[Federal Register: September 15, 2008 (Volume 73, Number 179)]
[Notices]
[Page 53319-53320]
[DOCID:fr15se08-138]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Noise Exposure Map Notice, Key West International Airport, Key
West, FL

AGENCY: Federal Aviation Administration, DOT.

ACTION: Notice.

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SUMMARY: The Federal Aviation Administration (FAA) announces its
determination that the Noise Exposure Maps submitted by Monroe County
for Key West International Airport under the provisions of 49 U.S.C.
47501 et seq. (Aviation Safety and Noise Abatement Act) and 14 CFR part
150 are in compliance with applicable requirements.

DATES: Effective Date: The effective date of the FAA's determination on
the noise exposure maps is August 27, 2008.

FOR FURTHER INFORMATION CONTACT: Ms. Lindy McDowell, Federal Aviation
Administration, Orlando Airports District Office, 5950 Hazeltine
National Drive, Suite 400, Orlando, Florida 32822,<PHONE_NUMBER>
extension 130.

SUPPLEMENTARY INFORMATION: This notice announces that the FAA finds
that the Noise Exposure Maps submitted for Key West International
Airport are in compliance with applicable requirements of Federal
Aviation Regulation (FAR) Part 150, effective August 27, 2008. Under 49
U.S.C. section 47503 of the Aviation Safety and Noise Abatement Act
(the Act), an airport operator may submit to the FAA Noise Exposure
Maps which meet applicable regulations and which depict non-compatible
land uses as of the date of submission of such maps, a description of
projected aircraft operations, and the ways in which such operations
will affect such maps. The Act requires such maps to be developed in
consultation with interested and affected parties in the local
community, government agencies, and persons using the airport. An
airport operator who has submitted Noise Exposure Maps that are found
by FAA to be in compliance with the requirements of FAR Part 150,
promulgated pursuant to the Act, may submit a Noise Compatibility
Program for FAA approval which sets forth the measures the airport
operator has taken or proposes to take to reduce existing non-
compatible uses and prevent the introduction of additional non-
compatible uses.
    The FAA has completed its review of the Noise Exposure Maps and
accompanying documentation submitted by Monroe County. The
documentation that constitutes the ``Noise Exposure Maps'' as defined
in Section 150.7 of FAR Part 150 includes: Table 4.2-1, 2008 Air
Carrier & Air Taxi Operations; 4.2-2, Air Carrier & Air Taxi Flight
Track Utilization; Table 4.2-3, 2008 Average Daily Engine Run-up
Operations; Table 4.2-4, 2008 General Aviation Operations; Table 4.2-5,
General Aviation Flight Track Utilization; Table 4.2-6, 2008 Military
Aircraft Operations; Table 4.2-7, Military Flight Track Utilization;
Table 4.2-8, Summary of 2008 Flight Operations; Table 4.3-1, 2008
Existing Condition Noise Exposure Estimates;

Figure 4.1, East Flow Radar Tracks; Figure 4.2, West Flow Radar Tracks;
Figure 4.3, East Flow Flight Tracks; Figure 4.4, West Flow Flight
Tracks; Figure 4.5, Touch and Go and Helicopter Flight Tracks; Figure
4.6, Run-up Locations; Figure 4.7, 2008 Existing Condition Noise
Exposure Map; Table 5.2-1, 2013 Air Carrier & Air Taxi Operations;
Table 5.2-2, 2013 Average Daily Engine Run-up Operations; Table 5.2-3,
2013 General Aviation Operations; Table 5.2-4, 2013 Military Aircraft
Operations; Table 5.2-5, Summary of 2013 Flight Operations; Table 5.3-
1, 2013 Future Condition Noise Exposure Estimates; Figure 5.1, 2013
Future Condition Noise Exposure Map; and, Figure 5.2, Future Condition
Noise Exposure Map with Flight Tracks. The FAA has determined that
these Noise Exposure Maps and accompanying documentation are in
compliance with applicable requirements. This determination is
effective on August 27, 2008.
    FAA's determination on the airport operator's Noise Exposure Maps
is limited to a finding that the maps were developed in accordance with
the procedures contained in Appendix A of FAR Part 150. Such
determination does not constitute approval of the airport operator's
data, information or plans, or a commitment to approve a Noise
Compatibility Program or to fund the implementation of that Program. If
questions arise concerning the precise relationship of specific
properties to noise exposure contours depicted on a Noise Exposure Map
submitted under Section 47503 of the Act, it should be noted that the
FAA is not involved in any way in determining the relative locations of
specific properties with regard to the depicted noise exposure
contours, or in interpreting the Noise Exposure Maps to resolve
questions concerning, for example, which properties should be covered
by the provisions of Section 47506 of the Act. These functions are
inseparable from the ultimate land use control and planning
responsibilities of local government. These local responsibilities are
not changed in any way under FAR Part 150 or through FAA's review of
Noise Exposure Maps. Therefore, the responsibility for the detailed
overlaying of noise exposure contours onto the map depicting properties
on the surface rests exclusively with the airport operator that
submitted those maps, or with those public agencies and planning
agencies with which consultation is required under Section 47503 of the
Act. The FAA has relied on the certification by the airport operator,
under Section 150.21 of FAR Part 150, that the statutorily required
consultation has been accomplished.
    Copies of the full Noise Exposure Maps documentation and of the
FAA's evaluation of the maps are available for examination at the
following locations: Federal Aviation Administration, Orlando Airports
District Office, 5950 Hazeltine National Drive, Suite 400, Orlando,
Florida 32822.
    Questions may be directed to the individual named above under the
heading, FOR FURTHER INFORMATION CONTACT.

