[Federal Register Volume 79, Number 69 (Thursday, April 10, 2014)]
[Rules and Regulations]
[Pages 19820-19830]
[FR Doc No: 2014-08048]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R10-OAR-2012-0942; FRL-9908-23-Region 10]

Approval and Promulgation of Implementation Plans; State of
Alaska; Revised Format of 40 CFR Part 52 for Materials Incorporated by
Reference

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule; administrative change.

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SUMMARY: The Environmental Protection Agency (EPA) is revising the
format for materials submitted by the State of Alaska that are
incorporated by reference (IBR) into the Alaska State Implementation
Plan (SIP). The regulations affected by this format change have all
been previously submitted by Alaska and approved by the EPA. This
format revision will primarily affect the ``Identification of plan''
section, as well as the format of the SIP materials that will be
available for public inspection at the National Archives and Records
Administration (NARA), the Air and Radiation Docket and Information
Center located at the EPA Headquarters in Washington, DC, and the EPA
Regional Office. The EPA is also adding a table in the ``Identification
of plan'' section which summarizes the approval actions that the EPA
has taken on the non-regulatory and quasi-regulatory portions of the
Alaska SIP.

DATES: This action is effective April 10, 2014.

ADDRESSES: SIP materials which are incorporated by reference into 40
CFR part 52 are available for inspection at the following locations:
     US Environmental Protection Agency, Region 10, Office of
Air, Waste, and Toxics (OAWT-107), 1200 Sixth Avenue, Seattle,
Washington 98101;
     Air and Radiation Docket and Information Center, EPA
Headquarters Library, Infoterra Room (Room Number 3334), EPA West
Building, 1301 Constitution Ave. NW., Washington, DC 20460; and
     National Archives and Records Administration (NARA).
    If you wish to obtain materials from a docket in the EPA
Headquarters Library, please call the Office of Air and Radiation (OAR)
Docket/Telephone number:<PHONE_NUMBER>. For information on the
availability of this material at NARA, call<PHONE_NUMBER>, or go to:
http://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Kristin Hall, EPA Region 10, (206)
553-6357<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, wherever ``we,''
``us'' or ``our'' is used, it is intended to refer to the EPA.
Information is organized as follows:

Table of Contents

I. Background
    A. What a SIP Is
    B. How the EPA Enforces SIPs
    C. How the State and the EPA Update the SIP
    D. How the EPA Compiles the SIPs
    E. How the EPA Organizes the SIP Compilation
    F. Where You Can Find a Copy of the SIP Compilation
    G. The Format of the New Identification of Plan Section
    H. When a SIP Revision Becomes Federally Enforceable
    I. The Historical Record of SIP Revision Approvals
II. What the EPA Is Doing in This Action
III. Statutory and Executive Order Review

I. Background

A. What a SIP Is

    Each state has a SIP containing the control measures and strategies
used to attain and maintain the national ambient air quality standards
(NAAQS). The SIP is extensive, containing such elements as air
pollution control regulations, emission inventories, monitoring
network, attainment demonstrations, and enforcement mechanisms.

B. How the EPA Enforces SIPs

    Each state must formally adopt the control measures and strategies
in the SIP after the public has had an opportunity to comment on them.
They are then submitted to the EPA as SIP revisions upon which the EPA
must formally act. Once these control measures and strategies are
approved by the EPA, after notice and comment, they are incorporated
into the Federally-approved SIP and are identified in part 52 (Approval
and Promulgation of Implementation Plans), title 40 of the Code of
Federal Regulations (40 CFR part 52). The actual state regulations
approved by the EPA are not reproduced in their entirety in 40 CFR part
52, but are ``incorporated by reference'' (IBR'd) which means that the
EPA has approved a given state regulation with a specific effective
date. This format allows both the EPA and the public to know which
measures are contained in a given SIP and ensures that the state is
enforcing the regulations. It also allows the EPA and the public to
take enforcement action,

should a state not enforce its SIP-approved regulations.

C. How the State and the EPA Update the SIP

    The SIP is a living document which the state can revise as
necessary to address the unique air pollution problems in the state.
Therefore, the EPA must, from time to time, take action on SIP
revisions containing new and/or revised regulations in order to make
them part of the SIP. On May 22, 1997 (62 FR 27968), the EPA revised
the procedures for IBR'ing Federally-approved SIPs, as a result of
consultations between the EPA and the Office of the Federal Register
(OFR).
    The EPA began the process of developing: (1) A revised SIP document
for each state that would be IBR'd under the provisions of title 1 CFR
part 51; (2) a revised mechanism for announcing the EPA approval of
revisions to an applicable SIP and updating both the IBR document and
the CFR; and (3) a revised format of the ``Identification of Plan''
sections for each applicable subpart to reflect these revised IBR
procedures. The description of the revised SIP document, IBR
procedures, and ``Identification of Plan'' format are discussed in
further detail in the May 22, 1997, Federal Register document.

D. How the EPA Compiles the SIPs

    The Federally-approved regulations, source-specific permits, and
nonregulatory provisions (entirely or portions of) submitted by each
state agency have been compiled by the EPA into a ``SIP compilation.''
The SIP compilation contains the updated regulations, source-specific
permits, and nonregulatory provisions approved by the EPA through
previous rulemaking actions in the Federal Register.

E. How the EPA Organizes the SIP Compilation

    Each compilation contains three parts. Part one contains the
regulations, part two contains the source-specific requirements that
have been approved as part of the SIP, and part three contains
nonregulatory provisions that have been EPA-approved. Each part
consists of a table of identifying information for each SIP-approved
regulation, each SIP-approved source-specific permit, and each
nonregulatory SIP provision. In this action, the EPA is publishing the
tables summarizing the applicable SIP requirements for Alaska. The EPA
Regional Offices have the primary responsibility for updating the
compilations and ensuring their accuracy.

F. Where You Can Find a Copy of the SIP Compilation

    The EPA Region 10 developed and will maintain the compilation for
Alaska. A copy of the full text of Alaska's regulatory and source-
specific SIP compilation will also be maintained at NARA and the EPA's
Air Docket and Information Center.

G. The Format of the New Identification of Plan Section

    In order to better serve the public, the EPA revised the
organization of the ``Identification of Plan'' section and included
additional information to clarify the enforceable elements of the SIP.
The revised Identification of Plan section contains five subsections:
    1. Purpose and scope.
    2. Incorporation by reference.
    3. EPA-approved regulations.
    4. EPA-approved source-specific requirements.
    5. EPA-approved nonregulatory and quasi-regulatory provisions.

H. When a SIP Revision Becomes Federally Enforceable

    All revisions to the applicable SIP become Federally enforceable as
of the effective date of the revisions to paragraphs (c), (d), or (e)
of the applicable Identification of Plan section found in each subpart
of 40 CFR part 52.

I. The Historical Record of SIP Revision Approvals

    To facilitate enforcement of previously approved SIP provisions and
provide a smooth transition to the new SIP processing system, the EPA
retains the original Identification of Plan section, previously
appearing in the CFR as the first or second section of part 52 for each
state subpart. After an initial two-year period, the EPA will review
its experience with the new system and enforceability of previously
approved SIP measures and will decide whether or not to retain the
Identification of Plan appendices for some further period. Although the
EPA is retaining the original Identification of Plan section, other
sections of part 52 are duplicative of the new Identification of Plan
section. The EPA is therefore removing sections 52.97 ``Interstate
Transport for the 1997 8-hour ozone and PM2.5 NAAQS'' and
52.98 ``Section 110(a)(2) infrastructure requirements'' as part of the
general ``housekeeping'' discussed below.

