[Federal Register Volume 79, Number 17 (Monday, January 27, 2014)]
[Notices]
[Pages 4348-4350]
[FR Doc No: 2014-01463]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-N-0383]

Agency Information Collection Activities: Proposed Collection;
Comment Request; Radioactive Drug Research Committees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
contained in regulations governing the use of radioactive drugs for
basic informational research.

DATES: Submit either electronic or written comments on the collection
of information by March 28, 2014.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Radioactive Drug Research Committees--(OMB Control Number 0910-0053)--
Extension

    Under sections 201, 505, and 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 355, and 371), FDA has the authority to
issue regulations governing the use of radioactive drugs for basic
scientific research. Section 361.1 (21 CFR 361.1) sets forth specific
regulations regarding the establishment and composition of Radioactive
Drug Research Committees (RDRC) and their role in approving and
monitoring basic research studies utilizing radiopharmaceuticals. No
basic research study involving any administration of a radioactive drug
to research subjects is permitted without the authorization of an FDA
approved RDRC (Sec.  361.1(d)(7)). The type of research that may be
undertaken with a radiopharmaceutical drug must be intended to obtain
basic information and not to carry out a clinical trial for safety or
efficacy. The types of basic research permitted are specified in the
regulation, and include studies of metabolism, human physiology,
pathophysiology, or biochemistry.
    Section 361.1(c)(2) requires that each RDRC shall select a
chairman, who shall sign all applications, minutes, and reports of the
committee. Each committee shall meet at least once each quarter in
which research activity has been authorized or conducted. Minutes shall
be kept and shall include the numerical results of votes on protocols
involving use in human subjects. Under Sec.  361.1(c)(3), each RDRC
shall submit an annual report to FDA. The annual report shall include
the names and qualifications of the members of, and of any consultants
used by, the RDRC, using Form FDA 2914, and a summary of each study
conducted during the preceding year, using Form FDA 2915.
    Under Sec.  361.1(d)(5), each investigator shall obtain the proper
consent required under the regulations. Each female research subject of
childbearing potential must state in writing that she is not pregnant,
or on the basis of a pregnancy test be confirmed as not pregnant.
    Under Sec.  361.1(d)(8), the investigator shall immediately report
to the RDRC all adverse effects associated with use of the drug, and
the committee shall then report to FDA all adverse reactions probably
attributed to the use of the radioactive drug.
    Section 361.1(f) sets forth labeling requirements for radioactive
drugs. These requirements are not in the reporting burden estimate
because they are information supplied by the Federal Government to the
recipient for the purposes of disclosure to the public (5 CFR
1320.3(c)(2)).
    Types of research studies not permitted under this regulation are
also specified, and include those intended for immediate therapeutic,
diagnostic, or similar purposes or to determine the safety or
effectiveness of the drug in humans for such purposes (i.e., to carry
out a clinical trial for safety or efficacy). These studies require
filing of an investigational new drug application (IND) under 21 CFR
part 312, and the associated information collections are covered in OMB
control number 0910-0014.
    The primary purpose of this collection of information is to
determine whether the research studies are being conducted in
accordance with required regulations and that human subject safety is
assured. If these studies were not reviewed, human subjects could be
subjected to inappropriate radiation or pharmacologic risks.
    Respondents to this information collection are the chairperson(s)
of each individual RDRC, investigators, and participants in the
studies.
    The burden estimates are based on FDA's experience with these
reporting and recordkeeping requirements over the past few years and
the number of submissions received by FDA under the regulations.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
     21 CFR sections/forms         Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
361.1(c)(3)&(4); Form FDA 2914              69               1              69  1...............              69
361.1(c)(3); Form FDA 2915....              48              10             480  3.5.............           1,680
361.1(d)(8)...................              10               5              50  0.5 (30 minutes)              25
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................           1,774
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of                     Average burden
        21 CFR section             Number of      records per    Total annual          per          Total hours
                                 recordkeepers   recordkeeper       records       recordkeeping
----------------------------------------------------------------------------------------------------------------
361.1(c)(2)...................              69               4             276  10..............           2,760
361.1(d)(5)...................              35              18             630  0.75............           472.5
                                                                                (45 minutes)....
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................         3,232.5
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: January 22, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-01463 Filed 1-24-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: March 16, 2010 (Volume 75, Number 50)]
[Notices]
[Page 12547-12549]
[DOCID:fr16mr10-61]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0119]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Registration of Food Facilities Under the Public
Health Security and Bioterrorism Preparedness and Response Act of 2002

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
provisions of the agency's regulations that require registration for
domestic and foreign facilities that manufacture, process, pack, or
hold food for human or animal consumption in the United States.

DATES: Submit written or electronic comments on the collection of
information by May 17, 2010.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Registration of Food Facilities Under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002--21 CFR 1.230-1.235
(OMB Control Number 0910-0502)--Extension

    The Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism Act) added section 415 of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 350d), which
requires domestic and foreign facilities that manufacture, process,
pack, or hold food for human or animal consumption in the United States
to register with FDA. Sections 1.230-1.235 of FDA's regulations (21 CFR
1.230-1.235) set forth the procedures for registration of food
facilities. Information provided to FDA under these regulations will
help the agency to notify quickly the facilities that might be affected
by a deliberate or accidental contamination of the food supply.
    Description of Respondents: The respondents to this information
collection include owners, operators, or agents in charge of domestic
or foreign facilities that manufacture/process, pack, or hold food for
human or animal consumption in the United States. Domestic facilities
are required to register whether or not food from the facility enters
interstate commerce. Foreign facilities that manufacture/process, pack,
or hold food also are required to register unless food from that
facility undergoes further processing (including packaging) by another
foreign facility before the food is exported to the United States.
However, if the subsequent foreign facility performs only a minimal
activity, such as putting on a label, both facilities are required to
register.
    FDA's regulations require that each facility that manufactures,
processes, packs, or holds food for human or animal consumption in the
United States register with FDA using Form FDA 3537 (Sec.  1.231). The
term ``Form FDA 3537'' refers to both the paper version of the form and
the electronic system known as the Food Facility Registration Module,
which is available at http://www.access.fda.gov. The agency strongly
encourages electronic registration because it is faster and more
convenient. The system the agency has developed can accept electronic
registrations from anywhere in the world 24 hours a day, 7 days a week.
A registering facility will receive confirmation of electronic
registration and its registration number instantaneously once all the
required fields on the registration screen are filled in. However,
paper registrations will be accepted. Form FDA 3537 is available for
download for registration by mail, fax, or CD-ROM. Registration by mail
may take several weeks to several months, depending on the speed of the
mail system and the number of paper registrations that FDA will have to
enter manually.
    Information FDA requires on the registration form includes the name
and full address of the facility; emergency contact information; all
trade names the facility uses; applicable food product categories
identified in Sec.  170.3 (21 CFR 170.3), unless ``most/all'' human
food categories ``or none of the above mandatory categories'' is
selected as a response; and a certification statement that includes the
name of the individual authorized to submit the registration form.
Additionally, facilities are encouraged to submit their preferred
mailing address; type of activity conducted at the facility; food
categories not included under Sec.  170.3, but which are helpful to FDA
for responding to an incident; type of storage, if the facility is
primarily a holding facility; and approximate dates of operation if the
facility's business is seasonal.
    In addition to registering, a facility is required to submit timely
updates within 60 days of a change to any required information on its
registration form, using Form FDA 3537 (Sec.  1.234), and to cancel its
registration when the facility ceases to operate or is sold to new
owners or ceases to manufacture/process, pack, or hold food for
consumption in the United States, using Form FDA 3537a (Sec.  1.235).
    FDA estimates the burden of complying with the information
collection provisions of the agency's regulations for food facility
registration as follows:

                                                      Table 1--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                               Annual Frequency     Total Annual        Hours  per
          21 CFR  Section               FDA Form No.     No. of  Respondents    per Respondent       Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Facilities
--------------------------------------------------------------------------------------------------------------------------------------------------------

Domestic
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.230-1.233                                FDA 3537\2\                13,560                  1             13,560                2.5             33,900
--------------------------------------------------------------------------------------------------------------------------------------------------------
Foreign
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.230-1.233                                   FDA 3537                23,370                  1             23,370                8.5            198,645
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Facility Registration Subtotal                                                                                232,545
--------------------------------------------------------------------------------------------------------------------------------------
Previously Registered Facilities-Updates (Form 3537) and Cancellations (Form 3537a)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.234                                         FDA 3537               118,530                  1            118,530                  1            118,530
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.235                                        FDA 3537a                 6,390                  1              6,390                  1              6,390
--------------------------------------------------------------------------------------------------------------------------------------------------------
Updates or Cancellations to Existing Registration Subtotal                                                                                124,920
--------------------------------------------------------------------------------------------------------------------------------------
Total Hours Annually                                                                                357,465
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The term ``Form FDA 3537'' refers to both the paper version of the form and the electronic system known as the Food Facility Registration Module,
  which is available at http://www.access.fda.gov.

