OMB Control # 2060 0446 Expiration Date [ Insert]

Developer  1 LMOP Project Developer Profile Information Please complete the following form and return it to LMOP according to the instructions in the cover letter. Any data in our records have been inserted into this form. Please review this information, make corrections, and fill in the remaining blanks. If you wish to provide additional information, please attach it to this form. Thank you for your assistance!

CONTACT INFORMATION Organization Name: Today's Date: / /

Name of LMOP Coordinator: Telephone Number: ( )

Title: Fax Number: ( )

E mail:

Mailing Address:

( Address) ( Dept./ Floor/ Suite/ Room) ( City) ( State) ( Zip Code)

Organization's Web Address:

May we provide a link from the LMOP Web site to your Web site? ( circle one) Yes No CAPABILITIES AND SERVICES We currently have the following description of your organization in our records:

[ Organization description to be pulled from tracking system]

If no description appears in the space above ( because you are new to LMOP or a description was not available in our records), we ask that you please provide a summary of your products and services. If a description from our records is available and you would like to revise it, you may do so below. Please provide the new or revised description:

May we include this information on the LMOP Web site or in other LMOP products? ( circle one) Yes No OMB Control # 2060 0446 Expiration Date [ Insert]

Developer  2 Landfill and Project Information Organization Name:______________________________________________________

Please make sufficient copies of this form and complete one form for each new LFGE project ( projects for which you did not receive a project profile with this questionnaire) your organization is developing or has developed. If you consider any of the information requested to be confidential, do not provide that information and write " confidential" instead. If you wish to provide additional information, please attach it to this form.

GENERAL LANDFILL INFORMATION Landfill Name:

Landfill City and State: Landfill County:

Landfill Owner: Landfill Owner Type: Public Private Year Landfill Opened: Landfill Closure Year:

Design Landfill Area ( acres): Current Landfill Area ( acres):

Design Landfill Depth ( feet): Current Landfill Depth ( feet):

Design Capacity ( tons):

Amount of Waste In Place ( tons): Percent that is Municipal Solid Waste: %

Annual Waste Acceptance Rate ( tons/ yr): Percent that is Municipal Solid Waste: %

For the waste that is in place, please estimate the percent that is not MSW ( if any):

_____ Construction and demolition _____ Industrial _____ Other ( please describe):

Is landfill currently required by New Source Performance Standards or Emissions Guidelines ( NSPS/ EG)

to combust landfill gas? Yes No If yes or not yet, by what date? / /

LANDFILL GAS INFORMATION How much landfill gas is generated? _______ mmscfd How was the amount of landfill gas generated determined?

Field Testing

Modeling Is a collection system in place? Yes No If yes, how much gas is collected? _______ mmscfd Are there flares in place and if so how many? Yes No Number of flares:______

How much gas is flared?_______ mmscfd If there is an operational LFGE project, how much gas is flared in a back up flare? ______ mmscfd OMB Control # 2060 0446 Expiration Date [ Insert]

Developer  3 Landfill and Project Information ( continued)

Organization Name:______________________________________________________

GAS TO ENERGY PROJECT DEVELOPMENT INFORMATION How is the recovered landfill gas used or intended to be used? For example, is the landfill gas burned directly in a boiler or heater, used as fuel for a turbine generating electricity that is sold, etc. Please describe:

What is the status of the project? Under Construction Operational Other _____________

On what date did or will the project become operational? / /

How much energy is or will be recovered? Please provide landfill gas flow to the project in mmscfd and/ or capacity in MW. If providing gas flow, please provide the Btu content of the gas.

Nameplate Capacity _______ MW _______ mmscfd of landfill gas at ______ Btu/ scf Actual Capacity _______ MW Who is the end user of the LFG energy?

Please list any other parties involved in this project: OMB Control # 2060 0446 Expiration Date [ Insert]

Industry Partner  1 LMOP Industry Partner Profile Information Please complete the following form and return it to LMOP according to the instructions in the cover letter. Any data in our records have been inserted into this form. Please review this information, make corrections, and fill in the remaining blanks. If you wish to provide additional information, please attach it to this form. Thank you for your assistance!

CONTACT INFORMATION Organization Name: Today's Date: / /

Name of LMOP Coordinator: Telephone Number: ( )

Title: Fax Number: ( )

E mail:

Mailing Address:

( Address) ( Dept./ Floor/ Suite/ Room) ( City) ( State) ( Zip Code)

Organization's Web Address:

May we provide a link from the LMOP Web site to your Web site? ( circle one) Yes No CAPABILITIES AND SERVICES We currently have the following description of your organization in our records:

[ Organization description to be pulled from tracking system]

If no description appears in the space above ( because you are new to the LMOP or a description was not available in our records), we ask that you please provide a summary of your products and services. If a description from our records is available and you would like to revise it, you may do so below. Please provide the new or revised description:

May we include this information on the LMOP Web site or in other LMOP products? ( circle one) Yes No OMB Control # 2060 0446 Expiration Date [ Insert]

Industry Partner  2 Profile Information ( continued)

Organization Name:___________________________________________________________________

INDUSTRY RESOURCE Please provide contact information for personnel in your organization with LFGE project expertise who can serve as a resource for technical information. Industry resources will be the primary contact for LMOP Partners with technical questions. Areas of resource expertise include project design/ installation, project financing, project facilitation/ development, landfill gas direct use, landfill gas treatment, equipment supplier, alternative uses of landfill gas, and/ or other areas as appropriate. Copy this form as necessary for additional experts. If this form has been filled in with information from our records, please review and correct the information, if necessary. If you wish to provide additional information, please attach it to this form.

Name: Telephone Number: ( )

Title: Fax Number: ( )

E mail:

Mailing Address:

( Address) ( Dept./ Floor/ Suite/ Room) ( City) ( State) ( Zip Code)

Areas of Expertise:

project design

project facilitation/ development

project installation

equipment supplier

project financing

landfill gas treatment

landfill gas direct use

alternative uses of landfill gas ( please describe):__________________________________________________

other ( please describe):_____________________________________________________________________ OMB Control # 2060 0446 Expiration Date [ Insert]

Community Partner  1 LMOP Community Partner Profile Information Please complete the following form and return it to the LMOP according to the instructions in the cover letter. Any data in our records have been inserted into this form. Please review this information, make corrections, and fill in the remaining blanks. If you wish to provide additional information, please attach it to this form. Thank you for your assistance!

CONTACT INFORMATION Organization Name: Today's Date: / /

Name of LMOP Coordinator: Telephone Number: ( )

Title: Fax Number: ( )

E mail:

Mailing Address:

( Address) ( Dept./ Floor/ Suite/ Room) ( City) ( State) ( Zip Code)

Organization's Web Address:

May we provide a link from the LMOP Web site to your Web site? ( circle one) Yes No PROJECT SUMMARY We currently have the following description of your organization's LFGE project in our records:

[ Project description to be pulled from tracking system]

If no description appears in the space above ( because you are new to the LMOP or a description was not available in our records), we ask that you please provide a short summary of your LFGE project so that we may share your experience with developing a LFGE project.

May we include this information on the LMOP Web site or in other LMOP products? ( circle one) Yes No OMB Control # 2060 0446 Expiration Date [ Insert]

Community Partner  2 Landfill and Project Information Organization Name:_____________________________________________________________

Please make sufficient copies of this form and complete one form for each new LFGE project ( projects for which you did not receive a project profile with this questionnaire) your organization is or has been involved with. If you consider any of the information requested to be confidential, do not provide that information and write in " confidential" instead. If you wish to provide additional information, please attach it to this form.

GENERAL LANDFILL INFORMATION Landfill Name: Project Developer:

Landfill City and State: Landfill County:

Landfill Owner: Landfill Owner Type: Public Private Year Landfill Opened: Landfill Closure Year:

Design Landfill Area ( acres): Current Landfill Area ( acres):

Design Landfill Depth ( feet): Current Landfill Depth ( feet):

Design Capacity ( tons):

Amount of Waste In Place ( tons): Percent that is Municipal Solid Waste: %

Annual Waste Acceptance Rate ( tons/ yr): Percent that is Municipal Solid Waste: %

For the waste that is in place, please estimate the percent that is not MSW ( if any):

_____ Construction and demolition _____ Industrial _____ Other ( please describe):

Is landfill currently required by New Source Performance Standards or Emissions Guidelines ( NSPS/ EG)

to combust landfill gas? Yes No If yes or not yet, by what date? / /

LANDFILL GAS INFORMATION How much landfill gas is generated? _______ mmscfd How was amount of landfill gas generated determined?