    Issued in Orlando, Florida on August 27, 2008.
William E. Farris,
Acting Manager, Orlando Airports District Office.
[FR Doc. E8-21185 Filed 9-12-08; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register Volume 78, Number 108 (Wednesday, June 5, 2013)]
[Notices]
[Pages 33869-33870]
[FR Doc No: 2013-13276]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-69674; File No. SR-NYSEArca-2013-54]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Amending Exchange
Rule 6.91 To Remove Provisions Governing How the Complex Matching
Engine Handles Electronic Complex Orders That Contain a Stock Leg

May 30, 2013.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on May 17, 2013, NYSE Arca, Inc. (the ``Exchange'' or
``NYSE Arca'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange proposes to amend Exchange Rule 6.91 to remove
provisions governing how the Complex Matching Engine (``CME'') handles
Electronic Complex Orders that contain a stock leg. The text of the
proposed rule change is available on the Exchange's Web site at
www.nyse.com, at the principal office of the Exchange, and at the
Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange is proposing to amend NYSE Arca Rule 6.91 to delete
provisions governing CME functionality for Electronic Complex Orders
\4\ containing a stock leg submitted to the Exchange by OTP Holders.
Exchange Rule 6.91(a) provides that Electronic Complex Orders that are
entered into the NYSE Arca system are routed to the CME for possible
execution. Provisions governing the functioning of the CME were
originally incorporated in Rule 6.91 in 2008.\5\ The Rule, amended in
2011,\6\ states that the execution of the stock component of a Complex
Order must be executed consistent with the rules of the stock execution
venue, and sets out the priority ranking used by Exchange systems to
execute Stock/Option Orders,\7\ Stock/Complex Orders,\8\ and the option
components of such orders.
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    \4\ An ``Electronic Complex Order'' is any Complex Order, as
defined in Exchange Options Rule 6.62(e), or Stock/Option Order or
Stock/Complex Order, as defined in Rule 6.62(h) (see, infra,
footnotes 6 and 7). Rule 6.62(e) defines a Complex Order as any
order involving the simultaneous purchase and/or sale of two or more
different option series in the same underlying security, for the
same account, in a ratio that is equal to or greater than one-to-
three (.333) and less than or equal to three-to-one (3.00) and for
the purpose of executing a particular investment strategy. Exchange
Options Rule 6.62 governs Complex Orders, Stock/Option Orders and
Stock/Complex Orders on the Exchange and Rule 6.92 lists definitions
applicable to intermarket linkage.
    \5\ See Securities Exchange Act Release No. 58174 (July 16,
2008), 73 FR 42640 (July 22, 2008) (SR-NYSEArca-2008-54) (order
granting approval).
    \6\ See Securities Exchange Act Release No. 63660 (Jan. 6.
2011), 76 FR 2183 (Jan. 12, 2011) (SR-NYSEArca-2010-124) (notice of
filing and immediate effectiveness).
    \7\ A Stock/Option Order is defined in Rule 6.62(h)(1) as an
order to buy or sell a stated number of units of an underlying stock
or a security convertible into the underlying stock coupled with the
purchase or sale of options contract(s) on the opposite side of the
market representing either (A) the same number of units of the
underlying stock or convertible security, or (B) the number of units
of the underlying stock necessary to create a delta neutral
position, but in no case in a ratio greater than eight options
contracts per unit of trading of the underlying stock or convertible
security established for that series by the Clearing Corporation.
    \8\ A Stock/Complex Order is defined in Rule 6.62(h)(2) as the
purchase or sale of a Complex Order coupled with an order to buy or
sell a stated number of units of an underlying stock or a security
convertible into the underlying stock (``convertible security'')
representing either (A) the same number of units of the underlying
stock or convertible security as are represented by the options leg
of the Complex Order with the least number of options contracts, or
(B) the number of units of the underlying stock necessary to create
a delta neutral position, but in no case in a ratio greater than
eight-to-one (8.00), where the ratio represents the total number of
units of the underlying stock or convertible security in the option
leg to the total number of units of the underlying stock or
convertible security in the stock leg.
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    The Exchange is proposing to amend Rule 6.91 to delete provisions
governing how the CME processes Electronic Complex Orders that contain
a stock leg. Two types of Electronic Complex Orders, Stock/Option
Orders and Stock/Complex Orders, contain a stock leg. Rule
6.91(a)(2)(i) provides that ``the CME will accept an incoming
Electronic Complex Order and will automatically execute it against
Electronic Complex Orders in the Consolidated Book.'' Rule
6.91(a)(2)(ii) further provides that ``[i]f an Electronic Complex Order
in the CME is not marketable against another Electronic Complex Order
it will automatically execute against individual orders or quotes
residing in the Consolidated Book,'' subject to specified conditions.
The CME, however, rejects Electronic Complex Orders that contain a
stock leg. The development and implementation of the technology
supporting the CME's capability to accept Electronic Complex Orders
that contain a stock leg has taken longer than anticipated to complete
and is not yet available. The Exchange is therefore proposing to delete
from the Rule those provisions that permit the CME to accept Electronic
Complex Orders that contain a stock leg.
    The Exchange expects that this CME functionality will not be ready
until the Fall of 2013. The Exchange therefore believes it is
appropriate to delete from Rule 6.91 provisions governing the described
functionality until such time as it is ready to be implemented. In
addition, the Exchange is proposing the deletion of Commentary .03 to
Rule 6.91 to conform the Rule's Commentary to the proposed amendments
to the Rule. When the CME functionality to support the acceptance of a
Stock/Option Order or Stock/Complex Order is ready to be implemented,
the Exchange will file a rule proposal to add back the provisions
relating to the functionality, amended as necessary to reflect how such
functionality would operate. The use of Stock/Option and Stock/Complex
Orders in open outcry trading on the Exchange Floor remains available
to OTP Holders and is not impacted by the proposed amendment to Rule
6.91,

