[Federal Register Volume 84, Number 121 (Monday, June 24, 2019)]
[Notices]
[Pages 29522-29524]
[FR Doc No: 2019-13350]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1163]

Providing Regulatory Submissions in Electronic and Non-Electronic
Format--Promotional Labeling and Advertising Materials for Human
Prescription Drugs; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Providing
Regulatory Submissions in Electronic and Non-Electronic Format--
Promotional Labeling and Advertising Materials for Human Prescription
Drugs.'' This guidance outlines the requirements and recommendations
for various types of submissions of promotional materials for
prescription drugs and biological products, including the specific
formats needed for use in the electronic common technical document
(eCTD) as well as non-eCTD and non-electronic formats. This guidance
finalizes the draft guidance issued in April 2015.

DATES: The announcement of the guidance is published in the Federal
Register on June 24, 2019.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-2015-D-1163 for ``Providing Regulatory Submissions in Electronic
and Non-Electronic Format--Promotional Labeling and Advertising
Materials for Human Prescription 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.
     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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or to the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding prescription human drugs: Kemi Asante, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3374, Silver Spring, MD 20993-0002, 301-
796-1200.
    Regarding prescription human biological products: Stephen Ripley,
Center for Biologics Evaluation and Research Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Providing Regulatory Submissions in Electronic and Non-
Electronic Format--Promotional Labeling and Advertising Materials for
Human Prescription Drugs.'' Portions of this guidance are intended to
be used in conjunction with the guidance for industry entitled
``Providing Regulatory Submissions in Electronic Format--Certain Human
Pharmaceutical Product Applications and Related Submissions Using the
eCTD Specifications'' (eCTD Guidance) and the specifications for module
1.\1\ This guidance outlines the requirements and recommendations for
manufacturers, packers, and distributors (firms) that may either be the
applicant or acting on behalf of the applicant, to make submissions
pertaining to promotional materials for human prescription drugs
(drugs) to the Office of Prescription Drug Promotion in the Center for
Drug Evaluation and Research (CDER) and the Advertising and Promotional
Labeling Branch in the Center for Biologics Evaluation and Research
(CBER). References to ``drugs'' in this guidance also include human
biological products that fall within the definition of ``drug'' under
section 201(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 321(g)).
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    \1\ The eCTD Guidance is available on the FDA website at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM333969.pdf. The
current version of the specification for industry entitled The eCTD
Backbone Files Specification for Module 1 provides additional
information and is available at https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM163552.pdf.
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    This guidance describes various types of regulatory submissions of
promotional materials that firms submit to CDER and CBER, along with
general considerations and formats for such submissions. For example,
the guidance describes the various types of voluntary submissions
(e.g., launch and non-launch voluntary submissions of draft promotional
materials for comments) and required submissions of promotional
labeling and advertising materials (e.g., fulfillment of the regulatory
requirements for postmarketing submissions of promotional materials and
submission of promotional materials for accelerated approval products).
In addition, this guidance discusses specific aspects of the content
and format for submitting promotional materials in paper copy and
electronic format, including how to submit promotional materials
electronically in module 1 of the eCTD using version 3.3 or higher of
the us-regional-backbone file. This guidance provides recommendations
for what to include with each type of submission and the number of
copies to include if it is a paper submission. This guidance provides
recommendations for

presentation considerations such as appearance, layout, format, and
visible impression of promotional materials submitted for all
promotional submission types.
    This guidance also provides instructions on how to submit
promotional labeling and advertising materials to FDA electronically in
eCTD format. It explains that for submissions of promotional materials
that fall within the scope of section 745A(a) of the FD&C Act (21
U.S.C. 379k-1), such submissions must be made in the electronic format
specified by FDA in this guidance and the guidance for industry
``Providing Regulatory Submissions in Electronic Format--Certain Human
Pharmaceutical Product Applications and Related Submissions Using the
eCTD Specifications'' (eCTD Guidance), beginning no earlier than 24
months after this guidance is issued. Specifically, (1) postmarketing
submissions of promotional materials using Form FDA 2253 (required by
21 CFR 314.81(b)(3)(i) and 21 CFR 601.12(f)(4)), and (2) submissions of
promotional materials for accelerated approval products (required by
section 506(c)(2)(B) of the FD&C Act (21 U.S.C. 356(c)(2)(B)) and
Sec. Sec.  314.550 and 601.45) and other products where such
submissions are required for approval, fall within the scope of section
745A(a) and are, therefore, subject to the mandatory electronic
submission requirement. The implementation date for the mandatory
electronic submission is June 24, 2021. When the implementation date
for the mandatory electronic submission requirement takes effect for
these types of submissions, they will only be accepted in eCTD format
using version 3.3 or higher of the us-regional-backbone file. The
guidance also provides that, while only promotional submissions that
fall under section 745A(a) of the FD&C Act will be required to be
submitted electronically no sooner than 24 months after this guidance
is issued, firms may choose--and are strongly encouraged, but not
required--to submit electronically the other types of promotional
submissions discussed in this guidance.
    In the Federal Register of April 22, 2015 (80 FR 22529), FDA
announced the availability of the draft guidance of the same title. FDA
received several comments regarding the need to provide clarity on
submission expectations and technical aspects of electronic
submissions, and those comments were considered as the guidance was
finalized. A summary of changes made in this guidance include: (1)
Changes to provide greater clarity on submission expectations, (2)
changes to provide greater clarity around technical aspects related to
electronic submissions, (3) changes to create consistency between terms
used in the final guidance and the eCTD guidance, (4) changes to
address unexpected technical issues that have been discovered since the
eCTD software launched, and (5) changes to encourage the submission of
a compact disc copy of paper submissions. In addition, editorial and
formatting changes were made to improve clarity.
    This guidance is being issued under section 745A(a) of the FD&C
Act; wherein Congress granted FDA authorization to require that
submissions under section 505(b), (i), or (j) of the FD&C Act (21
U.S.C. 355(b), 21 U.S.C. 355(i), or 21 U.S.C. 355(j), respectively) and
submissions under section 351(a) or (k) of the Public Health Service
Act (PHS Act); be submitted in an electronic format specified by FDA
through guidance. Accordingly, insofar as this guidance requires that
submissions under section 505(b), (i), or (j) of the FD&C Act and
submissions under section 351(a) or (k) of the PHS Act be submitted in
electronic format specified by FDA, this document is not subject to the
usual restriction in FDA's good guidance practice regulations that
guidances not establish legally enforceable responsibilities. (See 21
CFR 10.115(d).) Therefore, the portion of this guidance that
establishes the requirement for electronic submissions under section
745A(a) of the FD&C Act has binding effect, as indicated by the use of
the words must, shall, or required. This guidance is not subject to
Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collection of information in this guidance was approved under OMB
control number 0910-0870.
    This guidance also refers to previously approved collections of
information found in FDA regulations. The collections of information in
21 CFR 202.1, including voluntary requests for advisory comments,\2\
resubmissions, and amendments for advertisements, have been approved
under OMB control number 0910-0686; the collections of information in
21 CFR 601.45 (presubmission of promotional materials for accelerated
approval products under part 601) have been approved under OMB control
number 0910-0338; the collections of information for Form FDA 2253 and
the presubmission of promotional materials for accelerated approval
products under part 314 have been approved under OMB control number
0910-0001.
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    \2\ Reference in this guidance to the voluntary request for
advisory comment(s) on proposed promotional materials by firms is
distinct from and not to be confused with the process identified in
21 CFR 10.85.
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III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.

