[Federal Register Volume 79, Number 211 (Friday, October 31, 2014)]
[Notices]
[Pages 64760-64761]
[FR Doc No: 2014-25931]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER10-2179-024; ER10-2181-024; ER10-2182-024.
    Applicants: Calvert Cliffs Nuclear Power Plant, LLC, Nine Mile
Point Nuclear Station, LLC, R.E. Ginna Nuclear Power Plant, LLC.
    Description: Notice of Non-material Change in Status of the CENG
Nuclear Entities.
    Filed Date: 10/23/14.
    Accession Number: 20141023-5173.
    Comments Due: 5 p.m. ET 11/13/14.

    Docket Numbers: ER14-1221-001.
    Applicants: PJM Interconnection, L.L.C.
    Description: Compliance filing per 35: Compliance Filling, First
Revised Service Agreement No. 3752 to be effective 12/31/2013.
    Filed Date: 10/24/14.
    Accession Number: 20141024-5066.
    Comments Due: 5 p.m. ET 11/14/14.

    Docket Numbers: ER14-2430-002.
    Applicants: Arizona Public Service Company.
    Description: Tariff Amendment per 35.17(b): Response to Hyder
Deficiency Letter dated 9/23/14 to be effective 8/13/2014.
    Filed Date: 10/24/14.
    Accession Number: 20141024-5076.
    Comments Due: 5 p.m. ET 11/14/14.

    Docket Numbers: ER14-2563-001.
    Applicants: Tucson Electric Power Company.
    Description: Compliance filing per 35: Additional Changes to Order
No. 792 Compliance Filing to be effective 8/4/2014.
    Filed Date: 10/24/14.
    Accession Number: 20141024-5069.
    Comments Due: 5 p.m. ET 11/14/14.

    Docket Numbers: ER14-2564-001.
    Applicants: UNS Electric, Inc.
    Description: Compliance filing per 35: Additional Changes to Order
No. 792 Compliance Filing to be effective 8/4/2014.
    Filed Date: 10/24/14.
    Accession Number: 20141024-5075.
    Comments Due: 5 p.m. ET 11/14/14.

    Docket Numbers: ER14-2939-001.
    Applicants: Imperial Valley Solar Company (IVSC) 2, LLC.
    Description: Tariff Amendment per 35.17(b): Amendment to Initial
Market-Based Rate Application to be effective 11/24/2014.
    Filed Date: 10/24/14.
    Accession Number: 20141024-5122.
    Comments Due: 5 p.m. ET 11/14/14.

    Docket Numbers: ER15-177-000.
    Applicants: Southern California Edison Company.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii):
Distribution Service Agreement with Ecos Energy, LLC for Utah-Mesa
Solar Project to be effective 12/24/2014.
    Filed Date: 10/24/14.
    Accession Number: 20141024-5002.
    Comments Due: 5 p.m. ET 11/14/14.

    Docket Numbers: ER15-178-000.
    Applicants: Southern California Edison Company.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii):
Distribution Serv Agmt with Ecos Energy, LLC for Shoshone Valley Solar
Project to be effective 12/24/2014.
    Filed Date: 10/24/14.
    Accession Number: 20141024-5003.
    Comments Due: 5 p.m. ET 11/14/14.

    Docket Numbers: ER15-179-000.
    Applicants: Nevada Power Company.
    Description: Baseline eTariff Filing per 35.1: NV Energy OATT
Relocation--NPC OATT & Service Agreements to be effective 11/1/2014.
    Filed Date: 10/24/14.
    Accession Number: 20141024-5048.
    Comments Due: 5 p.m. ET 11/14/14.

    Docket Numbers: ER15-180-000.
    Applicants: Nevada Power Company.
    Description: Tariff Withdrawal per 35.15: NV Energy OATT
Relocation' Cancellation of NPC-NVE Concurrence to be effective 11/1/
2014.
    Filed Date: 10/24/14.
    Accession Number: 20141024-5052.
    Comments Due: 5 p.m. ET 11/14/14.

    Docket Numbers: ER15-181-000.
    Applicants: Sierra Pacific Power Company.
    Description: Tariff Withdrawal per 35.15: NV Energy OATT
Relocation' Cancellation of SPPC-NVE Concurrence to be effective 11/1/
2014.
    Filed Date: 10/24/14.
    Accession Number: 20141024-5055.
    Comments Due: 5 p.m. ET 11/14/14.

    Docket Numbers: ER15-182-000.
    Applicants: Sierra Pacific Power Company.
    Description: Baseline eTariff Filing per 35.1: NV Energy OATT
Relocation--SPPC Concurrence & Service Agreements to be effective 11/1/
2014.
    Filed Date: 10/24/14.

    Accession Number: 20141024-5056.
    Comments Due: 5 p.m. ET 11/14/14.

    Docket Numbers: ER15-183-000.
    Applicants: Nevada Power Company.
    Description: Tariff Withdrawal per 35.15: Rate Schedule 122
Collation Correction--Cancel Existing Collation to be effective 11/1/
2014.
    Filed Date: 10/24/14.
    Accession Number: 20141024-5058.
    Comments Due: 5 p.m. ET 11/14/14.

    Docket Numbers: ER15-184-000.
    Applicants: Nevada Power Company.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): Rate
Schedule 122 Collation Correction--File With New Collation to be
effective 11/1/2014.
    Filed Date: 10/24/14.
    Accession Number: 20141024-5059.
    Comments Due: 5 p.m. ET 11/14/14.

    Docket Numbers: ER15-185-000.
    Applicants: NV Energy, Inc.
    Description: Tariff Withdrawal per 35.15: NV Energy OATT
Relocation--Cancellation of NVE Tariff ID to be effective 11/1/2014.
    Filed Date: 10/24/14.
    Accession Number: 20141024-5060.
    Comments Due: 5 p.m. ET 11/14/14.

    Docket Numbers: ER15-186-000.
    Applicants: Arizona Public Service Company.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): Rate
Schedule No. 217 Exhibit B.LIB and Exhibit B.NGA Revision No. 4 to be
effective 12/24/2014.
    Filed Date: 10/24/14.
    Accession Number: 20141024-5072.
    Comments Due: 5 p.m. ET 11/14/14.

    Docket Numbers: ER15-187-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): First
Revised Service Agreement No. 2367; Queue Z1-088 to be effective 9/25/
2014.
    Filed Date: 10/24/14.
    Accession Number: 20141024-5077.
    Comments Due: 5 p.m. ET 11/14/14.

    Docket Numbers: ER15-188-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): First
Revised Service Agreement No. 2390; Queue Z1-089 to be effective 9/25/
2014.
    Filed Date: 10/24/14.
    Accession Number: 20141024-5083.
    Comments Due: 5 p.m. ET 11/14/14.

    Docket Numbers: ER15-189-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii):
Original Service Agreement No. 3986; Queue No. W3-099 to be effective
9/24/2014.
    Filed Date: 10/24/14.
    Accession Number: 20141024-5093.
    Comments Due: 5 p.m. ET 11/14/14.

    Docket Numbers: ER15-190-000.
    Applicants: Duke Energy Renewable Services, LLC.
    Description: Baseline eTariff Filing per 35.1: Duke Energy
Renewable Services MBR Application to be effective 12/1/2014.
    Filed Date: 10/24/14.
    Accession Number: 20141024-5094.
    Comments Due: 5 p.m. ET 11/14/14.

    Docket Numbers: ER15-191-000.
    Applicants: Duke Energy Progress, Inc.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii):
Depreciation Rate Schedule and PPA Filing to be effective 1/1/2013.
    Filed Date: 10/24/14.
    Accession Number: 20141024-5125.
    Comments Due: 5 p.m. ET 11/14/14.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: October 24, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-25931 Filed 10-30-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 100 (Friday, May 22, 2020)]
[Proposed Rules]
[Pages 31104-31111]
[FR Doc No: 2020-11079]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 2

[EPA-HQ-OA-2020-0128, FRL-010007-83-OP]
RIN 2010-AA13

EPA Guidance; Administrative Procedures for Issuance and Public
Petitions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: These proposed regulations would, if finalized, establish the
procedures and requirements for how the U.S. Environmental Protection
Agency (EPA) will manage the issuance of guidance documents subject to
the requirements of the Executive order entitled ``Promoting the Rule
of Law Through Improved Agency Guidance Documents.'' These regulations
establish general requirements and procedures for certain guidance
documents issued by the EPA and incorporates additional requirements
for guidance documents determined to be significant guidance under the
Executive order. These regulations also provide procedures for the
public to petition for the modification or withdrawal of active
guidance documents under the Executive order. These regulations are
intended to increase the transparency of EPA's guidance practices and
improve the process used to manage EPA guidance documents.

