[Federal Register Volume 87, Number 21 (Tuesday, February 1, 2022)]
[Notices]
[Pages 5479-5481]
[FR Doc No: 2022-02047]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2020-0682; FRL-9518-01-ORD]

Request for Nomination of Experts for the Biofuels and the
Environment: Third Triennial Report to Congress Peer Review Panel

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; nomination of experts for peer review panel.

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SUMMARY: The U.S. Environmental Protection Agency (EPA) is requesting
nominations for an external expert panel to peer review EPA's Biofuels
and the Environment: Third Triennial Report to Congress (RtC3). The
peer review will be conducted under the framework of EPA's Scientific
Integrity Policy (https://www.epa.gov/sites/default/files/2014-02/documents/scientific_integrity_policy_2012.pdf) and follow procedures
established in EPA's Peer Review Handbook 4th Edition, 2015 (EPA/100/B-
15/001). EPA invites the public to nominate scientific experts to be
considered as peer reviewers for this contractor-managed peer review.
Nominations of peer review candidates will be accepted by EPA's
contractor, Eastern Research Group, Inc. (ERG). Relevant expertise
includes economics, engineering, agronomics, land use change, remote
sensing, air quality, biogeochemistry, water quality, hydrology,
conservation biology, limnology, and ecology. EPA has instructed ERG to
formulate a single pool of eighteen (18) candidate external reviewers
to provide independent external peer review. After consideration of
peer reviewer nominations submitted to ERG in response to this Federal
Register notice (FRN) and after consideration of public comments on the
List of Candidates (to be announced in a future FRN), ERG will select
from this pool the final list of up to nine (9) peer reviewers in a
manner consistent with EPA's Peer Review Handbook 4th Edition, 2015
(EPA/100/B-15/001), ensuring their combined expertise best spans the
above disciplines.

DATES: Nominations should be submitted by March 3, 2022.

ADDRESSES: Any interested person or organization may nominate
scientific experts to be considered as peer reviewers. Self-nominations
will also be accepted. Nominations should be submitted to ERG no later
than March 3, 2022 by sending an email to: [email protected] (subject
line: RtC3 Peer Review). Nominations should include all nominee
information described in section II of the SUPPLEMENTARY INFORMATION
section of this document.

FOR FURTHER INFORMATION CONTACT: Questions concerning nominations of
expert peer reviewers should be directed to EPA's contractor, ERG, by
email to [email protected] (subject line: RtC3 Peer Review). For
information on the period of submission, contact the ORD Docket at the
EPA Headquarters Docket Center; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
or email: [email protected]. For technical information, contact
Christopher Clark; phone:<PHONE_NUMBER>; or email:
[email protected].

SUPPLEMENTARY INFORMATION:

I. Information About the Document

    In 2007, Congress enacted the Energy Independence and Security Act
(EISA) with the stated goals of ``mov[ing] the United States toward
greater energy independence and security [and] to increase the
production of clean renewable fuels.'' In accordance with these goals,
EISA revised the Renewable Fuel Standard (RFS) Program, which was
created under the 2005 Energy Policy Act and is administered by EPA, to
increase the volume of renewable fuel required to be blended into
transportation fuel to 36 billion gallons per year by 2022. Section 204
of EISA directs EPA, in consultation with the U.S. Departments of
Agriculture and Energy, to assess and report triennially to Congress on
the environmental and resource conservation impacts of the RFS Program.
    The first report to Congress (RtC1) was completed in 2011 and
provided an assessment of the environmental and resource conservation
impacts associated with increased biofuel production and use (EPA/600/
R-10/183F). The overarching conclusions of this first report were: (1)
The environmental impacts of increased biofuel production and use were
likely negative but limited in impact; (2) there was a potential for
both positive and negative impacts in the future; and (3) EISA goals
for biofuels production could be achieved with minimal environmental
impacts if best practices were used and if technologies advanced to
facilitate the use of second-generation biofuel feedstocks (corn
stover, perennial grasses, woody biomass, algae, and waste).
    The second report to Congress (RtC2) was completed in 2018 and
reaffirmed the overarching conclusions of the RtC1 (EPA/600/R-18/195).
The RtC2 noted that the biofuel production and use conditions that led
to the conclusions of the RtC1 had not materially changed, and that the
production of biofuels from cellulosic feedstocks anticipated by both
the EISA and the RtC1 had not materialized. Noting observed increases
in acreage for corn and soybean production in the period prior to and
following implementation of the RFS2 Program, the RtC2 concluded that
the environmental and resource conservation impacts associated with
land use change were likely due, at least in part, to the RFS and
associated production of biofuel feedstocks but that further research
was needed.
    This RtC3 builds on the previous two reports and provides an update
on the impacts to date of the RFS Program on the environment. This
report assesses air, water, and soil quality; ecosystem health and
biodiversity; and other effects. This third report also includes new
analyses not previously included in the first and second reports.

