[Federal Register Volume 77, Number 115 (Thursday, June 14, 2012)]
[Notices]
[Pages 35690-35691]
[FR Doc No: 2012-14486]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2011-M-0726, FDA-2011-M-0919, FDA-2012-M-0024, FDA-
2012-M-0056, FDA-2012-M-0074, FDA-2012-M-0075, FDA-2012-M-0082, FDA-
2012-M-0112, FDA-2012-M-0172, FDA-2012-M-0173, FDA-2012-M-0177, FDA-
2012-M-0180, FDA-2012-M-0181, FDA-2012-M-0207, FDA-2012-M-0208, FDA-
2012-M-0209, FDA-2012-M-0210, FDA-2012-M-0221, and FDA-2012-M-0250]

Medical Devices; Availability of Safety and Effectiveness
Summaries for Premarket Approval Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
premarket approval applications (PMAs) that have been approved. This
list is intended to inform the public of the availability of safety and
effectiveness summaries of approved PMAs through the Internet and the
Agency's Division of Dockets Management.

ADDRESSES: Submit written requests for copies of summaries of safety
and effectiveness data to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Please cite the appropriate docket number as listed in table
1 of this document when submitting a written request. See the
SUPPLEMENTARY INFORMATION section for electronic access to the
summaries of safety and effectiveness.

FOR FURTHER INFORMATION CONTACT: Nicole Wolanski, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 1650, Silver Spring, MD 20993-0002, 301-
796-6570.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 515(d)(4) and (e)(2) of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e(d)(4) and
(e)(2)), notification of an order approving, denying, or withdrawing
approval of a PMA will continue to include a notice of opportunity to
request review of the order under section 515(g) of the FD&C Act. The
30-day period for requesting reconsideration of an FDA action under
Sec.  10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a
PMA begins on the day the notice is placed on the Internet. Section
10.33(b) provides that FDA may, for good cause, extend this 30-day
period. Reconsideration of a denial or withdrawal of approval of a PMA
may be sought only by the applicant; in these cases, the 30-day period
will begin when the applicant is notified by FDA in writing of its
decision.
    The regulations provide that FDA publish a quarterly list of
available safety and effectiveness summaries of PMA approvals and
denials that were announced during that quarter. The following is a
list of approved PMAs for which summaries of safety and effectiveness
were placed on the Internet from January 1, 2012, through March 31,
2012. There were no denial actions during this period. The list
provides the manufacturer's name, the product's generic name or the
trade name, and the approval date.

   Table 1--List of Safety and Effectiveness Summaries for Approved PMAs Made Available From January 1, 2012,
                                             Through March 31, 2012
----------------------------------------------------------------------------------------------------------------
        PMA No., Docket No.               Applicant             Trade name                Approval date
----------------------------------------------------------------------------------------------------------------
P090012, FDA-2012-M-0074..........  Mela Sciences, Inc...  MelaFind............  November 1, 2011.
H100008, FDA-2011-M-0726..........  TriVascular, Inc.....  OVATION Abdominal     November 1, 2011.
                                                            Stent Graft System.
H090002, FDA-2011-M-0848..........  BSD Medical            BSD-2000              November 18, 2011.
                                     Corporation.           Hyperthermia System.
H100004, FDA-2011-M-0919..........  Berlin Heart, Inc....  Berlin Heart EXCOR    December 16, 2011.
                                                            Pediatric
                                                            Ventricular Assist
                                                            Device.
P110031, FDA-2012-M-0024..........  Roche Diagnostics      Elecsys Anti-HBc IgM  January 3, 2012.
                                     Corp.                  Immunoassay and
                                                            Elecsys
                                                            PreciControl Anti-
                                                            HBc IgM.
P040043.S040, FDA-2012-M-0056.....  W.L. Gore &            Gore TAG Thoracic     January 13, 2012.
                                     Associates, Inc.       Endoprosthesis.
P100039, FDA-2012-M-0075..........  Siemens Healthcare     ADVIA Centaur Anti-   January 20, 2012.
                                     Diagnostics Inc.       HBs2 Assay and
                                                            Quality Control
                                                            Material.
P100005, FDA-2012-M-0082..........  Vucomp, Inc..........  M-Vu Algorithm        January 23, 2012.
                                                            Engine.
P110016, FDA-2012-M-0112..........  St. Jude Medical,      Therapy Cool Path     January 25, 2012.
                                     Inc. (parent company   Duo/Safire BLU Duo
                                     for Irvine             Ablation Catheter
                                     Biomedical, Inc.).     and IBI 1500T9-CP
                                                            V1.6 Cardiac
                                                            Ablation Generator.
P080012, FDA-2012-M-0180..........  Flowonix Medical,      Prometra              February 7, 2012.
                                     Inc. (approved under   Programmable
                                     Medasys, Inc.).        Infusion Pump
                                                            System.
P100007, FDA-2012-M-0172..........  Almen Laboratories,    Breast Companion      February 10, 2012.
                                     Inc.                   Software System.
P100033, FDA-2012-M-0173..........  Gen-Probe Inc........  PROGENSA PCA3 Assay.  February 13, 2012.
P110013, FDA-2012-M-0177..........  Medtronic Vascular...  Resolute MicroTrac/   February 17, 2012.
                                                            Resolute Integrity
                                                            Zotarolimus-Eluting
                                                            Coronary Stent
                                                            System.
P110028, FDA-2012-M-0181..........  Abbott Vascular Inc..  Absolute Pro          February 22, 2012.
                                                            Vascular Self-
                                                            Expanding Stent
                                                            System.
P100025, FDA-2012-M-0207..........  Otsuka America         BreathTek UBT H.      February 22, 2012.
                                     Pharmaceutical, Inc.   pylori Kit and
                                                            Pediatric Urea
                                                            Hydrolysis Rate
                                                            Calculation
                                                            Application (PUHR-
                                                            CA), Version 1.0.
P100023.S015, FDA-2012-M-0208.....  Boston Scientific      ION Paclitaxel-       February 22, 2012.
                                     Corp.                  Eluting Coronary
                                                            Stent System
                                                            (Monorail and Over-
                                                            The-Wire Delivery
                                                            Systems).

P060008.S046, FDA-2012-M-0210.....  Boston Scientific      TAXUS Libert[eacute]  February 22, 2012.
                                     Corp.                  Paclitaxel-Eluting
                                                            Coronary Stent
                                                            System (Monorail
                                                            and Over-The-Wire
                                                            Delivery Systems).
P030025.S086, FDA-2012-M-0209.....  Boston Scientific      TAXUS Express2        February 22, 2012.
                                     Corp.                  Paclitaxel-Eluting
                                                            Coronary Stent
                                                            System (Monorail
                                                            and Over-The-Wire
                                                            Delivery Systems).
P110023, FDA-2012-M-0221..........  ev3, Inc.............  Everflex Self-        March 7, 2012.
                                                            Expanding
                                                            Peripheral Stent
                                                            System (Everflex).
P070004, FDA-2012-M-0250..........  Sientra, Inc.........  SIENTRA Silicone Gel  March 9, 2012.
                                                            Breast Implants.
----------------------------------------------------------------------------------------------------------------

II. Electronic Access

    Persons with access to the Internet may obtain the documents at
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm and http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/HDEApprovals/ucm161827.htm.

    Dated: June 8, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-14486 Filed 6-13-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: November 16, 2009 (Volume 74, Number 219)]
[Rules and Regulations]
[Page 58849-58851]
[DOCID:fr16no09-5]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 206

[Docket ID FEMA-2009-0007]
RIN 1660-AA01

Criminal and Civil Penalties Under the Robert T. Stafford
Disaster Relief and Emergency Assistance Act

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule.

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SUMMARY: The Federal Emergency Management Agency (FEMA) is adopting as
final, without substantive change, a proposed rule that increases the
maximum civil monetary penalty under the Robert T. Stafford Disaster
Relief and Emergency Assistance Act from $5,000 to $5,500. The Federal
Civil Penalties Inflation Adjustment Act of 1990 mandates this
increase.