DATES: Comments must be received on or before June 22, 2020.

ADDRESSES: Send comments, identified by Docket ID No. EPA-HQ-OA-2020-
0128, by any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov/
(our preferred method). Follow the online instructions for submitting
comments.
     Email<EMAIL_ADDRESS>Include Docket ID No. EPA-HQ-
OA-2020-0128 in the subject line of the message.
    Instructions: All submissions received must include the Docket ID
No. for this rulemaking. Comments received may be posted without change
to https://www.regulations.gov/, including any personal information
provided. For detailed instructions on sending comments and additional
information on the rulemaking process, see the ``Public Participation''
heading of the SUPPLEMENTARY INFORMATION section of this document. Out
of an abundance of caution for members of the public and our staff, the
EPA Docket Center and Reading Room was closed to public visitors on
March 31, 2020, to reduce the risk of transmitting COVID-19. Our Docket
Center staff will continue to provide remote customer service via
email, phone, and webform. We encourage the public to submit comments
via https://www.regulations.gov or email, as there is a temporary
suspension of mail delivery to EPA, and no hand deliveries are
currently accepted. For further information on EPA Docket Center
services and the current status, please visit us online at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Sharon Cooperstein, Policy and
Regulatory Analysis Division, Office of Regulatory Policy and
Management (Mail Code 1803A), Environmental Protection Agency, 1200
Pennsylvania Avenue Northwest, Washington, DC 20460; telephone number:
202-564-7051; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Written Comments

    Submit your comments, identified by Docket ID No. EPA-HQ-OA-2020-
0128, at https://www.regulations.gov (our preferred method), or the
other methods identified in the ADDRESSES section. Once submitted,
comments cannot be edited or removed from the docket. The EPA may
publish any comment received to its public docket. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Multimedia submissions (audio, video, etc.) must be
accompanied by a written comment. The written comment is considered the
official comment and should include

discussion of all points you wish to make. The EPA will generally not
consider comments or comment contents located outside of the primary
submission (i.e. on the web, cloud, or other file sharing system). For
additional submission methods, the full EPA public comment policy,
information about CBI or multimedia submissions, and general guidance
on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

B. Does this action apply to me?

    This is a rule of Agency procedure and practice. The provisions
only apply to the EPA and do not regulate any external entities.

C. What action is the Agency taking?

    This action solicits comment from the public on a proposed
regulation establishing procedures that the EPA intends to use to issue
guidance documents that are subject to the requirements of Executive
Order (E.O.) 13891, ``Promoting the Rule of Law Through Improved Agency
Guidance Documents'' (84 FR 55237, October 15, 2019), which directs
Federal agencies to develop regulations to set forth processes and
procedures for issuing guidance documents. The Administrator has sole
and unreviewable discretion to deviate from this procedure.

D. What is the Agency's authority for taking this action?

    The EPA is authorized to promulgate this rule under its
housekeeping authority. The Federal Housekeeping Statute provides that
``[t]he head of an Executive department or military department may
prescribe regulations for the government of his department, the conduct
of its employees, the distribution and performance of its business, and
the custody, use, and preservation of its records, papers, and
property.'' 5 U.S.C. 301. The EPA gained housekeeping authority through
the Reorganization Plan No. 3 of 1970, 84 Stat. 2086 (July 9, 1970),
which ``convey[s] to the [EPA] Administrator all of the housekeeping
authority available to other department heads under section 301'' and
demonstrates that ``Congress has vested the Administrator with the
authority to run EPA, to exercise its functions, and to issue
regulations incidental to the performance of those functions.'' \1\
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    \1\ Authority of EPA to Hold Employees Liable for Negligent
Loss, Damage, or Destruction of Government Personal Property, 32
O.L.C. 79, 2008 WL 4422366 at * 4 (May 28, 2008) (``OLC Opinion'')
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    The Agency considers this action a rule of agency organization,
procedure, or practice that lacks the force and effect of law. The EPA
determined, as a matter of good government, to seek comment from the
public. The Administrative Procedure Act (APA), 5 U.S.C. 553(b)(3)(A),
provides that an agency may issue interpretive rules, general
statements of policy, or rules of agency organization, procedure, or
practice without providing notice and an opportunity for public
comment.

II. Background

    The EPA uses an open and fair regulatory process, including notice
and an opportunity for comment, when imposing new obligations on the
public, consistent with applicable law and following appropriate
procedures. The EPA considers and responds to applicable comments
before publishing final regulations in the Federal Register. Legally
binding requirements are imposed on the public only through statutes
and implementing regulations and on parties on a case-by-case basis
through adjudications. Exceptions may exist when legally binding
requirements are authorized by law through other means or when they are
incorporated into a contract.
    The EPA may issue non-binding guidance using a variety of methods
to clarify existing obligations and provide information to help
regulated entities comply with requirements. Guidance documents come in
a variety of formats, including interpretive memoranda, policy
statements, manuals, bulletins, advisories, and more. Any document that
satisfies the definition of ``guidance document'' above would qualify,
regardless of name or format.
    Such guidance is not subject to APA notice-and-comment
requirements. As such, EPA guidance documents are legally non-binding.
The EPA does, however, often work with stakeholders to develop guidance
documents, provide opportunities for public review and comment on the
draft guidance document, and announces the availability of final
guidance documents. Nevertheless, members of the public have noted that
it is often difficult to identify all guidance documents that the EPA
uses and relies upon. This regulation will improve the ability of
members of the public to more easily identify all the guidance
documents that the EPA uses and relies upon, resolving any concerns
over the difficulty assessing the final and effective guidance of the
Agency.
    Well-designed guidance documents can serve many important functions
in regulatory programs. The EPA may provide guidance to interpret
existing law or to clarify how it intends to implement a legal
requirement. Additionally, EPA may generate guidance that sets forth a
policy on a statutory, regulatory, or technical issue. Guidance
documents, when used properly, can also help increase efficiency, and
improve the public's understanding of the EPA's policies. Over reliance
on guidance, to the exclusion of rulemaking, however, decreases the
transparency of Agency implementation of legal requirements and can
lead to inequitable outcomes.
    On October 9, 2019, the President signed E.O. 13891, ``Promoting
the Rule of Law Through Improved Agency Guidance Documents.'' E.O.
13891 directs Federal agencies to finalize regulations that ``set forth
processes and procedures for issuing guidance documents.'' \2\ E.O.
13891 notes that ``Americans deserve an open and fair regulatory
process that imposes new obligations on the public only when consistent
with applicable law and after an agency follows appropriate
procedures.'' \3\ A central principle of E.O. 13891 is that guidance
documents should clarify existing obligations only; they should not be
a vehicle for implementing new, binding requirements on the public.
E.O. 13891 recognizes that these documents, when designated as
significant guidance documents, could benefit from public input prior
to issuance. On October 31, 2019, the White House Office of Management
and Budget (OMB) Office of Information and Regulatory Affairs (OIRA)
issued a memorandum to Federal agencies outlining how to implement,
E.O. 13891.\4\
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    \2\ See section 4(a) of Executive Order 13891 (October 15, 2019;
84 FR 55237).
    \3\ See section 1 of Executive Order 13891 (84 FR 55235).
    \4\ Guidance Implementing Executive Order 13891, Dominic J.
Mancini, Acting Director, OIRA, October 31, 2019, (M-20-02).
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    Consistent with E.O. 13891 and OMB's implementing memorandum, this
action proposes the EPA's procedures for developing and issuing
guidance documents and to establish a petition process for public
requests to modify or withdraw an active guidance document. The purpose
is to ensure that the EPA's guidance documents are:
     Developed with appropriate review;
     Accessible and transparent to the public; and,
     Provided for public participation in the development of
significant guidance documents.
    Implementing these procedures will lead to enhanced transparency
and help to ensure that guidance documents are not improperly treated
as legally binding requirements by the EPA or by

the regulated community. Moreover, the proposed regulation includes a
definition of ``guidance document'' to provide greater clarity to the
public regarding the scope of the proposed regulation.
    Specifically, consistent with the E.O., this regulation provides
that the EPA will use an online portal to clearly identify EPA guidance
documents for the public and proposes to establish: Definitions of
``guidance document'' and ``significant guidance document,'' standard
elements for such guidance documents and significant guidance
documents, procedures for the EPA to enable the public to comment on
proposed significant guidance documents, and procedures for the public
to request that an active guidance document be modified or withdrawn.
The EPA intends that this regulation be interpreted and implemented in
a manner that, consistent with the goals of improving the Agency's
accountability and the transparency of the EPA's guidance documents,
provides appropriate flexibility for the EPA to take those actions
necessary to accomplish its mission.

