[Federal Register Volume 80, Number 207 (Tuesday, October 27, 2015)]
[Notices]
[Page 65770]
[FR Doc No: 2015-27196]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]

Joint Meeting of the Pulmonary-Allergy Drugs Advisory Committee
and the Drug Safety and Risk Management Advisory Committee; Notice of
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committees: Pulmonary-Allergy Drugs Advisory Committee and
the Drug Safety and Risk Management Advisory Committee.
    General Function of the Committees: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on December 10, 2015, from
8 a.m. to 4 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    Contact Person: Cindy Hong, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, Rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX: 301-847-
8533<EMAIL_ADDRESS>or FDA Advisory Committee Information Line, 1-
800-741-8138<PHONE_NUMBER> in the Washington, DC area). A notice in the
Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    Agenda: The committees will discuss the safety of codeine in
children 18 years of age and younger. Codeine (most often in
combination with acetaminophen) is used for the treatment of pain in
children; however, it is contraindicated for the management of pain
after tonsillectomy and/or adenoidectomy. Codeine (in combination with
other medicines) is used for the relief of cough associated with upper
respiratory allergies or the common cold in children.
    Codeine is available by prescription and also through the over-the-
counter (OTC) Drug Monograph for Cold, Cough, Allergy, Bronchodilator,
and Antiasthmatic Drug Products (21 CFR 341.14, 21 CFR 341.74, and 21
CFR 341.90).
    The focus of the meeting will be the risk of serious adverse
events, such as respiratory depression and death, including reports in
children who are CYP2D6 ultra-rapid metabolizers. The committees will
discuss whether the use of codeine in children should be restricted
further beyond the current contraindication described previously and
whether codeine should be available through the OTC Drug Monograph.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committees.
Written submissions may be made to the contact person on or before
November 24, 2015. Oral presentations from the public will be scheduled
between approximately 11 a.m. and 12 p.m. Those individuals interested
in making formal oral presentations should notify the contact person
and submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before November 16, 2015. Time allotted
for each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by November 17, 2015.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Cindy Hong at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: October 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27196 Filed 10-26-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 194 (Friday, October 7, 2022)]
[Notices]
[Pages 61052-61054]
[FR Doc No: 2022-21841]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0030]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Human Drug
Compounding Under Sections 503A and 503B of the Federal Food, Drug, and
Cosmetic Act

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.

DATES: Submit written comments (including recommendations) on the
collection of information by November 7, 2022.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0800. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

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.

Human Drug Compounding Under Sections 503A and 503B of the Federal
Food, Drug, and Cosmetic Act

OMB Control Number 0910-0800--Revision

    This information collection helps support implementation of
sections 503A (21 U.S.C. 353a) and 503B (21 U.S.C. 353b) of the Federal
Food Drug and Cosmetic Act (FD&C Act), which govern requirements for
pharmacy compounding and outsourcing facilities, respectively. For
efficiency of Agency operations, we are revising the information
collection to include related reporting activities currently approved
under OMB control number 0910-0827. Specifically, upon electing and in
order to become an outsourcing facility, respondents must register
under section 503B of the FD&C Act and submit certain reports and
updates to FDA. The information is required to be submitted by
electronic means unless otherwise exempt, and prepared in such form and
manner as the Secretary of the Department of Health and Human Services
may prescribe through regulation or guidance.
    In the guidance for industry entitled ``Electronic Drug Product
Reporting for Human Drug Compounding Outsourcing Facilities Under
Section 503B of the Federal Food, Drug, and Cosmetic Act'' (December
2016), available on our website at https://www.fda.gov/media/90173/download, we explain how facilities that elect to register with FDA as
outsourcing facilities are to submit drug product reports, consistent
with section 503B of the FD&C Act. The guidance document describes who
must report and what information must be provided to FDA. The guidance
document also explains that drug compounding reports must be submitted
in structured product labeling (SPL) format using FDA's electronic
submissions system and discusses the consequences of outsourcing
facilities' failure to submit reports.
    In the Federal Register of June 17, 2022 (87 FR 36507) we published
a 60-day notice requesting public comment on the proposed collection of
information. No comments were received.
    We estimate the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
 Section 503B of the FD&C Act      Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Initial product reports.......               3              53             159  0.0833 (5                  13.25
                                                                                minutes).
Waiver request from electronic               1               1               1  1...............               1
 submission of initial product
 reports.
June product reports..........              75              53           3,975  0.025 (1.5                99.375
                                                                                minutes).
December product reports......              75              53           3,975  0.025 (1.5                99.375
                                                                                minutes).
Waiver request from electronic               1               1               1  1...............               1
 submission of product reports.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................             214
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Respondents to this collection of information are outsourcing
facilities. Based upon our evaluation of the information collection, we
have adjusted our estimate downward by 16 hours (from 230 to 214)
annually to reflect more recent Agency data. We estimate that each year
three outsourcing facilities will submit a product report upon initial
registration under section 503B of the FD&C Act. We estimate that twice
each year 75 outsourcing facilities will submit a report identifying
all human drugs compounded in the facility in the previous 6 months.
For the purposes of this estimate, each product's SPL submission is
considered a separate product response, and therefore each facility's
product report will include multiple product responses. We estimate
that each facility will average 53 product responses. We expect each
product report will consist of multiple product responses per facility
and estimate that preparing and submitting this information
electronically may take up to 5 minutes for each initial product
response.
    Assuming an average of 53 product responses per facility, we
estimate that, for semiannual reports, preparing and submitting this
information electronically will take 1.5 minutes per product response.
Our burden estimate for semiannual product report submissions is lower
than for initial product reports because outsourcing facilities can
save each product response once initially created and submitted. For
subsequent reports, an outsourcing facility may resubmit the same
file(s) after changing the RootID and version number (both SPL
metadata), effective date (to identify the reporting period), and the
number of units produced, along with other data as appropriate, to
appropriate values for the reporting period. Furthermore, if a product
was not compounded during a particular reporting period, no product
response would be sent for that product during that reporting period.
    We expect to receive no more than one waiver request from the
electronic submission process for initial product reports and
semiannual reports, and that each waiver request will take 60 minutes
to prepare and submit.

    Dated: September 30, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-21841 Filed 10-6-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: May 14, 2008 (Volume 73, Number 94)]
[Rules and Regulations]
[Page 27727-27728]
[DOCID:fr14my08-4]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 111

[Docket No. FDA-2008-N-0152] (Formerly Docket No. 1996N-0417)
RIN 0910-AB88

Current Good Manufacturing Practice in Manufacturing, Packaging,
Labeling, or Holding Operations for Dietary Supplements; Technical
Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a final
rule that appeared in the Federal Register of June 25, 2007 (72 FR
34752). The final rule established current good manufacturing practice
(CGMP) requirements in manufacturing, packaging, labeling, or holding
operations for dietary supplements. The final rule was published with
an inadvertent error in the codified section. This document corrects
that error. This action is being taken to improve the accuracy of the
agency's regulations.

DATES: This rule is effective May 14, 2008.

FOR FURTHER INFORMATION CONTACT: Vasilios H. Frankos, Center for Food
Safety and Applied Nutrition (HFS-810), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of June 25, 2007 (72
FR 34752), FDA established CGMP requirements in manufacturing,
packaging, labeling, or holding operations for dietary supplements
(part 111 (21 CFR part 111)). In the codified section of the rule,
Sec.  111.75(c)(3) provides that ``You must provide adequate
documentation of your basis for determining compliance with the
specification(s) selected under paragraph (c)(1) of this section,
through the use of appropriate tests or examinations conducted under
paragraph (c)(2) of this section, will ensure that your finished batch
of the dietary supplement meets all product specifications for
identity, purity, strength, and composition, and the limits on those
types of contamination that may adulterate, or that may lead to the
adulteration of, the dietary supplement'' (72 FR 34752 at 34949). Due
to an inadvertent error, the word ``that'' was omitted between
``determining'' and ``compliance.'' This document corrects that error.

List of Subjects in 21 CFR Part 111

    Dietary foods, Drugs, Foods, Packaging and containers.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
111 is amended as follows:

PART 111--CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING,
PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS

0
1. The authority citation for 21 CFR part 111 continues to read as
follows:

    Authority: 21 U.S.C. 321, 342, 343, 371, 374, 381, 393; 42
U.S.C. 264.

0
2. Section 111.75 is amended by revising paragraph (c)(3) to read as
follows:

Sec.  111.75  What must you do to determine whether specifications are
met?

