[Federal Register Volume 88, Number 117 (Tuesday, June 20, 2023)]
[Notices]
[Pages 39845-39847]
[FR Doc No: 2023-13013]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2023-0270; FRL-10998-01-OCSPP]

Implementation of PRIA 5 Bilingual Labeling Requirements To Make
Bilingual Pesticide Labeling Accessible to Farmworkers; Request for
Comments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Pesticide Registration Improvement Act of 2022 (PRIA 5)
requires the U.S. Environmental Protection Agency (EPA) to begin to
seek stakeholder input on ways to make bilingual pesticide labeling
accessible to farmworkers by June 30, 2023, and to implement a plan to
ensure that farmworkers have access to the bilingual pesticide labeling
by December 2025. EPA hosted the Bilingual Pesticide Labeling National
Webinar on June 15, 2023 and is opening a docket to receive written
public comments. The purpose of the public comment period is to obtain
feedback from stakeholders on ways to make bilingual pesticide labeling
accessible to farmworkers to aid

in the development of a plan to ensure that farmworkers have access to
the bilingual pesticide labeling. Public input that includes
environmental justice perspectives with solutions will be key in
helping the Agency develop a strong starting point for addressing
historical disadvantages for farmworkers.

DATES: Submit your comments on or before August 21, 2023.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2023-0270, through the Federal eRulemaking
Portal at https://www.regulations.gov. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Bartow, Office of Chemical
Safety and Pollution Prevention, Pesticide Re-evaluation Division
(7508M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This notice is directed to the general public and may be of
specific interest to persons (e.g., industry, non-governmental
organizations (NGOs), farmworkers, and academia) who are interested in
making bilingual pesticide labeling accessible to farmworkers. Because
other entities may also be interested in this notice, the agency has
not attempted to describe all the specific entities that may be
interested in this subject. If you have any questions regarding the
applicability of this action to a particular entity, contact the person
listed under FOR FURTHER INFORMATION CONTACT.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit CBI information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. In addition to one complete
version of the comment that includes information claimed as CBI, a copy
of the comment that does not contain the information claimed as CBI
must be submitted for inclusion in the public docket. Information so
marked will not be disclosed except in accordance with procedures set
forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see Tips for Effective Comments at https://www.epa.gov/dockets. Please note that once submitted, comments cannot be edited or
removed from the docket. The EPA may publish any comment received to
its public docket.

II. Background

A. What is the Agency's authority for taking this action?

    The Federal, Insecticide, Fungicide, and Rodenticide Act (FIFRA)
section 3(f)(5)(D) requires EPA to seek stakeholder input on ways to
make bilingual labeling accessible to farmworkers.

B. What action is the Agency taking?

    The Pesticide Registration Improvement Act of 2022 (PRIA 5),
enacted on December 29, 2022, amended FIFRA requiring Spanish language
translation for sections of the end-use pesticide product labels where
translation is available in the EPA Spanish Translation Guide for
Pesticide Labeling. The Spanish Translation Guide is located at:
https://www.epa.gov/pesticide-labels/spanish-translation-guide-pesticide-labeling. It contains translations of the health and safety
portions of pesticide product labels. Specifically, it has Spanish
translations of the ``keep out of reach of children'' statement, the
restricted use pesticide statement for restricted use products, the
signal word, the first aid section, the precautionary statement
section, the personal protective equipment section, the misuse
statement, and the storage and disposal statements. It also has
examples of pesticide product label language for the agricultural use
requirements section (including restricted entry interval information)
and precautionary statements.
    PRIA 5 requires that the Spanish language translation for sections
of the end-use pesticide product labels (where translation is available
in the EPA Spanish Translation Guide) must appear on the pesticide
product container or a link to such translation via scannable
technology or other electronic methods readily accessible on the
product label. These translations are required on a rolling schedule
from December 2025 to December 2030 depending on the type of pesticide
product and the toxicity category.
    PRIA 5 also requires EPA to begin to seek stakeholder input on ways
to make bilingual pesticide labeling accessible to farmworkers by June
30, 2023, and to implement a plan to ensure that farmworkers have
access to the bilingual pesticide labeling by December 2025.
    On June 15, 2023, EPA hosted the Bilingual Pesticide Labeling
National Webinar to obtain input from the public on ways to make
bilingual pesticide labeling accessible to farmworkers as required by
the Pesticide Registration Improvement Act of 2022. EPA is now opening
a comment period for 60 days through a Federal Register Notice. The
purpose of the public comment period is to obtain feedback from
stakeholders on ways to make bilingual pesticide labeling accessible to
farmworkers to aid in the development of a plan to ensure that
farmworkers have access to the bilingual pesticide labeling. Public
input that includes environmental justice perspectives with solutions
will be key in helping the Agency develop a strong starting point for
addressing historical disadvantages for farmworkers.

C. What feedback does EPA hope to gain from the public comments?

    The Agency is interested in suggestions focusing on how to make
bilingual pesticide labeling accessible to farmworkers. We are not
seeking input or comments about any specific products or other topics
outside of that scope. Here are some questions to consider as you
provide feedback to EPA on making bilingual pesticide labeling
accessible to farmworkers:
     What communication approaches, processes or strategies
should the Agency consider to ensure bilingual pesticide labels are
accessible to farmworkers? What specific approaches should the Agency
avoid or adopt when implementing efforts to best ensure access by
farmworkers to bilingual pesticide labels?
     What technologies, mobile applications, and internet
access should the Agency consider? Would web-based labels be accessible
to farmworkers? How should the Agency overcome internet connectivity
issues that some farmworkers may face?
     How can the Agency effectively share health and safety
information on pesticide labels with farmworkers? What should on-the-
ground logistics look like? Which entities (e.g., community-based
organizations) should the Agency work with to provide label information
to farmworkers?

     As the Agency implements actions to meet this requirement,
how can EPA effectively increase farmworker access to bilingual
pesticide labels (e.g., communication plans, outreach strategies)?

D. How is EPA seeking public comments?

    EPA is seeking public comments through several planned activities
including through this Federal Register document, EPA is soliciting
comment on the questions posed in Unit II.B. Following the close of the
comment period, EPA will consider comments received during the public
webinar and public comment period in the development of a plan to
ensure that farmworkers have access to the bilingual pesticide
labeling.
    Authority: 7 U.S.C. 136 et seq.

    Dated: June 13, 2023.
Michal Freedhoff,
Assistant Administrator.
[FR Doc. 2023-13013 Filed 6-16-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 93 (Friday, May 13, 2022)]
[Notices]
[Pages 29310-29311]
[FR Doc No: 2022-10366]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL OP-OFA-016]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or https://www.epa.gov/nepa.

Weekly receipt of Environmental Impact Statements (EIS)
Filed May 2, 2022 10 a.m. EST Through May 9, 2022 10 a.m. EST
Pursuant to 40 CFR 1506.9.

Notice

    Section 309(a) of the Clean Air Act requires that EPA make public
its comments on EISs issued by other Federal agencies. EPA's comment
letters on EISs are available at: https://cdxnodengn.epa.gov/cdx-enepa-public/action/eis/search.

EIS No. 20220063, Final, USFWS, WA, Thurston County Habitat
Conservation Plan, Thurston County, Washington, Review Period Ends: 06/
13/2022, Contact: Kevin Connally<PHONE_NUMBER>.
EIS No. 20220064, Final, NMFS, MD, Final Amendment 13 to the 2006
Consolidated Atlantic Highly Migratory Species Fishery Management Plan,
Review Period Ends: 06/13/2022, Contact: Tom Warren<PHONE_NUMBER>.
EIS No. 20220065, Draft, NMFS, Other, Saltonstall-Kennedy Grant Program
Programmatic Environmental Impact Statement, Comment Period Ends: 06/
27/2022, Contact: Clifford Cosgrove<PHONE_NUMBER>.
EIS No. 20220066, Final Supplement, USFWS, AZ, Proposed Revision to the

Regulations for the Nonessential Experimental Population of the Mexican
Wolf, Review Period Ends: 06/13/2022, Contact: Brady McGee 505-761-
4748.
EIS No. 20220067, Final Supplement, USACE, WA, Howard A. Hanson Dam
Additional Water Storage Project Final Integrated Validation Report and
Supplemental Environmental Impact Statement, Review Period Ends: 06/13/
2022, Contact: Nancy Gleason<PHONE_NUMBER>.
EIS No. 20220068, Final, TVA, AL, North Alabama Utility-Scale Solar
Project, Review Period Ends: 06/13/2022, Contact: Elizabeth R Smith
865-632-3053.