II. How To Submit Nominations for Peer Reviewers

    Expertise sought: EPA is seeking candidates who are nationally and/
or internationally recognized scientific experts to serve as external
peer reviewers for the draft report. Nominees should possess a strong
background and demonstrated expertise in one or more of the following
areas: Economics, engineering, agronomics, land use change, remote
sensing, air quality, biogeochemistry, water quality, hydrology,
conservation biology, limnology, and ecology. Economists should have
expertise in partial equilibrium modeling (PE), computable general
equilibrium modeling (CGE), and/or econometric studies. All candidates
should have scientific credentials equivalent to a Ph.D., broad
expertise in biofuels, and should be familiar with the Renewable Fuel
Standard (RFS) Program.
    Selection criteria: From the pool of nominees, EPA's contractor,
ERG, will select nine peer reviewers, in a manner consistent with EPA's
Peer Review Handbook 4th Edition, 2015 (EPA/100/B-15/001), based on the
following factors: (1) Demonstrated expertise in the areas listed above
through relevant peer-reviewed publications; (2) professional
accomplishments and recognition by professional societies; (3)
demonstrated ability to work constructively and effectively in a
committee setting; (4) absence of conflicts of interest; (5) no
appearance of a lack of impartiality; (6) willingness to commit
adequate time for a thorough review of the draft report, including
preparation of individual written comments that will be made publicly
available; and (7) availability to participate virtually in a public
two-day or three-day peer review meeting and to provide subsequent
revised individual comments. Registration information, meeting dates,
and other logistical information will be provided in a subsequent FRN
at least 30 days prior to the external peer review meeting.
    Required nominee information: To receive full consideration, the
following information should be provided for each nominee in the
submission to ERG at [email protected] (subject line: RtC3 Peer
Review): (1) Contact information for the person making the nomination;
(2) contact information for the nominee; (3) the disciplinary and
specific areas of expertise of the nominee; (4) the nominee's
curriculum vitae; (5) a biographical sketch of the nominee indicating
current position, educational background, past and current research
activities, recent service on other advisory committees, peer review
panels, editorial boards or professional organizations, sources of
recent grant and/or contract support, and (6) any other comments on the
relevance of the nominee's expertise to this peer review topic.
Compensation for non-federal peer reviewers will be provided by ERG.
    Selection process: ERG will notify nominees of selection or non-
selection. ERG will also conduct an independent search for candidates
to assemble a balanced group representing the expertise needed to fully
evaluate EPA's Third Triennial Biofuels and the Environment Report to
Congress (RtC3). ERG will consider and screen all nominees against the
criteria previously described. Following the screening process, ERG
will narrow the list of potential reviewers to eighteen candidates.
Prior to selecting the final peer reviewers, an FRN will be published
(exact date to be determined) to solicit comments on the pool of
eighteen candidates. In that notice, the public will be requested to
provide relevant information or documentation on the candidate pool
within 15 days of the announcement of the interim list of candidates.
After considering the public comments on the candidate pool, ERG will
select nine peer reviewers, carefully

weighing a number of factors including the candidates' areas of
expertise and professional qualifications.

Timothy Watkins,
Acting Director, Center for Public Health and Environmental Assessment.
[FR Doc. 2022-02047 Filed 1-31-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 134 (Thursday, July 12, 2012)]
[Rules and Regulations]
[Pages 41075-41081]
[FR Doc No: 2012-17031]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[EPA-R09-OAR-2012-0286; FRL-9698-7]

Delegation of National Emission Standards for Hazardous Air
Pollutants for Source Categories; Gila River Indian Community

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is taking direct final action to delegate the authority to
implement and enforce specific National Emission Standards for
Hazardous Air Pollutants (NESHAP) to the Gila River Indian Community
Department of Environmental Quality (GRIC) in Arizona. The preamble
outlines the process that GRIC will use to receive delegation of any
future NESHAP, and identifies the NESHAP categories to be delegated by
today's action. EPA has reviewed GRIC's request for delegation and has
found that this request satisfies all of the requirements necessary to
qualify for approval. Thus, EPA is hereby granting GRIC the authority
to implement and enforce the unchanged NESHAP categories listed in this
rule.

DATES: This rule is effective on September 10, 2012 without further
notice, unless EPA receives relevant adverse comments by August 13,
2012. If we receive such comments, we will publish a timely withdrawal
in the Federal Register to notify the public that this direct final
rule will not take effect.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2012-0286, by one of the following methods:
    1. Federal eRulemaking Portal: www.regulations.gov. Follow the on-
line instructions.
    2. Email<EMAIL_ADDRESS>    3. Mail or deliver: Andrew Steckel (Air-4), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at www.regulations.gov,
including any personal information provided, unless the comment
includes Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Information that you
consider CBI or otherwise protected should be clearly identified as
such and should not be submitted through www.regulations.gov or email.
www.regulations.gov is an ``anonymous access'' system, and EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send email directly to EPA, your email
address will be automatically captured and included as part of the
public comment. 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: Generally, documents in the docket for this action are
available electronically at www.regulations.gov and in hard copy at EPA
Region IX, 75 Hawthorne Street, San Francisco, California 94105. While
all documents in the docket are listed at www.regulations.gov, some
information may be publicly available only at the hard copy location
(e.g., copyrighted material, large maps), and some may not be publicly
available in either location (e.g., CBI). To inspect the hard copy
materials, please schedule an appointment during normal business hours
with the contact listed in the FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Rynda Kay, EPA Region IX, (415) 947-
4118<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us,''
and ``our'' refer to EPA.

Table of Contents

I. Background
II. EPA's Action
    A. Delegation for Specific Standards
    B. Delegation Mechanism for Future Standards
    C. Public Comment and Final Action
III. Statutory and Executive Order Reviews

I. Background

    Section 112(l) of the Clean Air Act, as amended in 1990 (CAA or the
Act), authorizes EPA to delegate to state, local, or tribal air
pollution control agencies, the authority to implement and enforce the
standards set out in the Code of Federal Regulations, Title 40 (40
CFR), Part 63, NESHAP for Source Categories. On November 26, 1993, EPA
promulgated regulations, codified at 40 CFR Part 63, Subpart E
(hereinafter referred to as ``Subpart E''), establishing procedures for
EPA's approval of state rules or programs under section 112(l) (see 58
FR 62262). Subpart E was later amended on September 14, 2000 (see 65 FR
55810).
    Any request for approval under CAA section 112(l) must meet the
approval criteria in 112(l)(5) and Subpart E. To streamline the
approval process for future applications, a state agency, local agency
or tribe may submit a one-time demonstration that it has adequate
authorities and resources to implement and enforce any CAA section 112
standard. If such demonstration is approved, then the requesting agency
or tribe would no longer need to resubmit a demonstration of these same
authorities and resources for every subsequent request for delegation
of CAA section 112 standards. 40 CFR 63.91(d)(2). However, EPA
maintains the authority to withdraw its approval if the delegated
agency or tribe does not adequately implement or enforce an approved
rule or program. 40 CFR 63.96(b).
    To be eligible to receive delegation to implement CAA programs,
GRIC as an Indian Tribe must receive a Treatment as a State (TAS)
determination from EPA pursuant to CAA section 301(d)(2) and EPA's
implementing regulations in 40 CFR Part 49 (Tribal Authority Rule or
``TAR'' \1\). See 63 FR 7254 (February 12, 1998), as amended at 76 FR
23879 (April 29, 2011). In addition to the TAS eligibility
determination, in order to be delegated authority to implement the
NESHAP standards, GRIC agreed in a Memorandum of Agreement (2008
Delegation Memorandum) with EPA that it would: (i) Obtain the
regulatory authority necessary to implement the standards by
incorporating the CAA section 112 federal rules into tribal codes of
regulation by reference; (ii) submit a letter to the Director of EPA
Region IX's Air Division requesting delegation of the section 112
federal rule, including proof that GRIC has obtained the necessary
regulatory authority to fully implement and enforce the section 112
rule for which it is seeking delegation; and (iii) receive approval
from EPA to implement the requested standard. The details of this
delegation mechanism are set forth in the 2008 Delegation Memorandum
between GRIC and EPA.
---------------------------------------------------------------------------

