[Federal Register Volume 79, Number 121 (Tuesday, June 24, 2014)]
[Rules and Regulations]
[Pages 35695-35699]
[FR Doc No: 2014-14531]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2012-0733, EPA-R01-OAR-2012-0935; A-1-FRL-9911-51-Region-
1]

Approval and Promulgation of Air Quality Implementation Plans;
Maine and New Hampshire; Ambient Air Quality Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving State
Implementation Plan (SIP) revisions submitted by the States of Maine
and New Hampshire. The revisions primarily update state regulations
containing ambient air quality standards (AAQS) consistent with EPA
national ambient air quality standards (NAAQS). The intended effect of
this action is to approve these requirements into the Maine and New
Hampshire SIPs. This action is being taken in accordance with the Clean
Air Act (CAA).

DATES: This direct final rule will be effective August 25, 2014, unless
EPA receives adverse comments by July 24, 2014. If adverse comments are
received, EPA will publish a timely withdrawal of the direct final rule
in the Federal Register informing the public that the rule will not
take effect.

ADDRESSES: Submit your comments identified by Docket ID Number EPA-R01-
OAR-2012-0733 for comments pertaining to our action for Maine, or EPA-
R01-OAR-2012-0935 for comments pertaining to our action for New
Hampshire, by one of the following methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. E-Mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``Docket Identification Number EPA-R01-OAR-2012-0733 or
EPA-R01-OAR-2012-0935,'' Anne Arnold, Manager, Air Quality Planning
Unit, Office of Ecosystem Protection, U.S. Environmental Protection
Agency, EPA New England Regional Office, 5 Post Office Square--Suite
100, (Mail Code OEP05-2), Boston, MA 02109-3912.
    5. Hand Delivery or Courier. Deliver your comments to: Anne Arnold,
Manager, Air Quality Planning Unit, Office of Ecosystem Protection,
U.S. Environmental Protection Agency, EPA New England Regional Office,
5 Post Office Square--Suite 100, (Mail Code OEP05-2), Boston, MA 02109-
3912. Such deliveries are only accepted during the Regional Office's
normal hours of operation. The Regional Office's official hours of
business are Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding
legal holidays.
    Instructions: Direct your comments to Docket ID Number EPA-R01-OAR-
2012-0733 for comments pertaining to our action for Maine, or EPA-R01-
OAR-2012-0935 for comments pertaining to our action for New Hampshire.
EPA's policy is that all comments received 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 information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit through www.regulations.gov, or
email, information that you consider to be CBI or otherwise protected.
The www.regulations.gov Web site 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 email
comment directly to EPA without going through www.regulations.gov your
email address will be automatically captured and included as part of
the comment that is placed in the public 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 electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., 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 electronically in www.regulations.gov or
in hard copy at Office of Ecosystem Protection, U.S. Environmental
Protection Agency, EPA New England Regional Office, 5 Post Office
Square--Suite 100, Boston, MA. EPA requests that if at all possible,
you contact the

contact listed in the FOR FURTHER INFORMATION CONTACT section to
schedule your inspection. The Regional Office's official hours of
business are Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding
legal holidays.
    In addition, copies of each state's submittal are available for
public inspection during normal business hours, by appointment at the
corresponding state environmental agency: Bureau of Air Quality
Control, Department of Environmental Protection, First Floor of the
Tyson Building, Augusta Mental Health Institute Complex, Augusta, ME
04333-0017; and Air Resources Division, Department of Environmental
Services, P.O. Box 95, 29 Hazen Drive, Concord, NH 03302-0095.

FOR FURTHER INFORMATION CONTACT: David Mackintosh, Air Quality Planning
Unit, U.S. Environmental Protection Agency, New England Regional
Office, 5 Post Office Square--Suite 100, (Mail Code OEP05-02), Boston,
MA 02109-3912, telephone<PHONE_NUMBER>, facsimile<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Throughout this document whenever ``we,'' ``us,'' or ``our'' is
used, we mean EPA.
    The following outline is provided to aid in locating information in
this preamble.

I. What action is EPA taking?
II. What is the background for this action?
III. What is included in the submittals?
    A. Maine
    B. New Hampshire
IV. EPA's Evaluation of the Submittals
    A. Maine
    B. New Hampshire
V. Final Action
VI. Statutory and Executive Order Reviews

I. What action is EPA taking?

    EPA is approving two SIP revisions submitted by the State of Maine,
which include Maine's revised Chapter 110, ``Ambient Air Quality
Standards,'' submitted to EPA on August 21, 2012, and Maine's revised
Chapter 114, ``Classification of Air Quality Control Regions,''
submitted to EPA on August 31, 2012. EPA is also approving a SIP
revision submitted by the State of New Hampshire on November 8, 2012,
which includes New Hampshire's revised Env-A 300, ``Ambient Air Quality
Standards.'' These state regulations were revised to reflect updates to
the federal NAAQS and to clarify the boundary description for an
existing air quality control region in the State of Maine.

II. What is the background for this action?

    Section 109 of the CAA directs EPA to establish NAAQS requisite to
protect public health with an adequate margin of safety (primary
standard) and for the protection of public welfare (secondary
standard). Section 109(d)(1) of the CAA requires EPA to complete a
thorough review of the NAAQS at 5-year intervals and promulgate new
standards when appropriate. Additionally, Section 107 of the CAA
requires the establishment of air quality control regions for the
purpose of implementing the NAAQS.
    On October 17, 2006 (71 FR 61144), EPA revised the primary and
secondary 24-hour NAAQS for fine particulate matter (PM2.5)
to 35 micrograms per cubic meter. This final rule became effective on
December 18, 2006.
    On March 27, 2008 (73 FR 16436), EPA revised the NAAQS for ozone,
setting the level of the primary and secondary 8-hour standard to 0.075
parts per million. This final ozone standard rule became effective on
May 27, 2008.
    On November 12, 2008 (73 FR 66964), EPA revised the NAAQS for lead,
setting the level of the primary and secondary standard to 0.15
micrograms per cubic meter and revised the averaging time to a rolling
3-month period with a maximum (not-to-be-exceeded) form, evaluated over
a 3-year period. The final lead standard rule became effective on
January 12, 2009.
    On February 9, 2010 (75 FR 6474), EPA revised the NAAQS for oxides
of nitrogen as measured by nitrogen dioxide (NO2). EPA
established a 1-hour primary standard for NO2 at a level of
100 parts per billion, based on the 3-year average of the 98th
percentile of the yearly distribution of 1-hour daily maximum
concentrations, to supplement the existing primary and secondary annual
standard of 53 parts per billion (61 FR 52852, Oct 8, 1996). The final
NO2 rule became effective on April 12, 2010.
    On June 22, 2010 (75 FR 35520), EPA revised the NAAQS for oxides of
sulfur as measured by sulfur dioxide (SO2). EPA established
a new 1-hour SO2 primary standard at a level of 75 parts per
billion, based on the 3-year average of the annual 99th percentile of
1-hour daily maximum concentrations. EPA also revoked both the previous
24-hour and annual primary SO2 standards. This final rule
became effective on August 23, 2010.
    On August 21, 2012, Maine submitted a SIP revision to update its
Chapter 110, ``Ambient Air Quality Standards.'' Then on August 31,
2012, Maine submitted a SIP revision to update its Chapter 114,
``Classification of Air Quality Control Regions.'' On November 8, 2012,
New Hampshire submitted a SIP revision to update its Env-A 300,
``Ambient Air Quality Standards.''
    On January 15, 2013 (78 FR 3086), EPA revised the primary
PM2.5 annual NAAQS, lowering the standard to 12.0 micrograms
per cubic meter. The final rule became effective on March 18, 2013.

