[Federal Register: February 16, 2007 (Volume 72, Number 32)]
[Notices]
[Page 7654]
[DOCID:fr16fe07-87]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2004-0076; FRL-8278-6]

Extension of Period for Objection for the Notice of Data
Availability for EGU NOX Annual and NOX Ozone Season Allocations for
the Clean Air Interstate Rule Federal Implementation Plan Trading
Programs

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice to extend period for objections.

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SUMMARY: EPA is extending the period for submission of objections
concerning the Notice of Data Availability (NODA) for EGU
NOX Annual and NOX Ozone Season Allocations for
the Clean Air Interstate Rule Federal Implementation Plan Trading
Programs (CAIR FIP) published on August 4, 2006 to June 1, 2007 for
cogeneration units combusting biomass (biomass cogeneration units). The
period had previously been extended to October 5, 2006 for all
objections, and further extended to February 20, 2007 for objections
concerning biomass cogeneration units. This notice further extends the
period for objections concerning biomass cogeneration units from
February 20, 2007 to June 1, 2007. Certain biomass cogeneration unit
owners and operators requested the additional time to submit objections
because of difficulties in collection of information relating to the
application of efficiency standards for cogeneration units (as defined
in the CAIR FIP) to biomass cogeneration units. For all other
objections, the deadline was October 5, 2006.

DATES: The EPA is establishing a period ending on June 1, 2007 only for
objections (including data) related to biomass cogeneration units.
Objections must be postmarked by the last day of the period for
objection and sent directly to the Docket Office listed in ADDRESSES
(in duplicate form if possible).

ADDRESSES: Submit your objections, identified by Docket Number OAR-
2004-0076 by one of the following methods:
    A. Federal Rulemaking Portal: http://www.regulations.gov. The NODA

is not a rulemaking, but you may use the Federal Rulemaking Portal to
submit objections to the NODA. To submit objections, follow the on-line
instructions for submitting comments.
    B. Mail: Air Docket, ATTN: Docket Number OAR-2004-0076,
Environmental Protection Agency, Mail Code: 6102T, 1200 Pennsylvania
Ave., NW., Washington, DC 20460
    C. E-mail<EMAIL_ADDRESS>    D. Hand Delivery: EPA Docket Center, 1301 Constitution Avenue, NW.,
Room 3334, Washington, DC. Such deliveries are only accepted during the
Docket's normal hours of operation, and special arrangements should be
made for deliveries of boxed information.

FOR FURTHER INFORMATION CONTACT: General questions concerning today's
action and technical questions concerning heat input or fuel data
should be addressed to Brian Fisher, USEPA Headquarters, Ariel Rios
Building, 1200 Pennsylvania Ave., Mail Code 6204 J, Washington, DC
20460. Telephone at<PHONE_NUMBER>, e-mail at<EMAIL_ADDRESS>If
mailing by courier, address package to Brian Fisher, 1310 L St., NW.,
RM  713G, Washington, DC 20005.

SUPPLEMENTARY INFORMATION:
    Docket: All documents in the docket are listed in the
http://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 http://www.regulations.gov or in hard copy at the EPA Docket Center, EPA

West, Room 3334, 1301 Constitution Avenue, NW., Washington, DC. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m, Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the Air
Docket is<PHONE_NUMBER>.