    Dated: June 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13350 Filed 6-21-19; 8:45 am]
BILLING CODE 4164-01-P


39 Table 6a. Annual Burden and Cost for the Federal Government to Implement ( First Year)

Proposed NESHAP for Existing Cyanide Chemicals Manufacturing Facilities A B C D E F Burden item Technical Technical Management Clerical Total cost hours per Occurrences hours per year hours per year hours per year per year occurrence per year ( C = A x B) ( C x 0.05) ( C x 0.1)

@ $ 34.00 @ $ 56.00 @ $ 17.00 Review initial notification reports 8 5 40 2 4 $ 1,540 Review notifications of compliance status 10 5 50 2.5 5 $ 1,925 Review semiannual summary reports 15 10 150 7.5 15 $ 5,775 Review notifications of performance tests 8 5 40 2 4 $ 1,540 Attend initial performance tests 240 5 1200 60 120 $ 46,200 Review test results 20 5 100 5 10 $ 3,850 Total hours 1580 79 158 Total costs $ 60,830


[Federal Register Volume 77, Number 141 (Monday, July 23, 2012)]
[Rules and Regulations]
[Pages 42952-42954]
[FR Doc No: 2012-17389]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0329; Directorate Identifier 2011-NM-139-AD;
Amendment 39-17127; AD 2012-14-13]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Airbus Model A318-112 and -121 airplanes; Model A319-111, -112, -115, -
132, and -133 airplanes; Model A320-214, -232, and -233 airplanes; and
Model A321-211, -212, -213, and -231 airplanes. This AD was prompted by
reports of some fuselage nuts found cracked. This AD requires an
inspection to determine if certain fuselage nuts are installed, a
detailed inspection for cracking of fuselage nuts having a certain part
number, and related investigative and corrective actions if necessary.
We are issuing this AD to detect and correct fuselage nuts found
cracked, which could result in reduced structural integrity of the
airplane.

DATES: This AD becomes effective August 27, 2012.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of August 27,
2012.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone (425)
227-1405; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on April 2, 2012 (77 FR
19567). That NPRM proposed to correct an

unsafe condition for the specified products. The MCAI states:

    During structural part assembly in Airbus production line, some
nuts Part Number (P/N) ASNA2531-4 were found cracked. Investigations
were performed to determine the batches of the affected nuts and had
revealed that these nuts have been installed in production on the
fuselage of aeroplanes listed in the applicability section of this
[EASA] AD.
    Static, fatigue and corrosion tests were performed, which
demonstrated that no immediate maintenance action is necessary.
However, a large number of these nuts are fitted on primary
structural elements, which could have long-term consequences.
    This condition, if not corrected, could impair the structural
integrity of the affected aeroplanes.
    For the reasons described above, this [EASA] AD requires [an
inspection to determine if certain fuselage nuts are installed,] a
detailed inspection [for cracking] of the affected nuts, associated
corrective actions, [general visual inspection for scratching of the
hole if necessary] depending on findings, and replacement of the
affected P/N ASNA2531-4 nuts with new ones, having the same P/N.
* * * * *
Required actions include related investigative and corrective actions
if necessary. Related investigative actions include a general visual
inspection for scratching of the hole. Corrective actions include
replacing the fastener and installing a new fuselage nut. You may
obtain further information by examining the MCAI in the AD docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (77 FR 19567, April 2,
2012) or on the determination of the cost to the public.

Conclusion

    We reviewed the available data and determined that air safety and
the public interest require adopting the AD as proposed.

Costs of Compliance

    We estimate that this AD will affect 152 products of U.S. registry.
We also estimate that it will take about 15 work-hours per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour. Based on these figures, we estimate the cost of
this AD to the U.S. operators to be $193,800, or $1,275 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 10 work-hours and require parts costing $362, for a cost of
$1,212 per product. We have no way of determining the number of
products that may need these actions.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM (77 FR 19567, April 2, 2012),
the regulatory evaluation, any comments received, and other
information. The street address for the Docket Operations office
(telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2012-14-13 Airbus: Amendment 39-17127. Docket No. FAA-2012-0329;
Directorate Identifier 2011-NM-139-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective August 27,
2012.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus Model A318-112 and -121 airplanes;
Model A319-111, -112, -115, -132, and -133 airplanes; Model A320-
214, -232, and -233 airplanes; and Model A321-211, -212, -213, and -
231 airplanes; certificated in any category; manufacturer serial
numbers 3339, 3340, 3350, 3355, 3360, 3367, 3369, 3372, 3380, 3382,
3385, 3387, 3388, 3390, 3393, 3395, 3397 through 3508 inclusive,
3510 through 3519 inclusive, 3522, 3523, 3525, 3527, 3529, 3530,
3537, 3539, 3542, 3544, 3546, 3548, 3552, and 3555.

(d) Subject

    Air Transport Association (ATA) of America Code 53: Fuselage.

(e) Reason

    This AD was prompted by reports of fuselage nuts found cracked.
We are issuing this AD to detect and correct fuselage nuts found
cracked, which could result in reduced structural integrity of the
airplane.

(f) Compliance

    You are responsible for having the actions required by this AD
performed within the compliance times specified, unless the actions
have already been done.

(g) Inspection and Replacement

    Within 72 months since first flight of the airplane or within 90
days after the effective date of this AD, whichever occurs later, do
an inspection for nuts having part number (P/N) ASNA2531-4 located
in the fuselage. If a nut having P/N ASNA2531-4 is found, before
further flight, do a detailed inspection for cracking of the nut,
and all applicable related investigative and corrective actions, in

accordance with the Accomplishment Instructions of Airbus Service
Bulletin A320-53-1218, Revision 01, including Appendices 01 and 02,
dated June 17, 2010. If any cracking is found, before further
flight, repair in accordance with the Accomplishment Instructions of
Airbus Service Bulletin A320-53-1218, Revision 01, including
Appendices 01 and 02, dated June 17, 2010.

(h) Reporting

    Submit a report of the findings of the inspection required by
paragraph (g) of this AD to Airbus in accordance with Appendix 01 of
Airbus Service Bulletin A320-53-1218, Revision 01, including
Appendices 01 and 02, dated June 17, 2010, at the applicable time
specified in paragraph (h)(1) or (h)(2) of this AD.
    (1) If the inspection was done on or after the effective date of
this AD: Submit the report within 90 days after the inspection.
    (2) If the inspection was done before the effective date of this
AD: Submit the report within 90 days after the effective date of
this AD.

(i) Credit for Previous Actions

    This paragraph provides credit for inspections and replacements
required by paragraph (g) of this AD, if those actions were
performed before the effective date of this AD using Airbus Service
Bulletin A320-53-1218, including Appendices 01 and 02, dated
February 8, 2010.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the International
Branch, send it to ATTN: Sanjay Ralhan, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, Washington 98057-3356; phone: 425-227-
1405; fax:<PHONE_NUMBER>. Information may be emailed to<EMAIL_ADDRESS>Before using any approved AMOC, notify your
appropriate principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office/
certificate holding district office. The AMOC approval letter must
specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: A federal agency may not conduct or
sponsor, and a person is not required to respond to, nor shall a
person be subject to a penalty for failure to comply with a
collection of information subject to the requirements of the
Paperwork Reduction Act unless that collection of information
displays a current valid OMB Control Number. The OMB Control Number
for this information collection is 2120-0056. Public reporting for
this collection of information is estimated to be approximately 5
minutes per response, including the time for reviewing instructions,
completing and reviewing the collection of information. All
responses to this collection of information are mandatory. Comments
concerning the accuracy of this burden and suggestions for reducing
the burden should be directed to the FAA at: 800 Independence Ave.
SW., Washington, DC 20591, Attn: Information Collection Clearance
Officer, AES-200.

(k) Related Information

    Refer to MCAI European Aviation Safety Agency Airworthiness
Directive 2011-0120R1, dated July 13, 2011; and Airbus Service
Bulletin A320-53-1218, Revision 01, including Appendices 01 and 02,
dated June 17, 2010; for related information.

