[Federal Register Volume 81, Number 26 (Tuesday, February 9, 2016)]
[Proposed Rules]
[Page 6813]
[FR Doc No: 2016-02422]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2015-0756; FRL-9941-10-Region 9]

Approval of California Air Plan Revisions, Yolo-Solano Air
Quality Management District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve revisions to the Yolo-Solano Air Quality Management District
(YSAQMD) portion of the California State Implementation Plan (SIP).
These revisions concern volatile organic compound (VOC) and oxides of
nitrogen (NOx) emissions from gasoline dispensing facilities and
stationary gas turbines. We are proposing to approve local rules to
regulate these emission sources under the Clean Air Act (CAA or the
Act).

DATES: Any comments on this proposal must arrive by March 10, 2016.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2015-0756 at http://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, the EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. The EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA. This proposal addresses local rules 2.22 and
2.34. In the Rules and Regulations section of this Federal Register, we
are approving these local rules in a direct final action without prior
proposal because we believe these SIP revisions are not controversial.
If we receive adverse comments, however, we will publish a timely
withdrawal of the direct final rule and address the comments in
subsequent action based on this proposed rule. Please note that if we
receive adverse comment on a particular rule, we may adopt as final
those rules that are not the subject of an adverse comment.
    We do not plan to open a second comment period, so anyone
interested in commenting should do so at this time. If we do not
receive adverse comments, no further activity is planned. For further
information, please see the direct final action.

    Dated: December 24, 2015.
Alexis Strauss,
Acting Regional Administrator, Region IX.
[FR Doc. 2016-02422 Filed 2-8-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 193 (Wednesday, October 5, 2011)]
[Notices]
[Pages 61731-61732]
[FR Doc No: 2011-25602]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4018-DR; Docket ID FEMA-2011-0001]

Iowa; 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 State of Iowa (FEMA-4018-DR), dated August 30, 2011,
and related determinations.

DATES: Effective Date: August 30, 2011.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, 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 August 30, 2011, 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 in certain areas of the State
of Iowa resulting from severe storms and flooding during the period
of July 27-29, 2011, 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 in the State of Iowa.
    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 in the
designated areas and Hazard Mitigation throughout the State.
Consistent with the requirement that Federal assistance is
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance and Hazard Mitigation will be limited to 75
percent of the total eligible costs.
    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, Michael R. Scott, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of Iowa have been designated as
adversely affected by this major disaster:

    Dubuque and Jackson Counties for Public Assistance.
    All counties within the State of Iowa are 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. 2011-25602 Filed 10-4-11; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 78, Number 21 (Thursday, January 31, 2013)]
[Rules and Regulations]
[Pages 6726-6727]
[FR Doc No: 2013-02031]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-1404; Airspace Docket No. 11-AGL-30]

Amendment of Class E Airspace; Ontonagon, MI

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Class E airspace at Ontonagon, MI.
Additional controlled airspace is necessary to accommodate new Area
Navigation (RNAV) Standard Instrument Approach Procedures at Ontonagon
County--Schuster Field Airport. Also, this action renames the airport.
The FAA is taking this action to enhance the safety and management of
Instrument Flight Rule (IFR) operations at the airport.

DATES: Effective date: 0901 UTC, May 2, 2013. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR Part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone 817-321-
7716.

SUPPLEMENTARY INFORMATION:

History

    On August 2, 2012, the FAA published in the Federal Register a
notice of proposed rulemaking (NPRM) to amend Class E airspace for the
Ontonagon, MI, area, creating additional controlled airspace at
Ontonagon County--Schuster Field Airport (77 FR 45984) Docket No. FAA-
2011-1404. Interested parties were invited to participate in this
rulemaking effort by submitting written comments on the proposal to the
FAA. No comments were received. Class E airspace designations are
published in paragraph 6005 of FAA Order 7400.9W dated August 8, 2012,
and effective September 15, 2012, which is incorporated by reference in
14 CFR 71.1. The Class E airspace designations listed in this document
will be published subsequently in the Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
Part 71 by amending Class E airspace extending upward from 700 feet
above the surface to accommodate new standard instrument approach
procedures at Ontonagon County--Schuster Field Airport, Ontonagon, MI.
This action is necessary for the safety and management of IFR
operations at the airport. The airport name is also updated from
Ontonagon County Airport to Ontonagon County--Schuster Field Airport to
coincide with the FAA's aeronautical database.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends

controlled airspace at Ontonagon County--Schuster Field Airport,
Ontonagon, MI.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, ``Environmental Impacts: Policies and
Procedures,'' paragraph 311a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of the Federal
Aviation Administration Order 7400.9W, Airspace Designations and
Reporting Points, dated August 8, 2012, and effective September 15,
2012, is amended as follows:

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface.