DATES: This final rule is effective December 16, 2009.

FOR FURTHER INFORMATION CONTACT: Erin McMunigal, Assistant Chief
Counsel for Regulation & Policy, Federal Emergency Management Agency,
500 C Street, SW., Washington, DC 20472, (phone)<PHONE_NUMBER>, or (e-
mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The Federal Emergency Management Agency (FEMA) is adopting as
final, without substantive change, a proposed rule that increases the
maximum civil penalty under the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5157(d), (``Stafford Act''), from
$5,000 to $5,500. This increase is mandated by the Federal Civil
Penalties Inflation Adjustment Act of 1990. Public Law 101-410, 104
Stat. 890 (Oct. 5, 1990), 28 U.S.C. 2461, note, (``Adjustment Act'') as
amended by the Debt Collection Improvement Act of 1996, Public Law 104-
134, sec. 31001, 110 Stat. 1321-373 (1996), as amended, Public Law 105-
362, tit. XIII, sec. 1301(a), 112 Stat. 3293 (Nov. 10, 1998).
    The Adjustment Act, as amended, requires each Federal agency to
adjust by regulation the civil monetary penalties within its
jurisdiction. FEMA's civil penalties are mandated by section 314(d) of
the Stafford Act, which provides, ``any individual who knowingly
violates any order or regulation under this Act shall be subject to a
civil penalty of not more than $5000 for each violation.'' 42 U.S.C.
5157(d). This provision is implemented in FEMA's regulations at 44 CFR
206.14(d), promulgated in 1990. 55 FR 2288 (Jan. 23, 1990).
    The Adjustment Act directs agencies to make the first such
adjustment by October 23, 1996, and then at least once every four years
thereafter. The Adjustment Act provides a cost-of-living adjustment
formula and requires agencies to use this formula in recalculating the
penalties. The formula reflects changes in the Department of Labor's
Consumer Price Index of all-urban consumers (CPI) in the years between
adjustments. The Adjustment Act also establishes a staged method for
rounding the calculated increase, and states that the first such
increase of a civil monetary penalty may not exceed 10 percent of the
penalty. A civil penalty is to be initially adjusted by the lesser of
the Adjustment Act's calculation or 10 percent of the current penalty.
    Since the promulgation of 44 CFR 206.14(d), the CPI has increased
by nearly 80 percent. However, this final rule is FEMA's first
adjustment of its civil penalty regulations since the passage of the
Adjustment Act. As described above, the first increase may not exceed
10 percent of the original penalty amount. The original penalty amount
was $5,000, as set out in the Stafford Act and FEMA regulations, making
the maximum allowable increase $500. Thus, properly adjusted, the
maximum civil penalty under section 314(d) of the Stafford Act and 44
CFR 206.14(d) will be $5,500.

II. Discussion of Public Comments

    FEMA published a Notice of Proposed Rulemaking on February 10,
1997. 62 FR 5957. FEMA received no substantive public comments.

III. Regulatory Requirements

A. Executive Order 12866, Regulatory Planning and Review

    Under Executive Order 12866, ``Regulatory Planning and Review,'' 58
FR 51735 (Oct 4. 1993), a ``significant regulatory action'' is subject
to Office of Management and Budget (OMB) review and the requirements of
Executive Order 12866. This rule, increasing the Stafford Act's civil
monetary penalty by $500, is not a significant regulatory action, and
has not been reviewed by OMB.

B. Regulatory Flexibility Act

    Under the Regulatory Flexibility Act, 5 U.S.C. 601-612, FEMA has
considered whether this rule would have a

significant economic impact on a substantial number of small entities.
The term ``small entities'' comprises small businesses, not-for-profit
organizations that are independently owned and operated and are not
dominant in their fields, and governmental jurisdictions with
populations of less than 50,000. FEMA certifies under 5 U.S.C. 605(b)
that this final rule will not have a significant economic impact on a
substantial number of small entities, because it will only affect those
persons who knowingly violate regulations issued under the Stafford
Act.

C. Unfunded Mandates

    The Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1531-1538,
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Unfunded Mandates Reform Act
addresses actions that may result in the expenditure by a State, local,
or Tribal government, in the aggregate, or by the private sector, of
$100,000,000 or more in any one year. This rule will not have the
requisite economic impact and is not a discretionary regulatory action,
so further analysis under the Unfunded Mandates Reform Act is not
necessary.

D. Executive Order 13132, Federalism

    This rule will not have substantial direct effects on the States,
on the relationship between the National Government and the States, or
on the distribution of power and responsibilities among the various
levels of government. It will not preempt any State laws. In accordance
with Section 6 of Executive Order 13132, FEMA determines that this rule
will not have federalism implications sufficient to warrant the
preparation of a federalism impact statement.

E. National Environmental Policy Act

    FEMA's regulations implementing the National Environmental Policy
Act of 1969, 42 U.S.C. 4321 et seq., at 44 CFR 10.8(d)(2), list the
categories of actions that have no significant effect on the human
environment and are therefore categorically excluded from the
preparation of environmental impact statements and environmental
assessments. Specifically, FEMA is not required to prepare such
statements and assessments under 44 CFR 10.8(d)(2)(ii) for the
preparation, revision, and adoption of regulations, directives,
manuals, and other guidance documents related to actions that qualify
for categorical exclusions, or, under 44 CFR 10.8(d)(2)(iv) for actions
to enforce Federal, State, or local codes, standards, or regulations.
Since this rulemaking action will not have a significant effect on the
human environment, it is categorically excluded from further NEPA
review, and no environmental impact assessment has been prepared.

F. Executive Order 12898, Environmental Justice

    Executive Order 12898, Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations, requires
Federal agencies to consider the ``disproportionately high and adverse
human health or environmental effects of its programs, policies, and
activities on minority populations'' to ensure that the programs do not
``exclude persons (including populations) from participating in or
getting the benefits of, or subject them to discrimination under such
programs, policies, and activities.'' This rule does not impact human
health or the environment or discriminate according to race, color, or
national origin because it uniformly increases the civil penalty of the
Stafford Act in accordance with a statutory mandate. Therefore, the
requirements of Executive Order 12898 do not apply to this rule.

G. Congressional Review of Agency Rulemaking

    FEMA has complied with the Congressional Review of Agency
Rulemaking Act, Public Law 104-121 sec. 801, 110 Stat. 847, 868 (1996),
(``Congressional Review Act''), by sending this final rule to the
Congress and to the Government Accountability Office. Since this rule
is not a ``major rule'' within the meaning of the Congressional Review
Act, the rule becomes effective without a Comptroller General's report
or an extended time for Congressional review.

H. Paperwork Reduction Act

    The Paperwork Reduction Act, 44 U.S.C. 3501-20, is designed to
minimize the burden of collecting and distributing information on any
organization or individual affected by legislation. Implementing this
final rule does not entail the collecting or distributing of
information for the purposes of the Paperwork Reduction Act.

I. Executive Order 12630, Taking of Private Property

    This rule will not affect a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

J. Executive Order 12988, Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

K. Executive Order 13175, Consultation and Coordination With Indian
Tribal Governments

    This rule does not have Tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments.
This rule would not have a substantial direct effect on one or more
Indian Tribes, on the relationship between the Federal Government and
Indian Tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian Tribes.

List of Subjects in 44 CFR Part 206

    Administrative practice and procedure, Coastal zone, Community
facilities, Disaster assistance, Fire prevention, Grant programs--
housing and community development, Housing, Insurance,
Intergovernmental relations, Loan programs--housing and community
development, Natural resources, Penalties, Reporting and recordkeeping
requirements.

0
For the reasons stated in the preamble, the Federal Emergency
Management Agency amends 44 CFR part 206 as follows:

PART 206--FEDERAL DISASTER ASSISTANCE

0
1. The authority citation for part 206 continues to read as follows:

    Authority: Robert T. Stafford Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121 through 5207; Reorganization Plan No.
3 of 1978, 43 FR 41943, 3 CFR, 1978 Comp., p. 329; Homeland Security
Act of 2002, 6 U.S.C. 101; E.O. 12127, 44 FR 19367, 3 CFR, 1979
Comp., p. 376; E.O. 12148, 44 FR 43239, 3 CFR, 1979 Comp., p. 412;
E.O. 13286, 68 FR 10619, 3 CFR, 2003 Comp., p. 166.