III. Guidance Document Procedures

    This rule proposes to establish the EPA's internal policies and
procedures for the issuance of future guidance documents pursuant to
the directives included in E.O. 13891 as well as codify the requirement
that the Agency maintain an internet portal with all active and
effective guidance of the Agency. The procedures contained in this
proposed rule would apply to guidance documents issued by the EPA that
are subject to the requirements of E.O. 13891 but not excluded under
Section 4(b) of the E.O., as described in Unit III.A below. Section
4(b) of the E.O. directs the Administrator of OIRA to issue memoranda
establishing exceptions from the E.O. for categories of guidance
documents, as appropriate. Categorical exceptions may include documents
that generally are only routine or ministerial, or that are otherwise
of limited importance to the public. The EPA is proposing that the
procedures established in this rule would not apply to guidance
documents excepted from the requirements of E.O. 13891 under Section
4(b) of the E.O.

A. Definition of Guidance Document and Significant Guidance Document
(Proposed 40 CFR 2.503)

    Consistent with the definitions in E.O. 13891 and OMB's
implementing memorandum, the EPA is proposing the following definitions
of the terms ``guidance document'' and ``significant guidance
document.''
    1. Guidance Document. For the purposes of this rule, ``guidance
document'' would mean an Agency statement of general applicability,
intended to have future effect on the behavior of regulated parties,
that sets forth a policy on a statutory, regulatory, or technical
issue, or an interpretation of a statute or regulation. The definition
is subject to the following exclusions:
     Rules promulgated pursuant to notice and comment under 5
U.S.C. 553, or similar statutory provisions;
     Rules exempt from rulemaking requirements under section 5
U.S.C. 553(a); \5\
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    \5\ 5 U.S.C. 553(a) applies, except to the extent that there is
involved: (1) A military or foreign affairs function of the United
States; or (2) a matter relating to agency management or personnel
or to public property, loans, grants, benefits, or contracts.
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     Rules of Agency organization, procedure, or practice;
     Decisions of Agency adjudications under 5 U.S.C. 554, or
similar statutory provisions;
     Internal guidance directed to the EPA or its components or
other agencies that is not intended to have substantial future effect
on the behavior of regulated parties;
     Agency statements of specific, rather than general,
applicability. The definition of ``guidance document'' would not apply
to advisory or legal opinions directed to particular parties about
circumstance-specific questions; notices regarding particular locations
or facilities; and correspondence with individual persons or entities
about particular matters, including congressional correspondence or
notices of violation;
     Agency statements that do not set forth a policy on a
statutory, regulatory, or technical issue or an interpretation of a
statute or regulation. This would exclude from the definition of
``guidance document'' Agency statements that merely communicate news
updates about the Agency, such as most speeches and press releases as
well as Agency statements of general applicability concerning
participation in the EPA's voluntary programs;
     Internal executive branch legal advice or legal opinions
addressed to executive branch officials or courts, including legal
opinions by the Office of General Counsel;
     Legal briefs and other court filings, because these are
intended to persuade a court rather than affect the conduct of
regulated parties;
     Grant solicitations and awards; or
     Contract solicitations and awards.
    2. Significant Guidance Document. For the purposes of this rule,
``significant guidance document'' would mean a guidance document
determined to be significant pursuant to E.O. 12866 and E.O. 13891.
    Section 2(c) of E.O. 13891 defines ``significant guidance
document'' to mean a guidance document that may reasonably be
anticipated to: (i) Lead to an annual effect on the economy of $100
million or more or adversely affect in a material way the economy, a
sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or State, local, or tribal
governments or communities; (ii) Create a serious inconsistency or
otherwise interfere with an action taken or planned by another agency;
(iii) Materially alter the budgetary impact of entitlements, grants,
user fees, or loan programs or the rights and obligations of recipients
thereof; or, (iv) Raise novel legal or policy issues arising out of
legal mandates, the President's priorities, or the principles of E.O.
12866.\6\
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    \6\ See section 2(c) of Executive Order 13891 (84 FR 55236).
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B. Inventory of Active Guidance Documents (Proposed 40 CFR 2.504)

    Section 3(a) of E.O. 13891 directs agencies to establish and
maintain a website guidance portal that contains or links to guidance
documents that are ``active'', i.e., those guidance documents under
this rule that the EPA expects to cite, use, or rely upon. The EPA
Guidance Portal was made publicly available on February 28, 2020
(https://www.EPA.gov/guidance).\7\ The E.O. requires that all active
guidance documents issued by an agency be included on the agency's
guidance portal and that any guidance document excluded from the portal
does not represent the final guidance of the agency and will have no
effect.
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    \7\ ``Notice of Public Guidance Portal,'' (85 FR 11986, February
28, 2020).
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    The EPA is providing here a description of the information that is
currently available on the EPA Guidance Portal. The EPA Guidance Portal
following information for each guidance document:
     A concise name for the guidance document;
     The date on which the guidance document was issued;
     The date on which the guidance document was posted to the
Guidance Portal;
     An EPA unique identifier;
     A hyperlink to the guidance document and any supporting or
ancillary documents;

     The general topic, program, and/or statute addressed by
the guidance document; and
     A brief summary of the guidance document's content.
    In addition to the information associated with each guidance
document, the EPA Guidance Portal includes a clearly visible note
expressing that (a) guidance documents lack the force and effect of
law, unless authorized by statute or incorporated into a contract; and
(b) the Agency may not cite, use, or rely on any guidance document as
defined in this rule, that is not posted on the EPA Guidance Portal,
except to establish historical facts. The EPA Guidance Portal will also
include a link to these EPA procedural regulations for guidance
documents once issued as final regulations, as well as to any future
proposed or final amendments.\8\
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    \8\ See Q12 in Guidance Implementing Executive Order 13891,
Dominic J. Mancini, Acting Director, OIRA, October 31, 2019 (M-20-
02).
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C. General Requirements and Procedures for Issuance of All Guidance
Documents (Proposed 40 CFR 2.505)

    Consistent with E.O. 13891, the EPA proposes to require certain
standard elements for all guidance documents issued after this rule is
finalized. Specifically, the EPA is proposing to require that each
guidance document would satisfy the following: \9\
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    \9\ See Q22 in Guidance Implementing Executive Order 13891,
Dominic J. Mancini, Acting Director, OIRA, October 31, 2019, (M-20-
02).
---------------------------------------------------------------------------

     Include the term ``guidance;''
     Identify the office issuing the document;
     Provide the title of the guidance;
     Provide the unique document identification number;
     Include the date of issuance;
     When practicable, identify the general activities to which
and the persons to whom the document applies;
     Include the citation to the statutory provision (including
the U.S.C. citation) or regulation (in CFR format) to which the
guidance document applies or which it interprets;
     Note if the guidance document is a revision to a
previously issued guidance document and, if so, identify the guidance
document that it modifies or replaces;
     Include a short summary of the subject matter covered in
the guidance document at the beginning of the document; and
     Include a disclaimer stating that the contents of the
guidance document do not have the force and effect of law and that the
Agency does not intend to bind the public in any way and intends only
to provide clarity to the public regarding existing requirements under
the law or Agency policies. If the guidance document is binding because
it is authorized by law or because the guidance is incorporated into a
contract, the EPA will make that clear in the document.\10\
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    \10\ See Q20 in Guidance Implementing Executive Order 13891,
Dominic J. Mancini, Acting Director, OIRA, October 31, 2019, (M-20-
02).
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    Consistent with the requirements of E.O. 13891 and OMB's
implementing memorandum, each new guidance document will be posted in
the EPA Guidance Portal upon issuance.\11\ When a new guidance document
has been issued, or an active guidance document has been modified, or
an active guidance document has been withdrawn, the EPA proposes to
inform the public via the EPA Guidance Portal or other Agency website.
The EPA solicits comment on the most effective means to inform the
public that a new guidance document has been issued, an active guidance
document has been modified, or an active guidance document has been
withdrawn. Note that specific procedures for announcing new, modified,
or withdrawn significant guidance documents are discussed in Unit
III.D. of this document.
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    \11\ See section 3(b) of Executive Order 13891 (84 FR 55236).
See Q9-Q12 in Guidance Implementing Executive Order 13891, Dominic
J. Mancini, Acting Director, OIRA, October 31, 2019, (M-20-02).
---------------------------------------------------------------------------