    \1\ EPA previously titled these regulations as the Tribal Clean
Air Act Authority, or ``Tribal Authority Rule'', but recently
changed the name to better reflect the scope of authority for
planning and management of air quality in Indian Country. (see 76 FR
23876, April 29, 2011). However, references to Part 49, Subpart A
(49.1-49.50), such as here, are still referred to as the ``Tribal
Authority Rule'', or ``TAR''.
---------------------------------------------------------------------------

    On October 21, 2009, EPA determined that GRIC met the eligibility
requirements set forth in section 301(d)(2) of the CAA and EPA's
implementing regulations in the TAR, making it eligible for treatment
as a state to implement four CAA programs, including the NESHAP
standards under CAA section 112 (see letter from Laura Yoshii, Acting
Regional Administrator, U.S. EPA Region IX to William Rhodes, Governor,
Gila River Indian Community). EPA granted GRIC's request for a TAS
eligibility determination based on our conclusion that the Tribe's
application met the eligibility criteria in CAA section 301(d)(2) and
the TAR, including the requirement to demonstrate that the Tribe has
adequate resources and

authorities to implement and enforce the NESHAP under CAA section 112.
    On November 10, 2008, GRIC informed EPA that it intended to obtain
the regulatory authority necessary to accept delegation of section 112
standards by incorporating section 112 rules into the GRIC Tribal Code
by reference. On November 18, 2008, GRIC submitted a letter to the
director of the Air Division for Region IX requesting delegation of
several individual section 112 standards that had been incorporated by
reference into the GRIC Tribal Code.
    The final step in the delegation process occurs when EPA approves
GRIC's formal delegation request for that standard. Today's action is
an approval of GRIC's November 18, 2008 delegation request. The
standards that are being delegated by today's action are listed in a
table at the end of this rule.

II. EPA's Action

A. Delegation for Specific Standards

    Based on our review of GRIC's request for delegation of various
NESHAP, EPA has determined that the Tribe's request meets all of the
requirements to qualify for approval under CAA section 112(l) and 40
CFR 63.91. Accordingly, EPA is granting GRIC the authority to implement
and enforce the requested NESHAP. This delegation of authority will be
effective on September 10, 2012. A table identifying the specific
NESHAP that will be delegated to GRIC is shown at the end of this rule.
Although GRIC will have primary implementation and enforcement
responsibility, EPA retains the right, pursuant to CAA section
112(l)(7), to enforce any applicable emission standard or requirement
under CAA section 112. In addition, EPA does not delegate any
authorities that require implementation through rulemaking in the
Federal Register, or where Federal overview is the only way to ensure
national consistency in the application of the standards or
requirements of CAA section 112.
    After a state, local or tribal agency has been delegated the
authority to implement and enforce a NESHAP, the delegated agency
becomes the primary point of contact with respect to that NESHAP.
Pursuant to 40 CFR sections 63.9(a)(4)(ii) and 63.10(a)(4)(ii), EPA
Region IX waives the requirement that notifications and reports for
delegated standards be submitted to EPA as well as to GRIC.
    In its November 18, 2008 request, GRIC included a request for
delegation of the regulations implementing CAA section 112(i)(5),
codified at 40 CFR Part 63, Subpart D. These requirements apply to non-
federal agencies that have a permit program approved under title V of
the Act (see 40 CFR 63.70). State, local, or tribal agencies
implementing the requirements under Subpart D do not need approval
under section 112(l). If the non-federal agency does not have an
approved permit program, then these requirements are carried out by
EPA. GRIC currently does not have a federally approved permit program,
therefore Subpart D will be administered by EPA. In the future, if GRIC
receives federal approval for their permitting program, then GRIC will
automatically be able to implement the requirements of Subpart D
without the need to obtain an additional delegation from EPA. Because
the authority to implement the requirements under Subpart D is directly
conferred to approved permitting authorities without the need for
delegation through CAA section 112(l), EPA is not taking action to
delegate 40 CFR Part 63, Subpart D to GRIC.
    GRIC also included a request for delegation of the regulations
implementing CAA sections 112(g) and 112(j), codified at 40 CFR Part
63, Subpart B. These requirements apply to major sources only, and need
not be delegated under the section 112(l) approval process. When
promulgating the regulations implementing section 112(g), EPA stated
its view that ``the Act directly confers on the permitting authority
the obligation to implement section 112(g) and to adopt a program which
conforms to the requirements of this rule. Therefore, the permitting
authority need not apply for approval under section 112(l) in order to
use its own program to implement section 112(g)'' (see 61 FR 68397,
December 27, 1996). Similarly, when promulgating the regulations
implementing section 112(j), EPA stated its belief that ``section
112(l) approvals do not have a great deal of overlap with the section
112(j) provision, because section 112(j) is designed to use the title V
permit process as the primary vehicle for establishing requirements''
(see 59 FR 26447, May 20, 1994). Therefore, state, local, or tribal
agencies implementing the requirements under sections 112(g) and 112(j)
do not need approval under section 112(l). As a result, EPA is not
taking action to delegate 40 CFR Part 63, Subpart B to GRIC.