* * * * *

AGL MI E5 Ontonagon, MI [Amended]

Ontonagon County--Schuster Field Airport, MI
    (Lat. 46[deg]50'44'' N., long. 89[deg]22'02'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.5-mile radius of Ontonagon County--Schuster Field
Airport; and that airspace extending upward from 1,200 feet above
the surface within an area bounded by a line beginning at lat.
46[deg]38'04'' N, long. 89[deg]52'32'' W; to lat. 46[deg]43'44'' N,
long. 89[deg]53'15'' W; to lat. 46[deg]48'35'' N, long.
89[deg]50'26'' W; to lat. 47[deg]02'15'' N, long. 89[deg]14'40'' W;
to lat. 47[deg]05'33'' N, long. 89[deg]10'19'' W; to lat.
47[deg]04'11'' N, long. 89[deg]08'23'' W; to lat. 47[deg]03'51'' N,
long. 89[deg]03'48'' W; to lat. 47[deg]01'42'' N, long.
88[deg]58'43'' W; to lat. 46[deg]55'42'' N, long. 88[deg]55'25'' W;
to lat. 46[deg]51'04'' N, long. 89[deg]00'15'' W; to lat.
46[deg]45'14'' N, long. 89[deg]12'25'' W; to lat. 46[deg]35'09'' N,
long. 89[deg]37'28'' W; to lat. 46[deg]34'26'' N, long.
89[deg]44'19'' W; thence to the point of beginning.

    Issued in Fort Worth, Texas, on January 4, 2013.
David P. Medina,
Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2013-02031 Filed 1-30-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: September 25, 2008 (Volume 73, Number 187)]
[Notices]
[Page 55570-55571]
[DOCID:fr25se08-87]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-58585; File No. SR-CTA/CQ-2008-02]

Consolidated Tape Association; Order Approving the Twelfth
Substantive Amendment to the Second Restatement of the Consolidated
Tape Association Plan and the Eighth Substantive Amendment to the
Restated Consolidated Quotation Plan

September 18, 2008.

I. Introduction

    On June 19, 2008, the Consolidated Tape Association (``CTA'') Plan
and Consolidated Quotation (``CQ'') Plan participants
(``Participants'') \1\ filed with the Securities and Exchange
Commission (``Commission'') pursuant to Rule 608 \2\ under the
Securities Exchange Act of 1934 (``Act'') \3\ a proposal to amend the
CTA and CQ Plans (collectively, the ``Plans'') \4\ to: (1) Permit
ministerial amendments to the Plans to be submitted to the Commission
under the signature of the Chairman of CTA/CQ Operating Committee,
rather than by means of each Participant's execution of a Plan
amendment; (2) accommodate recent changes to the names and addresses of
certain Participants; and (3) change the Plans' references to
Commission rules to reflect the re-designation of rules by Regulation
NMS \5\ (``Amendments''). The proposed Amendments were published for
comment in the Federal Register on August 20, 2008.\6\ No comment
letters were received in response to the Notice. This order approves
the Amendments.
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    \1\ Each Participant executed the proposed amendment. The
Participants are the American Stock Exchange LLC; Boston Stock
Exchange, Inc.; Chicago Board Options Exchange, Incorporated;
Chicago Stock Exchange, Inc.; Financial Industry Regulatory
Authority, Inc., International Securities Exchange, LLC; The NASDAQ
Stock Market LLC (``NASDAQ''); National Stock Exchange, Inc.; New
York Stock Exchange LLC; NYSE Arca, Inc.; and Philadelphia Stock
Exchange, Inc.
    \2\ 17 CFR 240.608.
    \3\ 15 U.S.C. 78k-1.
    \4\ See Securities Exchange Act Release Nos. 10787 (May 10,
1974), 39 FR 17799 (order approving CTA Plan); 15009 (July 28,
1978), 43 FR 34851 (August 7, 1978) (order temporarily approving CQ
Plan); and 16518 (January 22, 1980), 45 FR 6521 (order permanently
approving CQ Plan). The most recent restatement of both Plans was in
1995. The CTA Plan, pursuant to which markets collect and
disseminate last sale price information for non-NASDAQ listed
securities, is a ``transaction reporting plan'' under Rule 601 under
the Act, 17 CFR 242.601, and a ``national market system plan'' under
Rule 608 under the Act, 17 CFR 242.608. The CQ Plan, pursuant to
which markets collect and disseminate bid/ask quotation information
for listed securities, is a ``national market system plan'' under
Rule 608 under the Act, 17 CFR 242.608.
    \5\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496 (June 29, 2005).
    \6\ See Securities Exchange Act Release No. 58358 (August 13,
2008), 73 FR 49225 (``Notice'').
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II. Description of the Proposal

