[Federal Register Volume 83, Number 213 (Friday, November 2, 2018)]
[Notices]
[Pages 55210-55214]
[FR Doc No: 2018-23963]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-84495; File No. SR-Phlx-2018-66]

Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Relocate the
Pricing Schedule Rules

October 29, 2018.
    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 October 18, 2018, Nasdaq PHLX LLC (``Phlx'' or ``Exchange'') filed
with the Securities and Exchange Commission (``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 (a) relocate rules from the Phlx's Pricing
Schedule (``Pricing Schedule'') and current Rule 909 to the Exchange's
rulebook's (``Rulebook'') shell structure,\3\ (b) eliminate the Pricing
Schedule's Table of Contents, obsolete text, and reserved rules; and
(c) make conforming cross-reference changes throughout the Rulebook.
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    \3\ In 2017, the Exchange added a shell structure to its
Rulebook with the purpose of improving efficiency and readability
and to align its rules closer to those of its five sister exchanges,
The Nasdaq Stock Market LLC; Nasdaq BX, Inc.; Nasdaq GEMX, LLC;
Nasdaq ISE, LLC; and Nasdaq MRX, LLC (``Affiliated Exchanges''). See
Securities Exchange Act Release No. 82169 (November 29, 2017), 82 FR
57508 (December 5, 2017) (SR-Phlx-2017-97).
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    The text of the proposed rule change is available on the Exchange's
website at http://nasdaqphlx.cchwallstreet.com/, at the principal
office of the Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the 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, as part of its continued effort to promote efficiency
and the conformity of its processes with those of the Affiliated
Exchanges, and the goal of harmonizing and uniformizing its rules,
proposes to relocate the Pricing Schedule rules and Rule 909 to the
Exchange's shell structure. Specifically, the Exchange will relocate
the Pricing Schedule rules described below respectively into the Equity
7 and Options 7 sections of the shell structure (both named ``Pricing
Schedule'').
    In addition, the Exchange proposes to delete the current Pricing
Schedule's Table of Contents and the obsolete term ``Phlx XL II'' at
current Chapter VI., A. Moreover, the Exchange proposes not to relocate
current Chapters X, XI, and XII, since these are reserved rules that do
not contain any rule text. Finally, the Exchange proposes to make
conforming cross-reference changes throughout the Rulebook.
(a) Table of Contents
    The Exchange proposes to eliminate the existing Table of Contents
in the Phlx Pricing Schedule. The Table of Contents is unnecessary. The
website where the Phlx rules are listed \4\ contains hyperlinks and a
skeleton of the available rules within the site and enables market
participants to view all rules in that section.
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    \4\ Phlx rules are located at: http://nasdaqphlx.cchwallstreet.com.
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(b) Relocation of Equity Rules
    The Exchange proposes to adopt, under Equity 7, Section 1
(``General Provisions'') a modified version of the current introductory
text in the Pricing Schedule. Proposed Equity 7, Section 1(a) will
refer to the calculation of fees in the Exchange, with a specific
reference to the exception concerning disputes of Nasdaq PSX fees and
proprietary data feed fees. The Exchange notes that the relocated text
will not include the reference to disputes concerning fees for co-
location services. The co-location services rule was recently moved to
the General 8 section of the Rulebook \5\ and the rules of the proposed
Pricing Schedule will not apply to co-location services.\6\
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    \5\ See Securities Exchange Act Release No. 83465 (June 19,
2018), 83 FR 29594 (June 25, 2018) (SR-Phlx-2018-46).
    \6\ See proposed Equity 7, Section 1(a): ``Policy for amending
billing information: Corrections submitted after trade date and
prior to the issuance of an invoice by the exchange must be
submitted to the Exchange in writing and must be accompanied by
supporting documentation. Only members may submit trade corrections.
    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
PSX fees and proprietary data feed fees. The Exchange calculates
fees on a trade date basis. Only members may submit billing
disputes.''
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    The Exchange proposes also to relocate to Equity 7, Section 1(b)
the portion of the Pricing's Schedule's Preface that applies only to
equities. This will include the paragraph that reads ``For PSX
Equities.'' The relocated text has no application to transactions in
options and, therefore, will not be included in Options 7, Section 1(b)
described below.
    The Exchange proposes also to relocate and renumber Phlx Rule 909
under both Equity 7, Section 2 and Options 7, Section 2 (both named
``Collection of Exchange Fees and Other Claims''). Rule 909 permits
Phlx to collect undisputed or final fees, fines, charges and/or other
monetary sanctions or other monies due and owing to the Exchange or
other charges related to Rule 924.\7\ The Exchange believes that,
unlike other rules in the 900 Rules Series (``Membership''), which
generally refer to the powers of the Board of Directors and the
authority it delegates to Senior Management of the Exchange, the direct
debit process established in Rule 909 will be better situated among the
relocated rules in the Equity 7 and Options 7 titles.
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    \7\ See Securities Exchange Act Release No. 61405 (January 21,
2010), 75 FR 4888 (January 29, 2010) (SR-Phlx-2009-101) (Order
Approving a Proposed Rule Change Relating to Collection of Exchange
Fees).
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    Next, the Exchange proposes to relocate and renumber current
Pricing Schedule's Chapter VIII (``NASDAQ PSX FEES'') as Equity 7,
Section 3 in the shell structure. The text of this rule will not be
substantively changed other than to update the capitalization of its
title.
    Today, Chapter VI of the Phlx Pricing Schedule consists of rule
text applicable to both equities and options. Specifically, references
to floor pricing apply to the options market, as only that market has a
trading floor. In Chapter VI, A. (``Permit and Registration Fees''),
the paragraph that describes PSX Only Permit Fees describes an equity
fee. The ``Application Fee,'' ``Application Fee for Lapsed
Applications,'' ``Transfer of Affiliation Fee,'' ``Account Fee,''
``Initiation Fee'' and ``Permit Fees'' apply to both equities and
options. Finally, the ``Inactive Nominee Fee'' and the ``Clerk Fee''
are floor fees and therefore apply to options only.\8\
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    \8\ As explained later, the Exchange is proposing to adopt a
parallel rule under the Options 7, Section 8 (``Membership Fees''),
with fees applicable to both options and equities and relocate only
the subsections from Chapter VI that apply to options.
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    The Exchange proposes to adopt Equity 7, Section 4 (``Membership
Fees''), A. (``Permit and Registration Fees'') by adapting text from
current Chapter VI, A. of the Pricing Schedule. Specifically, as
previously noted, Equity 7, Section 4, A. will consist of the following
fees: ``Application Fee,'' ``Application Fee for Lapsed Applications,''
``Transfer of Affiliation Fee,'' ``Account Fee,'' ``Initiation Fee,''
and ``Permit Fees.'' Proposed Equity 7, Section 4 will also include
text from the current rule which is only applicable to PSX
transactions; thus, the Exchange proposes to relocate the text under
the subheading ``PSX Only Permit Fees.''
    Additionally, the Exchange will relocate the callout (``*'') and
respective