* * * * *
    (c) * * *

    (3) You must provide adequate documentation of your basis for
determining that compliance with the specification(s) selected under
paragraph (c)(1) of this section, through the use of appropriate tests
or examinations conducted under paragraph (c)(2) of this section, will
ensure that your finished batch of the dietary supplement meets all
product specifications for identity, purity, strength, and composition,
and the limits on those types of contamination that may adulterate, or
that may lead to the adulteration of, the dietary supplement; and
* * * * *

    Dated: May 7, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-10727 Filed 5-13-08; 8:45 am]

BILLING CODE 4160-01-S


                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                                  REGION III
                               1650 Arch Street
                       Philadelphia, Pennsylvania  19103

DATE:           March 20, 2014
SUBJECT:    Technical Support Document (TSD) for the State of Maryland Implementation Plan for Section 110(a)(2) Infrastructure Requirements for the 2008 Lead (Pb) National Ambient Air Quality Standards

FROM:	Ruth Knapp /s/, Environmental Protection Specialist
                        Office of Air Program Planning

TO:		File

THRU:	 Cristina Fernandez /s/,
		 Associate Director, Office of Air Program Planning

A.   INTRODUCTION

 The U.S. Environmental Protection Agency (EPA) is taking action on the State of  Maryland State Implementation Plan (SIP) revisions submitted by the Maryland Department of the Environment (MDE) to meet the Clean Air Act (CAA) section 110(a)(2) requirements for the revised 2008 Lead National Ambient Air Quality Standard (NAAQS).

B.  BACKGROUND
2008 Lead NAAQS

On October 15, 2008, EPA revised the primary and secondary lead NAAQS from 1.5 micrograms per cubic meter (ug/m[3]) to 0.15 ug/m[3].  Section 110(a) of the CAA requires states to submit SIPs that provide for the implementation, maintenance, and enforcement of new or revised NAAQS within three years following the promulgation of such NAAQS.  Section 110(a) of the CAA imposes the obligation upon states to make a SIP submission to EPA for a new or revised NAAQS.  For the 2008 lead NAAQS, states typically have met many of the basic program elements required in section 110(a)(2) of the CAA through earlier SIP submissions in connection with previous lead standards.  Section 110(a)(2) of the CAA lists specific elements that states must meet or continue to meet in these SIP submissions.  The requirements include SIP infrastructure elements such as requirements for modeling, monitoring, and emissions inventories that are designed to assure attainment and maintenance of the NAAQS.  Section 110(a)(2) of the CAA infrastructure elements (A) through (M) are listed in EPA's memorandum from Stephen D. Page, Director, Office of Air Quality Planning and Standards to the Regional Air Division Directors, Regions 1-10, "Guidance on Infrastructure State Implementation Plan (SIP) Elements Required Under Sections 110(a)(1) and 110(a)(2) for the 2008 Lead (Pb) National Ambient Air Quality Standards (NAAQS)," October 14, 2011,  (hereafter referred to as "Lead Infrastructure Guidance").

C.  EPA REQUIREMENTS

As discussed above, for the 2008 lead NAAQS, states must provide SIP submissions, or provide certification that the existing SIP contains provisions addressing relevant infrastructure SIP elements from section 110(a)(2)(A) through (M) of the CAA.  To help states meet this statutory requirement, EPA issued the Lead Infrastructure Guidance, which listed the basic elements that states must include in their SIPs.

D.  STATE'S SUBMITTAL

To satisfy the requirements of section 110(a)(1) and (2) of the CAA for the 2008 lead NAAQS, MDE submitted two SIP revisions in accordance with the Lead Infrastructure Guidance.  The first lead infrastructure SIP revision was submitted to EPA on January 3, 2013, and a supplemental revision was submitted on August 14, 2013.  EPA is acting on both submittals and is acting on all elements except 110(a)(2)(I) and portions of elements that pertain to Part D nonattainment area requirements.

E.  EVALUATION OF STATE SUBMITTAL

1.  Section 110(a)(2)(A)

According to the lead infrastructure submittal of January 3, 2013 and Maryland's current SIP, enforceable emission limitations and other control measures are found in portions of the Maryland SIP including, but not limited to, COMAR 26.11.01, 26.11.02, 26.11.04, 26.11.06 and 26.11.17.  Source specific rules are listed in 40 CFR 52. 1070(d) and approved plans are in 40 CFR 52.1070(e).  Based upon EPA's review of the January submittal, the Lead Infrastructure Guidance,  and Maryland's current SIP,  EPA finds that Maryland has met its obligations pursuant to110(a)(2)(A) of the CAA.

EPA does not consider SIP requirements triggered by the nonattainment area mandates in part D of Title I of the CAA to be governed by the submission deadline of section 110(a)(1).  Nevertheless, the State may have included some previous EPA-approved SIP provisions originally submitted in response to part D in its submission documenting its compliance with the requirements of sections 110(a)(1) and (2) of the CAA.  For the purposes of this rulemaking action, EPA has reviewed the above identified Maryland submittals, including any rules originally submitted in response to part D, or references thereto, solely for the purposes of determining whether such submittals support a finding that the state has met the basic infrastructure requirements under section 110(a)(2).

In this rulemaking action, EPA is not proposing to approve or disapprove any existing Maryland provisions with regard to excess emissions during startup, shutdown, and malfunction (SSM) of operations at a facility.  EPA believes that a number of states have SSM provisions which are contrary to the CAA and existing EPA guidance (August 11, 1999 Steven Herman and Robert Perciasepe Guidance Memorandum, "State Implementation Plans: Policy Regarding Excess Emissions During Malfunctions, Startup, and Shutdown"), and the Agency is addressing such state regulations in a separate rulemaking. See 78 FR 12460.  In the meantime, EPA encourages any state having a deficient SSM provision which is contrary to the CAA and EPA guidance to take steps to correct it as soon as possible.

Also in this rulemaking action, EPA is not proposing to approve or disapprove any existing Maryland rules with regard to director's discretion or variance provisions.  EPA believes that a number of states have such provisions which are contrary to the CAA and existing EPA guidance (52 FR 45109, November 1987), and the Agency is addressing such state regulations in a separate rulemaking. See 78 FR 12460.  In the meantime, EPA encourages any state having director's discretion or variance provisions which are contrary to the CAA and EPA guidance to take steps to correct the deficiency as soon as possible.

2.  Section 110(a)(2)(B)

According to the January 2013 submittal and Maryland's current SIP, Maryland's authority to monitor can be found in §§2-103(b)(2) and 2-301(a)(1), Environment Article, Annotated Code of Maryland and in COMAR <IP_ADDRESS> (specifying methods of measuring ambient air quality levels shall be those specified in 40 CFR Parts 50, 53 and 58).

Maryland operates and maintains a network of ambient air monitors throughout the State.  All ambient air monitors in the Maryland network that are used to determine compliance with the NAAQS have been designated by EPA as either Reference or Equivalent monitors. All ambient air monitors in the Maryland network are subjected to the Quality Assurance requirements of 40 CFR Part 58 Appendix A.   In addition, all samplers are located at sites that have met the minimum siting requirements of Part 58, Appendix E.

In Maryland, no specific statutory authority is necessary to authorize data analysis or the submission of such data to EPA. Federal grant requirements establish the obligation to provide data to EPA.

In order to keep EPA informed of changes to the sampling network, MDE provides EPA Region III with prior notification of any planned changes to the network. As needed, details of these changes and anticipated approvals of the changes are communicated to EPA. Pursuant to 40 CFR Part 58, Subpart B, Section 58.10, MDE sends the EPA Regional Administrator an Annual Monitoring Network Plan for approval that details any modifications to the network. This plan also provides a description of each modification, the reason for each modification, and any other information relevant to the modifications. 40 CFR Section 58.10 also requires MDE (beginning July 1, 2010) to perform and submit to the EPA Regional Administrator an assessment of the Maryland ambient air monitoring network every five years to determine, at a minimum, if the network meets the monitoring objectives defined in 40 CFR Part 58, Appendix D.  The docket for this proposed rulemaking contains the most recent approval from EPA of the current monitoring network plan.
Maryland has.  MDE will continue to submit data to EPA's Air Quality System (AQS). MDE collects and reports to EPA ambient air quality data for lead as well as other NAAQS.  The reports comply with the federal requirements of 40 CFR 58.35.  As necessary, the submitted data is reviewed, edited, validated, and entered into the EPA AQS for updating pursuant to prescribed AQS procedures.  MDE analyzes such air quality data to determine attainment status or progress.