III. What is included in the submittals?

A. Maine

    Maine's August 21, 2012, SIP submittal includes revised Chapter
110, ``Ambient Air Quality Standards.'' This regulation has been
revised to explicitly incorporate the new NAAQS, discussed above, with
the exception of the latest revision to the PM2.5 primary
standard. Maine's SIP revision was submitted on August 21, 2012, prior
EPA's adoption of the 12.0 microgram per cubic meter PM2.5
primary annual standard. Specifically, Maine adopted the following
substantive changes:
    1. The lead primary and secondary rolling 3-month average standards
of 0.15 micrograms per cubic meter;
    2. The nitrogen dioxide primary 1-hour standard of 100 parts per
billion;
    3. The ozone primary and secondary 8-hour standards of 0.075 parts
per million;
    4. The PM2.5 primary and secondary annual standard of
15.0 micrograms per cubic meter;
    5. The PM2.5 primary and secondary 24-hour standards of
35.0 micrograms per cubic meter;
    6. The sulfur dioxide primary 1-hour standard of 75 parts per
billion; and
    7. Ambient air increments for PM2.5 under the Prevention
of Significant Deterioration (PSD) permit program.

Maine's August 31, 2012 SIP revision includes Maine's revised Chapter
114, ``Classification of Air Quality Control Regions,'' which was
revised to clarify that the Moosehorn Wilderness Area located in
Moosehorn National Wildlife Refuge is a Class I area. Maine also
deleted the rule's prior reference to ozone nonattainment areas.

B. New Hampshire

    New Hampshire's SIP submittal contains revised Env-A 300, ``Ambient
Air Quality Standards.'' This regulation has been revised to explicitly
incorporate the revised NAAQS, discussed above, with the exception of
the latest revision to the PM2.5 primary standard. New
Hampshire's SIP revision was submitted on November 8, 2012, prior EPA`s
adoption of the 12.0

microgram per cubic meter PM2.5 primary annual standard.
Specifically, New Hampshire adopted the following substantive changes:
    1. The lead primary and secondary rolling 3-month-average standards
of 0.15 micrograms per cubic meter;
    2. The nitrogen dioxide primary 1-hour standard of 100 parts per
billion;
    3. The ozone primary and secondary 8-hour standards of 0.075 parts
per million;
    4. The PM2.5 primary and secondary annual standards of
15 micrograms per cubic meter;
    5. The PM2.5 primary and secondary 24-hour standards of
35 micrograms per cubic meter;
    6. The PM10 primary and secondary 24-hour standards of
150 micrograms per cubic meter; and
    7. The sulfur dioxide primary 1-hour standard of 75 parts per
billion.

IV. EPA's Evaluation of the Submittals

A. Maine

    Maine's Chapter 110 was originally approved into the Maine SIP on
January 30, 1980 (45 FR 6784). Several updates to the rule were also
approved into the Maine SIP, the most recent of which occurred on March
22, 2004 (69 FR 13227). EPA has reviewed Maine's revised Chapter 110
and has determined that it is consistent with the NAAQS in 40 CFR Part
50, with the exception of EPA's latest revision to the PM2.5
standard which occurred subsequent to Maine's adoption of the Chapter
110 revised rule.
    In addition, Section 8 of Maine's Chapter 110, ``Establishment of
Ambient Increments,'' was revised to include ambient air increments for
PM2.5, as required under the Clean Air Act's Prevention of
Significant Deterioration permit program. (The previously SIP-approved
version of the rule included increments for PM10, sulfur
dioxide, and nitrogen dioxide which are also in the revised rule.) EPA
has reviewed the maximum allowable increases Maine has established for
PM2.5 and determined that they are consistent with 40 CFR
51.166(c). Therefore, we are approving those PM2.5 maximum
allowable increases into Maine's SIP. In approving those maximum
allowable increases, EPA is not taking action on, or making any
determinations about, the way in which these maximum allowable
increases relate to existing SIP provisions or recently amended
provisions of Maine's Chapters 100 and 115 pertaining to the way in
which ``increment'' is calculated or used in the PSD permit program.
    In summary, Maine's revised Chapter 110 includes additional and
more stringent air quality standards than the previous SIP-approved
version of the rule. The revised rule also includes ambient air
increments for PM2.5 that were not included in the previous
SIP-approved version of the rule. Thus, the revised Chapter 110
satisfies the anti-back sliding requirements in Section 110(l) of the
CAA and we are approving Maine's revised rule into the Maine SIP.
    Maine's Chapter 114 was originally approved into the Maine SIP on
January 30, 1980 (45 FR 6874). Updates to the rule were also approved
into the Maine SIP, the most recent of which occurred on August 30,
1995 (60 FR 45056). In the current SIP revision, Chapter 114 was
revised to clarify that the Moosehorn Wilderness Area located in
Moosehorn National Wildlife Refuge is a Class I area and the rule's
prior reference to ozone nonattainment areas was deleted.
    Maine's updates to Chapter 114 are appropriate. All of Maine was
designated as unclassifiable/attainment for the 2008 ozone standard on
May 21, 2012 (77 FR 30088). In addition, Maine's nonattainment areas
for the 1997 ozone standard were redesignated to attainment on December
11, 2006 (71 FR 71489). See also 40 CFR 81.320. Furthermore, Maine's
clarification that Moosehorn Wilderness Area located in Moosehorn
National Wildlife Refuge is a Class I area is consistent with 40 CFR
Part 81, Subpart D.
    In summary, Maine's Chapter 114 revised rule includes updates that
are consistent with the applicable sections of the Code of Federal
Regulations and is no less stringent than the previous SIP-approved
version of the rule. Therefore, Maine's revised Chapter 114 satisfies
the anti-back sliding requirements in Section 110(l) of the CAA and we
are approving Maine's revised rule into the Maine SIP.