footnote that accompany the ``Application Fee,'' ``Application Fee for
Lapsed Applications,'' ``Account Fee,'' and ``Initiation Fee''
subheadings; this is because the footnote is exclusively applicable to
those who only apply for PSX membership, and therefore should be moved
to the Equity 7 title.
    The Exchange notes that it will not relocate the obsolete term
``Phlx XL II'' used in the footnote described above; the term is a
legacy reference and its removal will not affect the rights of
prospective or existing members of the Exchange.
    The Exchange will thus relocate and renumber the above-referenced
rules as follows:

----------------------------------------------------------------------------------------------------------------
         Equity 7--Pricing schedule (Proposed)                          Schedule of fees (Current)
----------------------------------------------------------------------------------------------------------------
Section 1. General Provisions--(a)                       Pricing Schedule's Introduction
Section 1. General Provisions--(b)                       PREFACE
Section 2. Collection of Exchange Fees and Other Claims  Rule 909. Collection of Exchange Fees and Other Claims
Section 3. Nasdaq PSX Fees                               VIII. Nasdaq PSX Fees
Section 4. Membership Fees                               VI. Membership Fees
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(c) Relocation of Options Rules
    The Exchange proposes to adopt, under Options 7, Section 1(a), a
modified version of the current introductory section in the Pricing
Schedule. Proposed Options 7, Section 1(a) will refer to the
calculation of fees in the Exchange, with a specific reference to the
exception concerning disputes of proprietary data fees, which applies
to transactions in options. The Exchange believes that this change will
improve the readability of the rules relocated under the Options 7
title.
    The Exchange also proposes to adopt under Options 7, Section 1(b)
the text from the Pricing Schedule's Preface that applies only to
transactions in options. Specifically, proposed Options 7, Section 1(b)
will contain the text that opens with ``For Phlx Options''; the
definitions of ``Customer''; ``Specialist''; ``ROT, SQT and RSQT'';
``Market Maker''; ``Registered Option Trader''; ``Streaming Quote
Trader''; ``Remote Streaming Quote Trader''; ``Firm'';
``Professional''; ``Broker-Dealer''; ``Joint Back Office''; ``Common
Ownership''; and ``Non-Customer''; and the rules that apply to options
transactions fees or rebates described under the subsection ``For
Purposes of Common Ownership Aggregation of Activity of Affiliated
Members and Member Organizations,'' including the terms ``Appointed
MM,'' ``Appointed OFP,'' and ``Affiliated Entity.''
    The Exchange additionally proposes that Subsections A and B
(respectively, ``Mini Options Fees'' and ``Customer Rebate Program'')
in the Pricing Schedule's Preface remain unchanged and be relocated to
proposed Options 7, Section 1(b).
    As previously explained, the Exchange proposes also to adopt a
rule, under Options 7, Section 2, for the collection of undisputed fees
or other monies identical to current Phlx Rule 909 (``Collection of
Exchange Fees and Other Claims''), which will parallel the rule under
Equity 7, Section 2.
    The Exchange proposes also to relocate, renumber, and add the word
``Section'' to each of the following chapters in the Pricing Schedule:
I (``Rebates and Fees for Adding and Removing Liquidity in SPY''); II
(``Multiply Listed Options Fees''), III (``Singly Listed Options''); IV
(``Other Transaction Fees''); V (``Routing Fees''); VII (``Other Member
Fees''); IX (``Proprietary Data Feed Fees''); and XIII (``Access and
Redistribution Fee'').
    With respect to the text in current Chapter VI of the Pricing
Schedule, as previously explained, the Exchange proposes to adopt
Options 7, Section 8, A. (``Permit and Registration Fees'') which will
include text applicable to both equities and options (the ``Application
Fee,'' ``Application Fee for Lapsed Applications,'' ``Transfer of
Affiliation Fee,'' ``Account Fee,'' ``Initiation Fee,'' and ``Permit
Fees.'').
    The Exchange proposes also to remove the callout (``*'') from the
Application, Account, and Initiation fees' subheadings since such
footnote is applicable to those who only apply for membership with PSX.
    Moreover, the Exchange proposes to include under Options 7, Section
8, A. portions of text from Chapter VI which apply only to transactions
in options (namely, ``Phlx Permit Fees,'' ``Inactive Nominee Fee,'' and
``Clerk Fee''). The Exchange additionally proposes to relocate to
Options 7, Section 8, subsections B. (``Streaming Quote Trader Fees''),
C. (``Remote Market Maker Organization Fee'') and D. (``Remote
Specialist Fee'') from current Chapter VI.
    The proposed relocation of options rules can be summarized as
follows:

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         Options 7--Pricing schedule (Proposed)                         Schedule of fees (Current)
----------------------------------------------------------------------------------------------------------------
Section 1. General Provisions--(a)                       Pricing Schedule's Introduction
Section 1. General Provisions--(b)                       PREFACE
Section 2. Collection of Exchange Fees and Other Claims  A. Mini Option Fees
Section 3. Rebates and Fees for Adding and Removing      B. Customer Rebate Program
 Liquidity in SPY                                        Rule 909. Collection of Exchange Fees and Other Claims
                                                         I. Rebates and Fees for Adding and Removing Liquidity
                                                          in SPY
Section 4. Multiply Listed Options Fees                  II. Multiply Listed Options Fees
Section 5. Singly Listed Options                         III. Singly Listed Options
Section 6. Other Transaction Fees                        IV. Other Transaction Fees
Section 7. Routing Fees                                  V. Routing Fees
Section 8. Membership Fees                               VI. Membership Fees
Section 9. Other Member Fees                             VII. Other Member Fees
Section 10. Proprietary Data Feed Fees                   IX. Proprietary Data Feed Fees
Section 11. Access and Redistribution Fee                XIII. Access and Redistribution Fee
----------------------------------------------------------------------------------------------------------------

    The Exchange believes that the changes previously explained are
non-substantive and that they will facilitate the use of the Rulebook
by Members \9\ of the Exchange, including those who are members of
other Affiliated Exchanges, and other market participants.
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    \9\ Exchange Rule 100(a)(32).
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(d) Pricing Schedule Rules To Be Removed
    The Exchange proposes Pricing Schedule's Chapters X, XI, and XII
not to be relocated to the shell structure and that they be removed
from the Rulebook. The aforementioned sections are currently marked as
``Reserved'' and their relocation to the shell structure is unnecessary
since the Exchange may amend and create new rules if needed.
(e) Cross-Reference Updates
    In connection with the changes described above, the Exchange
proposes to update all cross-references in the Rulebook that direct the
reader to the current location of the Pricing Schedule rules and/or any
of their subsections.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\10\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\11\ 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, by promoting efficiency and the structural conformity of the
Exchange's processes with those of the Affiliated Exchanges and to make
the Exchange's Rulebook easier to read and more accessible to its
Members and market participants. The Exchange believes that the
relocation and renumbering of rules in the Equity 7 and Options 7
Pricing Schedules, related cross-reference updates, and the deletion of
the Table of Contents, the obsolete term ``Phlx XL II,'' and unused
Pricing Schedule chapters are of a non-substantive nature.
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    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The proposed changes do not
impose a burden on competition because, as previously stated, they (i)
are of a non-substantive nature, (ii) are intended to harmonize the
structure of the Exchange's rules with those of its Affiliated
Exchanges, and (iii) are intended to organize the Rulebook in a way
that it will ease the Members' and market participants' navigation and
reading of the Equities' and Options' Pricing Schedules.

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) of the Act \12\ and Rule 19b-
4(f)(6) thereunder.\13\
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    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of 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 pursuant to Rule 19b-4(f)(6) under the
Act \14\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \15\ 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 requested that the Commission waive the 30-day operative delay so
that the proposed rule change may become operative upon filing. Waiver
of the operative delay would allow the Exchange to promptly relocate
the Pricing Schedule rules, which the Exchange believes will improve
the organization and readability of the Exchange's Rulebook. Therefore,
the Commission believes that waiver of the 30-day operative delay is
consistent with the protection of investors and the public interest.
Accordingly, the Commission hereby waives the operative delay and
designates the proposed rule change operative upon filing.\16\
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    \14\ 17 CFR 240.19b-4(f)(6).
    \15\ 17 CFR 240.19b-4(f)(6)(iii).
    \16\ For purposes only of waiving the 30-day operative delay,
the Commission also has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of 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 change 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 protected]. Please include
File Number SR-Phlx-2018-66 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-2018-66. 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-2018-66, and should be submitted on or before November 23, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
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    \17\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-23963 Filed 11-1-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 83 (Tuesday, April 30, 2013)]
[Notices]
[Page 25345]
[FR Doc No: 2013-10068]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2013-0034]

