72.
6
663,850
80.
4
633,474
7
7
.
1
664,074
80.9
683,115
80.4
736,672
86.
3
18-
44
483,297
34.7
614,097
44.
0
495,630
35.
3
401,595
28.
4
670,130
4
7
.
1
608,292
42.5
624,012
43.4
613,177
42.
1
45-
64
251,084
44.8
265,660
45.
9
151,304
25.
2
278,686
44.
4
271,703
4
1
.
6
320,550
46.9
269,789
36.6
340,064
44.
4
65+
121,635
46.2
63,609
23.
9
7
6,849
29.
0
93,194
34.
7
113,090
4
1
.
8
98,637
35.8
44,232
15.5
125,824
43.
7
SOURCE: NATIONAL CENTER FOR HEALTH STATISTICS, NATIONAL HEALTH INTERVIEW SURVEY, 1997-2004
CALCULATIONS PERFORMED BY THE EPIDEMIOLOGY AND STATISTICS UNIT
Notes:
200
4
(1) Attack prevalence is defined as answering yes to " Have you EVER been told by a doctor or other health professional that you had asthma?" and "During the
PAST 12 MONTHS, have you had an episode of asthma or asthma attack?"
2003
2002
2001
1
997
199
8
1999
2000

TABLE 11: ASTHMA-NUMBER OF CONDITIONS AND PREVALENCE RATE PER 1,000 PERSONS BY ORIGIN, 1998-2004
Number
Rate
CI of Rate
1
Number
Rate
CI of Rate
1
Number
Rate
CI of Rate
1
Number
Rate
CI of Rate
1
Lifetime Prevalence
2
199
8
2,627,891
84.7
(76.4-93.0)
18,887,569
97.2
(93.0-101.4)
4,105,291
124.
9
(116.1-133.7)
773,286
71.
8
(58.3-85.2)
199
9
2,564,233
80.2
(71.6-88.8)
17,833,735
91.1
(87.1-95.1)
3,424,782
102.
8
(93.0-112.7)
878,864
82.
7
(65.5-99.9)
200
0
2,700,985
81.7
(74.4-89.1)
19,958,214
102.
2
(98-106.4)
3,900,457
115.
8
(107.0-124.6)
1,055,350
87.
9
(69.8-106)
200
1
3,232,703
94.7
(86.8-102.5)
22,607,687
115.
3
(110.7-120.0)
4,291,178
126.
2
(116.7-135.6)
1,222,089
99.
1
(81.9-116.3)
200
2
2,925,277
83.0
(75.5-90.5)
21,850,318
111.
2
(106.4-116.0)
4,736,386
137.
7
(126.5-149.0)
1,309,144
10
3.5
(85.6-121.4)
200
3
3,478,767
87.5
(79.6-95.5)
20,663,795
104.
0
(99.9-108.1)
4,563,212
129.
3
(119.5-139.1)
1,061,767
86.
1
(68.6-103.7)
200
4
3,436,124
84.3
(77.0-91.6)
20,982,719
105.
7
(101.2-110.2)
4,734,121
132.
9
(122.1-143.7)
1,036,486
77.
2
(61.3-93.1)
Current Prevalence
3
200
1
2,007,520
58.8
(55.3-62.3)
14,603,075
74.5
(72.3-76.7)
2,933,767
86.2
(80.8-91.7)
736,241
59.
7
(51.5-68.0)
200
2
1,726,590
49.0
(45.5-52.5)
14,245,694
72.5
(70.3-74.7)
3,271,962
95.1
(90.9-99.4)
781,470
61.
8
(52.7-70.9)
200
3
2,198,710
55.3
(51.4-59.3)
13,750,543
69.2
(66.9-71.5)
3,269,269
92.6
(87.6-97.7)
617,479
50.
1
(41.7-58.5)
200
4
2,123,900
52.1
(48.2-56.0)
14,475,412
72.9
(70.8-75.1)
3,355,168
94.2
(88.9-99.4)
590,356
4
4
(36.5-51.4)
Attack Prevalence
4
199
8
1,117,182
36.0
(32.3-39.7)
7,570,852
39.0
(37.0-41.0)
1,648,035
50.1
(45.1-55.1)
276,987
25.
7
(19.0-32.4)
199
9
1,089,428
34.1
(30.2-37.9)
7,500,035
38.3
(36.3-40.3)
1,526,119
45.8
(41.2-50.4)
372,702
35.
1
(25.9-44.2)
200
0
1,087,330
32.9
(29.7-36.1)
7,864,152
40.3
(36.8-42.5)
1,601,492
47.6
(42.6-52.5)
426,248
35.
5
(27.5-43.5)
200
1
1,164,204
34.1
(30.2-38.0)
8,581,795
43.8
(41.5-46.0)
1,847,680
54.3
(48.7-59.9)
392,380
31.
8
(24.0-39.6)
200
2
1,087,489
30.8
(27.3-34.4)
8,401,593
42.8
(40.4-45.1)
1,895,262
55.1
(50.2-60.0)
523,847
41.
4
(33.1-49.8)
200
3
1,317,684
33.2
(29.6-36.7)
7,494,952
37.7
(35.6-39.9)
1,823,502
51.7
(46.6-56.7)
409,750
33.
2
(25.1-41.4)
200
4
1,242,176
30.5
(27.2-33.8)
8,162,307
41.1
(38.7-43.6)
1,948,083
54.7
(49.7-59.7)
331,788
24.
7
(18.0-31.4)
SOURCE: NATIONAL CENTER FOR HEALTH STATISTICS, NATIONAL HEALTH INTERVIEW SURVEY, 1998-2004
CALCULATIONSL PERFORMED BY THE AMERICAN LUNG ASSOCIATION, EPIDEMIOLOGY AND STATISTICS UNIT
NOTES:
(1) 95% Confidence Interval.
Non-Hispanic Others
(2) Lifetime prevalence was defined as answering "yes" to "Have you EVER been told by a health professional that you had asthma?"
(4) Attack prevalence was defined as answering yes to " Have you EVER been told by a health professional that you had asthma?" and "During the PAST 12
MONTHS, have you had an episode of asthma or asthma attack?"
(3) With the revision of the National Health Interview Survey in 1997, the question "During the past 12 months, did anyone in the family have asthma?" was
eliminated and was replaced with two questions: "Have you ever been told by a doctor or other health professional that you had asthma?" (Table 6) and
"During the past 12 months, have you had an episode of asthma or asthma attack?" (Table 10). Realizing the information gap resulting with the revised
questions, "Do you still have asthma?" was added in 2001- reinstating a measure of current prevalence. However,
data between 1982 and 1996 should
not be compared to 2001-2004 estimates.
Non-Hispanic White
Hispanic
Non-Hispanic Black

TABLE 12: ASTHMA-ESTIMATED LIFETIME PREVALENCE (%) IN ADULTS, BY STATE, 2000-2005
STATE
NUMBER
%
NUMBER
%
NUMBER
%
NUMBER
%
NUMBER
%
NUMBER
(2)
%
United States
21,311,096
10.
4
2
3,210,259
1
1.
0
25,176,198
11.
8
25,777,202
11.
9
2
9,064,305
1
3
.
3
28,090,493
12.
6
Alabama
298
,612
9.
1
323,695
9
.
7
369,224
11.
0
391
,671
11.
6
476,083
1
4
.
0
3
8
8
,422
1
1
.
2
Alaska
48,997
11.
3
51,029
1
1
.
5
5
1
,547
11.
6
60,933
13.
3
59,546
13
.
0
5
9
,417
1
2
.
5
Arizona
395
,300
11.
1
474,929
1
2.
4
551,442
13.
9
511
,360
12.
5
513,810
1
2
.
4
5
3
1


[Federal Register Volume 85, Number 136 (Wednesday, July 15, 2020)]
[Notices]
[Pages 42879-42880]
[FR Doc No: 2020-15240]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1402]

Biomarkers and Surrogate Endpoints in Clinical Studies To Support
Effectiveness of New Animal Drugs; Draft Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry (GFI) #267 entitled
``Biomarkers and Surrogate Endpoints in Clinical Studies Support
Effectiveness of New Animal Drugs.'' The draft guidance, if finalized,
will describe FDA's current thinking with respect to assisting sponsors
in incorporating biomarkers and surrogate endpoints into proposed
clinical investigation protocols and applications for new animal drugs
under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

DATES: Submit either electronic or written comments on the draft
guidance by October 13, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-D-1402 for ``Biomarkers and Surrogate Endpoints in Clinical
Studies to Support Effectiveness of New Animal Drugs.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Susan Storey, Center for Veterinary
Medicine (HFV-131), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of draft GFI #267 entitled
``Biomarkers and Surrogate Endpoints in Clinical Studies to Support
Effectiveness of New Animal Drugs.'' Section 305 of the Animal Drug and
Animal Generic Drug User Fee Amendments of 2018 (Pub. L. 115-234),
among other things, directed FDA to hold a public meeting for
interested parties to discuss innovative animal drug investigation
designs and to issue guidance addressing the incorporation of the use
of such elements of investigations as complex adaptive and other novel
investigation designs, data from foreign countries, real-world evidence
(including ongoing surveillance activities, observational studies, and
registry data), biomarkers, and surrogate endpoints into proposed
clinical investigation protocols and applications for new animal drugs.
    In the Federal Register of July 9, 2019 (84 FR 32749), FDA's Center
for Veterinary Medicine (CVM) published a notice of a public meeting
entitled ``Incorporating Alternative Approaches in Clinical
Investigations for New Animal Drugs'' giving interested persons until
August 17, 2019, to comment on the topics discussed at the public
meeting and the questions published in the meeting notice (84 FR 32749
at 32750 to 32751).\1\ On August 13, 2019, we published a notice
announcing the extension of the comment period to September 16, 2019
(84 FR 40071). CVM received numerous comments on the topics discussed
at the public meeting and the questions published in the meeting notice
and those comments were considered as the draft GFI #267 was developed.
---------------------------------------------------------------------------