Field Testing

Modeling Is a collection system in place? Yes No If yes, how much gas is collected? _______ mmscfd Are there flares in place and if so how many? Yes No Number of flares:______

How much gas is flared? _______ mmscfd If there is an operational LFGE project, how much gas is flared in a back up flare? ______ mmscfd OMB Control # 2060 0446 Expiration Date [ Insert]

Community Partner  3 Landfill and Project Information ( continued)

Organization Name:_____________________________________________________________

GAS TO ENERGY PROJECT DEVELOPMENT INFORMATION How is the recovered landfill gas used or intended to be used? For example, is the landfill gas burned directly in a boiler or heater, used as fuel for a turbine generating electricity that is sold, etc. Please describe:

What is the status of the project? Under Construction Operational Other _______________

On what date did or will the project become operational? / /

How much energy is or will be recovered? Please provide landfill gas flow to the project in mmscfd and/ or capacity in MW. If providing gas flow, please provide the Btu content of the gas.

Nameplate Capacity _______ MW _______ mmscfd of landfill gas at ______ Btu/ scf Actual Capacity _______ MW Who is the end user of the LFG energy?

Please list any other parties involved in this project: OMB Control # 2060 0446 Expiration Date [ Insert]

State Partner  1 LMOP State Partner Profile Information Please complete the following form and return it to the LMOP according to the instructions in the cover letter. Any data in our records have been inserted into this form. Please review this information, make corrections, and fill in the remaining blanks. If you wish to provide additional information, please attach it to this form. Thank you for your assistance!

CONTACT INFORMATION Organization Name: Today's Date: / / Name of LMOP Coordinator: Telephone Number: ( ) Title: Fax Number: ( ) E mail: Mailing Address:

( Address) ( Dept./ Floor/ Suite/ Room) ( City) ( State) ( Zip Code) Organization's Web Address: May we provide a link from the LMOP Web site to your Web site? ( circle one) Yes No STATE INCENTIVES Does your state offer incentives ( grants, tax credits, etc.) for landfill gas to energy projects? Yes No If yes, please describe: OMB Control # 2060 0446 Expiration Date [ Insert]

Utility Partner  1 LMOP Energy Partner: Utility Profile Information Please complete the following form and return it to the LMOP according to the instructions in the cover letter. Any data in our records have been inserted into this form. Please review this information, make corrections, and fill in the remaining blanks. If you wish to provide additional information, please attach it to this form. Thank you for your assistance!

CONTACT INFORMATION Organization Name: Today's Date: / /

Name of LMOP Coordinator: Telephone Number: ( )

Title: Fax Number: ( )

E mail:

Mailing Address:

( Address) ( Dept./ Floor/ Suite/ Room) ( City) ( State) ( Zip Code)

Organization's Web Address:

May we provide a link from the LMOP Web site to your Web site? ( circle one) Yes No Do you have a green power program? Yes No If yes, is LFG included? Yes No Do you have a green pricing program? Yes No If yes, is LFG included? Yes No Does your state have a renewable portfolio standard ( RPS) or goal? Yes No If yes, is LFG included? Yes No OMB Control # 2060 0446 Expiration Date [ Insert]

Utility Partner  2 Project Information Organization Name:___________________________________________________________________

Please make sufficient copies of this form and complete one form for each LFGE project your organization is or has been involved with. If you consider any of the information requested to be confidential, do not provide that information and write in " confidential" instead. If you wish to provide additional information, please attach it to this form.

GENERAL LANDFILL INFORMATION Landfill Name: Landfill City and State:

Landfill Owner: Project Developer:

GAS TO ENERGY PROJECT DEVELOPMENT INFORMATION How is the recovered landfill gas used or intended to be used? For example, is the landfill gas burned directly in a boiler or heater, used as fuel for a turbine generating electricity that is sold, etc. Please describe:

How much energy is or will be recovered? Please provide landfill gas flow to the project in mmscfd and/ or capacity in MW. If providing gas flow, please provide the Btu content of the gas.

Nameplate Capacity _______ MW _______ mmscfd of landfill gas at ______ Btu/ scf Actual Capacity _______ MW On what date did you or will you begin to use LFG? / /

Please list any other parties involved in this project: OMB Control # 2060 0446 Expiration Date [ Insert]

End User Partner  1 LMOP Energy Partner: End User Profile Information Please complete the following form and return it to the LMOP according to the instructions in the cover letter. Any data in our records have been inserted into this form. Please review this information, make corrections, and fill in the remaining blanks. If you wish to provide additional information, please attach it to this form. Thank you for your assistance!

CONTACT INFORMATION Organization Name: Today's Date: / /

Name of LMOP Coordinator: Telephone Number: ( )

Title: Fax Number: ( )

E mail:

Mailing Address:

( Address) ( Dept./ Floor/ Suite/ Room) ( City) ( State) ( Zip Code)

Organization's Web Address:

May we provide a link from the LMOP Web site to your Web site? ( circle one) Yes No Please provide a brief description of your organization:

ORGANIZATIONAL GOALS We currently have the following description of your organization's goals in our records:

[ Goals to be pulled from tracking system]

If no description appears in the space above ( because you are new to LMOP or a description was not available in our records), we ask that you please provide a summary of any environmental goals your organization may have. If a description from our records is available and you would like to revise it, you may do so below. Please provide the new or revised description:

May we include this information on the LMOP Web site or in other LMOP products? ( circle one) Yes No OMB Control # 2060 0446 Expiration Date [ Insert]

End User Partner  2 Project Information Organization Name:_______________________________________________________________

Please make sufficient copies of this form and complete one form for each new LFGE project ( projects for which you did not receive a project profile with this questionnaire) your organization is or has been involved with. If you consider any of the information requested to be confidential, do not provide that information and write in " confidential" instead. If you wish to provide additional information, please attach it to this form.

GENERAL LANDFILL INFORMATION Landfill Name: Landfill City and State:

Landfill Owner: Project Developer:

GAS TO ENERGY PROJECT DEVELOPMENT INFORMATION How is the recovered landfill gas used or intended to be used? For example, is the landfill gas burned directly in a boiler or heater, used as fuel for a turbine generating electricity that is sold, etc. Please describe:

What is the status of the project? Under Construction Operational Other _____________

On what date did or will the project become operational? / /

How much landfill gas is generated? _______ mmscfd How much energy is or will be recovered? Please provide landfill gas flow to the project in mmscfd and/ or capacity in MW. If providing gas flow, please provide the Btu content of the gas.

Nameplate Capacity _______ MW _______ mmscfd of landfill gas at ______ Btu/ scf Actual Capacity _______ MW Please list any other LMOP parties involved in this project:


[Federal Register Volume 79, Number 101 (Tuesday, May 27, 2014)]
[Notices]
[Pages 30206-30209]
[FR Doc No: 2014-12075]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72196; File No. SR-FINRA-2014-005]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing of Partial Amendment No. 1 and Order
Instituting Proceedings to Determine Whether to Approve or Disapprove a
Proposed Rule Change, as Modified by Partial Amendment No. 1, Relating
to Broadening Arbitrators' Authority to Make Referrals During an
Arbitration Proceeding

May 20, 2014.