    Dated: May 9, 2022.
Cindy S. Barger,
Director, NEPA Compliance Division, Office of Federal Activities.
[FR Doc. 2022-10366 Filed 5-12-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 91 (Friday, May 12, 2017)]
[Rules and Regulations]
[Pages 22076-22079]
[FR Doc No: 2017-09504]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2016-0373; FRL-9961-87-Region 3]

Approval and Promulgation of Air Quality Implementation Plans;
West Virginia; Infrastructure Requirements for the 2012 Fine
Particulate Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving
portions of a state implementation plan (SIP) revision submitted by the
State of West Virginia. Whenever new or revised national ambient air
quality standards (NAAQS) are promulgated, the Clean Air Act (CAA)
requires states to submit a plan to address basic program elements,
including, but not limited to, regulatory structure, monitoring,
modeling, legal authority, and adequate resources necessary to assure
implementation, maintenance, and enforcement of the NAAQS. These
elements are referred to as infrastructure requirements. The State of
West Virginia made a submittal addressing the infrastructure
requirements for the 2012 fine particulate matter (PM2.5)
NAAQS, and EPA is approving portions of this SIP revision in accordance
with the requirements of the CAA.

DATES: This final rule is effective on June 12, 2017.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2016-0373. All documents in the docket are listed on
the www.regulations.gov Web site. Although listed in the index, some
information is not publicly available, e.g., confidential business
information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the Internet and will be publicly available only in hard
copy form. Publicly available docket materials are available through
http://www.regulations.gov, or please contact the person identified in
the For Further Information Contact section for additional availability
information.

FOR FURTHER INFORMATION CONTACT: Ellen Schmitt,<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On July 16, 1997, the EPA promulgated a new 24-hour and a new
annual NAAQS for PM2.5. See 62 FR 38652 (July 18, 1997).
Subsequently, on December 14, 2012, the EPA revised the level of the
health based (primary) annual PM2.5 standard to 12
micrograms per cubic meter ([micro]g/m\3\). See 78 FR 3086 (January 15,
2013).\1\
---------------------------------------------------------------------------

    \1\ In EPA's 2012 PM2.5 NAAQS revision, EPA left
unchanged the existing welfare (secondary) standards for
PM2.5 to address PM related effects such as visibility
impairment, ecological effects, damage to materials and climate
impacts. This includes a secondary annual standard of 15 [mu]g/m\3\
and a 24-hour standard of 35 [mu]g/m\3\.
---------------------------------------------------------------------------

    Pursuant to section 110(a)(1) of the CAA, states are required to
submit SIPs meeting the applicable requirements of section 110(a)(2)
within three years after promulgation of a new or revised NAAQS or
within such shorter period as EPA may prescribe. Section 110(a)(2)
requires states to address basic SIP elements such as requirements for
monitoring, basic program requirements, and legal authority that are
designed to assure attainment and maintenance of the NAAQS. Section
110(a) imposes the obligation upon states to make a SIP submission to
EPA for a new or revised NAAQS, but the contents of that submission may
vary depending upon the facts and

circumstances. In particular, the data and analytical tools available
at the time the state develops and submits the SIP for a new or revised
NAAQS affect the content of the submission. The content of such SIP
submission may also vary depending upon what provisions the state's
existing SIP already contains.

II. Summary of SIP Revision

    On November 17, 2015, the State of West Virginia, through the West
Virginia Department of Environmental Protection (WVDEP), submitted a
revision to its SIP to satisfy the requirements of section 110(a)(2) of
the CAA for the 2012 PM2.5 NAAQS. On December 23, 2016 (81
FR 94281), EPA published a notice of proposed rulemaking (NPR)
proposing approval of portions of the West Virginia November 17, 2015
SIP submittal. In the NPR, EPA proposed approval of the following
infrastructure elements: Section 110(a)(2)(A), (B), (C), (D)(i)(II)
(relating to prevention of significant deterioration), (D)(ii), (E),
(F), (G), (H), (J), (K), (L), and (M) of the CAA.
    At this time, EPA is not taking action on the portions of West
Virginia's November 17, 2015 SIP submission which addressed section
110(a)(2)(D)(i)(I) of the CAA relating to interstate transport of
emissions, nor is the Agency taking action on the portion of the
November 17, 2015 SIP submission which addressed section
110(a)(2)(D)(i)(II) relating to visibility protection. EPA intends to
take later separate action on these portions of West Virginia's
submittal as explained in the NPR and the Technical Support Document
(TSD), which accompanied the NPR. The TSD is available in the docket
for this rulemaking which is also available online at
www.regulations.gov. Finally, West Virginia did not address in its
submittal section 110(a)(2)(I) which pertains to the nonattainment
requirements of part D, title I of the CAA, because this element is not
required to be submitted by the 3-year submission deadline of section
110(a)(1) and will be addressed in a separate process if necessary.
    The rationale supporting EPA's proposed rulemaking action,
including the scope of infrastructure SIPs in general, is explained in
the published NPR and the TSD and will not be restated here. The NPR
and TSD are available in the docket for this rulemaking at
www.regulations.gov, Docket ID Number EPA-R03-OAR-2016-0373.

III. Public Comments and EPA's Responses

    EPA received two anonymous comments on the December 23, 2016
proposed approval of portions of the West Virginia's 2012
PM2.5 infrastructure SIP.
    Comment 1: One commenter asked why West Virginia is any different
than other states and stated that how particulate matter is measured
and ``the standard'' for particulate matter should be the same for all
states. The commenter stated that ``[w]hat is safe in one State, should
not be different than another.''
    Response 1: EPA thanks the commenter for the submitted statements.
To clarify, West Virginia is not treated any differently than any other
state in the United States under the CAA's NAAQS. Indeed, the
``standard'' for particulate matter and how particulate matter is
``measured'' (i.e., monitored) is the same for all states.
    Sections 108 and 109 of the CAA require EPA to promulgate primary
NAAQS to protect public health and secondary NAAQS to protect public
welfare. The NAAQS apply equally throughout all states. Once EPA sets a
new or revised NAAQS, EPA must designate areas in every state as either
attainment, unclassifiable, or nonattainment pursuant to section
107(d)(1)(B) and states must develop, adopt, and submit to EPA for
approval a SIP that contains emissions limitations and other control
measures to attain and maintain the relevant NAAQS in accordance with
section 110(a).
    Pursuant to sections 108 and 109 of the CAA, EPA has promulgated
NAAQS for two sizes of particulate matter: PM10 and
PM2.5.\2\ Because this action concerns the 2012
PM2.5 NAAQS, EPA's response addresses the relevant NAAQS. On
December 14, 2012, EPA revised the health based (primary) annual
PM2.5 NAAQS to 12 [mu]g/m\3\, and this standard applies
equally throughout all states. See 78 FR 3086 (January 15, 2013). Two
years later, on December 14, 2014, EPA designated all areas in West
Virginia as ``unclassifiable/attainment'' for the primary 2012
PM2.5 NAAQS. See 80 FR 2206, 2278-2279 (January 15,
2015).\3\ Finally, on November 17, 2015, West Virginia submitted a SIP
revision to EPA to address the requirements of section 110(a)(2) of the
CAA for the 2012 PM2.5 NAAQS and identified West Virginia's
measures to attain and maintain that NAAQS.
---------------------------------------------------------------------------

    \2\ Coarse particulate matter (PM10) are generally 10
micrometers and smaller, while fine particulate matter (or
PM2.5) consist of fine inhalable particles, with
diameters that are generally 2.5 micrometers and smaller.
    \3\ The rule explains that ``EPA is designating areas as
nonattainment, unclassifiable, or unclassifiable/attainment.''
---------------------------------------------------------------------------

    Regarding measurement of particulate matter, state and, where
applicable, local and/or tribal, agencies (referred to herein as
``monitoring agencies'') are responsible for providing an air quality
surveillance system in order to, among other goals, assess the extent
of pollution, provide information on air quality trends, and support
the implementation of air quality goals or standards (i.e., the NAAQS).
Monitoring agencies are required to submit to EPA an annual monitoring
network plan which provides for the documentation of the establishment
and maintenance of their air quality surveillance system.\4\ These
annual monitoring network plans require that ambient particulate matter
data are collected through an approved network of specified ambient
monitoring stations. Data from the approved monitoring stations are
used to compare an area's air pollution levels against the NAAQS to
make sure air quality is protective of public health and the
environment. Monitoring agencies provide all ambient air quality data,
including those related to PM2.5, to EPA through the
Agency's Air Quality Management System (AQS).
---------------------------------------------------------------------------