which only relates to CME's current inability to accept Electronic
Complex Orders that contain a stock leg.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) \9\ of the
Act, in general, and furthers the objectives of Section 6(b)(5),\10\ in
particular, in that it is designed to promote just and equitable
principles of trade, to remove impediments to and perfect the mechanism
of a free and open market and a national market system and, in general,
to protect investors and the public interest. Specifically, the
Exchange believes that the removal of unavailable functionality would
add transparency and clarity to the Exchange's rules. Additionally, the
removal would reduce potential confusion that may result from the
Exchange's rulebook referring to order execution functionality that is
unavailable. Finally, the proposed amendment would not otherwise affect
the operation of any other provision of the Rule on Exchange Systems,
including the availability of Stock/Option and Stock/Complex Orders in
open outcry trading referenced above.
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    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change imposes
any burden on competition. The proposed change is not designed to
address any competitive issue but rather would delete unavailable
functionality in the Exchange's rulebook, thereby reducing confusion
and making the Exchange's rules easier to understand and navigate.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \11\ and Rule 19b-4(f)(6) thereunder.\12\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6)(iii) thereunder.
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    \11\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \12\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under Rule 19b-4(f)(6) \13\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b4(f)(6)(iii),\14\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest.
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    \13\ Id.
    \14\ 17 CFR 240.19b-4(f)(6)(iii).
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    The Exchange has asked the Commission to waive the 30-day operative
delay so that the proposal may become operative immediately upon
filing. The Exchange believes that the waiver of the operative delay is
consistent with the protection of investors and the public interest
because the change will provide clarity as to what functionality is
offered by the Exchange, and because the CME functionality proposed to
be removed from the rule set is not actually available, its removal
will not have a negative effect on investors. Furthermore, the Exchange
notes that the waiver of the 30-day operative period will enable the
Exchange's rules to immediately reflect the functionality available on
the Exchange. The Commission believes that waiver of the operative
delay is consistent with the protection of investors and the public
interest. Therefore, the Commission waives the operative delay and
designates the proposal operative upon filing.\15\
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    \15\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2013-54 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEArca-2013-54. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room at 100 F Street NE.,
Washington, DC 20549-1090 on official business days between the hours
of 10:00 a.m. and 3:00 p.m. Copies of such filing also will be
available for inspection and copying at the principal offices of the
Exchange. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
NYSEArca-2013-54, and should be submitted on or before June 26, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
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    \16\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-13276 Filed 6-4-13; 8:45 am]
BILLING CODE 8011-01-P


1 Date: August 22, 2003 Subject: Telephone Conference Summary  EPA and representatives from the taconite industry From: Chris Sarsony, Alpha Gamma Technologies, Inc.

To: Docket OAR 2002 0039 I. Purpose The primary purpose of the meeting was to discuss the Economic Impact Analysis ( EIA) prepared by EPA at proposal and to get clarification on the taconite industry's written comments on the EIA.

II. Date April 21, 2003 III. Attendees U. S. Environmental Protection Agency Steve Fruh, OAQPS/ ESD/ MG Conrad Chin, OAQPS/ ESD/ MG Larry Sorrels, OAQPS/ ESD/ ISEG Taconite industry representatives Don Ahola, Empire Mining John Meier, Cleveland Cliffs Brad Anderson, EVTAC Rhonda Ross, Warner Norcross & Judd Dave Crouch, Cleveland Cliffs Larry Salmela, U. S. Steel Mr. Bill Kubiak  U. S. Steel Dave Skolasinski, Northshore Mining LaTisha Gietzen, National Steel Andrea Hayden, Hibbing Taconite Alpha Gamma Technologies, Inc.