    \1\ https://www.fda.gov/animal-veterinary/workshops-conferences-meetings/public-meeting-incorporating-alternative-approaches-clinical-investigations-new-animal-drugs.
---------------------------------------------------------------------------

    This draft guidance describes how CVM intends to evaluate
biomarkers, including surrogate endpoints, when they are incorporated
into clinical investigations submitted to CVM to demonstrate
substantial evidence of effectiveness for new animal drug applications
or a reasonable expectation of effectiveness for applications for
conditional approval of a new animal drug. It also provides information
about how sponsors may obtain feedback from CVM on technical issues
related to the use of biomarkers before the submission of an
application.
    This level 1 draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
if finalized, will represent the current thinking of FDA regarding the
use of biomarkers, including surrogate endpoints, to support the
effectiveness of new animal drugs. It does not establish any rights for
any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this draft guidance contains no
collection of information. Therefore, clearance by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3521) is not required.
    However, this draft guidance refers to previously approved FDA
collections of information found in FDA regulations for new animal drug
applications submitted under sections 512(b) (21 U.S.C. 360b(b)) and
571 of the FD&C Act. These collections of information are subject to
review by the OMB under the PRA. The collections of information in 21
part 514 have been approved under OMB control number 0910-0032.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry or https://www.regulations.gov.

    Dated: July 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15240 Filed 7-14-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 89 (Monday, May 9, 2011)]
[Rules and Regulations]
[Pages 26609-26615]
[FR Doc No: 2011-11133]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2010-0430; FRL-9292-7]

Revisions to the California State Implementation Plan, San
Joaquin Valley Unified Air Pollution Control District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: EPA is finalizing approval of revisions to the San Joaquin
Valley Unified Air Pollution Control District (SJVUAPCD) portion of the
California State Implementation Plan (SIP). These revisions were
proposed in the Federal Register on May 21, 2010 and concern oxides of
nitrogen (NOx) and particulate matter (PM) emissions primarily from
indirect sources associated with new development projects as well as
NOx and PM emissions from certain transportation and transit projects.
We are approving local rules that regulate these emission sources under
the Clean Air Act as amended in 1990 (CAA or the Act).

DATES: Effective Date: This rule is effective on June 8, 2011.

ADDRESSES: EPA has established docket number EPA-R09-OAR-2010-0430 for
this action. The index to the docket is available electronically at
http://www.regulations.gov and in hard copy at EPA Region IX, 75
Hawthorne Street, San Francisco, California. While all documents in the
docket are listed in the index, some information may be publicly
available only at the hard copy location (e.g., copyrighted material),
and some may not be publicly available in either location (e.g.,
Confidential Business Information). 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: Lily Wong, EPA Region IX, (415) 947-
4114<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to EPA.

Table of Contents

I. Proposed Action
II. Public Comments and EPA Responses
III. EPA Action
IV. Statutory and Executive Order Reviews

I. Proposed Action

    On May 21, 2010 (75 FR 28509), EPA proposed to approve the
following rule into the California SIP.

----------------------------------------------------------------------------------------------------------------
              Local agency                 Rule No.           Rule title              Adopted        Submitted
----------------------------------------------------------------------------------------------------------------
SJVUAPCD...............................         9510  Indirect Source Review            12/15/05        12/29/06
                                                       (ISR).
----------------------------------------------------------------------------------------------------------------

    We proposed to approve this rule because we determined that it
complied with the relevant CAA requirements. Our proposed action
contains more information on the rule and our evaluation.

II. Public Comments and EPA Responses

    EPA's proposed action provided a 30-day public comment period.
During this period, we received comments from the following parties.
    1. Susan Asmus, National Association of Home Builders (NAHB);
letter dated July 6, 2010.
    2. Lawrence J. Joseph, representing the American Road &
Transportation Builders Association (ARTBA); letter dated July 6, 2010.
    3. Paul Cort, EarthJustice; letter dated July 6, 2010.
    4. Mat Ciremele, email dated May 25, 2010.
    The comments and our responses are summarized below.
    Comment #1: NAHB asserts that EPA must disapprove Rule 9510 because
a state must provide adequate assurances of the legal authority to
carry out all SIP revisions and, in light of NAHB's legal challenge to
Rule 9510 in the U.S. Court of Appeals and the possibility of the
court's finding section 6.1.1 of Rule 9510 preempted and unenforceable,
the SJVUAPCD cannot enforce the emission limitations in section 6.1.1
because the limitations are preempted standards or other requirements.
    Response #1: The commenter is correct in asserting that a state
must provide assurances of legal authority to carry out SIPs and SIP
revisions. See CAA section 110(a)(2)(E)(SIPs must ``provide (i)
necessary assurances that the State * * * will have adequate * * *
authority under State (and, as appropriate, local) law to carry out
such implementation plan * * * ''). In our Technical Support Document
(TSD) for

the proposed rule, we recognized the legal challenge brought by NAHB
against the SJVUAPCD in connection with enforcement of Rule 9510. At
the time we proposed action on Rule 9510, NAHB had appealed to the
Ninth Circuit Court of Appeals [in National Association of Home
Builders v. San Joaquin Valley Unified Air Pollution Control District
(No. 08-17309)] to overturn a District Court ruling that held that Rule
9510 was not preempted under the CAA, but the Ninth Circuit had not yet
reached a decision on the appeal. Based on the information available to
us at the time, we concluded that the SJVUAPCD had the authority to
adopt and implement Rule 9510 because we believed that the limits in
the rule were not preempted under CAA section 209(e), consistent with
the District Court ruling.
    Since publication of the proposed rule, the Ninth Circuit has
published its opinion in National Association of Home Builders v. San
Joaquin Valley Unified Air Pollution Control District, 627 F.3d 730
(9th Cir. 2010) (``NAHB''). In an opinion filed December 7, 2010, the
Ninth Circuit affirmed the District Court's ruling that Rule 9510 was
not preempted. With respect to the express preemption of CAA section
209(e)(1), which preempts states and subdivisions thereof from adopting
or attempting to enforce any standard or other requirement relating to
the control of emissions from either of two categories of new nonroad
vehicles or engines, the court held that Rule 9510 was not preempted
because none of the construction equipment that Rule 9510 regulates
would be considered ``new'' under EPA's pre-existing (and permissible,
in the court's view) definition of ``new.''
    Before turning to the implied preemption of CAA section 209(e)(2),
which preempts states and subdivisions thereof from adopting or
attempting to enforce any standard or other requirement relating to the
control of emissions from all other types of nonroad vehicles and
engines not covered in CAA section 209(e)(1), the court first
determined that Rule 9510 was authorized under CAA section 110(a)(5),
the CAA section that allows states and subdivisions thereof to include
indirect source review (ISR) programs in a SIP. CAA section
110(a)(5)(C) defines ``indirect sources'' as meaning ``a facility,
building, structure, installation, real property, road, or highway
which attracts, or may attract, mobile sources of pollution,'' but also
provides that ``[d]irect emissions sources or facilities at, within, or
associated with, any indirect source shall not be deemed indirect
sources for the purposes of this paragraph.''
    Noting that Rule 9510 is ultimately directed at emissions that come
from construction equipment (i.e., direct sources), the court,
nonetheless, concluded that Rule 9510 was authorized under section
110(a)(5) because in the court's view, the limitation only makes sense
if it is read to prohibit an indirect source review program from
targeting direct sources at, within, or associated with, any indirect
source apart from the program's regulation of an indirect source, and
Rule 9510 does not target construction equipment apart from its
regulation of development sites. The court also notes that the scope of
Rule 9510 indicates that the rule targets sites rather than equipment.
The reach of the rule depends on the character of the site, not on the
character of the equipment. The court then concluded that the feature
that allows Rule 9510 to qualify as an indirect source for the purposes
of CAA section 110(a)(5), i.e., its site-based regulation of emissions,
was the same feature that allows the rule to avoid preemption under CAA
section 209(e)(2).
    Given the appellate court's decision, we believe that any
significant doubt about the SJVUAPCD's authority to enforce the
emissions requirements in section 6.1.1 has been removed, and that our
approval of Rule 9510 is consistent with CAA section 110(a)(2)(E) as
explained in the proposal.
    Comment #2: NAHB asserts that the emission limits of section 6.1.1
of Rule 9510 are preempted under CAA section 209(e)(1) because they
represent ``standards or other requirements'' relating to the control
of emissions from new nonroad construction vehicles or engines less
than 175 horsepower.
    Response #2: CAA section 209(e)(1) states: ``No State or any
political subdivision thereof shall adopt or attempt to enforce any
standard or other requirement relating to the control of emissions from
* * * (A) New engines which are used in construction equipment or
vehicles or used in farm equipment or vehicles and which are smaller
than 175 horsepower. (B) New locomotives or new engines used in
locomotives. Subsection (b) of this section shall not apply for
purposes of this paragraph.'' The construction equipment to which
section 6.1.1 of Rule 9510 applies is not new equipment. Under EPA's
nonroad emissions standard regulations, ``new'' means ``a nonroad
engine, nonroad vehicle, or nonroad equipment the equitable or legal
title to which has never been transferred to an ultimate purchaser.
Where the equitable or legal title to the engine, vehicle, or equipment
is not transferred to an ultimate purchaser until after the engine,
vehicle, or equipment is placed into service, then the engine, vehicle,
or equipment will no longer be new after it is placed into service.''
See 40 CFR 89.2. This definition was upheld by the Court of Appeals for
the District of Columbia in Engine Manufacturers Association v. EPA, 88
F.3d 1075 (DC Cir. 1996) (EMA v. EPA), and the 9th Circuit, in NAHB,
also indicated its view that this definition was permissible.
    Rule 9510 applies to applicants that seek final discretionary
approval for certain development projects, and thus the emission limits
in section 6.1.1 of Rule 9510 apply to construction equipment that has
already been purchased or placed into service, and brought to a
development site to meet the particular construction needs of a given
development project. Therefore, the limits do not apply to new
construction equipment within the meaning of CAA section 209(e)(1).
    Even if the emission limits in the rule could have the consequence
of influencing an applicant early in the planning process in connection
with the purchase of construction equipment, for the reasons provided
in the TSD to EPA's proposed rule on Rule 9510 and in the responses,
EPA believes that the emission limits in section 6.1.1 of Rule 9510 do
not represent a standard or other requirement relating to the control
of emissions from new nonroad engines or nonroad vehicles, and thus are
not preempted under CAA section 209(e)(1).
    NAHB references the Supreme Court's decision in Engine
Manufacturers Assocation v. South Coast Air Quality Management
District, 541 U.S. 246 (2004) (EMA v. South Coast). However, that case
involved a regulation of vehicles that clearly were ``new,'' as defined
in the statute, as the regulations applied to vehicles at the time of
purchase. Rule 9510 applies after the time of purchase of the engine
and in any case is directed to the site of the project, not the engine,
and can be met in ways that do not implicate the purchase of new
engines. The Court of Appeals has ruled that Rule 9510 is not preempted
under section 209(e)(1) and we follow and agree with that decision.
    Comment #3: NAHB asserts that the emission limits of section 6.1.1
of Rule 9510 are preempted under CAA section 209(e)(2) because they
apply to used nonroad construction equipment greater than 50
horsepower.
    Response #3: CAA section 209(e)(2) applies to, among other
categories of nonroad vehicles and engines, used