    \4\ Each monitoring agency must submit to EPA for approval an
annual monitoring network plan that is in accordance with the
monitoring requirements contained in 40 CFR parts 50, 53, and 58.
---------------------------------------------------------------------------

    As discussed in the TSD for this action, WVDEP has the authority
under state law ``to develop ways and means for the regulation and
control of pollution of the air of the state'' and ``conduct such
studies and research relating to air pollution and its control and
abatement.'' EPA-R03-OAR-2016-0373-0006, p. 10. WVDEP currently
operates and maintains an established network of ambient air monitors
in West Virginia for the purpose of assessing compliance with the 2012
PM2.5 NAAQS, and submits to EPA for approval, on an annual
basis, a monitoring network plan, which describes how West Virginia is
complying with monitoring requirements and explains any changes to the
monitoring network. Id.; see also EPA-R03-OAR-2016-0373-0007 (Approval
letter regarding WVDEP's 2015 annual monitoring network plan).
    In summary, the NAAQS apply to all states in the country, all
states monitor (or measure) particulate matter in accordance with CAA
statutory and regulatory requirements, and West Virginia is not treated
any differently for such purposes.

    Comment 2: The commenter stated that ``[A]ir quality is important
for our environment and our health. Infrastructure improvements can
provide jobs as well.''
    Response 2: EPA thanks the commenter for the support for air
quality and health. The commenter's statement regarding
``infrastructure improvements'' likely reflects the commenter's concern
for improvements to bridges and roads which are more traditionally
understood as ``infrastructure'' in the United States. Thus, EPA
believes the comment related to ``infrastructure improvements'' is
likely unrelated to EPA's approval of West Virginia's
``infrastructure'' SIP submittal which addresses requirements in CAA
section 110(a)(2) to provide the necessary structural requirements such
as emission limitations and monitoring requirements for attaining and
maintaining the 2012 PM2.5 NAAQS in West Virginia. EPA
described in detail in the NPR and in the TSD, which accompanied the
NPR, how West Virginia's SIP provides the basic structural
requirements. As the comment is not germane to EPA's rulemaking, no
further response is provided.

IV. Final Action

    EPA is approving portions of the West Virginia's SIP revision
regarding the infrastructure program elements specified in section
110(a)(2)(A), (B), (C), (D)(i)(II) (relating to prevention of
significant deterioration), (D)(ii), (E), (F), (G), (H), (J), (K), (L),
and (M) of the CAA, or portions thereof, necessary to implement,
maintain, and enforce the 2012 PM2.5 NAAQS. EPA will conduct
separate rulemaking action on the portions of West Virginia's November
17, 2015 SIP submission addressing section 110(a)(2)(D)(i)(I) of the
CAA relating to interstate transport of emissions and addressing
section 110(a)(2)(D)(i)(II) relating to visibility protection. This
rulemaking action does not include any action addressing section
110(a)(2)(I) of the CAA for the 2012 PM2.5 NAAQS which
pertains to the nonattainment requirements of part D, Title I of the
CAA, because this element is not required to be submitted by the 3-year
submission deadline of section 110(a)(1), and will be addressed in a
separate process, if necessary.

V. Statutory and Executive Order Reviews

A. General Requirements

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA 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 CAA. Accordingly, this
action merely approves state law as meeting federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide 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 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.

B. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by July 11, 2017. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action which approves portions of the West Virginia SIP
submittal to address the CAA section 110(a)(2) infrastructure
requirements for the 2012 PM2.5 NAAQS, may not be challenged
later in proceedings to enforce its requirements. See CAA section
307(b)(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Particulate matter, Reporting and recordkeeping
requirements.

    Dated: April 12, 2017.
Cecil Rodrigues,
Acting Regional Administrator, Region III.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart XX--West Virginia

0
2. In Sec.  52.2520, the table in paragraph (e) is amended by adding
the entry ``Section 110(a)(2) Infrastructure Requirements for the 2012
PM2.5 NAAQS'' at the end of the table to read as follows:

Sec.  52.2520  Identification of plan.

* * * * *
    (e) * * *

----------------------------------------------------------------------------------------------------------------
  Name of non-regulatory SIP    Applicable  geographic       State                               Additional
           revision                      area           submittal date  EPA approval date       explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Section 110(a)(2)               Statewide.............        11/17/15  5/12/17, [insert   This action addresses
 Infrastructure Requirements                                             Federal Register   the following CAA
 for the 2012 PM2.5 NAAQS.                                               citation].         elements:
                                                                                110(a)(2)(A), (B),
                                                                                (C), (D)(i)(II)
                                                                                (prevention of
                                                                                significant
                                                                                deterioration),
                                                                                (D)(ii), (E), (F),
                                                                                (G), (H), (J), (K),
                                                                                (L), and (M), or
                                                                                portions thereof.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2017-09504 Filed 5-11-17; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 12 (Thursday, January 19, 2012)]
[Notices]
[Page 2718]
[FR Doc No: 2012-904]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 10198-030]

Pelican Utility District, City of Pelican; Notice of Application
for Partial Transfer of License, and Soliciting Comments and Motions To
Intervene

    On November 30, 2011, Pelican Utility District (transferor) and the
City of Pelican (transferee) filed an application to transfer the
license for the Pelican Hydroelectric Water Project No. 10198, located
on Pelican Creek in the borough of Sitka, Alaska.
    Applicants seek Commission approval to transfer the license for the
Pelican Hydroelectric Water Project from the transferor to the
transferee.
    Applicants' Contact: Transferor: Shannon Heim, Dorsey & Whitney,
LLP, 50 S. Sixth Street, Minneapolis, MN 55402,<PHONE_NUMBER>.
Transferee: Mr. Donald W. Edwards, Attorney, Russell Wagg Gabbert &
Budzinski, P.C., 510 L Street, Suite 300, Anchorage, AK 99501, (907)
258-1747.
    FERC Contact: Patricia W. Gillis<PHONE_NUMBER>,
<EMAIL_ADDRESS>    Deadline for filing comments and motions to intervene: 30 days from
the issuance date of this notice. Comments and motions to intervene may
be filed electronically via the Internet. See 18 CFR 385.2001(a)(1) and
the instructions on the Commission's Web site under http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You
must include your name and contact information at the end of your
comments. If unable to be filed electronically, documents may be paper-
filed. To paper-file, an original plus seven copies should be mailed
to: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission,
888 First Street, NE., Washington, DC 20426. More information about
this project can be viewed or printed on the eLibrary link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-10198) in the docket number field to access
the document. For assistance, call toll-free 1-(866) 208-3372.

    Dated: January 11, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-904 Filed 1-18-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 148 (Thursday, August 1, 2013)]
[Notices]
[Pages 46656-46660]
[FR Doc No: 2013-18476]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-70053; File No. 4-663]

Program for Allocation of Regulatory Responsibilities Pursuant to
Rule 17d-2; Notice of Filing of Proposed Plan for the Allocation of
Regulatory Responsibilities Between the Financial Industry Regulatory
Authority, Inc. and Topaz Exchange, LLC

 July 26, 2013.
    Pursuant to Section 17(d) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 17d-2 thereunder,\2\ notice is hereby given that
on June 21, 2013, Topaz Exchange, LLC (``Topaz'') and the Financial
Industry Regulatory Authority, Inc. (``FINRA'') (together with Topaz,
the ``Parties'') filed with the Securities and Exchange Commission
(``Commission'' or ``SEC'') a plan for the allocation of regulatory
responsibilities, dated June 21, 2013 (``17d-2 Plan'' or the ``Plan'').
The Commission is publishing this notice to solicit comments on the
17d-2 Plan from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78q(d).
    \2\ 17 CFR 240.17d-2.
---------------------------------------------------------------------------

I. Introduction

    Section 19(g)(1) of the Act,\3\ among other things, requires every
self-regulatory organization (``SRO'') registered as either a national
securities exchange or national securities association to examine for,
and enforce compliance by, its members and persons associated with its
members with the Act, the rules and regulations thereunder, and the
SRO's own rules, unless the SRO is relieved of this responsibility
pursuant to Section 17(d) or Section 19(g)(2) of the Act.\4\ Without
this relief, the statutory obligation of each individual SRO could
result in a pattern of multiple examinations of

broker-dealers that maintain memberships in more than one SRO (``common
members''). Such regulatory duplication would add unnecessary expenses
for common members and their SROs.
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78s(g)(1).
    \4\ 15 U.S.C. 78q(d) and 15 U.S.C. 78s(g)(2), respectively.
---------------------------------------------------------------------------