Based upon EPA's review of the January 2013 submittal, the Lead Infrastructure Guidance, and Maryland's current SIP, EPA finds that Maryland has met its obligations pursuant to 110(a)(2)(B) of the CAA.

3.  Section 110(a)(2)(C)

Maryland's statutory provisions for the enforcement of the provisions described in section 110(a)(2)(A) of the CAA are found at §§2-601- 2-614 of the Environment Article of the Annotated Code of Maryland.  Specific enforcement provisions for the items under section 110(a)(2)(A), above, may also be found in Maryland's SIP at 40 CFR 52.1070.

The Maryland SIP includes a SIP approved program to provide for regulation of modification and construction of stationary sources within the State, including Maryland's permitting program for part C of Title I of the CAA.

          * Maryland's permit to construct and Prevention of Significant Deterioration (PSD) approval program requirements are found in COMAR 26.11.02, which also contains enforcement provisions for violations of permits to construct, PSD approvals, and operating permits.

          * COMAR <IP_ADDRESS> contains pre-construction permitting requirements for PSD sources and was last approved by EPA on August 2, 2012 (77 FR 45949) to implement requirements of EPA's final PSD and Title V Greenhouse Gas Tailoring Rule, which was published in the Federal Register on June 3, 2010 (75 FR 31514).

          * COMAR 20.79, "Applications Concerning the Construction or Modification of Generating Stations and Overhead Transmission Lines," particularly the EPA SIP-approved portions of this chapter, regulate construction and modification of electric generating stations, including consideration of related air quality impacts.

          * The following SIP-approved portions of the Public Utilities Article, Annotated Code of Maryland also establish requirements for construction and modification of electric generating stations:
             o § 7-205, Electric companies  -  Modification of power plant
             o § 7-207, Generating stations or transmission lines -- General certification procedure
             o § 7-208, Generating stations or transmission lines -- Joint construction of station and associated lines

          * Maryland's Title V permits are under COMAR 26.11.03.  This chapter of COMAR also includes provisions providing for enforcement of Title V permits (COMAR <IP_ADDRESS>, "General Part 70 Permits").  Note that COMAR 26.11.03 is not part of Maryland's EPA-approved SIP and is mentioned here just for reference purposes.

Based upon EPA's review of the January 2013 submittal, the Lead Infrastructure Guidance, and Maryland's current SIP, EPA finds that Maryland has met its obligations pursuant to 110(a)(2)(C) of the CAA.

4. Section 110(a)(2)(D)

Section 110(a)(2)(D)(i)(I)

In accordance with the decision of the U.S. Court of Appeals for the District of Columbia,  the EPA at this time is not treating the 110(a)(2)(D)(i)(I) SIP submission from the State of Maryland as a required SIP submission.  See EME Homer City Generation, L.P. v. EPA, 696 F .3d 7 (D.C. Cir. 2012), cert. granted, 133 U.S. 2857 (2013).  However, even if the submission is not considered to be "required," the EPA must act on the 110(a)(2)(D)(i)(I) SIP submission from Maryland  because section 110(k)(2) of the CAA requires the EPA to act on all SIP submissions.  Unless the EME Homer City decision is reversed or otherwise modified by the Supreme Court, states are not required to submit 110(a)(2)(D)(i)(I) SIPs until the EPA has quantified their obligations under that section.  The portions of the SIP submission relating to 110(a)(2)(D)(i)(II) and 110(a)(2)(D)(ii), in contrast, are required.  In this rulemaking action, EPA is proposing to act on all portions of Maryland's 110(a)(2)(D) submittal.

All areas of Maryland are covered by a SIP approved PSD program as discussed above for section 110(a)(2)(C), and Maryland does not have any Class I Areas.  The physical properties of lead prevent lead emissions from experiencing the same travel or formation phenomena as fine particulate matter (PM2.5) or ozone.  There is a sharp decrease in lead concentrations, at least in the coarse fraction, as the distance from a source increases. While it is possible for a source in a state to emit lead in a location and in quantities that may contribute significantly to nonattainment or interfere with maintenance in another state, EPA believes this would be a rare situation, e.g., where large sources are in close proximity to state boundaries.  See Lead Infrastructure Guidance.  According to the 2011 National Emission Inventory (NEI) Version 1, there are no sources in Maryland with emissions above 0.5 tons per year (tpy) of lead.  The largest source of emissions from Frederick Airport has 0.43 tpy of lead emissions.  This source is more than seven miles from the border of Pennsylvania. Therefore, because the physical properties of lead prevent lead emissions from traveling long distances and there is a sharp decrease in lead concentrations as the distance from a source increases, EPA finds lead sources in Maryland do not have emissions that impact neighboring states such that they contribute significantly to nonattainment or interfere with maintenance by any other states.

Based upon EPA's review of the January 2013 submittal, information from Version 1 of the 2011 NEI and the Lead Infrastructure Guidance, EPA finds that Maryland  has met its obligations pursuant to 110(a)(2)(D)(i)(I) of the CAA.

Section 110(a)(2)(D)(i)(II)

For all areas of Maryland, a SIP approved PSD program is in place.  The permitting program is codified at 40 CFR 52.1070 and is discussed in detail above for 110(a)(2)(C) of the CAA.

 The following EPA SIP-approved regulations pertain to PSD:
                        EPA SIP-approved PSD provisions
                            COMAR Subtitle/Chapter
                                  Description
                                   26.11.02
Permits, Approvals, and Registration
                                  <IP_ADDRESS>
Pre-construction permitting for PSD sources
                   <IP_ADDRESS>,<IP_ADDRESS>, and <IP_ADDRESS>
Provisions implementing EPA's final PSD and Title V Greenhouse Gas Tailoring Rule
                        <IP_ADDRESS> through <IP_ADDRESS>
Regulation of construction and modification of electric generating stations
              Annotated Code of Maryland  -  Environment Article
                                  Description
                       Sections 7-205, 7-207, and 7-208
Requirements for construction and modification of generating stations

 EPA is proposing to approve the infrastructure SIP submissions with respect to 110(a)(2)(D)(i)(II) prong 3 (for the part C of Title I of the CAA permit program) because Maryland's SIP contains an approved PSD program.

Prong 4 of section 110(a)(2)(D)(i) requires that SIPs include provisions prohibiting any source or other type of emissions activity in one state from interfering with measures to protect visibility required to be included in another state's SIP.  EPA's Lead Infrastructure Guidance states that "[w]ith regard to the requirement of prong 4, i.e., visibility under subsection (2)(D)(i)(II) significant impacts from Pb emissions from stationary sources are expected to be limited to short distances from the source and most, if not all Pb stationary sources are located at distances from Class I areas such that visibility impacts would be negligible."  This is the case in Maryland and Maryland itself does not have any Class I areas.

 Also, EPA notes that Maryland's February 13, 2012 Regional Haze SIP submittal was fully approved by EPA on July 6, 2012 (77 FR 39938).  Thus, EPA is proposing to approve the infrastructure SIP submissions with respect to 110(a)(2)(D)(i)(II) prong 4 because lead emissions are unlikely to have visibility impacts and Maryland's approved regional haze SIP adequately prevents sources in Maryland from interfering with measures adopted by other states to protect visibility during the first planning period.

Based upon EPA's review of the January 2013 submittal, the Maryland  SIP, Version 1 of the 2011 NEI, and the Lead Infrastructure Guidance, EPA finds that Maryland has met its obligations pursuant to 110(a)(2)(D)(i)(II).

Section 110(a)(2)(D)(ii)

As discussed above for 110(a)(2)(C) and (D)(i)(II), Maryland has a SIP approved permitting program for part C of Title I of the CAA.  Therefore, Maryland has demonstrated that it has met its obligations pursuant to CAA section 126(a).  In addition, Maryland has no currently pending obligations pursuant to CAA Section 126(b), and has made the necessary submittals through its infrastructure SIP submittals to demonstrate that the State has adequate provisions insuring future compliance with the requirements of sections 126 and 115 of the CAA.  Therefore, EPA finds Maryland's infrastructure SIP meets the requirements of CAA section 110(a)(2)(D)(ii).

5.  Section 110(a)(2)(E)

According to the January 2013 submittal, Maryland has a variety of resources to carry out implementation of the SIP including section 103 and 105 grants, Title V grant funds, and Title V permit fees (collected under the authority § 2-403 of the Environment Article, Annotated Code of Maryland and pursuant to COMAR <IP_ADDRESS>.)