Petition for Waiver of Compliance

    In accordance with Part 211 of Title 49 Code of Federal Regulations
(CFR), this document provides the public notice that by a document
dated March 11, 2013, the Charlotte Southern Railroad (CHS) has
petitioned the Federal Railroad Administration (FRA) for a waiver of
compliance from certain provisions of the Federal railroad safety
regulations contained at 49 CFR Part 223, Safety Glazing Standards--
Locomotives, Passenger Cars and Cabooses. FRA assigned the petition
Docket Number FRA-2013-0034.
    CHS has requested a waiver of compliance from the glazing
requirements set forth in 49 CFR 223.11 and 223.15 for one locomotive,
two cars, and one equipment/generator car. Specifically, CHS seeks a
waiver of compliance for Locomotive CHS 3 constructed in 1956,
Butternut Creek 5206 constructed in 1937, Battle Creek
2502 constructed in 1955, and Power Car 5874
constructed in 1949.
    CHS operates on approximately 3[frac12] miles of track, and the
majority of its operations are through rural or lightly populated
areas. In its petition, CHS states that the existing glazing in its
locomotive, cars, and equipment/generator car, is in good condition and
has no history of glazing-related accidents or injuries.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's Docket Operations Facility, 1200 New Jersey Avenue
SE., W12-140, Washington, DC 20590. The Docket Operations Facility is
open from 9 a.m. to 5 p.m., Monday through Friday, except Federal
holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by June 14, 2013 will be considered by FRA
before final action is taken. Comments received after that date will be
considered as far as is practicable.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the document,
if submitted on behalf of an association, business, labor union, etc.).
See http://www.regulations.gov/#!privacyNotice for the privacy notice
of regulations.gov or interested parties may review DOT's complete
Privacy Act Statement in the Federal Register published on April 11,
2000 (65 FR 19477).

    Issued in Washington, DC, on April 24, 2013.
Robert C. Lauby,
Deputy Associate Administrator for Regulatory and Legislative
Operations.
[FR Doc. 2013-10068 Filed 4-29-13; 8:45 am]
BILLING CODE 4910-06-P


DRAFT DRAFT DISCUSSION OUTLINE August 28, 2001 Coal Ash Management I. Categories of Coal Ash Management 1) Used as product ( i. e. concrete; asphalt filler; etc) 2) Used beneficially in the environment ( i. e. structural fill; soil amendment/ additive) 3) Beneficially used in active or abandoned coal/ noncoal minesites 4) Disposal II. Coal Ash Management Principles for Beneficial Use ° Proper coal ash characterization to insure adequate protection of public health and safety and the environment ° Reutilization ° Beneficial use of coal ash placement in mines: ° Case studies and monitoring required by the states support the concept that coal ash is a manageable material in a mine environment. ° Unique opportunity to increase usage for mine reclamation and provide a safe environment for disposal of ash. ° Opportunity for cost effective placement of coal ash to help resolve the disposal/ placement of increased amounts of coal ash being generated today and into the future. ° Opportunity to save green space by minimizing the need to develop ash disposal sites near power plants, often in flood plains. ° Opportunity to place ash back into its place of origin, usually in a geochemical environment conducive for such placement.

III. Coal Ash Regulatory Principles for Beneficial Use ° Coal ash is NOT a hazardous waste, but should be properly managed. ° Few proven damage cases related to coal ash placement. ° States believe that through cooperation at the state AND federal levels we can make the best use of existing regulatory and statutory authorities to protect public health and safety and the environment. ° Flexibility and discretion are necessary for the achievement of successful program outcomes due to the difference in coal ashes, regional geology, regional climate, mine site conditions, types of uses, and other factors. ° Inter agency cooperation: ° State programs ( i. e. mining programs, solid waste programs, air and water programs) have substantial experience and expertise in managing coal ash placement in a mining environment ( often via coordination of efforts among state agencies). DRAFT DRAFT ° Present day regulatory framework in states demonstrates ability to manage coal ash acceptably. ° Opportunity for public involvement is necessary. ° Parameters for determination of beneficial use at mine sites: ° Ash composition is compatible for intended uses ° Use at selected site will not create problems or exacerbate existing problems ° There must be a valid purpose for using the ash, which could include: ° Acid Mind Drainage ( AMD) remediation ° Solid enhancement/ replacement ° Subsidence control ° Approximate Original Contour ° Appropriate Post mining Land Use ° Mine fire control ° Mine reclamation IV. Conclusions ° Approved beneficial use determinations by the states preclude the need for further waste regulation by EPA ° Experience at the state level in implementing existing state and federal laws substantiates the adequacy of the existing regulatory structure. ° Comprehensive federal regulations will be difficult to implement from a nationwide perspective due to differences in regional geology, climate, ash composition and other factors. ° State data and information supports these conclusions and are available for review.

V. Disposal/ Placement at Minesites ( other than Beneficial Use)

° Can be done safely and with adequate environmental controls under existing state and federal regulations ( including SMCRA, CWA, state statutes and regulations) ° Potential program components include: ° Waste characterization ° Site considerations ( i. e. site prohibitions; operation plans; approximate original contour; buffer zones; physical hazards; hydrologic analyses) ° Environmental controls ( i. e. volume restrictions; placement requirements; use of liners; compaction; state ground water protection plans; water quality standards; air quality standards; monitoring; reporting) ° Determination of End Points ( i. e. active mining = contemporaneous reclamation; abandoned mines = reclamation; disposal = closure) ° Assurance of Project Completion ( i. e. financial assurances ( surety bonds, insurance, etc.); enforcement authorities; clean up authorities and funds ( CERCLA); risk analysis; other regulatory controls ( BMPs, NPDES, Waste Regulations)).


[Federal Register Volume 84, Number 114 (Thursday, June 13, 2019)]
[Notices]
[Page 27691]
[FR Doc No: 2019-12488]

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DEPARTMENT OF TRANSPORTATION

[Docket No. DOT-OST-2015-0271]

Agency Request for Renewal of a Previously Approved Information
Collection: Prioritization and Allocation Authority Exercised by the
Secretary of Transportation Under the Defense Production Act

AGENCY: Office of the Secretary of Transportation, DOT.

ACTION: Notice and request for comments.