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the following service
information under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use the following service information to do the
actions required by this AD, unless the AD specifies otherwise.
    (i) Airbus Service Bulletin A320-53-1218, Revision 01, including
Appendices 01 and 02, dated June 17, 2010.
    (3) For service information identified in this AD, contact
Airbus, Airworthiness Office--EAS, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5
61 93 44 51; email<EMAIL_ADDRESS>Internet http://www.airbus.com.
    (4) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.
    (5) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at an NARA facility, call<PHONE_NUMBER>, or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

    Issued in Renton, Washington, on July 5, 2012.
Kalene C. Yanamura,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-17389 Filed 7-20-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 119 (Thursday, June 20, 2013)]
[Rules and Regulations]
[Pages 37130-37132]
[FR Doc No: 2013-14511]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2013-0362; FRL-9815-5]

Revisions to the California State Implementation Plan, San Diego
Air Pollution Control District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is taking direct final action to approve a revision to the
San Diego Air Pollution Control District (SDAPCD) portion of the
California State Implementation Plan (SIP). This revision concerns
volatile organic compound (VOC) emissions from architectural coatings.
We are approving a local rule that regulates this emission source under
the Clean Air Act (CAA or the Act).

DATES: This rule is effective on August 19, 2013 without further
notice, unless EPA receives adverse comments by July 22, 2013. If we
receive such comments, we will publish a timely withdrawal in the
Federal Register to notify the public that this direct final rule will
not take effect.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2013-0362, by one of the following methods:
    1. Federal eRulemaking Portal: www.regulations.gov. Follow the on-
line instructions.
    2. Email<EMAIL_ADDRESS>    3. Mail or deliver: Andrew Steckel (Air-4), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at www.regulations.gov,
including any personal information provided, unless the comment
includes Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Information that you
consider CBI or otherwise protected should be clearly identified as
such and should not be submitted through www.regulations.gov or email.
www.regulations.gov is an ``anonymous access'' system, and EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send email directly to EPA, your email
address will be automatically captured and included as part of the
public comment. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment. Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses.
    Docket: Generally, documents in the docket for this action are
available electronically at www.regulations.gov and in hard copy at EPA
Region IX, 75 Hawthorne Street, San Francisco, California 94105-3901.
While all documents in the docket are listed at www.regulations.gov,
some information may be publicly available only at the hard copy
location (e.g., copyrighted material, large maps), and some may not be
publicly available in either location (e.g., CBI). To inspect the hard
copy materials, please schedule an appointment during normal business
hours with the contact listed in the FOR FURTHER INFORMATION CONTACT
section.

FOR FURTHER INFORMATION CONTACT: Nicole Law, EPA Region IX, (415) 947-
4126<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us,''
and ``our'' refer to EPA.

Table of Contents

I. The State's Submittal
    A. What rule did the State submit?
    B. Are there other versions of this rule?
    C. What is the purpose of the submitted rule?
II. EPA's Evaluation and Action
    A. How is EPA evaluating the rule?
    B. Does the rule meet the evaluation criteria?
    C. EPA Recommendations to Further Improve the Rule
    D. Public Comment and Final Action
III. Statutory and Executive Order Reviews

I. The State's Submittal

A. What rule did the State submit?

    Table 1 lists the rule we are approving with the dates that it was
adopted by the local air agency and submitted by the California Air
Resources Board (CARB).

                                            Table 1--Submitted Rules
----------------------------------------------------------------------------------------------------------------
             Local agency                  Rule No.            Rule title             Adopted        Submitted
----------------------------------------------------------------------------------------------------------------
SDAPCD................................            67.0  Architectural Coatings..        12/12/01        03/07/08
----------------------------------------------------------------------------------------------------------------

    On April 17, 2008, EPA determined that the submittal for SDAPCD
Rule 67.0 met the completeness criteria in 40 CFR part 51 Appendix V,
which must be met before formal EPA review.

B. Are there other versions of this rule?

    We approved an earlier version of Rule 67.0 into the SIP on March
27, 1997 (62 FR 14639). The SDAPCD adopted revisions to the SIP-
approved version on December 12, 2001 and CARB submitted them to us on
March 7, 2008. While we can act on only the most recently submitted
version, we have reviewed materials provided with previous submittals.

C. What is the purpose of the submitted rule?

    VOCs help produce ground-level ozone and smog, which harm human
health and the environment. Section 110(a) of the CAA requires States
to submit regulations that control VOC emissions. SDAPCD Rule 67.0 adds
several new coating categories and lowers existing VOC limits. EPA's
technical support document (TSD) has more information about this rule.

II. EPA's Evaluation and Action

A. How is EPA evaluating the rule?

    Generally, SIP rules must be enforceable (see section 110(a) of the
Act), must require Reasonably Available Control Technology (RACT) for
each category of sources covered by a Control Techniques Guidelines
(CTG) document as well as each VOC major stationary source in ozone
nonattainment areas classified as moderate or above (see sections
182(b)(2)), and must not relax existing requirements (see sections
110(l) and 193). Because SDAPCD Rule 67.0 covers an area source and not
a stationary source and does not have a CTG, it does not need to
require RACT controls.
    Guidance and policy documents that we use to evaluate
enforceability and stringency requirements consistently include the
following:
    1. ``State Implementation Plans; General Preamble for the
Implementation of Title I of the Clean Air Act Amendments of 1990,'' 57
FR 13498 (April 16, 1992); 57 FR 18070 (April 28, 1992).

    2. ``Issues Relating to VOC Regulation Cutpoints, Deficiencies, and
Deviations,'' EPA, May 25, 1988 (the Bluebook).
    3. ``Guidance Document for Correcting Common VOC & Other Rule
Deficiencies,'' EPA Region 9, August 21, 2001 (the Little Bluebook).
    4. ``Suggested Control Measure for Architectural Coatings,'' CARB,
October 2007.

B. Does the rule meet the evaluation criteria?

    We believe this rule is consistent with the relevant policy and
guidance regarding enforceability, stringency, and SIP relaxations. The
TSD has more information on our evaluation.

C. EPA Recommendations to Further Improve the Rule

    The TSD describes additional rule revisions that we recommend for
the next time the local agency modifies the rule.

D. Public Comment and Final Action

    As authorized in section 110(k)(3) of the Act, EPA is fully
approving the submitted rule because we believe it fulfills all
relevant requirements. We do not think anyone will object to this
approval, so we are finalizing it without proposing it in advance.
However, in the Proposed Rules section of this Federal Register, we are
simultaneously proposing approval of the same submitted rule. If we
receive adverse comments by July 22, 2013, we will publish a timely
withdrawal in the Federal Register to notify the public that the direct
final approval will not take effect and we will address the comments in
a subsequent final action based on the proposal. If we do not receive
timely adverse comments, the direct final approval will be effective
without further notice on August 19, 2013. This will incorporate the
rule into the federally enforceable SIP.

III. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve State
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves State law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by State law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     does not provide EPA with the discretionary authority to
address disproportionate human health or environmental effects with
practical, appropriate, and legally permissible methods under Executive
Order 12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have tribal implications as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000), because the
SIP is not approved to apply in Indian country located in the State,
and EPA notes that it will not impose substantial direct costs on
tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by August 19, 2013. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. Parties with objections to this direct final
rule are encouraged to file a comment in response to the parallel
notice of proposed rulemaking for this action published in the Proposed
Rules section of today's Federal Register, rather than file an
immediate petition for judicial review of this direct final rule, so
that EPA can withdraw this direct final rule and address the comment in
the proposed rulemaking. This action may not be challenged later in
proceedings to enforce its requirements (see section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Reporting and
recordkeeping requirements, Volatile organic compounds.

    Dated: May 6, 2013.
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)(354)(i)(F)(3) to
read as follows:

Sec.  52.220  Identification of plan.

* * * * *
    (c) * * *
    (354) * * *
    (i) * * *
    (F) * * *

    (3) Rule 67.0, ``Architectural Coatings,'' adopted on December 12,
2001.
* * * * *

[FR Doc. 2013-14511 Filed 6-19-13; 8:45 am]
BILLING CODE 6560-50-P


1 6560 50 P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 51 [ OAR 2003 0079; FRL ]

RIN 2060

Implementation of the 8 Hour Ozone National Ambient Air Quality Standard B Phase 1: Reconsideration AGENCY: Environmental Protection Agency ( EPA).