nonroad vehicles or engines, and it allows EPA to authorize, after
notice and opportunity for public hearing, the State of California to
adopt and enforce standards and other requirements relating to the
control of emissions from such vehicles or engines if certain criteria
are met. As asserted by the commenter, no authorization has been sought
from EPA by California for the emission limitations in section 6.1.1 of
Rule 9510. However, EPA does not believe such authorization is required
because, while section 6.1.1 sets standards relating to the control of
emissions from used construction equipment, EPA notes that the
standards at issue in this SIP revision relate directly only to
emissions associated with development sites. As the Court of Appeals
stated, this regulation is authorized as an indirect source review
program under section 110(a)(5) of the Act. Rule 9510 does not regulate
nonroad engines directly and would not affect nonroad engines apart
from the possible effects from the regulation of the indirect source as
a whole. The court noted that given the language in section 110
authorizing indirect source programs, they would cautiously examine the
Act before concluding that section 209(e)(2) preempted such a program.
The court also distinguished the cases cited by NAHB, EMA v. South
Coast and Pacific Merchant Shipping Ass'n v. Goldstene, 517 F.3d 1108
(9th Cir. 2008), by noting that the regulations in those cases were
directed at vehicles, not sites. EPA also notes that Rule 9510 allows
compliance with the site-based requirement using actions that would not
affect the engines at the site or would only affect the use of the
engine, which EPA has already determined is not preempted by section
209(e)(2). See also, EMA v. EPA and Pacific Merchant Shipping Ass'n v.
Goldstene, 2009 U.S. Dist Lexis 55516, 70 ERC 1337 (E.D. Cal. 2009).
Thus any argument that the requirements are de facto standards on
nonroad engines is not persuasive. The Court of Appeals has ruled that
Rule 9510 is not preempted under section 209(e)(2) and we follow and
agree with that decision.
    Comment #4: Citing Engine Manufacturers Association v. South Coast
Air Quality Management District [541 U.S. 246 (2004)], NAHB asserts
that EPA erred in finding that the emissions limits in Rule 9510 are
not preempted under CAA section 209(e) because the standards can be met
in numerous ways including options that do not involve any changes to
nonroad equipment and that the emission limits in Rule 9510 would be
preempted only if they impose burdens so onerous that manufacturers
would be forced to alter the design or emission control equipment on
new nonroad engines or vehicles.
    Response #4: EPA agrees that, if the emission limits in Rule 9510
were standards or other requirements relating to the emissions from
nonroad vehicles or engines, then the limits would be preempted under
section 209(e) regardless of whether the rule provides for compliance
options other than direct reduction of emissions from nonroad vehicles
or engines and regardless of whether the limits would in practical
effect force manufacturers to alter the design or emission control
equipment on new nonroad engines or vehicles. In this case, though, as
noted above and as found by the Court of Appeals, the emission limits
in Rule 9510 are not such standards.
    In the TSD, EPA describes the flexibility provided in Rule 9510 to
developers in meeting the emissions limitations not to show that the
standards are therefore not preempted, but as further evidence that the
rule truly is an indirect source rule that only indirectly regulates
emissions from direct sources (such as construction equipment).
Furthermore, in the TSD, EPA evaluates the potential for Rule 9510, as
an ISR rule otherwise authorized under CAA section 110(a)(5), to
nevertheless run afoul of CAA section 209(e), and in so doing, EPA
identified two ways that an ISR rule that on its face is authorized
under CAA section 110(a)(5) could nonetheless be preempted. First, the
ISR rule could be preempted if the rule in practice as applied acts to
compel the manufacturer or user of a nonroad engine or vehicle to
change the emission control design of the engine or vehicle, or second,
an ISR rule could be preempted if it creates incentives so onerous as
to be in effect a purchase mandate. EPA concluded, however, that Rule
9510 would not have either type of effect and would not operate in such
a way as to amount to a standard controlling the emissions of nonroad
vehicles or engines, and thus would not be preempted.
    Comment #5: NAHB contrasts EPA's stated position on preemption of
state attempts to enforce fleet-based nonroad emissions standards with
EPA's proposed approval of section 6.1.1 of Rule 9510 which, in NAHB's
view, establishes emissions standards for fleets of construction
equipment when used at construction sites subject to Rule 9510.
    Response #5: EPA agrees that, if the emission limits in Rule 9510
were standards or other requirements relating to the control of
emissions from nonroad vehicles or engines, then the fact that they
apply to fleets of construction equipment, rather than to individual
nonroad vehicles or engines, would not make any difference as to
preemption. Such fleet-based nonroad emission limits would be preempted
just as would emission limits that apply to individual nonroad engines
or vehicles.
    However, as the Court of Appeals found, the emission limits in
section 6.1.1. of Rule 9510 are not standards or other requirements
relating to the control of emissions from nonroad vehicles or engines,
but rather, are emission reduction obligations that relate to the
construction-phase at development sites, and as such are not preempted.
EPA notes that the rule by its terms (see section 2.0 of the rule)
applies to applicants seeking discretionary approval for development
projects that meet certain size criteria and to certain transportation
or transit projects, not to fleets of nonroad vehicles or engines. EPA
also notes that a developer has numerous options to meet the emission
reduction obligation in section 6.1.1, including options that do not
involve any changes to construction equipment (see section 6.3 of the
rule). The flexibility provided in the rule in meeting the emission
reduction obligation in section 6.1.1 provides further evidence that
the rule is intended to reduce emissions from construction sites as an
indirect source of emissions, rather than to regulate the construction
equipment directly, either as a fleet or as individual pieces of
equipment.
    Comment #6: ARTBA petitions EPA to amend EPA's rules implementing
CAA section 209(e) to clarify that: (1) Section 209(e) preempts rules
based on nonroad fleets to the same extent that it preempts rules based
on individual nonroad vehicles and engines; (2) section 209(e)'s
preemption lasts throughout nonroad vehicles and engines' useful life;
(3) section 209(e)(1)(A) preempts California standards and other
requirements related to emissions from farm and construction equipment
under 175 horsepower to the same extent that section 209(e)(1)(B)
preempts California standards and other requirements related to
emissions from locomotives; and (4) section 209(e) preempts emission-
based regulation of the use and operation of nonroad vehicles and
engines, such as regulations on hours of usage, daily mass emission
limits, and fuel restrictions.
    Response #6: ARTBA's petition seems to be little more than a
renewal of its earlier request for an amendment to