I. Introduction

    On July 12, 2010, the Financial Industry Regulatory Authority
(``FINRA'') filed a proposal pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder,\2\ with the Securities and Exchange Commission

(``Commission'') to amend Rule 12104 (Effect of Arbitration on FINRA
Regulatory Activities) of the Code of Arbitration Procedure for
Customer Disputes (``Customer Code'') and Rule 13104 (Effect of
Arbitration on FINRA Regulatory Activities) of the Code of Arbitration
Procedure for Industry Disputes (``Industry Code'') (together,
``Codes'') to permit arbitrators to make referrals to FINRA during an
arbitration case, and to adopt new rules to address the assessment of
hearing session fees, costs, and expenses if an arbitrator made a
referral during a case that resulted in withdrawal of the entire panel
(``original proposal'').\3\ Under the original proposal, if an
arbitrator made a mid-case referral, a party could request that the
referring arbitrator withdraw. Upon a party's request that the
referring arbitrator withdraw, the entire panel also would have been
required to withdraw. On July 7, 2011, FINRA responded to comments
received by the Commission by filing an amendment to the original
proposal,\4\ which replaced it in its entirety.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Rel. No. 62930 (Sept. 17, 2010),
75 FR 58007 (Sept. 23, 2010) (SR-FINRA-2010-036).
    \4\ See Securities Exchange Act Rel. No. 64954 (Jul. 25, 2011),
76 FR 45631 (Jul. 29, 2011) (SR-FINRA-2010-036) (Notice of Filing
Proposed Rule Change and Amendment No. 1 to Amend the Codes of
Arbitration Procedure To Permit Arbitrators To Make Mid-Case
Referrals) (hereinafter, the ``amended original proposal,'' to
distinguish Amendment No.1 to the original proposal from the current
proposal as amended by Partial Amendment No. 1. See infra, Section
IV).
---------------------------------------------------------------------------

    Under the amended original proposal, an arbitrator would have been
permitted to make a mid-case referral if he or she became aware of any
matter or conduct that the arbitrator had reason to believe posed a
serious ongoing or imminent threat that was likely to harm investors. A
mid-case referral could not have been based solely on allegations in
the pleadings. The amended original proposal also would have instructed
the arbitrator to wait until the arbitration concluded to make a
referral if investor protection would not have been materially
compromised by the delay. Further, if an arbitrator made a mid-case
referral, the Director of Arbitration (``Director'') would have
disclosed the act of making the referral to the parties, and a party
would have been permitted to request recusal of the referring
arbitrator. The amended original proposal would have required either
the President of FINRA Dispute Resolution (``President'') or the
Director to evaluate the referral and determine whether to forward it
to other divisions of FINRA for further review. Finally, the amended
original proposal would have retained the provision in Rule 12104(b) of
the Customer Code and Rule 13104(b) of the Industry Code that permits
an arbitrator to make a post-case referral. The Commission received
five comment letters in response to the amended original proposal.
    On January 29, 2014, FINRA withdrew the amended original proposal
\5\ without responding to the comments and filed the current proposal.
The current proposal is identical to the amended original proposal and
FINRA's filing responds to comments received on the amended original
proposal. The proposed rule change was published for comment in the
Federal Register on February 12, 2014.\6\ The Commission received ten
comment letters in response to the current proposal.\7\ On March 28,
2014, FINRA extended to May 20, 2014 the time period in which the
Commission must approve the proposed rule change, disapprove the
proposed rule change, or institute proceedings to determine whether to
approve or disapprove the proposed rule change. On May 19, 2014, FINRA
responded to the comments and filed Partial Amendment No. 1 to the
current proposal.\8\
---------------------------------------------------------------------------

    \5\ See SR-FINRA-2010-036, Withdrawal of Proposed Rule Change,
available at http://www.finra.org/Industry/Regulation/RuleFilings/2010/P121722.
    \6\ See Securities Exchange Act Rel. No. 71534 (Feb 12, 2014),
79 FR 9523 (Feb. 19, 2014) (SR-FINRA-2014-005) (``Notice of
Filing'').
    \7\ See Letters from Gary Berne, Stolle Berne, dated Feb. 6,
2014 (``Berne''); Jason Doss, President, Public Investors
Arbitration Bar Association, dated Feb. 26, 2014 (``PIABA''); Steven
B. Caruso, Esq., Maddox Hargett & Caruso, P.C., dated Mar. 4, 2014
(``Caruso''); George H. Friedman, George H. Friedman Consulting,
LLC, dated Mar. 5, 2014 (``Friedman''); William A. Jacobson,
Clinical Professor of Law, Cornell Law School, and Director, Cornell
Securities Law Clinic, dated Mar. 11, 2014 (``Cornell''); William D.
Nelson, Lewis Roca Rothgerber LLP, dated Mar. 11, 2014 (``Nelson'');
Nicole G. Iannarone, Esq., Assistant Clinical Professor, Georgia
State University College of Law Investor Advocacy Clinic, dated Mar.
11, 2014 (``GSU''); Elissa Germaine, Supervising Attorney, and
Michelle N. Robinson, Student Intern, Pace Investor Rights Clinic,
Pace Law School, dated Mar. 12, 2014 (``Pace''); Ryan Jennings,
Christian Corkery, and Daniel Coleman, Legal Interns, St. John's
University School of Law Securities Arbitration Clinic, dated Mar.
12, 2014 (``St. John's''); and Richard P. Ryder, Esquire, President,
Securities Arbitration Commentator, dated Mar. 12, 2014 (``Ryder'').
Comment letters are available at http://www.sec.gov.
    \8\ See Letter from Mignon McLemore, Assistant General Counsel,
FINRA Dispute Resolution, to Lourdes Gonzalez, Commission, dated May
19, 2014 (``FINRA Response''). The FINRA Response and the text of
Partial Amendment No. 1 are available on FINRA's Web site at http://www.finra.org, at the principal office of FINRA, and at the
Commission's Public Reference Room. The FINRA Response is also
available on the Commission's Web site at http://www.sec.gov.
---------------------------------------------------------------------------

    The Commission is publishing this notice and order to solicit
comments on Partial Amendment No. 1 from interested persons and to
institute proceedings pursuant to Section 19(b)(2)(B) of the Act \9\ to
determine whether to approve or disapprove the proposed rule change as
modified by Partial Amendment No. 1.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

    Institution of proceedings does not indicate that the Commission
has reached any conclusions with respect to the proposed rule change,
nor does it mean that the Commission will ultimately disapprove the
proposed rule change. Rather, as discussed below, the Commission seeks
additional input from interested parties on the proposed rule change,
as modified by Partial Amendment No. 1, and issues presented by the
proposal.

II. Description of the Proposed Rule Change

    As further described in the Notice of Filing, FINRA is proposing to
amend Rule 12104 of the Customer Code and Rule 13104 of the Industry
Code to broaden arbitrators' authority to make referrals during an
arbitration proceeding. Under the current proposal, an arbitrator would
be permitted to make a mid-case referral if the arbitrator becomes
aware of any matter or conduct that the arbitrator has reason to
believe poses a serious ongoing or imminent threat that is likely to
harm investors. A mid-case referral could not be based solely on
allegations in the pleadings. The proposed rule change would further
provide that when a case is nearing completion, the arbitrator should
wait until the case concludes to make a referral if, in the
arbitrator's judgment, investor protection would not be materially
compromised by the delay. If an arbitrator makes a mid-case referral,
the Director would disclose the act of making the referral to the
parties, and a party would be permitted to request recusal of the
referring arbitrator. The proposal would require either the President
or the Director to evaluate the referral and determine whether to
forward it to other divisions of FINRA for further review. Finally, the
proposal would retain the provision in Rule 12104(b) of the Customer
Code and Rule 13104(b) of the Industry Code that permits an arbitrator
to make a post-case referral.

