[Federal Register Volume 76, Number 141 (Friday, July 22, 2011)]
[Notices]
[Pages 44031-44032]
[FR Doc No: 2011-18622]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4000-DR; Docket ID FEMA-2011-0001]

Arkansas; 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 Arkansas (FEMA-4000-DR), dated July 8, 2011,
and related determinations.

DATES: Effective Date: July 8, 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 July 8, 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 Arkansas resulting from severe storms, tornadoes, and flooding
during the period of May 24-26, 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 Arkansas.
    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 Individual Assistance and 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, Hazard Mitigation, and Other Needs Assistance
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 time period prescribed for the implementation of section
310(a), Priority to Certain Applications for Public Facility and Public
Housing Assistance, 42 U.S.C. 5153, shall be for a period not to exceed
six months after the date of this declaration.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Nancy M. Casper, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of Arkansas have been designated
as adversely affected by this major disaster:

    Franklin and Johnson Counties for Individual Assistance.
    Crawford, Franklin, and Johnson Counties for Public Assistance.
    All counties within the State of Arkansas 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.

    Dated: July 18, 2011.
W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-18622 Filed 7-21-11; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 86, Number 172 (Thursday, September 9, 2021)]
[Notices]
[Pages 50584-50586]
[FR Doc No: 2021-19423]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-92873; File No. SR-Phlx-2021-48]

Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend Various
Phlx Rules

September 2, 2021.
    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 23, 2021, Nasdaq PHLX LLC (``Phlx'' or ``Exchange'') filed
with the Securities and Exchange Commission (``SEC'' or ``Commission'')
the proposed rule change as described in Items I and II 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.
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    \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 to amend Phlx Options 2, Section 5,
Electronic Market Maker Obligations and Quoting Requirements, Options
2, Section 10, Directed Orders, Options 3, Section 13, Price
Improvement XL (``PIXL''), and Options 3, Section 26, Message Traffic
Mitigation.
    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/phlx/rules, at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

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

    In its filing with the Commission, the 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 proposes to amend Phlx Rules at Options 2, Section 5,
Electronic Market Maker Obligations and Quoting Requirements, Options
2, Section 10, Directed Orders, Options 3, Section 13, Price
Improvement XL (``PIXL''), and Options 3, Section 26, Message Traffic
Mitigation. Each change is described below.
Options 2, Section 5
    The Exchange proposes to amend Options 2, Section 5, which
describes quoting obligations for Market Makers \3\ and Lead Market
Makers,\4\ to conform the description of a LEAP for index options with
Options 4A, Section 12(b)(2). Today, SQTs and RSQTs are not required to
make two-sided markets in any Quarterly Option Series, any adjusted
option series, and any option series with an expiration of nine months
or greater, otherwise known as long-term options series or ``LEAPs.''
Current Options 2, Section 5(c)(2)(A) describes a LEAP as any option
series with an expiration of nine months or greater, while Options 4A,
Section 12(b)(2) describes a LEAP on an index option as a series of
options having not less than twelve and up to 60 months to
expiration.\5\ The Exchange proposes to amend Options 2, Section
5(c)(2)(A) to explicitly define a LEAP by product. Specifically, the
Exchange proposes to add the following phrase to end of the paragraph,
``for options on equities and exchange-traded funds (``ETFs'') or with
an expiration of twelve months or greater for index options'' to
distinguish LEAPs for options on equities and ETFs, which have an
opening month of 9 months, from LEAPS for index options, which have an
opening month of 12 months. This proposal is non-substantive as Options
4A, Section 12(b)(2) already defines a LEAP on an index option. The
Exchange is simply conforming Options 2, Section 5(c)(2)(A) to Options
4A, Section 12(b)(2).
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    \3\ A ``Market Maker'' means a Streaming Quote Trader or a
Remote Streaming Quote Trader who enters quotations for his own
account electronically into the System. See Options 1, Section
1(b)(28). A ``Streaming Quote Trader'' or ``SQT'' means a Market
Maker who has received permission from the Exchange to generate and
submit option quotations electronically in options to which such SQT
is assigned. An SQT may only submit such quotations while such SQT
is physically present on the trading floor of the Exchange. An SQT
may only submit quotes in classes of options in which the SQT is
assigned. See Options 1, Section 1(b)(54). A ``Remote Streaming
Quote Trader'' or ``RSQT'' means a Market Maker that is a member
affiliated with an Remote Streaming Quote Trader Organization with
no physical trading floor presence who has received permission from
the Exchange to generate and submit option quotations electronically
in options to which such RSQT has been assigned. A qualified RSQT
may function as a Remote Lead Market Maker upon Exchange approval.
An RSQT is also known as a Remote Market Maker (``RMM'') pursuant to
Options 2, Section 11. A Remote Streaming Quote Organization
(``RSQTO'') or Remote Market Maker Organization (``RMO'') are
Exchange member organizations that have qualified pursuant to
Options 2, Section 1. See Options 1, Section 1(b)(49).
    \4\ A ``Lead Market Maker'' means a member who is registered as
an options Lead Market Maker pursuant to Options 2, Section 12(a). A
Lead Market Maker includes a Remote Lead Market Maker which is
defined as a Lead Market Maker in one or more classes that does not
have a physical presence on an Exchange's trading floor and is
approved by the Exchange pursuant to Options 2, Section 11. See
Options 1, Section 1(b)(27).
    \5\ Phlx previously amended its Options 4A, Section 12, Terms of
Option Contracts, to change the number of expirations that the
Exchange may open for trading in series of options related to Long-
Term Options Series of index options. See Securities Exchange Act
Release No. 88460 (March 23, 2020), 85 FR 17146 (March 26, 2020)
(SR-Phlx-2020-10) (Notice of Filing and Immediate Effectiveness of
Proposed Rule Change To Amend Options 4A, Section 12, Terms of
Option Contracts). This proposal amended Phlx's current expiration
for long-term index options from those series not having less than
nine and up to 60 months to expirations to a number of expirations
not having less than twelve and up to 60 months to expiration with
respect to Long-Term Options Series.
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    Similar changes to distinguish terms for LEAPs on index options are
proposed for Options 2, Section 5(c)(2)(B) and (C) which are applicable
to Lead Market Makers,\6\ and Directed SQTs and Directed RSQTs.\7\
Also, a similar change is proposed to be added to Options 2, Section
5(c)(2)(D) which generally describes the manner in which the Exchange
calculates quoting obligations. This amendment will bring greater
clarity to the Exchange's rules.
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    \6\ Lead Market Makers are required to make two-sided markets in
any Quarterly Option Series, any Adjusted Option Series, and any
LEAP. See Options 2, Section 5(c)(2)(B).
    \7\ Directed SQTs and Directed RSQTs are not required to make
two-sided markets in any Quarterly Option Series, any Adjusted
Option Series, and any LEAP. See Options 2, Section 5(c)(2)(C).
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Options 2, Section 10
    The Exchange proposes to correct an improper citation within
Options 2, Section 10(a)(iii) to Options 10, Section 11(a)(1)(C). The
citation should refer to the allocation rule at Options 3, Section
10(a)(1).
Options 3, Section 13
    The Exchange proposes to amend Options 3, Section 13, Price
Improvement XL (``PIXL''). Specifically, the Exchange proposes to
update rule citations within Options 3, Section