EPA's rule implementing CAA section 209(e). EPA denied ARTBA's
petition. See 73 FR 59034 (October 8, 2008). ARTBA's challenge to EPA's
denial of ARTBA's petition was dismissed for lack of subject matter
jurisdiction by the U.S. Court of Appeals for the DC Circuit. See Am.
Rd. & Transp. Builders Ass'n v. EPA, 588 F.3d 1109 (DC Cir. 2009),
petition for cert. denied, No. 09-1485 (U.S. Oct. 4, 2010). ARTBA's
petition, except as discussed below, is related to the general
preemption issues that ARTBA has raised previously and not specifically
to the proposal to add Rule 9510 to the California SIP. EPA has already
reviewed these issues several times and is not revisiting these broader
issues in this limited proceeding. To the extent ARTBA intends EPA to
do so, the request is denied. Further, because EPA did not propose any
changes to its rules implementing section 209(e) in this rulemaking on
the California SIP, it could not make any such revisions in this final
rule in any event.
    Comment #7: ARTBA contends that, in EPA's final rule on
California's submittal of Rule 9510, EPA should find that EPA's action
has ``nationwide scope or effect'' pursuant to CAA section 307(b)(1)
leading to exclusive jurisdiction in the U.S. Court of Appeals for the
District of Columbia to ensure nationwide uniformity in the
interpretation and enforcement of these important CAA issues.
    Response #7: CAA section 307(b)(1) generally provides that judicial
review of EPA action in approving a SIP or SIP revisions may be filed
only in the U.S. Court of Appeals for the appropriate circuit. Thus,
final EPA actions on revisions to the California SIP, such as Rule
9510, are generally subject to timely challenges filed in the U.S.
Court of Appeals for the Ninth Circuit. However, judicial review of an
EPA SIP action may be filed only in the U.S. Court of Appeals for the
District of Columbia if such action is based on a determination of
nationwide scope or effect and if in taking such action the EPA finds
and publishes that such action is based on such a determination.
    We do not believe that our action approving Rule 9510 as a revision
to the California SIP is based on a determination of ``nationwide scope
or effect.'' While we recognize Rule 9510 as a novel approach for
advancing air quality goals, the innovative or unusual nature of the
rule alone does not give our approval of it under CAA section 110
``nationwide scope or effect.'' Once approved, Rule 9510 will become
enforceable under the CAA by its terms only to certain development
projects within the geographic jurisdiction covered by the SJVUAPCD.
Thus, EPA's approval of Rule 9510 is clearly regional in scope and
effect.
    Of course, EPA's rationale for approval of Rule 9510 sets a
precedent for future rulemaking actions on similar ISR rules submitted
to EPA as SIP revisions by California or any other state, but the
precedential effect in this instance is no different than for EPA
actions approving or disapproving any other SIP or SIP revision
anywhere in the country. Thus, EPA's action on Rule 9510 is based on a
determination of no greater scope or effect than any other EPA action
on SIPs, which are reviewable only in the U.S. Courts of Appeal of the
appropriate circuit, not necessarily the U.S. Court of Appeals for the
District of Columbia.
    Comment #8: ARTBA contends that EPA cannot approve Rule 9510 as a
SIP revision because: (1) Section 209(e) preempts Rule 9510 as an
impermissible standard and ``other requirement'' related to emissions
for construction equipment both above and below 175 horsepower; (2)
California and the SJVUAPCD therefore lack authority to enforce Rule
9510, and (3) SIP approval does not meet the criteria or procedures for
waiving federal preemption such as California's protectiveness
determination, consistency with sections 209 and 202(a), and the
opportunity for an EPA hearing.
    Response #8: As to preemption issues, please see our responses to
comments 2 through 5 above. As to the legal authority
to enforce Rule 9510, please see our response to comment 1.
Lastly, as to the failure by Rule 9510 to meet the criteria or
procedures for waiving preemption, we do not believe that Rule 9510
requires a waiver because, as discussed above and as determined by the
Court of Appeals, it is not preempted as it does not establish
standards or other requirements relating to the control of emissions of
nonroad engines or vehicles for the purposes of CAA section 209(e) but
rather establishes standards relating to the control of emissions from
an indirect source, the construction phase of development projects.
    Comment #9: Citing EPA's TSD for Rule 9510, NAHB notes EPA has
concluded that some provisions of Rule 9510 concerning on-site and off-
site emissions reductions are not federally enforceable. NAHB asserts
that section 172(c)(6) the CAA (42 U.S.C. 7502(c)(6)) prohibits EPA
from incorporating into a SIP ``any portion of Rule 9510 that it has
determined to be federally unenforceable.''
    Response #9: NAHB misinterprets section 172(c)(6) the Act. As cited
by NAHB, section 172(c)(6) does state that SIPs ``shall include
enforceable emissions limitations.'' However, NAHB reads this language
to mean that SIPs shall only include enforceable emissions limitations.
This reading is far from correct. SIPs contain many aspects which are
not federally enforceable emissions limitations. For example, approved
SIPs contain such items as current emissions inventories, future
emissions inventory projections based upon economic and technological
trends, and air quality modeling. In addition, section 172(c)(6)
expressly provides for ``other control measures, means or techniques''
which may not include enforceable emissions limitations. One example
given in section 172(c)(6) is ``economic incentives such as fees.'' The
imposition of a fee on a polluting activity may create an incentive to
minimize the resulting pollution from that activity, and the incentive
might be successful in accomplishing that goal. However, imposition of
the fee, in itself, in no way creates an enforceable emissions
limitation.
    In addition, as noted in EPA's TSD, through policies such as
``Guidance for Incorporating Voluntary Mobile Source Emission Reduction
Programs in State Implementation Plans (VMEP)'' and ``Incorporating
Emerging and Voluntary Measures into a State Implementation Plan
(SIP),'' EPA has recognized that measures and rules which are not
federally enforceable can be incorporated into a SIP pursuant to the
Act in appropriate circumstances.
    Finally, in evaluating rules or measures which contain novel and/or
voluntary aspects, some issues regarding federal enforceability really
concern the amount of emissions reductions which can be legally
compelled pursuant to such a rule or measure, and, therefore, what
amount of emissions reductions, if any, should be credited toward
satisfying the planning requirements of section 110 of the Act. This is
the case with Rule 9510. As noted by NAHB, many of the issues described
in EPA's TSD concern the mechanisms created by Rule 9510 to accomplish
emissions reductions. For example, a project developer subject to Rule
9510 might choose to pay fees instead of reducing emissions associated
with the project site. In turn, the SJVUAPCD would use these collected
fees to generate off-site emissions reductions. The SJVUAPCD's ability
to require these reductions would rely on a contract between the
SJVUAPCD and an off-site project applicant.
    If Rule 9510 was incorporated into the SIP, EPA could use the Act's

enforcement authority to require that the appropriate fees be collected
from a project developer, and that the collected fees be used by the
SJVUAPCD to seek off-site emissions reductions. However, the issue of
federal enforceability arises because EPA may not be able to enforce
the terms of a contract between the SJVUAPCD and an off-site project
applicant, and thus the emissions reductions required by that contract,
pursuant to its enforcement authority under the Act. Thus the issue is
not EPA's ability to enforce the provisions of Rule 9510 as they are
written, but whether those provisions create adequate legal authority
for EPA to require emissions reductions which are sought or claimed by
the rule. In view of these enforceability concerns, among other issues,
the TSD recommends approving Rule 9510 into the SIP, but also
recommends that ``reductions from the Rule should not be credited in
any attainment and rate of progress/reasonable further progress
demonstrations or used to meet contingency measure requirements until
the District corrects the identified problems, which we believe the
District should easily be able to do.'' In today's final rule we
therefore approve Rule 9510 but we do not assign any emissions
reduction credit to the rule for purposes of any attainment or progress
demonstration in any area.
    Comment #10: NAHB states that Rule 9510 is not an ``incentive''
program that ``encourages'' reductions, but rather Rule 9510 requires
developers to achieve emission reductions. NAHB therefore asserts that
Rule 9510 is not an economic incentive program and EPA's guidance,
``Improving Air Quality with Economic Incentive Programs'' (EIP
Guidance) does not apply.
    Response #10: Economic incentive programs (EIPs), as defined by
EPA's EIP Guidance,\1\ are programs which may include State established
measures directed toward stationary, area, and/or mobile sources, to
achieve emission reductions milestones to attain and maintain ambient
air quality standards, and/or to provide more flexible, lower-cost
approaches to meeting environmental goals. EIPs use market-based
strategies to encourage reducing emissions in the most efficient manner
(see EIP Guidance sections 1.1 and 15.1). While Rule 9510 requires
developers subject to the rule to reduce emissions, it also provides
developers the flexibility of paying a fee as an alternative means to
comply. The developer may choose to pay a fee when it is a lower cost
approach to meeting the rule requirements. Rule 9510 also requires
SJVUAPCD to administer a program that uses these funds to achieve
surplus emission reductions. Because the program as a whole includes
this separate program where SJVUAPCD will use the funds to obtain
emission reductions, it allows for a more flexible and potentially
lower cost approach to getting emission reductions from the program.
For these two reasons, Rule 9510 is an economic incentive program and
EPA's EIP Guidance applies.
---------------------------------------------------------------------------

    \1\ EPA's EIP Guidance, ``Improving Air Quality with Economic
Incentive Programs'' published on January 2001 (EPA-452/R-01-001) is
available at http://www.epa.gov/ttn/oarpg/t1/memoranda/eipfin.pdf.
---------------------------------------------------------------------------