II. What the EPA Is Doing in This Action

    This action constitutes a ``housekeeping'' exercise to ensure that
all revisions to the state programs that have occurred are accurately
reflected in 40 CFR part 52. State SIP revisions are controlled by the
EPA regulations at 40 CFR part 51. When the EPA receives a formal SIP
revision request, the EPA must publish the proposed revision in the
Federal Register and provide for public comment before approval.
    The EPA has determined that this action falls under the ``good
cause'' exemption in section 553(b)(3)(B) of the Administrative
Procedures Act (APA) which, upon finding ``good cause,'' authorizes
agencies to dispense with public participation and section 553(d)(3)
which allows an agency to make a rule effective immediately (thereby
avoiding the 30-day delayed effective date otherwise provided for in
the APA). This action simply codifies provisions which are already in
effect as a matter of law in Federal and approved state programs. Under
section 553 of the APA, an agency may find good cause where procedures
are ``impractical, unnecessary, or contrary to the public interest.''
Public comment is ``unnecessary'' and ``contrary to the public
interest'' since the codification only reflects existing law. Immediate
notice in the CFR benefits the public by removing outdated citations.

III. Statutory and Executive Order Reviews

A. General Requirements

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and is therefore not
subject to review by the Office of Management and Budget. This rule is
not subject to Executive Order 13211, ``Actions Concerning Regulations
That Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001) because it is not a significant regulatory action
under Executive Order 12866. Because the agency has made a ``good
cause'' finding that this action is not subject to notice-and-comment
requirements under the Administrative Procedure Act or any other
statute as indicated in the SUPPLEMENTARY INFORMATION section above, it
is not subject to the regulatory flexibility provisions of the
Regulatory Flexibility Act (5 U.S.C. 601 et seq.), or to sections 202
and 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L.
104-4). In addition, this action does not significantly or uniquely
affect small governments or impose a significant intergovernmental
mandate, as described in sections 203 and 204 of UMRA. This rule also
does not have a substantial direct effect on one or more Indian tribes,
on the relationship between the Federal government and Indian tribes,
or on the distribution of

power and responsibilities between the Federal government and Indian
tribes, as specified by Executive Order 13175 (65 FR 67249, November 9,
2000), nor will it have substantial direct effects on the states, on
the relationship between the national government and the states, or on
the distribution of power and responsibilities among the various levels
of government, as specified in Executive Order 13132 (64 FR 43255,
August 10, 1999). This rule also is not subject to Executive Order
13045 (62 FR 19885, April 23, 1997), because it is not economically
significant. This rule does not involve technical standards; thus the
requirements of section 12(d) of the National Technology Transfer and
Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. The rule
also does not involve special consideration of environmental justice
related issues as required by Executive Order 12898 (59 FR 7629,
February 16, 1994). In issuing this rule, the EPA has taken the
necessary steps to eliminate drafting errors and ambiguity, minimize
potential litigation, and provide a clear legal standard for affected
conduct, as required by section 3 of Executive Order 12988 (61 FR 4729,
February 7, 1996). The EPA has complied with Executive Order 12630 (63
FR 8859, March 15, 1998) by examining the takings implications of the
rule in accordance with the ``Attorney General's Supplemental
Guidelines for the Evaluation of Risk and Avoidance of Unanticipated
Takings'' issued under the executive order. This rule does not impose
an information collection burden under the Paperwork Reduction Act of
1995 (44 U.S.C. 3501 et seq.). The EPA's compliance with these statutes
and Executive Orders for the underlying rules is discussed in previous
actions taken on the State's rules.

B. Submission to Congress and the Comptroller General

    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. Section 808 allows the issuing agency to
make a rule effective sooner than otherwise provided by the CRA if the
agency makes a good cause finding that notice and public procedure is
impracticable, unnecessary or contrary to the public interest. This
action simply codifies provisions which are already in effect as a
matter of law in Federal and approved state programs. 5 U.S.C. 802(2).
As stated previously, the EPA has made such a good cause finding,
including the reasons therefore, and established an effective of April
10, 2014. The EPA will submit a report containing this rule 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. The changes in
format to the ``Identification of plan'' section for Alaska are not a
`major rule' as defined by 5 U.S.C. 804(2).

C. Petitions for Judicial Review

    The EPA has also determined that the provisions of section
307(b)(1) of the Clean Air Act pertaining to petitions for judicial
review are not applicable to this action. Prior EPA rulemaking actions
for each individual component of the Alaska SIP compilations had
previously afforded interested parties the opportunity to file a
petition for judicial review in the United States Court of Appeals for
the appropriate circuit within 60 days of such rulemaking action. Thus,
the EPA sees no need in this action to reopen the 60-day period for
filing such petitions for judicial review for these ``Identification of
plan'' reorganization actions for Alaska.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur dioxide, Volatile organic compounds.

    Dated: March 10, 2014.
Dennis J. McLerran,
Regional Administrator, Region 10.

    Part 52 of chapter I, title 40 of the Code of Federal Regulations,
is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTION PLANS

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

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

Subpart C--Alaska

Sec.  52.70  [Redesignated as Sec.  52.74]

0
2. Section 52.70 is redesignated as Sec.  52.74 and the section heading
and paragraph (a) are revised to read as follows:

Sec.  52.74  Original identification of plan section.

    (a) This section identified the original ``Air Quality
Implementation Plan for the State of Alaska'' and all revisions
submitted by Alaska that were Federally-approved prior to March 4,
2014.
* * * * *

0
3. New Sec.  52.70 is added to read as follows:

Sec.  52.70  Identification of plan.

    (a) Purpose and scope. This section sets forth the applicable State
implementation plan for the State of Alaska under section 110 of the
Clean Air Act, 42 U.S.C. 7401-7671q and 40 CFR part 51 to meet national
ambient air quality standards.
    (b) Incorporation by reference. (1) Material listed in paragraphs
(c) and (d) of this section with an EPA approval date prior to March 4,
2014, was approved for incorporation by reference by the Director of
the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part
51. Material is incorporated as it exists on the date of the approval,
and notice of any change in the material will be published in the
Federal Register. Entries in paragraphs (c) and (d) of this section
with EPA approval dates after March 4, 2014, will be incorporated by
reference in the next update to the SIP compilation.
    (2) The EPA Region 10 certifies that the rules/regulations provided
by the EPA in the SIP compilation at the addresses in paragraph (b)(3)
of this section are an exact duplicate of the officially promulgated
State rules/regulations which have been approved as part of the State
Implementation Plan as of March 4, 2014.
    (3) Copies of the materials incorporated by reference may be
inspected at the EPA Region 10 Office at 1200 Sixth Avenue, Seattle WA,
98101; the EPA, Air and Radiation Docket and Information Center, EPA
Headquarters Library, Infoterra Room (Room Number 3334), EPA West
Building, 1301 Constitution Ave. NW., Washington, DC; or the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call<PHONE_NUMBER>, or go to:
http://www.archives.gov/federal-register/cfr/ibr-locations.html.
    (c) EPA approved regulations.