    This estimate is based on FDA's experience and the average number
of new facility registrations, updates and cancellations received in
the past 3 years. FDA received 12,681 new domestic facility
registrations during 2006; 14,629 during 2007; and 13,378 during 2008.
Based on this experience, FDA estimates the annual number of new
domestic facility registrations will be 13,560. FDA estimates that
listing the information required by the Bioterrorism Act and presenting
it in a format that will meet the agency's registration regulations
will require a burden of approximately 2.5 hours per average domestic
facility registration. The average domestic facility burden hour
estimate of 2.5 hours takes into account that some respondents
completing the registration may not have readily available Internet
access. Thus, the total annual burden for new domestic facility
registrations is estimated to be 33,900 hours (13,560 x 2.5 hours).
    FDA received 25,513 new foreign facility registrations during 2006;
23,302 during 2007; and 21,281 during 2008. Based on this experience,
FDA estimates the annual number of new foreign facility registrations
will be 23,370. FDA estimates that listing the information required by
the Bioterrorism Act and presenting it in a format that will meet the
agency's registration regulations will require a burden of
approximately 8.5 hours per average foreign facility registration. The
average foreign facility burden hour estimate of 8.5 hours includes an
estimate of the additional burden on a foreign facility to obtain a
U.S. agent, and takes into account that for some foreign facilities the
respondent completing the registration may not be fluent in English
and/or not have readily available Internet access. Thus, the total
annual burden for new foreign facility registrations is estimated to be
198,645 hours (23,370 x 8.5 hours).
    FDA received 114,199 updates to facility registrations during 2006;
128,070 during 2007; and 113,318 during 2008. Based on this experience,
FDA estimates that it will receive 118,530 updates annually. FDA also
estimates that updating a registration will, on average, require a
burden of approximately 1 hour, taking into account fluency in English
and Internet access. Thus, the total annual burden for updating all
registrations is estimated to be 118,530 hours.
    FDA received 5,703 cancellations of facility registrations during
2006; 5,578 during 2007; and 7,888 during 2008. Based on this
experience, FDA estimates the annual number of cancellations will be
6,390. FDA also estimates that cancelling a registration will, on
average, require a burden of approximately 1 hour, taking into account
fluency in English and Internet access. Thus, the total annual burden
for cancelling registrations is estimated to be 6,390 hours.

    Dated: March 11, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-5656 Filed 3-15-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 78, Number 172 (Thursday, September 5, 2013)]
[Notices]
[Pages 54667-54668]
[FR Doc No: 2013-21625]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[USCG-2013-0779]

Information Collection Requests to Office of Management and
Budget

AGENCY: Coast Guard, DHS.

ACTION: Sixty-day notice requesting comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit Information Collection Requests
(ICRs) to the Office of Management and Budget (OMB), Office of
Information and Regulatory Affairs (OIRA), requesting approval of an
extension to the following collections of information: 1625-0007,
Characteristics of Liquid Chemicals Proposed for Bulk Water Movement
and 1625-0100, Advance Notice of Vessel Arrival. Our ICRs describe the
information we seek to collect from the public. Before submitting these
ICRs to OIRA, the Coast Guard is inviting comments as described below.

DATES: Comments must reach the Coast Guard on or before November 4,
2013.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2013-0779] to the Docket Management Facility (DMF) at the
U.S. Department of Transportation (DOT). To avoid duplicate
submissions, please use only one of the following means:
    (1) Online: http://www.regulations.gov.
    (2) Mail: DMF (M-30), DOT, West Building Ground Floor, Room W12-
140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
    (3) Hand Delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    (4) Fax:<PHONE_NUMBER>. To ensure your comments are received in a
timely manner, mark the fax, to attention Desk Officer for the Coast
Guard.
    The DMF maintains the public docket for this Notice. Comments and
material received from the public, as well as documents mentioned in
this Notice as being available in the docket, will become part of the
docket and will be available for inspection or copying at room W12-140
on the West Building Ground Floor, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. You may also find the docket on the Internet
at http://www.regulations.gov.
    Copies of the ICRs are available through the docket on the Internet
at http://www.regulations.gov. Additionally, copies are available from:
COMMANDANT (CG-612), ATTN PAPERWORK REDUCTION ACT MANAGER, US COAST
GUARD, 2703 MARTIN LUTHER KING JR AVE SE STOP 7710, WASHINGTON DC
20593-7710.

FOR FURTHER INFORMATION: Contact Mr. Anthony Smith, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>,
for questions on these documents. Contact Ms. Barbara Hairston, Program
Manager, Docket Operations,<PHONE_NUMBER>, for questions on the docket.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collections. There is
one ICR for each Collection.
    The Coast Guard invites comments on whether these ICRs should be
granted based on the Collections being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) the practical utility of the
Collections; (2) the accuracy of the estimated burden of the

Collections; (3) ways to enhance the quality, utility, and clarity of
information subject to the Collections; and (4) ways to minimize the
burden of the Collections on respondents, including the use of
automated collection techniques or other forms of information
technology. In response to your comments, we may revise these ICRs or
decide not to seek approval of revisions of the Collections. We will
consider all comments and material received during the comment period.
    We encourage you to respond to this request by submitting comments
and related materials. Comments must contain the OMB Control Number of
the ICR and the docket number of this request, [USCG-2013-0779], and
must be received by November 4, 2013. We will post all comments
received, without change, to http://www.regulations.gov. They will
include any personal information you provide. We have an agreement with
DOT to use their DMF. Please see the ``Privacy Act'' paragraph below.

Submitting Comments

    If you submit a comment, please include the docket number [USCG-
2013-0779], indicate the specific section of the document to which each
comment applies, providing a reason for each comment. You may submit
your comments and material online (via http://www.regulations.gov), by
fax, mail, or hand delivery, but please use only one of these means. If
you submit a comment online via www.regulations.gov, it will be
considered received by the Coast Guard when you successfully transmit
the comment. If you fax, hand deliver, or mail your comment, it will be
considered as having been received by the Coast Guard when it is
received at the DMF. We recommend you include your name, mailing
address, an email address, or other contact information in the body of
your document so that we can contact you if we have questions regarding
your submission.
    You may submit your comments and material by electronic means,
mail, fax, or delivery to the DMF at the address under ADDRESSES; but
please submit them by only one means. To submit your comment online, go
to http://www.regulations.gov, and type ``USCG-2013-0779'' in the
``Keyword'' box. If you submit your comments by mail or hand delivery,
submit them in an unbound format, no larger than 8\1/2\ by 11 inches,
suitable for copying and electronic filing. If you submit comments by
mail and would like to know that they reached the Facility, please
enclose a stamped, self-addressed postcard or envelope. We will
consider all comments and material received during the comment period
and will address them accordingly.
    Viewing comments and documents: To view comments, as well as
documents mentioned in this Notice as being available in the docket, go
to http://www.regulations.gov, click on the ``read comments'' box,
which will then become highlighted in blue. In the ``Keyword'' box
insert ``USCG-2013-0779'' and click ``Search.'' Click the ``Open Docket
Folder'' in the ``Actions'' column. You may also visit the DMF in Room
W12-140 on the ground floor of the DOT West Building, 1200 New Jersey
Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

Privacy Act

    Anyone can search the electronic form of comments received in
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 a Privacy Act statement
regarding Coast Guard public dockets in the January 17, 2008, issue of
the Federal Register (73 FR 3316).