    Given their legally nonbinding nature, guidance documents will
avoid including mandatory language such as ``shall,'' ``must,''
``required'' or ``requirement,'' unless these words are used to
describe a statutory or regulatory requirement, or the language is
addressed to EPA staff and will not foreclose consideration by the EPA
of positions advanced by affected private parties. For example, a
guidance document may explain how the EPA believes a statute or
regulation applies to certain regulated entities or activities. As a
practical matter, the EPA also may describe laws of nature, scientific
principles, and technical requirements in mandatory terms so long as it
is clear that the guidance document itself does not impose legally
enforceable rights or obligations.\12\
---------------------------------------------------------------------------

    \12\ Final Bulletin for Agency Good Guidance Practices (72 FR
3432, 3436).
---------------------------------------------------------------------------

    Before issuing a new guidance document covered by this rule that is
developed by an EPA Regional Office, the EPA is proposing that the EPA
Regional Office must receive concurrence from the corresponding
Presidentially-appointed EPA official (i.e., the relevant Assistant
Administrator or an official who is serving in the acting capacity) at
EPA headquarters who is responsible for administering the national
program to which the guidance document pertains.
    The EPA will seek significance determinations from OIRA for certain
guidance documents, as appropriate, in the same manner as for
rulemakings.

D. Requirements for Issuance of Significant Guidance Documents
(Proposed 40 CFR 2.506)

    In addition to all the requirements described in Unit III.C., and
consistent with the requirements of E.O. 13891, the EPA is proposing
specific requirements for significant guidance documents.
    The EPA does not intend to supersede non-conflicting internal
policy and procedures that the EPA established for significant guidance
documents in 2007 as part of its implementation of the OMB Bulletin for
Agency Good Guidance Practices.\13\ Specifically, the EPA is proposing
the following additional requirements for significant guidance
documents.
---------------------------------------------------------------------------

    \13\ Final Bulletin for Agency Good Guidance Practices (72 FR
3432).
---------------------------------------------------------------------------

    1. Notice and Public Comment Opportunities. This proposed rule
would establish a public review and comment opportunity for all
significant guidance documents, whether that document is new or a
modification or withdrawal of an active guidance document. The EPA is
proposing to generally require the EPA to publish a Notice in the
Federal Register to announce the availability of a new draft
significant guidance document and provide a 30-day public comment
opportunity prior to issuing the final significant guidance document.
It also proposes to require the EPA to similarly publish a Notice in
the Federal Register announcing the proposed modification or withdrawal
of an active significant guidance document and provide a 30-day public
comment opportunity before finalizing the modification or withdrawal of
such a document. In addition to the published announcement of the
availability of the draft significant guidance document, the draft
significant guidance document itself (including a link to any
supporting documents) would be posted on the EPA's website concurrently
and labeled appropriately.\14\ To ensure comments will be received and
responded to by the EPA, public comments on draft significant guidance
documents and draft modifications or withdrawals of

significant active guidance documents should be submitted using the
methods specified in the Notice in the Federal Register announcing the
availability of the draft significant guidance document or its
withdrawal.
---------------------------------------------------------------------------

    \14\ See section 4(a)(iii)(A) of Executive Order 13891 (84 FR
55237), and Q23 in Guidance Implementing Executive Order 13891,
Dominic J. Mancini, Acting Director, OIRA, October 31, 2019, (M-20-
02).
---------------------------------------------------------------------------

    All comments received on a draft significant guidance document, or
draft modification or withdrawal of an active significant guidance
document, would be made available to the public either through the
Federal eRulemaking Portal (i.e., https://www.regulations.gov/) or on
the EPA website.
    2. Finalizing significant guidance documents. The EPA is proposing
to publish a Notice in the Federal Register announcing when the
issuance of a new or modified active significant guidance document or
withdrawal of an active significant guidance document is finalized.
    The proposed regulations would also require the EPA, when issuing a
final new significant guidance document or a final modification or
withdrawal of an active significant guidance document, to respond to
major public comments and identify in the required Notice in the
Federal Register how the public may access the comments received and
the Agency's response.
    The EPA solicits comment on whether the issuance of a modification
to an active significant guidance document or the withdrawal of an
active significant guidance document should be announced via the
Federal Register and subject to a 30-day public comment period, or if
other means of public engagement, such as the EPA's Guidance Portal or
other Agency website, could be used to announce such actions.
    3. Procedural exceptions. The EPA proposes limited exceptions to
the significant guidance document notice and comment process. The EPA
would not seek or respond to public comment before it implements a
significant guidance document (or any other category of guidance
document) if exigent circumstances, as determined by the Administrator,
(e.g., a public health, safety, environment or other emergency) make it
impracticable to delay issuance of the guidance document, or there is a
statutory or judicial requirement that compels the EPA to immediately
issue the document.\15\ Further, the EPA would not seek or respond to
public comment when it finds good cause that notice and public comment
is impracticable, unnecessary, or contrary to public interest. The EPA
would present the good cause finding in the guidance document or notice
of availability in the Federal Register.
---------------------------------------------------------------------------

    \15\ See section 4(a)(iii)(A) of Executive Order 13891 (84 FR
55237) and Final Bulletin for Agency Good Guidance Practices. (72 FR
3432; 3438-3439).
---------------------------------------------------------------------------

    4. Required approval. The EPA Administrator or other
Presidentially-appointed EPA official, or an official who is serving in
an acting capacity of either of the foregoing, would approve each
significant guidance document before it is issued and posted on the EPA
Guidance Portal.\16\
---------------------------------------------------------------------------

    \16\ See section 4(a)(iii)(B) of Executive Order 13891 (84 FR
55237) and, Q25 in Guidance Implementing Executive Order 13891,
Dominic J. Mancini, Acting Director, OIRA, October 31, 2019, (M-20-
02).
---------------------------------------------------------------------------

    5. Compliance with other applicable requirements. Section 5 of E.O.
13891 specifies that significant guidance documents must demonstrate
compliance with the requirements of E.O. 12866, ``Regulatory Planning
and Review;'' E.O. 13563, ``Improving Regulation and Regulatory
Review;'' and E.O. 13609, ``Promoting International Regulatory
Cooperation,'' consistent with the requirements of section 4 of E.O.
13891. E.O. 13891 directs that significant guidance documents must
comply with the applicable requirements for regulations or rules,
including significant regulatory actions, set forth in these executive
orders.
    Accordingly, the EPA would comply with the requirements of
Executive Orders 12866, 13563, 13609, and 13891 when issuing
significant guidance documents. For example, the EPA would assess the
potential impacts of the significant guidance document if those effects
may reasonably be anticipated to lead to an annual effect on the
economy of $100 million.\17\ The analysis (Regulatory Impact Analysis
(RIA) or Economic Analysis (EA)) would focus on how that economically
significant guidance document affects the incentives of regulated
parties and would conform to OMB Circular A-4 on Regulatory Analysis
and EPA Guidelines for Preparing Economic Analyses.\18\ The EPA has not
historically issued economically significant guidance documents (i.e.,
those that lead to an annual effect on the economy of $100 million or
more).
---------------------------------------------------------------------------