B. New Hampshire

    New Hampshire's Env-A 300, ``Ambient Air Quality Standards,'' was
originally approved into the New Hampshire SIP on March 15, 1983 (48 FR
10830). Updates to the rule were also approved into the New Hampshire
SIP, the most recent of which occurred on August 19, 1994 (59 FR
42766). EPA has reviewed New Hampshire's revised Env-A 300 and has
determined that it is consistent with the NAAQS in 40 CFR Part 50, with
the exception of EPA's latest revision to the PM2.5 standard
which occurred subsequent to New Hampshire's adoption of the Env-A 300
revised rule.
    New Hampshire's revised Env-A 300 includes additional and more
stringent air quality standards than the previous SIP-approved version
of the rule. Thus, the revised Chapter 110 satisfies the anti-back
sliding requirements in Section 110(l) of the CAA and we are approving
Maine's revised rule into the Maine SIP.

V. Final Action

    EPA is approving, and incorporating into the Maine SIP, Maine's
revised Chapter 110, ``Ambient Air Quality Standards,'' submitted to
EPA on August 21, 2012, and Maine's revised Chapter 114,
``Classification of Air Quality Control Regions,'' submitted to EPA on
August 31, 2012. EPA is also approving, and incorporating into the New
Hampshire SIP, New Hampshire's revised Env-A 300, ``Ambient Air Quality
Standards,'' submitted to EPA on November 8, 2012.
    The EPA is publishing this action without prior proposal because
the Agency views this as a noncontroversial amendment and anticipates
no adverse comments. However, in the proposed rules section of this
Federal Register publication, EPA is publishing a separate document
that will serve as the proposal to approve these SIP revisions should
relevant adverse comments be filed. This rule will be effective August
25, 2014 without further notice unless the Agency receives relevant
adverse comments by July 24, 2014.
    If the EPA receives such comments, then EPA will publish a notice
withdrawing the final rule and informing the public that the rule will
not take effect. All public comments received will then be addressed in
a subsequent final rule based on the proposed rule. The EPA will not
institute a second comment period on the proposed rule. All parties
interested in commenting on the proposed rule should do so at this
time. If no such comments are received, the public is advised that this
rule will be effective on August 25, 2014 and no further action will be
taken on the proposed rule. Please note that if EPA receives 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.

VI. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve

state choices, provided that they meet the criteria of the Clean Air
Act. Accordingly, this action merely approves state law as meeting
Federal requirements and does not impose additional requirements beyond
those imposed by state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     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);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     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 (59 FR 7629, February 16, 1994).
In addition, this rule does not have tribal implications as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000), because the
SIP is not approved to apply in Indian country located in the state,
and EPA notes that it will not impose substantial direct costs on
tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by August 25, 2014. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. Parties with objections to this direct final
rule are encouraged to file a comment in response to the parallel
notice of proposed rulemaking for this action published in the proposed
rules section of today's Federal Register, rather than file an
immediate petition for judicial review of this direct final rule, so
that EPA can withdraw this direct final rule and address the comment in
the proposed rulemaking. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Lead, NAAQS, Nitrogen dioxide, Ozone,
Particulate matter, Reporting and recordkeeping requirements, Sulfur
oxides.

    Dated: June 16, 2014.
H. Curtis Spalding,
Regional Administrator, EPA New England.
    Part 52 of chapter I, title 40 of the Code of Federal Regulations
is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

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

Subpart U--Maine

0
2. In Sec.  52.1020, Table (c) ``EPA-APPROVED MAINE REGULATIONS'' is
amended by revising existing entries for Chapter 110 and Chapter 114 to
read as follows:

Sec.  52.1020  Identification of plan.

* * * * *
    (c) EPA approved regulations.

                                                             EPA-Approved Maine Regulations
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                                                                State       EPA approval date  EPA approval date
          State citation                Title/subject      effective date             and citation \1\                          Explanations
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                                                                      * * * * * * *
Chapter 110.......................  Ambient Air Quality          8/6/2012  6/24/14 [Insert Federal Register        .....................................
                                     Standards.                             citation].
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                                                                      * * * * * * *
Chapter 114.......................  Classification of Air       8/29/2012  6/24/14 [Insert Federal Register        .....................................
                                     Quality Control                        citation].
                                     Regions.
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                                                                      * * * * * * *
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    \1\ In order to determing the EPA effective date for a specific
provision listed in this table, consult the Federal Register notice
cited in this column for the particular provision.
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* * * * *

Subpart EE--New Hampshire

0
3. In Sec.  52.1520, Table (c) ``EPA-APPROVED NEW HAMPSHIRE
REGULATIONS'' is amended by revising the existing entry for Env-A 300
to read as follows:

Sec.  52.1520  Identification of plan.

* * * * *
    (c) EPA approved regulations.

                                                         EPA-Approved New Hampshire Regulations
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                State
          State citation                Title/subject      effective date           EPA approval date \1\                       Explanations
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
Env-A 300.........................  Ambient Air Quality          9/1/2012  6/24/14...............................  .....................................
                                     Standards..                           [Insert Federal Register page number
                                                                            where the document begins].
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
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    \1\ In order to determine the EPA effective date for a specific
provision listed in this table, consult the Federal Register notice
cited in this column for the particular provision.
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* * * * *
[FR Doc. 2014-14531 Filed 6-23-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 3 (Wednesday, January 5, 2011)]
[Notices]
[Pages 570-571]
[FR Doc No: 2010-33293]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0636]

Draft Guidance for Industry and Food and Drug Administration
Staff; Establishing the Performance Characteristics of In Vitro
Diagnostic Devices for the Detection of Antibodies to Borrelia
Burgdorferi; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Draft Guidance for
Industry and Food and Drug Administration Staff; Establishing the
Performance Characteristics of In Vitro Diagnostic Devices for the
Detection of Antibodies to Borrelia burgdorferi.'' FDA is issuing this
draft guidance to provide industry and agency staff with
recommendations for studies to establish the analytical and clinical
performance of in vitro

diagnostic devices (IVDs) intended for the detection of antibodies to
Borrelia burgdorferi. These devices are used to aid in the diagnosis of
Lyme disease. This draft guidance is not final nor is it in effect at
this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment of this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 5, 2011.

ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Draft Guidance for Industry and Food and
Drug Administration Staff; Establishing the Performance Characteristics
of In Vitro Diagnostic Devices for the Detection of Antibodies to
Borrelia burgdorferi'' to the Division of Small Manufacturers,
International, and Consumer Assistance, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
request, or fax your request to<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the
guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Prasad Rao, Center for Devices and
Radiological Health Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5508, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance recommends studies for establishing the
performance characteristics of in vitro diagnostic devices for the
detection of antibodies to B. burgdorferi in human serum, plasma, and
blood. These devices are used to aid in the diagnosis of Lyme disease.
This document does not apply to B. burgdorferi nucleic acid
amplification assays. A manufacturer who intends to market an in vitro
device for the detection of antibodies to B. burgdorferi must conform
to the general controls of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) and, unless exempt, obtain premarket clearance or approval
prior to marketing the device.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized will represent the Agency's current thinking on establishing
the performance characteristics of in vitro diagnostic devices for the
detection of antibodies to B. burgdorferi. It does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. A search capability for all CDRH guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. To receive
``Draft Guidance for Industry and Food and Drug Administration Staff;
Establishing the Performance Characteristics of In Vitro Diagnostic
Devices for the Detection of Antibodies to Borrelia burgdorferi,'' you
may either send an e-mail request to<EMAIL_ADDRESS>to receive an
electronic copy of the document or send a fax request to<PHONE_NUMBER>
to receive a hard copy. Please use the document number 1721 to identify
the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 807 subpart E have
been approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 801 and 21 CFR 809.10 have been approved
under OMB control number 0910-0485; the collections of information in
21 CFR part 812 have been approved under OMB control number 0910-0078;
the collections of information in 42 CFR 493.15 have been approved
under OMB control number 0910-0598; the collections of information 21
CFR 50.23 have been approved under OMB control number 0910-0586 and the
collections of information in 21 CFR 56.115 have been approved under
OMB control number 0910-0130.

V. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: December 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-33293 Filed 1-4-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 85, Number 72 (Tuesday, April 14, 2020)]
[Notices]
[Page 20702]
[FR Doc No: 2020-07843]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4480-DR; Docket ID FEMA-2020-0001]

New York; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of New York (FEMA-4480-DR), dated March 20,
2020, and related determinations.

DATES: The declaration was issued March 20, 2020.

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

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated March 20, 2020, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the emergency conditions in the State of
New York resulting from the Coronavirus Disease 2019 (COVID-19)
pandemic beginning on January 20, 2020, and continuing, are of
sufficient severity and magnitude to warrant a major disaster
declaration under the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''). Therefore, I declare that such a major disaster exists in
the State of New York.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Individual Assistance limited to
the Crisis Counseling Program and assistance for emergency
protective measures (Category B), including direct Federal
assistance, under the Public Assistance program throughout the
State. Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance will be limited to 75 percent of the total
eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Seamus K. Leary, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of New York have been designated
as adversely affected by this major disaster:

    Individual Assistance limited to the Crisis Counseling Program
in all areas in the State of New York.
    Emergency protective measures (Category B) not authorized under
other Federal statutes, including direct federal assistance, under
the Public Assistance program at 75 percent federal funding for all
areas in the State of New York.

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

Pete Gaynor,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2020-07843 Filed 4-13-20; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register Volume 78, Number 12 (Thursday, January 17, 2013)]
[Notices]
[Pages 3925-3928]
[FR Doc No: 2013-00874]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68632; File No. SR-FINRA-2013-003]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing of Proposed Rule Change Relating to
Amendments to the Customer and Industry Codes of Arbitration Procedure
To Revise the Public Arbitrator Definition

January 11, 2013.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Exchange Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby
given that on January 4, 2013, Financial Industry Regulatory Authority,
Inc. (``FINRA'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by FINRA. The Commission
is publishing this notice to

solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    FINRA is proposing to amend the Customer and Industry Codes of
Arbitration Procedure (``Codes'') to revise the definition of ``public
arbitrator'' to exclude persons associated with a mutual fund or hedge
fund from serving as public arbitrators and to require individuals to
wait for two years after ending certain affiliations before they may be
permitted to serve as public arbitrators. FINRA believes that the
proposed amendments to the public arbitrator definition would improve
investors' perception about the fairness and neutrality of FINRA's
public arbitrator roster.
    The text of the proposed rule change is available on FINRA's Web
site at http://www.finra.org, at the principal office of FINRA, and at
the Commission's Public Reference Room.

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

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

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

1. Purpose
Background
    FINRA classifies arbitrators under the Codes as either ``non-
public'' or ``public'' (non-public arbitrators are often referred to as
``industry'' arbitrators). Non-public arbitrators are affiliated with
the securities industry either through their current or former
employment in a securities business, or because they provide
professional services to securities businesses. Public arbitrators do
not have any significant affiliation with the securities industry; nor
are they related to anyone with a significant affiliation with the
securities industry.
    To improve investor confidence in the neutrality of FINRA's public
arbitrator roster, FINRA has amended its arbitrator definitions a
number of times over the years.
    In 2004, FINRA amended the definitions of public arbitrator and
non-public arbitrator to:
     Increase from three years to five years the period for
transitioning from a non-public to public arbitrator after leaving the
securities industry;
     Clarify that the term ``retired'' from the industry
includes anyone who spent a substantial part of his or her career in
the industry;
     Prohibit anyone who has been associated with the industry
for at least twenty years from ever becoming a public arbitrator,
regardless of how long ago the association ended;
     Exclude from the public arbitrator roster attorneys,
accountants, or other professionals whose firms have derived ten
percent or more of their annual revenue in the previous two years from
clients involved in securities-related activities; and
     Provide that investment advisers may not serve as public
arbitrators, and may only serve as non-public arbitrators if they
otherwise qualify as non-public.\3\
---------------------------------------------------------------------------

    \3\ See Exchange Act Rel. No. 49573 (April 16, 2004), 69 FR
21871 (Apr. 22, 2004) (File No. SR-NASD-2003-95) (Order Granting
Approval to a Proposed Rule Change Relating to Arbitrator
Classification and Disclosure in NASD Arbitrations). The changes
were announced in Notice to Members 04-49 (June 2004).
---------------------------------------------------------------------------