0
2. Revise Sec.  206.14, paragraph (d) to read as follows:

Sec.  206.14  Criminal and civil penalties.

* * * * *
    (d) Civil penalty. Any individual who knowingly violates any order
or regulation shall be subject to a civil penalty of not more than
$5,500 for each violation.

    Dated: November 5, 2009.
W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. E9-27358 Filed 11-13-09; 8:45 am]

BILLING CODE 9111-21-P


[Federal Register Volume 79, Number 174 (Tuesday, September 9, 2014)]
[Notices]
[Pages 53494-53496]
[FR Doc No: 2014-21362]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72968; File No. SR-Phlx-2014-57]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Relating to
Common Ownership

September 3, 2014.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on August 20, 2014, NASDAQ OMX PHLX LLC (``Phlx'' or ``Exchange'')
filed with the Securities and Exchange Commission (``SEC'' or
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes proposal to harmonize the treatment of the
aggregation of activity of affiliated member organizations for the
purposes of assessing charges or credits.
    The Exchange requests that this filing become operative on December
1, 2014.
    The text of the proposed rule change is set forth below. Proposed
new language is in italics; deleted text is in brackets.

NASDAQ OMX PHLX LLC \1\ PRICING SCHEDULE

    ALL BILLING DISPUTES MUST BE SUBMITTED TO THE EXCHANGE IN WRITING
AND MUST BE ACCOMPANIED BY SUPPORTING DOCUMENTATION. ALL DISPUTES MUST
BE SUBMITTED NO LATER THAN SIXTY (60) DAYS AFTER RECEIPT OF A BILLING
INVOICE, EXCEPT FOR DISPUTES CONCERNING NASDAQ OMX PSX FEES,
PROPRIETARY DATA FEED FEES AND CO-LOCATION SERVICES FEES. AS OF JANUARY
3, 2011, THE EXCHANGE WILL CALCULATE FEES ON A TRADE DATE BASIS.

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\1\PHLX[supreg] is a registered trademark of The NASDAQ OMX Group,
Inc.
* * * * *

VIII. NASDAQ OMX PSX FEES

* * * * *

Aggregation of Activity of Affiliated Member Organizations

    (a) No Change
    (b) No Change
    (c) For purposes of this provision, the term[s set forth below
shall have the following meanings:]
    [(1) An] ``affiliate'' of a member organization shall mean any
[wholly owned subsidiary, parent, or sister of the ]member organization
under 75% common ownership or control of that [is also a ]member
organization.
    [(2) A ``wholly owned subsidiary'' shall mean a subsidiary of a
member organization, 100% of whose voting stock or comparable ownership
interest is owned by the member organization, either directly or
indirectly through other wholly owned subsidiaries.]
    [(3) A ``parent'' shall mean an entity that directly or indirectly
owns 100% of the voting stock or comparable ownership interest of a
member organization.]
    [(4) A ``sister'' shall mean an entity, 100% of whose voting stock
or comparable ownership interest is owned by a parent that also owns
100% of the voting stock or comparable ownership interest of a member
organization.]
* * * * *

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

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

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

1. Purpose
    The Exchange is proposing to amend Chapter VIII of the Pricing
Schedule to harmonize the treatment of the aggregation of activity of
affiliated member organizations for the purposes of assessing charges
or credits by making it consistent with the definition of ``Common
Ownership'' in the Preface of the Pricing Schedule which relates to
options pricing. For purposes of applying any PSX charge or credit
where the charge assessed, or credit provided, by Phlx depends upon the
volume of a member organization's activity. A member organization may
request that the Exchange aggregate its activity with the activity of
its affiliates.\3\ Therefore, for purposes of applying any PSX charge
or credit where the charge assessed, or credit provided, by Phlx
depends upon the volume of a member organization's activity, references
to an entity (including references to a ``member organization'', or a
``participant'') shall be deemed to include the entity and its
affiliates that have been approved for aggregation.\4\
---------------------------------------------------------------------------

    \3\ See Chapter VIII of the Pricing Schedule.
    \4\ Id.
---------------------------------------------------------------------------

    Currently, PSX Rules state that for purposes of applying any PSX
charge or credit where the charge assessed, or credit provided, by Phlx
depends upon the volume of a member organization's activity, a member
organization may request that the Exchange aggregate its activity with
the activity of its affiliates.\5\ The Exchange proposes to amend
Chapter VIII of the Pricing Schedule to conform that rule to that of
Phlx Options Pricing Rules so that equities and options members/member
organizations are treated consistently with respect to affiliations of
member organizations for purposes of pricing. Phlx's Options Rule
provides, ``Common Ownership'' shall mean Participants under 75 percent
common ownership or control.\6\ The Exchange desires to take the
current standard of 100 percent for equities member organizations and
align that standard to the 75 percent standard for options members and
member organizations.
---------------------------------------------------------------------------

    \5\ An ``affiliate'' of a member organization shall mean any
wholly owned subsidiary, parent, or sister of the member
organization that is also a member organization. A ``wholly owned
subsidiary'' shall mean a subsidiary of a member organization, 100
percent of whose voting stock or comparable ownership interest is
owned by the member organization, either directly or indirectly
through other wholly owned subsidiaries. A ``parent'' shall mean an
entity that directly or indirectly owns 100 percent of the voting
stock or comparable ownership interest of a member organization. A
``sister'' shall mean an entity, 100 percent of whose voting stock
or comparable ownership interest is owned by a parent that also owns
100 percent of the voting stock or comparable ownership interest of
a member organization. See Chapter VIII of the Pricing Schedule.
    \6\ See the Preface of the Pricing Schedule.
---------------------------------------------------------------------------

    Pursuant to Chapter VIII of the Pricing Schedule, a member
organization requesting aggregation of affiliate activity shall be
required to certify to the Exchange the affiliate status of entities
whose activity it seeks to aggregate prior to receiving approval for
aggregation, and shall be required to inform the Exchange immediately
of any event that causes an entity to cease to be an affiliate. In
addition, the Exchange reserves the right to request information to
verify the affiliate status of an entity.\7\
---------------------------------------------------------------------------

    \7\ See Chapter VIII of the Pricing Schedule.
---------------------------------------------------------------------------

    The Exchange intends to amend the Phlx options rules to similarly
require the certifications and approvals as noted herein. The Exchange
intends that this rule change and the options rule changes noted herein
harmonize the process by which the Exchange gathers information related
to affiliated member organizations and then in turn, for purposes of
pricing, treat both equities and options members alike with respect to
the application of aggregated pricing.
    The Exchange proposes to apply this pricing as of December 1, 2014
and issue an Options Trader Alert to its members.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \8\ in general, and furthers the objectives of Section
6(b)(5) of the Act \9\ 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,
in that the proposal will harmonize the treatment of the aggregation of
activity of affiliated member organizations for the purposes of
assessing charges or credits with the treatment of the aggregation of
activity of affiliated member organizations in relation to options
pricing so that more member organizations will be able to benefit from
lower charges and/or increased credits. The proposal will further serve
to reduce disparity of treatment between member organizations with
regards to the pricing of different services and reduce any potential
for confusion in how activity can be aggregated. The Exchange believes
the rule change avoids disparate treatment of members that have divided
their various business activities between separate corporate entities
as compared to members that operate those business activities within a
single corporate entity. By way of example, subject to appropriate
information barriers, many firms that are members of the Exchange
operate both a market making desk and a public customer business within
the same corporate entity. In contrast, other members may be part of a
corporate structure that separates those business lines into different
corporate affiliates, either for business, compliance or historical
reasons, and those affiliates are not also considered wholly owned
affiliates. Those corporate affiliates, in turn, are required to
maintain separate memberships with the Exchange. Absent the proposed
change, such corporate affiliates that cannot be considered wholly
owned but are under common control would not receive the same treatment
as members who are considered wholly owned affiliates. Accordingly, the
Exchange believes that its proposed policy is fair and equitable, and
not unreasonably discriminatory in permitting both wholly owned and
common control. In addition to ensuring fair and equal treatment of its
members, the Exchange does not want to create incentives for its
members to restructure their business operations or compliance
functions simply due to the Exchange's pricing structure.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that this proposed rule change may enable
additional equity member organizations to aggregate pricing because the
standard will be reduced from 100 percent to 75 percent for these
member organizations. There are no current equity member organizations
that would no longer be entitled to the aggregation as a result of this
rule change. Further, the Exchange seeks to harmonize the manner in
which aggregated pricing is treated on its three markets, The NASDAQ
Stock Market LLC, NASDAQ OMX BX, Inc. and Phlx and as between equities
and options, by developing one standard for aggregated pricing and one
method for collecting such information on aggregated pricing to ensure
proper validation of that pricing in the manner in which it is
occurring on Phlx for equity member organizations today.
    Today, BATS Exchange, Inc. (``BATS'') equity members are permitted
to aggregate share volume calculations for wholly owned affiliates. The
Exchange [sic] allows a member to aggregate volume with other members