III. Discussion of Public Comments on the Proposed Rule

    The Commission received ten comment letters \10\ on the current
proposal, two of which support the

current proposal; \11\ three of which support the goal of the current
proposal, but seek some modifications; \12\ and five of which oppose
the current proposal.\13\ Supporters believe that permitting
arbitrators to make mid-case referrals would be beneficial for public
investors \14\ and help FINRA to detect and respond to ongoing fraud
more quickly.\15\ Other commenters, however, raised concerns regarding
various aspects of the proposal. For example, some commenters suggested
that a referral would lead to requests for recusals or challenges to
awards because of perceived bias, and that investors would be unfairly
burdened by disruptions in arbitration proceedings that might result
from an arbitrator making a mid-case referral and receiving a recusal
request.\16\ Commenters suggested different approaches, including
requiring FINRA or the party that requested recusal to compensate an
investor whose case is disrupted by a mid-case referral that leads to
one or more arbitrators recusing themselves,\17\ explicitly excluding
referrals as a basis for recusal of an arbitrator or panel,\18\ and
excluding referrals as a basis for challenging an award.\19\ Some
commenters suggested that the proposed rule would offer limited help to
FINRA to uncover fraud \20\ and would negatively affect investors if a
mid-case referral could be used as grounds to request recusal of an
arbitrator \21\ or to challenge the arbitration award.\22\ Other
commenters suggested that the proposed rule would compromise the
integrity of the arbitration process and arbitrator neutrality.\23\ On
May 19, 2014, FINRA responded to the comments \24\ and filed Partial
Amendment No. 1 to the proposed rule change. The Commission is
considering FINRA's response and Partial Amendment No. 1, both of which
are in the public comment file for this rule filing.
---------------------------------------------------------------------------

    \10\ See note 7, supra.
    \11\ See Caruso and Friedman.
    \12\ See GSU, PACE, and Cornell.
    \13\ See PIABA, Berne, Nelson, St. John's, and Ryder.
    \14\ See Caruso.
    \15\ See Friedman.
    \16\ See Berne, PIABA, GSU, PACE, Nelson, St. John's, and Ryder.
    \17\ See PIABA.
    \18\ See PACE and Cornell.
    \19\ See Cornell.
    \20\ See St. John's, Nelson, PIABA.
    \21\ See PACE, GSU, and Cornell.
    \22\ See Cornell.
    \23\ See Berne, Nelson, Ryder, and St. John's.
    \24\ See FINRA Response, note 8, supra.
---------------------------------------------------------------------------

IV. escription of Partial Amendment No. 1

    On May 19, 2014, FINRA proposed in Partial Amendment No. 1 that a
party that wishes to request recusal of an arbitrator following a mid-
case referral must do so within three days of being notified of the
referral. FINRA believes that Partial Amendment No. 1 would prevent a
party from receiving notice of the mid-case referral and reserving the
right to strategically request recusal when it would best benefit that
party.

V. Proceedings to Determine Whether to Approve or Disapprove SR-FINRA-
2014-005 and Grounds for Disapproval Under Consideration

    The Commission is instituting proceedings pursuant to Section
19(b)(2)(B) of the Act to determine whether to approve or disapprove
the proposed rule change.\25\ Institution of such proceedings appears
appropriate at this time in view of the legal and policy issues raised
by the proposal. As noted above, institution of proceedings does not
indicate that the Commission has reached any conclusions with respect
to any of the issues involved. Rather, the Commission seeks and
encourages interested persons to comment on the proposed rule change,
as modified by Partial Amendment No. 1, and to provide the Commission
with arguments to support the Commission's analysis as to whether to
approve or disapprove the proposal, as amended.
---------------------------------------------------------------------------

    \25\ 15 U.S.C. 78s(b)(2). Section 19(b)(2)(B) of the Act
provides that proceedings to determine whether to approve or
disapprove a proposed rule change must be concluded within 180 days
of the date of publication of notice of the filing of the proposed
rule change. The time for conclusion of the proceedings may be
extended for up to an additional 60 days if the Commission
determines that a longer period is appropriate and publishes its
reasons for so finding or if the self-regulatory organization that
filed the proposed rule change consents to the extension.
---------------------------------------------------------------------------

    Pursuant to Section 19(b)(2)(B) of the Act,\26\ the Commission is
providing notice of the grounds for disapproval under consideration.
Section 15A(b)(6) of the Act\27\ requires, among other things, that
FINRA rules must 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. The
Commission believes FINRA's proposed rule change, as amended, raises
questions as to whether it is consistent with the requirements of
Section 15A(b)(6) of the Act.
---------------------------------------------------------------------------

    \26\ 15 U.S.C. 78s(b)(2)(B).
    \27\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

VI. Request for Written Comments

    The Commission requests that interested persons provide written
submissions of their views, data, and arguments with respect any issues
raised by the proposed rule change, as modified by Partial Amendment
No. 1. In particular, the Commission invites the written views of
interested persons concerning (1) any issues related to the changes
made to the proposal by Partial Amendment No. 1 and (2) whether the
proposed rule change, as modified by Partial Amendment No. 1, is
consistent with Section 15A(b)(6) of the Act. The Commission also
requests comment on the issues raised by FINRA's response to comments.
    In addition, the Commission requests that interested persons
provide written submissions of their views, data, and arguments with
respect to questions raised by commenters about the potentially adverse
consequences of the proposal for retail investors whose cases may be
delayed or disrupted by a mid-case referral. These questions include:
     Would the proposal adversely affect retail investors? If
so, how?
     Should FINRA propose a different standard for referral? If
so, what standard(s) would be appropriate?
     Does Partial Amendment No. 1 ameliorate commenters'
concerns that notifying parties of a mid-case referral could lead to
adverse consequences to the claimant, including requests for recusal
and challenges to an award? If not, should FINRA amend the proposal to
preclude the Director, or anyone else, from notifying the parties of a
referral?
    Although there do not appear to be any issues relevant to approval
or disapproval that would be facilitated by an oral presentation of
views, data, and arguments, the Commission will consider, pursuant to
Rule 19b-4(g) promulgated under the Act, any request for an opportunity
to make an oral presentation.\28\
---------------------------------------------------------------------------

    \28\ See Section 19(b)(2) of the Act, as amended by the
Securities Acts Amendments of 1975, Public Law 94-29, 89 Stat. 97
(1975), grants the Commission flexibility to determine what type of
proceeding--either oral or notice and opportunity for written
comments--is appropriate for consideration of a particular proposal
by a self-regulatory organization. See also Securities Acts
Amendments of 1975, Report of the Senate Committee on Banking,
Housing and Urban Affairs to Accompany S. 249, S. Rep. No. 75, 94th
Cong., 1st Sess. 30 (1975).
---------------------------------------------------------------------------

    Interested persons are invited to submit written data, views, and
arguments by June 26, 2014 concerning whether the proposed rule change,
as modified by Partial Amendment No. 1, should be approved or
disapproved. Any person who wishes to file a rebuttal to any other
person's submission must file that rebuttal by July 11, 2014. Comments
may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2014-005 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-FINRA-2014-005. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principle office of FINRA. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make publicly available.
    All submissions should refer to File Number SR-FINRA-2014-005 and
should be submitted on or before June 26, 2014. If comments are
received, any rebuttal comments should be submitted by July 11, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\29\
Kevin M. O'Neill,
Deputy Secretary.
---------------------------------------------------------------------------

    \29\ 17 CFR 200.30-3(a)(12); 17 CFR 200.30-3(a)(57).
---------------------------------------------------------------------------

[FR Doc. 2014-12075 Filed 5-23-14; 8:45 am]
BILLING CODE 8011-01-P


Proposed Rule:  Final Confidentiality Determinations for Nine Subparts and Amendments to Subpart A and I under the Mandatory Reporting of Greenhouse Gases Rule
Meeting Documentation:  SIA and IBM, March 30, 2012

Date
Staff Contact Information (Name, email, phone #)
Name of Organization (Attach list of all attendees names and emails if possible)
Summary of Discussion (e.g., applicability, reporting requirements, etc.)
Written Comments Provided?
Did they also submit to Docket?
Date sent to EPA- CCD

3/30/12

Lisa Bacanskas
<EMAIL_ADDRESS>202-343-9758

On the phone:

Julie Hatcher, SIA
David Isaacs, SIA
Jay Dietrich, IBM
Brian Lynk, Department of Justice

Among the issues: CBI determinations for subpart I
Submitted comments to the docket


[Federal Register: July 21, 2006 (Volume 71, Number 140)]
[Notices]
[Page 41485-41487]
[DOCID:fr21jy06-81]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-54153; File No. SR-CBOE-2006-63]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change Relating to Its Marketing Fee Program

July 14, 2006.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on June 30, 2006, the Chicago Board Options Exchange, Incorporated
(``CBOE'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been prepared by the
Exchange. The CBOE has designated this proposal as one establishing or
changing a due, fee, or other charge imposed by the CBOE under Section
19(b)(3)(A)(ii) of the Act \3\ and Rule 19b-4(f)(2) thereunder,\4\
which renders the proposal effective upon filing with the Commission.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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

    The CBOE proposes to amend its marketing fee program. Below is the
text of the proposed rule change. Proposed new language is in italics;
deleted language is in [brackets].