                                  EPA-Approved Alaska Regulations and Statutes
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                                                        State effective
         State citation              Title/subject           date          EPA approval date     Explanations
----------------------------------------------------------------------------------------------------------------
   Alaska Administrative Code Title 18 Environmental Conservation, Chapter 50 Air Quality Control (18 AAC 50)
----------------------------------------------------------------------------------------------------------------
                               18 AAC 50 Article 1. Ambient Air Quality Management
----------------------------------------------------------------------------------------------------------------
18 AAC 50.005...................  Purpose and         10/1/04...........  8/14/07, 72 FR
                                   Applicability of                        45378.
                                   Chapter.
18 AAC 50.010...................  Ambient Air         10/1/04; 4/1/10...  8/14/07, 72 FR      except subsections
                                   Quality Standards.                      45378; 10/22/12,    (7) and (8).
                                                                           77 FR 64425.
18 AAC 50.015...................  Air Quality         10/1/04...........  8/14/07, 72 FR
                                   Designations,                           45378.
                                   Classifications,
                                   and Control
                                   Regions.
18 AAC 50.020...................  Baseline Dates and  10/1/04...........  8/14/07, 72 FR
                                   Maximum Allowable                       45378.
                                   Increases.
18 AAC 50.025...................  Visibility and      6/21/98...........  8/14/07, 72 FR
                                   Other Special                           45378.
                                   Protection Areas.
18 AAC 50.035...................  Documents,          12/3/05; 4/1/10...  8/14/07, 72 FR      except (b)(4).
                                   Procedures and                          45378; 10/22/12,
                                   Methods Adopted                         77 FR 64425.
                                   by Reference.
18 AAC 50.040...................  Federal Standards   12/3/05; 12/9/10..  8/14/07, 72 FR      except (a), (b),
                                   Adopted by                              45378; 2/9/11, 76   (c), (d), (e),
                                   Reference.                              FR 7116; 10/22/     (g), (h)(17),
                                                                           12, 77 FR 64425.    (h)(18), (h)(19),
                                                                                (i)(7), (i)(8),
                                                                                (i)(9), and (j).
18 AAC 50.045...................  Prohibitions......  10/1/04...........  8/14/07, 72 FR
                                                                           45378.
18 AAC 50.050...................  Incinerator         5/3/02............  8/14/07, 72 FR
                                   Emission                                45378.
                                   Standards.
18 AAC 50.055...................  Industrial          10/1/04...........  8/14/07, 72 FR      except (d)(2)(B).
                                   Processes and                           45378.
                                   Fuel-Burning
                                   Equipment.
18 AAC 50.060...................  Pulp Mills........  1/18/97...........  11/18/98, 63 FR
                                                                           63983.
18 AAC 50.065...................  Open Burning......  1/18/97...........  11/18/98, 63 FR
                                                                           63983.
18 AAC 50.070...................  Marine Vessel       6/21/98...........  8/14/07, 72 FR
                                   Visible Emission                        45378.
                                   Standards.
18 AAC 50.075...................  Wood-Fired Heating  5/6/09............  5/9/13, 78 FR
                                   Device Visible                          27078.
                                   Emission
                                   Standards.
18 AAC 50.080...................  Ice Fog Standards.  1/18/97...........  8/14/07, 72 FR
                                                                           45378.
18 AAC 50.100...................  Nonroad Engines...  10/1/04...........  8/14/07, 72 FR
                                                                           45378.
18 AAC 50.110...................  Air Pollution       5/26/72...........  5/31/72, 37 FR
                                   Prohibited.                             10842.
----------------------------------------------------------------------------------------------------------------
                                   18 AAC 50 Article 2. Program Administration
----------------------------------------------------------------------------------------------------------------
18 AAC 50.200...................  Information         10/1/04...........  8/14/07, 72 FR
                                   Requests.                               45378.
18 AAC 50.201...................  Ambient Air         10/1/04...........  8/14/07, 72 FR
                                   Quality                                 45378.
                                   Investigation.
18 AAC 50.205...................  Certification.....  10/1/04...........  8/14/07, 72 FR
                                                                           45378.
18 AAC 50.215...................  Ambient Air         10/1/04; 4/1/10...  8/14/07, 72 FR      except (a)(3).
                                   Quality Analysis                        45378; 10/22/12,
                                   Methods.                                77 FR 64425.
18 AAC 50.220...................  Enforceable Test    10/1/04...........  8/14/07, 72 FR      except (c)(2).
                                   Methods.                                45378.
18 AAC 50.225...................  Owner-Requested     1/29/05...........  8/14/07, 72 FR
                                   Limits.                                 45378.
18 AAC 50.230...................  Preapproved         1/29/05...........  8/14/07, 72 FR      except (d).
                                   Emission Limits.                        45378.
18 AAC 50.240...................  Excess Emissions..  1/18/97...........  11/18/98, 63 FR
                                                                           63983.
18 AAC 50.245...................  Air Episodes and    10/1/04...........  8/14/07, 72 FR
                                   Advisories.                             45378.
18 AAC 50.250...................  Procedures and      10/1/04...........  8/14/07, 72 FR
                                   Criteria for                            45378.
                                   Revising Air
                                   Quality
                                   Classifications.
18 AAC 50.260...................  Guidelines for      12/30/07..........  2/14/13, 78 FR
                                   Best Available                          10546.
                                   Retrofit
                                   Technology under
                                   the Regional Haze
                                   Rule.
----------------------------------------------------------------------------------------------------------------
                              18 AAC 50 Article 3. Major Stationary Source Permits
----------------------------------------------------------------------------------------------------------------
18 AAC 50.301...................  Permit Continuity.  10/1/04...........  8/14/07, 72 FR
                                                                           45378.
18 AAC 50.302...................  Construction        10/1/04...........  8/14/07, 72 FR
                                   Permits.                                45378.
18 AAC 50.306...................  Prevention of       10/1/04...........  8/14/07, 72 FR      except (b)(2) and
                                   Significant                             45378.              (b)(3).
                                   Deterioration
                                   (PSD) Permits.
18 AAC 50.311...................  Nonattainment Area  10/1/04...........  8/14/07, 72 FR
                                   Major Stationary                        45378.
                                   Source Permits.