    \17\ See Q5 in Guidance Implementing Executive Order 13891,
Dominic J. Mancini, Acting Director, OIRA, October 31, 2019, (M-20-
02).
    \18\ EPA Guidelines for Preparing Economic Analyses. December
17, 2010 (updated May 2014). Accessible at https://www.epa.gov/sites/production/files/2017-08/documents/ee-0568-50.pdf.
---------------------------------------------------------------------------

E. Procedures for Public To Petition for Modification or Withdrawal
(Proposed 40 CFR 2.507)

    Consistent with E.O. 13891, the EPA is proposing procedures to
allow the public to petition the EPA for the modification or withdrawal
of an active guidance document posted on the EPA Guidance Portal. The
EPA Guidance Portal will provide clear and specific instructions to the
public regarding how to request the modification or withdrawal of an
active guidance document. The EPA is proposing that the public may
submit petitions using one of the two following methods described on
the EPA Guidance Portal: (1) An electronic submission through the EPA's
designated submission system identified on the EPA Guidance Portal
(i.e., using a link labeled ``Submit a petition for Agency modification
or withdrawal of guidance documents''), or, (2) a paper submission to
the EPA's designated mailing address listed on the EPA Guidance Portal.
    1. Format and content elements for public petitions. The EPA is
proposing the following formatting elements for petitions:
     The petitioner's name and a means for the EPA to contact
the petitioner such as an email address or mailing address, in addition
to any other contact information (such as telephone number) that the
petitioner chooses to include; and
     A heading, preceding its text that states, either
``Petition to Modify a Guidance Document'' or ``Petition to Withdraw a
Guidance Document.''
    The EPA is proposing that a petition should include the following
content elements:
     Identification of the specific title and the EPA unique
identifier of the guidance document that the petitioner is requesting
be modified or withdrawn;
     The nature of the relief sought (i.e., modification or
withdrawal);
     An explanation of the interest of the petitioner in the
requested action;
     If practicable, specification of the text that the
petitioner request be modified or withdrawn, and, where possible,
suggested text for the Agency to consider; and
     A rationale for the requested modification or withdrawal.
    Although the EPA may be able to consider incomplete petitions,
petitions that omit the specified information may impede the EPA from
fully evaluating the merits of the requested action. The EPA is
proposing that a petition that is not submitted using one of the two
methods described above (as well as on the EPA Guidance Portal), but
that includes the required formatting and content elements, will be
treated as a properly filed petition, received as of the time it is
discovered and identified. The EPA notes that if a document does not
include all of the format and content

elements described above, the EPA may be unable to identify the
document as a petition for modification or withdrawal of a guidance
document. These will instead be treated according to the existing
correspondence or other appropriate procedures of the EPA, and any
suggestions contained in it will be considered at the discretion of the
Administrator.
    The EPA solicits comment on whether the procedural rule should
specify any other information elements that should be addressed in a
petition to modify or withdraw an active guidance document. The EPA
requests that any such comments explain how additional information
elements would enable the Agency to correctly identify and more
completely evaluate a petition.
    2. Required EPA response to public petitions. The EPA would respond
to petitions in a timely manner, but no later than 90 calendar days
after receipt of the petition. If the EPA requires more than 90
calendar days to consider a petition, the EPA would inform the
petitioner that more time is required and indicate the reason why and
provide an estimated decision date. The EPA will only extend the
response date one time for a period not to exceed 90 calendar days
before providing a response.
    It is important to note that the response and the set timeframes
for responding to the petition are not intended to capture the
implementation of the response. For example, if the Agency agrees with
a petitioner seeking a modification to a guidance document, the Agency
will pursue the modification in accordance with applicable procedures.
In such cases, the Agency intends for the response to the petition to
include its approach for completing the modification of that guidance
document.
    Duplicative petitions and petitions submitted as part of a mass
petitioning effort may be responded to in a single response to ensure
an efficient and consistent response to the petitions. Petitions that
request a change to the underlying statute or promulgated rules, rather
than specific text in the guidance document, will not be considered
valid petitions under this process because they are not petitions to
modify or withdraw a guidance document.
    The EPA requests comment on whether the Agency should create
unified public petition procedures, similar to those proposed in this
rule for guidance documents, for EPA rulemakings in addition to the
public petition right established in APA section 553(e).\19\
---------------------------------------------------------------------------

    \19\ (Pub. L. 89-554, Sept. 6, 1966, 80 Stat. 383.)
---------------------------------------------------------------------------

IV. Statutory and Executive Orders Reviews

    Additional information about these statues and Executive orders can
be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was
therefore not submitted to OMB for review under Executive Orders 12866.
The EPA does not anticipate that this rulemaking will have an economic
impact on regulated entities. This is a rule of agency procedure and
practice. The EPA expects the benefits of this rule to be improved
transparency and management of the EPA's guidance documents.

B. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs

    This action is not expected to be an Executive Order 13771
regulatory action because it relates to ``agency organization,
management or personnel.''

C. Paperwork Reduction Act (PRA)

    This action does not contain any information collection activities
and therefore does not impose an information collection burden under
the PRA.

D. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. This is
a rule of agency procedure and practice. The EPA expects the benefits
of this rule to be improved transparency and management of the EPA's
guidance documents.

E. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. The action imposes no enforceable duty on any state,
local, or tribal governments or the private sector.

F. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects 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.

G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this action.

H. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that the EPA has reason to believe may disproportionately affect
children. Per the definition of ``covered regulatory action'' in
section 2-202 of Executive Order 13891 and because this action does not
concern an environmental health risk or safety risk, it is not subject
to Executive Order 13045.

I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use

    This action is not subject to Executive Order 13211, because it is
not a significant regulatory action under Executive Order 12866.

J. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve technical standards.

K. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    The EPA believes that this action is not subject to Executive Order
12898 (59 FR 7629, February 16, 1994) because it does not establish an
environmental health or safety standard.

List of Subjects in 40 CFR Part 2

    Environmental protection, Administrative practice and procedure,
Organization and functions (Government agencies).

Andrew Wheeler,
Administrator.

    For the reasons set forth in the preamble, the Environmental
Protection Agency proposes to amend 40 CFR part 2 as follows:

PART 2--PUBLIC INFORMATION

0
1. The authority citation for part 2 continues to read as follows:

    Authority:  5 U.S.C. 301, 552, 552a, 553; 28 U.S.C. 509, 510,
534; 31 U.S.C. 3717.

0
2. Add subpart D to read as follows:

Subpart D--Guidance Procedures

Sec.
2.501 General.
2.502 Scope.
2.503 Definitions.
2.504 Public access to active guidance documents.
2.505 Guidance document general requirements and procedures.
2.506 Significant guidance document requirements and procedures.
2.507 Procedures for the public to petition for modification or
withdrawal.

Sec.  2.5012.501  General.

    This subpart establishes procedures for the issuance of EPA
guidance documents subject to Executive Order 13891, ``Promoting the
Rule of Law Through Improved Agency Guidance Documents'' (October 15,
2019). This subpart also establishes procedures for the public to
petition for modification or withdrawal of such guidance documents.

Sec.  2.502  Scope.

    (a) The procedures in this subpart do not apply to guidance
documents excepted from the requirements of Executive Order 13891 under
Section 4(b) of the Executive order or that are not otherwise subject
to Executive Order 13891.
    (b) Subject to the qualifications and exemptions contained in this
subpart, the procedures in this subpart apply to all active guidance
documents as defined in this subpart, issued by all components of the
Environmental Protection Agency (EPA) after [date of issuance for the
final rule].
    (c) Rescinded guidance documents are not active guidance documents
pursuant to Executive Order 13891 and may only be used to establish
historical facts.
    (d) This subpart is intended to improve the internal management of
the EPA. As such, it is for the use of EPA personnel only and is not
intended to, and does not, create any right or benefit, substantive or
procedural, enforceable at law or in equity by any party against the
United States, its agencies or other entities, its officers or
employees, or any other person.
    (e) If Executive Order 13891, or any provision thereof, is
rescinded or superseded, this subpart remains in force.
    (f) The Agency may deviate from the procedures in this subpart,
when necessary, at the written direction of the Administrator. The
decision to deviate from the procedures in this subpart is in the
Administrator's sole and unreviewable discretion.

Sec.  2.503  Definitions.