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SUMMARY: The Department of Transportation (DOT) invites public comments
about our intention to request the Office of Management and Budget
(OMB) approval to renew an information collection. The collection
involves information required in an application to request Special
Priorities Assistance. The information to be collected is necessary to
facilitate the supply of civil transportation resources to promote the
national defense. We are required to publish this notice in the Federal
Register by the Paperwork Reduction Act of 1995. A 60-day notice was
published in the Federal Register on March 25, 2019. No comments were
received.

DATES: Written comments should be submitted by July 15, 2019.

ADDRESSES: Your comments should be identified by Docket No. DOT-OST-
2015-0271 and may be submitted through one of the following methods:
     Office of Management and Budget, Attention: Desk Officer
for U.S. Department of Transportation, Office of Information and
Regulatory Affairs, Office of Management and Budget, Docket Library,
Room 10102, 725 17th Street NW, Washington, DC 20503.
     Email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>. Attention: DOT/OST Desk Officer.

FOR FURTHER INFORMATION CONTACT: Anita Womack,<PHONE_NUMBER>, Office of
Intelligence, Security and Emergency Response, Office of the Secretary
of Transportation, U.S. Department of Transportation, 1200 New Jersey
Avenue SE, Washington, DC 20590.

SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2105-0567.
    Title: Prioritization and Allocation Authority Exercised by the
Secretary of Transportation Under the Defense Production Act.
    Form Numbers: OST F 1254.
    Type of Review: Renewal of a previously approved information
collection.
    Background: The Defense Production Act Reauthorization of 2009
(Pub. L. 111-67, September 30, 2009) requires each Federal agency with
delegated authority under section 101 of the Defense Production Act of
1950, as amended (50 U.S.C. App. Sec. 2061 et seq.) to issue final
rules establishing standards and procedures by which the priorities and
allocations authority is used to promote the national defense. The
Secretary of Transportation has the delegated authority for all forms
of civil transportation. DOT's final rule, Transportation Priorities
and Allocation System (TPAS), published October 2012, requires this
information collection. Form OST F 1254, Request for Special Priorities
Assistance, would be filled out by private sector applicants, such as
transportation companies or organizations. The private sector applicant
must submit company information, the services or items for which the
assistance is requested, and specific information about those services
or items.
    Respondents: Private sector applicants, such as transportation
companies or organizations.
    Number of Respondents: We estimate 6 respondents.
    Total Annual Burden: We estimate an average burden of 30 minutes
per respondent for an estimated total annual burden of 3 hours.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for the Department's
performance; (b) the accuracy of the estimated burden; (c) ways for the
Department to enhance the quality, utility and clarity of the
information collection; and (d) ways that the burden could be minimized
without reducing the quality of the collected information. The agency
will summarize and/or include your comments in the request for OMB's
clearance of this information collection.
    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter
35, as amended; and 49 CFR 1:48.

    Issued in Washington, DC, on June 7, 2019.
Donna O'Berry,
Deputy Director, Office of Intelligence, Security and Emergency
Response.
[FR Doc. 2019-12488 Filed 6-12-19; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register Volume 84, Number 29 (Tuesday, February 12, 2019)]
[Notices]
[Pages 3478-3479]
[FR Doc No: 2019-02017]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4411-DR: Docket ID FEMA-2019-0001]

Virginia; 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 Commonwealth of Virginia (FEMA-4411-DR), dated
December 18, 2018, and related determinations.

DATES: The declaration was issued December 18, 2018.

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 December 18, 2018, 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
Commonwealth of Virginia resulting from Tropical Storm Michael
during the period of October 9-16, 2018, 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 Commonwealth of Virginia.
    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 Commonwealth.
Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Hazard Mitigation will be limited to 75 percent of the total
eligible costs. Federal funds provided under the Stafford Act for
Public Assistance also will be limited to 75 percent of the total
eligible costs, with the exception of projects that meet the
eligibility criteria for a higher Federal cost-sharing percentage
under the Public Assistance Alternative Procedures Pilot Program for
Debris Removal implemented pursuant to section 428 of the Stafford
Act.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

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

    Amelia, Appomattox, Brunswick, Campbell, Charlotte,
Chesterfield, Cumberland, Dinwiddie, Essex, Floyd, Fluvanna,
Franklin, Halifax, King and Queen, Lunenburg, Montgomery, New Kent,
Northumberland, Nottoway, Pittsylvania, Powhatan, Prince Edward,
Rappahannock, Richmond, and Roanoke Counties and the independent
cities of Danville and Galax for Public Assistance.
    All areas within the Commonwealth of Virginia 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.

Brock Long,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2019-02017 Filed 2-11-19; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register: August 4, 2009 (Volume 74, Number 148)]
[Notices]
[Page 38648-38654]
[DOCID:fr04au09-57]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0276]

Authorizations of Emergency Use of Certain Antiviral Drugs--
Zanamivir and Oseltamivir Phosphate; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of two Emergency Use Authorizations (EUAs) (the
Authorizations) for certain products from the neuraminidase class of
antivirals--Zanamivir and oseltamivir phosphate. FDA is issuing the
Authorizations under the Federal Food, Drug, and Cosmetic Act (the
act), as requested by the Centers for Disease Control and Prevention
(CDC). The Authorizations contain, among other things, conditions on
the emergency use of the authorized zanamivir and oseltamivir phosphate
products. The Authorizations follow the determination by the Acting
Secretary of the Department of Health and Human Services, Charles E.
Johnson (the Acting Secretary), that a public health emergency exists
involving Swine Influenza A (now known as 2009 H1N1 Influenza A or 2009
H1N1 flu) that affects, or has the significant potential to affect,
national security. On the basis of such determination, the Acting
Secretary declared an emergency justifying the authorization of the
emergency use of certain products from the neuraminidase class of
antivirals--Zanamivir and oseltamivir phosphate, accompanied by
emergency use information subject to the terms of any authorization
issued under the act. The Authorizations, which include an explanation
of the reasons for issuance, are reprinted in this document. Elsewhere
in this issue of the Federal Register, FDA is announcing the issuance
of EUAs for certain in vitro diagnostic devices and the issuance of an
EUA for certain personal respiratory protection devices.