    Section 17(d)(1) of the Act \5\ was intended, in part, to eliminate
unnecessary multiple examinations and regulatory duplication.\6\ With
respect to a common member, Section 17(d)(1) authorizes the Commission,
by rule or order, to relieve an SRO of the responsibility to receive
regulatory reports, to examine for and enforce compliance with
applicable statutes, rules, and regulations, or to perform other
specified regulatory functions.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78q(d)(1).
    \6\ See Securities Act Amendments of 1975, Report of the Senate
Committee on Banking, Housing, and Urban Affairs to Accompany S.
249, S. Rep. No. 94-75, 94th Cong., 1st Session 32 (1975).
---------------------------------------------------------------------------

    To implement Section 17(d)(1), the Commission adopted two rules:
Rule 17d-1 and Rule 17d-2 under the Act.\7\ Rule 17d-1 authorizes the
Commission to name a single SRO as the designated examining authority
(``DEA'') to examine common members for compliance with the financial
responsibility requirements imposed by the Act, or by Commission or SRO
rules.\8\ When an SRO has been named as a common member's DEA, all
other SROs to which the common member belongs are relieved of the
responsibility to examine the firm for compliance with the applicable
financial responsibility rules. On its face, Rule 17d-1 deals only with
an SRO's obligations to enforce member compliance with financial
responsibility requirements. Rule 17d-1 does not relieve an SRO from
its obligation to examine a common member for compliance with its own
rules and provisions of the federal securities laws governing matters
other than financial responsibility, including sales practices and
trading activities and practices.
---------------------------------------------------------------------------

    \7\ 17 CFR 240.17d-1 and 17 CFR 240.17d-2, respectively.
    \8\ See Securities Exchange Act Release No. 12352 (April 20,
1976), 41 FR 18808 (May 7, 1976).
---------------------------------------------------------------------------

    To address regulatory duplication in these and other areas, the
Commission adopted Rule 17d-2 under the Act.\9\ Rule 17d-2 permits SROs
to propose joint plans for the allocation of regulatory
responsibilities with respect to their common members. Under paragraph
(c) of Rule 17d-2, the Commission may declare such a plan effective if,
after providing for appropriate notice and comment, it determines that
the plan is necessary or appropriate in the public interest and for the
protection of investors; to foster cooperation and coordination among
the SROs; to remove impediments to, and foster the development of, a
national market system and a national clearance and settlement system;
and is in conformity with the factors set forth in Section 17(d) of the
Act. Commission approval of a plan filed pursuant to Rule 17d-2
relieves an SRO of those regulatory responsibilities allocated by the
plan to another SRO.
---------------------------------------------------------------------------

    \9\ See Securities Exchange Act Release No. 12935 (October 28,
1976), 41 FR 49091 (November 8, 1976).
---------------------------------------------------------------------------

II. Proposed Plan

    The proposed 17d-2 Plan is intended to reduce regulatory
duplication for firms that are common members of both Topaz and
FINRA.\10\ Pursuant to the proposed 17d-2 Plan, FINRA would assume
certain examination and enforcement responsibilities for common members
with respect to certain applicable laws, rules, and regulations.
---------------------------------------------------------------------------

    \10\ The proposed 17d-2 Plan refers to these common members as
``Dual Members.'' See Paragraph 1(c) of the proposed 17d-2 Plan.
---------------------------------------------------------------------------

    The text of the Plan delineates the proposed regulatory
responsibilities with respect to the Parties. Included in the proposed
Plan is an exhibit (the ``Topaz Certification of Common Rules,''
referred to herein as the ``Certification'') that lists every Topaz
rule for which FINRA would bear responsibility under the Plan for
overseeing and enforcing with respect to Topaz members that are also
members of FINRA and the associated persons therewith (``Dual
Members'').
    Specifically, under the 17d-2 Plan, FINRA would assume examination
and enforcement responsibility relating to compliance by Dual Members
with the rules of Topaz that are substantially similar to the
applicable rules of FINRA,\11\ as well as any provisions of the federal
securities laws and the rules and regulations thereunder delineated in
the Certification (``Common Rules''). In the event that a Dual Member
is the subject of an investigation relating to a transaction on Topaz,
the plan acknowledges that Topaz may, in its discretion, exercise
concurrent jurisdiction and responsibility for such matter.\12\
---------------------------------------------------------------------------

    \11\ See paragraph 1(b) of the proposed 17d-2 Plan (defining
Common Rules). See also paragraph 1(f) of the proposed 17d-2 Plan
(defining Regulatory Responsibilities). Paragraph 2 of the Plan
provides that annually, or more frequently as required by changes in
either Topaz rules or FINRA rules, the parties shall review and
update, if necessary, the list of Common Rules. Further, paragraph 3
of the Plan provides that Topaz shall furnish FINRA with a list of
Dual Members, and shall update the list no less frequently than once
each calendar quarter.
    \12\ See paragraph 6 of the proposed 17d-2 Plan.
---------------------------------------------------------------------------

    Under the Plan, Topaz would retain full responsibility for
surveillance and enforcement with respect to trading activities or
practices involving Topaz's own marketplace, including, without
limitation, registration pursuant to its applicable rules of associated
persons (i.e., registration rules that are not Common Rules); its
duties as a DEA pursuant to Rule 17d-1 under the Act; and any Topaz
rules that are not Common Rules.\13\
---------------------------------------------------------------------------

    \13\ See paragraph 2 of the proposed 17d-2 Plan.
---------------------------------------------------------------------------

    The text of the proposed 17d-2 Plan is as follows:

Agreement Between Financial Industry Regulatory Authority, Inc. and
Topaz Exchange, LLC Pursuant to Rule 17d-2 Under The Securities
Exchange Act of 1934

    This Agreement, by and between Financial Industry Regulatory
Authority, Inc. (``FINRA'') and Topaz Exchange, LLC (``Topaz''), is
made this 21st day of June, 2013 (the ``Agreement''), pursuant to
Section 17(d) of the Securities Exchange Act of 1934 (the ``Exchange
Act'') and Rule 17d-2 thereunder which permits agreements between self-
regulatory organizations to allocate regulatory responsibility to
eliminate regulatory duplication. FINRA and Topaz may be referred to
individually as a ``party'' and together as the ``parties.''
    Whereas, FINRA and Topaz desire to reduce duplication in the
examination of their Dual Members (as defined herein) and in the filing
and processing of certain registration and membership records; and
    Whereas, FINRA and Topaz desire to execute an agreement covering
such subjects pursuant to the provisions of Rule 17d-2 under the
Exchange Act and to file such agreement with the Securities and
Exchange Commission (the ``SEC'' or ``Commission'') for its approval.
    Now, therefore, in consideration of the mutual covenants contained
hereinafter, FINRA and Topaz hereby agree as follows:
    1. Definitions. Unless otherwise defined in this Agreement or the
context otherwise requires, the terms used in this Agreement shall have
the same meaning as they have under the Exchange Act and the rules and
regulations thereunder. As used in this Agreement, the following terms
shall have the following meanings:
    (a) ``Topaz Rules'' or ``FINRA Rules'' shall mean the rules of
Topaz or FINRA, respectively, as the rules of an exchange or
association are defined in Exchange Act Section 3(a)(27).