Extension of Period for Objections

    In the August 4, 2006 NODA (71 FR 44283), EPA provided notice that
it had placed in the CAIR FIP docket allocation tables for EGU
NOX annual and EGU NOX ozone season allocations
for control periods 2009-2014. The allocation tables also included
inventories of heat input and inventories of potentially exempt units.
In addition, EPA also placed in the docket a Technical Support Document
describing the allocation table data fields.
    The EPA originally provided a 30-day period for the unit owners,
unit operators, and the public to submit objections regarding
individual units' treatment as potentially covered or not covered by
CAIR and, for units treated as potential CAIR units, the data used in
the allocation calculations and the allocations resulting from such
calculations. In response to a request from the American Forest and
Paper Association, EPA extended the period for all objections an
additional 30 days to October 5, 2006.
    In requesting an additional extension of the period, certain
biomass cogeneration unit owners noted the unique nature of the fuels
utilized by biomass cogeneration units and the difficulties encountered
in collecting data necessary to apply the efficiency standard to this
type of cogeneration unit. In light of these circumstances, the EPA had
extended the period until February 20, 2007 for objections (including
data) related to any biomass cogeneration units, and further extends it
to June 1, 2007 in this notice. For all other objections, the deadline
was October 5, 2006.
    EPA believes the additional time will provide the Agency more
adequate time to receive and evaluate necessary data and, if
appropriate, address the concerns raised about application of the
efficiency standard to biomass cogeneration units.

    Dated: February 12, 2007.
Brian J. McLean,
Director, Office of Atmospheric Programs.
 [FR Doc. E7-2806 Filed 2-15-07; 8:45 am]

BILLING CODE 6560-50-P


	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

	WASHINGTON, D.C.  20460

OFFICE OF PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES

	August 24, 2006

MEMORANDUM

SUBJECT:	Review of Hexythiazox Incident Reports

		DP Barcode 333939, Chemical #128849

FROM:	Monica S. Hawkins, M.P.H., Environmental Health Scientist

		Chemistry and Exposure Branch

		Health Effects Division (7509P)

		Hans Allender, Ph.D., Statistician

		Chemistry and Exposure Branch

		Health Effects Division (7509P)

THRU:	David J. Miller, Chief

		Chemistry and Exposure Branch

		Health Effects Division (7509P)

TO:		Kennan Garvey

		Special Review and Reregistration Division (7508P)

BACKGROUND

	The following data bases have been consulted for the poisoning incident
data on the active ingredient Hexythiazox (128849):

1)  OPP Incident Data System (IDS) - reports of incidents from various
sources, including registrants, other federal and state health and
environmental agencies and individual consumers, submitted to OPP since
1992.  Reports submitted to the Incident Data System represent anecdotal
reports or allegations only, unless otherwise stated.  Typically no
conclusions can be drawn implicating the pesticide as a cause of any of
the reported health effects.  Nevertheless, sometimes with enough cases
and/or documentation risk mitigation measures may be suggested.

2)  Poison Control Centers - as the result of a data purchase by EPA,
OPP received Poison Control Center data covering the years 1993 through
2003 for all pesticides.  Most of the national Poison Control Centers
(PCCs) participate in a national data collection system, the Toxic
Exposure Surveillance System which obtains data from about 65-70 centers
at hospitals and universities.  PCCs provide telephone consultation for
individuals and health care providers on suspected poisonings, involving
drugs, household products, pesticides, etc.

3)  California Department of Pesticide Regulation  - California has
collected uniform data on suspected pesticide poisonings since 1982.
Physicians are required, by statute, to report to their local health
officer all occurrences of illness suspected of being related to
exposure to pesticides.  The majority of the incidents involve workers.
Information on exposure (worker activity), type of illness (systemic,
eye, skin, eye/skin and respiratory), likelihood of a causal
relationship, and number of days off work and in the hospital are
provided.

4)  National Pesticide Information Center (NPIC) - NPIC is a toll-free
information service supported by OPP.  A ranking of the top 200 active
ingredients for which telephone calls were received during calendar
years 1984-1991, inclusive has been prepared.  The total number of calls
was tabulated for the categories human incidents, animal incidents,
calls for information, and others.

