[Federal Register Volume 84, Number 133 (Thursday, July 11, 2019)]
[Rules and Regulations]
[Pages 33002-33004]
[FR Doc No: 2019-14692]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2018-0761; FRL-9996-38-Region 9]

Air Plan Approval; Arizona; Regional Haze Progress Report

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving
Arizona's Regional Haze Progress Report (``Progress Report'' or
``Report''), submitted on November 12, 2015, as a revision to its state
implementation plan (SIP). This SIP revision addresses requirements of
the Clean Air Act (CAA) and the EPA's rules that require states to
submit periodic reports describing progress toward reasonable progress
goals (RPGs) established for regional haze and a determination of
adequacy of the state's existing regional haze plan. The EPA is
approving the Report on the basis that it addresses the progress report
and adequacy determination requirements for the first implementation
period for regional haze.

DATES: This rule is effective on August 12, 2019.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R09-OAR-2018-0761. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, i.e.,
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Certain other material, such as

copyrighted material, is not placed on the internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available at https://www.regulations.gov, or please
contact the person identified in the FOR FURTHER INFORMATION CONTACT
section for additional availability information.

FOR FURTHER INFORMATION CONTACT: Panah Stauffer, Air Planning Office
(ARD-2), EPA Region IX, 75 Hawthorne Street, San Francisco, CA 94105,
(415) 972-3247<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean the EPA.

Table of Contents

I. Background Information
II. Public Comment
III. Final Action
IV. Statutory and Executive Order Reviews

I. Background Information

    On March 27, 2019, the EPA published a notice of proposed
rulemaking (NPRM) proposing to approve the Progress Report submitted by
the Arizona Department of Environmental Quality (ADEQ) on November 12,
2015.\1\ A detailed discussion of the Report and the EPA's rationale
for approving the SIP revision is provided in the NPRM and will not be
restated here.
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    \1\ 84 FR 11455.
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II. Public Comment

    The EPA's proposed action provided a 30-day public comment period.
During this period, we received no comments.

III. Final Action

    The EPA is approving the Progress Report, submitted by ADEQ on
November 12, 2015, as meeting the applicable requirements of the CAA
and the federal Regional Haze Rule, as set forth in 40 CFR 51.308(g),
as a revision to the Arizona SIP. The EPA is approving Arizona's
determination that the existing regional haze plan is adequate to meet
the state's visibility goals and requires no substantive revision at
this time, as set forth in 40 CFR 51.308(h).
    We have also determined that Arizona fulfilled the requirements in
40 CFR 51.308(i) regarding state coordination with federal land
managers.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     is not an Executive Order 13771 regulatory action because
this action is not significant under Executive Order 12866;
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     does not provide the EPA with the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible
methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).
    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. The EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register.
    A major rule cannot take effect until 60 days after it is published
in the Federal Register. This action is not a ``major rule'' as defined
by 5 U.S.C. 804(2). Under section 307(b)(1) of the CAA, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by September 9, 2019. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

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

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

    Dated: June 27, 2019.
Deborah Jordan,
Acting Regional Administrator, EPA Region IX.
    Part 52, chapter I, title 40 of the Code of Federal Regulations is
amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart D--Arizona

0
2. In Sec.  52.120 (e), amend Table 1 by adding an entry for ``Arizona
State Implementation Plan Revision: Regional Haze 5-Year Progress
Report'' before the entry for ``Arizona State Implementation Plan
Revision under Clean Air Act Section 110(a)(1) and (2); Implementation
of the 2008 Lead National Ambient Air Quality Standards, excluding the
appendices.''
    The addition reads as follows:

Sec.  52.120  Identification of plan.