13(c)--(e) to Options 9. The rule citations to ``Options 9, Section 1''
and ``Options 9, Section'' are being replaced with ``General 9, Section
1(c).'' The Exchange previously relocated Options 9, Section 1, Conduct
Inconsistent with Just and Equitable Principles of Trade, to General 9,
Section 1(c).\8\ Certain citations were missing the Section ``1'' as
well. The Exchange also proposes to make ``exceed'' plural within
Options 3, Section 13(d).
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    \8\ See Securities Exchange Act Release No. 91058 (February 4,
2021), 86 FR 8966 (February 10, 2021) (SR-Phlx-2021-04) (Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To
Relocate Its PSX Equity and General Rules From Its Current Rulebook
Into Its New Rulebook Shell and Make Other Changes to the Phlx
Rules).
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Options 3 Section 26
    The Exchange proposes to amend Options 3, Section 26, Message
Traffic Mitigation. Specifically, the Exchange proposes to amend
Options 3, Section 26(a)(3) which currently provides, ``The Exchange
shall disseminate an updated bid and offer price, together with the
size associated with such bid and offer, when:. . . the size associated
with the Exchange's bid (offer) increases by an amount greater than or
equal to a percentage (never to exceed 20%) of the size associated with
previously disseminated bid (offer). Such percentage, which shall never
exceed 20%, shall be determined on an issue-by-issue basis by the
Exchange and announced to membership via Exchange circular.'' The
Exchange proposes to make some non-substantive amendments to the
sentence, such as changing ``shall'' to ``will'' and moving the phrase
``by the Exchange''. The Exchange also proposes to amend the practice
of issuing a circular to announce the percentage specified in Options
3, Section 26(a)(3) to instead posting the percentage on the Exchange's
website. The Exchange believes that posting the information on the
Exchange's website will provide members and member organizations a
reference to the current percentage provided for within Options 3,
Section 26(a)(3) without the need to locate a notice that was
previously issued. Further, this practice will continue to provide
transparency to members and member organizations.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\9\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\10\ in particular, in that it is designed to
promote just and equitable principles of trade and to protect investors
and the public interest.
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    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
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Options 2, Section 5
    The proposed amendment to Options 2, Section 5 is consistent with
the Act because it will distinguish LEAPs for options on equities and
ETFs, which have an opening month of 9 months, from LEAPS for index
options, which have an opening month of 12 months. This proposal is
non-substantive as Options 4A, Section 12(b)(2) already defines a LEAP
on an index option. The Exchange is simply conforming Options 2,
Section 5(c)(2)(A) to Options 4A, Section 12(b)(2). This amendment will
bring greater clarity to the Exchange's rules.
Options 2, Section 10
    The Exchange's proposal to correct an improper citation within
Options 2, Section 10(a)(iii) is consistent with the Act and will bring
greater clarity to the Exchange's rules.
Options 3, Section 13
    The Exchange's proposal to update rule citations within Options 3,
Section 13(c)--(e) from ``Options 9'' or ``Options 9, Section 1'' to
``General 9, Section 1(c)'' is consistent with the Act and will bring
greater clarity to the Exchange's Rulebook.
Options 3 Section 26
    The Exchange's proposal to amend Options 3, Section 26(a)(3) to
make some non-substantive amendments, such as changing ``shall'' to
``will'' and moving the phrase ``by the Exchange'' and amending the
practice of issuing a circular to instead posting the percentage on the
Exchange's website are consistent with the Act. The Exchange believes
that posting the information on the Exchange's website will provide
members and member organizations a reference to the current percentage
within Options 3, Section 26(a)(3) without the need to locate a notice
that was previously issued. Further, this practice will continue to
provide transparency to members and member organizations.