B. Delegation Mechanism for Future Standards

    Today's document serves to notify the public of the details of
GRIC's procedure for receiving delegation of future NESHAPs. As set
forth in the 2008 Delegation Memorandum, GRIC intends to incorporate by
reference, into the GRIC Tribal Code, each newly promulgated NESHAP for
which it intends to seek delegation. GRIC will then submit a letter to
EPA Region IX, along with proof of regulatory authority, requesting
delegation for each individual NESHAP. Region IX will respond in
writing that delegation is either granted or denied. If a request is
approved, the delegation of authorities will be considered effective
upon the date of the response letter from Region IX. Periodically, EPA
will publish in the Federal Register a listing of the standards that
have been delegated. Although EPA reserves its right, pursuant to 40
CFR 63.96, to review the appropriateness of any future delegation
request, EPA will not institute any additional comment periods on these
future delegation actions. Any parties interested in commenting on this
procedure for delegating future unchanged NESHAP should do so at this
time.

C. Public Comment and Final Action

    As authorized in section 112(l)(5) of the Act, EPA is fully
approving this delegation request because we believe it fulfills all
relevant requirements. We do not think anyone will object to this
approval, so we are finalizing it without proposing it in advance.
However, in the Proposed Rules section of this Federal Register, we are
simultaneously publishing a separate document that will serve as the
proposal for this action. If we receive adverse comments by August 13,
2012, we will publish a timely withdrawal in the Federal Register to
notify the public that this direct final approval will not take effect
and we will address the comments in a subsequent final action based on
the proposal. EPA will not institute a second comment period on the
proposed rule. Any parties interested in commenting on the proposed
rule should do so at this time. If we do not receive timely adverse
comments, the direct final approval will be effective without further
notice on September 10, 2012 and no further action will be taken on the
proposed rule. Please note that if EPA receives an adverse comment on
an amendment, paragraph, or section of this rule and if that provision
may be severed from the remainder of the rule, EPA may adopt as final
those provisions of the rule that are not the subject of an adverse
comment.

III. Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and

therefore is not subject to review by the Office of Management and
Budget. For this reason, this action is also not subject to Executive
Order 13211, ``Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This
action merely approves an eligible Indian tribe's request for
delegation of authority to implement federal requirements through
tribal law and imposes no additional requirements beyond those imposed
by tribal law. Accordingly, the Administrator certifies that this
direct final rule will not have a significant economic impact on a
substantial number of small entities under the Regulatory Flexibility
Act (5 U.S.C. 601, et seq.). Because this rule approves an Indian
tribe's request for delegation of authority to implement a federal
program through pre-existing requirements under tribal law and does not
impose any additional enforceable duty beyond that required by tribal
law, it does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4).
    Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' EPA has concluded that this
rule will have tribal implications in that it will have substantial
direct effects on the Gila River Indian Community. However, it will
neither impose substantial direct compliance costs on tribal
governments, nor preempt tribal law. EPA is approving GRIC's request
for delegation of authority to implement the federal NESHAP at the
request of the Tribe. Tribal law will not be preempted as GRIC
incorporated the federal NESHAP it seeks to implement into Tribal Law
on December 13, 2006. The Tribe has requested, and fully supports, our
approval of this delegation request, which makes the Tribe's
regulations incorporating the NESHAP federally enforceable.
    EPA worked and consulted with officials of the GRIC early in the
process of developing this program to permit them to have meaningful
and timely input into its development. In order to administer the
NESHAP, tribes must be determined eligible (40 CFR Part 49) for TAS for
the purpose of administering these standards. During the TAS
eligibility process, the Tribe and EPA worked together to ensure that
the appropriate information was submitted to EPA. GRIC and EPA also
worked together throughout the process of developing and adopting
GRIC's regulations to implement the NESHAP. The Tribe and EPA also
entered into a Memorandum of Agreement, which establishes procedures to
facilitate delegation of authority to implement and enforce the NESHAP
to GRIC and outlines the agencies' related responsibilities.
    This action also does not have Federalism implications because it
does 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, as specified in Executive Order 13132 (64 FR 43255, August
10, 1999). This action merely approves a tribal request to implement
federal emission standards that apply within the exterior boundaries of
the GRIC reservation, and does not alter the relationship or the
distribution of power and responsibilities established in the CAA. This
rule does not provide EPA with the discretionary authority to address,
as appropriate, disproportionate human health or environmental effects,
using practicable and legally permissible methods, under Executive
Order 12898, ``Federal Actions to Address Environmental Justice in
Minority Populations and Low-Income Populations'' (59 FR 7629, February
16, 1994). This rule also is not subject to Executive Order 13045
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), because it is not economically
significant.
    The requirements of section 12(d) of the National Technology
Transfer and Advancement Act (NTTAA) of 1995 (15 U.S.C. 272) do not
apply to this rule. In reviewing requests for delegation of CAA
authority, the EPA's role is to approve an eligible tribe's request,
provided that it meets the criteria of the CAA. In this context, in the
absence of a prior existing requirement for the Tribe to use Voluntary
Consensus Standards (VCS), the EPA has no authority to disapprove a
delegation request for failure to use VCS. It would thus be
inconsistent with applicable law for EPA, when it reviews a delegation
request, to use VCS in place of a submission that otherwise satisfies
the provisions of the CAA. Thus, the requirements of section 12(d) of
NTTAA do not apply. This rule does not impose an information collection
burden under the provisions of the Paperwork Reduction Act of 1995 (44
U.S.C. 3501, et seq.).

List of Subjects in 40 CFR Part 63

    Environmental protection, Administrative practice and procedure,
Air pollution control, Hazardous substances, Intergovernmental
relations, Reporting and recordkeeping requirements.

    Authority:  This action is issued under the authority of Section
112 of the Clean Air Act, as amended, 42 U.S.C. Section 7412.