    Comment #11: NAHB states that Rule 9510 is not a voluntary program,
that it is a mandatory program. NAHB asserts that EPA's ``Guidance on
Incorporating Voluntary Mobile Source Emission Reduction Programs in
State Implementation Plans (VMEP)'' does not apply.
    Response #11: First, we wish to clarify that EPA proposed to
approve Rule 9510 because it strengthens the SIP. EPA did not propose
to approve Rule 9510 as a measure under VMEP.\2\ Our discussion of VMEP
and the Emerging and Voluntary Measures Policy \3\ was intended to
provide the SJVUAPCD and the public with information concerning certain
deficiencies in Rule 9510 and how these deficiencies might be addressed
under the policies so that SIP emission reduction credit could be
granted for the emission reductions achieved by Rule 9510. In addition,
we acknowledge that we may not have made fully clear in the TSD the
difference between enforceability in the context of reviewing the
provisions of an individual emissions control rule as distinct from
being able to assure that a state's commitment to achieve emissions
reductions is fully accomplished.
---------------------------------------------------------------------------

    \2\ A copy of VMEP (October 23, 1997) is available at http://www.epa.gov/otaq/stateresources/policy/general/vmep-gud.pdf.
    \3\ This guidance is entitled, ``Incorporating Emerging and
Voluntary Measures into a State Implementation Plan (SIP),''
September 2004, and is available at http://www.epa.gov/ttn/oarpg/t1/memoranda/evm_ievm_g.pdf.
---------------------------------------------------------------------------

    The commenter is correct that entities subject to Rule 9510 are
required to comply with the rule, and in that sense the provisions are
mandatory. However, the commenter misunderstands the scope and
potential applicability of VMEP.
    VMEP defines voluntary measures as emission reduction programs that
rely on voluntary actions of individuals or other parties for achieving
emission reductions. However, a State's obligations with respect to
VMEPs must be enforceable at the State and Federal levels. That is,
under the VMEP policy guidance, the State is not responsible,
necessarily, for implementing a program dependent on voluntary actions.
However, the State is obligated to monitor, assess and report on the
implementation of voluntary actions and the emission reductions
achieved from the voluntary actions and to remedy in a timely manner
emission reduction shortfalls should the voluntary measure not achieve
projected emission reductions.
    While the developer must comply with the rule, several of the
developer's compliance options rely upon voluntary emission reductions.
For instance, the developer could include on-site mitigation measures
designed to reduce vehicle miles travelled by the residents. Emission
reductions would occur when residents voluntarily choose to drive less.
Alternatively, the developer could also pay a fee in lieu of
implementing on-site mitigation measures. While the SJVUAPCD would use
the funds to achieve emission reductions, the entities actually
providing the emission reductions are voluntarily participating in the
program and are not subject to a rule. Because some of the activities
generating the actual emission reductions are voluntary, VMEP could be
used to help evaluate whether SIP credit is appropriate if the
deficiencies discussed in section (5)(f) of our TSD are addressed.
    Comment #12: NAHB notes that EPA's guidance ``Incorporating
Emerging and Voluntary Measures into a State Implementation Plan
(SIP)'' (Emerging and Voluntary Measures Policy) does not apply to
emissions from mobile sources. NAHB states that while EPA asserts that
developers are the entities subject to the rule, developers are not the
``sources'' of NOX and PM10 mobile source
emissions. NAHB states that nonroad engines and vehicles are the
``source'' of emissions regulated by Section 6.1.1. NAHB therefore
concludes that this policy does not apply.
    Response #12: In section (5)(b)(iv) of our TSD (page 13), we
discuss enforceability and how prohibitory rules typically hold
``sources'' of emissions legally responsible for the required emission
reductions. Rule 9510 in contrast applies to developers. As the entity
subject to the rule and legally responsible for the emission
reductions, our reference to the developer as the ``source'' in Rule
9510 was shorthand to reflect their legal responsibility under Rule
9510. The commenter is correct that sources of emissions are normally

categorized as mobile, stationary, or area sources. However, as we
described in Response 1, the CAA recognizes that development
projects are ``indirect sources'' and can be subject to regulation in a
SIP.
    Development projects indirectly result in new emissions from
mobile, stationary, and area sources, including those from new or
longer vehicle trips, fuel combustion from stationary and area sources,
use of consumer products, landscaping maintenance, and construction
activities.
    While the calculation of emission reductions required by Rule 9510
takes into account construction equipment emissions (Section 6.1) and
operational emissions (Section 6.2), the emission reduction obligation
is expressed in tons of NOX and tons of PM10
without regard to whether the reductions must come from mobile,
stationary, or area sources. Indeed, Section 6.3 allows the emission
reduction requirement to be met through any combination of on-site
measures or off-site fees.
    Because the sources of emissions are mobile, stationary, and area
sources and the emission reductions could come from all three types of
sources, EPA has appropriately considered the guidances ``Incorporating
Emerging and Voluntary Measures into a State Implementation Plan
(SIP)'' which applies to stationary and area sources, and ``Guidance on
Incorporating Voluntary Mobile Source Emission Reduction Programs in
State Implementation Plans (VMEP)'' which applies to mobile sources. As
we clarified in Response 11, the discussion in the TSD on the
consideration of these policies was largely to provide the SJVUAPCD and
the public with information on how rule deficiencies might be addressed
in the future.
    Comment #13: NAHB states that even if the Emerging and Voluntary
Measures Policy applied to non-road mobile sources under Rule 9510, EPA
cannot approve Rule 9510 because the non-road mobile source reductions
are not permanent. The reductions are not permanent because they are
not federally enforceable.
    Response #13: As we stated in Responses 11 and
12, EPA did not propose to approve Rule 9510 as a measure
under the Emerging and Voluntary Measures Policy, and the discussion in
the TSD was largely to provide information on how rule deficiencies
might be addressed in the future to obtain SIP credit for emission
reductions. While thus not relevant to our action in approving Rule
9510, we will elaborate on the concept of permanent.
    Whether a reduction is considered ``permanent'' is dependent on the
duration of the obligation which the particular measure and resulting
emission reductions are meant to address. The commenter has noted that
EPA identified enforceability concerns with the provisions requiring
implementation of the mitigation measure, and Response 9
addresses the enforceability issue. Enforceability is a separate
question from whether the non-road mobile source mitigation measure, if
implemented, results in permanent reductions. If a developer's
mitigation measure is the use of lower emitting construction equipment,
the very use of that equipment results in a stream of emission
reductions during the construction phase. Although these reductions may
not be federally enforceable, they can still be permanent during the
relevant time period.

III. EPA Action

    No comments were submitted that change our assessment that the
submitted rules comply with the relevant CAA requirements. Therefore,
as authorized in section 110(k)(3) of the Act, EPA is fully approving
this rule into the California SIP.

IV. 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 interfere with Executive Order 12898 (59 FR 7629
(Feb. 16, 1994)) because EPA lacks the discretionary authority to
address environmental justice in this rulemaking.
    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 July 8, 2011. 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. 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, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Particulate matter, Reporting and recordkeeping requirements.

    Dated: March 31, 2011.
Jared Blumenfeld,
Regional Administrator, Region IX.

    Part 52, Chapter I, Title 40 of the Code of Federal Regulations is
amended as follows:

PART 52--[AMENDED]

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

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

Subpart F--California

0
2. Section 52.220, is amended by adding paragraph (c)(348) (i)(A)(3) to
read as follows:

Sec.  52.220  Identification of plan.

* * * * *
    (c) * * *
    (348) * * *
    (i) * * *
    (A) * * *
    (3) Rule 9510, ``Indirect Source Review (ISR),'' adopted on
December 15, 2005.
* * * * *
[FR Doc. 2011-11133 Filed 5-6-11; 8:45 am]
BILLING CODE 6560-50-P


Renewal of an

Information collection request

 for

Regulatory Pilot Projects

OMB Control No. 2010-0026

EPA ICR No. 1755.09

The United States Environmental Protection Agency

February 2011

Table of Contents

Title										Page

1.	Identification of the Information Collection	1

1(a) Title of the Information Collection	1

1(b) Short Characterization/Abstract	1

2.	Need for and Use of the Collection

2(a) Need/Authority for the Collection	 3

2(b) Practical Utility/Users of the Data	3

3. 	Nonduplication, Consultations, and Other Collection Criteria

3(a) Nonduplication	3

3(b) Public Notice Required Prior to ICR Submission to OMB	4

3(c) Consultations	4

3(d) Effects of Less Frequent Collection	4

3(e) General Guidelines	4

3(f) Confidentiality	 4

  	3(g) Sensitive Questions	4

4.	The Respondents and the Information Requested

4(a) Respondents/NAICS Codes	4

4(b) Information Requested	 4

(I) Data items, including record keeping requirements

(II) Respondent Activities

5.	The Information Collected--Agency Activities, Collection Methodology,

and Information Management

5(a) Agency Activities	5

5(b) Collection Methodology and Management	6

5(c) Small Entity Flexibility	6

5(d) Collection Schedule	6

6.	Estimating the Burden and Cost of the Collection

6(a) Estimating Respondent Burden and Cost	6

6(b) Estimating Agency Burden and Cost	9

6(c) Estimating the Respondent Universe and Total Burden and Costs	10

6(d) Reason for Burden Hour Change	10

Burden Statement	10

U.S. ENVIRONMENTAL PROTECTION AGENCY

Regulatory Innovation Pilot Projects (ICR) No. 1755.09

1.  Identification of the information collection

1(a) Title and Number of the Information Collection

Title:  Regulatory Innovation Pilot Projects, ICR No. 1755.09, OMB
Control No. 2010-0026.