18 AAC 50.345...................  Construction and    10/1/04...........  8/14/07, 72 FR      except (b),
                                   Operating                               45378.              (c)(3), and (l).
                                   Permits: Standard
                                   Permit Conditions.
----------------------------------------------------------------------------------------------------------------
                                       18 AAC 50 Article 5. Minor Permits
----------------------------------------------------------------------------------------------------------------
18 AAC 50.502...................  Minor Permits for   12/3/05...........  8/14/07, 72 FR      except (g)(1) and
                                   Air Quality                             45378.              (g)(2).
                                   Protection.
18 AAC 50.508...................  Minor Permits       10/1/04...........  8/14/07, 72 FR      except (1) and
                                   Requested by the                        45378.              (2).
                                   Owner or Operator.
18 AAC 50.540...................  Minor Permit:       12/3/05...........  8/14/07, 72 FR      except (f) and
                                   Application.                            45378.              (g).
18 AAC 50.542...................  Minor Permit:       12/1/04...........  8/14/07, 72 FR      except (b)(2),
                                   Review and                              45378.              (f)(4), (f)(5),
                                   Issuance.                                                   and (g)(1) but
                                                                                only with respect
                                                                                to clean units
                                                                                and pollution
                                                                                control projects.
18 AAC 50.544...................  Minor Permits:      1/29/05...........  8/14/07, 72 FR      except (e).
                                   Content.                                45378.
18 AAC 50.546...................  Minor Permits:      10/1/04...........  8/14/07, 72 FR      except (b).
                                   Revisions.                              45378.
18 AAC 50.560...................  General Minor       10/1/04...........  8/14/07, 72 FR      ..................
                                   Permits.                                45378.
----------------------------------------------------------------------------------------------------------------
                                         18 AAC 50 Article 7. Conformity
----------------------------------------------------------------------------------------------------------------
18 AAC 50.700...................  Purpose of 18 AAC   9/4/98............  12/29/99, 64 FR
                                   50.700-18 AAC                           72940.
                                   50.785.
18 AAC 50.705...................  Coverage of 18 AAC  9/4/98............  12/29/99, 64 FR
                                   50.710-18 AAC                           72940.
                                   50.735:
                                   Obligations of
                                   Responsible
                                   Agency.
18 AAC 50.710...................  Transportation      9/4/98............  12/29/99, 64 FR     exceptions--IBR
                                   Conformity:                             72940.              93.102(c)&(d);
                                   Incorporation by                                            93.104(d)&(e)(2);
                                   Reference of                                                93.109(c)-(f);
                                   Federal                                                     93.118(e);
                                   Regulations.                                                93.119(f)(3);
                                                                                93.120(a)(2);
                                                                                93.121(a)(1) &
                                                                                (b); 93.124(b).
18 AAC 50.715...................  Transportation      9/4/98............  12/29/99, 64 FR
                                   Conformity:                             72940.
                                   Interagency
                                   Consultation
                                   Procedures.
18 AAC 50.720...................  Transportation      9/4/98............  12/29/99, 64 FR
                                   Conformity:                             72940.
                                   Public
                                   Involvement.
18 AAC 50.725...................  General             1/4/95............  9/27/95, 60 FR
                                   Conformity:                             49765.
                                   Incorporation by
                                   Reference of
                                   Federal
                                   Regulations.
18 AAC 50.730...................  General             1/4/95............  9/27/95, 60 FR
                                   Conformity:                             49765.
                                   Mitigation of Air
                                   Quality Impacts.
18 AAC 50.735...................  General             1/4/95............  9/27/95, 60 FR
                                   Conformity:                             49765.
                                   Frequency of
                                   Conformity
                                   Determinations.
----------------------------------------------------------------------------------------------------------------
                                     18 AAC 50 Article 9. General Provisions
----------------------------------------------------------------------------------------------------------------
18 AAC 50.900...................  Small Business      10/1/04...........  8/14/07, 72 FR
                                   Assistance                              45378.
                                   Program.
18 AAC 50.990...................  Definitions.......  10/1/04; 4/1/10;    8/14/07, 72 FR      except (21) and
                                                       12/9/10.            45378; 10/22/12,    (77).
                                                                           77 FR 64425.
----------------------------------------------------------------------------------------------------------------
 Alaska Administrative Code Title 18 Environmental Conservation, Chapter 52 Emissions Inspection and Maintenance
                                            Requirements (18 AAC 52)
----------------------------------------------------------------------------------------------------------------
                     18 AAC 52 Article 1. Emissions Inspection and Maintenance Requirements
----------------------------------------------------------------------------------------------------------------
18 AAC 52.005...................  Applicability and   5/17/08...........  3/22/10, 75 FR
                                   General                                 13436.
                                   Requirements.
18 AAC 52.007...................  Suspension and      5/17/08...........  3/22/10, 75 FR
                                   Reestablishment                         13436.
                                   of I/M
                                   Requirements.
18 AAC 52.010...................  I/M Program         2/18/06...........  3/22/10, 75 FR
                                   Administration                          13436.
                                   Office.

18 AAC 52.015...................  Motor Vehicle       2/18/06...........  3/22/10, 75 FR
                                   Maintenance                             13436.
                                   Requirements.
18 AAC 52.020...................  Certificate of      2/18/06...........  3/22/10, 75 FR
                                   Inspection                              13436.
                                   Requirements.
18 AAC 52.025...................  Visual              2/18/06...........  3/22/10, 75 FR
                                   Identification of                       13436.
                                   Certificate of
                                   Inspection,
                                   Waivers, and
                                   Exempt Vehicles.
18 AAC 52.030...................  Department-         2/1/94............  4/5/95, 60 FR
                                   Administered I/M                        17232.
                                   Program.
18 AAC 52.035...................  I/M Program         3/27/02...........  3/22/10, 75 FR
                                   Administered by                         13436.
                                   an Implementing
                                   Agency.
18 AAC 52.037...................  Reporting           2/18/06...........  3/22/10, 75 FR
                                   Requirements for                        13436.
                                   an I/M Program
                                   Administered by
                                   an Implementing
                                   Agency.
18 AAC 52.040...................  Centralized         2/1/94............  4/5/95, 60 FR
                                   Inspection                              17232.
                                   Program.
18 AAC 52.045...................  Decentralized       2/1/94............  4/5/95, 60 FR
                                   Inspection                              17232.
                                   Program.
18 AAC 52.050...................  Emissions           3/27/02...........  3/22/10, 75 FR
                                   Standards.                              13436.
18 AAC 52.055...................  Alternative         1/1/00............  1/8/02, 67 FR 822.
                                   Requirements,
                                   Standards and
                                   Test Procedures.
18 AAC 52.060...................  Waivers...........  5/17/08...........  3/22/10, 75 FR
                                                                           13436.
18 AAC 52.065...................  Emissions-Related   1/1/00............  1/8/02, 67 FR 822.
                                   Repair Cost
                                   Minimum.
18 AAC 52.070...................  Referee Facility..  3/27/02...........  3/22/10, 75 FR
                                                                           13436.
18 AAC 52.075...................  Kit Cars and        2/1/94............  4/5/95, 60 FR
                                   Custom-                                 17232.
                                   Manufactured
                                   Vehicles.
18 AAC 52.080...................  Grey Market         3/27/02...........  3/22/10, 75 FR
                                   Vehicles.                               13436.
18 AAC 52.085...................  Vehicle             2/18/06...........  3/22/10, 75 FR
                                   Modifications.                          13436.
18 AAC 52.090...................  Repair of           1/1/98............  12/29/99, 64 FR
                                   Nonconforming                           72940.
                                   Vehicles.
18 AAC 52.095...................  Minimum             1/1/98............  12/29/99, 64 FR
                                   Certification                           72940.
                                   Requirements.
18 AAC 52.100...................  Enforcement         12/14/06..........  3/22/10, 75 FR
                                   Procedures for                          13436.
                                   Violations by
                                   Motorists.
18 AAC 52.105...................  Enforcement         1/1/00............  1/8/02, 67 FR 822.
                                   Procedures for
                                   Violations by
                                   Certified
                                   Mechanics or
                                   Stations.
----------------------------------------------------------------------------------------------------------------
                                 18 AAC 52 Article 4. Certification Requirements
----------------------------------------------------------------------------------------------------------------
18 AAC 52.400...................  Mechanic            1/1/98............  12/29/99, 64 FR
                                   Certification.                          72940.
18 AAC 52.405...................  Certified Mechanic  3/27/02...........  3/22/10, 75 FR
                                   Examinations.                           13436.
18 AAC 52.410...................  Training Course     2/18/06...........  3/22/10, 75 FR
                                   Certification.                          13436.
18 AAC 52.415...................  I/M Station         1/1/00............  1/8/02, 67 FR 822.
                                   Certification.
18 AAC 52.420...................  Equipment           1/1/00............  1/8/02, 67 FR 822.
                                   Certification.
18 AAC 52.425...................  Renewal of          1/1/98............  12/29/99, 64 FR
                                   Certification.                          72940.
18 AAC 52.430...................  Duty to Report      2/1/94............  4/5/95, 60 FR
                                   Change in Status.                       17232.
18 AAC 52.440...................  Monitoring of       1/1/00............  1/8/02, 67 FR 822.
                                   Certified
                                   Mechanics and
                                   Stations.
18 AAC 52.445...................  Suspension or       2/1/94............  4/5/95, 60 FR
                                   Revocation of                           17232.
                                   Certification.
----------------------------------------------------------------------------------------------------------------
                               18 AAC 52 Article 5. Certified Station Requirements
----------------------------------------------------------------------------------------------------------------
18 AAC 52.500...................  General Operating   1/1/00............  1/8/02, 67 FR 822.
                                   Requirements.
18 AAC 52.505...................  Display of          2/1/94............  4/5/95, 60 FR
                                   Certified Station                       17232.
                                   Sign.
18 AAC 52.510...................  Display of          2/18/06...........  3/22/10, 75 FR
                                   Certificates.                           13436.
18 AAC 52.515...................  Inspection Charges  2/18/06...........  3/22/10, 75 FR
                                                                           13436.
18 AAC 52.520...................  Required Tools and  2/18/06...........  3/22/10, 75 FR
                                   Equipment.                              13436.