ACTION: Proposed rule; notice of public hearing; reopening comment period.

SUMMARY: The EPA is requesting comment on the overwhelming transport classification for 8 hour ozone nonattainment areas as requested in a petition for reconsideration of EPA's final rule to implement the 8 hour ozone national ambient air quality standard ( NAAQS or standard). We are requesting comment on the draft overwhelming transport guidance and we are reopening the comment period on our proposed rule regarding how the Clean Air Act ( CAA) section 172 requirements would apply to an area that might receive an overwhelming transport classification.

DATES: Comments must be received on or before [ insert date 45 days from date of publication in the Federal Register]. 2 A public hearing will be held in Research Triangle Park,

North Carolina, on xxx________________, and will convene at 10: 00 a. m. and will end when those preregistered to provide testimony have done so and when others in attendance at that time have had an opportunity to do so. Because of the need to resolve the issues in this document in a timely manner, EPA will not grant requests for extensions of the public comment period. For additional information on the public hearing, see the ADDRESSEES section of this preamble.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA HQ OAR 2003 0079, by one of the following methods:

C www. regulations. gov: Follow the on line instructions for submitting comments.

C E mail: A and R Docket@ epa. gov. Attention Docket ID No. EPA HQ OAR 2003 0079.

C Fax: The fax number of the Air Docket is ( 202) 566

1741. Attention Docket ID No. EPA HQ OAR 2003 0079.

C Mail: EPA Docket Center, EPA West ( Air Docket),

Attention Docket ID No. EPA HQ OAR 2003 0079,

Environmental Protection Agency, Mail Code: 6102T,

1200 Pennsylvania Ave., NW, Washington, D. C. 3 C Hand Delivery: EPA Docket Center ( Air Docket),

Attention Docket ID No. EPA HQ OAR 2003 0079,

Environmental Protection Agency, 1301 Constitution Avenue, N. W., Room B102, Washington, D. C. Such deliveries are only accepted during the Docket= s normal hours of operation, and special arrangements should be made for deliveries of boxed information.

Instructions: Direct your comments to Docket ID No.

EPAHQ OAR 2003 0079. The EPA's policy is that all comments received will be included in the public docket without change and may be made available on line at www. regulations. gov, including any personal information provided, unless the comment includes information claimed to be confidential business information ( CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through www. regulations. gov, or e mail.

The Federal www. regulations. gov website is an Aanonymous access@ system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e mail comment directly to EPA without going through www. regulations. gov, your e mail 4 address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA= s public docket, visit the EPA Docket Center homepage at http:// www. epa. gov/ epahome/ dockets. htm.

Docket: All documents in the docket are listed in the www. regulations. govindex. Although listed in the index,

some information is not publicly available, i. e., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically in www. regulations. gov or in hard copy at 5 the EPA Docket Center ( Air Docket), EPA/ DC, EPA West, Room B102, 1301 Constitution Ave., N. W., Washington, D. C. The 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 Public Reading Room is ( 202) 566

1744 and the fax number is ( 202) 566 1749.

Public Hearing. A public hearing will be held on xxx __________________ from 10: 00 a. m. and end when those preregistered to provide testimony have done so and when others in attendance at that time have had an opportunity to do so. The public hearing will be held at the Environmental Protection Agency, Building C, xxx ____________ 109 T. W. Alexander Drive, Research Triangle Park, North Carolina 27709. Persons wishing to speak at the public hearing need to contact: Ms. Denise Gerth, at telephone number ( 919) 541 5550 or by e mail at gerth. denise@ epa. gov. Oral testimony may be limited to 3 to 5 minutes depending on the number of people who sign up to speak. Commenters may also supplement their oral testimony with written comments. The hearing will be limited to the subject matter of this document. The public hearing schedule, including the list of speakers, will be 6 posted on EPA's website at:

http:// www. epa. gov/ ttn/ naaqs/ ozone/ o3imp8hr. A verbatim transcript of the hearing and written statements will be made available for copying during normal working hours at the EPA Docket Center ( Air Docket) at the address listed above for inspection of documents.

FOR FURTHER INFORMATION CONTACT: For general information:

Mr. John Silvasi, Office of Air Quality Planning and Standards, U. S. Environmental Protection Agency, Mail Code C539 02, Research Triangle Park, NC 27711, phone number ( 919) 54l 5666, fax number ( 919) 54l 0824 or by e mail at silvasi. john@ epa. gov or Ms. Denise Gerth, Office of Air Quality Planning and Standards, U. S. Environmental Protection Agency, Mail Code C539 02, Research Triangle Park, NC 27711, phone number ( 919) 54l 5550, fax number ( 919) 54l 0824 or by e mail at gerth. denise@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. GENERAL INFORMATION 1. Tips for Preparing Your Comments. When submitting comments, remember to: 7 a. Identify the rulemaking by docket number and other identifying information ( subject heading, Federal Register date and page number).

b. Follow directions  The agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations ( CFR) part or section number.

c. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

d. Describe any assumptions and provide any technical information and/ or data that you used.

e. If you estimate potential costs or burdens,

explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

f. Provide specific examples to illustrate your concerns, and suggest alternatives.

g. Explain your views as clearly as possible,

avoiding the use of profanity or personal threats.

h. Make sure to submit your comments by the comment period deadline identified.

Outline 8 Supplementary Information I. General Information II. Background III. Today's Action A. Invitation for Comment on Draft Guidance on Criteria for Assessing Whether an Ozone Nonattainment Area is Affected by Overwhelming Transport 1. Criteria for Determining Overwhelming Transport B. Proposed Requirements that Apply to Subpart 1 Ozone Areas that Receive the Overwhelming Transport Classification 1. General Background 2. Requirements for RACT/ RACM 3. Attainment Demonstration 4. Reasonable Further Progress 5. Contingency Measures IV. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review B. Paperwork Reduction Act C. Regulatory Flexibility Act D. Unfunded Mandates Reform Act E. Executive Order 13132: Federalism F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments G. Executive Order 13045: Protection of Children From Environmental Health and Safety Risks H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution or Use I. National Technology Transfer Advancement Act 9 J. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations II. BACKGROUND In the Final Rule to Implement the 8 Hour Ozone National Ambient Air Quality Standard ( NAAQS or standard) B Phase 1 Rule B ( April 30, 2004; 69 FR 23951), we established an Aoverwhelming transport area@ ( OTA) classification for certain areas that were not subject to classification under subpart 2 of part D of the CAA and were thus subject only to subpart 1 ( subpart 1 ozone areas). We established three criteria that subpart 1 ozone areas must meet to receive the overwhelming transport classification:

C The area meets the criteria as specified for rural transport areas under section 182( h) of the CAA;

C Transport of ozone and/ or precursors into the area is so overwhelming that the contribution of local emissions to observed 8 hour ozone concentration above the level of the NAAQS is relatively minor; and C The Administrator finds that sources of volatile organic compounds ( VOC) and, where the Administrator determines relevant, nitrogen oxides ( NOx) emissions 10 within the area do not make a significant contribution to the ozone concentrations measured in other areas.

In the preamble of the Phase 1 Rule, we explained that an area will be classified as an OTA upon full approval of an analysis that demonstrates that the nonattainment problem in the area is due to " overwhelming transport." We indicated that we would issue guidance more fully explaining how to assess whether an area was affected by overwhelming transport. We indicated that the existing guidance on overwhelming transport needed to be updated and that we were retracting that guidance.

On June 29, 2004, Earthjustice filed a Petition for Reconsideration ( Petition) on behalf of several environmental organizations, seeking reconsideration of certain specified aspects of the Phase 1 Rule. We responded to the Petition in letters dated September 23,

2004 and January 10, 2005 granting some aspects of their Petition and denying others. In the January 10, 2005 letter, we granted reconsideration of the overwhelming transport classification because the overwhelming transport guidance was not publicly available during the comment period on the Phase 1 Rule. We also stated that we would 11 request public comments on our draft revision of the overwhelming transport guidance and simultaneously reopen the comment period on the 8 hour ozone implementation provisions that would apply to such areas.