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.
Options 2, Section 5
    The proposed amendment to Options 2, Section 5 does not impose an
undue burden on competition because the proposal is a non-substantive
amendment to add specificity to the rule by distinguishing LEAPs for
options on equities and ETFs, which have an opening month of 9 months,
from LEAPS for index options, which have an opening month of 12 months.
This proposal will conform Options 2, Section 5(c)(2)(A) to Options 4A,
Section 12(b)(2).
Options 2, Section 10
    The Exchange's proposal to correct an improper citation within
Options 2, Section 10(a)(iii) does not impose an undue burden on
competition, rather it will bring greater clarity to the Exchange's
rules.
Options 3, Section 13
    The Exchange's proposal to update rule citations within Options 3,
Section 13(c)--(e) from ``Options 9'' or ``Options 9, Section 1'' to
``General 9, Section 1(c)'' does not impose an undue burden on
competition, rather the proposal will bring greater clarity to the
Exchange's Rulebook.
Options 3 Section 26
    The Exchange's proposal to amend Options 3, Section 26(a)(3) to
make some non-substantive amendments, such as changing ``shall'' to
``will'' and moving the phrase ``by the Exchange'' and amending the
practice of issuing a circular to instead posting the percentage within
Options 3, Section 26(a)(3) on the Exchange's website does not impose
an undue burden on competition. The Exchange believes that posting the
information on the Exchange's website will continue to provide
transparency to members and member organizations.

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)(iii) of the Act \11\ and

subparagraph (f)(6) of Rule 19b-4 thereunder.\12\
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    \11\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \12\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
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    A proposed rule change filed under Rule 19b-4(f)(6) \13\ normally
does not become operative prior to 30 days after the date of the
filing. However, Rule 19b-4(f)(6)(iii) \14\ permits the Commission to
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
that the Commission waive the operative delay to permit the Exchange to
immediately amend Options 2, Section 5 to distinguish LEAPs for options
on equities and ETFs, which have an opening month of 9 months or
greater, from LEAPS for index options, which have an opening month of
12 months or greater, thereby conforming Options 2, Section 5(c)(2)(A)
to Options 4A, Section 12(b)(2). Further, the Exchange states that
amending Options 3, Section 26(a)(3) will continue to provide
transparency to members and member organizations with respect to the
manner in which the Exchange manages quote traffic. The Commission
believes that waiving the 30-day operative delay is consistent with the
protection of investors and the public interest because (1) it will
allow the Exchange to immediately implement the proposed changes which
are designed to add clarity and consistency to the Exchange's rules
concerning LEAPs and (2) it will allow the Exchange to immediately
implement a change designed to better communicate to market
participants information concerning quote mitigation. Therefore, the
Commission hereby waives the 30-day operative delay and designates the
proposed rule change as operative upon filing.\15\
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    \13\ 17 CFR 240.19b-4(f)(6).
    \14\ 17 CFR 240.19b-4(f)(6)(iii).
    \15\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

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-2021-48 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Phlx-2021-48. 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 website (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 website 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. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly.
    All submissions should refer to File Number SR-Phlx-2021-48 and
should be submitted on or before September 30, 2021.
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    \16\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-19423 Filed 9-8-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 185 (Tuesday, September 26, 2023)]
[Notices]
[Pages 66068-66069]
[FR Doc No: 2023-20806]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-98448; File No. SR-NYSENAT-2023-18]