that control, are controlled by, or are under common control with such
member.\10\ To the extent two or more affiliated companies maintain
separate Exchange memberships and can demonstrate their affiliation by
showing they control, are controlled by, or are under common control
with each other, the Exchange will permit such members to count overall
volume of the affiliates in calculating volume. BATS does not specify a
specific percentage for such aggregation. The Exchange is specifying 75
percent, similar to the percentage applied to Options Participants.
---------------------------------------------------------------------------

    \10\ See Securities Exchange Act Release No. 64211 (April 6,
2011), 76 FR 20414 (April 12, 2014) [sic] (SR-BATS-2011-012).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The Exchange is merely seeking
to harmonize the treatment of the aggregation of activity of affiliated
member organizations for the purposes of assessing charges or credits
with those rules contained in Chapter XV which relate to options
pricing. The Exchange also believes that certain market participants
may be able to aggregate because the standard is decreasing from 100
percent to 75 percent.

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

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A)(ii) of the Act \11\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\12\
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(a)(ii).
    \12\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) 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-Phlx-2014-57 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 SRPhlx-2014-57. 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-Phlx-2014-57 and should be
submitted on or before September 30, 2014.
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-21362 Filed 9-8-14; 8:45 am]
BILLING CODE 8011-01-P


COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE  (7/1/2006)

EPA Registration Division contact: [Julie Chao,<PHONE_NUMBER>]

INSTRUCTIONS:  Please utilize this outline in preparing tolerance
petition documents.  In cases where the outline element does not apply
please insert “NA-Remove” and maintain the outline.  The comment
notes that appear on the left margin represent hidden typesetting codes
designed to expedite the processing of the Federal Register document.
Please do not remove or alter these comment notes or change the margins,
font, or format in your document. Simply replace the instructions that
appear in italics and brackets, i.e., “[insert company name],” with
the information specific to your action.]

TEMPLATE:

[BASF Corporation]

[7F7260]

	EPA has received a pesticide petition ([7F7260]) from [BASF
Corporation], [P.O. Box 13528, Research Triangle Park, NC 27709]
proposing, pursuant to section 408(d) of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.

	1. by establishing a tolerance for residues of

	[metaflumizone] in or on the raw agricultural commodity [grape] at
[0.04] parts per million (ppm); [crop group 10: citrus fruits group] at
[0.04] ppm; [crop group 14: tree nuts group] at [0.04] ppm; and [almond
hulls] at [0.04] ppm.  EPA has determined that the petition contains
data or information regarding the elements set forth in section 408
(d)(2) of the FDDCA; however, EPA has not fully evaluated the
sufficiency of the submitted data at this time or whether the data
supports granting of the petition. Additional data may be needed before
EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism. [In three plant metabolism studies (cabbage,
tomato and cotton), the major component of the residue was
metaflumizone.  The major degradate was the ketone, M320I04 and an
oxidized and cyclized metabolite, M320I23, was present in lesser
amounts.  These four compounds were defined as the residues of concern
and were incorporated into an analytical method.  In the confined
rotational crop studies plant uptake was very limited and the residues
were a mixture of minor and polar components.]

	2. Analytical method. [BASF Analytical Method No. 531/0 was developed
to determine residues of metaflumizone and its metabolites M320I04 and
M320I23, the residues of concern in plants, and in crop matrices.  In
this method, residues of metaflumizone are extracted from plant matrices
with methanol/water (70:30; v/v) and then partitioned into
dichloromethane.  For oily matrices, the residues are extracted with a
mixture of isohexane/acetonitrile (1:1; v/v).  The final determination
of metaflumizone and its metabolites is performed by LC/MS/MS.]

	3. Magnitude of residues. [Field trials were carried out in order to
determine the magnitude of residue in grapes, citrus, and tree nuts.
Twelve field trials were conducted for grape in the US and Canada.
Twenty-three citrus trials were conducted in the US, including
grapefruit, orange and lemon.  Ten field trials were conducted in the US
on pecans and almonds.  Field trials were conducted in the required
regions for each crop.  Field trials were carried out using 4x the
maximum label rate, the maximum number of applications and the minimum
preharvest interval.  In addition, processing studies were conducted on
grapes and citrus to determine the concentration factors during normal
processing of the raw agricultural commodities.]

B. Toxicological Profile

	1. Acute toxicity.  [Based on the available acute toxicity data,
metaflumizone and its formulated product do not pose acute toxicity
risks.  For metaflumizone:

Oral LD50                 Rat	      LD50 > 5000 mg/kg b.w.
category IV  TC \l5 "

Oral LD50                 Mouse	      LD50 > 5000 mg/kg b.w.
category IV

Dermal LD50            Rat	      LD50 > 5000 mg/kg b.w.        category
IV

Inhalation LC50       Rat	      > 5.2 mg/L
category IV

Eye Irritation           Rabbit	      Not irritating
     category IV

Skin Irritation          Rabbit	      Not irritating
     category IV

Skin Sensitization    Guinea pig   Not sensitizing (Maximization Test)]

	2. Genotoxicty. [In a battery of three in vitro and two in vivo
mutagenicity assays consisting of all required end-points (point
mutation, chromosomal damage, and DNA damage and repair), the
weight-of-the-evidence for metaflumizone indicates a lack of potential
genotoxicity.

Specifically, for the battery of three in vitro mutagenicity assays with
metaflumizone, no positive responses were observed for increased
revertant frequencies with and without metabolic activation [bacterial
reverse mutation assay] or for increased mutant frequencies with and
without metabolic activation [HGPRT locus assay].  Although there was a
positive result for a statistically increased number of structurally
aberrant metaphases in the chromosomes, which indicates clastogenic
potential under in vitro conditions, this result was only observed
without metabolic activation [cytogenicity study with V79 cells.

Importantly, the potential biological significance of this apparent
chromosome damage observed in vitro only without metabolic activation,
was evaluated in vivo using the mouse micronucleus assay.  Testing in
the in vivo micronucleus study with NMRI mice was conducted at a high
dose level (2000 mg/kg b.w.) that demonstrated clinical symptoms of
toxicity, including piloerection and poor general state, in 5 of 5
animals.  No significant or dose-related increases in chromosomal damage
were observed in this in vivo test, indicating that metaflumizone does
not cause chromosomal aberrations in intact animals.