Chicago Board Options Exchange, Inc.

Fees Schedule

June [2]30, 2006
    1. No Change.
    2. MARKETING FEE (6)(16)--$.65
    3.-4. No Change.

Footnotes:

    (1)-(5) No Change.
    (6) The Marketing Fee will be assessed only on transactions of
Market-Makers, RMMs, e-DPMs, DPMs, and LMMs resulting from orders for
less than 1,000 contracts (i) from payment accepting firms, or (ii)
that have designated a ``Preferred Market-Maker'' under CBOE Rule 8.13
at the rate of $.65 per contract on all classes of equity options,
options on HOLDRs, options on SPDRs, options on DIA, options on NDX,
and options on RUT. The fee will not apply to: Market-Maker-to-Market-
Maker transactions including transactions resulting from orders from
non-member market-makers; transactions resulting from inbound P/A
orders or a transaction resulting from the execution of an order
against the DPM's account if an order directly related to that order is
represented and executed through the Linkage Plan using the DPM's
account; transactions resulting from accommodation liquidations
(cabinet trades); and transactions resulting from dividend strategies,
merger strategies, and short stock interest strategies as defined in
footnote 13 of this Fees Schedule. This fee shall not apply to index
options and options on ETFs (other than options on SPDRs, options on
DIA, options on NDX, and options on RUT). A Preferred Market-Maker will
only be given access to the marketing fee funds generated from a
Preferred order if the Preferred Market-Maker has an appointment in the
class in which the Preferred order is received and executed.
    DPM/LMM Rebate/Carryover Process. If less than 80% of the marketing
fee funds collected in a given month are paid out by the DPM/LMM [or
Preferred Market-Maker in a given month], then the Exchange would
refund such surplus at the end of the month on a pro rata basis based
upon contributions made by the Market-Makers, RMMs, e-DPMs, DPMs and
LMMs in that month. However, if 80% or more of the [accumulated] funds
collected in a given month are paid out by the DPM/LMM [or Preferred
Market-Maker], there will not be a rebate for that month and the excess
funds will [carry over and will] be included in [the] an Excess [p]Pool
of funds to be used by the DPM/LMM [or Preferred Market-Maker the
following] in subsequent months. The total balance of the Excess Pool
of funds cannot exceed $25,000, and if in any month the balance were to
exceed $25,000, the funds in excess of $25,000 would be refunded[At the
end of each quarter, the Exchange would then refund any surplus, if
any,] on a pro rata basis based upon contributions made by the Market-
Makers, RMMs, DPMs, e-DPMs and LMMs in that month.
    Preferred Market-Maker Rebate/Carryover Process. If less than 80%
of the marketing fee funds are paid out by the Preferred Market-Maker
in a given month, then the Exchange would refund such surplus at the
end of the month on a pro rata basis based upon contributions made by
the Market-Makers, RMMs, e-DPMs, DPMs and LMMs in that month. However,
if 80%

or more of the accumulated funds in a given month are paid out by the
Preferred Market-Maker, there will not be a rebate for that month and
the funds will carry over and will be included in the pool of funds to
be used by the Preferred Market-Maker the following month. At the end
of each quarter, the Exchange would then refund any surplus, if any, on
a pro rata basis based upon contributions made by the Market-Makers,
RMMs, DPMs, e-DPMs and LMMs in the final month of the quarter. CBOE's
marketing fee program as described above will be in effect until June
2, 2007.
    Remainder of Fees Schedule--No change.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change, and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The CBOE has prepared summaries, set forth in Sections
A, B, and C below, of the most significant aspects of such statements.

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

1. Purpose
    The CBOE proposes to amend its marketing fee to modify the manner
in which marketing fee funds collected during a calendar quarter are
refunded. The CBOE states that its marketing fee currently provides
that if less than 80% of the marketing fee funds are paid out by the
DPM/LMM or Preferred Market-Maker in a given month, then the Exchange
would refund such surplus at the end of the month on a pro rata basis
based upon contributions made by the Market-Makers, RMMs, e-DPMs, DPMs,
and LMMs. However, if 80% or more of the accumulated funds in a given
month are paid out by the DPM/LMM or Preferred Market-Maker, there will
not be a rebate for that month and the funds will carry over and will
be included in the pool of funds to be used by the DPM/LMM or Preferred
Market-Maker the following month. At the end of each quarter, the
Exchange would then refund any surplus, if any, on a pro rata basis
based upon contributions made by the Market-Makers, RMMs, DPMs, e-DPMs,
and LMMs.
    The CBOE states that the purpose of this rule change is to modify
the rebate process as it relates to DPMs. As amended, if less than 80%
of the marketing fee funds collected in a given month are paid out by
the DPM/LMM, then the Exchange would refund such surplus at the end of
the month on a pro rata basis based upon contributions made by the
Market-Makers, RMMs, e-DPMs, DPMs, and LMMs in that month. However, if
80% or more of the funds collected in a given month are paid out by the
DPM/LMM, there would not be a rebate for that month and the excess
funds would be included in an excess pool (``Excess Pool'') of funds to
be used by the DPM/LMM in subsequent months. The CBOE states that the
total balance of the Excess Pool of funds could not exceed $25,000, and
if in any month the balance were to exceed $25,000, the funds in excess
of $25,000 would be refunded on a pro rata basis based upon
contributions made by the Market-Makers, RMMs, DPMs, e-DPMs, and LMMs
in that month. As before, in the event a DPM/LMM is also marked as a
Preferred Market-Maker on a particular order, the funds collected from
the order will be allocated to the DPM in its capacity as a DPM and not
as a Preferred Market-Maker.
    The Exchange states that the rebate and carryover process for
Preferred Market-Makers will continue to operate on a quarterly basis.
However, CBOE proposes to make one clarification to the rebate process
for Preferred Market-Makers in the text of the Fees Schedule to make it
consistent with the current process and procedure for rebating excess
funds. As noted above, if less than 80% of the marketing fee funds are
paid out by the Preferred Market-Maker in a given month, then the
Exchange would refund such surplus at the end of the month on a pro
rata basis based upon contributions made by the Market-Makers, RMMs, e-
DPMs, DPMs, and LMMs. CBOE states that it refunds the money based on
the contributions made by these market participants in that specific
month.
    If there are surplus funds at the end of the quarter, CBOE
represents that it refunds the money on a pro rata basis based upon
contributions made by the Market-Makers, RMMs, e-DPMs, DPMs, and LMMs
in the final month of the quarter. CBOE believes that refunding surplus
funds to market participants on a pro rata basis based upon
contributions made in the final month of the quarter, as opposed to
based upon contributions made during the preceding three months, would
be an equitable allocation of dues and fees due to the manner in which
the marketing fee funds collected are paid out and how CBOE accounts
for the funds on a month-to-month basis. For example, if at least 80%,
but less than 100%, of the funds collected in the 1st month of a
quarter is paid out, the balance that carries over to the 2nd month is
paid out first in that 2nd month. Similarly, if at least 80%, but less
than 100%, of the funds collected in the 2nd month is paid out, the
balance that carries over to the 3rd month is paid out first in that
3rd month. As a result, any surplus of funds at the end of the quarter
(the 3rd month) was contributed by the Market-Makers, RMMs, e-DPMs,
DPMs, and LMMs who were assessed the fee in that month.
    CBOE states that it is not amending its marketing fee program in
any other respects.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\5\ in general, and furthers the
objectives of Section 6(b)(4) of the Act,\6\ in particular, in that it
is designed to provide for the equitable allocation of reasonable dues,
fees, and other charges among CBOE members.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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

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

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

    The Exchange neither solicited nor received comments on the
proposal.

