidential Memos EPA is required to implement public involvement provisions of laws, executive orders and presidential memos that include, but may not be limited to:

Clean Air Act, 42 U. S. C. 7401 7671q ( 1994 & Supp. 2000)

Clean Water Act 33 U. S. C. 1251 1387 ( 1982 & Supp. 2000)

Comprehensive Environmental Response, Compensation and Liability Act, as amended by the Superfund Amendments and Reauthorization Act of 1986, 42 U. S. C. 9601 9675 ( 1994 and Supp. 2000)

Emergency Planning and Community Right to Know Act 42 U. S. C. 11011 11050). ( 1994) Federal Insecticide, Fungicide and Rodenticide Act, ( including the Food Quality Protection Act of 1996), 7 U. S. C. 135 136y ( 1994)

Marine Protection Research and Sanctuaries Act of 1972 ( including the Ocean Dumping Act), 33 U. S. C. 1401 1445 ( 1982)

National Environmental Policy Act of 1969, 42 U. S. C. 4321 4347e ( 1988 & Supp. 2000)

Noise Control Act of 1972, 42 U. S. C. 4901 4918 ( 1995)

Solid Waste Disposal Act as amended by the Resource Conservation and Recovery Act, 42 U. S. C. 6901 6992k ( 1994 and Supp. 2000) S afe Drinking Water Act, 42 U. S. C. 300f 300j 26 ( 1988)

Toxic Substances Control Act, 15 U. S. C. 2601 2692 ( 1994 & Supp. 2000)

Chemical Safety Information, Site Security and Fuels Regulatory Relief Act of 1999, Pub. L. 106 40, 113 Stat. 207 ( 1999)

Shore Protection Act 33 U. S. C. 2601 2623 ( Supp. 2000)

This Draft Policy also applies to EPA activities under the following Executive Orders:

E. O. 12580 Superfund Implementation E. O. 12856 Federal Compliance with Right to Know Laws and Pollution Prevention Requirements E. O. 12866 Regulatory Planning and Review E. O. 13132 Federalism ( which replaced E. O. 12875 Enhancing the Intergovernmental Partnerships)

E. O. 12898 Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations E. O. 13045 Protection of Children from Environmental Health Risks and Safety Risks E. O. 13007 Indian Sacred Sites E. O. 13175 Consultation and Coordination with Indian Tribal Governments E. O. 11988 Floodplain Management E. O. 13166 Improving Access to Services for Persons with Limited English Proficiency In addition, this Draft Policy is effective for EPA activities conducted under the following statutes for which other agencies have primary responsibility:

Atomic Energy Act, 42 U. S. C. 2011 2297g 4 ( 1995)

Energy Policy Act of 1992, Pub. L. 102 486, 106 Stat. 2776 ( codified as amended in scattered sections of 15, 16, 25, 26, 30, 42 and 43 U. S. C.)

Federal Food, Drug and Cosmetic Act, 21 U. S. C. 301 397 ( 1994)

Intermodal Surface Transportation Efficiency Act, Pub. L. 102 240, 105 Stat. 1914 ( codified as amended in scattered sections of 15, 16, 23, 26, and 33 U. S. C.)

Occupational Safety and Health Act, 29 U. S. C. 651 678 ( 1994 & Supp. 2000)

Oil Pollution Act of 1990, 33 U. S. C. 2702 2761 ( Supp. 2000)

Motor Vehicle Information and Cost Savings Act, 49 U. S. C. 32901 32919 ( 1994 & Supp. 2000) Nuclear Waste Policy Act, 42 U. S. C. 10101 110270 ( 1994 and Supp. 2000)

Uranium Mill Tailings Radiation Control Act, 42 U. S. C. 7901 7942 ( 1995)

WIPP Land Withdrawal Act, Pub. L. 102 579, 106 Stat. 4777 ( 1992) as amended by Pub. L. 104 201, 110 Stat. 2422 Implementing public involvement activities may also involve complying with the following Acts, Executive Orders, Executive Memoranda, and Regulation:

Administrative Procedure Act 5 U. S. C. 550 596 (( 1996)

Freedom of Information Act 5 U. S. C. 552 ( 1994 & Supp. 2000)

Civil Rights Act of 1964 , Pub. L. 88 352, 78 Stat. 241 ( codified as amended in scattered sections of 42 U. S. C.)

Federal Advisory Committee Act 5 U. S. C. app. 2, secs. 1 15 ( 1996)

Government Performance and Results Act, Pub. L. 103 62, 107 Stat. 285 ( codified in scattered sections of 31 U. S. C.)