DATES: The Authorizations are effective as of April 27, 2009.

ADDRESSES: Submit written requests for single copies of the EUAs to the
Office of Counterterrorism and Emerging Threats (HF-29), Food and Drug
Administration, 5600 Fishers Lane, rm. 14C-26, Rockville, MD 20857.
Send one self-addressed adhesive label to assist that office in
processing your request or include a fax number to which the
Authorization(s) may be sent. See the SUPPLEMENTARY INFORMATION section
for electronic access to the Authorizations.

FOR FURTHER INFORMATION CONTACT: Boris Lushniak, Office of
Counterterrorism and Emerging Threats (HF-29), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the act (21 U.S.C. 360bbb-3), as amended by the
Project BioShield Act of 2004 (Public Law 108-276), allows FDA to
strengthen the public health protections against biological, chemical,
nuclear, and radiological agents. Among other things, section 564 of
the act allows FDA to authorize the use of an unapproved medical
product or an unapproved use of an approved medical product during a
public health emergency that affects, or has a significant potential to
affect, national security, and that involves biological, chemical,
radiological, or nuclear agent or agents, or a specified disease or
condition that may be attributable to such agent or agents. With this
EUA authority, FDA can help assure that medical countermeasures may be
used in an emergency to diagnose, treat, or prevent serious or life-
threatening diseases or conditions caused by such agents, when there
are no adequate, approved, and available alternatives.
    Section 564(b)(1) of the act provides that, before an EUA may be
issued, the Secretary must declare an emergency justifying the
authorization based on one of the following grounds: ``(A) a
determination by the Secretary of Homeland Security that there is a
domestic emergency, or a significant potential for a domestic
emergency, involving a heightened risk of attack with a specified
biological, chemical, radiological, or nuclear agent or agents; (B) a
determination by the Secretary of Defense that there is a military
emergency, or a significant potential for a military emergency,
involving a heightened risk to United States military

forces of attack with a specified biological, chemical, radiological,
or nuclear agent or agents; or (C) a determination by the Secretary of
a public health emergency under section 319 of the Public Health
Service Act that affects, or has a significant potential to affect,
national security, and that involves a specified biological, chemical,
radiological, or nuclear agent or agents, or a specified disease or
condition that may be attributable to such agent or agents.''
    Once the Secretary has declared an emergency justifying an
authorization under section 564 of the act, FDA may authorize the
emergency use of a drug, device, or biological product if the agency
concludes that the statutory criteria are satisfied. Under section
564(h)(1) of the act, FDA is required to publish, in the Federal
Register, a notice of each authorization, and each termination or
revocation of an authorization, and an explanation of the reasons for
the action. Section 564 of the act permits FDA to authorize the
introduction into interstate commerce of a drug, device, or biological
product intended for use in a declared emergency. Products appropriate
for emergency use may include products and uses that are not approved,
cleared, or licensed under sections 505, 510(k), and 515 of the act (21
U.S.C. 355, 360(k), and 360e) or section 351 of the Public Health
Service Act (PHS Act) (42 U.S.C. 262). FDA may issue an EUA only if,
after consultation with the National Institutes of Health and CDC (to
the extent feasible and appropriate given the circumstances of the
emergency), FDA\1\ concludes: (1) That an agent specified in a
declaration of emergency can cause a serious or life-threatening
disease or condition; (2) that, based on the totality of scientific
evidence available to FDA, including data from adequate and well-
controlled clinical trials, if available, it is reasonable to believe
that: (A) the product may be effective in diagnosing, treating, or
preventing--(1) such disease or condition; or (2) a serious or life-
threatening disease or condition caused by a product authorized under
Section 564, approved or cleared under this Act, or licensed under
Section 351 of the PHS Act, for diagnosing, treating, or preventing
such a disease or condition caused by such an agent; and (B) the known
and potential benefits of the product, when used to diagnose, prevent,
or treat such disease or condition, outweigh the known and potential
risks of the product; (3) that there is no adequate, approved, and
available alternative to the product for diagnosing, preventing, or
treating such disease or condition; and (4) that such other criteria as
the Secretary may by regulation prescribe are satisfied.
---------------------------------------------------------------------------

    \1\ The Secretary has delegated his authority to issue an EUA
under section 564 of the act to the Commissioner of Food and Drugs.
---------------------------------------------------------------------------

    No other criteria of issuance have been prescribed by regulation
under section 564(c)(4) of the act. Because the statute is self-
executing, FDA does not require regulations or guidance to implement
the EUA authority. However, in the Federal Register of July 26, 2007
(72 FR 41083), FDA announced the availability of a guidance entitled
``Emergency Use Authorization of Medical Products.'' The guidance
provides more information for stakeholders and the public about the EUA
authority and the agency's process for the consideration of EUA
requests.