Moreover, it has also been recognized by U.S. EPA that more weight
should be placed on in vivo systems than in vitro systems as expressed
in the Agency’s weight-of-evidence for genotoxic evaluation of a
chemical included in the "Guidelines for Mutagenicity Risk Assessment"
(Federal Register, September 24, 1986, Vol. 51: 34006-34012).  Thus, the
negative in vivo results (non-clastogenicity for chromosomal
aberrations) observed in the mouse micronucleus assay and the rat
hepatocytes assay, should override the positive results obtained in the
in vitro assay only without metabolic activation.  Furthermore, it has
been noted that in vitro systems may simulate abnormal physiological
conditions from prolonged exposure to a chemical in the absence of S-9
metabolic activation [Brusick, D.J. (editor) 1987. Genotoxicity Produced
in Cultured Mammalian Cell Assay by Treatment Conditions. Mutation
Research, Vol. 189, No.1: 1-69] and [Sofuni, T. 1993. Japanese
Guidelines for Mutagenicity Testing. Environmental and Molecular
Mutagenesis, Vol. 21, No.1: 2-7].  Consequently, based on the
weight-of-the-evidence presented above, metaflumizone does not pose a
genotoxic concern.]

	3. Reproductive and developmental toxicity. [Potential reproductive
toxicity of metaflumizone was investigated in a two-generation
reproduction toxicity study in Wistar rats by oral gavage
administration.  Originally, the highest dose tested by oral gavage was
75 mg/kg b.w../day, which induced both excessive maternal toxicity (very
high incidences of poor general health in females during premating,
gestation, and lactation; and statistically decreased food consumption,
body weights, and body weight gain) as well as excessive developmental
toxicity (statistically impaired pup body weights and body weight gain),
which altogether resulted in high pup mortality.  Consequently, a
meaningful assessment of the potential reproductive toxicity of the test
compound at this excessively toxic dose level was not possible.
Thereafter, for the next two successive parental generations of rats,
which were originally derived from the parents treated at 75 mg/kg
b.w./day, the highest dose tested was 50 mg/kg b.w./day.

Subsequently, the NOAEL for parental toxicity was 20 mg/kg b.w./day,
based on the following effects for females at 50 mg/kg b.w./day (highest
dose tested for two consecutive generations) -- increased incidences of
poor general health in females during premating, gestation, and
lactation; 3 of 25 dams with complete litter losses; and statistically
significantly reduced body weights during premating, gestation, and
lactation.

The NOAEL for offspring/pup toxicity was 20 mg/kg b.w./day, based on a
slight increased incidence of pup mortality at 50 mg/kg b.w./day.
Whereas the NOAEL for fertility in this study was 50 mg/kg b.w./day
(highest dose tested for two generations), the NOAEL for reproductive
performance was considered to be 20 mg/kg b.w./day, based on 3 of 25
dams with complete litter losses, of which 2 of these 3 dams had
indications of poor nursing for their first generation of pups.  It is
noteworthy that because most of the pup mortality was due to poor
nursing in only 2 of 25 dams, this finding may be considered to be
incidental.  Importantly, no comparable impairment of reproductive
performance occurred for the succeeding parental generation treated by
oral gavage administration at 50 mg/kg b.w./day.

In a developmental (teratology) toxicity study in the Wistar rat, the
results indicated that the NOAEL for maternal toxicity was 40 mg/kg
b.w./day, based on statistically decreased food consumption and body
weight gains at 120 mg/kg b.w./day (highest dose tested).  The NOAEL for
fetal (prenatal)/developmental toxicity was 120 mg/kg b.w./day (highest
dose tested).  In addition, there were no indications of any teratogenic
effects in the rat fetuses at 120 mg/kg b.w./day (highest dose tested).
Therefore, metaflumizone is considered to be neither a developmental
toxicant nor a teratogenic agent in the rat.

In a developmental (teratology) toxicity study in the Himalayan rabbit,
the results indicated that the NOAEL for maternal toxicity was 100 mg/kg
b.w./day, based on several clinical symptoms of toxicity (including
ataxia and poor general state) occurring in 4 of 25 does at 300 mg/kg
b.w./day, for which 2 of these 4 does had abortions prior to being
sacrificed early, with a third doe at 300 mg/kg b.w./day being
sacrificed moribund.  Similarly, the NOAEL for fetal (prenatal) /
developmental toxicity was 100 mg/kg b.w./day, based on slightly
decreased mean fetal body weights as well as an increased rate for a
certain skeletal variation, namely incomplete ossification of
sternabrae.  Because developmental toxicity was only observed at dose
levels that were maternally toxic, metaflumizone is not selectively
toxic to the fetal rabbit.

Lastly, in this rabbit developmental toxicity study, there were no
indications of any teratogenic effects in the rabbit fetuses at 300
mg/kg b.w./day (highest dose tested).  Therefore, metaflumizone is not
teratogenic in the rabbit.]

	4. Subchronic toxicity. [In the Sprague-Dawley rat, treatment by oral
gavage with metaflumizone for a subchronic duration (90-day timepoint in
the chronic toxicity/carcinogenicity study) resulted in reduced food
consumption and/or decreased mean body weight and/or body weight gains
in males and females at 300 mg/kg b.w./day and in increased incidences
of hepatocellular centrilobular hypertrophy in the livers of males at
300 mg/kg b.w./day.  Under the conditions of the study, the NOAEL for
oral administration of metaflumizone for 90 days was 60 mg/kg b.w./day.

In the beagle dog, treatment by oral gavage with metaflumizone for a
subchronic duration (90-day timepoint in the chronic toxicity study)
resulted in reduced body weight gain and/or decreased food consumption
in several dogs at 30 mg/kg b.w./day and slightly decreased mean MCHC at
30 mg/kg b.w./day.  Under the conditions of the study, the NOAEL for
oral administration of metaflumizone for 90 days was 12 mg/kg b.w./day.

For a subchronic (90-day) dermal toxicity study conducted with
metaflumizone in Wistar rats, the results support a NOAEL of 100 mg/kg
b.w./day, based on decreased food consumption (females) and decreased
body weight gain in males and females at 300 mg/kg b.w./day, the next
highest dose tested.  Several microscopic changes were observed in
female animals at 300 mg/kg b.w./day and above, but these morphologic
changes were regarded to be indirect effects of the impaired body weight
gain.

For a subacute (28-day) inhalation toxicity study conducted with
metaflumizone in Wistar rats, the results support a NOAEL of 0.03 mg/L,
based on decreased food consumption (females) and decreased body weight
/ body weight gain (females) and several microscopic changes in the
respiratory tract at 0.10 mg/L, the next highest dose tested.  Several
microscopic changes in non-respiratory tract tissues were observed in
animals at these two dose levels, but these morphologic changes were
regarded to be indirect effects of the impaired body weight / body
weight gain.

Testing for metaflumizone’s potential immunotoxicity, two studies were
conducted, namely “28-Day Oral Immunotoxicity Study [by
Thymic-Dependent Antibody Response (TDAR) Assay] in the Female Wistar
Rat”  and  “28-Day Oral Immunotoxicity Study [by Natural Killer (NK)
Cell Assay] in the Female Wistar Rat.”   Results from both studies
indicate a lack of immunotoxic potential for metaflumizone (BAS 320 I)
up to the highest dose tested (HTD).  Both Study Reports have been
submitted to U.S. EPA (in 2011).

	5. Chronic toxicity. [In the Sprague-Dawley rat, treatment by oral
gavage with metaflumizone for a 2-year chronic duration resulted in
dose-related increased incidences of hepatocellular centrilobular
hypertrophy in the livers of males and females at 60 mg/kg b.w./day and
at 300/200 mg/kg b.w./day and hepatocellular basophilic alteration in
males at 60 and 300 mg/kg b.w./day.  [NOTE:  Beginning the first day of
Week 3, the dose level of the high-dose females was lowered from 300 to
200 mg/kg b.w./day, due to an adverse effect of -71% decreased body
weight gain as compared to controls.]

Therefore, the no-observable-adverse-effect-level (NOAEL) for systemic
toxicity following oral administration of metaflumizone for 24 months to
Sprague-Dawley rats was 30 mg/kg b.w./day for males and females.
Importantly, treatment with metaflumizone to rats for 2 years resulted
in no test substance-related neoplastic findings, and therefore, the
NOAEL for oncogenicity was 300/200 mg/kg b.w./day (highest dose tested).