Maryland also has a Clean Air Fund (Environment Article, §2-107, Annotated Code of Maryland) composed of funds collected from application fees, permit fees, renewal fees, and civil or administrative penalties or fines which support air quality activities.  Maryland's Clean Air Fund may be used for (1) identifying, monitoring, and regulating air pollution in the State, including program development of these activities as provided in the State budget; and (2) providing grants to local governments to supplement funding for programs conducted by local governments that are consistent with the Maryland program.

Several other authorities to implement the Maryland SIP are identified below:

Authority to monitor ambient air quality in the State: Environment Article,
§§2-103(b)(2), Annotated Code of Maryland.

Authority to advise the Governor when an air pollution emergency exists:
Environment Article, §2-105, Annotated Code of Maryland.

Authority to adopt regulations that establish standards and procedures to be followed whenever pollution of the air reaches an emergency condition:
Environment Article, §2-301(a)(2), Annotated Code of Maryland.

Air Quality Control Advisory Council - consultation advice regarding proposed regulations: Environment Article, §§ 2-201- 2-206, Annotated Code of Maryland.

Authority to adopt rules and regulations for the control of air pollution in the State, including testing, monitoring, record keeping, and reporting requirements: Environment Article, §2-301(a)(1), Annotated Code of Maryland.

Authority to set emission standards and ambient air quality standards for each air quality control area in the State: Environment Article, §2-302 (b)-(d), Annotated Code of Maryland.

EPA finds Maryland has adequate resources to implement the SIP pursuant to 110(a)(2)(E)(i).

On December 6, 2013, EPA took a direct final action to approve a SIP submittal for Maryland that meets section 128 of the CAA and therefore E(ii) for this Lead NAAQS regarding compliance with state boards as described in section 128 of the CAA.  A detailed rationale for the approval was set forth in the direct final rule (78 FR 73472) which was effective on February 4, 2014.

Therefore, EPA finds that Maryland's SIP adequately addresses 110(a)(2)(E)(ii).

Finally, as explained in the January 2013 SIP submittal, Maryland does not rely on any local or regional government, agency, or instrumentality for implementing the SIP.  EPA finds that Maryland's January 2013 SIP submittal and existing SIP adequately address 110(a)(2)(E)(iii).

Therefore, based upon EPA's review of the January 2013 SIP submittal, Maryland's SIP, and the Lead Infrastructure Guidance, EPA finds that Maryland has met its obligations pursuant to all portions of 110(a)(2)(E).

6.  Section 110(a)(2)(F)

According to Maryland's January 2013 submittal, the two main statutory provisions which provide authority for source emissions testing and monitoring are §2-103(b)(1) and  §2-301(a)(1), Environment Article, Annotated Code of Maryland.  In addition, several SIP -approved regulations require installation and maintenance of monitoring equipment, including COMAR <IP_ADDRESS>, "Testing & Monitoring" and COMAR <IP_ADDRESS> Continuous Emissions Monitoring (CEMs) Requirements.  Also, Maryland's Title V program (COMAR 26.11.03) contains requirements related to source testing/monitoring.

Several Maryland SIP approved regulations include stationary source monitoring and emission reporting, including:  COMAR <IP_ADDRESS> "Testing and Monitoring"; COMAR <IP_ADDRESS> "Records and Information"; COMAR <IP_ADDRESS> -1 "Emission Statements"; COMAR <IP_ADDRESS> "Malfunctions and other Temporary Increase in Emissions; COMAR <IP_ADDRESS> Continuous Emissions Monitoring;  COMAR <IP_ADDRESS> "Emissions Limitations for Power Plants, Monitoring and Reporting Requirements"; and COMAR <IP_ADDRESS>, "Information Required as Part of Application for a Part 70 Permit."  However COMAR <IP_ADDRESS> is not included in Maryland's SIP-approved regulations but is included here for reference.  These regulations address requirements in 40 CFR 51.211 (emissions reports and record keeping), 40 CFR 51.212, and 40 CFR Part 51 Subpart A (Air Emissions Reporting Requirements).

In addition, §2-103(b), Environment Article, Annotated Code of Maryland provides statutory authority over emissions, ambient air quality and air quality monitoring.  COMAR <IP_ADDRESS> requires sources to maintain records to determine compliance with emission standards and COMAR <IP_ADDRESS>(B)(4) requires all information received under this provision to be provided for public inspection.  Criteria pollutant emissions information related data is available to the public for inspection in accordance with 40 CFR 51.116 (data availability).

Based upon EPA's review of the January 2013 submittal, the Maryland SIP, Maryland's Annotated Code,  and the Lead Infrastructure Guidance, EPA finds that Maryland  has met its obligations pursuant to 110(a)(2)(F) of the CAA.

7.  Section 110(a)(2)(G)

According to the Maryland January 3, 2013 lead infrastructure SIP submittal referenced above, Maryland can address air pollution emergencies as authorized by §2-105, Environment Article, Annotated Code of Maryland.  The authority to adopt regulations that establish standards and procedures to be followed whenever pollution of the air reaches an emergency condition are found in §2-301(a) (2), Environment Article, Annotated Code of Maryland.  Maryland's SIP under 40 CFR 52.1070(c) includes Air Pollution Episode System (COMAR 26.11.05).  Additionally, Maryland's authority regarding accidental or other releases that are not authorized by statute, regulation or permit or occur in conjunction with violations of existing regulatory requirements can be found in §2-604 (Administrative corrective order authority), Environment Article, Annotated Code of Maryland and § 2-609 (a) (Civil injunctive authority), Environment Article, Annotated Code of  Maryland.

Based upon EPA's review of the January 2013 submittal and Maryland's SIP, EPA finds that Maryland has met its obligations pursuant to 110(a)(2)(G) of the CAA.

8.  Section 110(a)(2)(H)

According to the Maryland January 2013 lead infrastructure SIP submittal referenced above, Maryland's SIP is essentially a compilation of regulations, source-specific provisions and plans to meet the NAAQS. The authority to develop or revise a SIP is based on the authority to adopt new regulations and revise existing regulations to meet the NAAQS (§2-301(a)(1), Environment Article, Annotated Code of Maryland.)  Nothing in Maryland's statutory or regulatory authority prohibits the State from revising the SIP when the NAAQS are revised by EPA.

This submission provides EPA with adequate assurances that Maryland will review and revise its SIP from time to time as may be necessary to take account of revisions to NAAQS or the availability of improved or more expeditious methods of attaining such standards.  EPA also finds these provisions provide adequate assurances that Maryland can revise its SIP whenever the Administrator finds, on the basis of information available to the Administrator, that Maryland's SIP is substantially inadequate to attain the NAAQS or to otherwise comply with any additional requirements established under the CAA.
Based upon EPA's review of the January 2013 submittal and the Lead Infrastructure Guidance, EPA finds that Maryland has met its obligations pursuant to 110(a)(2)(H) of the CAA.

9.  Section 110(a)(2)(J)

According to Maryland's SIP submittals mentioned above and the Maryland SIP, Maryland meets the requirements of Section 121 (relating to consultation).  All Maryland SIP revisions undergo public notice and hearing, which provides for comment by the public and local political subdivisions, including, but not limited to, the Baltimore Regional Transportation Board, the National Capital Transportation Planning Board, the Wilmington Area Planning Council, and Hagerstown/Eastern Panhandle Metropolitan Planning Organization. Public hearings on proposed Maryland regulations are held in accordance with EPA requirements under 40 CFR 51.102.  Public hearings on proposed Maryland regulations are held in accordance with Section 2-303(b) of the Environment Article of the Annotated Code of Maryland which requires that a public hearing be held before adopting air quality regulations. In addition, Subtitle 1 of Title 10, State Government Article of the Annotated Code of Maryland provides administrative procedure requirements for adopting or modifying regulations and these procedures include public notification and participation requirements.  Maryland also addresses the consultation requirements through the public notification statutory provisions discussed below.