Information Collection Requests

    1. Title: Characteristics of Liquid Chemicals Proposed for Bulk
Water Movement.
    OMB Control Number: 1625-0007.
    Summary: The Coast Guard requires manufacturers of new chemicals to
submit data on new materials. From these data, the Coast Guard
determines the appropriate precautions to take.
    Need: 46 CFR parts 30 to 40, 151, 153, and 154 govern the
transportation of hazardous materials. The chemical industry constantly
produces new materials that must be moved by water. Each of these new
materials has unique characteristics that require special attention to
their mode of shipment.
    Forms: N/A.
    Respondents: Manufacturers of certain hazardous chemicals.
    Frequency: On occasion.
    Burden Estimate: The estimated burden of 600 hours a year remains
unchanged.
    2. Title: Advance Notice of Vessel Arrival.
    OMB Control Number: 1625-0100.
    Summary: The Ports and Waterways Safety Act authorizes the Coast
Guard to require pre-arrival messages from any vessel entering a port
or place in the United States.
    Need: This information is required under 33 CFR part 160 subpart C
to control vessel traffic, develop contingency plans, and enforce
regulations.
    Forms: N/A.
    Respondents: Vessel owners and operators.
    Frequency: On occasion.
    Burden Estimate: The estimated burden remains 164,144 hours a year.

    Dated: August 29, 2013.
R.E. Day,
Rear Admiral, U. S. Coast Guard, Assistant Commandant for Command,
Control, Communications, Computers and Information Technology.
[FR Doc. 2013-21625 Filed 9-4-13; 8:45 am]
BILLING CODE 9110-04-P


KENTUCKY PM2.5 STANDARD PARTIAL COUNTY DESIGNATIONS Fayette County That portion of Fayette County within the boundaries described as follows:

Beginning at the intersection of U. S. Highway 421 and State Highway 4 ( New Circle Road) proceeding southeast along U. S. Highway 421 to the intersection of U. S. Highway 421 and State Highway 922 ( Newtown Pike); proceed northeast to the intersection of State Highway 922 and W. 3rd Street; proceed southeast on W. 3rd Street to the intersection of W. 3rd Street and Jefferson Street; proceed northeast along Jefferson Street to the intersection of Jefferson Street and W. 6th Street; proceed southeast on W. 6th Street to the intersection of W. 6th Street and N. Broadway; proceed northeast along N. Broadway to the intersection of N. Broadway and E. Loudon Avenue; proceed southeast along E. Loudon Avenue to the intersection of E. Loudon Avenue and U. S. Highway 60 ( Winchester Pike); proceed west along U. S. Highway 60 to the intersection of U. S. 60 and Liberty Road; proceed southeast along Liberty Road to the intersection of Liberty Road and State Highway 4; proceeding south and clockwise along State Highway 4 to the northwestern intersection of U. S. Highway 421 and State Highway 4.

Lawrence County That portion of Lawrence County within the boundaries described as follows:

Beginning at the intersection of the Lawrence/ Boyd County line with U. S. Highway 23; proceeding east along said county line to the Big Sandy River; proceeding south along the Big Sandy River to a point directly east of the intersection of U. S. Highway 23 and State Highway 3398; proceeding directly west to the intersection of U. S. Highway 23 and State Highway 3398; proceeding north on U. S. Highway 23 to the Lawrence/ Boyd County line.


[Federal Register Volume 79, Number 226 (Monday, November 24, 2014)]
[Proposed Rules]
[Pages 69796-69802]
[FR Doc No: 2014-27752]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2014-0258; FRL-9919-50-Region 9]

Approval and Promulgation of State Implementation Plans; Arizona;
Infrastructure Requirements for the 2008 Lead (Pb) and the 2008 8-Hour
Ozone National Ambient Air Quality Standards (NAAQS)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a State Implementation Plan (SIP) revision submitted by the
State of Arizona to address the requirements of section 110(a)(1) and
(2) of the Clean Air Act (CAA) for the 2008 Lead (Pb) and 2008 ozone
national ambient air quality standards (NAAQS). Section 110(a) of the
CAA requires that each State adopt and submit a SIP for the
implementation, maintenance, and enforcement of each NAAQS promulgated
by EPA. We refer to such SIP revisions as ``infrastructure'' SIPs
because they are intended to address basic structural SIP requirements
for new or revised NAAQS including, but not limited to, legal
authority, regulatory structure, resources, permit programs,
monitoring, and modeling necessary to assure attainment and maintenance
of the standards. In addition, we are proposing to approve several
state provisions addressing CAA conflict of interest and monitoring
requirements into the Arizona SIP. We are taking comments on this
proposal and plan to follow with a final action.

DATES: Written comments must be received on or before December 24,
2014.

ADDRESSES: Submit your comments, identified by Docket No. EPA-R09-OAR-
2014-0258, by one of the following methods:
    1. Federal Rulemaking Portal: http://www.regulations.gov. Follow
the on-line instructions for submitting comments.
    2. Email: Jeffrey Buss at<EMAIL_ADDRESS>    3. Fax: Jeffrey Buss, Air Planning Office (AIR-2), at fax number
415-947-3579.
    4. Mail: Jeffrey Buss, Air Planning Office (AIR-2), U.S.
Environmental Protection Agency, Region IX, 75 Hawthorne, San
Francisco, California 94105.
    5. Hand or Courier Delivery: Jeffrey Buss, Air Planning Section
(AIR-2), U.S. Environmental Protection Agency, Region IX, 75 Hawthorne,
San Francisco, California 94105. Such deliveries are only accepted
during the Regional Office's normal hours of operation. Special
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R09-OAR-
2014-0258. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information the disclosure of which
is restricted by statute. Do not submit information through
www.regulations.gov or email that you consider to be CBI or otherwise
protected from disclosure. The www.regulations.gov Web site is an
anonymous access system, which means EPA will not know your identity or
contact information unless you provide it in the body of your comment.
If you send an email comment directly to EPA without going through
www.regulations.gov, your email address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly

available only in hard copy. Publicly available docket materials are
available either electronically in www.regulations.gov or in hard copy
at the Air Planning Office (AIR-2), U.S. Environmental Protection
Agency, Region IX, 75 Hawthorne Street, San Francisco, California
94105. EPA requests that if at all possible, you contact the person
listed in the FOR FURTHER INFORMATION CONTACT section to schedule your
inspection during normal business hours.

FOR FURTHER INFORMATION CONTACT: Jeffrey Buss, Office of Air Planning,
U.S. Environmental Protection Agency, Region 9,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, the terms ``we,''
``us,'' and ``our'' refer to EPA.