1(b) Short Characterization

This is a request for renewal of currently approved ICR No. 1755.08,
which authorizes the solicitation of proposals for innovative pilot
projects. A 60-day comment period for this ICR renewal in the Federal
Register concluded on December 6, 2010, during which one comment was
received.

In 1995, the U.S. Environmental Protection Agency (EPA) began to solicit
innovative pilot projects in response to a challenge to transform the
environmental regulatory system to better meet the needs of a rapidly
changing society while maintaining the nation’s commitment to protect
human health and safeguard the natural environment. Since then, through
a number of mechanisms including: site-specific agreements with project
sponsors at the facility or community level; broader agreements under
the Joint EPA – State Agreement to Pursue Regulatory Innovation (
HYPERLINK "http://www.ecos.org/files/1426_file_Agreement.pdf"
http://www.ecos.org/files/1426_file_Agreement.pdf ); and at the State
whole-regulatory program-level through the Agency’s State Innovation
Grant Program, EPA has been working effectively with partners to test
innovative approaches to environmental regulation that focus on better
environmental outcomes and better efficiency. Under prior Information
Collection Requests (ICRs), EPA has been gathering data on performance
under the earlier, facility-specific innovation projects identified
under Project XL (http://www.epa.gov/projctxl/). Project experience
gained in these earlier projects is helping the Agency redesign current
approaches in pursuit of improved public health and environmental
protection and more efficient use of limited resources.  Through these
projects, sponsors private facilities, multiple facilities, industry
sectors, Federal facilities, communities, universities, Tribes and
States are implementing innovative strategies that produce superior
environmental performance, provide flexibility, cost savings, paperwork
reduction or other benefits to sponsors, and promote greater
accountability to the public.

The intent of conducting and supporting innovative pilot projects is to
allow EPA to experiment with untried, potentially promising regulatory
approaches, both to assess whether they provide superior environmental
performance or other benefits, and whether they should be considered for
wider application.  Using this piloting approach, EPA can rely on
carefully controlled, but smaller scale tests to evaluate methodically
the broader applicability of any specific regulatory innovation. This
piloting approach provides EPA with a structured, applied policy
laboratory where tests of innovation at a manageable scale can be
controlled and evaluated carefully much the same as engineering
innovations require component-by component tests and evaluation to bring
an innovation to implementation.  The piloting, or applied policy
laboratory approach allows EPA to propose and adopt changes based upon
an actual assessment of success at a small scale. Thus, the careful
piloting of a regulatory innovation allows EPA to identify possible new
policy approaches within the general statutory directive, and suggest
alternative regulatory approaches aimed at better results and better
efficiency, so long as the alternative proposed is permissible under
statute.

The adoption of such alternative approaches or interpretations in the
context of a pilot project does not, however, signal EPA's willingness
to adopt that interpretation as a general matter, or even in the context
of other pilot projects. It would be inconsistent with the
forward-looking nature of these pilot projects to adopt such innovative
approaches prematurely on a widespread basis without first determining
whether or not they are viable in practice and successful for the
particular projects that embody them. These pilot projects are not
intended to be a means for piecemeal revision of entire programs.
Depending on the results of these projects, EPA may or may not be
willing to consider adopting the alternative approach or interpretation
again, either generally or for other specific facilities.  EPA believes
that testing alternative policy approaches and/or interpretations, on a
limited basis (e.g., in a site-specific circumstance or within a
specific, state-managed permitting program) and under the tight control
of a carefully selected pilot project is consistent with the
expectations of Congress about EPA's role in implementing the
environmental statutes (so long as EPA acts within the discretion
allowed by the statute). Congress' recognition that there is a need for
experimentation and research, as well as ongoing reevaluation of
environmental programs, is reflected in a variety of statutory
provisions.

EPA’s Office of Policy  (OP) has tested and evaluated innovative
approaches in collaboration with state environmental agencies and
directly with regulated entities through pilot projects supported
through formal mechanisms such as the State Innovation Grant Program
which ran from 2002 through 2009 and under Project XL which ran from
1995 through 2003,. The Office of Policy historically has managed a
careful program to pilot test, evaluate and implement select innovations
in support of the Agencies regulatory programs. Since 1995, EPA has
implemented pilot projects to test innovative ideas working with EPA
headquarters, EPA regions, Federal, State, and local government
agencies, as well as individual facilities and whole business sectors.
The renewal of this ICR is important as it will allow the Agency to
continue to monitor and present the outcomes of the projects still
remaining from those earlier programs even though they are no longer
creating new pilot projects.  It will also allow the Agency to continue
its commitment to testing and evaluating innovative approaches for
better environmental results as a partner with States, Tribes and
communities.  The renewal of this ICR will allow EPA to continue to
collaborate with the states as co-regulators to test innovative
approaches for addressing emerging environmental issues such as climate
change adaptation.  In addition, the renewal of this ICR is necessary to
allow EPA to continue information collection supporting its commitments
to current projects under previous approved ICR amendments
(1755.03-1755.08).

2. 	Need for and Use of the Collection

2(a)	Need/Authority for the Collection

The information is needed to allow the Agency to continue its ongoing
work with states, regulated entities, and other stakeholders that are
already engaged in innovative regulatory piloting projects. The
information is of value to the Agency in meeting its commitment to
document and transfer practical innovation and regulatory flexibility
for attainment of compliance and superior environmental results in
partnership with regulated facilities, communities, states and tribes.
The information will support the reporting of improved environmental
results and the analysis of pilot projects to determine their efficacy
and potential for broader use.  States implementing innovative
regulatory pilot tests in projects funded by a State Innovation Grant
are required to report on progress during the operation of a project and
to provide a final project report summarizing outcomes and major
findings of each project.  EPA’s policy on performance measurement in
assistance agreements is an implementation outcome under the Government
Performance and Results Act (GPRA § 1115 (a)(4) and §1116(c) ).  The
renewal of this ICR will allow OEPI to continue to receive and work with
project sponsors on proposals for innovation as well as document results
from those projects.

Responses related to inquiries by EPA about Project XL pilot projects
are voluntary, as are any responses by state environmental agencies to
EPA’s request for input for the design of the annual competition.
Under this ICR, EPA would be allowed to solicit its co-regulators and
the regulated entities for their best ideas on pilot projects to test
and evaluate innovative practices, and for information that will
document the processes and environmental outcomes of pilot testing.  .

2(b)	Practical Utility/Uses of the Data

Information collected under this ICR renewal will have two purposes.
First, EPA seeks to document the results of regulatory innovation pilot
projects: to provide accountability reflected in environmental results;
to understand the circumstances under which these innovative approaches
work best; and to fully document the projects and their outcomes in a
way that allows other states or tribes to work with regulated entities
to adopt successful approaches. Second, EPA will be allowed to consult
with state and local environmental regulatory agencies on development
and testing of  novel approaches to addressing emerging environmental
issues

3.  Nonduplication, Consultations, and Other Collection Criteria

3(a) 	Nonduplication

The information to be obtained under this ICR has not been collected by
EPA or any other Federal agency.

3(b)	Public Notice Required Prior to ICR Submission to OMB

In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.),
EPA solicited comments on this ICR.  A Federal Register (F.R.) notice
for this ICR package was first published in the Federal Register on
October 5, 2010, (Volume 75, Number 192, page 61483 – 61485).

One public comment was received in the 60-day first notice in the
Federal Register.  This comment, from the Wisconsin Department of
Commerce provided a reminder to the EPA Office of Policy that EPA Region
5 had committed to providing technical assistance in the form of
inspections for a State Innovation Grant supported project for the
state’s inspection of facilities participating in the auto body sector
Environmental Results Program pilot.  In response to that comment, the
annual and total burden for EPA has been recalculated in the support
document to include a total (over the lifetime of this ICR amendment
additional burden of 100 hours by EPA.

3(c)	Consultations

This notice was developed by the Office of Policy in consultation with
EPA Regional personnel.

3 (d)  	General Guidelines

This ICR complies with OMB’s general guidelines for the collection of
information.

3(e)	Confidentiality

The nature of the data being requested as part of this information
collection is not confidential.

3(f) 	Sensitive Questions

The information gathering activities discussed in this ICR do not
involve any sensitive questions.

4.  	The Respondents and the Information Requested

4(a)	Respondents/NAICS Codes

EPA historically has worked with states, tribes, local governments,
businesses and other regulated entities on regulatory innovation
piloting.  Potential respondents include the states and tribes as well
as entities regulated by EPA and its co-regulators in state and tribal
agencies pursuant to its authority under the various environmental
statutes who are participating in innovative pilot projects.

4(b)	Information Requested

No new proposals are being accepted through Project XL or the State
Innovation Grant program  Therefore the information collection
activities fall generally into two categories within this ICR: (1)
progress reporting and final reporting for all projects in
implementation under Project XL and the existing State Innovation Grant
Program;  (2)  occasional consultation with state, tribal and local
environmental agencies related to pilot testing and evaluation of
innovative approaches to address emerging environmental issues.