II. EUA Request for Certain Products From the Neuraminidase Class of
Antivirals, Zanamivir and Oseltamivir Phosphate

    On April 26, 2009, under section 564(b)(1)(C) of the act, the
Acting Secretary determined that a public health emergency exists,
involving Swine Influenza A (now known as 2009 H1N1 Influenza A or 2009
H1N1 flu) that affects, or has the significant potential to affect,
national security. On April 26, 2009, under section 564(b) of the act,
and on the basis of such determination, the Acting Secretary declared
an emergency justifying the authorization of the emergency use of
certain products from the neuraminidase class of antivirals--Zanamivir
and oseltamivir phosphate, accompanied by emergency use information
subject to the terms of any authorization issued under 21 U.S.C.
360bbb-3(a). Notice of the determination and the declaration of the
Acting Secretary is published elsewhere in this issue of the Federal
Register. On April 26, 2009, CDC requested and, on April 27, 2009, FDA
issued EUAs for zanamivir inhalation powder and certain oseltamivir
phosphate capsules and oral suspension for the treatment and
prophylaxis of influenza, accompanied by emergency use instructions,
which are authorized under the EUAs. On April 27, 2009, FDA also
amended the EUAs for zanamivir and oseltamivir phosphate, including the
emergency use instructions authorized under the EUAs.

III. Electronic Access

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

IV. The Authorizations

    Having concluded that the criteria for issuance of the
Authorizations under section 564(c) of the act are met, FDA has
authorized the emergency use of certain zanamivir inhalation powder and
certain oseltamivir phosphate capsules and oral suspension for the
treatment and prophylaxis of influenza, accompanied by emergency use
information, subject to the terms and conditions of the authorizations.
    The Authorization (as amended) for certain zanamivir inhalation
powder follows and provides an explanation of the reasons for its
issuance, as required by section 564(h)(1) of the act:

 Richard E. Besser, MD
 Acting Director
 Centers for Disease Control and Prevention
 1600 Clifton Rd, MS D-14
 Atlanta, GA 30333

 Dear Dr. Besser:

 This letter is in response to your request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for the emergency use of zanamivir inhalation powder for
 treatment and prophylaxis of influenza, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. Sec.   360bbb-3).

 On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. Sec.   360bbb-3(b)(1)(C)), the Secretary of the Department of Health and Human Services (DHHS) determined that a
 public health emergency exists involving Swine Influenza A that affects or has significant potential to affect national security. Pursuant to section 564(b) of the Act (21 U.S.C. Sec.
 360bbb-3(b)), and on the basis of such determination, the Secretary of DHHS then declared an emergency justifying the authorization of the emergency use of certain zanamivir products subject
 to the terms of any authorization issued under section 564(a) of the Act (21 U.S.C. Sec.   360bbb-3(a)).

 Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. Sec.   360bbb-3(b)) are met, I am authorizing the emergency use of certain
 zanamivir products\1\ for the treatment and prophylaxis of influenza, subject to the terms of this authorization.

 I. Criteria for Issuance of Authorization

 I have concluded that the emergency use of certain zanamivir products for the treatment and prophylaxis of influenza meets the criteria for issuance of an authorization under section 564(c)
 of the Act, because I have concluded that:

    (1) Swine Influenza A can cause influenza, a serious or life-threatening disease or condition;

    (2) based on the totality of scientific evidence available to FDA, it is reasonable to believe that certain zanamivir products may be effective for the treatment and prophylaxis of
     influenza, and that the known and potential benefits of certain zanamivir products, when used for the treatment and prophylaxis of influenza, outweigh the known and potential risks of
     such products; and

    (3) there is no adequate, approved, and available alternative to the emergency use of certain zanamivir products for the treatment and prophylaxis of influenza.\2\

 Therefore, I have concluded that the emergency use of certain zanamivir products for the treatment and prophylaxis of influenza meets the above statutory criteria for issuance of an
 authorization.

 II. Scope of Authorization

 I have concluded, pursuant to section 564(d)(1) of the Act, that the scope of this authorization is limited to the use of authorized zanamivir products for the treatment and prophylaxis of
 influenza for individuals exposed to Swine Influenza A. The emergency use of authorized zanamivir products under this EUA must be consistent with, and may not exceed, the terms of this
 letter, including the scope and the conditions of authorization set forth below.

 The authorized zanamivir products are as follows:

     Relenza (zanamivir) Inhalation Powder

 Zanamivir products are approved and indicated for the treatment of uncomplicated acute illness due to influenza A and B virus in adults and pediatric patients 7 years of age and older who
 have been symptomatic for no more than 2 days. Zanamivir products are also approved and indicated for prophylaxis of influenza in adults and pediatric patients 5 years of age and older.\3\

 1. The above zanamivir products are authorized for use at later time points (i.e., patients who are symptomatic for more than 2 days) and/or in patients sick enough to require hospitalization
 (i.e., patients who do not have ``uncomplicated acute illness'' per se).

 2. The above zanamivir products labeled consistent with the manufacturer's label are authorized to be distributed under this EUA. Such products are authorized to be distributed or dispensed
 without the requisite prescription label information under section 503(b)(2) of the Act (e.g., name and address of dispenser, serial number, date of prescription or of its filling, name of
 prescriber, name of patient, if stated on prescription, directions for use and cautionary statements, if contained in the prescription).

 3. The above zanamivir products are authorized to be accompanied by the following written information pertaining to the emergency use, which are authorized to be made available to health care
 providers\4\ and recipients:

         Fact Sheet for Health Care Provider
         Fact Sheet for Recipients

 CDC and the appropriate state and/or local public health authority(ies) are also authorized to make available additional information relating to the emergency use of authorized zanamivir
 products that is consistent with, and does not exceed, the terms of this letter of authorization. (See section IV).

 I have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of authorized zanamivir products, when used for the
 treatment and prophylaxis of influenza, outweigh the known and potential risks of such products.