Section 127 (relating to public notification).  As mentioned above, Section 2-303(b) of the Environment Article of the Annotated Code of Maryland requires that public hearings be held before Maryland adopts air quality regulations.  In addition, Subtitle 1 of Title 10, State Government Article of the Annotated Code of Maryland sets forth the administrative procedures for Maryland to adopt or modify regulations.  In addition, EPA SIP-approved regulations and statutory provisions in which public notification and hearings are addressed are listed below:

                            COMAR Subtitle/Chapter
                                  Description
                                  <IP_ADDRESS>
"Procedures for Obtaining Permits to Construct Certain Significant Sources"
                                  <IP_ADDRESS>
"Procedures for Obtaining Approvals of PSD Sources and NSR Sources, Permits to Construct, Permit to Construct MACT Determinations On a Case-by-Case Basis in Accordance with 40 CFR 63, Subpart B, and Certain 100-Ton Sources"
                                <IP_ADDRESS>[a]
"Permits, Approvals, and Registration  -  Title V Permits, Applicability and General Requirements"
                                 <IP_ADDRESS> a
"Permits, Approvals, and Registration  -  Title V Permits, Public Participation Procedures"
                                 <IP_ADDRESS> a
"Permits, Approvals, and Registration  -  Title V Permits, Review by Affected States of Part 70 Permits"
                                 <IP_ADDRESS> a
"Permits, Approvals, and Registration  -  Title V Permits, Significant Permit Modifications"
                                  <IP_ADDRESS>
"Ambient Air Quality Standards, Definitions, Reference Conditions, and Methods of Measurement," this adopts 40 CFR 58.50, "Index reporting," which reports air quality to the public several times per day
                                  <IP_ADDRESS>
"Air Pollution Episode Criteria"
                Annotated Code of Maryland  -  Article, Section
                                  Description
                        Public Utilities Article, 7-207
"Generating stations or transmission lines  -  General certification procedure"
                        Public Utilities Article, 7-208
"Generating stations or transmission lines  -  Joint construction of station and associated lines"
                      Environment Article, 2-103.2(b)[a]
Provides public access to all air monitoring data via the Internet
[a] These provisions were cited by Maryland for reference purposes only and are not included in the Maryland SIP.

Part C (relating to visibility protection).  With regard to the visibility protection aspect of 110(a)(2)(J) and as discussed in the Lead Infrastructure Guidance, EPA recognizes that states are subject to visibility and regional haze program requirements under part C of Title I of the CAA (which includes sections 169A and 169B of the CAA).  In the event of the establishment of a new NAAQS, however, the visibility and regional haze program requirements under part C of Title I of the CAA do not change.  Thus, EPA finds that there are no applicable visibility obligations under part C "triggered" under section 110(a)(2)(J) when a new NAAQS becomes effective.  Maryland has an approved regional haze SIP which addresses  the requirements of CAA Sections 169A and 169B, as discussed above for section 110(a)(2)(D)(i)(II)of the CAA.

For a discussion on how Maryland meets the requirements of part C of Title I of the CAA with respect to PSD, see Section 110(a)(2)(C) and Section 110(a)(2)(D)(i)(II)(prong 3) above.

Based upon EPA's review of the above referenced submittals, Maryland's SIP and the Lead Infrastructure Guidance,  EPA finds Maryland's infrastructure SIP meets the requirements of CAA section 110(a)(2)(J) relating to consultation, public notification, and visibility protection requirements.

10.  Section 110(a)(2)(K)

According to the January 2013 submittal, Maryland has authority under §2-302 of the Environment Article, Annotated Code of Maryland, to do modeling since inherent in the obligation to meet the NAAQS is the authority for the Department to perform modeling as required under the CAA to demonstrate attainment.   Maryland has a SIP approved PSD program (see 40 CFR 52.1070) which includes modeling.  Also, Maryland submits air quality modeling data as part of Maryland's relevant SIP submissions in accordance with the Clean Air Act and through federal grant commitments.

For the authority to perform air quality modeling and the submission of relevant data, see Sections 2-103 and 2-302 of the Environment Article of the Annotated Code of Maryland and Sections 7-205, 7-207, 7-207.1, and 7-208 of the Public Utilities Article of the Code which is in the approved Maryland SIP.  SIP-approved portions of COMAR 20.79.01, 20.79.02, and 20.79.03 establish requirements for the calculation of increases in air emissions related to modifications of facilities at power plants and require modeling.

In addition, COMAR <IP_ADDRESS> which is in the Maryland SIP establishes requirements for applications regarding construction and modification of generating stations to demonstrate compliance with environmental restrictions.  This includes providing information to show the impact on air quality including the ability of the generating station to comply with PSD and NSR provisions and the impact on PSD areas.

Maryland also stated that it can provide modeling analysis to EPA to assess the effect of the State's air emissions on the NAAQS, citing past examples such as modeling for 8-hour ozone and PM2.5 SIPs.  Therefore, based upon EPA's review of the January 2013 submittal, Maryland's SIP and the Lead Infrastructure Guidance, EPA finds Maryland's lead infrastructure SIP meets the requirements of CAA section 110(a)(2)(K).

11.  Section 110(a)(2)(L)

Maryland has an approved Title V program which contains a fee schedule.  EPA approved Maryland's Title V program on January 15, 2003 (68 FR 1974).  Maryland states in its recent August 14, 2013 Nitrogen Dioxide (NO2) infrastructure SIP submittal that Maryland's "Title V permit fees are collected under the authority of  Section 2-403 of the Environment Article, Annotated Code of Maryland and pursuant to COMAR <IP_ADDRESS>, .17 and .19.  These fees are used to fund programs such as the permitting of new and existing sources of air pollution, compliance and enforcement of sources of air pollution."  In EPA's TSD supporting its rulemaking proposing approval of the Maryland NO2 infrastructure SIP submittal, EPA found Maryland met the requirements of CAA section 110(a)(2)(L).

Based on EPA's review of Maryland's January 2013 submittal, the Lead Infrastructure Guidance, Maryland's Title V program and statements in the August 14, 2013 NO2 infrastructure SIP submittal, and our conclusions in the TSD for the rulemaking proposing approval of Maryland's NO2 infrastructure SIP,  EPA finds Maryland's lead infrastructure SIP meets the requirements of CAA section 110(a)(2)(L).

12.  Section 110(a)(2)(M)

According to the above referenced lead infrastructure SIP submittals, Maryland provides for consultation and participation by local political subdivisions affected by the SIP via all the means and measures previously discussed for section 110(a)(2)(J) requirements.  Also, statutory authority under Sections 2-103 and 2-302 of the Environmental Article, Annotated Code of Maryland, as well as COMAR 26.11.16, provide the structure for a consultation process between the Maryland Department of the Environment, Maryland Department of Transportation and several Metropolitan Planning Organizations.

 Based upon EPA's review of the above referenced submittals, the Maryland SIP, and the Lead Infrastructure Guidance, EPA finds that Maryland  has met its obligations pursuant to 110(a)(2)(M).

F.  CONCLUSIONS AND RECOMMENDED AGENCY ACTION

EPA's analysis of  Maryland's infrastructure submittals for the 2008 Lead NAAQS concludes that Maryland's submittals and existing SIP meet the requirements for section 110(a)(2)(A), (B), (C), (D), (E), (F), (G), (H), (J), (K), (L), and (M) as described above.  It is recommended that a rulemaking be prepared proposing approval of Maryland's infrastructure submittals for the 2008 Lead NAAQS for the elements indentified above.


[Federal Register Volume 77, Number 180 (Monday, September 17, 2012)]
[Proposed Rules]
[Pages 57068-57069]
[FR Doc No: 2012-22880]

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DEPARTMENT OF TRANSPORTATION

 Federal Motor Carrier Safety Administration (FMCSA)

49 CFR Part 395

[Docket No. FMCSA-2012-0183]

Hours of Service of Drivers of Commercial Motor Vehicles;
Regulatory Guidance for Oil Field Exception

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of public listening session.

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SUMMARY: FMCSA announces that it will hold its third and final public
listening session to receive comments on the Agency's June 5, 2012,
notice concerning regulatory guidance on the applicability of the
oilfield operations exceptions in the hours-of-service regulations. In
an August 6, 2012, Federal Register notice, the Agency extended the
deadline for public comments from August 6 to October 5, 2012. As with
the previous sessions, the Dallas listening session will be open to the
public and webcast in its entirety.

DATES: This listening session will be held on September, 27, 2012, in
Dallas, TX, at the Hyatt Regency DFW, 2334 North International Parkway,
P.O. Box 619014, DFW Airport, Texas 75261, Telephone:<PHONE_NUMBER>,
Fax:<PHONE_NUMBER>. The listening session will begin at 1:00 p.m.,
local time, and end at 5:30 p.m. local time, or earlier if all
participants wishing to comment have expressed their views. Written
comments to the docket must be received on or before October 5, 2012.