Self-Regulatory Organizations; NYSE National, Inc.; Notice of
Designation of a Longer Period for Commission Action on Proposed Rule
Change To Amend the Connectivity Fee Schedule Regarding Power
Allocation

September 20, 2023.
    On August 17, 2023, NYSE National, Inc., filed with the Securities
and Exchange Commission (``Commission''), pursuant to section 19(b)(1)
of the Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to amend the connectivity fee
schedule to include an alternative procedure to allocate power in the
Mahwah Data Center. The proposed rule change was published for comment
in the Federal Register on August 25, 2023.\3\ The Commission has
received no comments on the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 98171 (August 21,
2023), 88 FR 58364.
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    Section 19(b)(2) of the Act \4\ provides that within 45 days of the
publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may

designate if it finds such longer period to be appropriate and
publishes its reasons for so finding or as to which the self-regulatory
organization consents, the Commission shall either approve the proposed
rule change, disapprove the proposed rule change, or institute
proceedings to determine whether the proposed rule change should be
disapproved. The 45th day after publication of the notice for this
proposed rule change is October 9, 2023. The Commission is extending
this 45-day time period.
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    \4\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission finds it appropriate to designate a longer period
within which to take action on the proposed rule change so that it has
sufficient time to consider the proposed rule change and the comments
received. Accordingly, the Commission, pursuant to section 19(b)(2) of
the Act,\5\ designates November 23, 2023 as the date by which the
Commission shall either approve or disapprove, or institute proceedings
to determine whether to disapprove, the proposed rule change (File No.
SR-NYSENAT-2023-18).
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    \5\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
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    \6\ 17 CFR 200.30-3(a)(31).
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Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-20806 Filed 9-25-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 95 (Friday, May 16, 2014)]
[Notices]
[Pages 28525-28526]
[FR Doc No: 2014-11322]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-N-0037]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Animal Drug User Fee
Act Waivers and Reductions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by June
16, 2014.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0540.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Animal Drug User Fees and Fee Waivers and Reductions (OMB Control
Number 0910-0540)--Extension

    Enacted on November 18, 2003, the Animal Drug User Fee Act (ADUFA)
(Pub. L. 108-130) amended the Federal Food, Drug, and Cosmetic Act and
requires FDA to assess and collect user fees for certain applications,
products, establishments, and sponsors. It also requires the Agency to
grant a waiver from, or a reduction of those fees in certain
circumstances. Thus, to implement this statutory provision of ADUFA,
FDA developed a guidance entitled ``Guidance for Industry: Animal Drug
User Fees and Fee Waivers and Reductions.'' This document provides
guidance on the types of fees FDA is authorized to collect under ADUFA,
and how to request waivers and reductions from FDA's animal drug user
fees. Further, this guidance also describes the types of fees and fee
waivers and reductions; what information FDA recommends be submitted in
support of a request for a fee waiver or reduction; how to submit such
a request; and FDA's process for reviewing requests.
    Respondents to this collection of information are new animal drug
sponsors. Requests for waivers or reductions may be submitted by a
person paying any of the animal drug user fees assessed including
application fees, product fees, establishment fees, or sponsor fees.
    In the Federal Register of February 25, 2014 (79 FR 10532) FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden for this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of                         Average
   21 CFR section; activity        Number of      responses per    Total annual     burden per      Total hours
                                  respondents      respondent        responses       response
----------------------------------------------------------------------------------------------------------------
740(d)(1)(A); significant                   45  1 time for each               45               2              90
 barrier to innovation.                          application.
740(d)(1)(B); fees exceed cost               8  3.75............              30         \2\ 0.5              15
740(d)(1)(C); free choice                    5  1 time for each                5               2              10
 feeds.                                          application.
740(d)(1)(D); minor use or                  76  1 time for each               76               2             152
 minor species.                                  application.
740(d)(1)(E); small business..               3  1 time for each                3               2               6
                                                 application.
Request for reconsideration of               2  1 time for each                2               2               4
 a decision.                                     application.
Request for review--(user fee                0  1 time for each                0               0               0
 appeal officer).                                application.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ................  ..............  ..............             277
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ 30 minutes.

    Based on FDA's database system, from fiscal years 2010 to 2012
there were an estimated 173 sponsors subject to ADUFA. However, not all
sponsors will have any submissions in a given year and some may have
multiple submissions. The total number of waiver requests is based on
the average number of submission types received by FDA in fiscal years
2010 to 2012.

    Dated: May 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-11322 Filed 5-15-14; 8:45 am]
BILLING CODE 4160-01-P