Table of Contents

I. EPA's approach to the Review of Infrastructure SIP Submittals
II. Background
III. Arizona's Submittals
IV. EPA's Evaluation and Proposed Action
V. Statutory and Executive Order Reviews

I. EPA's Approach to the Review of Infrastructure SIP Submittals

    EPA is acting upon several SIP submittals from Arizona that address
the infrastructure requirements of CAA sections 110(a)(1) and 110(a)(2)
for the 2008 ozone and 2008 Pb NAAQS. The requirement for states to
make a SIP submittal of this type arises out of CAA section 110(a)(1).
Pursuant to section 110(a)(1), states must make SIP submittals ``within
3 years (or such shorter period as the Administrator may prescribe)
after the promulgation of a national primary ambient air quality
standard (or any revision thereof),'' and these SIP submittals are to
provide for the ``implementation, maintenance, and enforcement'' of
such NAAQS. The statute directly imposes on states the duty to make
these SIP submittals, and the requirement to make the submittals is not
conditioned upon EPA's taking any action other than promulgating a new
or revised NAAQS. Section 110(a)(2) includes a list of specific
elements that ``[e]ach such plan'' submittal must address.
    EPA has historically referred to these SIP submittals made for the
purpose of satisfying the requirements of CAA sections 110(a)(1) and
110(a)(2) as ``infrastructure SIP'' submittals. Although the term
``infrastructure SIP'' does not appear in the CAA, EPA uses the term to
distinguish this particular type of SIP submittal from submittals that
are intended to satisfy other SIP requirements under the CAA, such as
``nonattainment SIP'' or ``attainment SIP'' submittals to address the
nonattainment planning requirements of part D of title I of the CAA,
``regional haze SIP'' submittals required by EPA rule to address the
visibility protection requirements of CAA section 169A, and
nonattainment new source review (NSR) permit program submittals to
address the permit requirements of CAA, title I, part D.
    Section 110(a)(1) addresses the timing and general requirements for
infrastructure SIP submittals, and section 110(a)(2) provides more
details concerning the required contents of these submittals. The list
of required elements provided in section 110(a)(2) contains a wide
variety of disparate provisions, some of which pertain to required
legal authority, some of which pertain to required substantive program
provisions, and some of which pertain to requirements for both
authority and substantive program provisions.\1\ EPA therefore believes
that while the timing requirement in section 110(a)(1) is unambiguous,
some of the other statutory provisions are ambiguous. In particular,
EPA believes that the list of required elements for infrastructure SIP
submittals provided in section 110(a)(2) contains ambiguities
concerning what is required for inclusion in an infrastructure SIP
submittal.
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    \1\ For example: Section 110(a)(2)(E)(i) provides that states
must provide assurances that they have adequate legal authority
under state and local law to carry out the SIP; section 110(a)(2)(C)
provides that states must have a SIP-approved program to address
certain sources as required by part C of title I of the CAA; and
section 110(a)(2)(G) provides that states must have legal authority
to address emergencies as well as contingency plans that are
triggered in the event of such emergencies.
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    The following examples of ambiguities illustrate the need for EPA
to interpret some section 110(a)(1) and section 110(a)(2) requirements
with respect to infrastructure SIP submittals for a given new or
revised NAAQS. One example of ambiguity is that section 110(a)(2)
requires that ``each'' SIP submittal must meet the list of requirements
therein, while EPA has long noted that this literal reading of the
statute is internally inconsistent and would create a conflict with the
nonattainment provisions in part D of title I of the Act, which
specifically address nonattainment SIP requirements.\2\ Section
110(a)(2)(I) pertains to nonattainment SIP requirements and part D
addresses when attainment plan SIP submittals to address nonattainment
area requirements are due. For example, section 172(b) requires EPA to
establish a schedule for submittal of such plans for certain pollutants
when the Administrator promulgates the designation of an area as
nonattainment, and section 107(d)(1)(B) allows up to two years, or in
some cases three years, for such designations to be promulgated.\3\
This ambiguity illustrates that rather than apply all the stated
requirements of section 110(a)(2) in a strict literal sense, EPA must
determine which provisions of section 110(a)(2) are applicable for a
particular infrastructure SIP submittal.
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    \2\ See, e.g., ``Rule To Reduce Interstate Transport of Fine
Particulate Matter and Ozone (Clean Air Interstate Rule); Revisions
to Acid Rain Program; Revisions to the NOX SIP Call;
Final Rule,'' 70 FR 25162, at 25163-25165, May 12, 2005 (explaining
relationship between timing requirement of section 110(a)(2)(D)
versus section 110(a)(2)(I)).
    \3\ EPA notes that this ambiguity within section 110(a)(2) is
heightened by the fact that various subparts of part D set specific
dates for submittal of certain types of SIP submittals in designated
nonattainment areas for various pollutants. Note, e.g., that section
182(a)(1) provides specific dates for submittal of emissions
inventories for the ozone NAAQS. Some of these specific dates are
necessarily later than three years after promulgation of the new or
revised NAAQS.
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    Another example of ambiguity within sections 110(a)(1) and
110(a)(2) with respect to infrastructure SIPs pertains to whether
states must meet all of the infrastructure SIP requirements in a single
SIP submittal, and whether EPA must act upon such SIP submittal in a
single action. Although section 110(a)(1) directs states to submit ``a
plan'' to meet these requirements, EPA interprets the CAA to allow
states to make multiple SIP submittals separately addressing
infrastructure SIP elements for the same NAAQS. If states elect to make
such multiple SIP submittals to meet the infrastructure SIP
requirements, EPA can elect to act on such submittals either
individually or in a larger combined action.\4\ Similarly, EPA
interprets the CAA to allow it to take action on the individual parts
of one larger, comprehensive infrastructure SIP submittal for a given
NAAQS without concurrent action on the entire submittal. For example,
EPA has sometimes elected to act at different times on various elements
and sub-

elements of the same infrastructure SIP submittal.\5\
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    \4\ See, e.g., ``Approval and Promulgation of Implementation
Plans; New Mexico; Revisions to the New Source Review (NSR) State
Implementation Plan (SIP); Prevention of Significant Deterioration
(PSD) and Nonattainment New Source Review (NNSR) Permitting,'' 78 FR
4339, January 22, 2013 (EPA's final action approving the structural
PSD elements of the New Mexico SIP submitted by the State separately
to meet the requirements of EPA's 2008 PM2.5 NSR rule),
and ``Approval and Promulgation of Air Quality Implementation Plans;
New Mexico; Infrastructure and Interstate Transport Requirements for
the 2006 PM2.5 NAAQS,'' 78 FR 4337, January 22, 2013
(EPA's final action on the infrastructure SIP for the 2006
PM2.5 NAAQS).
    \5\ On December 14, 2007, the State of Tennessee, through the
Tennessee Department of Environment and Conservation, made a SIP
revision to EPA demonstrating that the State meets the requirements
of sections 110(a)(1) and (2). EPA proposed action for
infrastructure SIP elements (C) and (J) on January 23, 2012 (77 FR
3213) and took final action on March 14, 2012 (77 FR 14976). On
April 16, 2012 (77 FR 22533) and July 23, 2012 (77 FR 42997), EPA
took separate proposed and final actions on all other section
110(a)(2) infrastructure SIP elements of Tennessee's December 14,
2007 submittal.
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    Ambiguities within sections 110(a)(1) and 110(a)(2) may also arise
with respect to infrastructure SIP submittal requirements for different
NAAQS. Thus, EPA notes that not every element of section 110(a)(2)
would be relevant, or as relevant, or relevant in the same way, for
each new or revised NAAQS. The states' attendant infrastructure SIP
submittals for each NAAQS therefore could be different. For example,
the monitoring requirements that a state might need to meet in its
infrastructure SIP submittal for purposes of section 110(a)(2)(B) could
be very different for different pollutants, for example because the
content and scope of a state's infrastructure SIP submittal to meet
this element might be very different for an entirely new NAAQS than for
a minor revision to an existing NAAQS.\6\
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    \6\ For example, implementation of the 1997 PM2.5
NAAQS required the deployment of a system of new monitors to measure
ambient levels of that new indicator species for the new NAAQS.
---------------------------------------------------------------------------