    Currently, both Plans require each Participant to execute most
amendments \7\ to the Plans before the amendments can be filed with the
Commission. The Participants propose to amend the Plans to permit the
submission to the Commission of ministerial amendments to the Plans
under the signature of the Chairman of the CTA/CQ Operating Committee,
in lieu of requiring each Participant's signature indicating that it
has executed the amendment as required by Section IV(b) of the CTA Plan
and Section IV(c) of the CQ Plan.
---------------------------------------------------------------------------

    \7\ Some Plan amendments do not require a unanimous vote;
therefore not every Participant would have to execute the amendment.
---------------------------------------------------------------------------

    The categories of ministerial Plan amendments that the Participants
may submit under the signature of the Chairman include amendments to
the Plans that pertain solely to one or more of the following:
    (1) Admitting a new Participant into the Plans;
    (2) Changing the name or address of a Participant;
    (3) Incorporating a change that the Commission has implemented by
rule and that requires no conforming language to the text of the Plans
(e.g., the Commission rule establishing the Advisory Committee);
    (4) Incorporating a change (i) that the Commission has implemented
by rule, (ii) that requires conforming language to the text of the
Plans (e.g., the Commission rule amending the revenue allocation
formula), and (iii) that a majority of all Participants has voted to
approve; \8\
---------------------------------------------------------------------------

    \8\ The Commission notes that the vote of the Participants would
concern the exact wording of conforming language, but not the change
implemented by the Commission.
---------------------------------------------------------------------------

    (5) Incorporating a purely technical change, such as correcting an
error or an inaccurate reference to a statutory provision, or removing
language that has become obsolete (e.g., language regarding the
Intermarket Trading System Plan).
    In addition, the Participants propose to amend the Plans to reflect
changes in the corporate names of the Chicago Board Options Exchange,
Incorporated (formerly, Chicago Board Options Exchange, Inc.)
(``CBOE''), the Financial Industry Regulatory Authority, Inc.
(formerly, the National Association of Securities Dealers, Inc.), and
National Securities Exchange, Inc. (formerly, National Securities
Exchange), as well as changes in the street address of CBOE.
    The Participants further propose to change references in the Plans
to Commission rules to reflect the re-designation of certain Commission
rules as a result of Regulation NMS.\9\
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    \9\ See supra note 5.
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III. Discussion

    After careful review, the Commission finds that the Amendments to
the Plans are consistent with the requirements of the Act and the rules
and regulations thereunder,\10\ and, in particular, Section 11A(a)(1)
of the Act \11\ and Rule 608 thereunder \12\ in that they are necessary
or appropriate in the public interest, for the protection of investors
and the maintenance of fair and orderly markets, to remove impediments
to, and perfect the mechanisms of, a national market

system. The Commission finds that permitting the Chairman of the CTA/CQ
Operating Committee to submit ministerial amendments will increase the
efficiency of the administration of the Plans and increase the
timeliness of updating the Plans for accuracy. Additionally, the
Commission finds that the proposed Amendments streamlining the process
for admitting new Participants remove impediments to competition by
facilitating the timely admission of a new Participant to the Plans.
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    \10\ The Commission has considered the proposed amendments'
impact on efficiency, competition, and capital formation. 15 U.S.C.
78c(f).
    \11\ 15 U.S.C. 78k-1(a)(1).
    \12\ 17 CFR 240.608.
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IV. Conclusion