    For the purposes of this subpart, the following definitions apply:
    Guidance document means an Agency statement of general
applicability, intended to have future effect on the behavior of
regulated parties, that sets forth a policy on a statutory, regulatory,
or technical issue, or an interpretation of a statute or regulation,
subject to the following exclusions:
    (1) Rules promulgated pursuant to notice and comment under 5 U.S.C.
553, or similar statutory provisions;
    (2) Rules exempt from rulemaking requirements under 5 U.S.C.
553(a);
    (3) Rules of Agency organization, procedure, or practice;
    (4) Decisions of Agency adjudications under 5 U.S.C. 554, or
similar statutory provisions;
    (5) Internal guidance directed to the EPA or its components or
other agencies that is not intended to have substantial future effect
on the behavior of regulated parties;
    (6) Internal executive branch legal advice or legal opinions
addressed to executive branch officials or courts, including legal
opinions by the Office of General Counsel;
    (7) Agency statements of specific, rather than general,
applicability. This would exclude from the definition of ``guidance''
advisory or legal opinions directed to particular parties about
circumstance-specific questions; notices regarding particular locations
or facilities; and correspondence with individual persons or entities
about particular matters, including congressional correspondence or
notices of violation unless a document is directed to a particular
party but designed to guide the conduct of the broader regulated
public;
    (8) Agency statements that do not set forth a policy on a
statutory, regulatory, or technical issue or an interpretation of a
statute or regulation, including news updates like speeches and press
releases, as well as statements of general applicability concerning
participation in the EPA's voluntary programs;
    (9) Legal briefs and other court filings;
    (10) Grant solicitations and awards; or
    (11) Contract solicitations and awards.
    Significant guidance document means a guidance document that is
determined to be ``significant'' pursuant to Executive Order 12866 and
Executive Order 13891.

Sec.  2.504  Public access to active guidance documents.

    All active guidance documents shall appear on the EPA Guidance
Portal on the EPA website.

Sec.  2.505  Guidance document general requirements and procedures.

    (a) Minimum guidance requirements. In each guidance document, the
EPA will:
    (1) Include the term ``guidance'';
    (2) Identify the component office issuing the document;
    (3) Provide the title of the guidance and the document
identification number;
    (4) Include the date of issuance;
    (5) When practicable, identify the general activities to which and
the persons to whom the document applies;
    (6) Include the citation to the statutory provision (including the
U.S.C. citation) or regulation (to the CFR) to which the guidance
document applies or which it interprets;
    (7) Note if the guidance document is a revision to a previously
issued guidance document and, if so, identify the guidance document
that it modifies or replaces;
    (8) Include a short summary of the subject matter covered in the
guidance document at the beginning of the document; and
    (9) Include a disclaimer stating that the contents of the guidance
document do not have the force and effect of law and that the Agency
does not bind the public in any way and intends only to provide clarity
to the public regarding existing requirements under the law or Agency
policies, except as authorized by law or as incorporated into a
contract. When a guidance document is binding because binding guidance
is authorized by law or because the guidance is incorporated into a
contract, the statement will reflect that.
    (b) Approval. A guidance document issued by an EPA Regional Office
must receive concurrence from the corresponding Presidentially-
appointed EPA official (i.e., the relevant Assistant Administrator or
an official who is serving in the acting capacity) at EPA headquarters
who is responsible for administering the national program to which the
guidance document pertains.
    (c) Avoid mandatory language. A guidance document will avoid
mandatory language such as ``shall,'' ``must,'' ``required'' or
``requirement,'' unless using these words to describe a statutory or
regulatory requirement, or the language is addressed to EPA staff and
will not foreclose consideration by the EPA of positions advanced by
affected private parties.

    (d) Significance determinations. The EPA will seek significance
determinations from the Office of Information and Regulatory Affairs
(OIRA) for certain guidance documents, as appropriate, in the same
manner as for rulemakings.

Sec.  2.506  Significant guidance document requirements and procedures.

    A significant guidance document will adhere to all the requirements
described in Sec.  2.505 and the requirements in this section.
    (a) Draft for public comment. (1) The EPA will make available a
draft significant guidance document, or draft modification or
withdrawal of a significant active guidance document, for public
comment before finalizing any significant guidance document. The EPA
will post appropriately labeled draft guidance and any supporting
documents on the EPA's website.
    (2) The EPA will publish a notice in the Federal Register
announcing the availability of a draft significant guidance document,
or draft modification or withdrawal of a significant active guidance
document, to open the public comment period.
    (b) Public comment process. (1) Except as provided in paragraph (c)
of this section, a draft significant guidance document, or a draft
modification or withdrawal of a significant active guidance document,
will have a minimum of 30 days public notice and comment before
issuance of a final guidance document or issuance of the final
modification or withdrawal of an active guidance document. Public
comments shall be available to the public online, either in a docket or
on the EPA website.
    (2) The EPA shall respond to major concerns and comments in the
final guidance document itself or in a companion document.
    (c) Exceptions to comment process. The EPA will not seek or respond
to public comment before the EPA implements a significant guidance
document if at the sole discretion of the Administrator:
    (1) Doing so is not feasible or appropriate because immediate
issuance is required by a public health, safety, environmental, or
other emergency requiring immediate issuance of the guidance document
or a statutory requirement or court order that requires immediate
issuance; or
    (2) When the Agency for good cause finds (and incorporates such
finding and a brief statement of reasons therefor into the guidance
document) that notice and public comment thereon are impracticable,
unnecessary, or contrary to the public interest.
    (d) Additional notices. The EPA also will publish a notice in the
Federal Register when it finalizes a significant guidance document or
finalizes a modification or withdrawal of a significant active guidance
document.
    (e) Approval. The EPA Administrator or other Presidentially-
appointed EPA official, or an official who is serving in the acting
capacity of either of the foregoing, will approve a significant
guidance document prior to its issuance and posting in the EPA Guidance
Portal website.
    (f) Executive order compliance. A significant guidance document
shall comply with the requirements of Executive Orders 12866, 13563,
13609, 13771, 13777, and 13891.

Sec.  2.507  Procedures for the public to petition for modification or
withdrawal.

    (a) Submission of a petition. The public may submit a petition to
the EPA for the modification or withdrawal of an active guidance
document.
    (b) Petition methods. A petitioner should only submit a petition to
the EPA using one of the two methods in paragraphs (b)(1) and (2) of
this section and not submit additional copies by any other method. A
petition should be submitted through:
    (1) An electronic submission through the EPA's designated
submission system identified on the EPA Guidance Portal website; or
    (2) A paper submission to the EPA's designated mailing address
listed on the EPA Guidance Portal website.
    (c) Petition format. A petition under this section should include:
    (1) The petitioner's name and a means for the EPA to contact the
petitioner such as an email address or mailing address, in addition to
any other contact information (such as telephone number) that the
petitioner chooses to include; and
    (2) A heading, preceding its text that states, ``Petition to Modify
a Guidance Document'' or ``Petition to Withdraw a Guidance Document.''
    (d) Petition content. A petition for modification or withdrawal of
an active guidance document should include the following elements:
    (1) Identification of the specific title and the EPA unique
identifier of the guidance document that the petitioner is requesting
be modified or withdrawn;
    (2) The nature of the relief sought (i.e., modification or
withdrawal);
    (3) An explanation of the interest of the petitioner in the
requested action (i.e., modification or withdrawal);
    (4) If practicable, specification of the text that the petitioner
request be modified or withdrawn, and, where possible, suggested text
for the Agency to consider; and
    (5) A rationale for the requested modification or withdrawal.
    (e) Petition handling. Failure to follow one of the submission
methods described in paragraph (b) of this section and to include in a
petition the elements in paragraphs (c) and (d) of this section may
create delays in processing time and may result in the EPA being unable
to evaluate the merits of the petition.
    (1) The EPA may treat a petition that is not submitted as specified
in paragraph (b) of this section, but that meets the other elements of
this section, as a properly filed petition and received as of the time
it is discovered and identified.
    (2) The EPA may treat a document that fails to conform to one or
more of the elements of paragraphs (c) and (d) of this section as if it
is not a petition under this section. The EPA may treat such a document
according to the existing correspondence or other appropriate
procedures of the EPA, and any suggestions contained in it will be
considered at the discretion of the Administrator.
    (f) Petition response timing. (1) The EPA should respond to a
petition in a timely manner, but no later than 90 calendar days after
receipt of the petition.
    (2) If, for any reason, the EPA needs more than 90 calendar days to
respond to a petition, the EPA will inform the petitioner that more
time is needed and indicate the reason why and an estimated response
date. The EPA will only extend the response date one time not to exceed
90 calendar days before providing a response.
    (g) Petition response. (1) The EPA may provide a single response to
issues raised by duplicative petitions and petitions submitted as part
of a mass petitioning effort.
    (2) In order to be considered a valid petition under this section,
the petition must address a specific issue in the guidance document in
question and not merely underlying statutory or regulatory text.