* * * * *
    (e) * * *

                                           Table 1--EPA-Approved Non-Regulatory and Quasi-Regulatory Measures
                           [Excluding certain resolutions and statutes, which are listed in tables 2 and 3, respectively] \1\
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                                          Applicable geographic or
       Name of SIP provision            nonattainment area or title/           State submittal date           EPA approval date         Explanation
                                                  subject
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                                             The State of Arizona Air Pollution Control Implementation Plan
                        Clean Air Act Section 110(a)(2) State Implementation Plan Elements (Excluding Part D Elements and Plans)
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
Arizona State Implementation Plan    State-wide.......................  November 12, 2015................  July 11, 2019, [Insert
 Revision: Regional Haze 5-Year                                                                             Federal Register
 Progress Report, excluding                                                                                Citation].
 Appendix A-Public Process.

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Table 1 is divided into three parts: Clean Air Act Section 110(a)(2) State Implementation Plan Elements (excluding Part D Elements and Plans), Part
  D Elements and Plans (other than for the Metropolitan Phoenix or Tucson Areas), and Part D Elements and Plans for the Metropolitan Phoenix and Tucson
  Areas.

* * * * *

0
3. Section 52.145 is amended by adding paragraph (n) to read as
follows:

Sec.  52.145   Visibility protection.

* * * * *
    (n) Approval. On November 12, 2015, the Arizona Department of
Environmental Quality submitted the ``Arizona State Implementation Plan
Revision: Regional Haze 5-Year Progress Report'' (``Progress Report'').
The Progress Report meets the requirements of the Regional Haze Rule in
40 CFR 51.308.

[FR Doc. 2019-14692 Filed 7-10-19; 8:45 a.m.]
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			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on November 25, 2002

NOTICE OF ACTION TAKEN -- DOCKET OST 1996-1501

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant:  AVEMEX, S.A. de C.V.
                                         Date Filed: October 9, 2002

Relief requested:  Exemption from 49 USC section 41301 to permit the
applicant to continue to conduct passenger charter operations between
Mexico and the United States, and other passenger charter operations in
accordance with 14 CFR Part 212, using small equipment.

If renewal, date and citation of last action:  November 29, 2001, in
this Docket.

Applicant representative(s):  Lee A. Bauer,<PHONE_NUMBER>           DOT
analyst:  Allen F. Brown,<PHONE_NUMBER>

Responsive pleadings:  None.

	DISPOSITION

Action:  Approved.
         Action date:  November 25, 2002

Effective dates of authority granted:  November 25, 2002, through
November 30, 2003.

Basis for approval (bilateral agreement/reciprocity):  United
States-Mexico Air Transport Services Agreement of August 15, 1960, as
amended and extended (Agreement).

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations indicated:  Standard exemption
conditions.

Special conditions/Partial grant/Denial basis/Remarks:  In the conduct
of these operations, the carrier must adhere to all applicable
provisions of the U.S.-Mexico Agreement.  In the conduct of these
operations, the carrier may only use aircraft capable of carrying no
more than 60 passengers and having a maximum payload capacity of no more
than 18,000 pounds (small equipment).  The above grant includes
authority to conduct Third and Fourth Freedom charter operations.  While
we have subjected, consistent with the provisions of the Agreement,
Mexican carriers conducting charter operations with large aircraft to
prior approval or submission of notice for their Third and Fourth
Freedom charters, we determined that any such requirement was not
necessary on public interest grounds in this case, since the carrier
will be conducting these operations solely with small aircraft.  (Other
charter operations to/from the United States under this authority,
however, are subject to prior approval under 14 CFR Part 212.)  Further,
we are continuing to allow Mexican carriers conducting passenger
charters using small equipment to make stopovers in the United States in
the conduct of such operations.