    (b) ``Common Rules'' shall mean the Topaz Rules that are
substantially similar to the applicable FINRA Rules in that examination
for compliance with such rules would not require FINRA to develop one
or more new examination standards, modules, procedures, or criteria in
order to analyze the application of the rule, or a Dual Member's
activity, conduct, or output in relation to such rule.
    (c) ``Dual Members'' shall mean those Topaz members that are also
members of FINRA and the associated persons therewith.
    (d) ``Effective Date'' shall have the meaning set forth in
paragraph 13.
    (e) ``Enforcement Responsibilities'' shall mean the conduct of
appropriate proceedings, in accordance with the FINRA Code of Procedure
(the Rule 9000 Series) and other applicable FINRA procedural rules, to
determine whether violations of pertinent laws, rules or regulations
have occurred, and if such violations are deemed to have occurred, the
imposition of appropriate sanctions as specified under the FINRA's Code
of Procedure and sanctions guidelines.
    (f) ``Regulatory Responsibilities'' shall mean the examination
responsibilities and Enforcement Responsibilities relating to
compliance by the Dual Members with the Common Rules and the provisions
of the Exchange Act and the rules and regulations thereunder, and other
applicable laws, rules and regulations, each as set forth on Exhibit 1
attached hereto.
    2. Regulatory and Enforcement Responsibilities. FINRA shall assume
Regulatory Responsibilities and Enforcement Responsibilities for Dual
Members. Attached as Exhibit 1 to this Agreement and made part hereof,
Topaz furnished FINRA with a current list of Common Rules and certified
to FINRA that such rules are substantially similar to the corresponding
FINRA Rule (the ``Certification''). FINRA hereby agrees that the rules
listed in the Certification are Common Rules as defined in this
Agreement. Each year following the Effective Date of this Agreement, or
more frequently if required by changes in either the Topaz Rules or
FINRA Rules, Topaz shall submit an updated list of Common Rules to
FINRA for review which shall add Topaz Rules not included in the
current list of Common Rules that qualify as Common Rules as defined in
this Agreement; delete Topaz Rules included in the current list of
Common Rules that no longer qualify as Common Rules as defined in this
Agreement; and confirm that the remaining rules on the current list of
Common Rules continue to be Topaz Rules that qualify as Common Rules as
defined in this Agreement. Within 30 days of receipt of such updated
list, FINRA shall confirm in writing whether the rules listed in any
updated list are Common Rules as defined in this Agreement.
Notwithstanding anything herein to the contrary, it is explicitly
understood that the term ``Regulatory Responsibilities'' does not
include, and Topaz shall retain full responsibility for (unless
otherwise addressed by separate agreement or rule) the following
(collectively, the ``Retained Responsibilities''):
    (a) Surveillance and enforcement with respect to trading activities
or practices involving Topaz's own marketplaces, including without
limitation Topaz's Rules relating to the rights and obligations of
market makers;
    (b) Registration pursuant to its applicable rules of associated
persons (i.e., registration rules that are not Common Rules);
    (c) Discharge of its duties and obligations as a Designated
Examining Authority pursuant to Rule 17d-1 under the Exchange Act; and
    (d) Any Topaz Rules that are not Common Rules.
    3. Dual Members. Prior to the Effective Date, Topaz shall furnish
FINRA with a current list of Dual Members, which shall be updated no
less frequently than once each quarter.
    4. No Charge. There shall be no charge to Topaz by FINRA for
performing the Regulatory Responsibilities and Enforcement
Responsibilities under this Agreement except as hereinafter provided.
FINRA shall provide Topaz with ninety (90) days advance written notice
in the event FINRA decides to impose any charges to Topaz for
performing the Regulatory Responsibilities under this Agreement. If
FINRA determines to impose a charge, Topaz shall have the right at the
time of the imposition of such charge to terminate this Agreement;
provided, however, that FINRA's Regulatory Responsibilities under this
Agreement shall continue until the Commission approves the termination
of this Agreement.
    5. Reassignment of Regulatory Responsibilities. Notwithstanding any
provision hereof, this Agreement shall be subject to any statute, or
any rule or order of the Commission, or effective industry agreement,
restructuring the regulatory framework of the securities industry or
reassigning Regulatory Responsibilities between self-regulatory
organizations. To the extent such action is inconsistent with this
Agreement, such action shall supersede the provisions hereof to the
extent necessary for them to be properly effectuated and the provisions
hereof in that respect shall be null and void.
    6. Notification of Violations. In the event that FINRA becomes
aware of apparent violations of any Topaz Rules, which are not listed
as Common Rules, discovered pursuant to the performance of the
Regulatory Responsibilities assumed hereunder, FINRA shall notify Topaz
of those apparent violations for such response as Topaz deems
appropriate. In the event Topaz becomes aware of apparent violations of
the Common Rules, discovered pursuant to the performance of the
Retained Responsibilities, Topaz shall notify FINRA of those apparent
violations and such matters shall be handled by FINRA as provided in
this Agreement. Apparent violations of all the Common Rules shall be
processed by, and enforcement proceedings in respect thereto shall be
conducted by FINRA as provided hereinbefore; provided, however, that in
the event a Dual Member is the subject of an investigation relating to
a transaction on Topaz, Topaz may in its discretion assume concurrent
jurisdiction and responsibility. Each party agrees to make available
promptly all files, records and witnesses necessary to assist the other
in its investigation or proceedings.
    7. Continued Assistance. FINRA shall make available to Topaz all
information obtained by FINRA in the performance by it of the
Regulatory Responsibilities hereunder in respect to the Dual Members
subject to this Agreement. In particular, and not in limitation of the
foregoing, FINRA shall furnish Topaz any information it obtains about
Dual Members which reflects adversely on their financial condition. It
is understood that such information is of an extremely sensitive nature
and, accordingly, Topaz acknowledges and agrees to take all reasonable
steps to maintain its confidentiality. Topaz shall make available to
FINRA any information coming to its attention that reflects adversely
on the financial condition of Dual Members or indicates possible
violations of applicable laws, rules or regulations by such firms.
    8. Dual Member Applications.
    (a) Dual Members subject to this Agreement shall be required to
submit, and FINRA shall be responsible for processing and acting upon
all applications submitted on behalf of allied persons, partners,
officers, registered personnel and any other person required to be
approved by the Topaz Rules and FINRA Rules or associated with Dual
Members thereof. Upon request, FINRA shall advise