    In 2007, FINRA revised the public arbitrator definition to exclude
individuals who were employed by, or who served as an officer or
director of, a company in a control relationship with a broker-dealer.
Individuals were also excluded if a spouse or immediate family member
served in such a capacity. In this rule change, FINRA also made it
clear that people registered through a broker-dealer could not be
public arbitrators even if they are employed by a non-broker-dealer
(such as a bank).\4\
---------------------------------------------------------------------------

    \4\ See Act Rel. No. 54607 (Oct. 16, 2006), 71 FR 62026 (Oct.
20, 2006) (File No. SR-NASD-2005-094)(Order Approving Proposed Rule
Change and Amendment No. 1 Thereto Relating to Amendments to the
Classification of Arbitrators Pursuant to Rule 10308 of the NASD
Code of Arbitration Procedure). The changes were announced in Notice
to Members 06-64 (Nov. 2006).
---------------------------------------------------------------------------

    Finally, in 2008, FINRA revised the public arbitrator definition to
add a dollar limit to the 2004 ten-percent rule. This precluded an
attorney, accountant, or other professional from serving as a public
arbitrator if the individual's firm derived $50,000 or more in annual
revenue in the past two years from professional services rendered to
certain industry entities relating to customer disputes concerning an
investment account or transaction.\5\
---------------------------------------------------------------------------

    \5\ See Exchange Act Rel. No. 57492 (Mar. 13, 2008), 73 FR 15025
(Mar. 20, 2008) (File No. SR-NASD-2007-021) (Order Approving
Proposed Rule Change To Amend the Definition of Public Arbitrator).
The changes were announced in Regulatory Notice 08-22 (May 2008).
---------------------------------------------------------------------------

Proposal To Amend the Arbitrator Definition
    Recently, FINRA investor representatives raised concerns that they
do not perceive certain arbitrators on the public roster as public
because of their background or experience. To respond to this
perception, FINRA is proposing to amend the public arbitrator
definition to exclude persons associated with a mutual fund or hedge
fund from serving as public arbitrators and to require individuals to
wait for two years after ending certain affiliations before FINRA
permits them to serve as public arbitrators.
    The public arbitrator definition does not expressly prohibit
individuals associated with mutual funds and hedge funds from serving
as public arbitrators. However, because of their association with the
financial services industry, FINRA believes that these individuals
should not serve as public arbitrators. Therefore, FINRA's current
practice is to exclude these individuals from the public arbitrator
roster until they terminate their affiliation with the hedge fund or
mutual fund. For example, FINRA removed a public arbitrator from the
roster because he was serving as a director of a mutual fund. FINRA is
proposing to amend Rules 12100(u)(3) and 13100(u)(3), which exclude
investment advisers from serving as public arbitrators, to exclude also
persons associated with, including registered through, a mutual fund or
hedge fund. The proposed rule change would respond to questions and
concerns raised about arbitrator service by persons associated with
mutual funds and hedge funds.
    FINRA is also proposing to amend the public arbitrator definition
to add a two-year ``cooling off'' period before FINRA permits certain
individuals to serve as public arbitrators. Currently under the Codes,
an individual may not serve as a public arbitrator if he or she is:
     An investment adviser;
     An attorney, accountant, or other professional whose firm
derived ten percent or more of its annual revenue in the past two years
from certain financial industry entities;
     An attorney, accountant, or other professional whose firm
derived $50,000 or more in annual revenue in the past two years from
professional

services rendered to certain financial industry entities relating to
any customer disputes concerning an investment account or transaction;
     Employed by, or is the spouse or an immediate family
member of a person who is employed by, an entity that directly or
indirectly controls, is controlled by, or is under common control with,
any partnership, corporation, or other organization that is engaged in
the securities business; or
     A director or officer of, or is the spouse or an immediate
family member of a person who is a director or officer of, an entity
that directly or indirectly controls, is controlled by, or is under
common control with, any partnership, corporation, or other
organization that is engaged in the securities business.
    However, as soon as the individual ends the affiliation that was
the basis for the exclusion from the public roster, the individual may
begin serving as a public arbitrator. In one instance, an individual
applying to be a public arbitrator had retired one month earlier from a
lengthy career at a law firm that represented securities industry
clients. Currently, Rule 12100(u)(5) provides that a public arbitrator
may not be an attorney, accountant, or other professional whose firm
derived $50,000 or more in annual revenue in the past two years from
professional services rendered to specified securities industry clients
relating to any customer disputes concerning an investment account or
transaction. The applicant confirmed that the firm derived revenue of
at least $50,000 during the past two years from clients in the
securities industry relating to customer disputes. If the individual
applied while employed at the firm, FINRA would not have approved the
application. However, since the applicant left the firm one month
earlier, and the rule does not include a cooling off period, the
applicant was permitted to join the public arbitrator roster.
    FINRA is proposing to amend Rules 12100(u) and 13100(u) to provide
that a person whom FINRA would not designate as a public arbitrator
because of an affiliation under subparagraphs (3)-(7) (the exclusions
detailed in the bullets above) shall not be designated as a public
arbitrator for two calendar years after ending the affiliation. As
stated above, FINRA is also proposing to add persons associated with
mutual funds and hedge funds to Rules 12100(u)(3) and 13100(u)(3).
Therefore, the two-year cooling off period would apply to these
individuals as well. FINRA believes that the cooling off period would
improve its constituents' perception about the neutrality of the
arbitrators on the public roster.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Exchange Act,\6\ which requires,
among other things, that FINRA rules must be designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, and, in general, to protect investors
and the public interest. FINRA believes that the proposed amendments to
the public arbitrator definition would benefit investors by addressing
concerns raised about the fairness and neutrality of FINRA's public
arbitrator roster. FINRA believes that by prohibiting persons
associated with mutual funds or hedge funds from serving on the public
roster, the proposed amendments further restrict the professional
affiliations that a public arbitrator may have with the securities
industry. The proposed two-year cooling off period seeks to ensure that
potential arbitrators have sufficient separation from their
affiliations with the securities industry. FINRA believes these
restrictions would improve investors' perception of fairness and
neutrality of the public roster.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

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

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

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

    Written comments were neither solicited nor received.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove such proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2013-003 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.
All submissions should refer to File Number SR-FINRA-2013-003. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of FINRA. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-FINRA-2013-003 and should be
submitted on or before February 7, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-00874 Filed 1-16-13; 8:45 am]
BILLING CODE 8011-01-P


DRAFT

ENVIRONMENTAL SAMPLING,

ANALYSIS and RESULTS: PROJECT

Standard No.: EX000002.2

July 10, 2009

This standard has been produced through the

Exchange Network Leadership Council (ENLC).