ADDRESSES: The September 27, 2012, listening session will be held at
the

Hyatt Regency DFW, 2334 North International Parkway, P.O. Box 619014,
DFW Airport, Texas 75261, Telephone:<PHONE_NUMBER>, Fax:<PHONE_NUMBER>.
    Internet Address for Alternative Media Broadcasts During and
Immediately After the Listening Session. FMCSA will post specific
information on how to participate via the Internet and telephone on the
FMCSA Web site at www.fmcsa.dot.gov.
    You may submit comments identified by Federal Docket Management
System Number FMCSA-2012-0183 by any of the following methods:
     Web site: www.regulations.gov. Follow the instructions for
submitting comments on the Federal electronic docket site.
     Fax: 1-202-493-2251.
     Mail: Docket Management Facility; U.S. Department of
Transportation, Room W-12-140, 1200 New Jersey Avenue SE., Washington,
DC 20590-0001.
     Hand Delivery: Ground Floor, Room W12-140, DOT Building,
1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.
e.t., Monday through Friday, except Federal Holidays.

All submissions must include the Agency name and docket number. For
detailed instruction on submitting comments and additional information,
see the ``Public Participation'' heading below. Note that all comments
received will be posted without change to www.regulations.gov,
including any personal information provided. Please see the ``Privacy
Act'' heading below.
    Docket: For access to the docket to read background documents or
comments received, go to www.regulations.gov at any time or to Room
W12-140, DOT Building, 1200 New Jersey Avenue SE., Washington, DC,
between 9 a.m. and 5 p.m., e.t., Monday through Friday, except Federal
holidays.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review the
DOT's complete Privacy Act Statement in the Federal Register published
on December 29, 2010 (75 FR 82133), or you may visit
www.regulations.gov.
    Public Participation: The www.regulations.gov Web site is generally
available 24 hours each day, 365 days each year. You can obtain
electronic submission and retrieval help and guidelines under the
``help'' section of that Web site, and at DOT's http://docketsinfo.dot.gov Web site. If you want us to notify you that we
received your comments, please include a self-addressed, stamped
envelope or postcard or print the acknowledgement page that appears
after submitting comments online.

FOR FURTHER INFORMATION CONTACT: For the regulatory guidance issued on
June 5, 2012, concerning oilfield hours-of-service exceptions: Mr.
Thomas Yager, Chief, Driver and Carrier Operations Division, Federal
Motor Carrier Safety Administration, 1200 New Jersey Avenue SE.,
Washington, DC 20590, phone<PHONE_NUMBER>, email<EMAIL_ADDRESS>For
the listening sessions: Ms. Shannon Watson, Senior Advisor to the
Associate Administrator for Policy, Federal Motor Carrier Safety
Administration, 1200 New Jersey Avenue SE., Washington, DC 20590, phone
(202) 385-2395, email<EMAIL_ADDRESS>    If you need sign language assistance to participate in a listening
session, please contact Ms. Watson no later than 10 days prior to the
listening session.

SUPPLEMENTARY INFORMATION:

Background

    On June 5, 2012, FMCSA published a notice in the Federal Register
concerning regulatory guidance about the ``oilfield operations''
exceptions in 49 CFR 395.1(d)(77 FR 33098). The regulatory guidance,
effective June 5, 2012, was issued to ensure consistent understanding
and application of the regulatory exceptions. Several groups or
organizations have requested that the Agency extend the comment period
and consider holding a listening session(s). On August 6, 2012, the
FMCSA announced (1) an extension of the comment period for the
submission of written comments in response to the June 5, 2012, notice,
and (2) listening sessions on the regulatory guidance. The previous two
listening sessions were held on August 17, 2012, in Denver, CO, and on
August 21, 2012, in Pittsburgh, PA. This represents the third and final
listening session on this issue.

Listening Session

    The listening session is open to the public. Speakers are not
required to preregister but should limit their remarks to 5 minutes.
The public may submit material to the FMCSA staff at the session for
inclusion in the docket, FMCSA-2012-0183.

Alternative Media Broadcasts During and Immediately After the Listening
Session

    FMCSA will provide webcast information for the listening session.
Prior to the session, the Agency will post the Web address for the live
webcast and instructions on how to participate at FMCSA's Web site,
www.fmcsa.dot.gov. After the listening session, FMCSA will place a full
transcript of the listening session in the docket referenced at the
beginning of this notice.

    Issued on: September 11, 2012.
 Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2012-22880 Filed 9-14-12; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 83, Number 68 (Monday, April 9, 2018)]
[Rules and Regulations]
[Pages 15045-15048]
[FR Doc No: 2018-06712]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0810; Product Identifier 2017-NM-045-AD; Amendment
39-19240; AD 2018-07-09]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc., Airplanes

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

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Bombardier, Inc., Model CL-600-2C10 (Regional Jet Series 700, 701, &
702), Model CL-600-2D15 (Regional Jet Series 705), Model CL-600-2D24
(Regional Jet Series 900), and Model CL-600-2E25 (Regional Jet Series
1000) airplanes. This AD was prompted by a report of a smoke-in-cabin
event due to a non-sustaining electrical fire. This AD requires
installation of protective sleeves on the bonding jumper wires of
affected galleys and lavatories. We are issuing this AD to address the
unsafe condition on these products.

DATES: This AD is effective May 14, 2018.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of May 14,
2018.

ADDRESSES: For service information identified in this final rule,
contact Bombardier, Inc., 400 C[ocirc]te Vertu Road West, Dorval,
Qu[eacute]bec H4S 1Y9, Canada; Widebody Customer Response Center North
America toll-free telephone: 1-866-538-1247 or direct-dial telephone:
1-514-855-2999; fax:<PHONE_NUMBER>; email: [email protected];
internet: http://www.bombardier.com. You may view this referenced
service information at the FAA, Transport

Standards Branch, 2200 South 216th St., Des Moines, WA. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>. It
is also available on the internet at http://www.regulations.gov by
searching for and locating Docket No. FAA-2017-0810.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0810; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The street address for the Docket Office (telephone:
800-647-5527) is Docket Management Facility, U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Assata Dessaline, Aerospace Engineer,
Avionics and Administrative Services Section, FAA, New York ACO Branch,
1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone: 516-228-
7301; fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain Bombardier, Inc.,
Model CL-600-2C10 (Regional Jet Series 700, 701, & 702), Model CL-600-
2D15 (Regional Jet Series 705), Model CL-600-2D24 (Regional Jet Series
900), and Model CL-600-2E25 (Regional Jet Series 1000) airplanes. The
NPRM published in the Federal Register on September 13, 2017 (82 FR
42953) (``the NPRM''). The NPRM was prompted by a report of a smoke-in-
cabin event due to a non-sustaining electrical fire. The NPRM proposed
to require installation of protective sleeves on the bonding jumper
wires of affected galleys and lavatories. We are issuing this AD to
prevent an electrical short of a bonding jumper wire that may result in
in-flight smoke or fire events, as well as failure of avionics
equipment, due to possible water spray or leakage from a damaged water
supply line.
    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued Canadian AD CF-2016-20R1, dated
February 3, 2017 (referred to after this as the Mandatory Continuing
Airworthiness Information, or ``the MCAI''), to correct an unsafe
condition for certain Bombardier, Inc., Model CL-600-2C10 (Regional Jet
Series 700, 701, & 702), Model CL-600-2D15 (Regional Jet Series 705),
Model CL-600-2D24 (Regional Jet Series 900), and Model CL-600-2E25
(Regional Jet Series 1000) airplanes. The MCAI states:

    A CRJ900 aeroplane reported a smoke in cabin event due to a non-
sustaining electrical fire. The source of smoke was traced to a
burnt heated water supply line behind the #2 Galley. The surrounding
insulation was also found burnt.
    The root cause of this electrical fire was an electrical short
between an un-insulated bonding jumper and a terminal block carrying
115 volts AC. The circuit resistance was high enough and the circuit
breakers that protect the wiring did not trip open.
    Electrical short of a bonding jumper may result in in-flight
smoke or fire events as well as failure of avionics equipment due to
possible water spray or leakage from a damaged water supply line.
The likelihood of this happening is increased by the removal and
installation of the galley or lavatory during maintenance, allowing
the bonding jumper to become wedged under the terminal block.
* * * * *
    Revision 1 of this [Canadian] AD is issued to mandate [the
installation of protective sleeves on the galley and lavatory
bonding jumper wires in accordance with] Bombardier Service Bulletin
(SB) 670BA-25-101 Revision B dated 12 January 2017. * * *

    You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0810.

Comments

    We gave the public the opportunity to participate in developing
this final rule. We considered the comment received. The Air Line
Pilots Association, International supported the NPRM.