5) National Institute of Occupational Safety and Health’s Sentinel
Event Notification System for Occupational Risks (NIOSH SENSOR) performs
standardized surveillance in nine states from 1998 through 2003.  States
included in this reporting system are Arizona, California, Florida,
Louisiana, Michigan, New York, Oregon, Texas, and Washington.  Reporting
varies from state to state because of the differing degrees of
cooperation from different sources of reporting (e.g., workers
compensation, Poison Control Centers, emergency departments and
hospitals, enforcement investigations, private physicians, etc.).
Therefore, these reports should not be characterized as estimating the
total magnitude of poisoning.  The focus is on occupationally-related
cases not residential or other non-occupational exposures.   However,
the information collected on each case is standardized and categorized
according to the certainty of the information collected and the severity
of the case.

HEXYTHIAZOX REVIEW

I. Incident Data System

	There were no reports for hexythiazox in the Incident Data System.

II. Poison Control Center Data - 1993 through 2003

	Results for the years 1993 through 2003 of the Poison Control Center
show a total of one exposure to hexythiazox.  Cases involving exposures
to multiple products are excluded. The one exposure was in the non
occupational class and the case was followed. This was too few cases to
warrant detailed analysis. The case reported involved a moderate outcome
that could not be attributed to the compound. Despite the small sample,
the Poison Control Center data for this compound suggests that exposure
to hexythiazox is unlikely to result in serious health effects.

III.  NIOSH SENSOR

	Out of 5,899 reported cases from 1998 to 2003, none involved
hexythiazox.

IV. Conclusion

	There was only 1 report of an ill effect from exposure to hexythiazox
in the available data bases.

V.  Recommendations

	No recommendations are made based on the limited information available.

cc:	Hexythiazox file (128849)

	David J. Miller (7509P)

഍഍഍

഍

഍഍഍

഍


[Federal Register Volume 80, Number 23 (Wednesday, February 4, 2015)]
[Notices]
[Page 6097]
[FR Doc No: 2015-02122]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4206-DR; Docket ID FEMA-2015-0002]

Soboba Band of Luise[ntilde]o Indians; Major Disaster and Related
Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the Soboba Band of Luise[ntilde]o Indians (FEMA-4206-DR),
dated January 27, 2015, and related determinations.

DATES: Effective Date: January 27, 2015.

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

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated January 27, 2015, the President issued a major disaster
declaration under the authority of the Robert T. Stafford Disaster
Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the
``Stafford Act''), as follows:

    I have determined that the damage to the lands associated with
the Soboba Band of Luise[ntilde]o Indians resulting from severe
storms, flooding, and mudslides during the period of December 4-6,
2014, is of sufficient severity and magnitude to warrant a major
disaster declaration under the Robert T. Stafford Disaster Relief
and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''). Therefore, I declare that such a major disaster exists for
the Soboba Band of Luise[ntilde]o Indians and associated lands.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance and Hazard
Mitigation for the Soboba Band of Luise[ntilde]o Indians and
associated lands. Consistent with the requirement that Federal
assistance be supplemental, any Federal funds provided under the
Stafford Act for Hazard Mitigation will be limited to 75 percent of
the total eligible costs. Federal funds provided under the Stafford
Act for Public Assistance also will be limited to 75 percent of the
total eligible costs, with the exception of projects that meet the
eligibility criteria for a higher Federal cost-sharing percentage
under the Public Assistance Alternative Procedures Pilot Program for
Debris Removal implemented pursuant to section 428 of the Stafford
Act.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Rosalyn L. Cole, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following area has been designated as adversely affected by
this major disaster:

    Soboba Band of Luise[ntilde]o Indians and associated lands for
Public Assistance.
    The Soboba Band of Luise[ntilde]o Indians is eligible to apply
for assistance under the Hazard Mitigation Grant Program.