Chris Sarsony Chuck Zukor OAR 2002 0039 IV E 14 2 IV. Discussion ° Larry Sorrels of EPA's Innovative Strategies and Economics Group gave a presentation titled " Economic Impact Analysis  Taconite Iron Ore NESHAP." A copy of this presentation is attached.

° The National Steel representative indicated that they are currently in bankruptcy and are being purchased by U. S. Steel. Their concern is whether their new employer will spend the money to upgrade the emission controls on the furnace. If they do not, then 470 people will be out of work.

° The EVTAC representative indicated that EVTAC is shutting down for an indefinite duration because they do not have any taconite orders.

° All of the plants indicated that because steel is a world market, anything that adds to operating costs puts them at a competitive disadvantage.

° In addition, the plants indicated that it is difficult to get capital for upgrades.

° The EPA pointed out that as serious as the economic problems of the taconite industry are, they are not the result of the taconite NESHAP. The EPA still has an obligation under the Clean Air Act to regulate sources of hazardous air pollutants. However, the EPA made it clear that the Agency wants to minimize the impact of the rule to the industry as much as possible.


[Federal Register Volume 79, Number 243 (Thursday, December 18, 2014)]
[Rules and Regulations]
[Pages 75431-75433]
[FR Doc No: 2014-29586]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2014-0661; FRL-9920-47-Region-5]

Approval and Promulgation of Air Quality Implementation Plans;
Indiana; Ozone and PM2.5 Standards

AGENCY: Environmental Protection Agency.

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking direct
final action to approve a submission by the State of Indiana as a
revision to the Indiana State Implementation Plan (SIP). The submitted
regulations revise Indiana's ambient air quality standards for ozone
and particulate matter (PM) to be consistent with EPA's 2008 ozone and
2012 fine particulate matter (PM2.5) National Ambient Air
Quality Standards (NAAQS). EPA is therefore approving this SIP
submission, in accordance with the requirements of the Clean Air Act
(CAA).

DATES: This direct final rule will be effective February 17, 2015,
unless EPA receives adverse comments by January 20, 2015. If adverse
comments are received, EPA will publish a timely withdrawal of the
direct final rule in the Federal Register informing the public that the
rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2014-0661, by one of the following methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: Douglas Aburano, Chief, Attainment Planning and
Maintenance Section, Air Programs Branch (AR-18J), U.S. Environmental
Protection Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604.
    5. Hand Delivery: Douglas Aburano, Chief, Attainment Planning and
Maintenance Section, Air Programs Branch (AR-18J), U.S. Environmental
Protection Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604.
Such deliveries are only accepted during the Regional Office normal
hours of operation, and special arrangements should be made for
deliveries of boxed information. The Regional Office official hours of
business are Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding
Federal holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R05-OAR-
2014-0661. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or email. The
www.regulations.gov Web site is an ``anonymous access'' system, which
means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through www.regulations.gov your email
address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the
www.regulations.gov

index. Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, will be publicly available only in hard copy. Publicly
available docket materials are available either electronically in
www.regulations.gov or in hard copy at the Environmental Protection
Agency, Region 5, Air and Radiation Division, 77 West Jackson
Boulevard, Chicago, Illinois 60604. This facility is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays.
We recommend that you telephone Eric Svingen, Environmental Engineer,
at<PHONE_NUMBER> before visiting the Region 5 office.

FOR FURTHER INFORMATION CONTACT: Eric Svingen, Environmental Engineer,
Attainment Planning and Maintenance Section, Air Programs Branch (AR-
18J), Environmental Protection Agency, Region 5, 77 West Jackson
Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This supplementary information
section is arranged as follows:

I. Background
II. Summary and Analysis of SIP Revision
III. What action is EPA taking?
IV. Statutory and Executive Order Reviews

I. Background

    On March 27, 2008 (73 FR 16436), EPA revised the 8-hour ozone
primary and secondary NAAQS to a level of 0.075 parts per million (ppm)
to provide increased protection for children and other at-risk
populations against an array of ozone-related adverse health effects.
These standards are based on the 3-year average of the annual fourth-
highest daily maximum 8-hour concentration.
    On January 15, 2013 (78 FR 3086), EPA revised the primary (health-
based) annual PM2.5 NAAQS to a level of 12.0 micrograms per
cubic meter ([micro]g/m\3\) and retained the 24-hour primary NAAQS for
PM2.5 at a level of 35 [micro]g/m\3\. EPA also retained the
existing annual PM2.5 secondary (welfare-based) NAAQS set at
a level of 15.0 [micro]g/m\3\, and retained the existing 24-hour coarse
particle (PM10) primary and secondary NAAQS at 150 [micro]g/
m\3\.
    On August 20, 2014, the Indiana Department of Environmental
Management (IDEM) submitted revisions to 326 Indiana Administrative
Code (IAC) 1-3-4, ``Ambient air quality standards''. These revisions
make Indiana's 8-hour ozone and annual PM2.5 ambient air
quality standards consistent with the NAAQS.
    The CAA specifies that EPA must reevaluate the appropriateness of
each of the NAAQS every five years. As part of the process, EPA
reviewed the latest health-based research and determined that several
NAAQS revisions were necessary to protect public health and welfare.