In the CD-1 mouse, treatment by oral gavage with metaflumizone for an
18-month chronic duration resulted in a treatment-related increased
incidence of increased brown pigment in the spleens of male and female
animals administered 1000 mg/kg b.w./day (highest dose tested), as
compared to controls.  Under the conditions of the study, the NOAEL for
systemic toxicity following oral administration of metaflumizone for 18
months to CD-1 mice was 250 mg/kg b.w./day (the next highest dose
tested) for males and females.  Importantly, treatment with
metaflumizone to mice for 18 months resulted in no test
substance-related neoplastic findings, and therefore, the NOAEL for
oncogenicity was 1000 mg/kg b.w./day (highest dose tested).

In the beagle dog, treatment via gelatin capsules with metaflumizone for
a 12-month chronic duration resulted in reduced body weight gain and/or
decreased food consumption in several dogs at 30 mg/kg b.w./day and
slightly decreased mean MCHC at 30 mg/kg b.w./day.  Under the conditions
of the study, the NOAEL for oral administration of metaflumizone for 12
months was 12 mg/kg b.w./day.

Threshold Effect.  For estimated chronic exposure, the calculation of
the chronic reference dose (chronic RfD) is based on the results of the
chronic toxicity studies in the rat, mouse, and dog, and the
two-generation reproduction study in the rat.  For metaflumizone, the
lowest NOAEL for chronic toxic effects is 12 mg/kg b.w./day from the
12-month dog study.  A safety factor of 100 is applied to the NOAEL of
12 mg/kg b.w./day, which results in a chronic RfD of 0.12 mg/kg
b.w./day.

Non-Threshold Effect.  Since there were no test substance-related
neoplastic findings following long-term treatment with metalfumizone to
mice for 18 months or to rats for 24 months, the NOAEL for oncogenicity
in both studies was established at the respective highest doses tested.
Therefore, metaflumizone should be classified as "not likely to be a
human carcinogen."]

	6. Animal metabolism. [In the rat, goat and hen metabolism studies, the
majority of the dose was rapidly excreted in the feces.  The low levels
that were absorbed were distributed throughout various tissues.
Metaflumizone was the major component of the extractable residues in all
tissues, milk, eggs and is the only residue of concern.  Metabolism of
metaflumizone occurs by hydroxylation and conjugation on either of the
phenyl rings or at the ethylene bridge and are the major routes of
detoxification.  Cleavage of the semicarbazide bond to yield M320I04
also occurs, usually with accompanying conjugation.  The only residue of
concern is metaflumizone.]

	7. Metabolite toxicology. [Toxicity of the metabolites of metaflumizone
with potential exposure to humans was concurrently evaluated during
toxicity testing of the parent except for the metabolite M320I23 that
was not observed in the rat metabolism study.  The Z-isomer (M320I02) of
metaflumizone was evaluated in additional toxicity tests to confirm no
differences between the minor Z-isomer component and metaflumizone with
a 9 to 1 E-isomer to Z-isomer ratio, respectively.  The results show no
toxicological concerns:

Toxicity Studies with the metabolite M320I23 of metaflumizone

(a)  Acute Toxicity Study with Metabolite M 320I023

The metabolite M 320I023 of metaflumizone demonstrates low acute
toxicity via the oral route of exposure in the rat.

Oral LD50  > 2000 mg/kg b.w. (category III).

(b)  Subchronic Toxicity Study with Metabolite M 320I023

In the Sprague-Dawley rat, treatment by oral gavage with metabolite M
320I023 of metaflumizone for a subchronic (90-day) duration resulted in
systemic toxicity effects of increased relative liver weights (females)
and increased incidences of liver hepatocellular centrilobular
hypertrophy in males and females at 1000 mg/kg b.w./day (highest dose
tested), as compared to controls.  Under the conditions of the study,
the NOAEL for oral administration of the metabolite M 320I023 of
metaflumizone for 90 days was 200 mg/kg b.w./day (next highest dose
tested) in males and females.

(c)  Mutagenicity/Genotoxicity Studies with Metabolite M 320I023

In a battery of three in vitro and one in vivo mutagenicity assays
consisting of all required end-points (point mutation, chromosomal
damage, and DNA damage and repair), the weight-of-the-evidence for the
metabolite M 320I023 (parent ketone) of metaflumizone insecticide
indicates a lack of potential genotoxicity.

Specifically, for the battery of three in vitro mutagenicity assays with
metabolite M 320I023 of metaflumizone, no positive responses were
observed for increased revertant frequencies with and without metabolic
activation [bacterial reverse mutation assay] or for increased mutant
frequencies with and without metabolic activation [HGPRT locus assay].
Although there was a positive result for a statistically increased
number of structurally aberrant metaphases in the chromosomes, which
indicates clastogenic potential under in vitro conditions, this result
was only observed with metabolic activation [cytogenicity study with V79
cells].

Importantly, the potential biological significance of this apparent
chromosome damage observed in vitro only with metabolic activation, was
evaluated in vivo using the mouse micronucleus assay.  Testing in this
in vivo micronucleus study with NMRI mice was conducted at a high dose
level (2000 mg/kg b.w.), that demonstrated no clinical symptoms of
toxicity but which represents the limit dose for this assay.  No
significant or dose-related increases in in vivo chromosomal damage were
observed, indicating that the metabolite M 320I023 of metaflumizone does
not cause chromosomal aberrations in intact animals.

Moreover, it has also been recognized by U.S. EPA that more weight
should be placed on in vivo systems than in vitro systems as expressed
in the Agency’s weight-of-evidence for genotoxic evaluation of a
chemical included in the "Guidelines for Mutagenicity Risk Assessment"
(Federal Register, September 24, 1986, Vol. 51: 34006-34012).  Thus, the
negative in vivo results (non-clastogenicity for chromosomal
aberrations) observed in the mouse micronucleus assay should override
the positive results obtained in the in vitro assay only with metabolic
activation.  Furthermore, it has been noted that in vitro systems may
simulate abnormal physiological conditions [Brusick, D.J. (editor) 1987.
Genotoxicity Produced in Cultured Mammalian Cell Assay by Treatment
Conditions. Mutation Research, Vol. 189, No.1: 1-69].  Additionally, it
has been reported in the literature that S-9 metabolic activation does
not often have adequate cofactors for activating detoxifying mechanisms
found in the whole animal system [Ashby, J. 1983. The unique role of
rodents in the detection of possible human carcinogens and mutagens.
Mutation Research, Vol. 115: 117-213] [Galloway, S.M. 1994. Chromosome
Aberrations Induced In Vitro:  Mechanisms. Delayed Expression, and
Intriguing Questions.  Environmental and Molecular Mutagenesis, Vol. 23,
Supplement 24: 44-53].  Consequently, based on the
weight-of-the-evidence presented above, the metabolite M 320I023 of
metaflumizone does not pose a genotoxic concern.

Therefore, as indicated from the results of the mammalian toxicity
studies as well as the mutagenicity assays, metabolite M 320I023 of
metaflumizone does not demonstrate more adverse toxicity when compared
to metaflumizone.

Toxicity Studies with the Z-Isomer of metaflumizone

(a)  Acute Toxicity Study with Z-Isomer

The Z-isomer of metaflumizone demonstrates low acute toxicity via the
oral route of exposure in the rat.

Oral LD50 > 5000 mg/kg b.w. (category IV).

(b)  Subchronic Toxicity Study with Z-Isomer

In the Sprague-Dawley rat, treatment by oral gavage with the Z-isomer of
metaflumizone for a subchronic (90-day) duration resulted in impaired
body weight gain only in females at the mid-dose (300 mg/kg b.w./day)
and the high-dose (1000 mg/kg b.w./day), as compared to controls.
Several microscopic changes were observed in female animals at these two
dose levels, but all morphologic changes were regarded to be indirect
effects of the impaired body weight gain.  Under the conditions of the
study, the NOAEL for oral administration of the Z-isomer of
metaflumizone for 90 days was 1000 mg/kg b.w./day (highest dose tested)
in males and 100 mg/kg b.w./day (lowest dose tested) in females.