Negotiated Rulemaking Act 5 U. S. C. 561 570a Administrative Disputes Resolution Act 5 U. S. C. 571 584 ( 1994)

Paperwork Reduction Act 44 U. S. C. 3501 3526 ( 1998 & Supp. 2000)

Regulatory Flexibility Act, as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 5 U. S. C. 601 612 ( 1994 & Supp. 2000)

Unfunded Mandates Reform Act 2 U. S. C. 1501 1571 ( 1994)

National Technology Transfer and Advancement Act of 1995, Pub. L. 104 113, 110 Stat. 775 ( codified as amended in scattered sections of 15 and 35 U. S. C.) Congressional Review Act, 5 U. S. C. 801 1808 ( 2000)

National Environmental Education Act of 1990, 20 U. S. C. 5501 5510 ( 1994)

Organotin Antifouling Paint Control Act, 33 U. S. C. 2401 2410 ( Supp. 2000)

National Historic Preservation Act of 1996, as amended, 16 U. S. C. 470 470x 6 ( Supp. 2000)

E. O. 12862 Setting Customer Service Standards E. O. 12999 Educational Technology Ensuring Opportunity for all Children in the Next Century E. O. 11593 Protection of and Enhancement of the Cultural Environment E. O. 11990 Protection of Wetlands Presidential Memorandum on Plain Language in Government Writing ( June 1, 1998)

Presidential Memorandum on Electronic Government ( December 17, 1999)

Presidential Memorandum on Government to Government Relations with Native American Tribal Governments ( April 29, 1994)

Public Participation in Programs Under the Resource Conservation and Recovery Act, the Safe Drinking Water Act, and the Clean Water Act, 40 CFR Part 25 ( 2000)

Minority Business Enterprise and Women's Business Enterprise Program, contained in portions of 40 CFR Parts 30, 31, 35 and 40 Appendix 2: Advisory Committees To gain advice from a representative group of stakeholders or experts, one of the methods that the Agency may choose is forming an advisory committee. These committees are usually subject to the [[ Page 82345]]

chartering, balanced membership, and open meeting requirements of the Federal Advisory Committee Act ( FACA). The Office of General Counsel or the Regional Counsel should be consulted to determine whether FACA applies to a particular group.

In general, any time the Agency forms a group of non federal people to provide EPA with collective advice, the requirements of the Federal Advisory Committee Act ( FACA) may apply. Such groups shall not meet until the requirements of FACA are met. Staff may contact the Committee Management Officer in the Office of Cooperative Environmental Management for advice on complying with these requirements, and to learn about the exceptions to FACA.

The primary function of an advisory group is to assist elected or appointed officials by making recommendations to them on issues that the decision making body considers relevant. These issues may include policy development, project alternatives, financial assistance applications, work plans, major contracts, interagency agreements, and budget submissions, among others. Advisory groups can provide a forum for addressing issues, promote constructive dialogue among the various interests represented on the group, and enhance community understanding of the Agency's action.

A. Requirements for Federal EPA Advisory Committees: When EPA establishes an advisory group, provisions of the Federal Advisory Committee Act 5, U. S. C. App. 2), and General Service Administration ( GSA) Regulations on Federal Advisory Committee Management must be followed. These requirements are:

The development of a Charter that has been approved by the General Services Administration and Office of Management and Budget. It must contain the committee's objectives and the scope of its activities, the period of time necessary for the committee to carry out its objectives, the agency responsible for providing the necessary support for the committee, and a description of the duties for which the committee is responsible. The Charter must be renewed every two years. 5 U. S. C. App. 2, sec. 9.

The Establishment Federal Register Notice. At least 15 days before the charter is filed for a new committee, EPA is required to publish an establishment notice in the Federal Register. Such notice describes the nature and purpose of the committee, the agency's plan to attain fairly balanced membership, and a statement that the committee is necessary and in the public interest 5 U. S. C. App. 2, sec. 9.

Balanced Membership. Advisory committees must be    fairly balanced'' in points of view represented. 5 U. S. C. App. 2, sec. 5.

The Meeting Federal Register Notice. Each advisory committee meeting must be noticed in the Federal Register at least 15 days prior to the meeting. 5 U. S. C. App. 2, sec. 10.

To close a meeting to the public, you must obtain the approval of both the Administrator and the General Counsel. 5 U. S. C. App. 2, sec. 10.

Detailed minutes must be kept of all advisory committee meetings. 5 U. S. C. App. 2, sec. 10.

Open Meetings. Interested persons may file written statements with any advisory committee, attend any advisory committee meeting ( unless properly closed), and appear before any advisory committee. 5 U. S. C. App. 2, sec. 10.

DFO Attendance. Each meeting must be attended by a Designated Federal Official ( DFO), a full time federal employee who is authorized to adjourn the meeting and approve the agenda. 5 U. S. C. App. 2, sec. 10.

Documents Available to the Public. All advisory committee documents ( including drafts) shall be available to the public upon request. 5 U. S. C. App. 2, sec. 10.

B. State and Local Advisory Committees: In instances where regulations, program guidance, or the public involvement plans of state, substate, or local agencies, call for advisory groups, they should follow applicable state and local laws.

Note: Find information about EPA's FACA committees at http:// www. epa. gov/ ocem/ websites. htm#. faca [ FR Doc. 00 33157 Filed 12 27 00; 8: 45 am]

BILLING CODE 6560 50 P


[Federal Register Volume 77, Number 210 (Tuesday, October 30, 2012)]
[Notices]
[Pages 65751-65752]
[FR Doc No: 2012-26640]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68095, File No. SR-CBOE-2012-085]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Order Approving Proposed Rule Change Relating to the
Complex Order Auction Process

October 24, 2012.