Conclusion

    We reviewed the relevant data, considered the comment received, and
determined that air safety and the public interest require adopting
this AD as proposed except for minor editorial changes. We have
determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    Bombardier, Inc., has issued Service Bulletin 670BA-25-101,
Revision B, dated January 12, 2017. The service information describes
procedures for installation of protective sleeves on the bonding jumper
wires of affected galleys and lavatories. This service information is
reasonably available because the interested parties have access to it
through their normal course of business or by the means identified in
the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 544 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
              Action                      Labor cost             Parts cost           product        operators
----------------------------------------------------------------------------------------------------------------
Install protective sleeves........  10 work-hours x $85    Negligible...........            $850        $462,400
                                     per hour = $850.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

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

products identified in this rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to transport category airplanes to
the Director of the System Oversight Division.

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2018-07-09 Bombardier, Inc.: Amendment 39-19240; Docket No. FAA-
2017-0810; Product Identifier 2017-NM-045-AD.

(a) Effective Date

    This AD is effective May 14, 2018.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the airplanes identified in paragraphs
(c)(1), (c)(2), and (c)(3) of this AD, certificated in any category,
all certificated models.
    (1) Bombardier, Inc., Model CL-600-2C10 (Regional Jet Series
700, 701, & 702) airplanes, serial numbers 10001 through 10344
inclusive.
    (2) Bombardier, Inc., Model CL-600-2D15 (Regional Jet Series
705) and Model CL-600-2D24 (Regional Jet Series 900) airplanes,
serial numbers 15001 through 15382 inclusive.
    (3) Bombardier, Inc., Model CL-600-2E25 (Regional Jet Series
1000) airplanes, serial numbers 19001 through 19044 inclusive.

(d) Subject

    Air Transport Association (ATA) of America Code 25, Equipment/
furnishings.

(e) Reason

    This AD was prompted by a report of a smoke-in-cabin event due
to a non-sustaining electrical fire. We are issuing this AD to
prevent an electrical short of a bonding jumper wire that may result
in in-flight smoke or fire events, as well as failure of avionics
equipment, due to possible water spray or leakage from a damaged
water supply line.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Protective Sleeve Installation

    (1) For airplanes on which the actions specified in Bombardier
Service Bulletin 670BA-25-101, dated December 17, 2015; or
Bombardier Service Bulletin 670BA-25-101, Revision A, dated October
31, 2016, have not been done, as of the effective date of this AD:
Within 6,600 flight hours or 36 months after the effective date of
this AD, whichever occurs first, install protective sleeves on the
bonding jumper wires of affected galleys and lavatories, in
accordance with Part A through Part E, as applicable, of the
Accomplishment Instructions of Bombardier Service Bulletin 670BA-25-
101, Revision B, dated January 12, 2017.
    (2) For airplanes on which the actions specified in Bombardier
Service Bulletin 670BA-25-101, dated December 17, 2015; or
Bombardier Service Bulletin 670BA-25-101, Revision A, dated October
31, 2016, have been done, as of the effective date of this AD:
Within 6,600 flight hours or 36 months after the effective date of
this AD, whichever occurs first, inspect, and if required, install
protective sleeves on the bonding jumper wires of affected galleys
and lavatories, in accordance with Part F of the Accomplishment
Instructions of Bombardier Service Bulletin 670BA-25-101, Revision
B, dated January 12, 2017.

(h) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York ACO Branch, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. In
accordance with 14 CFR 39.19, send your request to your principal
inspector or local Flight Standards District Office, as appropriate.
If sending information directly to the manager of the certification
office, send it to ATTN: Program Manager, Continuing Operational
Safety, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
local flight standards district office/certificate holding district
office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, New York ACO
Branch, FAA; or Transport Canada Civil Aviation (TCCA); or
Bombardier, Inc.'s TCCA Design Approval Organization (DAO). If
approved by the DAO, the approval must include the DAO-authorized
signature.

(i) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) Canadian AD CF-2016-20R1, dated February 3, 2017, for related
information. This MCAI may be found in the AD docket on the internet
at http://www.regulations.gov by searching for and locating Docket
No. FAA-2017-0810.
    (2) For more information about this AD, contact Assata
Dessaline, Aerospace Engineer, Avionics and Administrative Services
Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.

(j) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Bombardier Service Bulletin 670BA-25-101, Revision B, dated
January 12, 2017.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Bombardier, Inc., 400 C[ocirc]te Vertu Road West, Dorval,
Qu[eacute]bec H4S 1Y9, Canada; Widebody Customer Response Center
North America toll-free telephone: 1-866-538-1247 or direct-dial
telephone: 1-514-855-2999; fax:<PHONE_NUMBER>; email:
[email protected]; internet: http://www.bombardier.com.
    (4) You may view this service information at the FAA, Transport
Standards Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call
206-231-3195.
    (5) You may view this service information that is incorporated
by reference at 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.

    Issued in Des Moines, Washington, on March 20, 2018.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2018-06712 Filed 4-6-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 46 (Friday, March 10, 2017)]
[Notices]
[Page 13375]
[FR Doc No: 2017-04696]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

[Docket No. DOT-OST-2016-0204]

Exploring Industry Practices on Distribution and Display of
Airline Fare, Schedule, and Availability Information

AGENCY: Office of the Secretary (OST), Department of Transportation
(DOT).

ACTION: Suspension of comment period.

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

SUMMARY: DOT is suspending the public comment period for the Request
for Information (RFI) Exploring Industry Practices on Distribution and
Display of Airline Fare, Schedule, and Availability Information,
effective March 10, 2017. DOT published the RFI on October 31, 2016,
and the comment period initially closed on December 30, 2016. On
December 22, 2016, DOT extended the comment period to March 31, 2017.
The suspension of the comment period will allow the President's
appointees the opportunity to review and consider this action.

DATES: The comment period for this RFI is indefinitely suspended
effective March 10, 2017.

ADDRESSES: Docket: For access to the docket to read background
documents and comments received, go to http://www.regulations.gov or to
the street address listed above. Follow the online instructions for
accessing the docket.

FOR FURTHER INFORMATION CONTACT: Kyle-Etienne Joseph, Trial Attorney,
or Kimberly Graber, Chief, Consumer Protection and Competition Law
Branch, Office of the Assistant General Counsel for Aviation
Enforcement and Proceedings, U.S. Department of Transportation, 1200
New Jersey Ave. SE., Washington, DC 20590,<PHONE_NUMBER>,<PHONE_NUMBER>
(fax<EMAIL_ADDRESS>or<EMAIL_ADDRESS>(email).

    Issued this 2nd day of March 2017, in Washington, DC.
Judith S. Kaleta,
Deputy General Counsel.
[FR Doc. 2017-04696 Filed 3-9-17; 8:45 am]
 BILLING CODE 4910-9X-P


[Federal Register Volume 82, Number 166 (Tuesday, August 29, 2017)]
[Notices]
[Page 41011]
[FR Doc No: 2017-18240]

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DEPARTMENT OF ENERGY

[Docket No. OR17-21-000]

Federal Energy Regulatory Commission

Grieve Pipeline, LLC; Notice of Petition for Declaratory Order

    Take notice that on August 11, 2017, pursuant to Rule 207(a)(2) of
the Federal Energy Regulatory Commission's (Commission) Rules of
Practice and Procedure, 18 CFR 385.207(a)(2) (2016), Grieve Pipeline,
LLC, a subsidiary of Elk Petroleum, Inc., filed a petition for a
declaratory order seeking approval of open season procedures, rate
structure, key contract and tariff terms, as more fully explained in
the petition.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Petitioner.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the eFiling link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
eLibrary link and is available for review in the Commission's Public
Reference Room in Washington, DC. There is an eSubscription link on the
Web site that enables subscribers to receive email notification when a
document is added to a subscribed docket(s). For assistance with any
FERC Online service, please email<EMAIL_ADDRESS>or call
(866) 208-3676 (toll free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern time on September 11, 2017.

    Dated: August 22, 2017.
 Kimberly D. Bose,
Secretary.
[FR Doc. 2017-18240 Filed 8-28-17; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 76 (Wednesday, April 20, 2016)]
[Notices]
[Page 23323]
[FR Doc No: 2016-09178]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4260-DR; Docket ID FEMA-2016-0001]

District of Columbia; Amendment No. 1 to Notice of a Major
Disaster Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the District of Columbia (FEMA-4260-DR), dated March 4, 2016, and
related determinations.

DATES: Effective Date: April 1, 2016.