Action taken by:   Paul L. Gretch, Director

		      Office of International Aviation

________________________________________________________________________
________________________________________________________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) the applicant was qualified to perform its proposed
operations; (3) grant of the authority was consistent with the public
interest; and (4) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted/deferred/dismissed, we denied all requests in
the referenced Docket.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for
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[Federal Register Volume 82, Number 221 (Friday, November 17, 2017)]
[Notices]
[Pages 54349-54351]
[FR Doc No: 2017-24836]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6154]

Evaluation of Devices Used With Regenerative Medicine Advanced
Therapies; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft document entitled ``Evaluation of Devices
Used with Regenerative Medicine Advanced Therapies; Draft Guidance for
Industry.'' The draft guidance document, when finalized, will provide
device manufacturers, applicants, and sponsors engaged in the
development of regenerative medicine therapies, with our current
thinking regarding evaluation of devices used in the recovery,
isolation or delivery of regenerative advanced therapies, which FDA
generally refers to as ``regenerative medicine advanced therapies'' or
``RMATs.'' Specifically, as required by the 21st Century Cures Act
(Cures Act),

the draft guidance addresses how FDA intends to simplify and streamline
its application of regulatory requirements for combination device and
cell or tissue products; what, if any, intended uses or specific
attributes would result in a device used with a regenerative therapy
product to be classified as a class III device; when a device may be
limited to a specific intended use with only one particular type of
cell; and application of the least burdensome approach to demonstrate
how a device may be used with more than one cell type.

DATES: Submit either electronic or written comments on the draft
guidance by February 15, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-D-6154 for ``Evaluation of Devices Used with Regenerative
Medicine Advanced Therapies; Draft Guidance for Industry.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Office of Communication, Outreach and Development, Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist the office in
processing your requests. The draft guidance may also be obtained by
mail by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.

FOR FURTHER INFORMATION CONTACT: Tami Belouin, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled
``Evaluation of Devices Used with Regenerative Medicine Advanced
Therapies; Draft Guidance for Industry.'' The draft guidance, when
finalized, will provide device manufacturers, applicants, and sponsors
engaged in the development of regenerative medicine therapies, with our
current thinking regarding evaluation of devices used in the recovery,
isolation or delivery of regenerative advanced therapies, which FDA
generally refers to as ``regenerative medicine advanced therapies'' or
``RMATs''. Specifically, as required by section 3034 of the 21st
Century Cures Act (Pub. L. 114-255) (Cures Act), the draft guidance
addresses how FDA intends to simplify and streamline its application of
regulatory requirements for combination device and cell or tissue
products; what, if any, intended uses or specific attributes would
result in a device used with a regenerative therapy product to be
classified as a class III device; when a device may be limited to a
specific intended use with only one particular type of cell; and
application of the least burdensome approach to demonstrate how a
device may be used with more than one cell type.
    The issuance of this draft guidance fulfills the statutory
requirement set forth in section 3034(a) of the Cures Act. Furthermore,
the Agency intends for this document, when finalized, to serve as a
source of information about the Agency's current thinking about a wide
range of concepts related to the regulation of devices, as they apply
to devices used in the recovery, isolation, and delivery of RMATs. FDA
has provided general information in the

draft guidance in lieu of specific examples because the Agency does not
yet possess a wide body of experience regarding the evaluation of
devices used with RMATs, given the recent establishment of the RMAT
designation program in the Cures Act.
    As we gain more experience with such devices, we intend to
incorporate such information into the final guidance. To that end,
although you are welcome to comment on any aspect of the guidance, we
encourage commenters to support their comments with information related
to specific marketed devices or types of devices that are used in the
recovery, isolation, and delivery of RMATs.
    Elsewhere in this issue of the Federal Register, FDA is announcing
the availability of a document entitled ``Expedited Programs for
Regenerative Medicine Therapies for Serious Conditions; Draft Guidance
for Industry.'' Among other things, that document provides information
about the RMAT designation program.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on Evaluation of
Devices Used with Regenerative Medicine Advanced Therapies. It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 807 have been approved under
OMB control number 0910-0120; the collections of information in 21 CFR
part 812 have been approved under OMB control number 0910-0078; 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 1271 have been approved under OMB control number 0910-0543.

III. Electronic Access

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

    Dated: November 13, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24836 Filed 11-16-17; 8:45 am]
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