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

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2015-02122 Filed 2-3-15; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 82, Number 57 (Monday, March 27, 2017)]
[Notices]
[Pages 15244-15247]
[FR Doc No: 2017-05920]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-80283; File No. SR-NYSEMKT-2017-14]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and
Immediate Effectiveness of Proposed Rule Change To Amend Its
Organizational Documents, Company Guide, Price List, Fee Schedules,
Independence Policy and Rules To Change the Name of the Exchange to
NYSE American LLC

March 21, 2017.
    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 March 16, 2017 NYSE MKT LLC (the ``Exchange'' or ``NYSE
MKT'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III 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 Substance
of the Proposed Rule Change

    The Exchange proposes, in connection with its name change to NYSE
American LLC, to amend certain organizational documents, the NYSE MKT
LLC Company Guide (``Company Guide''), the NYSE MKT Equities Price List
(``Price List''), the NYSE Amex Options Fee Schedule (``Fee
Schedule''), the NYSE MKT LLC Equities Proprietary Market Data Fees
(``Market Data Fees''), the Independence Policy of the Board of
Directors (``Independence Policy''), and rules of the Exchange to
reflect that name change. The proposed 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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    NYSE MKT proposes, in connection with its name change to NYSE
American LLC (``NYSE American''), to amend certain organizational
documents, the Company Guide, Price List, Fee Schedule, Market Data
Fees, Independence Policy, and rules of the Exchange to reflect that
name change.
Name Change of the Exchange
    In 2008, NYSE Euronext acquired the American Stock Exchange LLC
(``Amex''), as a result of which the Exchange, as the successor entity
to Amex, became a wholly owned subsidiary of NYSE Group, Inc. At that
time, the Exchange was named ``NYSE Alternext US LLC.'' \4\ In 2009,
the name of the Exchange was changed to ``NYSE Amex LLC'' \5\ and in
2012 it was changed to ``NYSE MKT LLC.'' \6\ The Exchange has now
determined that for marketing purposes it would be desirable to change
the name of the Exchange to ``NYSE American LLC.''
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    \4\ See Securities Exchange Act Release No. 58673 (September 29,
2008), 73 FR 57707 (October 3, 2008) (SR-Amex-2008-62).
    \5\ See Securities Exchange Act Release No. 59575 (March 13,
2009), 74 FR 11803 (March 19, 2009) (SR-NYSEALTR-2009-24).
    \6\ See Securities Exchange Act Release No. 67037 (May 21,
2012), 77 FR 31415 (May 25, 2012) (SR-NYSEAmex-2012-32).
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    In connection with the name change, the Exchange proposes to amend
the following documents as described below:
     Certificate of Formation: The Exchange proposes to replace
``NYSE MKT LLC'' with ``NYSE American LLC'' in number 1 of the
certificate of formation and to make conforming changes to the title.
     Tenth Amended and Restated Operating Agreement of NYSE MKT
LLC: The Exchange proposes to replace ``NYSE MKT LLC'' with ``NYSE
American LLC'' in Article I, Section 1.01 (Name) and to replace ``NYSE
MKT DCRC'' with ``NYSE American DCRC'' in Article II, Section 2.03
(Board). The Exchange also proposes to make conforming changes to the
title, preamble, recitals, and signature line.
     Company Guide: The Exchange proposes to replace ``NYSE MKT
LLC'' with ``NYSE American LLC'' in the title, Section 211(c) (Original
Listing Application--General) and Section 350 (Cancellation Notice),
and in the Appendix forms for an Initial Public Offering, Common Stock,
and Listing Agreement.
     Price List: The Exchange proposes to replace ``NYSE MKT''
with ``NYSE American'' in the title and throughout the Price List.
Under ``Co-Location Fees,'' the Exchange proposes to replace ``NYSE MKT
Equities Price List'' with ``NYSE American Equities Price List'' and
``NYSE MKT Options Fee Schedule'' with ``NYSE American Options Fee
Schedule.'' Under ``Listing Fees,'' the Exchange proposes to replace
``NYSE MKT Company Guide'' with ``NYSE American Company Guide.''
     Fee Schedule: The Exchange proposes to replace ``NYSE MKT
LLC'' with ``NYSE American LLC'' in the title. Additionally, the
Exchange proposes to replace all references to ``NYSE MKT'' with ``NYSE