The Exchange Network Leadership Council (ENLC) is a partnership among US
EPA, States and Tribal partners to promote the efficient sharing of
environmental information through the efficient management of the
Exchange Network development and adoption of data standards. More
information about is available at www.exchangenetwork.net/standards
HYPERLINK "http://"   .

Foreword

The Exchange Network Leadership Council (ENLC) is a partnership among US
EPA, States and Tribal partners to develop and agree upon data standards
for environmental information collection and exchange.  The Council
seeks to promote efficient sharing of environmental information between
State, US EPA and Tribal partners through the development of data
standards.  More information about data standards is available at
http://www.exchangenetwork.net/standards.

.

1.0	INTRODUCTION

Environmental information is a key tool in the effective management of
our environmental resources and human health conditions.  As a result,
much effort goes into data acquisition, management, maintenance,
exchange, and oversight.  Greater access is the goal of many data
consumers, and data managers. Providers invest significant resources
meeting their requirements. In response, many data providers are
improving access as they post usable copies of their environmental
information on the web.  These efforts are a vast improvement over
previous conditions; however, there is a growing desire and need to both
provide and receive data in a clearly defined and a uniform way.  Data
from multiple sources can then be aggregated and used without the
inherent variations that exist between data sets across agencies.

1.1	Scope

This standard provides data elements and describes data groupings that
are used to catalogue and exchange project information. The
Environmental Sampling, Analysis and Results: Project data standard also
identifies descriptors for environmental data project activities.

1.2	Revision History

Date	Version	Description

January 6, 2006	EX000002.1	Initial Environmental Data Standards Council
Adoption

July 22, 2008	EX000002.2	Modification of data standard to incorporate
additional water quality data elements.

1.3	References to Other Data Standards

This standard relies on other standards to make it complete and provide
the necessary support.  Users should consider the Normative Standards
(references), noted below, integral to this standard. These include:

Attached Binary Object [EX000006.1] Data Standard

Bibliographic Reference [EX000007.1] Data Standard

Contact Information [EX000019.2] Data Standard

Facility Site Identification [EX000020.2] Data Standard

Representation of Date and Time [EX000013.1] Data Standard

1.4	Terms and Definitions

For the purposes of this document, the following terms and definitions
apply.

Term	Definition

Project	An environmental data collection effort that has a stated
purpose and puts a series of samples/results into a meaningful context.

1.5	Implementation

Users are encouraged to use the XML registry housed on the Exchange
Network Web site to download schema components for the construction of
XML schema flows ( HYPERLINK "http://www.exchangenetwork.net/"
http://www.exchangenetwork.net ).

1.6	Document Structure

The structure of this document is briefly described below:

Section 2.0 Diagram, illustrates the principal data groupings contained
within this standard.

Section 3.0 ESAR: Project Data Standard Table provides information on
the high level, intermediate and elemental Project data groupings.
Where applicable, for each level of this data standard a definition, XML
tag, note(s), example list of values and format are provided. The format
column may list the number of characters for the associated data
element, where “A” specifies alphanumeric, “N” designates
numeric, and date and time reference the Representation of Date and Time
Standard. The format column may include the number of characters for the
associated data element, where “A” specifies alphanumeric, “N”
designates numeric, “G” and “D” are used for grouping and
date/time.

Data Element Numbering: For purposes of clarity and to enhance
understanding of data standard hierarchy and relationships, each data
group is numerically classified from the primary to the elemental level.

Code and Identifier Metadata: Metadata, defined here as data about data
or data elements, includes their descriptions and/or any needed context
setting information required to identify the origin, conditions of use,
interpretation, or understanding  the information being exchanged or
transferred.  (Adapted from ISO/IEC 2382-17:1999 Information Technology
Vocabulary—Part 17: Databases 17.06.05 metadata).  Based on the
business need, additional metadata may be required to sufficiently
describe an identifier or a code. A note regarding this additional
metadata is included in the notes column for identifier and code
elements. Additional metadata for identifiers may include:

Identifier Context, which identifies the source or data system that
created or defined the identifier

Additional metadata for codes may include:

Code List Identifier, which is a standardized reference to the context
or source of the set of codes

Code List Version Identifier, which identifies the particular version of
the set of codes.

Code List Version Agency Identifier, which identifies the agency
responsible for maintaining the set of codes

Code List Name, which describes the corresponding name for which the
code represents

Appendix A ESAR: Project Data Structure Diagram, illustrates the
hierarchical classification of the Project data standard. This diagram
enables business and technical users of this standard to quickly
understand its general content and complexity.  Appendix B, lists the
references for the ESAR Project Document.

2.0 	ENVIRONMENTAL SAMPLING, ANALYSIS, AND RESULTS: PROJECT DIAGRAM

This diagram specifies the major data groups that may be used to
identify the characteristics and /or to catalog an Environmental
Sampling, Analysis, and Results: Project.

3.0	ENVIRONMENTAL SAMPLING, ANALYSIS, AND RESULTS: PROJECT DATA
STANDARD TABLE

1.0	Project Point of Contact

Definition:	Identifies the organization(s) and/or person(s) related to
the project.  Identifies the organization or person with knowledge of
the project and who can assist the public in finding additional
information about a given project. It may be the project lead, the
principle investigator, project staff, or a grant officer.

	Relationship:	None.

	Notes:		None.

	XML Tag:	ProjectPointOfContact

Data Element Name	Data Element Definitions	Notes	Format	XML Tags

1.1 Project Contact 	Identifies the initial organization or person
responsible for the data collection.	Note: Refer to the Contact
Information [EX000019.2] Data Standard.

The following items are expected to define the project Entity/Person
information:

Individual Full Name,

Individual Identifier,

Individual Identifier Type,

Organization Formal Name,

Affiliation Type,

Mailing Address,

Supplemental Address Text,

Mailing Address City Name,

Mailing Address State Name,

Mailing Address State Code,

Mailing Address Country Name,

Mailing Address Country Code,  	G	ProjectContact

Data Element Name	Data Element Definitions	Notes	Format	XML Tags

1.1 Project Contact (cont.)

Mailing Address Zip Code/International Postal Code,

Telephone Number,

Telephone Number Type Name,

Electronic Address Text,

Electronic Address Type Name.

1.2 Project Client Contact 	Identifies the initial organization or
person requesting the data collection.	Note: Refer to the Contact
Information [EX000019.2] Data Standard.