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

    The foregoing proposed rule change has been designated as a fee
change pursuant to Section 19(b)(3)(A)(ii) of the Act \7\ and Rule 19b-
4(f)(2) \8\ thereunder, because it establishes or changes a due, fee,
or other charge imposed by the Exchange. Accordingly, the proposal will
take effect upon filing with the Commission. At any time within 60 days
of the filing of such proposed rule change the Commission may summarily
abrogate such rule change if it appears to the Commission that such
action is necessary or appropriate in the public

interest, for the protection of investors, or otherwise in furtherance
of the purposes of the Act.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \8\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

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

File Number SR-CBOE-2006-63 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CBOE-2006-63. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of the CBOE. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-CBOE-2006-63 and should be submitted on or before August
11, 2006.

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

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

Jill M. Peterson,
Assistant Secretary.
 [FR Doc. E6-11568 Filed 7-20-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 87, Number 208 (Friday, October 28, 2022)]
[Notices]
[Pages 65210-65211]
[FR Doc No: 2022-23457]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-1261]

Clostridioides difficile Infection: Developing Drugs for
Treatment, Reduction of Recurrence, and Prevention; Draft Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Clostridioides difficile Infection: Developing Drugs for Treatment,
Reduction of Recurrence, and Prevention.'' The purpose of this draft
guidance is to assist sponsors in the clinical development of drugs for
the treatment of Clostridioides difficile infection (CDI), reduction of
recurrence, or prevention of CDI.

DATES: Submit either electronic or written comments on the draft
guidance by December 27, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

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

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked, and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2022-D-1261 for ``Clostridioides difficile Infection: Developing
Drugs for Treatment, Reduction of Recurrence, and Prevention.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Ramya Gopinath, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6154, Silver Spring, MD 20993, 240-402-
5328.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Clostridioides difficile Infection: Developing Drugs for
Treatment, Reduction of Recurrence, and Prevention.'' The purpose of
this draft guidance is to assist sponsors in the clinical development
of drugs for treatment, reduction of recurrence, or prevention of CDI.
Specifically, this guidance addresses FDA's current thinking regarding
clinical trial design considerations such as trial populations and
efficacy endpoints for treatment of CDI, reduction of recurrence, and
prevention.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on
``Clostridioides difficile Infection: Developing Drugs for Treatment,
Reduction of Recurrence, and Prevention.'' It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information relating to regulations found in 21 CFR parts 58, 312,
314, and 601 have been approved under OMB control numbers 0910-0119,
0910-0014, 0910-0001, and 0910-0338, respectively.

III. Electronic Access

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

    Dated: October 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23457 Filed 10-27-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 70 (Wednesday, April 12, 2023)]
[Proposed Rules]
[Pages 21940-21944]
[FR Doc No: 2023-07647]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2022-0237]
RIN 1625-AA09

Drawbridge Operation Regulation; Keweenaw Waterway, Between
Houghton and Hancock, MI

AGENCY: Coast Guard, DHS.

ACTION: Notification of proposed rulemaking.

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

SUMMARY: The Coast Guard proposes to change the operating schedule that
governs the US41 Bridge, mile 16.0, over the Keweenaw Waterway between
the towns of Houghton and Hancock, Michigan. The Michigan Department of
Transportation, who owns and operates the bridge, has requested a
change to the drawbridge operation schedule to help facilitate the
movement of all modes of transportation at the bridge. We invite your
comments on this proposed rulemaking.

DATES: Comments and related material must reach the Coast Guard on or
before June 12, 2023.

ADDRESSES: You may submit comments identified by docket number USCG-
2022-0237 using Federal Decision-Making Portal at https://www.regulations.gov.
    See the ``Public Participation and Request for Comments'' portion
of the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call or email Mr. Lee D. Soule, Bridge Management Specialist,
Ninth Coast Guard District; telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
IGLD85 International Great Lakes Datum of 1985
LWD Low Water Datum Based on IGLD85
OMB Office of Management and Budget
MDOT Michigan Department of Transportation
NPRM Notice of Proposed Rulemaking (Advance, Supplemental)
Sec.  Section
U.S.C. United States Code

II. Background, Purpose and Legal Basis

    The US41 Bridge, mile 16.0, over the Keweenaw Waterway between the
towns of Houghton and Hancock, Michigan, is owned and operated by MDOT
and is the only crossing over the waterway. The US41 Bridge, mile 16.0,
over the Keweenaw Waterway is a combination highway and railroad double
deck lift bridge that provides a horizontal clearance of 7-feet in the
down position, 103-feet in the open position, and 35-feet in the
intermediate position above LWD.
    The Keweenaw Waterway divides the Keweenaw Peninsula and is in the
middle of the south shore of Lake Superior, a Great Lake known for
hazardous weather conditions.
    The federal government improved the Keweenaw Waterway in 1861 to
accommodate interstate commerce and create a harbor of safe refuge for
vessels caught in bad weather and is located halfway between Duluth,
Minnesota and Sault Ste. Marie, Michigan. Commercial vessels, including
some over 700-feet in length, and powered and non-powered recreational
vessels utilize the waterway. The passenger vessel RANGER III operates
from the east side of the US41 Bridge, mile 16.0, over the Keweenaw
Waterway to Isle Royal and is operated by the National Park Service
with a capacity of 128-passengers. A U.S. Coast Guard Station is
located at the far west end of the waterway.
    The bridge has special operating conditions listed in 33 CFR
117.635 that requires the bridge to open on signal; except that from
April 15 through December 14, between midnight and 4 a.m., the draw
shall be placed in the intermediate position and open on signal if at
least 2 hours' notice is given. From December 15 through April 14 the
draw shall open on signal if at least 12 hours' notice is given.
    MDOT has requested a new operating schedule to relieve commuter and
commercial vehicle traffic congestion at the bridge on weekdays; the
new schedule will not apply to federal holidays. Traffic data impacted
by COVID-19 restrictions would not provide the public with an accurate
assessment of the traffic conditions at the bridge and have
intentionally not been considered.

III. Discussion of Proposed Rule

    The MDOT requested three ``rush hour restrictions for openings at
the bridge to ease the traffic congestion at the crossing. During the
test deviation we gathered data and proved there was not three rush
hours at the bridge but rather a gradual increase throughout the day in
the number of vehicles crossing the bridge. From there we developed a
test deviation to gather data throughout the summer and developed the
proposed rule.
    On November 1, 2022, we published in the Federal Register (87 FR
30418) a Notice of temporary deviation from regulations with a request
for comments. The commenting period was open from May 1, 2022, through
November 1, 2022, to give everyone ample time to observe the test
deviation and comment. The State of Michigan's Department of
Transportation gathered data throughout the test deviation, and we will
present that data later in this document.
    The test deviation and how the public could comment was shared in
the local online newspapers, television, and radio stations. The Coast
Guard informally reached out to local government and local marine users
before the test deviation was started to see what the perceived issues
were at the bridge and how scheduled openings could help alleviate the
disparities between vehicle crossings and vessel traffic.
    The Coast Guard advertised the test deviation in the Local Notice
to Mariners and a Broadcast Notice to Mariners that was also released.
The Ninth Coast Guard Bridge Office also included the test deviation in
its weekly bridge email that is shared with approximately 350 waterway
users.
    The Michigan Department of Transportation provided vehicle crossing
data during the test deviation to discover if there were peak traffic
hours often referred to as rush hours at this crossing. The following
chart shows the vehicle data collected.
BILLING CODE 9110-04-P

[GRAPHIC] [TIFF OMITTED] TP12AP23.026

    There is a traffic spike on June 15 and June 16 associated with a
festival celebrating the bridge. Otherwise the data proves the delays
at the bridge are not commensurate with traditional rush hour times and
limiting bridge openings to three times a day would not help elevate
congestion at the bridge. The bridge experiences a steady flow of
traffic from 7 a.m. to 7 p.m.
[GRAPHIC] [TIFF OMITTED] TP12AP23.027

    Local politicians and law enforcement departments insisted that
there are three definite rush hours at the bridge and limiting openings
during those times would successfully improve the flow of traffic;
however, the data provided does not support the theory of three
distinct rush hours at the bridge. Based on the data above provided by
the MDOT the flow of traffic increases from 6 a.m. to 4 p.m. and then
it reduces without any significant spikes typical in a rush hour.