    It is therefore ordered, pursuant to Section 11A of the Act,\13\
and Rule 608 thereunder,\14\ that the proposed amendments to the CTA
and CQ Plans (SR-CTA/CQ-2008-02) are approved.
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    \13\ 15 U.S.C. 78k-1.
    \14\ 17 CFR 240.608.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
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    \15\ 17 CFR 200.30-3(a)(27).
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J. Lynn Taylor,
Assistant Secretary.
[FR Doc. E8-22489 Filed 9-24-08; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 80, Number 126 (Wednesday, July 1, 2015)]
[Notices]
[Pages 37625-37633]
[FR Doc No: 2015-16125]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-2044]

Authorization of Emergency Use of an In Vitro Diagnostic Device
for Detection of Enterovirus D68; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of an Emergency Use Authorization (EUA) (the Authorization)
for in an vitro diagnostic device for detection of Enterovirus D68 (EV-
D68) strains detected in North America in 2014. FDA issued this
Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C
Act), as requested by the Centers for Disease Control and Prevention
(CDC). The Authorization contains, among other things, conditions on
the emergency use of the authorized in vitro diagnostic device. The
Authorization follows the February 6, 2015, determination by the
Department of Health and Human Services (HHS) Secretary that there is a
significant potential for a public health emergency that has a
significant potential to affect national security or the health and
security of U.S. citizens living abroad and that involves EV-D68. On
the basis of such determination, the Secretary of HHS also declared on
February 6, 2015, that circumstances exist justifying the authorization
of emergency use of in vitro diagnostic devices for detection of EV-D68
subject to the terms of any authorization issued under the FD&C Act.
The Authorization, which includes an explanation of the reasons for
issuance, is reprinted in this document.

DATES: The Authorization is effective as of May 12, 2015.

ADDRESSES: Submit written requests for single copies of the EUA to the
Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a fax number to which
the Authorization may be sent. See the SUPPLEMENTARY INFORMATION
section for electronic access to the Authorization.

FOR FURTHER INFORMATION CONTACT: Carmen Maher, Acting Assistant
Commissioner for Counterterrorism Policy and Acting Director, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4347, Silver Spring, MD 20993-
0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the
Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and
All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5)
allows FDA to strengthen the public health protections against
biological, chemical, nuclear, and radiological agents. Among other
things, section 564 of the FD&C Act allows FDA to authorize the use of
an unapproved medical product or an unapproved use of an approved
medical product in certain situations. With this EUA authority, FDA can
help assure that medical countermeasures may be used in emergencies to
diagnose, treat, or prevent serious or life-threatening diseases or
conditions caused by biological, chemical, nuclear, or radiological
agents when there are no adequate, approved, and available
alternatives.
    Section 564(b)(1) of the FD&C Act provides that, before an EUA may
be issued, the Secretary of HHS must declare that circumstances exist
justifying the authorization based on one of the following grounds: (1)
A determination by the Secretary of Homeland Security that there is a
domestic emergency, or a significant potential for a domestic
emergency, involving a heightened risk of attack with a biological,
chemical, radiological, or nuclear agent or agents; (2) a determination
by the Secretary of Defense that there is a military emergency, or a
significant potential for a military emergency, involving a heightened
risk to U.S. military forces of attack with a biological, chemical,
radiological, or nuclear agent or agents; (3) a determination by the
Secretary of HHS that there is a public health emergency, or a
significant potential for a public health emergency, that affects, or
has a significant potential to affect, national security or the health
and security of U.S. citizens living abroad, and that involves a
biological, chemical, radiological, or nuclear agent or agents, or a
disease or condition that may be attributable to such agent or agents;
or (4) the identification of a material threat by the Secretary of
Homeland Security under section 319F-2 of the Public Health Service
(PHS) Act (42 U.S.C. 247d-6b) sufficient to affect national security or
the health and security of U.S. citizens living abroad.
    Once the Secretary of HHS has declared that circumstances exist
justifying an authorization under section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug, device, or biological product if
the Agency concludes that the statutory criteria are satisfied. Under
section 564(h)(1) of the FD&C Act, FDA is required to publish in the
Federal Register a notice of each authorization, and each termination
or revocation of an authorization, and an explanation of the reasons
for the action. Section 564 of the FD&C Act permits FDA to authorize
the introduction into interstate commerce of a drug, device, or
biological product intended for use when the Secretary of HHS has
declared that circumstances exist justifying the authorization of
emergency use. Products appropriate for emergency use may include
products and uses that are not approved, cleared, or licensed under
sections 505, 510(k), or 515 of the FD&C Act (21 U.S.C. 355, 360(k),
and 360e) or section 351 of the PHS Act (42 U.S.C. 262).