    EPA notes that interpretation of section 110(a)(2) is also
necessary when EPA reviews other types of SIP submittals required under
the CAA. Therefore, as with infrastructure SIP submittals, EPA also has
to identify and interpret the relevant elements of section 110(a)(2)
that logically apply to these other types of SIP submittals. For
example, section 172(c)(7) requires that attainment plan SIP submittals
required by part D have to meet the ``applicable requirements'' of
section 110(a)(2). Thus, for example, attainment plan SIP submittals
must meet the requirements of section 110(a)(2)(A) regarding
enforceable emission limits and control measures and section
110(a)(2)(E)(i) regarding air agency resources and authority. By
contrast, it is clear that attainment plan SIP submittals required by
part D would not need to meet the portion of section 110(a)(2)(C) that
pertains to the air quality prevention of significant deterioration
(PSD) program required in part C of title I of the CAA, because PSD
does not apply to a pollutant for which an area is designated
nonattainment and thus subject to part D planning requirements. As this
example illustrates, each type of SIP submittal may implicate some
elements of section 110(a)(2) but not others.
    Given the potential for ambiguity in some of the statutory language
of section 110(a)(1) and section 110(a)(2), EPA believes that it is
appropriate to interpret the ambiguous portions of section 110(a)(1)
and section 110(a)(2) in the context of acting on a particular SIP
submittal. In other words, EPA assumes that Congress could not have
intended that each and every SIP submittal, regardless of the NAAQS in
question or the history of SIP development for the relevant pollutant,
would meet each of the requirements, or meet each of them in the same
way. Therefore, EPA has adopted an approach under which it reviews
infrastructure SIP submittals against the list of elements in section
110(a)(2), but only to the extent each element applies for that
particular NAAQS.
    Historically, EPA has elected to use guidance documents to make
recommendations to states for infrastructure SIPs, in some cases
conveying needed interpretations on newly arising issues and in some
cases conveying interpretations that have already been developed and
applied to individual SIP submittals for particular elements.\7\ EPA
most recently issued guidance for infrastructure SIPs on September 13,
2013 (2013 Infrastructure SIP Guidance).\8\ EPA developed this document
to provide states with up-to-date guidance for infrastructure SIPs for
any new or revised NAAQS. Within this guidance, EPA describes the duty
of states to make infrastructure SIP submittals to meet basic
structural SIP requirements within three years of promulgation of a new
or revised NAAQS. EPA also made recommendations about many specific
subsections of section 110(a)(2) that are relevant in the context of
infrastructure SIP submittals.\9\ The guidance also discusses the
substantively important issues that are germane to certain subsections
of section 110(a)(2). Significantly, EPA interprets sections 110(a)(1)
and 110(a)(2) such that infrastructure SIP submittals need to address
certain issues and need not address others. Accordingly, EPA reviews
each infrastructure SIP submittal for compliance with the applicable
statutory provisions of section 110(a)(2), as appropriate.
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    \7\ EPA notes, however, that nothing in the CAA requires EPA to
provide guidance or to promulgate regulations for infrastructure SIP
submittals. The CAA directly applies to states and requires the
submittal of infrastructure SIP submittals, regardless of whether or
not EPA provides guidance or regulations pertaining to such
submittals. EPA elects to issue such guidance in order to assist
states, as appropriate.
    \8\ ``Guidance on Infrastructure State Implementation Plan (SIP)
Elements under Clean Air Act Sections 110(a)(1) and 110(a)(2),''
Memorandum from Stephen D. Page, September 13, 2013.
    \9\ EPA's September 13, 2013, guidance did not make
recommendations with respect to infrastructure SIP submittals to
address section 110(a)(2)(D)(i)(I). EPA issued the guidance shortly
after the U.S. Supreme Court agreed to review the D.C. Circuit
decision in EME Homer City, 696 F.3d7 (D.C. Cir. 2012) which had
interpreted the requirements of section 110(a)(2)(D)(i)(I). In light
of the uncertainty created by ongoing litigation, EPA elected not to
provide additional guidance on the requirements of section
110(a)(2)(D)(i)(I) at that time. As the guidance is neither binding
nor required by statute, whether EPA elects to provide guidance on a
particular section has no impact on a state's CAA obligations.
---------------------------------------------------------------------------

    As an example, section 110(a)(2)(E)(ii) is a required element of
section 110(a)(2) for infrastructure SIP submittals. Under this
element, a state must meet the substantive requirements of section 128,
which pertain to state boards that approve permits or enforcement
orders and heads of executive agencies with similar powers. Thus, EPA
reviews infrastructure SIP submittals to ensure that the state's SIP
appropriately addresses the requirements of section 110(a)(2)(E)(ii)
and section 128. The 2013 Infrastructure SIP Guidance explains EPA's
interpretation that there may be a variety of ways by which states can
appropriately address these substantive statutory requirements,
depending on the structure of an individual state's permitting or
enforcement program (e.g., whether permits and enforcement orders are
approved by a multi-member board or by a head of an executive agency).
However they are addressed by the state, the substantive requirements
of section 128 are necessarily included in EPA's evaluation of
infrastructure SIP submittals because section 110(a)(2)(E)(ii)
explicitly requires that the state satisfy the provisions of section
128.
    As another example, EPA's review of infrastructure SIP submittals
with respect to the PSD program requirements in sections 110(a)(2)(C),
(D)(i)(II), and (J) focuses upon the structural PSD program
requirements contained in part C, title I of the Act and EPA's PSD
regulations. Structural PSD program requirements include provisions
necessary for the PSD program to address all regulated sources and
regulated NSR pollutants, including greenhouse gases (GHGs). By
contrast, structural PSD program requirements do not include provisions
that are not required under EPA's regulations at 40