    Dated: June 22, 2012.
Elizabeth Adams,
Acting Director, Air Division Region IX.
    Therefore, 40 CFR chapter I is amended as follows:

PART 63--[AMENDED]

0
1. The authority citation for Part 63 continues to read as follows:

    Authority:  42 U.S.C. 7401, et seq.

Subpart E--Approval of State Programs and Delegation of Federal
Authorities

0
2. Amend Sec.  63.99 by revising the table in paragraph (a)(3)(i) to
read as follows:

Sec.  63.99  Delegated Federal authorities.

    (a) * * *
    (3) * * *
    (i) * * *

                                Delegation Status for Part 63 Standards--Arizona
----------------------------------------------------------------------------------------------------------------
        Subpart             Description       ADEQ \1\      MCAQD \2\     PDEQ \3\     PCAQCD \4\     GRIC \5\
----------------------------------------------------------------------------------------------------------------
A......................  General                      X             X             X             X             X
                          Provisions.
F......................  Synthetic Organic            X             X             X             X             X
                          Chemical
                          Manufacturing
                          Industry.
G......................  Synthetic Organic            X             X             X             X             X
                          Chemical
                          Manufacturing
                          Industry:
                          Process Vents,
                          Storage Vessels,
                          Transfer
                          Operations, and
                          Wastewater.

H......................  Organic Hazardous            X             X             X             X             X
                          Air Pollutants:
                          Equipment Leaks.
I......................  Organic Hazardous            X             X             X             X             X
                          Air Pollutants:
                          Certain
                          Processes
                          Subject to the
                          Negotiated
                          Regulation for
                          Equipment Leaks.
J......................  Polyvinyl                    X             X             X   ............            X
                          Chloride and
                          Copolymers
                          Production.
L......................  Coke Oven                    X             X             X             X             X
                          Batteries.
M......................  Perchloroethylene            X             X             X             X             X
                          Dry Cleaning.
N......................  Hard and                     X             X             X             X             X
                          Decorative
                          Chromium
                          Electroplating
                          and Chromium
                          Anodizing Tanks.
O......................  Ethylene Oxide               X             X             X             X             X
                          Sterilization
                          Facilities.
Q......................  Industrial                   X             X             X             X             X
                          Process Cooling
                          Towers.
R......................  Gasoline                     X             X             X             X             X
                          Distribution
                          Facilities.
S......................  Pulp and Paper...            X             X             X   ............            X
T......................  Halogenated                  X             X             X             X             X
                          Solvent Cleaning.
U......................  Group I Polymers             X             X             X             X             X
                          and Resins.
W......................  Epoxy Resins                 X             X             X             X             X
                          Production and
                          Non-Nylon
                          Polyamides
                          Production.
X......................  Secondary Lead               X             X             X             X             X
                          Smelting.
Y......................  Marine Tank        ............  ............  ............  ............            X
                          Vessel Loading
                          Operations.
AA.....................  Phosphoric Acid              X             X             X   ............            X
                          Manufacturing
                          Plants.
BB.....................  Phosphate                    X             X             X   ............            X
                          Fertilizers
                          Production
                          Plants.
CC.....................  Petroleum                    X             X             X             X             X
                          Refineries.
DD.....................  Off-Site Waste               X             X             X             X             X
                          and Recovery
                          Operations.
EE.....................  Magnetic Tape                X             X             X             X             X
                          Manufacturing
                          Operations.
GG.....................  Aerospace                    X             X             X             X             X
                          Manufacturing
                          and Rework
                          Facilities.
HH.....................  Oil and Natural              X             X             X   ............            X
                          Gas Production
                          Facilities.
II.....................  Shipbuilding and   ............  ............  ............  ............            X
                          Ship Repair
                          (Surface
                          Coating).
JJ.....................  Wood Furniture               X             X             X             X             X
                          Manufacturing
                          Operations.
KK.....................  Printing and                 X             X             X             X             X
                          Publishing
                          Industry.
LL.....................  Primary Aluminum             X   ............            X   ............            X
                          Reduction Plants.
MM.....................  Chemical Recovery            X             X             X   ............            X
                          Combustion
                          Sources at
                          Kraft, Soda,
                          Sulfite, and
                          Stand-Alone
                          Semichemical
                          Pulp Mills.
OO.....................  Tanks--Level 1...            X             X             X             X             X
PP.....................  Containers.......            X             X             X             X             X
QQ.....................  Surface                      X             X             X             X             X
                          Impoundments.
RR.....................  Individual Drain             X             X             X             X             X
                          Systems.
SS.....................  Closed Vent                  X             X             X   ............            X
                          Systems, Control
                          Devices,
                          Recovery Devices
                          and Routing to a
                          Fuel Gas System
                          or a Process.
TT.....................  Equipment Leaks--            X             X             X   ............            X
                          Control Level 1.
UU.....................  Equipment Leaks--            X             X             X   ............            X
                          Control Level 2.
VV.....................  Oil-Water                    X             X             X             X             X
                          Separators and
                          Organic-Water
                          Separators.
WW.....................  Storage Vessels              X             X             X   ............            X
                          (Tanks)--Control
                          Level 2.
XX.....................  Ethylene                     X             X             X   ............            X
                          Manufacturing
                          Process Units:
                          Heat Exchange
                          Systems and
                          Waste Operations.
YY.....................  Generic MACT                 X             X             X   ............            X
                          Standards.
CCC....................  Steel Pickling...            X             X             X   ............            X
DDD....................  Mineral Wool                 X             X             X   ............            X
                          Production.
EEE....................  Hazardous Waste              X             X             X   ............            X
                          Combustors.
GGG....................  Pharmaceuticals              X             X             X   ............            X
                          Production.
HHH....................  Natural Gas                  X             X             X   ............            X
                          Transmission and
                          Storage
                          Facilities.
III....................  Flexible                     X             X             X   ............            X
                          Polyurethane
                          Foam Production.
JJJ....................  Group IV Polymers            X             X             X             X             X
                          and Resins.
LLL....................  Portland Cement              X             X             X   ............            X
                          Manufacturing
                          Industry.
MMM....................  Pesticide Active             X             X             X   ............            X
                          Ingredient
                          Production.
NNN....................  Wool Fiberglass              X             X             X   ............            X
                          Manufacturing.
OOO....................  Manufacture of               X             X             X   ............            X
                          Amino/Phenolic
                          Resins.
PPP....................  Polyether Polyols            X             X             X   ............            X
                          Production.
QQQ....................  Primary Copper               X             X             X   ............            X
                          Smelting.
RRR....................  Secondary                    X             X             X   ............            X
                          Aluminum
                          Production.
TTT....................  Primary Lead                 X             X             X   ............            X
                          Smelting.
UUU....................  Petroleum                    X             X             X   ............            X
                          Refineries:
                          Catalytic
                          Cracking,
                          Catalytic
                          Reforming, and
                          Sulfur Recovery
                          Units.
VVV....................  Publicly Owned               X             X             X   ............            X
                          Treatment Works.
XXX....................  Ferroalloys                  X             X             X   ............            X
                          Production.
AAAA...................  Municipal Solid              X             X             X   ............            X
                          Waste Landfills.
CCCC...................  Manufacturing of             X             X             X   ............            X
                          Nutritional
                          Yeast.
DDDD...................  Plywood and                  X             X             X   ............            X
                          Composite Wood
                          Products.
EEEE...................  Organic Liquids              X             X             X   ............            X
                          Distribution
                          (non-gasoline).