I. Introduction

    On August 30, 2012, the Chicago Board Options Exchange
(``Exchange'' or ``CBOE'') filed with the Securities and Exchange
Commission (``Commission''), pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934 (``Act''),\1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to modify CBOE Rule 6.53C(d),
``Process for Complex Order RFR Auction,'' to: (i) Include the side of
the market in the request for response (``RFR'') message sent to
Trading Permit Holders at the start of a Complex Order Auction
(``COA''); and (ii) require responses to an RFR message (``RFR
Responses'') to be on the opposite side of the market from the order
being auctioned in a COA. The proposed rule change was published for
comment in the Federal Register on September 17, 2012.\3\ The
Commission received no comment letters regarding the proposal. This
order approves the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 67827 (September 11,
2012), 77 FR 57171 (``Notice'').
---------------------------------------------------------------------------

II. Description of the Proposal

    COA is an automated RFR auction process for COA-eligible orders.\4\
On receipt of a COA-eligible order and a request from the Trading
Permit Holder representing the order that the order be subjected to a
COA, CBOE sends an RFR message to all Trading Permit Holders that have
elected to receive RFR messages.\5\ The RFR message identifies the
component series, the size of the COA-eligible order, and any
contingencies, if applicable, but not the side of the market (i.e.
whether the order is to buy or to sell).\6\ Responders to the COA, who
do not know the side of the market of the order being auctioned, may
submit RFR Responses on both sides of the market.\7\ Because RFR
Responses on the same side of the market as the COA-eligible order
cannot trade with the order and thus are unnecessary, CBOE's trading
system automatically rejects these RFR Responses.\8\
---------------------------------------------------------------------------

    \4\ A ``COA-eligible order'' is a complex order that, as
determined by the Exchange on a class-by-class basis, is eligible
for a COA considering the order's marketability (defined as a number
of ticks away from the current market), size, complex order type,
and complex order origin type. See CBOE Rule 6.53C(d)(i)(2).
    \5\ See CBOE Rule 6.53C(d)(ii).
    \6\ See id.
    \7\ See Notice, supra note 3, at 57172.
    \8\ See id.
---------------------------------------------------------------------------

    The Exchange proposes to amend CBOE Rule 6.53C(d) to: (i) Include
the side of the market in the RFR message sent to Trading Permit
Holders at the start of a COA; and (ii) require RFR Responses to be on
the opposite side of the market from the order being auctioned in a
COA. CBOE believes that these proposed changes will make the COA
process more efficient by eliminating the entry of unnecessary RFR
Responses that cannot trade with the COA order.\9\ CBOE also believes
that this increased efficiency could lead to more meaningful and
competitively priced RFR Responses, which could result in better prices
for customers.\10\
---------------------------------------------------------------------------

    \9\ See id.
    \10\ See id.
---------------------------------------------------------------------------

III. Discussion

    After careful consideration of the proposed rule change, the
Commission finds that the proposal is consistent with the requirements
of the Act and the rules and regulations thereunder applicable to a
national securities exchange.\11\ The Commission believes that the
proposed rule change is consistent with Section 6(b) of the Act, in
general, and Section 6(b)(5) of the Act,\12\ in particular, in that it
is designed to promote just and equitable principles of trade, to
foster cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general, to protect investors and the public interest.
More specifically, the Commission believes that the proposal could
improve the efficiency of the COA process by eliminating unnecessary
RFR Responses, which otherwise would have been rejected automatically
by CBOE's trading system.
---------------------------------------------------------------------------

    \11\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \12\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\13\ that the

proposed rule change (SR-CBOE-2012-085) is approved.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-26640 Filed 10-29-12; 8:45 am]
BILLING CODE 8011-01-P


 ADVANCE \y63

	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

	REGION III

1650 Arch Street

	Philadelphia, Pennsylvania 19103-2029

January 13, 2011

Mr. George S. Aburn, Jr., Director

Maryland Department of the Environment

Air and Radiation Management Administration

1800 Washington Boulevard

Baltimore, MD 21230  SEQ CHAPTER \h \r 1

Dear Mr. Aburn:

On December 20, 2010, the U.S. Environmental Protection Agency (EPA)
received a revision to the Maryland State Implementation Plan (SIP) from
the Maryland Department of the Environment.  The SIP revision pertains
to the definition of “fuel-burning equipment,” and includes
amendments to Regulation .01 under COMAR 26.11.01 and Regulation .01
under COMAR 26.11.09.  EPA has determined that the submittal is
administratively and technically complete, and is reviewing it to
prepare a Notice of Proposed Rulemaking.

If members of your staff have any questions, they may direct them to Ms.
Irene Shandruk, at<PHONE_NUMBER>.  She is the principal contact for
this rulemaking.

Sincerely,

/s/

         Diana Esher, Director

                          			         Air Protection Division

cc:  Brian Hug, MDE

	Customer Service Hotline: 1-800-438-2474