The following items are expected to define the project Entity/Person
information:

Individual Full Name,

Individual Identifier,

Individual Identifier Type,

Organization Formal Name,

Affiliation Type,

Mailing Address,

Supplemental Address Text,

Mailing Address City Name,

Mailing Address State Name,

Mailing Address State Code,

Mailing Address Country Name,

Mailing Address Country Code,

Mailing Address Zip Code/International Postal Code,

Telephone Number,

Telephone Number Type Name,	G	ProjectClientContact

Data Element Name	Data Element Definitions	Notes	Format	XML Tags

1.2 Project Client Contact (cont.)

Electronic Address Text,

Electronic Address Type Name.

2.0	Project Identification

	Definition:	Data elements relating to the identification of a project.

	Relationship:	None.

	Notes:		None.

	XML Tag:	ProjectIdentification

Data Element Name	Data Element Definitions	Notes	Format	XML Tags

2.1 Project Identifier	A designator used to uniquely identify the
project to organizations sharing data.	Note: Based on the business need,
additional metadata may be required to sufficiently describe an
identifier. This additional metadata is described in section 1.6.d in
the Introduction.

Precise meaning will be agreed upon during development of the Trading
Partner Agreement for the Exchange Network.	A	ProjectIdentifier

2.2 Project Name

	The name assigned to the Project by the project leader or principal
investigator.	Example List of Values:

Central Columbia Basin GWMA – Nitrate Characterization Study 	A
ProjectName

2.3 Project Environmental Interest Name	The environmental permits and
regulatory programs that apply to the project.	Example List of Values:

Section 106 Grant

Section 105 Grant

NPDES Permit

Superfund Site

Remedial Investigation	A	ProjectEnvironmentalInterestName

3.0	Project Duration

	Definition:	Data elements relating to the length and status of a
project.

	Relationship:	None.

	Notes:		The Representation of Date and Time [EX000013.1] Data Standard
will apply anytime a date is reported.

	XML Tag:	ProjectDuration

Data Element Name	Data Element Definitions	Notes	Format	XML Tags

3.1 Project Start Date	The calendar date on which a project began.
Reported as 4-digit year, 2-digit month, and 2-digit day.	D
ProjectStartDate

3.2 Project End Date	The calendar date on which a project ended; may be
after actual field activities have ended.	Reported as 4-digit year,
2-digit month, and 2-digit day.	D	ProjectEndDate

3.3 Project Duration Text	Planned length or duration of the project
activity.	Example List of Values:

Five Years

1 Year Study

Irrigation Season

On-going Monitoring

Low Flow Period (May-October)	A	ProjectDurationText

3.4 Project Status Text	Description of the current state of the Project.
Example List of Values:

ACTIVE: The project is currently active with field activities and/or
data entry.

COMPLETED: The project has been completed.  All data has been collected
and a Quality Assurance (QA) review has been completed.

	A	ProjectStatusText

3.4 Project Status Text (cont.)

DATA COMPLETED: All study data has been collected, but a QA review has
not yet been completed for the project. Data should be considered
preliminary.

3.5 Project Status Date	Date indicating when the Project Status was
determined.	Reference the Representation of Date and Time [EX000013.1]
Data Standard Reported as 4-digit year, 2-digit month, and 2-digit day.
D	ProjectStatusDate

4.0	Project Reason

	Definition:	The explanation of or justification for the project.

	Relationship:	None.

	Notes:		None.

	XML Tag:	ProjectReason

Data Element Name	Data Element Definitions	Notes	Format	XML Tags

4.1 Project Purpose Text	A summary description of the purpose of, or the
hypothesis to be tested by the project. 	Note: The Project Purpose
should include the reason(s) for initiating the project plus its goals
and expectations. This data field should also be used to describe any
relationship that this project has with other activities.

Example:

The purpose of the study is to characterize the baseline concentration
and three dimensional distribution of nitrate in groundwater in the
Central Columbia Basin (Grant, Adams, and Franklin counties).	A
ProjectPurposeText

Data Element Name	Data Element Definitions	Notes	Format	XML Tags

4.2 Project Objective Text	Summary of the objectives to be accomplished
by the project.	Example:  Collect sufficient information to determine
permit compliance with a 95% level of confidence.	A	ProjectObjectiveText

4.3 Sampling Design Type Name	A name used to identify the type of
sampling design employed for this project to ensure that sampling
activities can support project objectives.	Example List of Values:

Stratified random sampling

Systematic random sampling

Cluster sampling

Grid	A	SamplingDesignTypeName

4.4 Project Outcome Description Text	A brief summary of the results of
the project. 	Note: The fully detailed project report may be referenced
by attaching the relevant bibliographic citation to the project.

Examples:

Final report describing the study findings and QA evaluation: USGS
Water-Resources Investigation.

Rpt. 99-4288; Summary of Nitrate Concentrations in Ground Water of
Adams, Franklin and Grant Counties, Washington, Fall 1998 – A Baseline
for Future Trend Analysis.	A	ProjectOutcomeDescriptionText

5.0	Data Collection Area

	Definition:	The geographic area for a project.

	Relationship:	None.

	Notes:		Multiple areas may exist for a project.

	XML Tag:	DataCollectionArea

Data Element Name	Data Element Definitions	Notes	Format	XML Tags

5.1 Data Collection Area Name	The common name assigned to the geographic
area of interest.  	Example List of Values:

1560 (CHATTANOOGA, TN-GA)

07 (BOS-WOR-LAW, MA-NH-ME-CT)

Central Columbia Basin GWMA

Area 51

Rocky Flats Arsenal	A	DataCollectionAreaName

5.2 Data Collection Area Description Text	A general description of the
geographic boundaries or spatial area being studied through the
monitoring activities conducted as part of the project.	Examples:

Central Columbia Basin Groundwater Management Area (GWMA) - Includes All
of Grant, Adams, and Franklin Counties

All sites within the Akron, Ohio City Limits

Potomac River from Lincoln Memorial Downstream to Wilson Bridge	A
DataCollectionAreaDescriptionText

5.3 Data Collection Area Type Name	The predominant focus or frame of
reference for the project area.

	Multiple selections may be present.

Example List of Values:

MSA (Metropolitan Statistical Area)

AQCR (Air Quality Control Region)

Aquifer

Estuary

Watershed

Airshed

Reservoir

Soil

Sediment

Landfill

Drums

Man-made Materials

1st through 3rd Order Streams

Streams Capable of Supporting Coho Salmon Spawning and Rearing	A
DataCollectionAreaTypeName

6.0	Data Collection Facility Site identification

	Definition:	Basic identification information for a facility site of the
project.