FFFF...................  Miscellaneous                X             X             X   ............            X
                          Organic Chemical
                          Manufacturing.
GGGG...................  Solvent                      X             X             X   ............            X
                          Extraction for
                          Vegetable Oil
                          Production.
HHHH...................  Wet-Formed                   X             X             X   ............            X
                          Fiberglass Mat
                          Production.
IIII...................  Surface Coating              X             X   ............  ............            X
                          of Automobiles
                          and Light-Duty
                          Trucks.
JJJJ...................  Paper and Other              X             X             X   ............            X
                          Web Coating.
KKKK...................  Surface Coating              X             X             X   ............            X
                          of Metal Cans.
MMMM...................  Miscellaneous                X             X             X   ............            X
                          Metal Parts and
                          Products.
NNNN...................  Large Appliances.            X             X             X   ............            X
OOOO...................  Printing,                    X             X             X   ............            X
                          Coating, and
                          Dyeing of
                          Fabrics and
                          Other Textiles.
PPPP...................  Surface Coating              X             X   ............  ............            X
                          of Plastic Parts
                          and Products.
QQQQ...................  Wood Building                X             X             X   ............            X
                          Products.
RRRR...................  Surface Coating              X             X             X   ............            X
                          of Metal
                          Furniture.
SSSS...................  Surface Coating              X             X             X   ............            X
                          of Metal Coil.
TTTT...................  Leather Finishing            X             X             X   ............            X
                          Operations.
UUUU...................  Cellulose                    X             X             X   ............            X
                          Products
                          Manufacturing.
VVVV...................  Boat                         X             X             X   ............            X
                          Manufacturing.
WWWW...................  Reinforced                   X             X             X   ............            X
                          Plastics
                          Composites
                          Production.
XXXX...................  Tire                         X             X             X   ............            X
                          Manufacturing.
YYYY...................  Stationary                   X             X             X   ............            X
                          Combustion
                          Turbines.
ZZZZ...................  Stationary                   X             X   ............  ............            X
                          Reciprocating
                          Internal
                          Combustion
                          Engines.
AAAAA..................  Lime                         X             X             X   ............            X
                          Manufacturing
                          Plants.
BBBBB..................  Semiconductor                X             X             X   ............            X
                          Manufacturing.
CCCCC..................  Coke Oven:                   X             X             X   ............            X
                          Pushing,
                          Quenching and
                          Battery Stacks.
DDDDD..................  Industrial,                  X             X   ............  ............            X
                          Commercial, and
                          Institutional
                          Boiler and
                          Process Heaters.
EEEEE..................  Iron and Steel               X             X             X   ............            X
                          Foundries.
FFFFF..................  Integrated Iron              X             X             X   ............            X
                          and Steel.
GGGGG..................  Site Remediation.            X             X             X   ............            X
HHHHH..................  Miscellaneous                X             X             X   ............            X
                          Coating
                          Manufacturing.
IIIII..................  Mercury Emissions            X             X             X   ............            X
                          from Mercury
                          Cell Chlor-
                          Alkali Plants.
JJJJJ..................  Brick and                    X             X             X   ............            X
                          Structural Clay
                          Products
                          Manufacturing.
KKKKK..................  Clay Ceramics                X             X             X   ............            X
                          Manufacturing.
LLLLL..................  Asphalt Roofing              X             X             X   ............            X
                          and Processing.
MMMMM..................  Flexible                     X             X             X   ............            X
                          Polyurethane
                          Foam Fabrication
                          Operation.
NNNNN..................  Hydrochloric Acid            X             X             X   ............            X
                          Production.
PPPPP..................  Engine Test Cells/           X             X             X   ............            X
                          Stands.
QQQQQ..................  Friction Products            X             X             X   ............            X
                          Manufacturing.
RRRRR..................  Taconite Iron Ore            X             X             X   ............            X
                          Processing.
SSSSS..................  Refractory                   X             X             X   ............            X
                          Products
                          Manufacturing.
TTTTT..................  Primary Magnesium            X             X             X   ............            X
                          Refining.
WWWWW..................  Hospital Ethylene  ............            X             X   ............  ............
                          Oxide
                          Sterilizers.
YYYYY..................  Area Sources:      ............            X             X   ............  ............
                          Electric Arc
                          Furnace
                          Steelmaking
                          Facilities.
ZZZZZ..................  Iron and Steel     ............            X             X   ............  ............
                          Foundries Area
                          Sources.
BBBBBB.................  Gasoline           ............            X             X   ............  ............
                          Distribution
                          Bulk Terminals,
                          Bulk Plants, and
                          Pipeline
                          Facilities.
CCCCCC.................  Gasoline           ............            X             X   ............  ............
                          Dispensing
                          Facilities.
DDDDDD.................  Polyvinyl          ............            X             X   ............  ............
                          Chloride and
                          Copolymers
                          Production Area
                          Sources.
EEEEEE.................  Primary Copper     ............            X             X   ............  ............
                          Smelting Area
                          Sources.
FFFFFF.................  Secondary Copper   ............            X             X   ............  ............
                          Smelting Area
                          Sources.
GGGGGG.................  Primary            ............            X             X   ............  ............
                          Nonferrous
                          Metals Area
                          Sources--Zinc,
                          Cadmium, and
                          Beryllium.
HHHHHH.................  Paint Stripping    ............            X             X   ............  ............
                          and
                          Miscellaneous
                          Surface Coating
                          Operations at
                          Area Sources.
LLLLLL.................  Acrylic and        ............            X             X   ............  ............
                          Modacrylic
                          Fibers
                          Production Area
                          Sources.
MMMMMM.................  Carbon Black       ............            X             X   ............  ............
                          Production Area
                          Sources.
NNNNNN.................  Chemical           ............            X             X   ............  ............
                          Manufacturing
                          Area Sources:
                          Chromium
                          Compounds.
OOOOOO.................  Flexible           ............            X             X   ............  ............
                          Polyurethane
                          Foam Production
                          and Fabrication
                          Area Sources.
PPPPPP.................  Lead Acid Battery  ............            X             X   ............  ............
                          Manufacturing
                          Area Sources.
QQQQQQ.................  Wood Preserving    ............            X             X   ............  ............
                          Area Sources.
RRRRRR.................  Clay Ceramics      ............            X             X   ............  ............
                          Manufacturing
                          Area Sources.
SSSSSS.................  Glass              ............            X             X   ............  ............
                          Manufacturing
                          Area Sources.