18 AAC 52.525...................  Remote Station      1/1/00............  1/8/02, 67 FR 822.
                                   Operation.
18 AAC 52.527...................  Prescreening        1/1/00............  1/8/02, 67 FR 822.
                                   Prohibited.
18 AAC 52.530...................  Preliminary         1/1/00............  1/8/02, 67 FR 822.
                                   Inspection.
18 AAC 52.535...................  Test Abort          3/27/02...........  3/22/10, 75 FR
                                   Conditions.                             13436.
18 AAC 52.540...................  Official I/M        3/27/02...........  3/22/10, 75 FR
                                   Testing.                                13436.
18 AAC 52.545...................  Parts on Order....  1/1/98............  12/29/99, 64 FR
                                                                           72940.
18 AAC 52.546...................  Unavailable Parts.  1/1/98............  12/29/99, 64 FR
                                                                           72940.
18 AAC 52.550...................  Recordkeeping       2/1/94............  4/5/95, 60 FR
                                   Requirements.                           17232.
----------------------------------------------------------------------------------------------------------------
                                     18 AAC 52 Article 9. General Provisions
----------------------------------------------------------------------------------------------------------------
18 AAC 52.990...................  Definitions.......  2/18/06...........  3/22/10, 75 FR
                                                                           13436.
----------------------------------------------------------------------------------------------------------------
 Alaska Administrative Code Title 18 Environmental Conservation, Chapter 53 Fuel Requirements For Motor Vehicles
                                                   (18 AAC 53)
----------------------------------------------------------------------------------------------------------------
                              18 AAC 53 Article 1. Oxygenated Gasoline Requirements
----------------------------------------------------------------------------------------------------------------
18 AAC 53.005...................  Purpose and         10/31/97..........  12/29/99, 64 FR
                                   Applicability;                          72940.
                                   General
                                   Requirements.
18 AAC 53.007...................  Dispenser Labeling  10/31/97..........  12/29/99, 64 FR
                                                                           72940.
18 AAC 53.010...................  Control Periods     2/20/04...........  6/23/04, 69 FR
                                   and Control Areas.                      34935.
18 AAC 53.020...................  Required Oxygen     10/31/97..........  12/29/99, 64 FR
                                   Content.                                72940.
18 AAC 53.030...................  Sampling, Testing   10/31/97..........  12/29/99, 64 FR
                                   and Oxygen                              72940.
                                   Content
                                   Calculations.
18 AAC 53.035...................  Per Gallon Method   10/31/97..........  12/29/99, 64 FR
                                   of Compliance.                          72940.
18 AAC 53.040...................  Averaging Oxygen    10/31/97..........  12/29/99, 64 FR
                                   Content Method of                       72940.
                                   Compliance.
18 AAC 53.045...................  Oxygen Credits and  10/31/97..........  12/29/99, 64 FR
                                   Debits.                                 72940.
18 AAC 53.060...................  Oxygenated          10/31/97..........  12/29/99, 64 FR
                                   Gasoline Blending.                      72940.
18 AAC 53.070...................  Registration and    10/31/97..........  12/29/99, 64 FR
                                   Permit.                                 72940.
18 AAC 53.080...................  Car Fees..........  12/30/00..........  1/08/02, 67 FR 822
18 AAC 53.090...................  Recordkeeping.....  10/31/97..........  12/29/99, 64 FR
                                                                           72940.
18 AAC 53.100...................  Reporting.........  10/31/97..........  12/29/99, 64 FR
                                                                           72940.
18 AAC 53.105...................  Product Transfer    10/31/97..........  12/29/99, 64 FR
                                   Document.                               72940.
18 AAC 53.120...................  Inspection and      10/31/97..........  12/29/99, 64 FR
                                   Sampling.                               72940.
18 AAC 53.130...................  Liability for       10/31/97..........  12/29/99, 64 FR
                                   Violation.                              72940.
18 AAC 53.140...................  Defenses for        10/31/97..........  12/29/99, 64 FR
                                   Violation.                              72940.
18 AAC 53.150...................  Temporary           10/31/97..........  12/29/99, 64 FR
                                   Variances.                              72940.
18 AAC 53.160...................  Quality Assurance   10/31/97..........  12/29/99, 64 FR
                                   Program.                                72940.
18 AAC 53.170...................  Attest Engagements  10/31/97..........  12/29/99, 64 FR
                                                                           72940.
18 AAC 53.190...................  Suspension and      2/20/04...........  6/23/04, 69 FR
                                   Reestablishment                         34935.
                                   of Control Period.
----------------------------------------------------------------------------------------------------------------
                                     18 AAC 53 Article 9. General Provisions
----------------------------------------------------------------------------------------------------------------
18 AAC 53.990...................  Definitions.......  10/31/97..........  12/29/99, 64 FR
                                                                           72940.
----------------------------------------------------------------------------------------------------------------
                                           City and County Ordinances
----------------------------------------------------------------------------------------------------------------
Anchorage Municipal Code          Improvement         1/16/87 (City       8/13/93, 58 FR      Eagle River PM
 21.85.030.                        Requirements by     effective date).    43084.              Plan--Contingency
                                   Improvement Area.                                           Plan.
Anchorage Municipal Code          Paving............  9/24/91 (City       8/13/93, 58 FR      Section W.7. Eagle
 21.45.080.W.7.                                        effective date).    43084.              River PM Plan--
                                                                                Contingency Plan.
Fairbanks North Star Borough      Mandating a         4/12/01 (City       2/4/02, 67 FR 5064  Fairbanks
 Ordinance No. 2001-17.            Fairbanks North     adoption date).                         Transportation
                                   Star Borough                                                Control Program--
                                   Motor Vehicle                                               Carbon Monoxide.
                                   Plug-in Program.