    FDA may issue an EUA only if, after consultation with the HHS
Assistant Secretary for Preparedness and Response, the Director of the
National Institutes of Health, and the Director of CDC (to the extent
feasible and appropriate given the applicable circumstances), FDA \1\
concludes: (1) That an agent referred to in a declaration of emergency
or threat can cause a serious or life-threatening disease or condition;
(2) that, based on the totality of scientific evidence available to
FDA, including data from adequate and well-controlled clinical trials,
if available, it is reasonable to believe that: (A) The product may be
effective in diagnosing, treating, or preventing (i) such disease or
condition; or (ii) a serious or life-threatening disease or condition
caused by a product authorized under section 564, approved or cleared
under the FD&C Act, or licensed under section 351 of the PHS Act, for
diagnosing, treating, or preventing such a disease or condition caused
by such an agent; and (B) the known and potential benefits of the
product, when used to diagnose, prevent, or treat such disease or
condition, outweigh the known and potential risks of the product,
taking into consideration the material threat posed by the agent or
agents identified in a declaration under section 564(b)(1)(D) of the
FD&C Act, if applicable; (3) that there is no adequate, approved, and
available alternative to the product for diagnosing, preventing, or
treating such disease or condition; and (4) that such other criteria as
may be prescribed by regulation are satisfied.
---------------------------------------------------------------------------

    \1\ The Secretary of HHS has delegated the authority to issue an
EUA under section 564 of the FD&C Act to the Commissioner of Food
and Drugs.
---------------------------------------------------------------------------

    No other criteria for issuance have been prescribed by regulation
under section 564(c)(4) of the FD&C Act. Because the statute is self-
executing, regulations or guidance are not required for FDA to
implement the EUA authority.

II. EUA Request for an In Vitro Diagnostic Device for Detection of EV-
D68

    On February 6, 2015, under section 564(b)(1)(C) of the FD&C Act (21
U.S.C. 360bbb-3(b)(1)(C)), the Secretary of HHS determined that there
is a significant potential for a public health emergency that has a
significant potential to affect national security or the health and
security of U.S. citizens living abroad and that involves EV-D68. Also
on February 6, 2015, under section 564(b)(1) of the FD&C Act and on the
basis of such determination, the Secretary of HHS declared that
circumstances exist justifying the authorization of emergency use of in
vitro diagnostics for detection of EV-D68, subject to the terms of any
authorization issued under section 564 of the FD&C Act. Notice of the
determination and declaration of the Secretary was published in the
Federal Register on February 27, 2015 (80 FR 10685). On April 24, 2015,
CDC requested, and on May 12, 2015, FDA issued, an EUA for the CDC EV-
D68 2014 Real-time RT-PCR Assay, subject to the terms of the
Authorization.

III. Electronic Access

    An electronic version of this document and the full text of the
Authorization are available on the Internet at http://www.regulations.gov.

IV. The Authorization

    Having concluded that the criteria for issuance of the
Authorization under section 564(c) of the FD&C Act are met, FDA has
authorized the emergency use of an in vitro diagnostic device for
detection of EV-D68 strains detected in North America in 2014 subject
to the terms of the Authorization. The Authorization in its entirety
(not including the authorized versions of the fact sheets and other
written materials) follows and provides an explanation of the reasons
for its issuance, as required by section 564(h)(1) of the FD&C Act:
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    Dated: June 25, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-16125 Filed 6-30-15; 8:45 am]
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HED has recently developed a framework that it proposes to use for conducting cumulative risk assessments on substances that have a common mechanism of toxicity. This guidance was issued for public comment on January 16, 2002 (67 FR 2210 2214) and is available fromthe OPPWebsite at: http:// www. epa. gov/ pesticides/ trac/ science/ cumulative_ guidance. pdf In the guidance, it is stated that a cumulative risk assessment of substances that cause a common toxic effect by a common mechanism will not be conducted until an aggregate exposure assessment of each substance has been completed. Before undertaking a cumulative risk assessment, HED will follow procedures for identifying chemicals that have a common mechanism of toxicity as set forth in the "Guidance for Identifying Pesticide Chemicals and Other Substances that Have a Common Mechanism of Toxicity" (64 FR 5795 5796, February 5, 1999). 43 VI. Risk Characterization The lindane risk assessment contains strengths, weaknesses, and uncertainties based on the existing toxicological and exposure data, modeling methodologies, data gaps, and gaps in scientific knowledge. This assessment uses standard assumptions regarding human body weight, work life, and other exposure parameters; and interspecies extrapolation to estimate risks. Additional assumptions were made regarding route to route extrapolation. Strengths and uncertainties of the assessment are described below.