(c)  Mutagenicity/Genotoxicity Study with Z-Isomer

In an in vitro mutagenicity assay with the Z-isomer of metaflumizone,
there were no positive responses observed for increased revertant
frequencies with and without metabolic activation [bacterial reverse
mutation assay].

Therefore, as indicated from the results of the mammalian toxicity
studies as well as the mutagenicity assay, the minor isomer of
metaflumizone, namely the Z isomer, does not demonstrate more adverse
toxicity when compared to metaflumizone.]

	8. Endocrine disruption. [Data from the reproduction / developmental
toxicity and short-and long-term repeated dose toxicity studies with
metaflumizone in the rat, rabbit, mouse, or dog, do not suggest any
endocrine disruption activity.  This information is based on the absence
of any treatment-related effects from the histopathological examination
of reproductive organs as well as a low level of concern for possible
effects on fertility, reproductive performance, or any other aspect of
reproductive function, or on growth and development of the offspring.]

C. Aggregate Exposure

	1. Dietary exposure.

Food. [

Metaflumizone and its metabolites (M320I04, M320I23) are expressed as
the parent compound (metaflumizone).  A dietary exposure analysis was
conducted for grape, crop group 10 – citrus fruits group, crop group
14 – tree nuts group at the tolerance of 0.04 ppm.

Acute Dietary Food Exposure:  The Health Effects Division (HED) of EPA
has determined that there are no toxic effects attributable to a single
dose of metaflumizone for the general populations including infants and
children.  Therefore, a quantitative acute dietary exposure and risk
assessment for these sub-populations is not required.

Acute dietary assessments were conducted to evaluate the potential risk
due to acute dietary exposure to females 13 – 49 years old.  The ARfD
for metaflumizone is 1.0 mg/kg bw/day.  The FQPA safety factor for
metaflumizone has been set to 1.  Therefore, the aPAD is 1.0 mg/kg
bw/day.  The tier 1 acute dietary exposure estimates were based on the
proposed tolerance values, 100 percent crop treated values,
concentration/processing factors and consumption data from the USDA
Continuing Survey of Food Intake by Individuals (CSFII 1994 - 1996,
1998) and the EPA Food Commodity Ingredient Database (FCID) using
Exponent's Dietary Exposure Evaluation Module (DEEM-FCID) software.
Drinking water exposure was included in the dietary exposure analysis.
Tolerances for meat, milk, egg, and poultry are not required.

Exposure estimates for the metaflumizone acute dietary assessments were
well below U.S. EPA’s level of concern (See tables below).  The
estimated acute dietary exposure for females 13 – 49 years old was
0.03 %.  Additional refinements such as the use of anticipated residues
and predicted percent crop treated would further reduce the estimated
acute dietary exposure.

Table 1. Summary of Acute Dietary Exposure and Risk for Metaflumizone
Considering Grape, Crop Group 10 – Citrus Fruits Group, Crop Group 14
– Tree Nuts Group and Drinking Water.

Population	Exposure Estimate	%aPAD

Subgroups	(mg/kg b.w./day)

Females (13-49 years old)	0.000301	0.03

aPAD = acute population adjusted dose (aPAD = 1.0 mg/kg bw/day)

Chronic Dietary Food Exposure:

A tier 1 dietary exposure assessment was conducted for all
sub-populations including infants and children.  The ADI for
metaflumizone is 0.12 mg/kg bw/day.  The FQPA safety factor for
metaflumizone has been set to 1.  Therefore, the cPAD is 0.12 mg/kg
bw/day.  The tier 1 chronic dietary exposure estimates were based on the
proposed tolerance values, 100 percent crop treated values,
concentration/processing factors and consumption data from the USDA
Continuing Survey of Food Intake by Individuals (CSFII 1994 - 1996,
1998) and the EPA Food Commodity Ingredient Database (FCID) using
Exponent's Dietary Exposure Evaluation Module (DEEM-FCID) software.
Drinking water exposure was included in the dietary exposure analysis.
Tolerances for meat, milk, egg, and poultry are not required.

Exposure estimates for the metaflumizone chronic dietary assessments
were well below U.S. EPA’s level of concern (See tables below.  The
most highly exposure sub-group was children 1-2 years old and the
exposure accounted for 0.25% of the cPAD.  Additional refinements such
as the use of anticipated residues and predicted percent crop treated
would further reduce the estimated chronic dietary exposure.

Table 2.  Summary of Chronic Dietary Exposure and Risk for Metaflumizone
Considering Grape, Crop Group 10 – Citrus Fruits Group, Crop Group 14
– Tree Nuts Group,  and Drinking Water.

Population	Exposure Estimate	%cPAD

Subgroups	(mg/kg b.w./day)

U.S. Population	0.015792	0.07

All Infants (< 1 year old)	0.008408	0.05

Children (1-2 years old)	0.019314	0.25

Children (3-5 years old)	0.019165	0.19

Children (6-12 years old)	0.01567	0.10

Youth (13-19 years old)	0.013229	0.16

Females (13-49 years old)	0.016063	0.05

Adults (20-49 years old)	0.015845	0.05

Adults (50+ years old)	0.016113	0.05

cPAD = chronic  population adjusted dose (cPAD = 0.12 mg/kg bw/day)]

	ii. Drinking Water. [The estimated drinking water concentrations
(EDWCs) used in this assessment were from the HED human health
assessment of metaflumizone, January 26, 2010.  The EDWC values were
calculated using the highest application rate (4 x 0.002 lb ai/acre).
The acute and chronic surface water EDWCs were 0.0399 and 0.0157 ppb,
respectively.  The acute and chronic ground water EDWC was 2.64 x 10-5
ppb.  The drinking water exposure was included in the dietary
assessment.   ]

	2. Non-dietary exposure. [

Metaflumizone is registered for fire ant bait.  This use can result in
residential exposure.  The EPA HED has evaluated these uses and
determined the exposure.  The exposure and MOE values in the below
tables are from the HED document January 24, 2006.   The MOE values were
calculated using the a short-term dermal NOAEL = 100 mg ai/kg bw/day and
short-term incidential oral NOAEL = 20 mg ai/kg bw/day.  The calculated
MOEs for all homeowner and toddler exposures are greater than 100 and
therefore do not exceed EPA’s level of concern.

Table 3.  Summary of Residential and Recreational Post-Application
Exposure and Risks from use of Fire Ant Bait.

Fire Ant Bait	mg/kg bw/day	MOE

Toddler oral hand to mouth (turf grass)	0.000015	1333333

Toddler oral ingestion of granules	0.013	1538

Toddler oral object to mouth (turf)	0.00000093	21505376

Adult dermal pos-app (Res. Turf)	0.000232	431034

Toddler dermal post-app (Res. Turf)	0.00039	256410

Adult golfer dermal post-app (turf)	0.000016	6250000

Child golfer dermal post-app (turf)	0.0000272	3676471

Toddler oral (hand to mouth + object to mouth)	0.000016	1250000

	3. Aggregate exposure.

[Acute Aggregate Risk:

No acute residential/recreational exposure are expected.  The acute
aggregate risk includes only exposure from food and water.  The food and
drinking water exposure accounts for less than 1 % aPAD which is below
HED’s level of concern.

Short-/Intermediate Term Aggregate Risk:

There is the potential for short-term, non-dietary exposure of children
and adults to metaflumizone from the use as fire ant bait.   Therefore,
the short-term aggregate exposure includes residential exposure, food
and water exposure.   The target MOE for metaflumizone aggregate risk is
100.

Table 7.  Summary of Short-/Intermediate Term Aggregate Risk from Fire
Ant Bait Use.