Code of Federal Regulations (CFR) 51.166 but are merely available as an
option for the state, such as the option to provide grandfathering of
complete permit applications with respect to the 2012 PM2.5
NAAQS. Accordingly, the latter optional provisions are types of
provisions EPA considers irrelevant in the context of an infrastructure
SIP action.
    For other section 110(a)(2) elements, however, EPA's review of a
state's infrastructure SIP submittal focuses on assuring that the
state's SIP meets basic structural requirements. For example, section
110(a)(2)(C) includes, inter alia, the requirement that states have a
program to regulate minor new sources. Thus, EPA evaluates whether the
state has a SIP-approved minor NSR program and whether the program
addresses the pollutants relevant to that NAAQS. In the context of
acting on an infrastructure SIP submittal, however, EPA does not think
it is necessary to conduct a review of each and every provision of a
state's existing minor source program (i.e., already in the existing
SIP) for compliance with the requirements of the CAA and EPA's
regulations that pertain to such programs.
    With respect to certain other issues, EPA does not believe that an
action on a state's infrastructure SIP submittal is necessarily the
appropriate type of action in which to address possible deficiencies in
a state's existing SIP. These issues include: (i) Existing provisions
related to excess emissions from sources during periods of startup,
shutdown, or malfunction that may be contrary to the CAA and EPA's
policies addressing such excess emissions (``SSM''); (ii) existing
provisions related to ``director's variance'' or ``director's
discretion'' that may be contrary to the CAA because they purport to
allow revisions to SIP-approved emissions limits while limiting public
process or not requiring further approval by EPA; and (iii) existing
provisions for PSD programs that may be inconsistent with current
requirements of EPA's ``Final NSR Improvement Rule,'' 67 FR 80186,
December 31, 2002, as amended by 72 FR 32526, June 13, 2007 (``NSR
Reform''). Thus, EPA believes it may approve an infrastructure SIP
submittal without scrutinizing the totality of the existing SIP for
such potentially deficient provisions and may approve the submittal
even if it is aware of such existing provisions.\10\ It is important to
note that EPA's approval of a state's infrastructure SIP submittal
should not be construed as explicit or implicit re-approval of any
existing potentially deficient provisions that relate to the three
specific issues just described.
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    \10\ By contrast, EPA notes that if a state were to include a
new provision in an infrastructure SIP submittal that contained a
legal deficiency, such as a new exemption for excess emissions
during SSM events, then EPA would need to evaluate that provision
for compliance against the rubric of applicable CAA requirements in
the context of the action on the infrastructure SIP.
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    EPA's approach to review of infrastructure SIP submittals is to
identify the CAA requirements that are logically applicable to that
submittal. EPA believes that this approach to the review of a
particular infrastructure SIP submittal is appropriate, because it
would not be reasonable to read the general requirements of section
110(a)(1) and the list of elements in 110(a)(2) as requiring review of
each and every provision of a state's existing SIP against all
requirements in the CAA and EPA regulations merely for purposes of
assuring that the state in question has the basic structural elements
for a functioning SIP for a new or revised NAAQS. Because SIPs have
grown by accretion over the decades as statutory and regulatory
requirements under the CAA have evolved, they may include some outmoded
provisions and historical artifacts. These provisions, while not fully
up to date, nevertheless may not pose a significant problem for the
purposes of ``implementation, maintenance, and enforcement'' of a new
or revised NAAQS when EPA evaluates adequacy of the infrastructure SIP
submittal. EPA believes that a better approach is for states and EPA to
focus attention on those elements of section 110(a)(2) of the CAA most
likely to warrant a specific SIP revision due to the promulgation of a
new or revised NAAQS or other factors.
    For example, EPA's 2013 Infrastructure SIP Guidance gives simpler
recommendations with respect to carbon monoxide than other NAAQS
pollutants to meet the visibility requirements of section
110(a)(2)(D)(i)(II), because carbon monoxide does not affect
visibility. As a result, an infrastructure SIP submittal for any future
new or revised NAAQS for carbon monoxide need only state this fact in
order to address the visibility prong of section 110(a)(2)(D)(i)(II).
    Finally, EPA believes that its approach with respect to
infrastructure SIP requirements is based on a reasonable reading of
sections 110(a)(1) and 110(a)(2) because the CAA provides other avenues
and mechanisms to address specific substantive deficiencies in existing
SIPs. These other statutory tools allow EPA to take appropriately
tailored action, depending upon the nature and severity of the alleged
SIP deficiency. Section 110(k)(5) authorizes EPA to issue a ``SIP
call'' whenever the Agency determines that a state's SIP is
substantially inadequate to attain or maintain the NAAQS, to mitigate
interstate transport, or to otherwise comply with the CAA.\11\ Section
110(k)(6) authorizes EPA to correct errors in past actions, such as
past approvals of SIP submittals.\12\ Significantly, EPA's
determination that an action on a state's infrastructure SIP submittal
is not the appropriate time and place to address all potential existing
SIP deficiencies does not preclude EPA's subsequent reliance on
provisions in section 110(a)(2) as part of the basis for action to
correct those deficiencies at a later time. For example, although it
may not be appropriate to require a state to eliminate all existing
inappropriate director's discretion provisions in the course of acting
on an infrastructure SIP submittal, EPA believes that section
110(a)(2)(A) may be among the statutory bases that EPA relies upon in
the course of addressing such deficiency in a subsequent action.\13\
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    \11\ For example, EPA issued a SIP call to Utah to address
specific existing SIP deficiencies related to the treatment of
excess emissions during SSM events. See ``Finding of Substantial
Inadequacy of Implementation Plan; Call for Utah State
Implementation Plan Revisions,'' 76 FR 21639, April 18, 2011.
    \12\ EPA has used this authority to correct errors in past
actions on SIP submittals related to PSD programs. See ``Limitation
of Approval of Prevention of Significant Deterioration Provisions
Concerning Greenhouse Gas Emitting-Sources in State Implementation
Plans; Final Rule,'' 75 FR 82536, December 30, 2010. EPA has
previously used its authority under CAA section 110(k)(6) to remove
numerous other SIP provisions that the Agency determined it had
approved in error. See, e.g., 61 FR 38664, July 25, 1996 and 62 FR
34641, June 27, 1997 (corrections to American Samoa, Arizona,
California, Hawaii, and Nevada SIPs); 69 FR 67062, November 16, 2004
(corrections to California SIP); and 74 FR 57051, November 3, 2009
(corrections to Arizona and Nevada SIPs).
    \13\ See, e.g., EPA's disapproval of a SIP submittal from
Colorado on the grounds that it would have included a director's
discretion provision inconsistent with CAA requirements, including
section 110(a)(2)(A). See, e.g., 75 FR 42342 at 42344, July 21, 2010
(proposed disapproval of director's discretion provisions); 76 FR
4540, January 26, 2011 (final disapproval of such provisions).
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II. Background

A. Statutory Framework

    As discussed in section I of this proposed rule, CAA section
110(a)(1) requires each state to submit to EPA, within three years
after the promulgation of a primary or secondary NAAQS or any revision
thereof, an infrastructure SIP revision that provides

for the implementation, maintenance, and enforcement of such NAAQS.
Section 110(a)(2) sets the content requirements of such a plan, which
generally relate to the information and authorities, compliance
assurances, procedural requirements, and control measures that
constitute the ``infrastructure'' of a state's air quality management
program. These infrastructure SIP elements required by section
110(a)(2) are as follows:
     Section 110(a)(2)(A): Emission limits and other control
measures.
     Section 110(a)(2)(B): Ambient air quality monitoring/data
system.
     Section 110(a)(2)(C): Program for enforcement of control
measures and regulation of new and modified stationary sources.
     Section 110(a)(2)(D)(i): Interstate pollution transport.
     Section 110(a)(2)(D)(ii): Interstate and international
pollution abatement.
     Section 110(a)(2)(E): Adequate resources and authority,
conflict of interest, and oversight of local and regional government
agencies.
     Section 110(a)(2)(F): Stationary source monitoring and
reporting.
     Section 110(a)(2)(G): Emergency episodes.
     Section 110(a)(2)(H): SIP revisions.
     Section 110(a)(2)(J): Consultation with government
officials, public notification, PSD, and visibility protection.
     Section 110(a)(2)(K): Air quality modeling and submittal
of modeling data.
     Section 110(a)(2)(L): Permitting fees.
     Section 110(a)(2)(M): Consultation/participation by
affected local entities.
    Two elements identified in section 110(a)(2) are not governed by
the three-year submittal deadline of section 110(a)(1) and are
therefore not addressed in this action. These two elements are: (i)
Section 110(a)(2)(C) to the extent it refers to permit programs
required under part D (nonattainment NSR), and (ii) section
110(a)(2)(I), pertaining to the nonattainment planning requirements of
part D. As a result, this action does not address infrastructure for
the nonattainment NSR portion of section 110(a)(2)(C) or the whole of
section 110(a)(2)(I).

B. Regulatory History

2008 Pb NAAQS
    On November 12, 2008, the U.S. Environmental Protection Agency
(EPA) issued a revised NAAQS for Pb.\14\ This action triggered a
requirement for states to submit an infrastructure SIP to address the
applicable requirements of section 110(a)(2) within three years of
issuance of the revised NAAQS. On October 14, 2011, EPA issued
``Guidance on Section 110 Infrastructure SIPs for the 2008 Pb NAAQS'',
referred to herein as EPA's 2011 Pb Guidance.\15\ Depending on the
timing of a given submittal, some states relied on the earlier draft
version of this guidance, referred to herein as EPA's 2011 Draft Pb
Guidance.\16\ EPA issued additional guidance on infrastructure SIPs on
September 13, 2013.\17\
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    \14\ 73 FR 66964 (November 12, 2008). The 1978 Pb standard (1.5
[micro]g/m\3\ as a quarterly average) was modified to a rolling 3
month average not to be exceeded of 0.15 [micro]g/m\3\. EPA also
revised the secondary NAAQS to 0.15 [micro]g/m\3\ and made it
identical to the revised primary standard. Id.
    \15\ See Memorandum from Stephen D. Page, Director, Office of
Air Quality Planning and Standards, to Regional Air Division
Directors, Regions 1-10 (October 14, 2011).
    \16\ ``DRAFT Guidance on SIP Elements Required Under Sections
110(a)(1) and (2) for the 2008 Lead (Pb) National Ambient Air
Quality Standards (NAAQS),'' June 17, 2011 version.
    \17\ See Memorandum dated September 13, 2013 from Stephen D.
Page, Director, EPA Office of Air Quality Planning and Standards, to
Regional Air Directors, EPA Regions 1-10, ``Guidance on
Infrastructure State Implementation Plan (SIP) Elements under Clean
Air Act Sections 110(a)(1) and 110(a)(2)'' (referred to herein as
``2013 Infrastructure SIP Guidance'').
---------------------------------------------------------------------------

2008 Ozone NAAQS
    On March 27, 2008, EPA issued a revised NAAQS for 8-hour Ozone.\18\
This action triggered a requirement for states to submit an
infrastructure SIP to address the applicable requirements of section
110(a)(2) within three years of issuance of the revised NAAQS. EPA did
not, however, prepare guidance at this time for states in submitting I-
SIP revisions for the 2008 Ozone NAAQS.\19\ On September 13, 2013, EPA
issued ``Guidance of Infrastructure State Implementation Plan (SIP)
Elements under Clean Air Act Sections 110(a)(1) and 110(a)(2),'' which
provides advice on the development of infrastructure SIPs for the 2008
ozone NAAQS (among other pollutants) as well as infrastructure SIPs for
new or revised NAAQS promulgated in the future.\20\
---------------------------------------------------------------------------