II. Summary and Analysis of SIP Revision

    IDEM's August 20, 2014, submission consists of amendments to 326
IAC 1-3-4, which includes the revised ambient air quality standards for
ozone and PM2.5. These revisions are: inclusion of the 8-
hour ozone standard of 0.075 ppm, inclusion of the annual
PM2.5 primary standard of 12.0 [micro]g/m\3\, retention of
the annual PM2.5 level of 15.0 [micro]g/m\3\ as the
secondary standard, incorporation by reference of appendix N to 40 CFR
50 (``Interpretation of the National Ambient Air Quality Standards for
PM2.5''), and incorporation by reference of appendix P to 40
CFR 50 (``Interpretation of the Primary and Secondary National Ambient
Air Quality Standards for Ozone''). The SIP submission is consistent
with the current NAAQS.
    On April 9, 2014, IDEM held a public hearing for the SIP
submission. No comments were received at this hearing.

III. What action is EPA taking?

    EPA is approving the SIP submission pertaining to the amendments of
Indiana's ambient air quality standards since it is consistent with the
NAAQS. Specifically, we are approving revised rule 326 IAC 1-3-4,
``Ambient air quality standards'' into the state SIP.
    We are publishing this action without prior proposal because we
view this as a noncontroversial amendment and anticipate no adverse
comments. However, in the proposed rules section of this Federal
Register publication, we are publishing a separate document that will
serve as the proposal to approve the state plan if relevant adverse
written comments are filed. This rule will be effective February 17,
2015 without further notice unless we receive relevant adverse written
comments by January 20, 2015. If we receive such comments, we will
withdraw this action before the effective date by publishing a
subsequent document that will withdraw the final action. All public
comments received will then be addressed in a subsequent final rule
based on the proposed action. EPA will not institute a second comment
period. Any parties interested in commenting on this action should do
so at this time. Please note that if EPA receives adverse comment on an
amendment, paragraph, or section of this rule and if that provision may
be severed from the remainder of the rule, EPA may adopt as final those
provisions of the rule that are not the subject of an adverse comment.
If we do not receive any comments, this action will be effective
February 17, 2015.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the 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 Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible

methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
    This rule is not approved to apply on any Indian reservation land
or in any other area where EPA or an Indian tribe has demonstrated that
a tribe has jurisdiction. In those areas of Indian country, the rule
does not have tribal implications as specified by Executive Order
13175, nor will it impose substantial direct costs on tribal
governments or preempt tribal law.
    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).
    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 February 17, 2015. 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. Parties with objections to this direct final rule are
encouraged to file a comment in response to the parallel notice of
proposed rulemaking for this action published in the proposed rules
section of today's Federal Register, rather than file an immediate
petition for judicial review of this direct final rule, so that EPA can
withdraw this direct final rule and address the comment in the proposed
rulemaking. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

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

    Dated: December 5, 2014.
Susan Hedman,
Regional Administrator, Region 5.
    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.

0
2. In Sec.  52.770 the table in paragraph (c) is amended by revising
the entry for 1-3-4 under ``Article 1. General Provisions'' ``Rule 3.
Ambient Air Quality Standards'' to read as follows:

Sec.  52.770  Identification of plan.

* * * * *
    (c) * * *

                                        EPA-Approved Indiana Regulations
----------------------------------------------------------------------------------------------------------------
                                                           Indiana
        Indiana citation                Subject           effective     EPA approval date           Notes
                                                            date
----------------------------------------------------------------------------------------------------------------
                                          Article 1. General Provisions
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                      Rule 3. Ambient Air Quality Standards
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
1-3-4...........................  Ambient air quality      08/07/2014  12/18/2014, [insert  ....................
                                   standards.                           Federal Register
                                                                        citation].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2014-29586 Filed 12-17-14; 8:45 am]
BILLING CODE 6560-50-P


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request Environmental Protection Agency  Office of Air and Radiation 2. OMB control number b. G None a. 2060 0348 3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. x Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. x Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes x No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. x Three years from approval date b. G Other Specify: / /___

7. Title National Volatile Organic Compound Emission Standards for Consumer Products 8. Agency form number( s) ( If applicable) EPA ICR No. 1764.03 9. Keywords consumer products, volatile organic compounds, VOC, 183( e)

10. Abstract The information collection includes initial reports and periodic recordkeeping necessary for EPA to ensure compliance with Federal standards for volatile organic compounds in consumer products. Respondents are manufacturers, distributors, and importers of consumer products. Responses to the collection are mandatory under 40 CFR part 59, subpart C  National Volatile Organic Compound Emission Standards for Consumer Products.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. P Business or other for profit e. Federal Government c. Not for profit institutions f. State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c. P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 367 b. Total annual responses 367 1. Percentage of these responses collected electronically 0 % c. Total hours requested 29,613 d. Current OMB inventory 29,695 e. Difference  82 f. Explanation of difference 1. Program Change 0 2. Adjustment  82 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs 0 b. Total annual costs ( O& M) 0 c. Total annualized cost requested 0 d. Current OMB inventory 0 e. Difference 0 f. Explanation of difference 1. Program change 0 2. Adjustment 0 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. __ Application for benefits e. __ Program planning or management b. __ Program evaluation f. __ Research c. __ General purpose statistics g. P Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. x Recordkeeping b. Q Third party disclosure c. x Reporting 1. x On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. Q Semi annually 6. Q Annually 7. Q Biannually 8. Q Other ( describe) Initial Notification 17. Statistical methods Does this information collection employ statistical methods?