[GRAPHIC] [TIFF OMITTED] TP12AP23.028

    We analyzed the data from the test deviation using the drawtender
logs to determine what class of vessel requested the most openings.
Recreational vessels request openings 55 times between the hours of 7
a.m. and 7 p.m. and the Passenger vessel Ranger III requested 43
openings during the same times.
    During the test deviation between 7 a.m. and 7 p.m., Monday through
Friday, less federal holidays, vessels 300 feet and smaller were
required to wait for an opening on the hour or half-hour. This limited
bridge openings to a 20-minute period every hour allowing vehicles to
cross the bridge during the other 40-minutes. The test deviation proved
that the reasonable needs of navigation can still be met at the bridge
with scheduled openings.
    We invited the public to comment on this test deviation and we
received three comments. Two commentors provided an analysis based on
their personal preference without providing any supportive data. The
third comment was from the National Parks Service--Isle Royale National
Park.
    The National Parks Service stated the test deviation did not
provide any opportunity for stakeholder input prior to its
implementation. However, in fact, the Coast Guard reached out directly
to the park and the Passenger Vessel Ranger III when we reached out to
local stake holders prior to developing a test schedule. With the
assistance of the MDOT and local Coast Guard Units we received comments
from the city of Houghton and Hancock, the Upper Peninsula Health Care
Group, the Houghton County Board of Commissioners, the Aspirus Keweenaw
Hospital, the Houghton County Sheriff Office, and the Michigan
Department of State Police Calumet Post. Additionally, the local news
outlets ran stories and interviews that the Coast Guard was considering
a schedule that would help balance both land and waterway modes of
travel at this crossing. Prior to the test deviation going into effect
several news outlets published the test deviation to the public.
    National Parks Service--Isle Royale National Park also commented
that the temporary deviation negatively impacted their passenger
vessel, the Ranger III, by adding expense to their services and claimed
a significant inconvenience to passengers without providing any data on
how delaying their arrival or departures by 10 or 15 minutes would
adversely affect their services.

[GRAPHIC] [TIFF OMITTED] TP12AP23.029

BILLING CODE 9110-04-C
    Almost 50% of the requested openings were from the Ranger III. The
Ranger III is not the only issue delaying vehicular traffic, but it is
a significant factor to consider if scheduled openings are needed at
this location. Awarding the Ranger III clemency to the proposed bridge
schedule would fail to balance the transportation needs at the bridge
and would eliminate the need for scheduled bridge openings.
    Commercial vessels over 300 feet and government vessels normally
enter the waterway to service the aids to navigation and stock rock
salt for the community. Large commercial vessels holding position in
the canal along with recreational vessels is dangerous due to their
size and limited maneuverability and will be passed through the draw of
the bridge as soon as possible.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive Orders related to rulemaking. Below we summarize our
analyses based on these statutes and Executive Orders.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This NPRM has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, the NPRM
has not been reviewed by the Office of Management and Budget (OMB).
    This regulatory action determination is based on the ability that
vessels can still transit the bridge twice an hour.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit the
bridge may be small entities, for the reasons stated in section IV.A
above this proposed rule would not have a significant economic impact
on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section. The Coast Guard will not retaliate against small entities that
question or complain about this proposed rule or any policy or action
of the Coast Guard.

C. Collection of Information

    This proposed rule would call for no new collection of information
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132
(Federalism), if it has a substantial direct effect on the States, on
the relationship between the National Government and the States, or on
the distribution of power and responsibilities among the various levels
of government. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this proposed rule does not have tribal implications under
Executive Order 13175 (Consultation and Coordination with Indian Tribal
Governments) because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this proposed rule has implications for federalism or
Indian tribes, please contact the person listed

in the FOR FURTHER INFORMATION CONTACT section.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule will not
result in such an expenditure, we do discuss the effects of this
proposed rule elsewhere in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01, Rev. 1, associated implementing
instructions, and Environmental Planning Policy COMDTINST 5090.1
(series), which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f). The
Coast Guard has determined that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This proposed rule promulgates the
operating regulations or procedures for drawbridges. Normally such
actions are categorically excluded from further review, under paragraph
L49, of Chapter 3, Table 3-1 of the U.S. Coast Guard Environmental
Planning Implementation Procedures.
    Neither a Record of Environmental Consideration nor a Memorandum
for the Record are required for this rule. We seek any comments or
information that may lead to the discovery of a significant
environmental impact from this proposed rule.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal Decision
Making Portal at https://www.regulations.gov. To do so, go to https://www.regulations.gov, type USCG-2022-0237 in the search box and click
``Search.'' Next, look for this document in the Search Results column,
and click on it. Then click on the Comment option. If your material
cannot be submitted using https://www.regulations.gov, contact the
person in the FOR FURTHER INFORMATION CONTACT section of this document
for alternate instructions.
    To view documents mentioned in this proposed rule as being
available in the docket, find the docket as described in the previous
paragraph, and then select ``Supporting & Related Material'' in the
Document Type column. Public comments will also be placed in our online
docket and can be viewed by following instructions on the https://www.regulations.gov Frequently Asked Questions web page. We review all
comments received, but we will only post comments that address the
topic of the proposed rule. We may choose not to post off-topic,
inappropriate, or duplicate comments that we receive. Additionally, if
you go to the online docket and sign up for email alerts, you will be
notified when comments are posted or a final rule is published of any
posting or updates to the docket.
    We accept anonymous comments. Comments we post to https://www.regulations.gov will include any personal information you have
provided. For more about privacy and submissions in response to this
document, see DHS's eRulemaking System of Records notice (85 FR 14226,
March 11, 2020).

List of Subjects in 33 CFR Part 117

    Bridges.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

0
1. The authority citation for part 117 continues to read as follows:

    Authority:  33 U.S.C. 499; 33 CFR 1.05-1; and DHS Delegation No.
0170.1, Revision No. 01.3.

0
2. Revise Sec.  117.635 to read as follows:

Sec.  117.635  Keweenaw Waterway

    The draw of the U.S. 41 Bridge, mile 16, shall open on signal,
except that:
    (a) From April 15 through December 14, between the hours of 7 a.m.
and 7 p.m. Monday through Friday, less Federal Holidays, the bridge
shall open on signal from five minutes before to five minutes after the
hour and half hour for vessels. Documented vessels over 300-feet shall
not be held at the bridge but will be passed as soon as possible.
    (b) From April 15 through December 14 between midnight and 4 a.m.
daily, the draw shall be placed in the intermediate position and open
on signal if at least 2 hours' notice is given.
    (c) From December 15 through April 14 the draw shall open on signal
if at least 12 hours' notice is given.

M.J. Johnston,
Rear Admiral, U.S. Coast Guard, Commander, Ninth Coast Guard District.
[FR Doc. 2023-07647 Filed 4-11-23; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 80, Number 142 (Friday, July 24, 2015)]
[Proposed Rules]
[Pages 43969-43970]
[FR Doc No: 2015-18221]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 21

[Docket No. FAA-2015-3031]

Proposed Primary Category Airworthiness Design Standards;
AutoGyro USA, LLC (AutoGyro) Model Calidus Gyroplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Request for comments.

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

SUMMARY: This notice announces the existence of and requests comments
on the proposed airworthiness design standards for acceptance of the
AutoGyro Model Calidus gyroplane under the regulations for primary
category aircraft.

DATES: We must receive comments by September 8, 2015.

ADDRESSES: Send all comments to the Federal Aviation Administration
(FAA), Rotorcraft Standards Staff, Rotorcraft Directorate (ASW-110),
FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177.

FOR FURTHER INFORMATION CONTACT: Gary Roach, Aviation Safety Engineer,
Regulations and Policy Group, Rotorcraft Directorate, FAA, 10101
Hillwood Pkwy., Fort Worth, Texas 76177; telephone<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Any person may obtain a copy of this
information by contacting the person named above under FOR FURTHER
INFORMATION CONTACT.

Comments Invited

    We invite you to submit comments on the proposed airworthiness
standards to the address specified above. Commenters must identify the
AutoGyro Model Calidus on all submitted correspondence. The FAA will
consider all communications received on or before the closing date
before issuing the final acceptance. The proposed airworthiness design
standards and comments received may be inspected at the FAA, Rotorcraft
Directorate, Rotorcraft Standards Staff (ASW-110), FAA, 2601 Meacham
Blvd., Fort Worth, TX 76137, between the hours of 7:30 a.m. and 4 p.m.
weekdays, except Federal holidays.