For projects in implementation under Project XL, EPA anticipates
collection of information to allow the Agency to document and evaluate
the outcomes of the remaining fourteen (14) pilot projects, including
measurements of environmental outcomes including collection of final
project reports, as identified in the Final Project Agreement or a
project workplan that will provide the information required to assess
the success and outcomes of each project. For the remaining twenty (20)
projects sponsored under the now-closed State Innovation Grant Program,
EPA anticipates collection of quarterly progress reports and a final
project report for each project to summarize results and provide
evaluative information to describe the success and broader applicability
of the piloted innovative approach. EPA will also provide direct
technical assistance to the State of Wisconsin for a project supported
under the State Innovation Grant Program by providing inspections for up
to one hundred and forty (140) facilities participating in the State’s
auto body repair shop Environmental Results Program (ERP) pilot.
Information collection for the compliance part of these inspections is
addressed in ICRs supporting the compliance program but, because this
pilot project, typical of other ERP projects provide measures of
beyond-compliance performance by small facilities intended to indicate
more effective environmental stewardship through waste and energy
minimization, some information requested for these  inspections by EPA
personnel would not be covered in existing ICRs for the compliance
inspection program.

EPA also anticipates needing the opportunity for occasional consultation
with state and tribal environmental regulatory agencies to identify
potential partnership areas for piloting and evaluating innovative
solutions to emerging environmental issues such as climate change
adaption.

5.  The Information Collected.  Agency Activities, Collection
Methodology, and Information Management.

5(a) 	Agency Activities

Agency activities associated with the collection of information for
innovative pilot projects include:

Gather information from project sponsors and participants on progress
and results from existing innovation pilot tests initiated under Project
XL and the State Innovation Grant Program.

Occasional consultation with state and tribal environmental agencies
through Federal Register Notices and responses, email, or written
correspondence as well as through symposia and other meetings to gather
ideas for pilot testing of innovative ideas focused on addressing
emerging environmental issues.

5(b)	Collection Methodology and Information Management

For projects implemented through Project XL and the State Innovation
Grant program: progress reports, correspondence, and final reports are
submitted by each project sponsor by email or mail and following review
these reports are kept in project files by EPA project personnel.  For
the occasional consultation with states and tribes on pilot testing
innovative approaches to address emerging environmental issues, EPA
anticipates using Federal Register Notices and responses, email, or
written correspondence  as well as through symposia and other meetings

5 (c)	Small Entity Flexibility.

Facilities participating in innovation projects under all projects under
Project XL and State Innovation Grant projects: participate on a
voluntary basis and entities can choose not to participate at any time
if undue burden exists.

5(d)	Collection Schedule.

No new proposals are being accepted through Project XL or the State
Innovation Grant Program.  For regulatory innovation projects in
implementation, progress reporting generally occurs quarterly and as a
final project report for grant-supported projects and annually and a
final project report for XL projects.

6.	Estimating the Burden and the Cost of the Collection

6(a)   Estimating Respondent Burden and Cost

This section presents EPA’s estimates of the burden and costs
necessary to complete the information collection activities associated
with this collection. Burden hours and costs were based upon estimates
provided by EPA staff with extensive experience working with innovative
pilot project sponsors and States to assess innovative pilot project
ideas and proposals.

EPA estimates average hourly respondent labor cost (including fringe and
overhead) of $82.23 for legal staff, $68.90 for managerial staff, $42.09
for technical staff, and $19.98 for clerical staff.  To derive these
estimates, EPA referred to the National Employment Cost Indexes
developed by the U.S. Bureau of Labor Statistics
(http://www.bls.gov/oes/current/oes_nat.htm).

In using this analysis it should be remembered not only that all
responses to this solicitation are voluntary, but that sponsors have
some expected value attached with their participation.  Not unlike a
contracts-based Request For Proposals, one would not expect a response
from any entity where the burdens associated with preparing the response
outweigh the expected benefits to the sponsor.

Facilities participating in projects implemented by states supported
under the State Innovation Grant Program will be required to report on
their environmental performance in order to allow states to meet their
obligation under the assistance agreements to measure the environmental
outcomes of their projects.  The nature of the metrics and reports vary
with the type of projects proposed.  They may range from pre- and
post-implementation compliance reporting which is generally covered
under programmatic ICR to reporting with innovative measures such as the
adoption of best environmental business practices that result in
pollution prevention through elimination of waste and business process
change.  This ICR is intended to allow the collection of this type of
information which provides a more reliable measure of the results of
innovative practice.  EPA anticipates that up to 800 facilities annually
may be asked to provide information on performance measures related to
adoption of innovation requiring 3,200 hours annually at an estimated
cost of $ 188,248.

For activities related to the preparation and submission of progress and
final reports related to State Innovation grant projects, EPA estimates
that States would expend up to 1,340 hours annually, costing
approximately $62,427.

EPA anticipates requesting final project reports from 12 XL Projects
during the lifetime of this ICR as a means of closing out and
documenting the results of these projects and evaluating the further
applicability of the ideas tested in these demonstrations.

No capital expenditures are needed by the respondent to complete the
interview since the responses can be made using existing equipment
(e.g., telephone). Moreover, no operating and maintenance costs are
needed since the activities (reviewing instructions, writing,
discussions, and submissions of proposals) can be conducted in with
existing equipment (e.g., phone, computer).

For progress and final reporting on XL Projects, EPA projects that each
project will require up to 20 hours to compile, compose and edit
material to fulfill the commitment made by project sponsors in the Final
Project Agreement to report fully on the outcomes of these voluntary
projects.  Thus, approximately 240 hours will be required over the
lifetime of this ICR (80 hours annually) for these reports. The cost of
this is estimated to be $4,154.88 annually.

For activities related to the collection of State input into the design
of the innovation pilots, EPA anticipates that States and Tribes may
expend up to 3 hours each to develop and submit comment to the Agency
for a total annual burden of 60 hours costing approximately $3,864.40.

Staff in the EPA Office of Strategic Environmental Management (formerly
the National Center for Environmental Innovation) that work on the
development of innovative pilot projects have reviewed the cost findings
of the report and found them to be reasonable and sound estimates of
current and future costs.

Table 1.  Average Annual Burden and Cost to Respondents

Table 1.  Average Annual Burden and Cost to Respondents

	Collection Activity

	Burden Hours and Individual Costs per Recipient

	Total Costs

Hours per Respondent per Activity

	Costs per

	Respondent

	per Activity

	Total Hours

	for all

	Respondents

	Total Costs

	for all

	Respondents

	Legal

	Mgmt

     Tech

	Cler

STATE INNOVATION GRANT SPONSORS: PROGRESS AND OUTCOME REPORTING PHASE

Collection of Annual Compliance and Other Performance Information By
Participating Facilities to Report to State Agencies (Assumes 800
Facilities Annually)

      1

      1

     2

     $235.31

   3,200

   $188,248.00

Quarterly  Project Reporting on State Innovation Grant Projects  (80
annually)

     1

     2

     8

   2

     $596.71

   1,040

    $47,736.80

Final Project Reports on State Innovation Grant Projects  (5 annually)

      4

     16

     32

   8

   $2,938.04

      300

    $14,690.20

TOTAL

      6

    19

      42

   10

    $3,770.06

    4,540

    $250,675.00

PROJECT XL FINAL REPORTING

Compile project information and develop final project report and
closeout  (assume 4 annually)

2

6

8

2	$954.54

72

$3,818.16

Consult with EPA to resolve any questions on final report and respond to
brief evaluation survey for closeout activities (assume 4 annually)

2

$84.18

8

$336.72

TOTAL

2

6

10

2

$1,038.72

80	$4,154.88

CONSULTATION WITH STATES ON INNOVATION PILOTING

Solicitation of Input from State Environmental Agencies  (Assume 20
Respondents)

        1

        1

          1

$193.22

             60

       $3,864.40

TOTAL

        1

        1

          1

$193.22

             60

       $3,864.40

EXTERNAL BURDEN TOTAL

9

26

53

12

4,680	$258,694.28

6(b)  Estimating Agency Burden and Cost

Agency burden hours and costs were based upon estimates provided by EPA
staff with extensive experience working with innovative pilot project
sponsors and States to assess innovative pilot project ideas and
proposals. The rate EPA used to estimate agency hourly wage was based
upon 2010 GS-13/01 salary (Baltimore-DC) of $89,033 (or $42.66) with
overhead of 110% factored in, resulting in approximately $90/hour.

To perform the necessary activities associated with this information
collection, EPA estimates that it will require the Agency 315 hours and
cost the Agency $20,250 per year.

Staff in the Office of Environmental Policy Innovation that work on the
development of innovative pilot projects have reviewed the cost findings
of the report and found them to be reasonable and sound estimates.

Table 2.  Annual Average Burden and Cost to Agency

	Collection Activity

	Costs

	Labor

	Total Hours

        Total

	Costs

	Hours

	Costs

EPA

Evaluation of State Innovation Grant Project Progress Reports (assume 80
quarterly reports)

       1

        $  90

            80

     $7,200

Evaluation of State innovation Grant Final Reports (assume 5 annually)

        8

        $720

            40

     $ 3,600

Technical Assistance for Wisconsin State Innovation Grant Pilot project
Inspections

         33

         $ 90

             33

     $2,970

Evaluate Project XL Final Reports (assume 4 annually)

8

         $720

32

     $ 2,880

Solicit state input on innovation piloting and develop recommendations
report

       40

      $3,600

            40

      $3,600

INTERNAL BURDEN TOTAL

90

$5,220

315

      $20,250

6(c) Bottom Line Total Burden and Costs

EPA anticipates a total annual burden to all entities (states and
tribes, participating private facilities and the Agency itself) of 4,995
hours at an estimated annual cost of $278,944.