Fairbanks North Star Borough      An Ordinance        10/30/03 (City      7/27/04, 69 FR      Fairbanks Carbon
 Ordinance No. 2003-71.            amending the        adoption date).     44601.              Monoxide
                                   Carbon Monoxide                                             Maintenance Plan.
                                   Emergency Episode
                                   Prevention Plan
                                   including
                                   implementing a
                                   Woodstove Control
                                   Ordinance.
Ordinance of the City and         An Ordinance        1/6/92 (City        3/24/94, 59 FR      Mendenhall Valley
 Borough of Juneau, No. 91-52.     amending the Wood   adoption date).     13884.              PM Plan.
                                   smoke control
                                   code to lower the
                                   particulate count
                                   threshold, and to
                                   prohibit the
                                   burning in
                                   woodstoves of
                                   substances other
                                   than paper,
                                   cardboard and
                                   untreated wood.
Ordinance of the City and         An Ordinance        1/6/92 (City        3/24/94, 59 FR      Mendenhall Valley
 Borough of Juneau, No. 91-53.     amending the wood   adoption date).     13884.              PM Plan.
                                   smoke control
                                   fine schedule to
                                   increase the
                                   fines for
                                   violations of the
                                   wood smoke
                                   control code.
Ordinance of the City and         Setting boundaries  2/8/93 (City        3/24/94, 59 FR      Mendenhall Valley
 Borough of Juneau No. 93-01.      for regrading and   adoption date).     13884.              PM Plan.
                                   surfacing.
Ordinance of the City and         Setting boundaries  4/5/93 (City        3/24/94, 59 FR      Mendenhall Valley
 Borough of Juneau, No. 93-06.     for regrading and   adoption date).     13884.              PM Plan.
                                   surfacing.
Ordinance of the City and         An Ordinance        11/17/93 (City      3/24/94, 59 FR      Mendenhall Valley
 Borough of Juneau, No. 93-39am.   creating Local      adoption date).     13884.              PM Plan.
                                   Improvement
                                   District No. 77
                                   of the City and
                                   Borough, setting
                                   boundaries for
                                   drainage and
                                   paving of streets
                                   in the Mendenhall
                                   Valley.
Anchorage Ordinance 2006-13.....  An ordinance        2/14/06 (City       3/22/10, 75 FR      Anchorage
                                   amending the        approval date).     13436.              Transportation
                                   Anchorage                                                   Control Program--
                                   Municipal Code,                                             Carbon Monoxide.
                                   Chapters 15.80
                                   and 15.85 to
                                   comply with State
                                   I/M regulations
                                   and to comply
                                   with DMV
                                   Electronic
                                   Procedures.
Ordinance of the City and         An Ordinance        9/8/08 (City        5/9/13, 78 FR       Mendenhall Valley
 Borough of Juneau, Serial No.     Amending the        adoption date).     27071.              PM Limited
 2008-28.                          Woodsmoke Control                                           Maintenance Plan.
                                   Program Regarding
                                   Solid Fuel-Fired
                                   Burning Devices.
----------------------------------------------------------------------------------------------------------------
                                                 Alaska Statutes
----------------------------------------------------------------------------------------------------------------
                           Title 45 Trade and Commerce, Chapter 45.45. Trade Practices
----------------------------------------------------------------------------------------------------------------
Sec. 45.45.400..................  Prohibited          6/25/93...........  11/18/98, 63 FR     except (b).
                                   Transfer of Used                        63983.
                                   Cars.
----------------------------------------------------------------------------------------------------------------
         Title 46 Water, Air, Energy, and Environmental Conservation, Chapter 46.14. Air Quality Control
----------------------------------------------------------------------------------------------------------------
Sec. 46.14.510..................  Motor Vehicle       6/25/93...........  11/18/98, 63 FR     except (a), (c),
                                   Pollution.                              63983.              and (d).
Sec. 46.14.550..................  Responsibilities    6/25/93...........  11/18/98, 63 FR
                                   of Owner and                            63983.
                                   Operator.
Sec. 46.14.560..................  Unavoidable         6/25/93...........  11/18/98, 63 FR
                                   Malfunctions and                        63983.
                                   Emergencies.
Sec. 46.14.990..................  Definitions.......  6/25/93...........  11/18/98, 63 FR     except (4), (5),
                                                                           63983.              (9), (11), (12),
                                                                                (14), (19), (20),
                                                                                (21), and (23).
----------------------------------------------------------------------------------------------------------------

    (d) EPA approved state source-specific requirements.

                                EPA-Approved Alaska Source-Specific Requirements
----------------------------------------------------------------------------------------------------------------
                                                        State effective
         Name of source            Order/Permit No.          date          EPA approval date      Explanation
----------------------------------------------------------------------------------------------------------------
None
----------------------------------------------------------------------------------------------------------------

    (e) EPA approved nonregulatory provisions and quasi-regulatory
measures.

                   EPA-Approved Alaska Nonregulatory Provisions and Quasi-Regulatory Measures
----------------------------------------------------------------------------------------------------------------
                                      Applicable
      Name of SIP provision          geographic or      State submittal    EPA approval date       Comments
                                  nonattainment area         date
----------------------------------------------------------------------------------------------------------------
           State of Alaska Air Quality Control Plan: Volume II. Analysis of Problems, Control Actions
----------------------------------------------------------------------------------------------------------------
                                              Section I Background
----------------------------------------------------------------------------------------------------------------
A. Introduction.................  Statewide.........  1/8/97............  12/29/99, 64 FR
                                                                           72940.
B. Air Quality Control Regions..  Statewide.........  1/8/97............  12/29/99, 64 FR
                                                                           72940.
C. Attainment/nonattainment       Statewide.........  1/8/97............  12/29/99, 64 FR
 Designations.                                                             72940.
D. Prevention of Significant      Statewide.........  1/8/97............  12/29/99, 64 FR
 Deterioration Designations.                                               72940.
E. New Source Review............  Statewide.........  1/8/97............  12/29/99, 64 FR
                                                                           72940.
----------------------------------------------------------------------------------------------------------------
                                  Section II State Air Quality Control Program
----------------------------------------------------------------------------------------------------------------
State Air Quality Control         Statewide.........  7/9/12............  10/22/12, 77 FR
 Program.                                                                  64425.
----------------------------------------------------------------------------------------------------------------
                                 Section III Area wide Pollutant Control Program
----------------------------------------------------------------------------------------------------------------
A. Statewide Carbon Monoxide      Statewide.........  6/5/08............  3/22/10, 75 FR
 Control Program.                                                          13436.
State Transportation Control      Statewide.........  1/1/00............  1/08/02, 67 FR 822
 Program.
B. Anchorage Transportation       Anchorage.........  1/4/02............  9/18/02, 67 FR
 Control Program.                                                          58711.
Anchorage Carbon Monoxide         Anchorage.........  9/20/11...........  3/3/14, 79 FR
 Maintenance Plan.                                                         11707.
Anchorage Second 10-year Carbon   Anchorage.........  4/22/13...........  3/3/14, 79 FR
 Monoxide Limited Maintenance                                              11707.
 Plan.
C. Fairbanks Transportation       Fairbanks.........  8/30/01...........  5/25/01, 66 FR
 Control Program.                                                          28836.
Fairbanks Carbon Monoxide         Fairbanks.........  9/29/10...........  1/10/12, 77 FR
 Maintenance Plan.                                                         1414.
Fairbanks Second 10-year Carbon   Fairbanks.........  4/22/13...........  8/9/13, 78 FR
 Monoxide Limited Maintenance                                              48611.
 Plan.
D. Particulate Matter...........  Statewide.........  10/15/91..........  8/13/93, 58 FR
                                                                           43084.
Eagle River PM10 Control Plan...  Eagle River.......  10/15/91..........  8/13/93, 58 FR
                                                                           43084.
Eagle River PM10 Limited          Eagle River.......  9/29/10...........  1/7/13, 78 FR 900.
 Maintenance Plan.
Mendenhall Valley PM10 Control    Mendenhall Valley.  6/22/93...........  3/24/94, 59 FR
 Plan.                                                                     13884.
Mendenhall Valley PM10 Limited    Mendenhall Valley.  5/14/09...........  5/9/13, 78 FR
 Maintenance Plan.                                                         27071.
E. Ice Fog......................  Statewide.........  1/18/80...........  7/5/83, 48 FR
                                                                           30623.
F. Open Burning.................  Statewide.........  4/4/11............  2/14/13, 78 FR
                                                                           10546.
G. Wood Smoke Pollution Control.  Statewide.........  11/15/83..........  4/24/84, 49 FR
                                                                           17497.
H. Lead Pollution Control.......  Statewide.........  11/15/83..........  1/3/84, 49 FR 67..
I. Transportation Conformity....  Statewide.........  12/05/94..........  9/27/95, 60 FR
                                                                           49765.
J. General Conformity...........  Statewide.........  12/05/94..........  9/27/95, 60 FR
                                                                           49765.