    \18\ 73 FR 16436 (March 27, 2008).
    \19\ Preparation of guidance for the 2008 Ozone NAAQS was
postponed given EPA's reconsideration of the standard. See 78 FR
34183 (June 6, 2013).
    \20\ See Memorandum dated September 13, 2013 from Stephen D.
Page, Director, EPA Office of Air Quality Planning and Standards, to
Regional Air Directors, EPA Regions 1-10, ``Guidance on
Infrastructure State Implementation Plan (SIP) Elements under Clean
Air Act Sections 110(a)(1) and 110(a)(2)'' (referred to herein as
``2013 Infrastructure SIP Guidance'').
---------------------------------------------------------------------------

III. The State's Submittals

    The Arizona Department of Environmental Quality (ADEQ) has
submitted several infrastructure SIP revisions pursuant to EPA's
promulgation of the NAAQS addressed by this proposed rule, including
the following:
     October 14, 2011--``Arizona State Implementation Plan
Revision under Clean Air Act Section 110(a)(2) and (2); 2008 Lead
NAAQS,'' to address all of the CAA section 110(a)(2) requirements,
except for section 110(a)(2)(G) \21\ for the 2008 Pb NAAQS (2011 Pb I-
SIP Submittal).
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    \21\ In a separate rulemaking, EPA fully approved Arizona's SIP
to address the requirements regarding air pollution emergency
episodes in CAA section 110(a)(2)(G) for the 1997 8-hour ozone
NAAQS. 77 FR 62452 (October 15, 2012). Although ADEQ did not submit
an analysis of Section 110(a)(2)(G) requirements, we discuss them in
our TSD, which is in the docket for this rulemaking.
---------------------------------------------------------------------------

     December 27, 2012--``Arizona State Implementation Plan
Revision under Clean Air Act Section 110(a)(2) and (2); 2008 8-hour
Ozone NAAQS,'' to address all of the CAA section 110(a)(2) requirements
for the 2008 8-hour Ozone NAAQS (2012 Ozone I-SIP Submittal).
     December 6, 2013--``Submittal of Maricopa County Rule 100
revising the Maricopa County Portion of the Arizona State
Implementation Plan for Section 110(a)(2) Infrastructure'' from Eric
Massey, Director of ADEQ (2013 Maricopa County Submittal). Maricopa
County Rule 100 was submitted to address a deficiency in section
110(a)(2)(E)(ii) of the SIP for Maricopa County concerning conflict of
interest requirements for hearing boards.
     December 19, 2013--``Submittal of Pima County Rules
revising the Pima County Portion of the Arizona State Implementation
Plan for Section 110(a)(2) Infrastructure'' from Eric Massey, Director
of ADEQ (2013 Pima County Submittal). This submittal included Pima
County Rule 17.04.190 ``Composition,'' adopted September 28, 1993; Pima
County Rule 17.12.040 ``Reporting for Compliance Evaluations,'' adopted
September 28, 1993; and Pima County Rule 17.24.040 ``Reporting
Requirements,'' adopted April 19, 2005 for inclusion into the Arizona
SIP. These rules were submitted to address deficiencies in section
110(a)(2)(E)(ii) of the SIP concerning conflict of interest
requirements for hearing boards and section 110(a)(2)(F) of the SIP
concerning stationary source monitoring and reporting.
     September 4, 2014--``Submittal of Pinal County Rule 1-3-
140 Revising the Pinal County Portion of the Arizona State
Implementation Plan for Section 110(a)(2) Infrastructure'' from Eric
Massey, Director of ADEQ (2014 Pinal

County Submittal). This submittal included Pinal County Rule 1-3-140
``Definitions,'' adopted July 23, 2014 for inclusion into the Arizona
SIP. Pinal County Rule 1-3-140 was submitted to address a deficiency in
section 110(a)(2)(E)(ii) of the SIP for Pinal County concerning
conflict of interest requirements for hearing boards.
    We find that these submittals meet the procedural requirements for
public participation under CAA section 110(a)(2) and 40 CFR 51.102.
    In addition to the above infrastructure submittals, on October 29,
2012, ADEQ submitted ``New Source Review State Implementation Plan
Submission'' as well as ``Supplemental Information to 2012 New Source
Review State Implementation Plan Submission'' on July 2, 2014. In
addition to addressing revisions to Arizona's New Source Review (NSR)
program, these submissions also relate to I-SIP elements in CAA
sections 110(a)(2)(C), (D), (J) and (K), which EPA is not acting on in
today's rulemaking. The I-SIP elements in CAA sections 110(a)(2)(C),
(D), (J) and (K) will be addressed in a future rulemaking.

IV. EPA's Evaluation and Proposed Action

    EPA has evaluated the 2011 Pb I-SIP Submittal, the 2012 Ozone I-SIP
Submittal, the 2013 Maricopa County Submittal, the 2013 Pima County
Submittal, and the 2014 Pinal County Submittal, as well as the existing
provisions of the Arizona SIP for compliance with the CAA section
110(a) requirements for the 2008 Pb and 2008 ozone NAAQS. Our Technical
Support Document (TSD) contains more detailed evaluations and is
available in the public docket for this rulemaking, which may be
accessed online at http://www.regulations.gov, docket number EPA-R09-
OAR-2014-0258.
    Based upon this analysis, EPA proposes to approve the 2011 Pb I-SIP
Submittal, the 2012 Ozone I-SIP Submittal, the 2013 Maricopa County
Submittal, the 2013 Pima County Submittal and the 2013 Pinal County
Submittal with respect to the following infrastructure SIP
requirements:
     Section 110(a)(2)(A): Emission limits and other control
measures.
     Section 110(a)(2)(B): Ambient air quality monitoring/data
system.
     Section 110(a)(2)(E): Adequate resources and authority,
conflict of interest, and oversight of local and regional government
agencies.
     Section 110(a)(2)(F): Stationary source monitoring and
reporting.
     Section 110(a)(2)(G): Emergency episodes.
     Section 110(a)(2)(H): SIP revisions.
     Section 110(a)(2)(K): Air quality modeling and submission
of modeling data.
     Section 110(a)(2)(L): Permitting fees.
     Section 110(a)(2)(M): Consultation/participation by
affected local entities.
    In addition, we are proposing to approve into the SIP certain
regulatory provisions included in the 2013 Pima County and Maricopa
County Submittals, and in the 2014 Pinal County Submittal, as discussed
in the TSD.\22\
---------------------------------------------------------------------------

    \22\ Copies of these Arizona county regulations are included in
the 2013 Pima County and Maricopa County Submittals, and 2014 Pinal
County Submittal, which are available in the docket for this action
and online at http://regulations.gov, docket number EPA-R09-OAR-
2014-0258.
---------------------------------------------------------------------------

    On November 5, 2012, EPA approved in part and disapproved in part
State Implementation Plan (SIP) revisions submitted by the state of
Arizona pursuant to the requirements of the Clean Air Act (CAA) for the
1997 8-hour ozone NAAQS and the 1997 and 2006 NAAQS for fine
particulate matter (PM2.5).\23\ In today's action, we
propose to approve certain portions of the previously disapproved
infrastructure SIP action. Specifically, today's proposed action will
correct the previous deficiencies with respect to CAA section
110(a)(2)(E)(ii) for Maricopa, Pima, and Pinal Counties and section
110(a)(2)(F) for Pima County. If finalized before the end of the two-
year FIP deadline established by our 2012 action on Arizona's I-SIP for
the 1997 8-hour ozone NAAQS and 1997 and 2006 PM2.5 NAAQS,
approval of these infrastructure SIP elements would relieve EPA of the
obligation to promulgate a FIP, as required under CAA Section
110(c)(1).
---------------------------------------------------------------------------