		Table 3.  Summary of ICR Burdens for Respondent Universe

Summary of ICR Burdens and Costs

Entity

	Annual Hours Required	Annual Costs	Total Hours Over ICR Lifetime (3 yr)
Total Costs Over ICR Lifetime (3yr)

States and Tribes	   1,400	$ 66,291.40	4,200	  $ 198,874.20

Private Facility Participants	   3,280	$ 192,402.88	9,840	  $ 577,208.64

PUBLIC BURDEN	4,680	$ 258,694.28	14,040	$ 776,082.84

EPA

	    315	$ 20,250	  945	  $ 60,750

TOTAL BURDEN	4,995	$ 278,944.28	  14,985	$ 836,832.84

6(d) Reasons for Burden Hour Change

With the renewal of this ICR, total annual hours needed to conduct
information collection activities described in this ICR will be
decreased by 3,068 hours.  This difference is largely a result of the
reduced number of Project XL and State Innovation Grant projects
reporting as those programs come to a close as well as our improved
ability to refine the estimates based upon the number of projects coming
to completion and almost 15 years of experience promoting regulatory
innovation and a better understanding of the burden requirements
necessary to develop and submit proposals for innovative pilot projects,
and an improved understanding of innovative pilot projects and how to
develop them.

7. Burden Statement

The annual public reporting and recordkeeping burden for this collection
of information is estimated to average 5 hours per response. Burden
means the total time, effort, or financial resources expended by persons
to generate, maintain, retain, or disclose or provide information to or
for a Federal agency.  This includes the time needed to review
instructions; develop, acquire, install, and utilize technology and
systems for the purposes of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and
providing information; adjust the existing ways to comply with any
previously applicable instructions and requirements; train personnel to
be able to respond to a collection of information; search data sources;
complete and review the collection of information; and transmit or
otherwise disclose the information.  An agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
The OMB control numbers for EPA's regulations are listed in 40 CFR part
9 and 48 CFR chapter 15.

	To comment on the Agency's need for this information, the accuracy of
the provided burden estimates, and any suggested methods for minimizing
respondent burden, including the use of automated collection techniques,
EPA has established a public docket for this ICR under Docket ID Number
EPA-HQ-AO-2010-0739, which is available for online viewing at
HYPERLINK "http://www.regulations.gov"  www.regulations.gov , or in
person viewing at the Office of Administrator (OA) Docket in the EPA
Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Avenue,
NW, Washington, D.C.  The EPA Docket Center Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays.  The telephone number for the Reading Room is<PHONE_NUMBER>,
and the telephone number for the OA Docket is<PHONE_NUMBER>. An
electronic version of the public docket is available at
www.regulations.gov.  This site can be used to submit or view public
comments, access the index listing of the contents of the public docket,
and to access those documents in the public docket that are available
electronically. When in the system, select “search,” then key in the
Docket ID Number identified above. Also, you can send comments to the
Office of Information and Regulatory Affairs, Office of Management and
Budget, 725 17th Street, NW, Washington, D.C. 20503, Attention: Desk
Officer for EPA.  Please include the EPA Docket ID Number
EPA-HQ-AO-2010-0739 and OMB Control Number 2010-0026 in any
correspondence.

 PAGE  11


[Federal Register Volume 79, Number 28 (Tuesday, February 11, 2014)]
[Notices]
[Pages 8183-8184]
[FR Doc No: 2014-02911]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

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

    Docket Numbers: EC14-52-000.
    Applicants: Lakeswind Power Partners, LLC, Union Bank of California
Leasing, Inc.
    Description: Section 203 Application of Lakeswind Power Partners,
LLC, et al.
    Filed Date: 2/3/14.
    Accession Number: 20140203-5247.
    Comments Due: 5 p.m. ET 2/24/14.

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

    Docket Numbers: ER12-309-006.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: 2014-02-03--Net Zero-Attachment X Compliance Filing to
be effective 1/1/2012.
    Filed Date: 2/3/14.
    Accession Number: 20140203-5164.
    Comments Due: 5 p.m. ET 2/24/14.

    Docket Numbers: ER14-485-001.
    Applicants: Tucson Electric Power Company.
    Description: TEP Order No. 784 Correction Filing to be effective 1/
27/2014.
    Filed Date: 2/3/14.
    Accession Number: 20140203-5166.
    Comments Due: 5 p.m. ET 2/24/14.

    Docket Numbers: ER14-486-001.
    Applicants: UNS Electric, Inc.
    Description: UNSE Order No. 784 Correction Filing to be effective
1/27/2014.
    Filed Date: 2/3/14.
    Accession Number: 20140203-5174.
    Comments Due: 5 p.m. ET 2/24/14.

    Docket Numbers: ER14-839-000.
    Applicants: Frederickson Power L.P.
    Description: Supplement to December 26, 2013 Frederickson Power
L.P. tariff filing.
    Filed Date: 1/16/14.
    Accession Number: 20140116-5092.
    Comments Due: 5 p.m. ET 2/6/14.

    Docket Numbers: ER14-1040-000.
    Applicants: Lumens Energy Supply LLC.
    Description: Market-Based Rate Tariff to be effective 2/13/2014.
    Filed Date: 1/17/14.
    Accession Number: 20140117-5316.
    Comments Due: 5 p.m. ET 2/7/14.

    Docket Numbers: ER14-1175-000.
    Applicants: Southwest Power Pool, Inc.
    Description: 2646 Kansas Municipal Energy Agency NITSA NOA to be
effective 1/1/2014.
    Filed Date: 1/28/14.
    Accession Number: 20140128-5248.
    Comments Due: 5 p.m. ET 2/18/14.

    Docket Numbers: ER14-1248-000.
    Applicants: Southwestern Electric Power Company.
    Description: SWEPCO-Hope PSA Amendment SPP Integrated Market to be
effective 3/1/2014.
    Filed Date: 2/3/14.
    Accession Number: 20140203-5158.
    Comments Due: 5 p.m. ET 2/24/14.

    Docket Numbers: ER14-1249-000.
    Applicants: Southwestern Electric Power Company.
    Description: SWEPCO-Bentonville PSA Amendment SPP Integrated Market
to be effective 3/1/2014.
    Filed Date: 2/3/14.
    Accession Number: 20140203-5159.
    Comments Due: 5 p.m. ET 2/24/14.

    Docket Numbers: ER14-1250-000.
    Applicants: Southwestern Electric Power Company.
    Description: SWEPCO-Prescott PSA Amendment SPP Integrated Market to
be effective 3/1/2014.
    Filed Date: 2/3/14.
    Accession Number: 20140203-5162.
    Comments Due: 5 p.m. ET 2/24/14.

    Docket Numbers: ER14-1251-000.
    Applicants: Peetz Logan Interconnect, LLC.
    Description: Peetz Logan Interconnect, LLC Compliance Filing Per
Order Nos. 764 and 764-A to be effective 4/4/2014.
    Filed Date: 2/3/14.
    Accession Number: 20140203-5175.
    Comments Due: 5 p.m. ET 2/24/14.

    Docket Numbers: ER14-1252-000.
    Applicants: Sagebrush, a California partnership.
    Description: Sagebrush, a California partnership Comp Filing Per
Order Nos. 764 and 764-A to be effective 4/4/2014.
    Filed Date: 2/3/14.
    Accession Number: 20140203-5178.
    Comments Due: 5 p.m. ET 2/24/14.

    Docket Numbers: ER14-1253-000.
    Applicants: Sky River LLC.
    Description: Sky River LLC Compliance Filing Per Order Nos. 764 and
764-A to be effective 4/4/2014.
    Filed Date: 2/3/14.
    Accession Number: 20140203-5182.
    Comments Due: 5 p.m. ET 2/24/14.

    Docket Numbers: ER14-1254-000.
    Applicants: Liberty Utilities (Granite State Electric) Corp.
    Description: Notice of Succession Borderline Sales Tariff to be
effective 2/4/2014.
    Filed Date: 2/3/14.
    Accession Number: 20140203-5204.
    Comments Due: 5 p.m. ET 2/24/14.

    Docket Numbers: ER14-1255-000.
    Applicants: Emera Maine.
    Description: Filing in Compliance with Order No. 784 to be
effective 1/1/2014.
    Filed Date: 2/4/14.
    Accession Number: 20140204-5017.
    Comments Due: 5 p.m. ET 2/25/14.

    Take notice that the Commission received the following land
acquisition reports:

    Docket Numbers: LA13-4-000.
    Applicants: Enel Green Power North America, Inc.
    Description: Quarterly Land Acquisition Report of Enel Green Power
North America, Inc. subsidiaries.
    Filed Date: 2/4/14.
    Accession Number: 20140204-5037.
    Comments Due: 5 p.m. ET 2/25/14.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: February 4, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-02911 Filed 2-10-14; 8:45 am]
BILLING CODE 6717-01-P


SN-18-0005 Sanitized Support Documents Index:
 SN-18-0005 Sanitized Determination Document (linked)
 SN-18-0005 Sanitized CHEM Report (attached)
 SN-18-0005 Sanitized ECO Report (attached)
 SN-18-0005 Sanitized ENG Report (attached)
 SN-18-0005 Sanitized EXP Report (attached)
 SN-18-0005 Sanitized Fate Report (attached)
 SN-18-0005 Sanitized HLTH Report_POST-FOCUS FINAL (attached)