The OPP/ Cancer Assessment Review Committee (CARC) has completed the review of newly submitted carcinogenicity study in CD 1 mice along with other data. In accordance with the EPA Draft Guidelines for Carcinogen Risk Assessment (July, 1999), the CARC has classified lindane into the category "Suggestive evidence of carcinogenicity, but not sufficient to assess human carcinogenic potential" based on an increased incidence of benign lung tumors in female mice only. The Committee, therefore, recommended that the quantification of human cancer risk is not required.

Lindane is a neurotoxicant. In acute, subchronic and developmental neurotoxicity studies, it was found to cause neurotoxic effects including tremors, convulsions, decreased motor activity, increased forelimb grip strength, hypersensitivity to touch, hunched posture and decreased motor activity habituation. There also appears to be a greater susceptibility to exposure by offspring compared to parental animals in the developmental neurotoxicity study. Lindane has also been implicated as a possible endocrine disruptor in birds, mammals and possibly fish. Further studies to ascertain the validity of such evidence is necessary to make informed risk assessment decisions.

Lindane is distributed to all organs at measurable concentrations within a few hours after oral administration. The highest concentrations are found in adipose tissue. The metabolism of lindane is initiated through one of several pathways: Dehydrogenation leading to gamma HCH, dehydrochlorination leading to formation of gamma hexchlorohexene or hydroxylation leading to formation of hexachlorocyclohexanol. Further metabolism leads to a large number of metabolites. Lindane is converted by enzymatic reactions, mainly in the liver.

Lindane appears to affect the liver and kidney in male rats when administered through the oral, dermal or inhalation routes of exposure. Kidney lesions in males indicative of alpha 2µ globulin accumulation were observed in animals treated with  10 ppm, but are not considered relevant to human health risk assessment The liver effects include: incidence of periacinar hepatocytic hypertrophy which was significantly (p  0.01) increased in male and female rats dosed at 100 ppm (4. 81 and 6.00 mg/ kg/ day, respectively). In addition, increased liver and spleen weights, and decreased platelets were also noted. 44 Lindane is not considered teratogenic when administered orally or subcutaneously. Developmental NOAELs were found to be at levels equal to or greater than maternal NOAELs, except in the developmental neurotoxicity study. The developmental neurotoxicity LOAEL was 5.6 mg/ kg/ day (NOAEL was 1. 2 mg/ kg/ day) based on reduced pup survival, decreased body weights and body weight gains during lactation, increased motor activity, and decreased motor activity habituation compared to a maternal toxicity LOAEL of 13.7 mg/ kg/ day (NOAEL is 5.6 mg/ kg/ day) based on decreased body weight gains, decreased food consumption, and increased reactivity to handling.

The data base for reproductive toxicity is considered complete. Both parental and offspring LOAELs are 13 mg/ kg; however there is a qualitative difference in the severity of effects. In the parental animals, toxicity was seen in the form of reduction in body weight gain during gestation while offspring toxicity was correlated with decreases in pup viability and pup body weight in the F1 and F2 generations as well as delayed maturation in the F2 generation. Evidence for quantitative increase in susceptibility could not be ascertained due to the wide spread in the doses tested.

In a mammalian cell gene mutation assay and an in vivo sister chromatid exchange assay, no mutagenic response was detected. These studies were classified as unacceptable. The open literature suggests, however, that technical grade HCH (hexachlorohexane; 6. 5%  HCH) may induce some mutagenic activity as evidenced in a dominant lethal mutation assay and sister chromatid exchanges. It has been noted, however, by the IPCS that lindane does not appear to have a mutagenic potential.