    \23\ 77 FR 66398 (November 5, 2012).
---------------------------------------------------------------------------

    We are not proposing to act today on those elements of the
infrastructure SIP that address the requirements of sections
110(a)(2)(C), (D), (J) and (K) of the Act. On October 29, 2012, ADEQ
submitted ``New Source Review State Implementation Plan Submission''
and on July 2, 2014 submitted ``Supplemental Information to 2012 New
Source Review State Implementation Plan Submission''. These submissions
address the permitting portions of I-SIP elements in CAA sections
110(a)(2)(C), (D), (J) and (K) and will be addressed in a subsequent
rulemaking.
    Section 110(l) of the Act prohibits EPA from approving any SIP
revision that would interfere with any applicable requirement
concerning attainment and reasonable further progress (RFP) or any
other applicable requirement of the Act. All of the elements of the
infrastructure SIP that we are proposing to approve, as explained in
the TSD, would improve the SIP by replacing obsolete statutes or
regulations and by updating the state and local agencies' SIP
implementation and enforcement authorities. We propose to determine
that our approval of the elements discussed above would comply with CAA
section 110(l) because the proposed SIP revision would not interfere
with the on-going process for ensuring that requirements for RFP and
attainment of the NAAQS are met, and the SIP revision clarifies and
updates the SIP. Our TSD contains a more detailed discussion of our
evaluation.

V. Statutory and Executive Order Reviews

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

Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note)
because application of those requirements would be inconsistent with
the Clean Air Act; and
     does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed rule does not have tribal implications
as specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

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

    Dated: September 30, 2014.
Jared Blumenfeld,
Regional Administrator, Region IX.
[FR Doc. 2014-27752 Filed 11-21-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 224 (Tuesday, November 20, 2018)]
[Notices]
[Pages 58640-58642]
[FR Doc No: 2018-25244]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-84588; File No. SR-NASDAQ-2018-088]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend Chapter IV, Securities Traded on NOM, Section 8, Long-Term
Options Contracts

November 14, 2018.
    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 November 7, 2018, The Nasdaq Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the 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 proposes to amend Chapter IV, Securities Traded on
NOM, Section 8, Long-Term Options Contracts.
    The text of the proposed rule change is available on the Exchange's
website at http://nasdaq.cchwallstreet.com, at the principal office of
the Exchange, 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 proposes to amend its rules at Chapter IV, Securities
Traded on NOM, Section 8, Long-Term Options Contracts, in order (i) to
clarify the number of long-term option contract (``LEAPS'') expiration
months that may be listed on the Exchange on underlying securities
under the current rule, and (ii) to expand the number of LEAPS
expiration months that may be listed in options on the SPDR[supreg] S&P
500[supreg] exchange-traded fund (the ``SPY ETF'') in particular.
Clarification of the Number of Permitted Expiration Months
    Pursuant to current Chapter IV, Section 8, the Exchange may list
LEAPS that expire from twelve (12) to thirty-nine (39) months from the
time they are listed. The rule provides that there may be up to six (6)
additional expiration months. Because the rule does not specify which
expiration months the six months are in addition to, and thus is
ambiguous, the Exchange proposes to delete the word ``additional.'' As
amended, the rule would clearly and simply provide that the Exchange
may list six expiration months having from twelve up to thirty-nine
months from the time they are listed until expiration. This aspect of
the proposed rule change is based upon Nasdaq PHLX, LLC (``Phlx'') Rule
1012, Series of Options Open for Trading, subsection (a)(i)(D).\3\
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 80769 (May 25,
2017), 82 FR 25472 (June 1, 2017) (SR-Phlx-2017-41).
---------------------------------------------------------------------------

Additional Expiration Months in SPY ETF LEAPS
    The Exchange proposes to further amend Chapter IV, Section 8, to
permit up to ten LEAPS expiration months for options on the SPY ETF in
response to customer demand.\4\ The proposal will add liquidity to the
SPY ETF options market by allowing market participants to hedge risks
relating to SPY ETF option positions over a longer time period with a
known and limited cost. This aspect of the proposed rule change is also
based upon Phlx Rule 1012, Series of Options Open for Trading,
subsection (a)(i)(D), as recently amended.\5\
---------------------------------------------------------------------------

    \4\ Chapter XIV, Index Rules, Section 11, Terms of Index Options
Contracts, subsection (b)(1)(i) currently permits the Exchange to
list up to ten (10) expiration months in long term index options.
    \5\ See Securities Exchange Act Release No. 84449 (October 18,
2018), 83 FR 53699 (October 24, 2018) (SR-Phlx-2018-64).
---------------------------------------------------------------------------

    The SPY ETF options market today is characterized by its tremendous
daily and annual liquidity. As a consequence the Exchange believes that
the listing of additional SPY ETF LEAPS expiration months would be well
received by investors. This proposal to expand the number of permitted
SPY ETF LEAPS expiration months would not apply to LEAPS on any other
security.\6\
---------------------------------------------------------------------------

    \6\ Historically, SPY ETF is the largest and most actively
traded ETF in the United States as measured by its assets under
management and the value of shares traded.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\7\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\8\ in particular, in that it is designed to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general to protect investors and the public interest.
First, as noted above, the proposal protects investors and the public
interest by clarifying ambiguous rule language associated with
permitted listings of long term options. Second, the proposal

would permit the Exchange to offer market participants additional LEAPS
on SPY ETF options for their investment and risk management purposes.
This aspect of the proposal is intended simply to provide additional
trading opportunities which have been requested by customers, thereby
facilitating transactions in options and contributing to the protection
of investors and the maintenance of fair and orderly markets. The
proposed rule change responds to the continuing needs of market
participants, particularly portfolio managers and other institutional
customers, by providing protection from long-term market moves and by
offering an alternative to hedging portfolios with futures positions or
off-exchange customized derivative instruments. The Exchange believes
that the addition today of four additional expiration months for SPY
ETF LEAPS does not represent a proliferation of expiration months, but
is instead a very modest expansion of LEAPS in response to stated
customer demand. Significantly, the proposal would feature new LEAPS
expiration months in only a single class of options that are very
liquid and heavily traded, as discussed above. Additionally, the
Exchange notes by way of precedent that ten expiration months are
already permitted for stock index LEAPS. Further, the Exchange has the
necessary systems capacity to support the [sic]
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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. On the contrary, the Exchange
believes that the proposed amendment will benefit investors, market
participants, and the marketplace in general by eliminating ambiguity
in the current rules regarding the number of permitted expiration
months in LEAPS generally. Additionally, the proposal merely provides
investors additional investment and risk management opportunities by
providing flexibility to the Exchange to list additional LEAPS
expiration series, expanding the number of SPY ETF LEAPS offered on the
Exchange from six expiration months to ten expiration months.

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

    No written comments were either solicited or received.

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

    Because the foregoing 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, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \9\ and Rule 19b-
4(f)(6) thereunder.\10\
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4. In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and 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 satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \11\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b4(f)(6)(iii),\12\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative on November 16, 2018, to coincide with the
effective date of Phlx's proposed rule change on which the proposal is
partially based.\13\ The Exchange's proposal would clarify ambiguous
rule text and would conform the Exchange's rules relating to permitted
number of SPY ETF LEAPS expirations to those of Phlx. Accordingly, the
Commission believes that the proposal raises no new or novel regulatory
issues and waiver of the 30-day operative delay is consistent with the
protection of investors and the public interest. The Commission
therefore waives the 30-day operative delay and designates the proposal
operative on November 16, 2018.\14\
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    \11\ 17 CFR 240.19b-4(f)(6).
    \12\ 17 CFR 240.19b-4(f)(6)(iii).
    \13\ See supra note 5.
    \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).
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    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.

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 protected]. Please include
File Number SR-NASDAQ-2018-088 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2018-088. 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 website (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 website 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. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NASDAQ-2018-088 and should be submitted
on or before December 11, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
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    \15\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-25244 Filed 11-19-18; 8:45 am]
 BILLING CODE 8011-01-P