Topaz of any changes of allied members, partners, officers, registered
personnel and other persons required to be approved by the Topaz Rules
and FINRA Rules.
    (b) Dual Members shall be required to send to FINRA all letters,
termination notices or other material respecting the individuals listed
in paragraph 8(a).
    (c) When as a result of processing such submissions FINRA becomes
aware of a statutory disqualification as defined in the Exchange Act
with respect to a Dual Member, FINRA shall determine pursuant to
Sections 15A(g) and/or Section 6(c) of the Exchange Act the
acceptability or continued applicability of the person to whom such
disqualification applies and keep Topaz advised of its actions in this
regard for such subsequent proceedings as Topaz may initiate.
    (d) Notwithstanding the foregoing, FINRA shall not review the
membership application, reports, filings, fingerprint cards, notices,
or other writings filed to determine if such documentation submitted by
a broker or dealer, or a person associated therewith or other persons
required to register or qualify by examination: (i) Meets the Topaz
requirements for general membership or for specified categories of
membership or participation in Topaz, such as (A) Primary Market Maker
Membership (``PMM''); (B) Competitive Market Maker Membership
(``CMM''); (C) Electronic Access Membership (``EAM'') (or any similar
type of Topaz membership or participation that is created after this
Agreement is executed); or (ii) meets the Topaz requirements to be
associated with, or employed by, a Topaz member or participant in any
capacity, such a Designated Trading Representative (``DTR'') (or any
similar type of participation, employment category or title, or
associate-person category or class that is created after this Agreement
is executed). FINRA shall not review applications or other
documentation filed to request a change in the rights or status
described in this paragraph 8(d), including termination or limitation
on activities, of a member or a participant of Topaz, or a person
associated with, or requesting association with, a member or
participant of Topaz.
    9. Branch Office Information. FINRA shall also be responsible for
processing and, if required, acting upon all requests for the opening,
address changes, and terminations of branch offices by Dual Members and
any other applications required of Dual Members with respect to the
Common Rules as they may be amended from time to time. Upon request,
FINRA shall advise Topaz of the opening, address change and termination
of branch and main offices of Dual Members and the names of such branch
office managers.
    10. Customer Complaints. Topaz shall forward to FINRA copies of all
customer complaints involving Dual Members received by Topaz relating
to FINRA's Regulatory Responsibilities under this Agreement. It shall
be FINRA's responsibility to review and take appropriate action in
respect to such complaints.
    11. No Restrictions on Regulatory Action. Nothing contained in this
Agreement shall restrict or in any way encumber the right of either
party to conduct its own independent or concurrent investigation,
examination or enforcement proceeding of or against Dual Members, as
either party, in its sole discretion, shall deem appropriate or
necessary.
    12. Termination. This Agreement may be terminated by Topaz or FINRA
at any time upon the approval of the Commission after one (1) year's
written notice to the other party (or such shorter time as may be
agreed by the parties), except as provided in paragraph 4.
    13. Effective Date. This Agreement shall be effective upon approval
of the Commission.
    14. Arbitration. In the event of a dispute between the parties as
to the operation of this Agreement, Topaz and FINRA hereby agree that
any such dispute shall be settled by arbitration in Washington, DC in
accordance with the rules of the American Arbitration Association then
in effect, or such other procedures as the parties may mutually agree
upon. Judgment on the award rendered by the arbitrator(s) may be
entered in any court having jurisdiction.
    15. Separate Agreement. This Agreement is wholly separate from (1)
the multiparty Agreement made pursuant to Rule 17d-2 of the Exchange
Act among BATS Exchange, Inc., BOX Options Exchange, LLC, the Chicago
Board Options Exchange, Incorporated, C2 Options Exchange,
Incorporated, the International Securities Exchange, LLC, Financial
Industry Regulatory Authority, Inc., Miami International Securities
Exchange, LLC, the New York Stock Exchange, LLC, the NYSE MKT LLC, the
NYSE Arca Inc., The NASDAQ Stock Market LLC, NASDAQ OMX BX, Inc., and
the NASDAQ OMX PHLX, LLC approved by the Commission on December 5, 2012
involving the allocation of regulatory responsibilities with respect to
common members for compliance with common rules relating to the conduct
by broker-dealers of accounts for listed options or index warrants or
(2) the multiparty Agreement made pursuant to Rule 17d-2 of the
Exchange Act among NYSE MKT LLC, BATS Exchange, Inc., BOX Options
Exchange, LLC, C2 Options Exchange, Incorporated, Chicago Board Options
Exchange, Incorporated, International Securities Exchange LLC,
Financial Industry Regulatory Authority, Inc., NYSE Arca, Inc., The
NASDAQ Stock Market LLC, NASDAQ OMX BX, Inc., NASDAQ OMX PHLX, Inc. and
Miami International Securities Exchange, LLC, approved by the
Commission on December 5, 2012 involving options-related market
surveillance matters and such agreements as may be amended from time to
time.
    16. Notification of Members. Topaz and FINRA shall notify Dual
Members of this Agreement after the Effective Date by means of a
uniform joint notice.
    17. Amendment. This Agreement may be amended in writing duly
approved by each party. All such amendments must be filed with and
approved by the Commission before they become effective.
    18. Limitation of Liability. Neither FINRA nor Topaz nor any of
their respective directors, governors, officers or employees shall be
liable to the other party to this Agreement for any liability, loss or
damage resulting from or claimed to have resulted from any delays,
inaccuracies, errors or omissions with respect to the provision of
Regulatory Responsibilities as provided hereby or for the failure to
provide any such responsibility, except with respect to such liability,
loss or damages as shall have been suffered by one or the other of
FINRA or Topaz and caused by the willful misconduct of the other party
or their respective directors, governors, officers or employees. No
warranties, express or implied, are made by FINRA or Topaz with respect
to any of the responsibilities to be performed by each of them
hereunder.
    19. Severability. Any term or provision of this Agreement that is
invalid or unenforceable in any jurisdiction shall, as to such
jurisdiction, be ineffective to the extent of such invalidity or
unenforceability without rendering invalid or unenforceable the
remaining terms and provisions of this Agreement or affecting the
validity or enforceability of any of the terms or provisions of this
Agreement in any other jurisdiction.
    20. Relief from Responsibility. Pursuant to Sections 17(d)(1)(A)
and 19(g) of the Exchange Act and Rule 17d-2 thereunder, FINRA and
Topaz join in requesting the Commission, upon its approval of this
Agreement or any part thereof, to relieve Topaz of any and all

responsibilities with respect to matters allocated to FINRA pursuant to
this Agreement; provided, however, that this Agreement shall not be
effective until the Effective Date.
    In witness whereof, each party has executed or caused this
Agreement to be executed on its behalf by a duly authorized officer as
of the date first written above.

FINANCIAL INDUSTRY REGULATORY AUTHORITY, INC.

By---------------------------------------------------------------------

Name:
Title:

TOPAZ EXCHANGE LLC

By---------------------------------------------------------------------

Name:
Title:

EXHIBIT 1

TOPAZ CERTIFICATION OF COMMON RULES
    Topaz hereby certifies that the requirements contained in the rules
listed below for Topaz are identical to, or substantially similar to,
the comparable FINRA Rules or SEC Rules identified.

------------------------------------------------------------------------
               Topaz rule                     FINRA or SEC rule \1\
------------------------------------------------------------------------
408(a)(1) Prevention of the Misuse of    Section 15(f) of the Securities
 Material, Nonpublic Information.         Exchange Act of 1934.
409 Disciplinary Action \2\............  FINRA Rule 4530(a)(1)(A) and
                                          (2) Reporting Requirements.
604 Continuing Education for Registered  FINRA Rule 1250 Continuing
 Persons.                                 Education Requirements.
614 Statements of Financial Condition    Rule 17a-5 of the Securities
 to Customers.                            Exchange Act of 1934.
622 Transfer of Accounts...............  FINRA rule 11870 Customer
                                          Account Transfer Contracts.
626 Telephone Solicitation.............  FINRA Rule 3230 Telemarketing.
1400(a) Maintenance, Retention, and      FINRA Rule 4511(a) Books and
 Furnishing of Books, Records and Other   Records--Requirements.
 Information \3\.
------------------------------------------------------------------------
\1\ Topaz will be responsible for any significant differences between
  its rules and the comparable FINRA rule identified, until such time
  amendments to such rule(s) may be approved.
\2\ FINRA shall not have Regulatory Responsibilities regarding the
  requirement to notify Topaz; responsibility for such requirement
  remains with Topaz.
\3\ FINRA shall not have Regulatory Responsibilities regarding the
  requirement to ``keep current and preserve such books and records as
  the Exchange may prescribe;'' responsibility for such requirement
  remains with Topaz.

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

    Pursuant to Section 17(d)(1) of the Act \14\ and Rule 17d-2
thereunder,\15\ after August 16, 2013, the Commission may, by written
notice, declare the plan submitted by Topaz and FINRA, File No. 4-663,
to be effective if the Commission finds that the plan is necessary or
appropriate in the public interest and for the protection of investors,
to foster cooperation and coordination among self-regulatory
organizations, or to remove impediments to and foster the development
of the national market system and a national system for the clearance
and settlement of securities transactions and in conformity with the
factors set forth in Section 17(d) of the Act.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78q(d)(1).
    \15\ 17 CFR 240.17d-2.
---------------------------------------------------------------------------

IV. Solicitation of Comments

    In order to assist the Commission in determining whether to approve
the proposed 17d-2 Plan and to relieve Topaz of the responsibilities
which would be assigned to FINRA, interested persons are invited to
submit written data, views, and arguments concerning the foregoing.
Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/other.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number 4-663 on the subject line.

Paper Comments

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

All submissions should refer to File Number 4-663. This file number
should be included on the subject line if email is used. To help the
Commission process and review your comments more efficiently, please
use only one method. The Commission will post all comments on the
Commission's Internet Web site (http://www.sec.gov/rules/other.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed plan that are filed with the
Commission, and all written communications relating to the proposed
plan between the Commission and any person, other than those that may
be withheld from the public in accordance with the provisions of 5
U.S.C. 552, will be available for Web site viewing and printing in the
Commission's Public Reference Room, on official business days between
the hours of 10:00 a.m. and 3:00 p.m. Copies of the plan also will be
available for inspection and copying at the principal offices of Topaz
and FINRA. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number 4-663
and should be submitted on or before August 16, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(34).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-18476 Filed 7-31-13; 8:45 am]
BILLING CODE 8011-01-P


Department of State

Division of Publications

312 Rosa L. Parks Avenue, 8th Floor Snodgrass/TN Tower

Nashville, TN 37243

Phone:<PHONE_NUMBER>

Fax:<PHONE_NUMBER>

Email<EMAIL_ADDRESS>For Department of State Use Only

Sequence Number:

Rule ID(s):

File Date:

Effective Date:

Rulemaking Hearing Rule(s) Filing Form

Rulemaking Hearing Rules are rules filed after and as a result of a rulemaking hearing. T.C.A. § 4-5-205

Agency/Board/Commission:	Environment and Conservation

Division:	Air Pollution Control

Contact Person:	Lacey J. Harding

Address:	15th Floor, William R. Snodgrass Tennessee Tower

312 Rosa L. Parks Avenue

Nashville, Tennessee

Zip:	37243

Phone:<PHONE_NUMBER>

Email:	  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>

Revision Type (check all that apply):