Today, we are providing additional information and soliciting comment on issues related to the overwhelming transport classification. We are soliciting comment on the following three issues, which are described in more detail in section III of the Supplementary Information section of this preamble: ( 1) overwhelming transport classification;

( 2) the overwhelming transport guidance, which provides more detail on the analyses that can be used to show whether an area meets the second and third eligibility criteria; and ( 3) the control requirements that apply under subpart 1 to an area that receives the OTA classification.

III. TODAY= S ACTION A. Invitation for Comment on Draft Guidance on Criteria for Assessing Whether an Ozone Nonattainment Area is Affected by Overwhelming Transport 12 1. Criteria for Determining Overwhelming Transport a. Background. The Phase 1 Rule established ' 51.904( a), in which we created an overwhelming transport classification that would be available to subpart 1 ozone areas that demonstrate: ( 1) they meet the definition of a rural transport area in section 182( h); ( 2) they are significantly affected by overwhelming transport from one or more upwind areas; and ( 3) their emissions do not significantly affect a downwind area.

Qualifying areas under the current rule are those that meet that part of the definition of a rural transport area in section 182( h) that requires that an area not be in or adjacent to a C/ MSA. 2 We are aware of only seven subpart 1 ozone areas that could potentially qualify under the portion of ' 51.904( a)( 1) which requires that the area not be in or adjacent to a C/ MSA:

1. Hancock, Knox, Lincoln and Waldo Counties, Maine,

2. Essex County, New York ( Whiteface Mountain),

3. Murray County, Georgia ( Chattahoochee National Forest),

2CSMA means either Consolidated Metropolitan Statistical Area or Metropolitan Statistical Area as defined by the Office of Management and Budget ( OMB) in 1999 ( June 30, 1999; 64 FR 35548). 13 4. Benzie County, Michigan,

5. Door County, Wisconsin,

6. Huron County, Michigan, and 7. Mason County, Michigan.

The EPA= s June 2, 2003 proposal referenced an EPA guidance document that States should use when developing their demonstration that contribution of sources in one or more other areas are an overwhelming cause of air quality violations in the area relating to the overwhelming transport classification. However, at the time we issued the final Phase 1 Rule, we noted that the guidance needed to be updated. Thus, we retracted our guidance and indicated in the Phase 2 Rule ( November 29, 2005; 70 FR 71612) that we would issue revised guidance. In addition,

in the Phase 2 Rule, we stated that we planned to take final action on the control requirements applicable to these areas. As noted above, the Petition stated that the provision for an overwhelming transport classification in the Phase 1 Rule relies on guidance that was not publicly available during the comment period and that the guidance was still unavailable at the time the Petition was submitted. 14 b. Request for Comment. On January 10, 2005, we granted the Petition on this issue and are now soliciting comment on the overwhelming transport classification as well as the draft guidance document, ACriteria For Assessing Whether an Ozone Nonattainment Area is Affected by Overwhelming Transport,@ which is found at the following internet website: www. epa. gov/ ttn/ scram/. This draft guidance outlines EPA's recommended approach for demonstrating that an area should receive the OTA classification.

As described in the draft guidance, the Phase 1 Rule established three criteria an area must meet for the area to be classified as an OTA [' 51.904( a)]. Two of these criteria are the focus of the overwhelming transport guidance. The two criteria concern: ( 1) whether an area is being affected by overwhelming transport; and ( 2)

whether the area is significantly contributing to another nonattainment area. Analyses for both of these criteria will involve assembling emissions, air quality,

meteorological, and/ or photochemical grid modeling data;

and making an informed decision regarding contribution based on the results of the composite set of analyses.

This aggregation of data is generally referred to as Aweight 15 of evidence@ and is discussed in detail in EPA modeling guidance on 8 hour ozone attainment demonstrations. 3 The end product of this weight of evidence determination is a document which describes analyses performed, data bases used, key assumptions and outcomes of each analysis, and why a State believes that the evidence, viewed as a whole,

supports a conclusion that the area is overwhelmingly affected by transport and does not significantly contribute to downwind problems.

It is expected that an area petitioning for an OTA classification would complete a full analysis consisting of evidence from multiple forms of weight of evidence analyses as described within this guidance. For an area to be classified as an OTA, the large majority of the tests identified in the " Criteria for Assessing Whether an Ozone Nonattainment Area is Affected by Overwhelming Transport"

would have to meet the criteria of ' 51.904( a)( 2) and ( 3).

3Guidance on the Use of Models and Other Analyses in Attainment Demonstrations for the 8 Hour Ozone NAAQS ( EPA 454 05 002, October 2005) www. epa. gov/ scram001/ guidance/ guide/ 8 hour o3 guidancefinal version[ 1] pdf. 16 B. Proposed Requirements that Apply to Subpart 1 Ozone Areas that Receive the Overwhelming Transport Classification 1. General Background Subpart 1 ozone areas are subject to the requirements of section 172( c) of the CAA. The plan provisions required to be submitted under section 172( c) include reasonably available control technology ( RACT) and reasonably available control measure ( RACM) plans, attainment demonstrations, reasonable further progress ( RFP) plans,

emission inventories, new source review ( NSR) plans, and contingency measures. In the June 2, 2003 proposal ( 68 FR 32814), we proposed that a subpart 1 ozone area classified as an OTA would be treated similar to an area classified as marginal under subpart 2 for purposes of emission control requirements. We are reopening the comment period on a number of these proposed requirements, as described below,

and we are also providing additional detail regarding these requirements. 17 We are not proposing that areas classified as overwhelming transport be treated differently than other subpart 1 areas for purposes of NSR, conformity and emissions inventory requirements. Thus, this proposal does not address these requirements.

2. Requirements for RACT/ RACM a. Background. Section 172( c)( 1) of the CAA requires implementation of all RACT/ RACM as expeditiously as practicable. For subpart 1 ozone areas, we proposed on June 2, 2003 an option interpreting RACT for ozone nonattainment areas for the 8 hour NAAQS similar to the Agency= s interpretation for pollutants other than ozone ( 68 FR 32838). Under this option, the State would be considered to meet the RACT/ RACM requirements by submitting an attainment demonstration State implementation plan ( SIP)

demonstrating that the area will attain as expeditiously as practicable.

b. Request for Comment. We are reopening the comment period, with respect to OTAs only, on the proposed approach described above for the RACT/ RACM requirements. Section 172( c)( 1) establishes the requirements for subpart 1 and RACT is included as a subset of RACM. Our long standing 18 interpretation of the RACM provision is that areas need only submit such RACM as will contribute to timely attainment and meet RFP, and that measures which might be available but would not advance attainment or contribute to RFP need not be considered RACM. This interpretation has been upheld in several recent court cases. See Sierra Club v. EPA, 294 F. 39 155, 162 ( D. C. Cir., 2002) ( concerning the Metropolitan Washington, D. C., attainment demonstration)

and Sierra Club v. EPA, No. 01 60537 ( 5th Cir., 2002)

( concerning the Beaumont attainment demonstration). Since subpart 1 RACT is a subset of RACM, these cases also support a conclusion that, where we are dealing only with section 172 RACT, it is reasonable to require only such RACT as will meet RFP and advance attainment. Consistent with our interpretation of RACM, EPA believes RACT would be met by control measures in a SIP demonstrating attainment of the standard as expeditiously as practicable and meeting RFP. Additionally, this approach has the benefit of providing States with flexibility to determine which control strategies are the most effective in reaching attainment as expeditiously as practicable. Specifically,

we propose a State would be considered to meet the 19 RACT/ RACM requirements for an OTA by submitting an attainment demonstration SIP demonstrating that the area will attain as expeditiously as practicable.