Background

    The ``primary'' category for aircraft was created specifically for
the simple, low performance personal aircraft. Section 21.17(f)
provides a means for applicants to propose airworthiness standards for
their particular primary category aircraft. The FAA procedure
establishing appropriate airworthiness standards includes reviewing and
possibly revising the applicant's proposal, publication of the
submittal in the Federal Register for public review and comment, and
addressing the comments. After all necessary revisions, the standards
are published as approved FAA airworthiness standards.
    Accordingly, the applicant, AutoGyro, has submitted a request to
the FAA to include the following:

Proposed Airworthiness Standards for Acceptance Under the Primary
Category Rule

    For Aircraft Certification and the Powerplant Installation:
    Section T Light Gyroplanes, of the British Civil Airworthiness
Requirements, Issue 3, dated August 12, 2005.
    14 CFR 27.853(a) and (c)(1) Amdt 27-37 Compartment Interior;
Sec. Sec.  23.735(a) through (c) Amdt 23-62 Brakes except that the
reference to 23.75 is replaced with Section T75 of BCAR Section T,
Issue 3; Sec. Sec.  27.735(a) and (c)(1) Amdt 27-21 Brakes; Sec. Sec.
27.1365(b) and (c) Amdt 27-35 Electrical Cables; and Sec.  27.1561(a)
Safety Equipment, as applicable to these aircraft.
    For Engine Assembly Certification:
    ASTM F2339-06 (2009), ``Standard Practice for Design and
Manufacture of Reciprocating Spark Ignition Engines for Light Sport
Aircraft,'' except paragraph A1.1.3.
    For Propeller Certification:
    Section T Light Gyroplanes, of the British Civil Airworthiness
Requirements, Issue 3, dated August 12, 2005; ASTM F2506-10 (2009),
``Standard Specification for Design and Testing of Fixed-Pitch or
Ground Adjustable Light Sport Aircraft Propellers,'' paragraph 5.5
Propeller Strength and Endurance and Section 6 Tests and Inspections.

    Issued in Fort Worth, Texas on July 16, 2015.
Bruce E. Cain,
Acting Directorate Manager, Rotorcraft Directorate, Aircraft
Certification Service.
[FR Doc. 2015-18221 Filed 7-23-15; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 204 (Tuesday, October 22, 2013)]
[Notices]
[Pages 62629-62630]
[FR Doc No: 2013-24693]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2005-0023; FRL--9901-73-OW]

Proposed Information Collection Request; Comment Request; Clean
Water Act Section 404 State-Assumed Programs (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency is planning to submit an
information collection request (ICR), ``Clean Water Act Section 404
State-Assumed Programs'' (EPA ICR No. 0220.12, OMB Control No. 2040-
0168) to the Office of Management and Budget (OMB) for review and
approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.). Before doing so, EPA is soliciting public comments on
specific aspects of the proposed information collection as described
below. This is a proposed extension of the ICR, which is currently
approved through January 31, 2014. An Agency may not conduct or sponsor
and a person is not required to respond to a collection of information
unless it displays a currently valid OMB control number.

DATES: Comments must be submitted on or before December 23, 2013.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OW-
2005-0023, online using www.regulations.gov (our preferred method), by
email to<EMAIL_ADDRESS>or by mail to: EPA Docket Center,
Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania
Ave. NW., Washington, DC 20460.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Kathy Hurld, Office of Wetlands,
Oceans, and Watersheds, Wetlands Division (4502T), Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460;
telephone:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Supporting documents which explain in detail the information that
the EPA will be collecting are available in the public docket for this
ICR. The docket can be viewed online at www.regulations.gov or in
person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution
Ave. NW., Washington, DC. The telephone number for the Docket Center is
202-566-1744. For additional information about EPA's public docket,
visit http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting
comments and information to enable it to: (i) Evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (ii) evaluate the accuracy of
the Agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (iii) enhance the quality, utility, and clarity of the
information to be collected; and (iv) minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses. EPA
will consider the comments received and amend the ICR as appropriate.
The final ICR package will then be submitted to OMB for review and
approval. At that time, EPA will issue another Federal Register notice
to announce the submission of the ICR to OMB and the opportunity to
submit additional comments to OMB.
    Abstract: Section 404(g) of the Clean Water Act authorizes States
[and Tribes] to assume the section 404 permit program for discharges of
dredged or fill material into certain Waters of the U.S. This ICR
covers the collection of information EPA needs to perform its program
approval and oversight responsibilities and the State/Tribe needs to
implement its program.
    Request to assume CWA section 404 permit program. States/Tribes
must demonstrate that they meet the statutory and regulatory
requirements (40 CFR 233) for an approvable program. Specified
information and documents must be submitted by the State/Tribe to EPA
to request assumption and must be sufficient to enable EPA to undertake
a thorough analysis of the State/Tribal program. Once the required
information and documents are submitted and EPA has a complete
assumption request package, the statutory time clock for EPA's decision
to either approve or disapprove the State/Tribe's assumption request
starts. The information contained in the assumption request submission
is provided to the other involved Federal agencies (Corps of Engineers,
US Fish and Wildlife Service, and National Marine Fisheries Service)
and to the general public for review and comment.
    States/Tribes with assumed programs must be able to issue permits
that assure compliance with all applicable statutory and regulatory
requirements, including the 404(b)(1) Guidelines. Sufficient
information must be provided in the application so that States/Tribes,
and Federal agencies reviewing the permit, are able to evaluate, avoid,
minimize and compensate for any anticipated impacts resulting from the
proposed project. EPA's assumption regulations establish required and
recommended elements that should be included in the State/Tribe's
permit application, so that sufficient information is available to make
a thorough analysis of anticipated impacts. (40 CFR 233.30). These
minimum information requirements generally reflect the information that
must be submitted when applying for a section 404 permit from the Corps
of Engineers. (CWA section 404(h); CWA section 404(j); 40 CFR 230.10,
233.20, 233.21, 233.34, and 233.50; 33 CFR 325).
    EPA has an oversight role for assumed 404 permitting programs to
ensure that State/Tribal programs are in compliance with applicable
requirements and that State/Tribal permit decisions adequately
consider, avoid, minimize and compensate for anticipated impacts.
States/Tribes must evaluate their programs annually and submit the
results in a report to EPA. EPA's assumption regulations establish
minimum requirements for the annual report (40 CFR 233.52).
    The information included in the State/Tribe's assumption request
and the information included in a permit application is made available
for public review and comment. The information included in the annual
report to EPA is made available to the public. EPA does not make any
assurances of confidentiality for this information.
    Form numbers: None.
    Respondents/affected entities: Entities potentially affected by
this action are those States/Tribes requesting assumption of the Clean
Water Act section 404 permit program; States/

Tribes with approved assumed programs; and permit applicants in States/
Tribes with assumed programs.
    Respondent's obligation to respond: Required to obtain or retain a
benefit (40 CFR 233)
    Estimated number of respondents: 2 States/Tribes to request program
assumption; 20,000 permit applicants; and 4 States/Tribes which have
assumed the program.
    Frequency of response: States/Tribes will respond one time to
request assumption and once the program is approved they will respond
annually for the annual permit and annual report; permit applicants
will respond one time when requesting a permit.
    Total estimated burden: The public reporting and recordkeeping
burden for this collection of information is estimated to be 101,360
hours per year. Burden is defined at 5 CFR 1320.3(b).
    Total estimated cost: Costs to states for assumed Section 404
permit programs will vary widely by state and permit, however there are
$0 capital or operation & maintenance costs.
    Changes in Estimates: There is no change in hours in the total
estimated respondent burden compared with the ICR currently approved by
OMB.

    Dated: September 27, 2013.
Benita Best-Wong,
Acting Director, Office of Wetlands, Oceans, and Watersheds.
[FR Doc. 2013-24693 Filed 10-21-13; 8:45 am]
BILLING CODE 6560-50-P