American'' in ``Section V. Technology & System Access Fees--Co-Location
Fees.''
     Market Data Fees: The Exchange proposes to replace ``NYSE
MKT LLC'' with ``NYSE American LLC'' in the title. Additionally, the
Exchange proposes to replace all references to ``NYSE MKT'' with ``NYSE
American'' in the product names and footnotes 1, 2, and 4.
     Independence Policy: The Exchange proposes to replace
``NYSE MKT LLC'' with ``NYSE American LLC'' throughout the Independence
Policy.\7\ Additionally, the Exchange proposes to replace ``[Insert
name of relevant NYSE U.S. Regulated Subsidiary]'' with ``NYSE American
LLC.'' The text being replaced was used in prior filings because
several entities used the same Independence Policy.\8\
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    \7\ In addition, the Exchange proposes to delete footnote 2 of
the Independence Policy, which has an obsolete reference to NYSE
Regulation, Inc. (``NYSE Regulation''). NYSE Regulation and NYSE
Market (DE), Inc. (``NYSE Market (DE)'') were previously parties to
a Delegation Agreement whereby the New York Stock Exchange LLC
delegated certain regulatory functions to NYSE Regulation and
certain market functions to NYSE Market (DE) (``Delegation
Agreement''). The Delegation Agreement was terminated when the New
York Stock Exchange LLC re-integrated its regulatory and market
functions. As a result, the two entities ceased being regulated
subsidiaries, and NYSE Regulation was merged out of existence. See
Securities Exchange Act Release No. 75991 (September 28, 2015), 80
FR 59837 (October 10, 2015) (SR-NYSE-2015-27).
    \8\ Prior to the termination of the Delegation Agreement, the
same Independence Policy applied to the Exchange, the New York Stock
Exchange LLC, NYSE Market (DE), and NYSE Regulation. See Securities
Exchange Act Release Nos. 72156 (May 13, 2014), 79 FR 28782 (May 19,
2014) (SR-NYSEMKT-2014-41); 67564 (August 1, 2012), 77 FR 47161
(August 7, 2012) (SR-NYSE-2012-17; SR-NYSEArca-2012-59; SR-NYSEMKT-
2012-07).
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    In addition, the Exchange proposes to amend its rules as follows:
     The Exchange proposes to replace ``NYSE MKT LLC'' with
``NYSE American LLC'' in definitions 11 (``The Exchange'') and 37
(``Company Guide''); Rule 341, Commentary .02 and .08 (Approval of
Registered Employees and Officers); Rule 1--Equities (The Exchange and
Related Entities); Rule 37--Equities (Visitors); Rule 98--Equities
(c)(6) (Operation of a DMM Unit); Rule 227--Equities Forms 6(a), 7(a),
and 12(a) (Depository Eligibility); Rule 497--Equities (a)(3)
(Additional Requirements for Listed Securities Issued by ICE or its
Affiliates); and Rule 900.2NY(45) and (47) (Definitions).
     The Exchange proposes to replace ``NYSE MKT LLC'' with
``the Exchange'' in Rule 341, Commentary .08 (Approval of Registered
Employees and Officers).
     The Exchange proposes to replace ``NYSE MKT Bonds'' with
``NYSE American Bonds'' in Rule 51--Equities (a), Supplementary
Material .20 (Hours for Business); Rule 72--Equities, Supplementary
Material .40 (Priority of Bids and Offers and Allocation of
Executions); Rule 86--Equities (NYSE MKT Bonds); Rule 119--Equities
(Change in Basis from ``And Interest'' to ``Flat''); and Rule 123B--
Equities, Supplementary Material .30 (Exchange Automated Order Routing
System).
     In Rule 86--Equities (b)(2) and (c), the Exchange proposes
to replace ``NYSE MKT Bonds Limit Order'' with ``NYSE American Bonds
Limit Order''; ``NYSE MKT Bonds Reserve Order'' with ``NYSE American
Bonds Reserve Order''; ``NYSE MKT Bonds Good `Til Cancelled Order''
with NYSE American Bonds Good `Til Cancelled Order''; and ``NYSE MKT
Bonds Day Order'' with ``NYSE American Bonds Day Order.''
     The Exchange proposes to replace ``NYSE MKT Company
Guide'' with ``Company Guide'' in Rule 2210--Equities (c)(7)(N)
(Communications with the Public).
     The Exchange proposes to replace ``NYSE MKT'' with ``NYSE
American'' in Rule 3170--Equities (a)(3) (Tape Recording of Registered
Persons by Certain Firms).
     In the Trading of Options Contracts portion of the
rulebook, the Exchange proposes to replace ``NYSE MKT'' with
``Exchange'' in Section 15 (Flexible Exchange (``FLEX'') Options), Rule
900G(b) (Applicability and Definitions); Rule 903G(b)(4) and (5) (Terms
of FLEX Options); and Rule 975NY(k)(3)(A) (Nullification and Adjustment
of Options Transactions including Obvious Errors).