[FR Doc. 2020-11079 Filed 5-21-20; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: November 21, 2008 (Volume 73, Number 226)]
[Notices]
[Page 70653-70654]
[DOCID:fr21no08-64]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-P-0029]

Determination That NUBAIN (Nalbuphine Hydrochloride) Injection,
10 and 20 Milligrams/Milliliter, Was Not Withdrawn From Sale for
Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing its
determination that NUBAIN (nalbuphine hydrochloride) injection, 10 and
20 milligrams/milliliter (mg/ml), was not withdrawn from sale for
reasons of safety or effectiveness. This determination will allow FDA
to approve abbreviated new drug applications (ANDAs) for nalbuphine
hydrochloride injection, 10 and 20 mg/ml, if all other legal and
regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Carol E. Drew, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6306, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
applicants must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of

the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA). The only clinical data
required in an ANDA are data to show that the drug that is the subject
of the ANDA is bioequivalent to the listed drug.
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness, or if FDA determines that the
listed drug was withdrawn from sale for reasons of safety or
effectiveness (21 CFR 314.162). Regulations also provide that the
agency must make a determination as to whether a listed drug was
withdrawn from sale for reasons of safety or effectiveness before an
ANDA that refers to that listed drug may be approved (Sec.
314.161(a)(1) (21 CFR 314.161(a)(1))). FDA may not approve an ANDA that
does not refer to a listed drug.
    On January 11, 2008, West-Ward Pharmaceutical Corp., on behalf of
Hikma Farmac[ecirc]utica of Portugal, submitted a citizen petition
(Docket No. FDA-2008-P-0029) to FDA under 21 CFR 10.30. The petition
requests that the agency determine whether NUBAIN (nalbuphine
hydrochloride) injection, 10 and 20 mg/ml (NDA 18-024), manufactured by
Endo Pharmaceuticals (Endo), was withdrawn from sale for reasons of
safety or effectiveness. NUBAIN was approved on May 15, 1979. NUBAIN is
an analgesic drug product used for the relief of moderate to severe
pain. NUBAIN may be used as a supplement to balanced anesthesia, for
preoperative and postoperative analgesia, and for obstetrical analgesia
during labor and delivery. Manufacture of NUBAIN was discontinued in
2003, and the drug product was moved from the prescription drug product
list to the ``Discontinued Drug Product List'' section of the Orange
Book.
    FDA has reviewed its records and, under Sec.  314.161, has
determined that NUBAIN (nalbuphine hydrochloride) injection, 10 and 20
mg/ml, was not withdrawn from sale for reasons of safety or
effectiveness. The petitioner identified no data or other information
suggesting that NUBAIN (nalbuphine hydrochloride) injection, 10 and 20
mg/ml, was withdrawn for reasons of safety or effectiveness. FDA has
independently evaluated relevant literature and data for possible
postmarketing adverse events and has found no information that would
indicate that this product was withdrawn from sale for reasons of
safety or effectiveness. Accordingly, the agency will continue to list
NUBAIN (nalbuphine hydrochloride) injection, 10 and 20 mg/ml, in the
``Discontinued Drug Product List'' section of the Orange Book. The
``Discontinued Drug Product List''delineates, among other items, drug
products that have been discontinued from marketing for reasons other
than safety or effectiveness. ANDAs that refer to NUBAIN (nalbuphine
hydrochloride) injection, 10 and 20 mg/ml, may be approved by the
agency if all other legal and regulatory requirementsfor the approval
of ANDAs are met. If FDA determines that labeling for this drug product
should be revised to meet current standards, the agency will advise
ANDA applicants to submit such labeling.

    Dated: November 14, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-27714 Filed 11-20-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register: May 19, 2010 (Volume 75, Number 96)]
[Notices]
[Page 28019-28021]
[DOCID:fr19my10-57]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0306; FRL-8825-7]

Resmethrin; Notice of Receipt of Requests to Voluntarily Cancel
Certain Pesticide Registrations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In accordance with section 6(f)(1) of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), as amended, EPA is issuing a
notice of receipt of requests by the registrants to voluntarily cancel
their registrations of certain products containing the pesticide
resmethrin. The requests would terminate resmethrin products registered
for use as a wide area mosquito abatement adulticide in the United
States. EPA intends to grant these requests at the close of the comment
period for this announcement unless the Agency receives substantive
comments within the comment period that would merit its further review
of the requests, or unless the registrants withdraw their requests. If
these requests are granted, any sale, distribution, or use of products
listed in this notice will be permitted after the registration has been
cancelled only if such sale, distribution, or use is consistent with
the terms as described in the final order. Resmethrin users or anyone
else that desires the retention of a resmethrin registration should
contact the applicable registrants during the comment period.

DATES: Comments must be received on or before November 15, 2010.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2010-0306, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2010-0306. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Tom Myers, Pesticide Re-evaluation
Division (7508P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-
mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1.  Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a

copy of the comment that does not contain the information claimed as
CBI must be submitted for inclusion in the public docket. Information
so marked will not be disclosed except in accordance with procedures
set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
     ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
     iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
     viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background on the Receipt of Requests to Cancel Registrations

    This notice announces receipt by EPA of requests from registrants
to cancel certain resmethrin product registrations. Resmethrin is a
member of the pyrethroid class of pesticides. It is a broad spectrum,
non-systemic, synthetic pyrethroid insecticide. Resmethrin is
registered for use as a wide area mosquito abatement insecticide for
use in industrial, recreational, and residential areas to control
flying and crawling insects. All remaining resmethrin end use products
not listed in this notice will be proposed for cancellation in a
subsequent Federal Register notice.
    The registrants have requested voluntary cancellation of these
resmethrin containing products based on the fact that the costs to
fulfill the data call-in requirements from the 2006 Resmethirn
Reregistration Eligibility Decision (RED), coupled with the costs to
satisfy the recently issued Endocrine Disrupter Screening Program
(EDSP) testing orders are not justified by the market opportunity in
the vector control business segment. Resmethrin users or anyone else
that desires the retention of a resmethrin registration should contact
the applicable registrants during the comment period. The data required
to support the resmethrin wide area mosquito abatement use are
identified in Table 1.

  Table 1.--Data Required to Support for the Mosquito Abatement Use of
                               Resmethrin
------------------------------------------------------------------------

------------------------------------------------------------------------
                    2006 Resmethrin RED Data Call-In
------------------------------------------------------------------------
810.3400                                   Mosquito, black fly, and
                                            biting midge (sand fly)
                                            treatments
------------------------------------------------------------------------
830.7050                                   UV/Visible absorption
------------------------------------------------------------------------
835.2410                                   Photodegradation of parent
                                            and degradates in soil
------------------------------------------------------------------------
850.1300                                   Daphnid chronic toxicity test
------------------------------------------------------------------------
850.1350                                   Mysid chronic toxicity test
------------------------------------------------------------------------
Non-guideline                              Chronic freshwater sediment
                                            testing - special study
------------------------------------------------------------------------
Non-guideline                              Chronic estuarine/marine
                                            sediment testing - special
                                            study
------------------------------------------------------------------------
870.6200                                   Neurotoxicity screening
                                            battery
------------------------------------------------------------------------
870.6300                                   Developmental neurotoxicity
                                            study
------------------------------------------------------------------------
                           EDSP testing orders
------------------------------------------------------------------------
2.1.1                                      Amphibian metamorphosis
                                            (frog)
------------------------------------------------------------------------
2.1.2                                      Androgen receptor binding
                                            (rat prostate)
------------------------------------------------------------------------
2.1.3                                      Aromatase (human recombinant)
------------------------------------------------------------------------
2.1.4                                      Estrogen receptor binding
------------------------------------------------------------------------
2.1.5                                      Estrogen receptor
                                            transcriptional activation
                                            (human cell line - HeLa-
                                            9903)
------------------------------------------------------------------------
2.1.6                                      Fish short-term reproduction
------------------------------------------------------------------------
2.1.7                                      Hershberger (rat)
------------------------------------------------------------------------
2.1.8                                      Female Pubertal (rat)
------------------------------------------------------------------------
2.1.9                                      Male pubertal (rat)
------------------------------------------------------------------------
2.1.10                                     Steroidogenesis (human cell
                                            line - H295R)
------------------------------------------------------------------------
2.1.11                                     Uterotrophic
------------------------------------------------------------------------

    In letters received by the Agency, the registrants requested EPA to
cancel certain pesticide product registrations identified in this
notice in Table 2. This action would terminate the use of resmethrin
products registered in the United States as a wide area mosquito
abatement insecticide.