K. Area Wide Pollutant Control    Statewide.........  4/4/11............  2/14/13, 78 FR
 Program for Regional Haze.                                                10546.
----------------------------------------------------------------------------------------------------------------
                                     Section IV Point Source Control Program
----------------------------------------------------------------------------------------------------------------
A. Summary......................  Statewide.........  11/15/83..........  4/24/84, 49 FR
                                                                           17497.
B. State Air Quality Regulations  Statewide.........  11/15/83..........  4/24/84, 49 FR
                                                                           17497.
C. Local Programs...............  Statewide.........  11/15/83..........  4/24/84, 49 FR
                                                                           17497.
D. Description of Source          Statewide.........  11/15/83..........  4/24/84, 49 FR
 Categories and Pollutants.                                                17497.
E. Point Source Control.........  Statewide.........  11/15/83..........  4/24/84, 49 FR
                                                                           17497.
F. Facility Review Procedures...  Statewide.........  9/12/88...........  7/31/89, 54 FR
                                                                           31522.
G. Application Review and Permit  Statewide.........  11/15/83..........  4/24/84, 49 FR
 Development.                                                              17497.
H. Permit Issuance Requirements.  Statewide.........  11/15/83..........  4/24/84, 49 FR
                                                                           17497.
----------------------------------------------------------------------------------------------------------------
                                        Section V Ambient Air Monitoring
----------------------------------------------------------------------------------------------------------------
A. Purpose......................  Statewide.........  1/18/80...........  4/15/81, 46 FR
                                                                           21994.
B. Completed Air Monitoring       Statewide.........  1/18/80...........  4/15/81, 46 FR
 Projects.                                                                 21994.
C. Air Monitoring Network.......  Statewide.........  1/18/80; 7/11/94..  4/15/81, 46 FR
                                                                           21994; 4/5/95, 60
                                                                           FR 17237.
E. Annual Review................  Statewide.........  1/18/80...........  4/15/81, 46 FR
                                                                           21994.
----------------------------------------------------------------------------------------------------------------
                        State of Alaska Air Quality Control Plan: Volume III. Appendices
----------------------------------------------------------------------------------------------------------------
                                  Section II State Air Quality Control Program
----------------------------------------------------------------------------------------------------------------
A. State Air Statutes...........  Statewide.........  12/11/06..........  3/22/10, 75 FR      except 46.03.170.
                                                                           13436.
In Situ Burning Guidelines......  Statewide.........  4/4/11............  2/14/13, 78 FR
                                                                           10546.
State Attorney General Opinions   Statewide.........  12/11/06..........  3/22/10, 75 FR
 on Legal Authority.                                                       13436.
B. Municipality of Anchorage....  Anchorage.........  4/22/13...........  3/3/14, 79 FR
                                                                           11707.
C. Fairbanks North Star Borough.  Fairbanks.........  12/11/06..........  3/22/10, 75 FR
                                                                           13436.
CAA Section 110 Infrastructure    Statewide.........  7/9/12............  10/22/12, 77 FR
 Certification Documentation and                                           64425.
 Supporting Documents.
----------------------------------------------------------------------------------------------------------------
                                 Section III Area wide Pollutant Control Program
----------------------------------------------------------------------------------------------------------------
A. I/M Program Manual...........  Statewide.........  6/5/08............  3/22/10, 75 FR
                                                                           13436.
B. Municipality of Anchorage....  Anchorage.........  4/22/13...........  3/3/14, 79 FR
                                                                           11707.
C. Fairbanks....................  Fairbanks.........  4/22/13...........  8/9/13, 78 FR
                                                                           48611.
D. Particulate Matter--PM10       Anchorage, Eagle    10/15/91; 9/29/10;  8/13/93, 58 FR
 Supporting Documents.             River, Mendenhall   5/14/09.            43084; 1/7/13, 78
                                   Valley.                                 FR 900; 5/9/13,
                                                                           78 FR 27071.
G. Ordinance of the City and      Juneau............  11/15/83..........  4/24/84, 49 FR
 Borough of Juneau.                                                        17497.
H. Support Documents for Lead     Statewide.........  11/15/83..........  1/3/84, 49 FR 67..
 Plan.
----------------------------------------------------------------------------------------------------------------
                                     Section IV Point Source Control Program
----------------------------------------------------------------------------------------------------------------
1. PSD Area Classification and    Statewide.........  11/15/83..........  4/24/84, 49 FR
 Reclassification.                                                         17497.
2. Compliance Assurance.........  Statewide.........  11/15/83..........  4/24/84, 49 FR
                                                                           17497.
3. Testing Procedures...........  Statewide.........  11/15/83..........  4/24/84, 49 FR
                                                                           17497.
----------------------------------------------------------------------------------------------------------------

                                        Section V Ambient Air Monitoring
----------------------------------------------------------------------------------------------------------------
ADEC Ambient Analysis Procedures  Statewide.........  11/15/83..........  4/24/84, 49 FR
                                                                           17497.
----------------------------------------------------------------------------------------------------------------
                                  Section VI Small Business Assistance Program
----------------------------------------------------------------------------------------------------------------
Section VI Small Business         Statewide.........  4/18/94...........  9/5/95, 60 FR
 Assistance Program.                                                       46024.
----------------------------------------------------------------------------------------------------------------
                                            Section 128 Requirements
----------------------------------------------------------------------------------------------------------------
Public Official Financial         Statewide.........  7/9/12............  10/22/12, 77 FR
 Disclosure (2 AAC 50.010-2 AAC                                            64425.
 50.200).
Executive Branch Code of Ethics   Statewide.........  7/9/12............  10/22/12, 77 FR
 (9 AAC 52.010-9 AAC 52.990).                                              64425.
----------------------------------------------------------------------------------------------------------------
                            Section 110(a)(2) Infrastructure and Interstate Transport
----------------------------------------------------------------------------------------------------------------
Interstate Transport              Statewide.........  2/7/08............  10/15/08, 73 FR     Approves SIP for
 Requirements--1997 8-Hour Ozone                                           60957.              purposes of CAA
 and PM2.5 NAAQS.                                                                              section
                                                                                110(a)(2)(D)(i)
                                                                                for the 1997 8-
                                                                                hour ozone and
                                                                                1997 PM2.5 NAAQS.
110(a)(2) Infrastructure          Statewide.........  7/9/12............  10/22/12, 77 FR     Approves SIP for
 Requirements--1997 ozone                                                  64425.              purposes of CAA
 standard.                                                                                sections
                                                                                110(a)(2)(A),
                                                                                (B), (C),
                                                                                (D)(ii), (E),
                                                                                (F), (G), (H),
                                                                                (J), (K), (L),
                                                                                and (M) for the
                                                                                1997 8-hour ozone
                                                                                NAAQS.
----------------------------------------------------------------------------------------------------------------

Sec.  52.97  [Removed and Reserved]

0
4. Remove and reserve Sec.  52.97.

Sec.  52.98  [Removed and Reserved]

0
5. Remove and reserve Sec.  52.98.
[FR Doc. 2014-08048 Filed 4-9-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 26 (Wednesday, February 7, 2018)]
[Notices]
[Pages 5440-5441]
[FR Doc No: 2018-02419]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA 2015-E-3854 and FDA-2015-E-3855]

Determination of Regulatory Review Period for Purposes of Patent
Extension; BLINCYTO

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for BLINCYTO and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human
biological product.