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

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the District of Columbia is hereby amended to include additional
categories of work under the Public Assistance program for the area
determined to have been adversely affected by the event declared a
major disaster by the President in his declaration of March 4, 2016.

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

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2016-09178 Filed 4-19-16; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register Volume 79, Number 3 (Monday, January 6, 2014)]
[Notices]
[Pages 681-683]
[FR Doc No: 2013-31520]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-71203; File No. SR-MIAX-2013-60]

Self-Regulatory Organizations; Miami International Securities
Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change Relating to the Short Term Option Series Program

December 30, 2013.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that, on December 23, 2013, Miami International Securities Exchange LLC
(``MIAX'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') a proposed rule change as described in
Items I and II below, which Items have been prepared by the Exchange.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange is filing a proposal to amend Rule 404 to allow the
Exchange to list five Short Term Option Series at one time and to
specify that new series of Short Term Option Series may be listed up
to, and including on, the expiration date.
    The text of the proposed rule change is available on the Exchange's
Web site at http://www.miaxoptions.com/filter/wotitle/rule_filing, at
MIAX's principal office, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange is proposing to amend Exchange Rule 404. Currently the
Exchange's Rules allow for the Exchange to list options in the Short
Term Option Series Program (``STOS Program'' or ``STOS option'') ``on
each of the next five consecutive Fridays that are business days.'' \3\
Related filings of other option exchanges, including MIAX, which
provided the Exchange with precedent for its rule to list five STOS
option expirations specifically states [sic] that ``the total number of
consecutive expirations will be five (5), including any existing
monthly or quarterly expirations'' for the STOS Program.\4\ The
Exchange is now proposing to make explicit that the next five STOS
options may be listed at one time, not including the monthly or
Quarterly options. The Exchange is also proposing to codify an existing
practice by adding language stating that strikes may be listed up until
and on the day of expiration.
---------------------------------------------------------------------------

    \3\ See Exchange Rule 404.02.
    \4\ See Securities Exchange Act Release Nos. 69658 (May 29,
2013), 78 FR 33454 (June 4, 2013) (SR-MIAX-2013-23); 68242 (November
15, 2012), 77 FR 69908 (November 21, 2012) (SR-CBOE-2012-110).
---------------------------------------------------------------------------

    As proposed, the Exchange will have the ability to list a total of
five STOS and that count of five would not include monthly or Quarterly
option expirations. The Exchange notes that this proposal would
restrict the five listed STOS to those closest to the Short Term Option
Opening Date. For example, if a class of options has five STOS listed
with expiration dates in July, the other two listed expiration dates
may not be in December. The Exchange believes that allowing otherwise
would undermine the purpose of the STOS Program.
    As examples of how this would work in practice, consider a
situation in which a Quarterly option expires week 1 and a monthly
option expire week 3 from now, the proposal would allow the following
expirations: Week 1 Quarterly option, week 2 STOS option, week 3
monthly option, week 4 STOS option, week 5 STOS option, week 6 STOS

option, and week 7 STOS option.\5\ As another example, if a Quarterly
option expires week 3 and a monthly option expires week 5, the
following expirations would be allowed: Week 1 STOS option, week 2 STOS
option, week 3 Quarterly option, week 4 STOS option, week 5 monthly
option, week 6 STOS option, week 7 STOS option.\6\
---------------------------------------------------------------------------

    \5\ The proposal would not allow, for example, for nothing to be
listed week 7 but week 8 a STOS option.
    \6\ Id.
---------------------------------------------------------------------------

    Next, the Exchange is proposing to add language to Rule 404 to
state that additional series of STOS options may be added up to, and
including on, the expiration date of the series.\7\ Currently, Exchange
rules state that the Exchange ``may open up to 20 initial series for
each option class that participates in the Short Term Option Series
Program'' and ``up to 10 additional series for each option class that
participates in the Short Term Option Series Program'' however the
Exchange's rules are silent on when series may be added.\8\ In
practice, however, the Exchange notes that other exchanges list
additional series until the expiration day.\9\ The Exchange believes
that codifying this provision will clearly provide the ability which is
currently not explicitly stated to add series up until the day of
expiration which is in the current Rules [sic]. In addition, given the
short lifespan of STOS, the Exchange believes that the ability to list
new series of options intraday is appropriate.
---------------------------------------------------------------------------

    \7\ The Exchange is also proposing to add language stating that
the proposed provisions in Rule 404.02 will not contradict current
provisions in Exchange Rules. The Exchange believes this addition
will eliminate any confusion about when additional series may be
added in the STOS Program in comparison to other Exchange listing
programs.
    \8\ See Exchange Rule 404.02.
    \9\ The Exchange notes that the Options Clearing Corporation
(``OCC'') has the ability to accommodate series in the STOS Program
added intraday.
---------------------------------------------------------------------------

    The Exchange notes that the STOS Program has been very well-
received by market participants, in particular by retail investors. The
Exchange believes that the current proposed revision to the STOS
Program will permit the Exchange to meet increased customer demand and
provide market participants with the ability to hedge in a greater
number of option classes and series. In addition, the proposed changes
will codify an existing practice in the options exchange industry.
2. Statutory Basis
    The Exchange believes that its proposed rule change is consistent
with Section 6(b) \10\ of the Act in general, and furthers the
objectives of Section 6(b)(5) \11\ of the Act in particular, in that it
is designed to prevent fraudulent and manipulative acts and practices,
to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in facilitating
transactions in securities, to remove impediments to and perfect the
mechanisms of a free and open market and a national market system and,
in general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    In particular, the Exchange believes that expanding the STOS
Program will result in a continuing benefit to investors by giving them
more flexibility to closely tailor their investment decisions and
hedging decisions in a greater number of securities. The Exchange also
believes that expanding the STOS Program will provide the investing
public and other market participants with additional opportunities to
hedge their investment thus allowing these investors to better manage
their risk exposure.
    With regard to the impact of this proposal on system capacity, the
Exchange has analyzed its capacity and represents that the Exchange and
the Options Price Reporting Authority (``OPRA'') has the necessary
systems capacity to handle any potential additional traffic associated
with this current amendment to the STOS Program. The Exchange believes
that its members will not have a capacity issue as a result of this
proposal. The Exchange also does not believe this expansion will cause
fragmentation to liquidity.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The Exchange believes this
proposed rule change will benefit investors by providing additional
methods to trade options on the liquid securities, and providing
greater ability to mitigate risk in managing large portfolios.
Specifically, the Exchange believes that investors would benefit from
the introduction and availability of additional series available as an
investing tool. The Exchange also believes the proposed changes will
provide investors with an additional tool for hedging risk in highly
liquid securities. For all the reasons stated, the Exchange does not
believe that the proposed rule change will impose any burden on
competition not necessary or appropriate in furtherance of the purposes
of the Act, and believes the proposed change will enhance competition.

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

    Written comments were neither solicited nor received.

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

    Because the proposed rule change does not (i) significantly affect
the protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate, the proposed rule change has become effective
pursuant to Section 19(b)(3)(A) of the Act \12\ and Rule 19b-4(f)(6)
thereunder.\13\
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 240.19b-4(f)(6). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission.
---------------------------------------------------------------------------

    The Exchange has asked the Commission to waive the 30-day operative
delay so that the proposal may become operative immediately upon
filing. The Exchange stated that waiver of this requirement will ensure
fair competition among the exchanges by allowing the Exchange to open
up to five expirations under the STOS Program in a manner consistent
with another competing exchange. The proposal will also clarify that,
like other options exchanges, the Exchange may list new STO series up
to, and including on, the expiration date. For these reasons, the
Commission believes that the proposed rule change presents no novel
issues and that waiver of the 30-day operative delay is consistent with
the protection of investors and the public interest and will allow the
Exchange to remain competitive with other exchanges. Therefore, the
Commission designates the proposed rule change to be operative upon
filing.\14\
---------------------------------------------------------------------------

    \14\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may

temporarily suspend such rule change if it appears to the Commission
that such action is necessary or appropriate in the public interest,
for the protection of investors, or otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml ); or
     Send an email to<EMAIL_ADDRESS>Please
include File Number SR-MIAX-2013-60 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-MIAX-2013-60. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for Web site viewing and printing in
the Commission's Public Reference Room, 100 F Street NE., Washington,
DC 20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-MIAX-2013-60 and should be
submitted on or before January 27, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Elizabeth M. Murphy,
Secretary.
[FR Doc. 2013-31520 Filed 1-3-14; 8:45 am]
BILLING CODE 8011-01-P