Q Yes x No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Bruce Moore OAQPS/ ESD/ OD moore. bruce@ epa. gov Phone: 919 541 5460 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( I) Why the information is being collected' ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( I) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Official Stephen D. Page, Director Office of Air Quality Planning and Standards Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95


[Federal Register Volume 78, Number 212 (Friday, November 1, 2013)]
[Notices]
[Pages 65636-65637]
[FR Doc No: 2013-26095]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP14-68-000 .

    Applicants: Ozark Gas Transmission, L.L.C.
    Description: BP Negotiated Rate 11-1-2013 to be effective 11/1/
2013.
    Filed Date: 10/24/13.
    Accession Number: 20131024-5070.
    Comments Due: 5 p.m. ET 11/5/13.

    Docket Numbers: RP14-69-000.
    Applicants: Transcontinental Gas Pipe Line Company.
    Description: GSS LSS Tracker Filing 11-01-2013 to be effective 11/
1/2013.
    Filed Date: 10/24/13.
    Accession Number: 20131024-5089.
    Comments Due: 5 p.m. ET 11/5/13.

    Docket Numbers: RP14-70-000.
    Applicants: Rochester Gas and Electric Corporation, Allegany
Generating Station LLC.
    Description: Joint Petition of Rochester Gas and Electric
Corporation and Allegany Generating Station LLC for Temporary Waiver of
Capacity Release Regulations and Policies, and Request for Expedited
Treatment.
    Filed Date: 10/24/13.
    Accession Number: 20131024-5123.
    Comments Due: 5 p.m. ET 10/31/13.

    Docket Numbers: RP14-71-000.
    Applicants: Cheniere Creole Trail Pipeline, L.P.
    Description: Compliance Filing to be effective 11/1/2013.
    Filed Date: 10/25/13.
    Accession Number: 20131025-5083.
    Comments Due: 5 p.m. ET 11/6/13.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP13-1348-001.
    Applicants: National Fuel Gas Supply Corporation.
    Description: Amendment-Appalachian Pooling Filing (RP13-1348) to be
effective 12/1/2013.
    Filed Date: 10/24/13.
    Accession Number: 20131024-5071.
    Comments Due: 5 p.m. ET 11/5/13.

    Docket Numbers: RP14-31-001.
    Applicants: Northwest Pipeline LLC.
    Description: RP14-31-001 South Seattle Lateral Compliance Filing to
be effective 11/1/2013.
    Filed Date: 10/24/13.
    Accession Number: 20131024-5102.
    Comments Due: 5 p.m. ET 11/5/13.

    Any person desiring to protest in any of the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: October 28, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-26095 Filed 10-31-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 135 (Tuesday, July 14, 2020)]
[Notices]
[Pages 42406-42407]
[FR Doc No: 2020-15089]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1118]

Select Updates for Guidance for the Non-Clinical and Clinical
Investigation of Devices Used for the Treatment of Benign Prostatic
Hyperplasia; Draft Guidance for Industry and Food and Drug
Administration Staff; Availability

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Select Updates for
Guidance for the Non-Clinical and Clinical Investigation of Devices
Used for the Treatment of Benign Prostatic Hyperplasia (BPH).'' FDA has
developed this draft guidance to propose select updates to certain
sections of the existing FDA guidance document ``Guidance for the
Non[hyphen]Clinical and Clinical Investigation of Devices Used for the
Treatment of Benign Prostatic Hyperplasia (BPH).'' 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 September 14, 2020 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-2020-D-1118 for ``Select Updates for Guidance for the Non-Clinical
and Clinical Investigation of Devices Used for the Treatment of Benign
Prostatic Hyperplasia (BPH).'' 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.govinfo.gov/content/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
``Select Updates for Guidance for the Non-Clinical and Clinical
Investigation of Devices Used for the Treatment of Benign Prostatic
Hyperplasia (BPH)'' 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. Send one self-addressed adhesive label to assist
that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Charles Viviano, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 2680, Silver Spring, MD 20993-0002, 240-
402-2975.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA has developed this draft guidance to propose select updates to
the FDA guidance document ``Guidance for the Non[hyphen]Clinical and
Clinical Investigation of Devices Used for the Treatment of Benign
Prostatic Hyperplasia (BPH).'' The existing guidance on devices used
for the treatment of BPH remains in effect, in its current form, until
this draft guidance is finalized. FDA intends to incorporate this draft
guidance into one final guidance document after obtaining and
considering public comment on these select updates. The sections of the
existing BPH guidance that are not affected by this select update will
not be substantively changed and will remain in effect.

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 ``Select
Updates for Guidance for the Non-Clinical and Clinical Investigation of
Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH).''
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.