III. What Action is the Agency Taking?

    This notice announces receipt by EPA of requests from registrants
to cancel certain resmethrin product registrations. The affected
products and the registrants making the requests are identified in
Tables 2 and 3 of this unit.
    Unless a request is withdrawn by the registrant or if the Agency
determines that there are substantive comments that warrant further
review of this request, EPA intends to issue an order canceling the
affected registrations.

  Table 2.--Resmethrin Product Registrations with Pending Requests for
                              Cancellation
------------------------------------------------------------------------
     Registration Number             Product Name            Chemical
------------------------------------------------------------------------
432-595                        SBP-1382 Insecticide      Resmethrin
                                Concentrate 40% Formula
                                I
------------------------------------------------------------------------
432-596                        SBP-1382 Insecticide 40   Resmethrin
                                MF Solvent Dilutable
                                Concentrate Formula I
------------------------------------------------------------------------
432-667                        SCOURGE Insecticide w/    Resmethrin
                                SBP-1382/PBO 18%+54% MF  Piperonyl
                                Formula II                butoxide
------------------------------------------------------------------------

432-716                        SCOURGE Insecticide w/    Resmethrin
                                SBP-1382/PBO 4%+12% MF   Piperonyl
                                Formula II                butoxide
------------------------------------------------------------------------
432-1246                       Aqua-SCOURGE              Resmethrin
                                                         Piperonyl
                                                          butoxide
------------------------------------------------------------------------
73049-78                       SBP-1382 Concentrate 40   Resmethrin
------------------------------------------------------------------------
73049-79                       SBP-1382 Insecticide      Resmethrin
                                Concentrate 15%
------------------------------------------------------------------------
73049-80                       SBP-1382 Pressurized      Resmethrin
                                Wasp and Hornet Spray
                                0.15%
------------------------------------------------------------------------
73049-86                       SBP-1382 Technical with   Resmethrin
                                Antioxidant
------------------------------------------------------------------------
73049-95                       SBP-1382 Bioallethrin/    Resmethrin
                                Insecticide Concentrate  S-Bioallethrin
                                10%-6.25% Formula I
------------------------------------------------------------------------
73049-101                      SBP-1382 T.E.C. 6%        Resmethrin
------------------------------------------------------------------------
73049-134                      SBP-1382 Insecticide      Resmethrin
                                Concentrate 40% Formula
                                II
------------------------------------------------------------------------
73049-372                      Synthrin Technical with   Resmethrin
                                Antioxidant Insecticide
------------------------------------------------------------------------

    Table 3 of this unit includes the names and addresses of record for
the registrants of the products listed in Table 2 of this unit, in
sequence by EPA company number. This number corresponds to the first
part of the EPA registration numbers of the products listed above.

         Table 3.--Registrants Requesting Voluntary Cancellation
------------------------------------------------------------------------
           EPA Company Number                Company Name and Address
------------------------------------------------------------------------
000432                                   Bayer Environmental Science
                                         P.O. Box 12014
                                         Research Triangle Park, NC
                                          27709
------------------------------------------------------------------------
073049                                   Valent BioSciences Corporation
                                         870 Technology Way
                                         Libertyville, IL 60048
------------------------------------------------------------------------

IV. What is the Agency's Authority for Taking this Action?

    Section 6(f)(1) of FIFRA provides that a registrant of a pesticide
product may at any time request that any of its pesticide registrations
be canceled or amended to terminate one or more uses. FIFRA further
provides that, before acting on the request, EPA must publish a notice
of receipt of any such request in the Federal Register.
    Section 6(f)(1)(B) of FIFRA requires that before acting on a
request for voluntary cancellation, EPA must provide a 30-day public
comment period on the request for voluntary cancellation or use
termination. In addition, section 6(f)(1)(C) of FIFRA requires that EPA
provide a 180-day comment period on a request for voluntary
cancellation or termination of any minor agricultural use before
granting the request, unless:
    1. The registrants request a waiver of the comment period, or
    2. The Administrator determines that continued use of the pesticide
would pose an unreasonable adverse effect on the environment.
    The resmethrin registrants have not requested that EPA waive the
180-day comment period. Accordingly, EPA will provide a 180-day comment
period on the proposed requests.

V. Procedures for Withdrawal of Requests

    Registrants who choose to withdraw a request for product
cancellation should submit the withdrawal in writing to the person
listed under FOR FURTHER INFORMATION CONTACT. If the products(s) have
been subject to a previous cancellation action, the effective date of
cancellation and all other provisions of any earlier cancellation
action are controlling.

VI. Provisions for Disposition of Existing Stocks

    Existing stocks are those stocks of registered pesticide products
that are currently in the United States and that were packaged,
labeled, and released for shipment prior to the effective date of the
action. If the requests for voluntary cancellation are granted, the
Agency intends to publish the cancellation order in the Federal
Register.
    In any order issued in response to these requests for cancellation
of product registrations, EPA proposes to include the following
provisions for the treatment of any existing stocks of the products
listed in Table 2.
    After December 31, 2012, registrants are prohibited from selling or
distributing existing stocks of products containing resmethrin for all
uses, including the use of resmethrin as a wide area mosquito abatement
insecticide.
    Persons other than the registrant may sell, distribute, or use
existing stocks of canceled products until supplies are exhausted,
provided that such sale, distribution, or use is consistent with the
terms of the previously approved labeling on, or that accompanied, the
canceled products.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: May 7, 2010.
 Richard P. Keigwin, Jr.,
Director, Pesticide Re-evaluation Division, Office of Pesticide
Programs.

[FR Doc. 2010-11697 Filed 5-18-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 76, Number 246 (Thursday, December 22, 2011)]
[Notices]
[Page 79675]
[FR Doc No: 2011-32737]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12790-001]

Pomperaug Hydro Project Andrew Peklo III; Notice of Site Visit
and Technical Meeting

    On January 18, 2012, Office of Energy Projects staff will hold a
site visit and technical meeting for the proposed Pomperaug Hydro
Project (FERC No. 12790-001). The purpose of the site visit is to view
the proposed site and to describe the proposed project layout. The
purpose of the technical meeting is to explain the exemption process
and discuss and clarify issues and comments filed with the Commission
in response to its November 3, 2011, notice of acceptance and ready for
environmental analysis.
    The site visit will begin at 1 p.m. EST. Attendees should park
along Pomperaug Road in Woodbury, in the vicinity of the Pomperaug Dam,
and meet by the doors under the sign at the mill. The technical meeting
will begin at 6 p.m. EST and conclude no later than 9 p.m. The meeting
will be held in the O and G Conference Room at the Woodbury Senior
Center, 265 Main Street South, Woodbury, CT 06798. Attached is an
agenda for the meeting. Anyone may attend either the site visit or the
technical meeting. If you have questions about the site visit or
meeting, please contact Steve Kartalia at<PHONE_NUMBER>, or via email
at<EMAIL_ADDRESS>
    Dated: December 15, 2011.
Kimberly D. Bose,
Secretary.

Technical Meeting Agenda

A. Introduction

1. Introduction of FERC staff
2. Meeting procedures and objectives
2. Description of the exemption process
3. Presentation of the proposed project

B. Discussion of Issues

C. Other Issues

D. Summary of Meeting

1. Issue Resolution
2. Follow-up Actions

[FR Doc. 2011-32737 Filed 12-21-11; 8:45 am]
BILLING CODE 6717-01-P