3. Attainment Demonstration a. Background. Section 172( c)( 1) of the CAA requires subpart 1 ozone areas to submit plan provisions that provide for attainment of the NAAQS. General requirements for an attainment demonstration are contained in 40 CFR ' 51.112. The June 2, 2003 proposal did not elaborate on the attainment demonstration for OTAs.

b. Request for Comment. The proposal noted that regional scale modeling for national rules, such as the NOx SIP Call and Tier II motor vehicle tailpipe standards, projects major ozone benefits for the 3 year period of 2004 2006.

In addition, subsequent modeling used to support the Clean Air Interstate Rule ( CAIR) indicates that regional control measures will be sufficient to bring many areas into attainment no later than 2010. As described in section VI. B. 1, of the Air Quality Modeling Technical Support Document for the final CAIR, we project that all of the potential OTAs would be attainment for 8 hour ozone under the assumptions in the 2010 base case. Thus, we anticipate 20 all OTAs will be in attainment by 2010 without adopting additional local controls.

We believe that an OTA should not be required to perform the detailed photochemical grid modeling needed to develop an attainment demonstration where there is existing modeling that shows that the area will attain in the short term. It would not be reasonable to require these areas to expend the amount of resources needed to perform a complex modeling analysis. Since attainment in the OTA is dependent on control measures chosen and adopted by the upwind nonattainment areas, an attainment demonstration specific to an OTA would be redundant. We anticipate that OTAs will be included in State, regional or national modeling analyses conducted by other, upwind nonattainment areas or by EPA. Where such modeling exists, it could be used to demonstrate attainment of an OTA. The demonstration must include modeling results and analyses that the State is relying on to support its claim. Such modeling should be consistent with EPA guidance and should be applicable and appropriate for the area. 5 Because it is 5If an assessment indicates that a regional modeling analysis is not applicable to a particular nonattainment area, additional local modeling would be required. 21 impossible for an OTA to demonstrate attainment on its own due to their nature, the attainment demonstration for the area must rely, to a significant extent, on control of sources outside the OTA. Consequently, as noted in the Phase 2 ozone implementation rule, we intend to determine on a case by case basis whether the area submitting an attainment demonstration that is upwind of an OTA needs to commit to submit a mid course review ( MCR). Such a MCR would serve the purpose of determining whether the OTA area is on track to attain the 8 hour standard by its attainment date as well as whether the upwind area is on track.

Therefore, we propose that no additional modeled attainment demonstration would be required for OTAs where ( 1) upwind areas complete attainment demonstrations with modeling domains including the OTA or ( 2) regional or national modeling exists that is appropriate for use in the area. In either case, the submitted attainment demonstration must demonstrate the area will attain the 8

hour standard as expeditiously as practicable. If acceptable available modeling does not demonstrate attainment, the area would need to submit a local modeled attainment demonstration. 22 In the Phase 1 Rule, we provided that we would approve an attainment date consistent with the attainment date timing provision of section 172( a)( 2)( A) at the time we approve an attainment demonstration for the area [' 51.904( b)]. We believe the section 172( a)( 2)( A)

provisions that allow an area to have an attainment date up to 10 years following designation ( based on the severity of the nonattainment and the availability and feasibility of controls) would allow consideration for OTAs of the attainment dates of upwind nonattainment areas that contribute to the downwind area= s problem, and the implementation schedules for controls in upwind areas that contribute.

4. Reasonable Further Progress a. Background. Section 172( c)( 2) of the CAA requires subpart 1 ozone areas to submit plan provisions which require RFP. The June 2, 2003 proposal did not discuss the requirement for RFP specifically for OTAs. However, we did propose that, generally, OTAs would be treated similar to areas classified as marginal under subpart 2 for purposes 23 of emission control requirements. 5 We also proposed several options for RFP for subpart 1 ozone areas in general. One of the options provided that an area with an attainment date within 3 to 6 years after designation could meet the RFP requirement with a SIP that provided for all emission reductions needed for attainment be implemented by the beginning of the ozone season immediately preceding the area's attainment date. In the final phase 2 rule for implementation of the 8 hour ozone standard, however, we adopted a somewhat different approach. Instead of an option for areas with attainment dates within 3 to 6 years after designation, the rule addresses areas with attainment dates 5 years or less after designation ( i. e., on or before June 15, 2009 for areas designated June 15, 2004). The final phase 2 rule provides that RFP for these areas would be met by ensuring emissions reductions needed for attainment are implemented as noted above by the beginning of the ozone season prior to the attainment date.

5 Areas classified marginal under subpart 2 are not subject to RFP requirements. 24 b. Request for comment. Similar to what we proposed for subpart 1 areas with attainment dates between 3 and 6 years after designation, and similar to the approach followed in the final phase 2 implementation rule for subpart 1 areas with attainment dates within 5 years after designation, we propose that an OTA with an approved attainment demonstration would be considered to have met the RFP obligation with the measures that will bring the area into attainment by the area's attainment date. That is, RFP is met by demonstrating the area could attain the standard as expeditiously as practicable. However, an OTA's attainment date will depend on when controls in upwind areas will be implemented. Thus, an OTA may have an attainment date that is later than 6 years after designation. Because an OTA will have little control over the emission reductions needed for attainment, we are proposing that regardless of the OTA's attainment date, RFP will be met so long as the area demonstrates attainment as expeditiously as practicable. We request additional comment on this position.

5. Contingency Measures 25 a. Background. Under the CAA, subpart 1 ozone areas must include in their SIPs contingency measures consistent with section 172( c)( 9). The general requirements for nonattainment plans under section 172( c)( 9) specify that each plan must contain additional measures that will take effect without further action by the State or EPA if an area either fails to meet a RFP milestone or to attain the 8 hour ozone standard by the applicable date. Contingency measures must accompany the attainment demonstration SIP.

All subpart 1 ozone areas and subpart 2 areas other than marginal areas need contingency measures. The June 2, 2003 proposal did not discuss the requirement for contingency measures specifically for OTAs. However, we did propose that for areas covered under subpart 1, we would provide additional guidance on the contingency measure requirement,

but that it is likely that it would be patterned after the subpart 2 requirement. Although OTAs by their very nature do not contribute significantly to their own problem but must rely on controls from upwind areas, such areas are still subject to the contingency measure requirements.

b. Request for Comment. By definition [' 51.904( a)( 2)], the contribution of local emissions to observed ozone 26 concentrations in the OTA is relatively minor. Thus, the effect of local control measures, including contingency measures, would also be minor. The EPA believes more effective contingency measures will be contained in the upwind areas= SIPs. Because upwind areas contribute overwhelmingly to nonattainment in the downwind OTA, we believe that OTAs may rely on contingency measures adopted by the upwind contributing areas.

IV. STATUTORY AND EXECUTIVE ORDER REVIEWS A. Executive Order 12866: Regulatory Planning and Review Under Executive Order 12866 ( 58 FR 51735, October 4,

1993), the Agency must determine whether the regulatory action is Asignificant@ and, therefore, subject to OMB review and the requirements of the Executive Order. The Order defines Asignificant regulatory action@ as one that is likely to result in a rule that may:

( 1) have an annual effect on the economy of $ 100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity,

competition, jobs, the environment, public health or safety, or State, local, or Tribal governments or communities; 27 ( 2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;

( 3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or ( 4) raise novel legal or policy issues arising out of legal mandates, the President= s priorities, or the principles set forth in the Executive Order.

Pursuant to the terms of Executive Order 12866, it has been determined that this proposed rule is a Asignificant regulatory action@ because it raises novel legal or policy issues arising out of legal mandates. As such this action will be submitted to OMB for review.

B. Paperwork Reduction Act The information collection requirements in this rule will be addressed along with those covering the Phase 1 Rule ( April 30, 2004; 69 FR 23951) and the Phase 2 Rule ( November 29, 2005; 70 FR 71612) which will be submitted for approval to OMB under the Paperwork Reduction Act, 44 U. S. C. 3501 et seq. The information collection 28 requirements are not enforceable until OMB approves them other than to the extent required by statute.