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.
Persons unable to download an electronic copy of ``Select Updates for
Guidance for the Non-Clinical and Clinical Investigation of Devices
Used for the Treatment of Benign Prostatic Hyperplasia (BPH)'' may send
an email request to<EMAIL_ADDRESS>to receive an electronic
copy of the document. Please use the document number 1724 and the full
title 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. 3501-3521). The collections of information in
the following FDA regulations and guidance have been approved by OMB as
listed in the following table:

------------------------------------------------------------------------
     21 CFR part or guidance              Topic          OMB control No.
------------------------------------------------------------------------
58...............................  Good Laboratory             0910-0119
                                    Practice (GLP)
                                    Regulations for
                                    Nonclinical
                                    Laboratory Studies.
800, 801, and 809................  Medical Device              0910-0485
                                    Labeling
                                    Regulations.
807, subpart E...................  Premarket                   0910-0120
                                    Notification.
812..............................  Investigational             0910-0078
                                    Device Exemption.
814, subparts A through E........  Premarket Approval          0910-0231
                                    Applications.
``De Novo Classification Process   De Novo                     0910-0844
 (Evaluation of Automatic Class     Classification
 III Designation)''.                Process.
``Requests for Feedback on         Q-submissions......         0910-0756
 Medical Device Submissions: The
 Pre-Submission Program and
 Meetings with Food and Drug
 Administration Staff''.
------------------------------------------------------------------------

    Dated: July 8, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15089 Filed 7-13-20; 8:45 am]
BILLING CODE 4164-01-P


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

      UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
       	     WASHINGTON, D.C. 20460

                         				OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION
                             OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

   MEMORANDUM                                                                   August 31, 2012

SUBJECT:	Summary of Ecotoxicity Data for Cytokinin Registration Review Document

               EPA Reg. #:		5905-LIU
               CAS #:		              525-79-1 and 133-32-4
               PC Code                             116801 and 116802

   FROM:	Michael Rexrode, Ph.D., Senior Biologist          /s/             08/31/2012
               Biochemical Pesticides Branch
               Biopesticide & Pollution Prevention Division (7511P)

   TO:		Leonard Cole, Regulatory Action Leader   /s/                      08/31/2012
               Biochemical Pesticides Branch
               Biopesticide & Pollution Prevention Division (7511P)

ACTION REQUESTED

The following is the final ecotoxicity assessment for cytokinin/kinin in support of the Registration Review Decision Document.

RECOMMENDATIONS AND CONCLUSIONS

Executive Summary
The plant regulator, cytokinin, was initially registered in the United States in 1978 as CYTEX(R) (EPA Reg. No. 35980-1) for applications to certain citrus, fruit and vegetable crops. Cytokinin acts as a plant regulator by promoting cell division; minimizing effects of stress; root stimulation; increased yield; increased vegetative growth; and increased tuber firmness.
During Phase 4 of the Reregistration Process, the data base for cytokinin was evaluated and determined to be inadequate in satisfying certain requirements for biochemical pesticides which include plant regulators.

Since the DCI, the Agency's initial position about these data gaps was re-evaluated and all of these data requirements, except for 154-B-11 Non-target insects, were waived because available information indicates cytokinin does not cause unreasonable adverse effects: 1) The principal constituents of cytokinin, algae and seaweed, are natural components of fish diets; 2) Cytokinin has a very low acute mammalian toxicity; 3) Cytokinin is used as a dietary supplement in animal feeds; and 4) are expected to have no adverse effects to fish and wildlife.
During development of the reregistration eligibility decision (RED), the data requirements for non-target insect testing were re-examined and these data requirements were waived based on the previously mentioned rationale for ecological effects (i.e., low acute mammalian toxicity; use as a fish and animal food supplement; and lack of expected adverse effects to fish and wildlife). Therefore, the data are adequate to support the currently registered uses of cytokinin.

This Reregistration Eligibility Decision reflects a reassessment of all data which were submitted in response to the Reregistration Process. Based on the available information for cytokinin the Agency does not foresee the need for additional ecotoxicity data for a new risk assessment and has waived all hazard and exposure data on these chemicals. The unique characteristics of these products, there non-toxic mode of action, and biodegradability (low to no persistence), will not result in toxic risk to non-targets, including threatened and endangered species. The Agency considers cytokinin use to have a no effect (NE) on endangered/threatened species.

Background
Cytokinin is generally found in higher concentrations in meristematic regions and growing tissues. They are believed to be synthesized in the roots and translocated via the xylem to shoots. Cytokinin biosynthesis happens through the biochemical modification of adenine. Cytokinins have been found in almost all higher plants as well as mosses, fungi, bacteria, and also in tRNA of many prokaryotes and eukaryotes. Today there are more than 200 natural and synthetic cytokinins combined. Cytokinin concentrations are highest in meristematic regions and areas of continuous growth potential such as roots, young leaves, developing fruits, and seeds (Arteca, 1996; Mauseth, 1991; Raven, 1992; Salisbury and Ross, 1992).