TTTTTT.................  Secondary          ............            X             X   ............  ............
                          Nonferrous
                          Metals
                          Processing Area
                          Sources.
VVVVVV.................  Chemical           ............            X   ............  ............  ............
                          Manufacturing
                          Industry--Area
                          Sources.
WWWWWW.................  Area Source        ............            X   ............  ............  ............
                          Standards for
                          Plating and
                          Polishing
                          Operations.
XXXXXX.................  Area Source        ............            X   ............  ............  ............
                          Standards for
                          Nine Metal
                          Fabrication and
                          Finishing Source
                          Categories.
YYYYYY.................  Area Sources:      ............            X   ............  ............  ............
                          Ferroalloys
                          Production
                          Facilities.
ZZZZZZ.................  Area Source        ............            X   ............  ............  ............
                          Standards for
                          Aluminum,
                          Copper, and
                          Other Nonferrous
                          Foundries.
AAAAAAA................  Asphalt            ............            X   ............  ............  ............
                          Processing and
                          Asphalt Roofing
                          Manufacturing--A
                          rea Sources.
BBBBBBB................  Chemical           ............            X   ............  ............  ............
                          Preparations
                          Industry--Area
                          Sources.
CCCCCCC................  Paint and Allied   ............            X   ............  ............  ............
                          Products
                          Manufacturing--A
                          rea Sources.
DDDDDDD................  Prepared Feeds     ............            X   ............  ............  ............
                          Manufacturing--A
                          rea Sources.
----------------------------------------------------------------------------------------------------------------
\1\ Arizona Department of Environmental Quality
\2\ Maricopa County Air Quality Department
\3\ Pima County Department of Environmental Quality
\4\ Pinal County Air Quality Control District
\5\ Gila River Indian Community Department of Environmental Quality. This table includes the GRIC DEQ only for
  purposes of identifying all state, local, and tribal agencies responsible for implementing part 63 standards
  within the geographical boundaries of the State of Arizona and does not establish any state regulatory
  authority in Indian country.

* * * * *
[FR Doc. 2012-17031 Filed 7-11-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 233 (Wednesday, December 4, 2019)]
[Notices]
[Pages 66429-66430]
[FR Doc No: 2019-26222]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-5119]

Oncologic Drugs Advisory Committee; Notice of Meeting;
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Oncologic Drugs Advisory
Committee. This notice is being published less than 15 days prior to
the date of the meeting. The general function of the committee is to
provide advice and recommendations to FDA on regulatory issues. The
meeting will be open to the public. FDA is establishing a docket for
public comment on this document.

DATES: The meeting will be held on December 17, 2019, from 8 a.m. to 5
p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2019-N-5119. The docket will close on December
16, 2019. Submit either electronic or written comments on this public
meeting by December 16, 2019. Please note that late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before December 16, 2019. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of December 16, 2019. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.
    Comments received on or before December 10, 2019, will be provided
to the committee. Comments received after that date will be taken into
consideration by FDA. In the event that the meeting is cancelled, FDA
will continue to evaluate any relevant applications or information, and
consider any comments submitted to the docket, as appropriate.
    You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-N-5119 for ``Oncologic Drugs Advisory Committee; Notice of
Meeting; Establishment of a Public Docket; Request for Comments.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA will review
this copy, including the claimed confidential information, in its
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify the information as ``confidential.'' Any
information marked as ``confidential'' will not be disclosed except in
accordance with 21 CFR 10.20 and other applicable disclosure law. For
more information about FDA's posting of comments to public dockets, see
80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lauren Tesh Hotaki, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, Fax:<PHONE_NUMBER>, email<EMAIL_ADDRESS>or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area). A notice in the Federal Register about last
minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the FDA's website at
https://www.fda.gov/AdvisoryCommittees/default.htm and