This rule provides an optional framework for the States to develop SIPs for certain areas ( viz., those affected by overwhelming transport of ozone and its precursors) to achieve a new or revised NAAQS. This framework reflects the requirements prescribed in CAA sections 110 and part D, subpart 1 of title I. In that sense, the present final rule does not establish any new information collection burden on States. Had this rule not been developed, States would still have the legal obligation under law to submit nonattainment area SIPs under part D of title I of the CAA within specified periods after their nonattainment designation for the 8 hour ozone standard, and the SIPs would have to meet the requirements of part D; however, without this rule, a few States would have less flexibility in planning for the areas noted above.

This rule does not establish requirements that directly affect the general public and the public and private sectors, but, rather, interprets the statutory requirements that apply to States in preparing their SIPs. 29 The SIPs themselves will likely establish requirements that directly affect the general public, and the public and private sectors.

The EPA has not yet projected cost and hour burden for the statutory SIP development obligation but has started that effort and will shortly prepare an Information Collection Request ( ICR) request. However, EPA did estimate administrative costs at the time of promulgation of the 8 hour ozone standard in 1997. See Chapter 10 of U. S. EPA 1997, Regulatory Impact Analyses for the Particulate Matter and Ozone National Ambient Air Quality Standards, Innovative Strategies and Economics Group,

Office of Air Quality Planning and Standards, Research Triangle Park, N. C., July 16, 1997. Assessments of some of the administrative cost categories identified as a part of the SIP for an 8 hour standard are already conducted as a result of other provisions of the CAA and associated ICRs ( e. g. emission inventory preparation, air quality monitoring program, conformity assessments, NSR, I/ M program).

The burden estimates in the ICR for this rule are incremental to what is required under other provisions of 30 the CAA and what would be required under a 1 hour standard.

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 in 40 CFR are listed in 40 CFR part 9. When this ICR is approved by OMB,

the Agency will publish a technical amendment to 40 CFR part 9 in the Federal Register to display the OMB control 31 number for the approved information collection requirements contained in this final rule. However, the failure to have an approved ICR for this rule does not affect the statutory obligation for the States to submit SIPs as required under part D of the CAA.

C. Regulatory Flexibility Act The Regulatory Flexibility Act generally requires an Agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedures Act or any other statute unless the Agency certifies the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses,

small organizations, and small governmental jurisdictions.

For purposes of assessing the impacts of today= s proposed rule on small entities, small entity is defined as: ( 1) a small business that is a small industrial entity as defined in the U. S. Small Business Administration ( SBA)

size standards ( See 13 CFR 12.201); ( 2) a governmental jurisdiction that is a government of a city, county, town,

school district or special district with a population of less than 50,000; and ( 3) a small organization that is any 32 not for profit enterprise which is independently owned and operated and is not dominant in its field.

In promulgating the Phase 1 and Phase 2 Rules, we concluded that those actions did not have a significant economic impact on a substantial number of small entities.

For those same reasons, I certify that this action will not have a significant economic impact on a substantial number of small entities. This proposed rule will not impose any requirements on small entities. We continue to be interested in the potential impacts of our proposed rules on small entities and welcome comments on issues related to such impacts.

D. Unfunded Mandates Reform Act Title II of the Unfunded Mandates Reform Act of 1995 ( UMRA), Public Law 104 4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and Tribal governments and the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement, including a cost benefit analysis, for proposed and final rules with AFederal mandates@ that may result in expenditures to State,

local, and Tribal governments, in the aggregate, or to the 33 private sector, of $ 100 million or more in any 1 year.

Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost effective or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most costeffective or least burdensome alternative if the Administrator publishes with the final rule an explanation why that alternative was not adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments,

including Tribal governments, it must have developed under section 203 of the UMRA a small government agency plan.

The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, 34 educating, and advising small governments on compliance with the regulatory requirements.

The EPA has determined that this proposed rule does not contain a Federal mandate that may result in expenditures of $ 100 million or more for State, local, and Tribal governments, in the aggregate, or the private sector in any 1 year. In promulgating the Phase 1 and Phase 2 Rules, we concluded that it was not subject to the requirements of sections 202 and 205 of the UMRA. For those same reasons, our reconsideration and reopening of the comment period on the proposed rule is not subject to the UMRA.

The EPA has determined that this proposed rule contains no regulatory requirements that may significantly or uniquely affect small governments, including Tribal governments.

E. Executive Order 13132: Federalism Executive Order 13132, entitled AFederalism@ ( 64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure Ameaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.@ 35 APolicies that have federalism implications@ is defined in the Executive Order to include regulations that have Asubstantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.@

This proposed rule does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. This proposed reconsideration requests comment on a broader applicability of the overwhelming transport classification and reopens the public comment period on the proposed rule on how the CAA section 172 requirements would apply. For the same reasons stated in the Phase 1 and Phase 2 Rules,

Executive Order 13132 does not apply to this proposed rule.

In the spirit of Executive Order 13132, and consistent with EPA policy to promote communications between EPA and State and local governments, EPA specifically solicits 36 comment on this proposed rule from State and local officials.

F. Executive Order 13175: Consultation and Coordination with Indian Tribal Governments Executive Order 13175, entitled AConsultation and Coordination with Indian Tribal Governments@ ( 65 FR 67249,

November 9, 2000), requires EPA to develop an accountable process to ensure Ameaningful and timely input by Tribal officials in the development of regulatory policies that have Tribal implications.@ This proposed rule does not have ATribal implications@ as specified in Executive Order 13175.

The purpose of this proposed rule is to reopen the comment period on the proposed rule on how the CAA section 172 requirements would apply to such areas. These issues concern the implementation of the 8 hour ozone standard in areas designated nonattainment for that standard. The CAA provides for States and Tribes to develop plans to regulate emissions of air pollutants within their jurisdictions.

The Tribal Authority Rule ( TAR) gives Tribes the opportunity to develop and implement CAA programs such as the 8 hour ozone NAAQS, but it leaves to the discretion of the Tribes whether to develop these programs and which 37 programs, or appropriate elements of a program, they will adopt.

For the same reasons stated in the Phase 1 and Phase 2 Rules, this proposed rule does not have Tribal implications as defined by Executive Order 13175. It does not have a substantial direct effect on one or more Indian Tribes,

since no Tribe has implemented a CAA program to attain the 8 hour ozone NAAQS at this time. Furthermore, this proposed rule does not affect the relationship or distribution of power and responsibilities between the Federal government and Indian Tribes. The CAA and the TAR establish the relationship of the Federal government and Tribes in developing plans to attain the NAAQS, and this proposed rule does nothing to modify that relationship.

Because this proposed rule does not have Tribal implications, Executive Order 13175 does not apply.

While the proposed rule would have Tribal implications upon a Tribe that is implementing such a plan, it would not impose substantial direct costs upon it nor would it preempt Tribal law.

Although Executive Order 13175 does not apply to this proposed rule, EPA contacted Tribal environmental 38 professionals about the development of this proposed rule on the " Tribal Designations and Implementation Work Group"

conference call; a subsequent meeting summary was sent to over 50 Tribes.

G. Executive Order 13045: Protection of Children from Environmental Health and Safety Risks Executive Order 13045: AProtection of Children From Environmental Health and Safety Risks@ ( 62 FR 19885, April 23, 1997) applies to any rule that ( 1) is determined to be Aeconomically significant@ as defined under Executive Order 12866, and ( 2) concerns an environmental health or safety risk that EPA has reason to believe may have disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency.

This proposed rule addresses one aspect of the Phase 1 Rule that the Agency was requested to reconsider and reopens the comment period on the proposed rule on how the CAA section 172 requirements would apply to such areas. 39 The proposed rule is not subject to Executive Order 13045 because the Agency does not have reason to believe the environmental health risks or safety risks addressed by this action present a disproportionate risk to children.

Nonetheless, we have evaluated the environmental health or safety effects of the 8 hour ozone NAAQS on children. The results of this evaluation are contained in 40 CFR part 50,

National Ambient Air Quality Standards for Ozone, Final Rule ( July 18, 1997; 62 FR 38855 38896, specifically, 62 FR 38860 and 62 FR 38865).