Toxicology
Summaries of the toxicology profile for cytokinin are shown in Table 1.0. Based on this information cytokinins are practically non-toxic to mammalian species (LD50 > 5,000 mg/kg) (Toxicology Cat. IV); can cause slight acute dermal effects (Toxicology Cat. III), and slight eye irritation (Toxicology Cat. III). Studies on kinetin (Table 2.0) show that the compound has a Toxicological Category IV for acute oral (LD50 > 5,000 mg/kg), Acute Dermal (LD50 > 5,000 mg/kg), Acute Inhalation (LC50 > 2.09 mg/L), and Dermal Irritation (non-irritating). The study on Eye Irritation showed mild effects and a Toxicology Category III.

Table 1.0. Acute Toxicological Values for Cytokinin
                                   Guideline
                                     Study
                                    Results
                                   Category
                                    MRID #
                                   870.1100
                               Acute Oral (rat)
                             LD50 > 5,000mg/kg
                                      IV
                                   00142864
                                   870.1200
                                 Acute Dermal
                             LD50 > 2,000 mg/kg
                                      III
                                   00138093
                                   870.1300
                               Acute Inhalation
                                    Waived

                                   870.2400
                                Eye irritation
                                    Slight
                                      III
                                   00138094
                                   870.2500
                               Dermal irritation
                                    Slight
                                      III
                                   00074304
                                   870.2600
                             Dermal sensitization
                                    Waived

Table 2.0. Acute Toxicological Values for Kinetin
                                   Guideline
                                     Study
                                    Results
                                   Category
                                    MRID #
                                   870.1100
                               Acute Oral (rat)
                             LD50 > 5,000mg/kg
                                      IV
                                   45500703
                                   870.1200
                                 Acute Dermal
                             LD50 > 5,000 mg/kg
                                      IV
                                   45500704
                                   870.1300
                               Acute Inhalation
                              LC50 > 2.09 mg/L
                                      IV
                                   45500705
                                   870.2400
                                Eye irritation
                                     mild
                                      III
                                   45500706
                                   870.2500
                               Dermal irritation
                                Non-irritating
                                      IV
                                   45500707
                                   870.2600
                             Dermal sensitization
                           Not a contact sensitizer

                                   45500708

Only the four naturally occurring cytokinins, derived from certain algal species, are exempt from the requirement of a tolerance when used as a plant growth regulator (40 CFR 180.1042). Tolerance exemptions are often based on the results of 90-Day (or longer) feeding and developmental toxicity studies submitted to support reregistration. However, it is the Agency's opinion that these studies can be waived for naturally occurring and synthetic cytokinin because of low acute mammalian toxicity and very low use rates (250 grams ai/A), which would not significantly increase dietary intake over natural consumption in foods. The Agency, will be proposing an exemption from the requirement of a tolerance for certain cytokinins (zeatin [6-(4-hydroxy-3-methylbut-trans-2-enylamino)-purine], N6-methylaminopurine, N6-dimethylamino purine, N6- isopentenyl- aminopurine), and synthetic cytokinin -- kinetin [6- (furfurylamino) purine] for all raw agricultural commodities (RACs). The exemption will apply only when application rates do not exceed 250 grams of active ingredient/acre/year. The Agency believes this action does not present any unreasonable risk. It is based on cytokinin's low acute mammalian toxicity, its low use rates, exposure in the diet from numerous natural plant food sources, and minimal exposure in the diet derived from consumption of treated commodities under the proposed maximum label use rates. The Agency has concluded that dietary exposure risks from consuming commodities treated with cytokinin, either naturally occurring or synthetic, are not expected.

Ecotoxicity
Ecological toxicity studies on non-target terrestrial and aquatic organisms were waived because available information shows that cytokinin does not cause unreasonable adverse effects: 1) The principal constituents of cytokinin, algae and seaweed, are natural components of fish diets; 2) Cytokinin has a very low acute mammalian toxicity; 3) Cytokinin is used as a dietary supplement in animal feeds; 4) are expected to have no adverse effects to fish and wildlife; and 5) no reported incidents. Data waivers were also granted for Nontarget Insect Testing (885.4340) and Nontarget Plant Testing (885.4300) in July of 1995 as part of the RED development process because of the unique characteristics of this product, its non-toxic mode of action, low use volumes (< 2g/A), and biodegradability (low to no persistence). Based on the current use patterns, the non-toxic effects to terrestrial and aquatic plants and animals, the Agency finds that Cytokinin use is a No Effect to endangered plant and animal species from current registered uses.

References

Arteca, R. (1996). Plant Growth Substances: Principles and Applications. New York: Chapman & Hall.
Mauseth, J. D. (1991). Botany: An Introduction to Plant Biology. Philadelphia: Saunders. pp. 348-415.
Raven, P. H., Evert, R. F., and Eichhorn, S. E. (1992). Biology of Plants. New York: Worth. pp. 545-572.
Salisbury, F. B., and Ross, C. W. (1992). Plant Physiology. Belmont, CA: Wadsworth. pp. 357-407, 531-548.
USEPA 738-R-95-025 Environmental Protection And Toxic Substances December 1995 Agency (7508W) Reregistration Eligibility Decision (RED).