scroll down to the appropriate advisory committee meeting link, or call
the advisory committee information line to learn about possible
modifications before coming to the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: During the morning session, the committee will discuss
supplemental new drug application (sNDA) 208558/010 for LYNPARZA
(olaparib) tablets, submitted by AstraZeneca Pharmaceuticals LP. The
proposed indication (use) for this product is for the maintenance
treatment of adult patients with deleterious or suspected deleterious
gBRCAm metastatic adenocarcinoma of the pancreas whose disease has not
progressed on first-line platinum-based chemotherapy.
    During the afternoon session, the committee will discuss
supplemental biologics license application (sBLA) 125514/066 for
KEYTRUDA (pembrolizumab) for injection, submitted by Merck Sharpe &
Dohme Corp. The proposed indication (use) for this product is for the
treatment of patients with bacillus Calmette-Gu[eacute]rin-
unresponsive, high-risk, non-muscle invasive bladder cancer with
carcinoma in-situ with or without papillary tumors who are ineligible
for or have elected not to undergo cystectomy.
    FDA regrets that it was unable to publish this notice 15 days prior
to the Oncologic Drugs Advisory Committee due to technical issues.
Because the Agency believes there is a need to bring these issues to
public discussion and qualified members of the committee were available
at this time and already scheduled to participate in the meeting, the
Agency concluded that it was in the public interest to hold this
meeting without the customary 15-day public notice.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's website after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the Docket (see
ADDRESSES) on or before December 10, 2019, will be provided to the
committee. Oral presentations from the public will be scheduled between
approximately 10:30 a.m. to 11 a.m. and 3:30 p.m. to 4 p.m. Those
individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
December 5, 2019. Time allotted for each presentation may be limited.
If the number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by December 6,
2019.
    Persons attending FDA's advisory committee meetings are advised
that FDA is not responsible for providing access to electrical outlets.
    For press inquiries, please contact the Office of Media Affairs at
<EMAIL_ADDRESS>or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Lauren Tesh Hotaki (see FOR FURTHER INFORMATION CONTACT) at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: November 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-26222 Filed 11-29-19; 4:15 pm]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 21 (Tuesday, February 1, 2011)]
[Notices]
[Page 5572]
[FR Doc No: 2011-2152]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

January 20, 2011.
    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG11-47-000.
    Applicants: Mountain View Power Partners IV, LLC.
    Description: Notice of Self-Certification as an Exempt Wholesale
Generator of Mountain View Power Partners IV, LLC.
    Filed Date: 01/20/2011.
    Accession Number: 20110120-5059.
    Comment Date: 5 p.m. Eastern Time on Thursday, February 10, 2011.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-2302-002.
    Applicants: Public Service Company of New Mexico.
    Description: Public Service Company of New Mexico submits tariff
filing per 35: PNM MBR Compliance Filing to be effective 8/24/2010.
    Filed Date: 01/10/2011.
    Accession Number: 20110110-5003.
    Comment Date: 5 p.m. Eastern Time on Monday, January 31, 2011.

    Docket Numbers: ER10-2345-003.
    Applicants: Woodland Pulp LLC.
    Description: Woodland Pulp LLC submits tariff filing per 35:
Market-Based Rate Tariff Compliance Filing to be effective 9/23/2010.
    Filed Date: 01/10/2011.
    Accession Number: 20110110-5001.
    Comment Date: 5 p.m. Eastern Time on Monday, January 31, 2011.

    Docket Numbers: ER11-2708-000.
    Applicants: Geodyne Energy, LLC.
    Description: Geodyne Energy, LLC submits tariff filing per 35.1:
Geodyne Energy, LLC Baseline Filing to be effective 1/19/2011.
    Filed Date: 01/19/2011.
    Accession Number: 20110119-5144.
    Comment Date: 5 p.m. Eastern Time on Wednesday, February 09, 2011.

    Docket Numbers: ER11-2709-000.
    Applicants: Public Service Company of New Mexico.
    Description: Public Service Company of New Mexico submits Notice of
Termination of two service agreements between PJM, US Departments of
Energy, et al.
    Filed Date: 01/19/2011.
    Accession Number: 20110120-0201.
    Comment Date: 5 p.m. Eastern Time on Wednesday, February 09, 2011.

    Docket Numbers: ER11-2710-000.
    Applicants: La Paloma Generating Company, LLC.
    Description: La Paloma Generating Company, LLC submits tariff
filing per 35: Compliance Filing to be effective 9/30/2010.
    Filed Date: 01/20/2011.
    Accession Number: 20110120-5036.
    Comment Date: 5 p.m. Eastern Time on Thursday, February 10, 2011.

    Docket Numbers: ER11-2711-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc. submits tariff filing per
35.13(a)(2)(iii: 2152 Rio Blanco Wind Farm, LLC GIA to be effective 1/
5/2011.
    Filed Date: 01/20/2011.
    Accession Number: 20110120-5064.
    Comment Date: 5 p.m. Eastern Time on Thursday, February 10, 2011.

    Docket Numbers: ER11-2712-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: PJM Interconnection, L.L.C. submits tariff filing per
35.13(a)(2)(iii: WMPA No. 2720, Queue V4-001, Flemington Solar, LLC and
JCPL to be effective 1/13/2011.
    Filed Date: 01/20/2011.
    Accession Number: 20110120-5066.
    Comment Date: 5 p.m. Eastern Time on Thursday, February 10, 2011.

    Docket Numbers: ER11-2713-000.
    Applicants: Otter Tail Power Company.
    Description: Otter Tail Power Company submits tariff filing per
35.13(a)(2)(iii: Bemidji-Grand Rapids Transmission Project Operation
and Maintenance Agreement to be effective 12/1/2010.
    Filed Date: 01/20/2011.
    Accession Number: 20110120-5087.
    Comment Date: 5 p.m. Eastern Time on Thursday, February 10, 2011.

    Docket Numbers: ER11-2714-000.
    Applicants: Otter Tail Power Company.
    Description: Otter Tail Power Company submits tariff filing per
35.13(a)(2)(iii: Bemidji-Grand Rapids Transmission Project Construction
Management Agreement to be effective 12/1/2010.
    Filed Date: 01/20/2011.
    Accession Number: 20110120-5105.
    Comment Date: 5 p.m. Eastern Time on Thursday, February 10, 2011.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-2152 Filed 1-31-11; 8:45 am]
BILLING CODE 6717-01-P