There are no adequate nature of the residue studies for plants from seed treatment application. A new metabolism study is required for cereal grains; however, a seed treatment metabolism study (which was classified as inadequate) was reviewed by the Agency and used in the determination of the TRR for use in the dietary exposure analysis. Additional residue data would be required if the HED MARC determines residues of concern include metabolites of lindane in addition to lindane per se. The lindane residue values were derived using a ratio of total radioactive residue divided by the amount of lindane present in the metabolism studies. This would be worstcase estimatesince we areassuming thatallofthe TRRwould be residues of concern.

The dietary exposure analyses using the total radioactive residues is a Tier 3 assessment since percent crop treated was used in the analyses. The dietary exposure analyses that were based on the adjustment of the lindane residues in the feeding studies is a Tier 3 assessment. Percent market share was available for all crops included in the analyses. Since lindane is registered for seed treatments only, there is no difference in the percent crop treated values between crops grown for the fresh market and those grown for processing. A processing study was available for canola only; the default DEEM™ processing factors were used for all other foods. 45 No acute or chronic residential use scenarios were identified for lindane; therefore, aggregate risk estimates address exposures from food and drinking water only. The lindane acute dietary risk estimates, including all sources of residues of lindane, range from 7% to 17% of the aPAD at the 99.9 th percentile of the population, with infants (< 1yr) being the highest exposed population subgroup. Thus, the acute dietary (food) risk estimate associated with lindane exposure is below the Agency's level of concern. The aggregate chronic dietary risk estimates include exposure to lindane residues in food and water. The resulting risk estimates are 3 % of the chronic PAD (% cPAD) for the U. S. Population and 11 % of the cPAD for Children 1 6 years of age (the most highly exposed population subgroup). The remaining population subgroups were <6 % of the cPAD when the total radioactive residue is adjusted using the metabolism studies. Chronic aggregate risk estimates, therefore, do not exceed HED's level of concern.

Exposure estimates for a number of occupational scenarios were derived from limited data from the submitted studies, scientific literature, and knowledge of cultural practices, in combination with models and literature studies. No residential exposure assessment was conducted by the Agency since pesticide uses have been limited to seed treatment only. The Agency considers the occupational exposure estimates to be the best available with current methodologies. The analysis indicates MOEs of concern (MOE< 100) for the following exposure scenarios/ pathways: dermal exposure from on farm seed treatment; inhalation exposure from commercial treatment (mixing/ loading/ application) of canola seed at both high and low end rates of 1. 5 and 0. 75 lb/ 100 lb seed; and inhalation exposure from commercial handling of canola treated at the high end application rate of 1. 5 lb/ 100 lb seed. All other exposure scenarios result in MOEs that are not of concern for either dermal or inhalation exposure pathways.

Volatilization appears to be an important route of its dissipation under the high temperature conditions of tropical regions. The presence of lindane in the environment, due to previous widespread agricultural use, is well documented in U. S. data bases. For example, In the U. S. EPA STORET data base, 720 detections in ground water were reported between the years 1968 and 1995, in nearly all regions of the country, with especially high numbers of detections in the South and West. For these 720 detections, the median and mean concentrations were 0.01 and 11 µg/ L, respectively. For surface waters, 8775 detections were reported with median and mean concentrations of 0.005 and 0. 18 µg/ L. STORET Detections were reported in nearly all regions of the conterminous U. S. In the USGS NAWQA study, lindane was detected in 2.58% of surface water samples (0. 67% at levels greater than 0.05 µ g/ L, maximum concentration reported was 0.13 µ g/ L). For groundwater, USGS NAWQA reported a detection frequency of 0. 1 % (0.07% at levels greater than 0.01 µ g/ L, maximum concentration reported was 0. 032 µ g/ L).

HCH and Lindane have been found in the tissues and fat of humans living in the Arctic. It appears that lindane is transported from regions where it is used to the Arctic and has been found at detectable levels in the food supply of the indigenous populations of Alaska and the Northwest Territories. Detectable levels of lindane along with other isomers of HCH have been documented in fish, elk, caribou and other aquatic and wildlife. It persists in the air, water, and 46 soil and continues to show patterns of long range atmospheric movement into areas where it has been banned or never been used. The continued worldwide use of lindane may pose an environmental, as well as a human toxicologic risk to the indigenous peoples of the Arctic.