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Rule(s) Revised (ALL chapters and rules contained in filing must be listed here. If needed, copy and paste additional tables to accommodate multiple chapters. Please enter only ONE Rule Number/Rule Title per row)

Chapter Number	Chapter Title

1200-03-18	Volatile Organic Compounds

Rule Number	Rule Title

1200-03-18-.02	General Provisions and Applicability

(Place substance of rules and other info here. Statutory authority must be given for each rule change. For information on formatting rules go to   HYPERLINK "http://state.tn.us/sos/rules/1360/1360.htm"  http://state.tn.us/sos/rules/1360/1360.htm )

Amendment

Chapter 1200-03-18

Volatile Organic Compounds

Paragraph (8) of Rule 1200-03-18-.02 General Provisions and Applicability is amended by deleting it in its entirety and substituting instead the following:

(8)	The owner or operator of any facility in Davidson, Rutherford, Shelby, Sumner, Knox, Blount, Anderson, Williamson, or Wilson County which has actual emissions from stationary sources of 25 tons or more of volatile organic compounds (VOC’s) and/or nitrogen oxides during a calendar year shall report to the Technical Secretary their permitting authority information and data concerning these emissions and nitrogen oxide emissions.  This information and data shall be in the form prescribed by the Technical Secretary, and shall be submitted before March 31 of the year following the calendar year for which the information and data is reported.  The first report shall be for the 1993 calendar year, and shall be submitted before March 31, 1994.  Each report shall be signed by an official of the company, certifying that the information and data contained in the report is accurate to the best knowledge of the individual certifying the report.

Authority: T.C.A. §§ 68-201-101 et seq. and 4-5-201 et seq.

* If a roll-call vote was necessary, the vote by the Agency on these rulemaking hearing rules was as follows:

Board Member	Aye	No	Abstain	Absent	Signature (if required)

J. Ronald Bailey

Involved with Institution of Higher Learning on air pollution evaluation and control

	X

	Thomas Beehan

Working on Municipal Government	X

	John Benitez

Licensed Physician with experience in health effects of air pollutants

	X

	Elaine Boyd

Commissioner's Designee, Dept. of Environment and Conservation	X

Karen Cisler

Environmental Interests	X

	Wayne T. Davis

Conservation Interests

	X

	Stephen Gossett

Working for Industry with technical experience	X

	Shawn A. Hawkins

Working in field related to Agriculture or Conservation

	X

	Helen Hennon

Registered Professional Engineer

	X

	Richard Holland

Working for Industry with technical experience	X

	John Roberts

Small Generator of Air Pollution representing Automotive Interests	X

	Larry Waters

County Mayor	X

Jimmy West

Commissioner's Designee, Dept. of Economic and Community Development	X

Alicia Wilson

Working in management in Private Manufacturing	X

I certify that this is an accurate and complete copy of rulemaking hearing rules, lawfully promulgated and adopted by the Air Pollution Control Board on 05/14/2014, and is in compliance with the provisions of T.C.A. § 4-5-222.

I further certify the following:

Notice of Rulemaking Hearing filed with the Department of State on: 02/28/14

Rulemaking Hearing(s) Conducted on: (add more dates).	04/22/14

Date:	May 16, 2014

Signature:

	Name of Officer:	Barry R. Stephens

Title of Officer: 	Technical Secretary

Subscribed and sworn to before me on:

	Notary Public Signature:

	My commission expires on:

All rulemaking hearing rules provided for herein have been examined by the Attorney General and Reporter of the State of Tennessee and are approved as to legality pursuant to the provisions of the Administrative Procedures Act, Tennessee Code Annotated, Title 4, Chapter 5.

______________________________

	Robert E. Cooper, Jr.

	Attorney General and Reporter

	______________________________

	Date

Department of State Use Only

Filed with the Department of State on:

	Effective on:

______________________________

Tre Hargett

Secretary of StatePublic Hearing Comments

One copy of a document containing responses to comments made at the public hearing must accompany the filing pursuant to T.C.A. § 4-5-222.  Agencies shall include only their responses to public hearing comments, which can be summarized.  No letters of inquiry from parties questioning the rule will be accepted. When no comments are received at the public hearing, the agency need only draft a memorandum stating such and include it with the Rulemaking Hearing Rule filing. Minutes of the meeting will not be accepted. Transcripts are not acceptable.

Comment:	A commenter pointed out that the first sentence of the proposed new paragraph (8) of Rule 1200-03-18-.02 should be amended as follows to comply with the federal Clean Air Act 42 U.S. CODE § 7511A – PLAN SUBMISSIONS AND REQUIREMENTS:

“The owner or operator of any facility in Davidson, Rutherford, Shelby, Sumner, Knox, Blount, Anderson, Williamson, or Wilson County which has actual emissions from stationary sources of 25 tons or more of volatile organic compounds (VOC’s) and/or nitrogen oxides during a calendar year shall report to their permitting authority information and data concerning these emissions.”

Response:	The Board agrees and the sentence has been revised as suggested.

Regulatory Flexibility Addendum

Pursuant to T.C.A. §§ 4-5-401 through 4-5-404, prior to initiating the rule making process as described in T.C.A.

§ 4-5-202(a)(3) and T.C.A. § 4-5-202(a), all agencies shall conduct a review of whether a proposed rule or rule affects small businesses.

This rulemaking amendment to Paragraph (8) of Rule 1200-03-18-.02 General Provisions and Applicability is exempt from the provisions of the Regulatory Flexibility Act of 2007, Acts 2007, § 6 of Public Chapter 464 because it is federally mandated.  The rule subject to this amendment is part of the requirements of 42 U.S.C. § 7511a of the Federal Clean Air Act, which is the source of the requirement for Tennessee to “require that the owner or operator of each stationary source of oxides of nitrogen or volatile organic compounds provide the State with a statement, in such form as the Administrator may prescribe (or accept an equivalent alternative developed by the State), for classes or categories of sources, showing the actual emissions of oxides of nitrogen and volatile organic compounds from that source.”

Impact on Local Governments

Pursuant to T.C.A. §§ 4-5-220 and 4-5-228 “any rule proposed to be promulgated shall state in a simple declarative sentence, without additional comments on the merits of the policy of the rules or regulation, whether the rule or regulation may have a projected impact on local governments.”  (See Public Chapter Number 1070 (http://state.tn.us/sos/acts/106/pub/pc1070.pdf) of the 2010 Session of the General Assembly)

The Department anticipates that this amended rule will have a financial impact on local governments.

Additional Information Required by Joint Government Operations Committee

All agencies, upon filing a rule, must also submit the following pursuant to T.C.A. § 4-5-226(i)(1).

A brief summary of the rule and a description of all relevant changes in previous regulations effectuated by such rule;

Paragraph (8) of Rule 1200-03-18-.02 is being revised to include the 2008 Ozone Knoxville Non-Attainment Area (the “Area”).  The Area is comprised of Knox, Blount, and Anderson Counties.  The Area is currently designated as a non-attainment area but the counties were inadvertently omitted from the language of the rule.  The amendment also relocates the phrase “nitrogen oxides” for clarification in response to the public hearing comment.  The Air Pollution Control Division intends to submit a redesignation request for the Area to be designated as attainment; however, before redesignation can occur the language of the rule must reflect the federal requirement that all sources located in a county designated non-attainment are required to report emissions of nitrogen oxides and/or volatile organic compounds greater than 25 tons per year. In addition, the rule is being revised to allow affected sources in counties that operate their own air pollution control program (local program) to send these reports to their permitting authority rather than the Technical Secretary of the Tennessee Air Pollution Control Board. This change will allow the local program to receive this data from their sources.

A citation to and brief description of any federal law or regulation or any state law or regulation mandating promulgation of such rule or establishing guidelines relevant thereto;

This amendment is being promulgated under the authority of T.C.A. § 68-201-101 et seq., and is consistent with 42 U.S.C. § 7511a of the Federal Clean Air Act.

Identification of persons, organizations, corporations or governmental entities most directly affected by this rule, and whether those persons, organizations, corporations or governmental entities urge adoption or rejection of this rule;

All sources of air pollution that emit volatile organic compounds and/or nitrogen oxides in amounts of 25 tons per year or more that are located in a county designated or previously designated non-attainment for ozone and operating a local program are affected by this rule. No comments were received from any affected sources.

Identification of any opinions of the attorney general and reporter or any judicial ruling that directly relates to the rule;

The Tennessee Air Pollution Control Board is not aware of any.