    None of the foregoing changes are substantive.\9\ The name change
and the above-listed changes would become operative upon the
effectiveness of an amendment to the Exchange's Certificate of
Formation, which is expected to be no later than June 30, 2017. The
Exchange will announce the name change via Trader Update.
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    \9\ The Exchange will submit subsequent rule filings as
necessary to make any technical corrections to proposed rule changes
that are pending as of the date of submission of this filing and
approved by the Commission thereafter.
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2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Exchange Act \10\ in general, and with Section
6(b)(1) \11\ in particular, in that it enables the Exchange to be so
organized as to have the capacity to be able to carry out the purposes
of the Exchange Act and to comply, and to enforce compliance by its
exchange members and persons associated with its exchange members, with
the provisions of the Exchange Act, the rules and regulations
thereunder, and the rules of the Exchange.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(1).
---------------------------------------------------------------------------

    The proposed rule change is a non-substantive change and does not
impact the governance or ownership of the Exchange. The Exchange
believes that the proposed rule change would enable the Exchange to
continue to be so organized as to have the capacity to carry out the
purposes of the Exchange Act and comply and enforce compliance with the
provisions of the Exchange Act by its members and persons associated
with its members, because ensuring that the Exchange's governing
documents, Company Guide, Price List, Fee Schedule, Market Data Fees,
Independence Policy and rulebook accurately reflect the name of the
Exchange would contribute to the orderly operation of the Exchange by
adding clarity and transparency to such documents and rules.
    For similar reasons, the Exchange also believes that the proposed
rule change is consistent with Section 6(b)(5) of the Act,\12\ in that
it is designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system and,
in general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that the proposed rule change would remove
impediments to and perfect the mechanism of a free and open market and
a national market system by ensuring that market participants can more
easily navigate, understand and comply with the Exchange's governing
documents, Company Guide, Price List, Fee Schedule, Market Data Fees,
Independence Policy and rulebook. The Exchange believes that, by
ensuring that such documents and rulebook accurately reflect the name
of the Exchange, the proposed rule change would reduce potential
investor or market participant confusion.
    The Exchange believes that the proposed changes to replace
``[Insert name of relevant NYSE U.S. Regulated Subsidiary]'' with
``NYSE American LLC'' would contribute to the orderly operation of the
Exchange by adding clarity and transparency to such document.
    Further, the Exchange believes that the proposed deletion of
footnote two of the Independence Policy would remove impediments to,
and perfect the mechanism of a free and open market and a national
market system and, in general, protect investors and the public
interest because the change would eliminate an obsolete reference to
NYSE Regulation, thereby reducing potential confusion. Market
participants and investors would not be harmed and in fact could
benefit from the increased clarity and transparency in the Independence
Policy, ensuring that market participants could more easily understand
the Independence Policy.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed rule change is
not intended to address competitive issues but rather is concerned
solely with updating the Exchange's organizational documents, Company
guide, Price List, Fee Schedule, Market Data Fees, Independence Policy
and rules to reflect its name change.