	Food + water	Non-dietary oral	Dermal	Aggregate

Population Sub-Group	MOE	MOE	MOE	MOE

US population	250,000	NA	431,034	158,228

All infants (< 1 yr old)	322,581	1333333	256,410	129,032

Children 1-2	65,574	1333333	256,410	50,251

children 3-5	90,090	1333333	256,410	63,492

Children 6-12	166,667	NA	3,676,471	159,439

Youth 13-19	285,714	NA	3,676,471	265,111

Adults 20-49	363,636	NA	431,034	197,239

Adults 50 + years	338,983	NA	431,034	189,753

The aggregate MOE values are all greater than the HED level of concern
which indicates that the aggregate use is below HED’s level of
concern.

Chronic Aggregate Risk:

No chronic residential/recreational exposure are expected.  The chronic
aggregate risk includes only exposure from food and water.  The chronic
food and drinking water exposure for all sub-populations are below
HED’s level of concern.  ]

D. Cumulative Effects>  [Section 408(b)(2)(D)(v) requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances that
have a common mechanism of toxicity.

The EPA is currently developing methodology to perform cumulative risk
assessments.  At this time, there is no available data to determine
whether metaflumizone has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment.]

E. Safety Determination

	1. U.S. population. [Using the conservative exposure assumptions
described above and based on the completeness and the reliability of the
toxicity data, BASF has estimated the aggregate exposure to
metaflumizone are well below the EPA’s level of concern.  ]

	2. Infants and children. [All subpopulations based on age were
considered. Infants and children aggregate risk is well below remained
below  EPA’s level of concern.  BASF, considering a worst-case
situation, concludes with reasonable certainty that no harm will result
to infants or children from aggregate exposure to metaflumizone
residues.]

F. International Tolerances

	[Maximum residue levels (MRLs) have been established for metaflumizone
by the Codex Alimentarius Commision (CODEX) in potato, tomato, pepper,
eggplant, Brussels sprout, Chinese cabbage, lettuce, and animal
products.  Harmonized EU MRLs have been established for metaflumizone in
potato, tomato, pepper, eggplant, leafy brassica, Brussels sprout,
lettuce and similar, and animal products.

Codex (based on parent only)

Potato	0.02

Tomato	0.6

Pepper, inc chili pepper	0.6

Eggplant	0.6

Brussels sprout	0.8

Chinese cabbage	6

Lettuce	7

Swine (all)	0.02

Bovine (meat, kidney, liver, fat, offal)	0.02

Sheep, goat (meat, kidney, liver, fat, offal)	0.02

Milk	0.01

Cream	0.02

EU harmonized (based on parent + M320I04)

Potato	0.05

Tomato	0.6

Pepper, inc chili pepper	1

Eggplant	0.6

Brussels sprout	1

Head cabbage	1

Leafy brassica	6

Lettuce and similar except scarole	10

Swine (all)	0.02

Bovine (meat, kidney, liver, fat, offal)	0.02

Sheep, goat (meat, kidney, liver, fat, offal)	0.02

Poultry (meat, liver, kidney, offal)	0.02

Poultry fat	0.1

Milk and cream	0.02

Eggs	0.02

]


[Federal Register: January 25, 2007 (Volume 72, Number 16)]
[Notices]
[Page 3389-3390]
[DOCID:fr25ja07-31]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2005-0012; FRL-8273-4]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; Questionnaire for the Chlorine
and Chlorinated Hydrocarbon Manufacturing Segments; EPA ICR No. 2214.01

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that an Information
Collection Request (ICR) has been forwarded to the Office of Management
and Budget (OMB) for review and approval. This is a request for a new
collection. The ICR, which is abstracted below, describes the nature of
the information collection and its estimated burden and cost.

DATES: Additional comments may be submitted on or before February 26,
2007.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OW-
2005-0012, to (1) EPA online using http://www.regulations.gov (our preferred method), by e-mail to<EMAIL_ADDRESS>or by mail to: EPA Docket

Center, Environmental Protection Agency, Water Docket, Mail Code:
4101T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and (2) OMB
by mail to: Office of Information and Regulatory Affairs, Office of
Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th
Street, NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Samantha Lewis, Office of Water,
Engineering and Analysis Division, (4303T), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone
number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On April 18, 2006 (71 FR 19887), EPA sought comments on this
ICR pursuant to 5 CFR 1320.8(d). EPA received 4 comments during the
comment period, which are addressed in the ICR. Any additional comments
on this ICR should be submitted to EPA and OMB within 30 days of this
notice.
    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OW-2005-0012, which is available for online viewing at
http://www.regulations.gov, or in person viewing at the Water Docket in

the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution
Ave., NW., Washington, DC. The EPA/DC Public Reading Room is open from
8 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.
The telephone number for the Reading Room is<PHONE_NUMBER>, and the
telephone number for the Water Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at
http://www.regulations.gov, to submit or view public comments, access the

index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov as EPA receives

them and without change, unless the comment contains copyrighted
material, CBI, or other information whose public disclosure is
restricted by statute. For further information about the electronic
docket, go to http://www.regulations.gov.

    Title: Questionnaire for the Chlorine and Chlorinated Hydrocarbon
Manufacturing Segments.
    ICR numbers: EPA ICR No. 2214.01.

    ICR Status: This ICR is for a new information collection activity.
An Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information, unless it displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR part 9, are displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control numbers in certain EPA regulations is
consolidated in 40 CFR part 9.
    Abstract: The U.S. Environmental Protection Agency is conducting a
census of facilities that manufacture chlorine and/or certain
chlorinated hydrocarbons (CCH) as part of its effort to review the
effluent limitations guidelines and standards for these operations. EPA
is considering revision of the Organic Chemicals, Plastics and
Synthetic Fibers Point Source Category regulations at 40 CFR Part 414
for facilities that manufacture ethylene dichloride, vinyl chloride
monomer, polyvinyl chloride and other chlorinated hydrocarbons. EPA is
also considering revision of the Inorganic Chemicals Point Source
Category regulations at 40 CFR Part 415 for facilities that manufacture
chlorine as well as chlorine manufacturers not regulated under 40 CFR
Part 415. The questionnaire seeks information on (1) Technical data,
including general facility information, manufacturing process
information, wastewater treatment and characterization information, and
information on sampling data; and (2) financial and economic data,
including ownership information, facility/company information, and
corporate parent financial information. The technical data will be used
to determine the industry production rates, water use for processes,
rates of wastewater generation, pollution prevention, and the practices
of wastewater management, treatment, and disposal. The financial and
economic data will be used to characterize the economic status of the
industry and to estimate the possible economic impacts of wastewater
regulations. This questionnaire will be sent to all identified
facilities engaged in CCH production. Completion of this one-time
questionnaire will be mandatory pursuant to Section 308 of the Clean
Water Act.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 435
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    Respondents/Affected Entities: Facilities that manufacture chlorine
and/or certain chlorinated hydrocarbons, including polyvinyl chloride.
    Estimated Number of Respondents: 65.
    Frequency of Response: One-time only.
    Estimated Total Annual Hour Burden: 28,300.
    Estimated Total Annual Cost: $1,082,000 includes $0 annualized
capital expenditure and $3,810 Respondent O&M costs.

    Dated: January 12, 2007.
Oscar Morales,
Director, Collection Strategies Division.
[FR Doc. E7-1096 Filed 1-24-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 23 (Thursday, February 3, 2022)]
[Notices]
[Pages 6189-6190]
[FR Doc No: 2022-02251]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4636-DR; Docket ID FEMA-2022-0001]

Missouri; 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 Missouri (FEMA-4636-DR), dated January 10,
2022, and related determinations.

DATES: The declaration was issued January 10, 2022.

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 10, 2022, 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 Missouri resulting from severe storms, straight-line winds, and
tornadoes on December 10, 2021, 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 Missouri.
    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 be
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, DuWayne Tewes, of FEMA is appointed
to act as the Federal Coordinating Officer for this major disaster.
    The following areas of the State of Missouri have been designated
as adversely affected by this major disaster:

    Bollinger, Dunklin, Iron, Madison, Pemiscot, Reynolds, and Wayne
Counties for Public Assistance.
    All areas within the State of Missouri are eligible 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.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2022-02251 Filed 2-2-22; 8:45 am]
BILLING CODE 9111-23-P