The Indigenous Peoples of the Arctic region of the U. S. (Alaska) rely heavily on subsistence diets as their food source. Thus, it is appropriate for the Agency to perform a supplementary dietary risk and exposure assessment to assess the risk to the Indigenous People from worldwide use and manufacture of lindane. HED performed a revised supplementary chronic dietary risk and exposure assessment to assess the risk to Indigenous People from worldwide use and manufacture of lindane (T. Morton, D222455, 4/ 17/ 02). Based on this revised exposure estimate, the chronic dietary risk to male and female adult Indigenous People is below HED's level of concern. Revised estimate of risks to a 10 kg child results in an estimated chronic dietary risk to an Indigenous child (1 6 years) of 0.0002  0. 0022 mg/ kg/ day (13 to 138% cPAD). Revised estimate of chronic dietary risk to a 7 12 year old indigenous child (29 kg body weight) is 0. 00007 0. 0008 mg/ kg/ day or 4 48% of the cPAD which is below HED's level of concern. It should be noted that factors such as bioaccumulation of lindane and the cumulative effects of combinations of chemicals which act through a common mode of action have not been incorporated into this assessment. As the Agency develops its cumulative risk assessment policies, if lindane is found to share a common mode of action with other chemicals, a more comprehensive evaluation of the contribution to public risk will be initiated.

This risk assessment does not at this time include an assessment of risks from exposure to lindane from uses other than seed treatment (e. g., use of lindane to treat head lice or scabies).

VII. Data Needs Most of the Reregistration data requirements for Lindane have been fulfilled. The few remaining data requirements are described below.

A. Toxicology Data Requirements 870.3700b Prenatal developmental in rabbit 870.5300 Gene Mutation Mammalian Cell 870.5450 Dominant Lethal Assay 870.5915 In Vivo Sister Chromatid Exchange Although the prenatal developmental study in rabbits was found unacceptable, a new study is not being required at this time. The rationale for this decision is contained in the body of this document. No further genetic toxicity testing are required at this time. The mutagenic potential of lindane will be reevaluated in conjunction with the carcinogenicity review and a determination as to the need for further studies will occur at that time. 47 B. Product and Residue Chemistry Data Requirements Product Chemistry  All pertinent product chemistry data are satisfied for the Kanoria 99.5% T/ TGAIs except additional data are required concerning UV/ visible absorption (OPPTS 830.7050). Pertinent product chemistry data remain outstanding for the Inquinosa 99.5% T/ TGAI concerning product identity, starting materials and production process, preliminary analysis, certified limits, oxidation/ reduction, explodability, storage stability, corrosion characteristics, and UV/ visible absorption (OPPTS 830.1550, 1600, 1620, 1700, 1750, 6314, 6316, 6317, 6320, and 7050). These data have been submitted and are currently under review by HED (T. Morton, D276302). Technical products registered to Kanoria Chemicals & Industries were suspended effective 12/ 5/ 00 for failure to comply with a cost sharing agreement with Inquinosa. Therefore, all technicals registered which are repackages of the Kanoria products would be required to change suppliers. The Kanoria products are shown in data summary tables which are attached to the Revised Residue Chemistry Chapter (T. Morton, 12/ 11/ 01, D279259) for informational purposes only. The Prentiss, Drexel, and Amvac 99. 5% technicals are repackaged from EPA registered products, and all data requirements will be satisfied by data for the technical source products. Provided that the registrants submit the data required in the data summary tables for the lindane T/ TGAIs in the Product and Residue Chemistry Chapters (T. Morton, 279259) and either certify that the suppliers of beginning materials and the manufacturing processes have not changed since the last comprehensive product chemistry reviews or submit complete updated product chemistry data packages, the Branch has no objections to the reregistration of lindane with respect to product chemistry data requirements.

Residue Chemistry  The Agency will not require a new confined rotational crop study provided the registrants propose a 30 day plantback interval for leafy vegetables and a 12 month plantback interval for all other unregistered crops on all of their end use product labels for lindane.

 New nature of the residue study is required for application of lindane as a seed treatment to a cereal grain.

 If, after submission of an acceptable cereal grain seed treatment metabolism study, the HED Metabolism Assessment Review Committee determines the residues of concern to include metabolites in addition to lindane, additional crop field trial data, magnitude of the residue in poultry and cattle, and processing studies will be required. In addition, an adequate residue analytical method and storage stability data will be required. 48