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 proposed rule change has become effective pursuant to Section
19(b)(3)(A) of the Ac t\13\ and Rule 19b-4(f)(3) \14\ thereunder in
that the proposed rule change is concerned solely with the
administration of the Exchange.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(3)(A).
    \14\ 17 CFR 240.19b-4(f)(3).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may suspend such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act. If the Commission takes such
action, the Commission shall institute proceedings under Section
19(b)(2)(B) \15\ of the Act to determine whether the proposed rule
change should be approved or disapproved.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

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-NYSEMKT-2017-14 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
All submissions should refer to File Number SR-NYSEMKT-2017-14. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the

public in accordance with the provisions of 5 U.S.C. 552, will be
available for Web site viewing and printing in the Commission's Public
Reference Room, 100 F Street NE., Washington, DC 20549 on official
business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of
the filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NYSEMKT-2017-14 and should be submitted on or before
April 17, 2017.

    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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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-05920 Filed 3-24-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 58 (Tuesday, March 26, 2019)]
[Notices]
[Pages 11305-11307]
[FR Doc No: 2019-05760]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6535]

Standards Development and the Use of Standards in Regulatory
Submissions Reviewed in the Center for Biologics Evaluation and
Research; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Standards Development
and the Use of Standards in Regulatory Submissions Reviewed in

the Center for Biologics Evaluation and Research; Guidance for
Industry.'' The guidance document provides the recommendations of the
Center for Biologics Evaluation and Research (CBER) on the use of
standards in product development and control as well as the use of such
standards in CBER's managed review process. CBER recognizes the value
of standards and encourages the use of appropriate standards in the
development and control of CBER-regulated medical products. Sponsors'
use of standards can facilitate product development and provide a more
efficient evaluation of regulatory submissions. The guidance announced
in this notice finalizes the draft guidance of the same title dated
December 2017.

DATES: The announcement of the guidance is published in the Federal
Register on March 26, 2019.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-2017-D-6535 for ``Standards Development and the Use of Standards in
Regulatory Submissions Reviewed in the Center for Biologics Evaluation
and Research; Guidance for Industry.'' Received comments will be placed
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist the office in processing
your requests. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Jonathan McKnight, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
301-796-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled
``Standards Development and the Use of Standards in Regulatory
Submissions Reviewed in the Center for Biologics Evaluation and
Research; Guidance for Industry.'' The purpose of this guidance is to
describe the recommendations of CBER on the use of standards in product
development and control as well as the use of such standards in CBER's
managed review process. CBER recognizes the value of standards and
encourages the use of appropriate standards in the development and
control of CBER-regulated medical products. Sponsors' use of standards
can facilitate product development and provide a more efficient
evaluation of regulatory submissions. This guidance does not endorse
the activities of specific Standards Development Organizations or
recommend specific standards for use in regulatory submissions.
    In the Federal Register of December 19, 2017 (82 FR 60204), FDA
announced the availability of the draft guidance of the same title
dated December 2017. FDA received several comments on the draft
guidance, and those comments were considered as the guidance was
finalized. Editorial changes were made to improve clarity. The guidance
announced in this notice finalizes the draft guidance dated December
2017.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115).

The guidance represents the current thinking of FDA on ``Standards
Development and the Use of Standards in Regulatory Submissions Reviewed
in the Center for Biologics Evaluation and Research.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 312 have been approved under
OMB control number 0910-0014; the collections of information in 21 CFR
part 314 have been approved under OMB control number 0910-0001; and the
collections of information in 21 CFR part 601 have been approved under
OMB control number 0910-0338.

III. Electronic Access

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

    Dated: March 20, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-05760 Filed 3-25-19; 8:45 am]
 BILLING CODE 4164-01-P