An estimate of the probable increase or decrease in state and local government revenues and expenditures, if any, resulting from the promulgation of this rule, and assumptions and reasoning upon which the estimate is based. An agency shall not state that the fiscal impact is minimal if the fiscal impact is more than two percent (2%) of the agency's annual budget or five hundred thousand dollars ($500,000), whichever is less;

There will be no significant impact in state and local government revenues and expenditures resulting from the promulgation of these amendments.

Identification of the appropriate agency representative or representatives, possessing substantial knowledge and understanding of the rule;

Lacey J. Hardin

Division of Air Pollution Control

William R. Snodgrass Tennessee Tower

312 Rosa L. Parks Avenue, 15th Floor

Nashville, Tennessee 37243

Identification of the appropriate agency representative or representatives who will explain the rule at a scheduled meeting of the committees;

Emily Urban

Assistant General Counsel

Office of General Counsel

Office address, telephone number, and email address of the agency representative or representatives who will explain the rule at a scheduled meeting of the committees; and

Office of General Counsel

Tennessee Department of Environment and Conservation

William R. Snodgrass Tennessee Tower

312 Rosa L. Parks Avenue, 2nd Floor

Nashville, Tennessee 37243

(615) 532-8685

  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>

Any additional information relevant to the rule proposed for continuation that the committee requests.

The Tennessee Air Pollution Control Board is not aware of any.

 PAGE

 PAGE   2

SS-7039 (October 2011)		RDA 1693


[Federal Register Volume 79, Number 12 (Friday, January 17, 2014)]
[Notices]
[Pages 3260-3261]
[FR Doc No: 2014-00795]

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

SECURITIES AND EXCHANGE COMMISSION

[Release Nos. 33-9510; 34-71289, File No. 265-28]

Notice of Meeting of Securities and Exchange Commission Dodd-
Frank Investor Advisory Committee

AGENCY: Securities and Exchange Commission.

ACTION: Notice of meeting of Securities and Exchange Commission Dodd-
Frank Investor Advisory Committee.

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

SUMMARY: The Securities and Exchange Commission Investor Advisory
Committee, established pursuant to Section 911 of the Dodd-Frank Wall
Street Reform and Consumer Protection Act of 2010, is providing notice
that it will hold a public meeting on Friday, January 31, 2014, in
Multi-Purpose Room LL-006 at the Commission's headquarters, 100 F
Street NE., Washington, DC 20549. The meeting will begin at 10:00 a.m.
(EDT) and end at 4:30 p.m. and will be open to the public, except
during portions of the meeting reserved for meetings of the Committee's
subcommittees. The meeting will be webcast on the Commission's Web site
at www.sec.gov. Persons needing special accommodations to take part
because of a disability should notify the contact person listed below.
The public is invited to submit written statements to the Committee.
The agenda for the meeting includes: Remarks from Commissioners; a
recommendation from the Market Structure Subcommittee and the Investor
as Purchaser Subcommittee regarding decimalization; discussion of
crowdfunding; discussion of rebates and payments for order flow; and
nonpublic subcommittee meetings.

DATES: Written statements should be received on or before January 31,
2014.

ADDRESSES: Written statements may be submitted by any of the following
methods:

Electronic Statements

    [ssquf] Use the Commission's Internet submission form (http://www.sec.gov/rules/other.shtml); or
    [ssquf] Send an email message to<EMAIL_ADDRESS>Please
include File No. 265-28 on the subject line; or

Paper Statements

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

All submissions should refer to File No. 265-28. This file number
should be included on the subject line if email is used. To help us
process and review your statement more efficiently, please use only one
method.
    Statements also will be available for Web site viewing and printing
in the Commission's Public Reference Room, 100 F Street NE., Room 1580,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. All statements received will be posted without
change; we do not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly.

FOR FURTHER INFORMATION CONTACT: M. Owen Donley III, Chief Counsel, at
(202) 551-6322, Office of Investor Education and Advocacy, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549.

    Dated: January 13, 2014.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2014-00795 Filed 1-16-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 182 (Thursday, September 19, 2019)]
[Notices]
[Pages 49306-49308]
[FR Doc No: 2019-20322]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-4048]

Safer Technologies Program for Medical Devices; Draft Guidance
for Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Safer Technologies
Program for Medical Devices.'' This draft guidance describes a new,
voluntary program for certain medical devices and device-led
combination products that are reasonably expected to significantly
improve the safety of currently available treatments or diagnostics
that target an underlying disease or condition associated with
morbidities and mortalities less serious than those eligible for the
Breakthrough Devices Program. Devices and device-led combination
products are eligible for this program if they are subject to review
under a premarket approval application (PMA), De Novo classification
request (``De Novo request''), or premarket notification (510(k)).
Consistent with the Agency's statutory mission to protect and promote
public health, FDA believes that this ``Safer Technologies Program'' or
``STeP'' will help patients have more timely access to these medical
devices and device-led combination products by expediting their
development, assessment, and review, while preserving the statutory
standards for premarket approval, De Novo marketing authorization, and
510(k) clearance. This draft guidance is not final nor is it in effect
at this time.

DATES: Submit either electronic or written comments on the draft
guidance by November 18, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-4048 for ``Safer Technologies Program for Medical Devices.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Safer Technologies Program for Medical Devices'' to the Office of
Policy, Guidance and Policy Development, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002 or to the Office
of Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your request.

FOR FURTHER INFORMATION CONTACT: Maureen Dreher, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1545, Silver Spring, MD 20993-0002,<PHONE_NUMBER>;
or Stephen Ripley, Center for Biologics Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is introducing a new, voluntary program for certain medical
devices and device-led combination products that are reasonably
expected to significantly improve the safety of currently available
treatments or diagnostics that target an underlying disease or
condition associated with morbidities and mortalities less serious than
those eligible for the Breakthrough Devices Program; for example, this
may include devices treating or diagnosing non-life-threatening or
reasonably reversible conditions. Devices and device-led combination
products are eligible for this program if they are subject to review
under a premarket approval application (PMA), De Novo classification
request (``De Novo request''), or premarket notification (510(k)).
Consistent with the Agency's statutory mission to protect and promote
public health, FDA believes that this ``Safer Technologies Program'' or
``STeP'' will help patients have more timely access to these medical
devices and device-led combination products by expediting their
development, assessment, and review, while preserving the statutory
standards for premarket approval, De Novo marketing authorization, and
510(k) clearance. FDA has modeled STeP on the key principles and
features of FDA's Breakthrough Devices Program as mandated in section
515B of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 360e-3) and
further described in the FDA guidance document entitled ``Breakthrough
Devices Program''.\1\ As resources permit, FDA intends for STeP to
incorporate similar features offered under the Breakthrough Devices
Program, such as interactive and timely communications, early
engagement on Data Development Plans, prioritized review, and senior
management engagement.
---------------------------------------------------------------------------

    \1\ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breakthrough-devices-program.
---------------------------------------------------------------------------

    FDA recognizes and anticipates that the Agency may need up to 60
days to perform activities to operationalize this STeP following
issuance of the final guidance. FDA does not intend to accept requests
for inclusion in STeP within this time period.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115).

The draft guidance, when finalized, will represent the current thinking
of FDA on Safer Technologies Program for Medical Devices. It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov or
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. Persons unable to
download an electronic copy of ``Safer Technologies Program for Medical
Devices'' may send an email request to<EMAIL_ADDRESS>to
receive an electronic copy of the document. Please use the document
number 19001 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in
the following FDA regulations and guidance have been approved by OMB as
listed in the following table:

------------------------------------------------------------------------
                                                            OMB control
      21 CFR part or guidance               Topic               No.
------------------------------------------------------------------------
807, subpart E....................  Premarket                  0910-0120
                                     Notification.
814, subparts A through E.........  Premarket Approval..       0910-0231
812...............................  Investigational            0910-0078
                                     Device Exemption.
820...............................  Current Good               0910-0073
                                     Manufacturing
                                     Practice (CGMP);
                                     Quality System (QS)
                                     Regulation.
``De Novo Classification Process    De Novo                    0910-0844
 (Evaluation of Automatic Class      Classification
 III Designation)''.                 Process.
``Requests for Feedback on Medical  Q-submissions.......       0910-0756
 Device Submissions: The Pre-
 Submission Program and Meetings
 with Food and Drug Administration
 Staff''.
------------------------------------------------------------------------

    Dated: September 13, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-20322 Filed 9-18-19; 8:45 am]
 BILLING CODE 4164-01-P