	Relationship:	None.

	Notes:		Refer to the Facility Site [EX000020.2] Data Standard.

				The following items may be needed:

				US EPA or State facility registry identifier

				Geographic address

				Geopolitical descriptors

				May also include:

					Locality name

				County or State FIPS codes

				Tribal name

				Geographic coordinates of latitude/longitude

				Note: Based on the business need, additional metadata may be
required to sufficiently describe an identifier. This 					additional
metadata is described in section 1.6.d. in the Introduction.

	XML Tag:	DataCollectionFacilitySiteIdentification

7.0	Data Collection Quality

	Definition:	The quality components for a project.

	Relationship:	None.

	Notes:		None.

	XML Tag:	DataCollectionQuality

Data Element Name	Data Element Definitions	Notes	Format	XML Tags

7.1 Data Collection Quality Assurance Plan Indicator	An indicator (Y/N)
of the existence of a Quality Assurance Plan for the project.	List of
Permitted Values:

Y – yes

N – no	A	DataCollectionQualityAssurancePlanIndicator

Data Element Name	Data Element Definitions	Notes	Format	XML Tags

7.2 Data Collection Quality Assurance Plan Description Text	A summary of
the Quality Assurance Plan approved for the project.	Note: This plan may
be a QAPP required by US EPA, a quality assurance plan required by a
state or other quality assurance plan.	A
DataCollectionQualityAssurancePlanDescriptionText

7.3 Data Collection Quality Assurance Plan Date	The date of the quality
assurance objectives document that relates to the data being collected.
Reported as 4-digit year, 2-digit month, and 2-digit day.	D
DataCollectionQualityAssurancePlanDate

7.4 Sample Collector Certification Text	Text providing any certification
obtained or experience level of personnel sampling for the project.
Note: For example, this could identify agency-trained or certified
personnel.	A	SampleCollectorCertificationText

8.0	Project Reference

	Definition:	References, either directly as electronic attachments or as
a bibliographic reference, documents, images, maps, photos,
laboratory materials, geospatial coverages, and other objects within the
data submission that pertain to the project.

	Relationship:	None.

	Notes:		Multiple objects may be attached to the data submission for
each project included in the submission.  May attach US EPA

 Quality Assurance Project Plan (QAPP), state or lab quality assurance
plan and/or Sampling Analysis Plan (SAP)

	XML Tag:	ProjectReference

9.0	Project Attached Binary Object

	Definition:	References electronic attachments to the project, including
documents, images, maps, photos, laboratory materials,

			geospatial coverage, and other objects.

	Relationship:	None.

	Notes:		Reference the Attached Binary Object [EX000006.1] Data
Standard.  May attach US EPA Quality Assurance Project

			Plan (QAPP), state or lab quality assurance plan and/or Sampling
Analysis Plan (SAP)

	XML Tag:	ProjectAttachedBinaryObject

10.0	Project Bibliographic Reference

	Definition:	Catalog information describing associated project
resources, including documents, images, maps, photos, laboratory
materials, geospatial coverages, and other objects.

	Relationship:	None.

	Notes:	Reference the Bibliographic Reference [EX000007.1] Data
Standard.  May reference US EPA Quality Assurance Project Plan (QAPP),
state or lab quality assurance plan and/or Sampling Analysis Plan (SAP)

	XML Tag:	ProjectBibliographicReference

Appendix A

Environmental Sampling, Analysis, and Results: Project Data Structure
Diagram

Appendix B

References

ISO/IEC 2382-17:1999 Information Technology Vocabulary—Part 17:
Databases 17.06.

 PAGE

	Environmental Sampling, Analysis and Results: Project Data Standard

Std No.: EX000002.2

June 28, 2005		Page   PAGE  1

July 22, 2008		Page   PAGE  4

	Environmental Sampling, Analysis and Results: Project Data Standard

Std No.: EX000002.2

July 22, 2008		Page   PAGE  16

Environmental Sampling, Analysis and Results

 Project

Data Standard

10.0 Project Bibliographic Reference

9.0 Project Attached Binary Object

7.0 Data Collection Quality

6.0 Data Collection Facility Site Identification

5.0 Data Collection Area

8.0 Project Reference

1.0 Project Point of Contact

2.0 Project Identification

3.0 Project Duration

4.0 Project Reason

Environmental Sampling, Analysis and Results:

 Project

Data Standard

4.0 Project Reason

4.1 Project Purpose Text

4.2 Project Objective Text

4.3 Sampling Design Type Name

4.4 Project Outcome Description Text

2.0 Project Identification

2.1 Project Identifier

2.2 Project Name

2.3 Project Environmental Interest Name

10 Project Bibliographic Reference

9.0 Project Attached Binary Object

8.0 Project Reference

7.0 Data Collection Quality

7.1 Data Collection Quality Assurance Plan Indicator

7.2 Data Collection Quality Assurance Plan Description Text

7.3 Data Collection Quality Assurance Plan Date

7.4 Sample Collector Certification Text

5.0 Data Collection Area

5.1 Data Collection Area Name

5.2 Data Collection Area Description Text

5.3 Data Collection Area Type Name

3.0 Project Duration

3.1 Project Start Date

3.2 Project End Date

3.3 Project Duration Text

3.4 Project Status Text

3.5 Project Status Date

1.0 Project Point of Contact

1.1 Project Contact

1.2 Project Client Contact

6.0 Data Collection Facility Site Identification


[Federal Register Volume 80, Number 186 (Friday, September 25, 2015)]
[Notices]
[Pages 57801-57802]
[FR Doc No: 2015-24377]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Effectiveness of Exempt Wholesale Generator Status

Panda Liberty LLC............................  EG15-92-000
Panda Patriot LLC............................  EG15-93-000
Panda Stonewall LLC..........................  EG15-94-000

Blue Sky West, LLC...........................  EG15-95-000
87RL 8me LLC.................................  EG15-96-000
Route 66 Wind Power, LLC.....................  EG15-97-000
North Star Solar, LLC........................  EG15-98-000
Indeck Corinth Limited Partnership...........  EG15-99-000
Greenleaf Energy Unit 1 LLC..................  EG15-100-000
Slate Creek Wind Project, LLC................  EG15-101-000

    Take notice that during the month of August 2015, the status of the
above-captioned entities as Exempt Wholesale Generators became
effective by operation of the Commission's regulations. 18 CFR
366.7(a).

    Dated: September 3, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-24377 Filed 9-24-15; 8:45 am]
BILLING CODE 6717-01-P