H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use This proposed rule is not a Asignificant energy action@

as defined in Executive Order 13211, AActions That Significantly Affect Energy Supply, Distribution, or Use,@

( 66 FR 28355, May 22, 2001) because it is not likely to have a significant adverse effect on the supply,

distribution, or use of energy. This proposed rule affects only a small number of relatively rural areas by its very nature. Recent EPA modeling projects that all of these areas will attain the 8 hour ozone by 2010 without any 40 additional local emission controls. 7 It does not require States or sources to take any particular actions, but merely provides an alternate mechanism for States to plan for attainment of such areas.

I. National Technology Transfer Advancement Act Section 12( d) of the National Technology Transfer Advancement Act of 1995 ( NTTAA), Public Law No. 104 113,

section 12( d) ( 15 U. S. C. 272 note) directs EPA to use voluntary consensus standards ( VCS) in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e. g.,

materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by VCS bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable VCS.

7Technical Support Document for the Final Clean Air Interstate Rule Air Quality Modeling, U. S. Environmental Protection Agency; Office of Air Quality Planning and Standards, Research Triangle Park, NC 27711. March 2005. Appendix E. Average Ambient and Projected 2010 and 2015 Base and CAIR Control 8 hour Ozone Concentrations. Available at: http:// www. epa. gov/ cair/ pdfs/ finaltech02. pdf. 41 This proposed rulemaking does not involve technical standards. Therefore, EPA is not considering the use of any VCS.

The EPA will encourage the States and Tribes to consider the use of such standards, where appropriate, in the development of the implementation plans.

J. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority Populations and Low

Income Populations Executive Order 12898 requires that each Federal agency make achieving environmental justice part of its mission by identifying and addressing, as appropriate,

disproportionate high and adverse human health or environmental effects of its programs, policies, and activities on minorities and low income populations.

The EPA concluded that the Phase 1 and Phase 2 Rules should not raise any environmental justice issues; for the same reasons, this proposal should not raise any environmental justice issues. The health and environmental risks associated with ozone were considered in the establishment of the 8 hour, 0.08 ppm ozone NAAQS. The level is designed to be protective with an adequate margin 42 of safety. The proposed rule provides a framework for improving environmental quality and reducing health risks for areas that may be designated nonattainment.

List of Subjects 40 CFR Part 51 Environmental protection, Air pollution control,

Carbon monoxide, Lead, Nitrogen dioxide, Ozone, Particulate matter, Sulfur oxides.

_______________________________

Dated:

________________________________

William L. Wehrum, Acting Assistant Administrator for Air and Radiation 43 For the reasons stated in the preamble, Title 40,

Chapter I of the Code of Federal Regulations, is proposed to be amended as follows:

PART 51 B AMENDED 1. The authority citation for part 51 continues to read as follows:

Authority: 23 U. S. C. 101; 42 U. S. C. 7401 7671q Subpart X B Provisions for Implementation of the 8 Hour Ozone National Ambient Air Quality Standard 2. ' 51.917 is proposed to be added as follows:

' 51.917 What requirements apply to overwhelming transport areas for modeling and attainment demonstration, reasonable further progress, and reasonably available control technology?

( a) Attainment demonstration.

( 1) An area classified as an overwhelming transport area under ' 51.904 must submit an attainment demonstration meeting the requirements of ' 51.112, which may be based on:

( i) photochemical grid modeling conducted for the OTA;

( ii) attainment demonstrations completed by areas upwind of the OTA, where the modeling domains include the OTA; or 44 ( iii) regional or national modeling that demonstrates the area will attain the 8 hour standard.

( 2) A mid course review ( MCR) is not required for an area classified as an overwhelming transport area under ' 51.904.

( b) Reasonable further progress ( RFP). An area classified as an overwhelming transport area under ' 51.904 with an approved attainment demonstration is considered to have met the RFP obligation under section 172( c)( 2) of the CAA with the measures that will bring the area into attainment by the attainment date.

( c) Reasonably available control technology ( RACT) and reasonably available control measures ( RACM). For an area classified as an overwhelming transport area under ' 51.904,

the State shall meet the RACT and RACM requirements of section 172( c)( 1) by submitting an attainment demonstration SIP showing that the area will attain as expeditiously as practicable, taking into consideration emissions reductions in upwind nonattainment areas that contribute to the overwhelming transport area's air quality.

( d) Contingency measures. Contingency measures must accompany the attainment demonstration SIP. All subpart 1 45 ozone areas and subpart 2 areas other than marginal areas need contingency measures.

* * * * *


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY                 NATIONAL VEHICLE AND FUEL EMISSIONS LABORATORY                              2000 TRAVERWOOD ROAD                            ANN ARBOR, MI  48105-2498

									          	OFFICE OF 										AIR AND RADIATION

July 21, 2011

MEMORANDUM

SUBJECT:	Meeting with Environment Canada

FROM:	Angela Cullen, Mechanical Engineer

TO:		Docket EPA-HQ-OAR-2010-0162

This memorandum documents a meeting held on March 24, 2011 between Environment Canada and EPA and included the following individuals:

      Environment Canada: Stephan Couroux and Luis Phillipe              EPA: Byron Bunker and Angela Cullen

The discussion focused primarily on aerodynamic testing of heavy duty programs at Natural Resources Canada and Transport Canada.


[Federal Register Volume 80, Number 161 (Thursday, August 20, 2015)]
[Notices]
[Page 50622]
[FR Doc No: 2015-20463]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Commission Staff Attendance

    The Federal Energy Regulatory Commission hereby gives notice that
members of the Commission's staff will attend the following meeting
related to the Midcontinent Independent System Operator, Inc. (MISO)--
PJM Interconnection, L.L.C. (PJM) Joint and Common Market Initiative
(Docket No. AD14-3-000): MISO/PJM Joint Stakeholder Meeting--August 20,
2015.
    The above-referenced meeting will be held at: PJM Conference &
Training Center, 2750 Monroe Boulevard, Audubon, PA 19403.
    The above-referenced meeting is open to the public.
    Further information may be found at www.pjm.com.
    The discussions at the meeting described above may address matters
at issue in the following proceedings:

Docket No. EL13-88, Northern Indiana Public Service Company v.
Midcontinent Independent System Operator, Inc. and PJM Interconnection,
L.L.C.
Docket No. EL11-34, Midcontinent Independent System Operator, Inc.
Docket No. EL14-21, Southwest Power Pool, Inc. v. Midcontinent
Independent System Operator, Inc.
Docket No. EL14-30, Midcontinent Independent System Operator, Inc. v.
Southwest Power Pool, Inc.
Docket No. ER11-1844, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER13-1864, Southwest Power Pool, Inc.
Docket No. ER10-1791, Midwest Independent Transmission System Operator,
Inc.
Docket Nos. ER13-1923, ER13-1938, ER13-1943, ER13-1945, Midcontinent
Independent System Operator, Inc.
Docket Nos. ER13-1924, ER13-1926, ER13-1927, ER13-1936, ER13-1944,
ER13-1947, PJM Interconnection, L.L.C.
Docket Nos. ER13-1937, ER13-1939, Southwest Power Pool, Inc.
Docket No. ER14-1174, Southwest Power Pool, Inc.
Docket No. ER14-1736, Midcontinent Independent System Operator, Inc.
Docket No. ER14-2022, Midcontinent Independent System Operator, Inc.
Docket No. ER14-2445, Midcontinent Independent System Operator, Inc.
Docket No. ER15-1874, PJM Interconnection, L.L.C.
Docket No. ER15-1890, Midcontinent Independent System Operator, Inc.

    For more information, contact Valerie Teeter, Office of Energy
Policy and Innovation, Federal Energy Regulatory Commission at (202)
502-8538 or<EMAIL_ADDRESS>
    Dated: August 13, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-20463 Filed 8-19-15; 8:45 am]
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