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
9, 2018. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by August 6, 2018.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 9, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 9, 2018. Comments received by
mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

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 Nos.
FDA 2015-E-3854 and FDA-2015-E-3855 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; BLINCYTO.'' Received
comments, those filed in a timely manner (see ADDRESSES) will be placed
in the dockets 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 Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human biological
product and continues until FDA grants permission to market the
biological

product. Although only a portion of a regulatory review period may
count toward the actual amount of extension that the Director of USPTO
may award (for example, half the testing phase must be subtracted as
well as any time that may have occurred before the patent was issued),
FDA's determination of the length of a regulatory review period for a
human biological product will include all of the testing phase and
approval phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human biologic product BLINCYTO
(blinatumomab). BLINCYTO is indicated for the treatment of Philadelphia
chromosome-negative relapsed or refractory B-cell precuror acute
lymphoblastic leukemia. This indication is approved under accelerated
approval. Continued approval for this indication may be contingent upon
verification of clinical benefit in subsequent trials. Subsequent to
this approval, the USPTO received patent term restoration applications
for BLINCYTO (U.S. Patent Nos. 7,112,324 and 8,007,796) from Amgen
Research (Munich) GMBH, and the USPTO requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated October 30, 2015, FDA advised the USPTO that this human
biological product had undergone a regulatory review period and that
the approval of BLINCYTO represented the first permitted commercial
marketing or use of the product. Thereafter, the USPTO requested that
FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
BLINCYTO is 2,850 days. Of this time, 2,774 days occurred during the
testing phase of the regulatory review period, while 76 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: February
15, 2007. FDA has verified the applicant's claims that the date the
investigational new drug application became effective was on February
15, 2007.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): September 19, 2014. FDA has verified the
applicant's claim that the biologics license application (BLA) for
BLINCYTO (BLA 125557) was initially submitted on September 19, 2014.
    3. The date the application was approved: December 3, 2014. FDA has
verified the applicant's claim that BLA 125557 was approved on December
3, 2014.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 1,462 or 432 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: January 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02419 Filed 2-6-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 119 (Tuesday, June 21, 2016)]
[Notices]
[Pages 40315-40316]
[FR Doc No: 2016-14562]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1593]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Device
Accessories

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995 (the PRA).

DATES: Fax written comments on the collection of information by July
21, 2016.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-NEW and
title ``Medical Device Accessories.'' Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Medical Device Accessories--OMB Control Number 0910-NEW

    The draft guidance encourages manufacturers and other parties to
utilize the process defined in section 513(f)(2) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) to request risk- and regulatory
control-based classifications of new types of accessories. This process
provides a pathway to class I or class II classification for accessory
devices for which general controls, or general and special controls,
provide a reasonable assurance of safety and effectiveness, but for
which there is no legally marketed predicate device.
    In accordance with section 513(f)(2) of the FD&C Act, manufacturers
and other parties may submit a de novo requesting FDA to make a
classification determination for the accessory device according to the
criteria in section 513(a)(1) of the FD&C Act. The de novo must include
a description of the device and detailed information and reasons for
any recommended classification (see section 513(f)(2)(A)(v) of the FD&C
Act).
    In the Federal Register of January 20, 2015 (80 FR 2710), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. We received a total of 12 comments on the
guidance. Of these the following were related to the information
collection:
    Two comments raised concerns regarding the possible difficulties
for manufacturers to submit a de novo for new accessories and for risk-
and regulatory control-based classification of accessories that were
approved under the premarket approval application (PMA) for the parent
medical devices. One comment questioned whether FDA considered the
possible ``practical and economic impact'' of the proposed definition
of ``accessories'' that may result in manufacturers being obligated to
list some components as accessories for FDA's registration and listing
process. The second comment anticipates that ``few companies are likely
to pursue this route given the associated costs and minimal advantage
in time to market.'' Neither comment specifically discusses the
potential PRA burden hours of voluntarily submitting a de novo
application; however, it may be inferred that this could impact their
resources under the PRA for submitting a de novo.
    Also, FDA is not proposing to limit or remove any mechanism that
currently exists for manufacturers to obtain marketing authorization
for accessories. De novos are typically less burdensome than PMAs for
the purpose of classifying a new accessory. Furthermore, if a
manufacturer wishes for an accessory to remain in the same regulatory
class as the parent device, that manufacturer may continue to submit
the accessory for clearance or

approval under the submission type applicable to the parent device.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                              Activity                                  Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Accessory classification de novo request...........................               8                1                8              180            1,440
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Respondents are medical device manufacturers seeking to market
device accessories. Of the approximately 41 de novo applications
received per year, only 2 have been associated with accessories. With
heightened awareness of the availability of the de novo pathway for
accessories, we expect to receive four to six additional accessories
applications per year. Therefore, we estimate that we will receive
approximately eight accessory classification de novo requests per year.
Based on estimates by FDA administrative and technical staff who are
familiar with the proposed submission process for accessory
classification requests and on our burden estimate for a similar
information collection request (see ``De Novo Classification Process
Evaluation of Automatic Class III Designation; Draft Guidance for
Industry and Food and Drug Administration Staff; Availability,'' 79 FR
47651 at 47653, August 14, 2014), we estimate that the submission
process for each accessory classification request will take
approximately 180 hours.
    The draft guidance also refers to previously approved collections
of information found in FDA regulations. The collections of information
in 21 CFR parts 801 and 809 have been approved under OMB control number
0910-0485; the collections of information in 21 CFR part 807, subpart E
have been approved under OMB control number 0910-0120; the collections
of information in 21 CFR part 814 have been approved under OMB control
number 0910-0231; and the collections of information in 21 CFR part
860, subpart C, have been approved under OMB control number 0910-0138.

    Dated: June 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14562 Filed 6-20-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 93 (Monday, May 14, 2012)]
[Notices]
[Pages 28413-28414]
[FR Doc No: 2012-11536]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66945; File No. SR-NYSEArca-2012-19]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of
Designation of a Longer Period for Commission Action on Proposed Rule
Change To Amend Commentary .01 to NYSE Arca Rule 6.35

May 8, 2012.
    On March 9, 2012, NYSE Arca, Inc. (``Exchange'') filed with the
Securities and Exchange Commission (``Commission''), pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4 thereunder,\2\ a proposed rule change to amend
Commentary .01 to NYSE Arca Rule 6.35 and to make non-substantive
changes to NYSE Arca Rules 6.35, 6.37, 6.84, and 10.12. The proposed
rule change was published for comment in the Federal Register on March
28, 2012.\3\ The Commission received no comments on this proposal.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 66642 (March 22,
2012), 77 FR 18875.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \4\ provides that within 45 days of the
publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day for this filing is May 12, 2012. The Commission is extending
this 45-day time period.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission finds it appropriate to designate a longer period
within which to take action on the proposed rule change so that it has
sufficient time to consider this proposed rule change, which would
allow a market maker's trades effected on the trading floor to
accommodate cross trades executed pursuant to NYSE Arca Rule 6.47 to
count toward the requirement that at least 75% of a market maker's
trading activity be effected in classes within the market maker's
appointment.
    Accordingly, the Commission, pursuant to Section 19(b)(2) of the
Act,\5\ designates June 26, 2012 as the date by which the Commission
should either

approve or disapprove, or institute proceedings to determine whether to
disapprove, the proposed rule change (File No. SR-NYSEArca-2012-19).
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
---------------------------------------------------------------------------

    \6\ 17 CFR 200.30-3(a)(31).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-11536 Filed 5-11-12; 8:45 am]
BILLING CODE 8011-01-P