 I have concluded, pursuant to section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that the authorized zanamivir
 products may be effective for the treatment and prophylaxis of influenza pursuant to section 564(c)(2)(A) of the Act. FDA has reviewed the scientific information available, including the
 information supporting the conclusions described in Section I above, and concludes that the authorized zanamivir products, when used for the treatment and prophylaxis of influenza in the
 specified population, meet the criteria set forth in section 564(c) of the Act concerning safety and potential effectiveness.

 Subject to the terms of this EUA and under the circumstances set forth in the Secretary of DHHS's determination under section 564(b)(1)(C) described above and the Secretary of DHHS's
 corresponding declaration under section 564(b)(1), the zanamivir products described above are authorized for the treatment and prophylaxis of influenza for individuals exposed to Swine
 Influenza A.

 This EUA will cease to be effective when the declaration of emergency is terminated under section 564(b)(2) of the Act or when the EUA is revoked under section 564(g) of the Act.

 III. Current Good Manufacturing Practice

 I am waiving current good manufacturing practice requirements with respect to the holding of authorized zanamivir products by CDC and other public health authority(ies) for a period of ninety
 days.

 IV. Conditions of Authorization

 Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization:

 CDC

  A. CDC will verify that authorized zanamivir products distributed to the Receive, Stage, Storage (RSS) sites are within their labeled expiration dates.

  B. CDC will ensure that the appropriate state and/or local public health authority(ies) are informed of this EUA, including the terms and conditions herein.

  C. CDC will make available to the appropriate state and/or local public health authority(ies) through appropriate means the authorized Fact Sheet for Health Care Providers, authorized Fact
   Sheet for Recipients, and at least one representative FDA-approved package insert that covers the dosage forms and strengths of authorized zanamivir products.

  D. Only CDC may request changes to the authorized Fact Sheet for Health Care Providers and authorized Fact Sheet for Recipients. Such requests will be made by contacting FDA concerning FDA
   review and approval.

 State and/or Local Public Health Authority(ies)

  E. The appropriate state and/or local public health authority(ies) will ensure that authorized zanamivir products are distributed to recipients in accordance with applicable state and local
   laws and/or in accordance with the public health and medical emergency response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the covered
   countermeasures, and their officials, agents, employees, contractors, or volunteers following a declaration of an emergency.

  F. The appropriate state and/or local public health authority(ies) will make available through appropriate means authorized Fact Sheets for Health Care Providers, authorized Fact Sheets for
   Recipients, and at least one representative FDA-approved package insert that covers the dosage forms and strengths of authorized zanamivir products.

 CDC and State and/or Local Public Health Authority(ies)

  G. CDC and the appropriate state and/or local public health authority(ies) are also authorized to make available additional information relating to the emergency use of authorized zanamivir
   products that is consistent with, and does not exceed, the terms of this letter of authorization.

 The emergency use of authorized zanamivir products as described in this letter of authorization must comply with the conditions above and all other terms of this authorization.

 V. Duration of Authorization

 This EUA will be effective until the declaration of emergency is terminated under section 564(b)(2) of the Act or the EUA is revoked under section 564(g) of the Act.

                   Joshua M. Sharfstein, M.D.
                   Principal Deputy Commissioner
                   Acting Commissioner of Food and Drugs

 \1\ FDA is authorizing the emergency use of Relenza (zanamivir) inhalation powder for treatment and prophylaxis of influenza as described in the scope section of this letter (Section II). For
  ease of reference, this letter of authorization will use the terms ``certain zanamivir product(s)'' and ``authorized zanamivir product(s).''
\2\ No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act.
\3\ Zanamivir products are not recommended for treatment or prophylaxis of influenza in individuals with underlying airways disease (such as asthma or chronic obstructive pulmonary disease)
  due to risk of serious bronchospasm. Zanamivir products have not been proven effective for treatment of influenza in individuals with underlying airways disease. Zanamivir products have not
  been proven effective for prophylaxis of influenza in the nursing home setting. Zanamivir products are not a substitute for early vaccination on an annual basis as recommended by the Centers
  for Disease Control and Prevention Advisory Committee on Immunization Practices. Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness.
  Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug
  susceptibility patterns and treatment effects when deciding whether to use zanamivir products. There is no evidence for efficacy of zanamivir in any illness caused by agents other than
  Influenza A and B. Patients should be advised that the use of zanamivir products for treatment of influenza has not been shown to reduce the risk of transmission of influenza to others.

\4\ It is possible that public health officials or other volunteers might distribute authorized zanamivir products to recipients, if permitted, in accordance with applicable state and local
  law and/or in accordance with the public health and medical emergency response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the covered
  countermeasures, and their officials, agents, employees, contractors, or volunteers following a declaration of an emergency. For ease of reference, this letter will use the term ``health
  care provider(s)'' to refer collectively to these individuals.

    (Please note that certain written emergency use information was
also amended).
    The Authorization (as amended) for certain oseltamivir phosphate
capsules and oral suspension follows and provides an explanation of the
reasons for its issuance, as required by section 564(h)(1) of the act:

 Richard E. Besser, MD
 Acting Director
 Centers for Disease Control and Prevention
 1600 Clifton Rd, MS D-14
 Atlanta, GA 30333

 Dear Dr. Besser:

 This letter is in response to your request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for the emergency use of certain oseltamivir phosphate
 capsules and oral suspension for treatment and prophylaxis of influenza, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. Sec.   360bbb-3).

 On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. Sec.   360bbb-3(b)(1)(C)), the Secretary of the Department of Health and Human Services (DHHS) determined that a
 public health emergency exists involving Swine Influenza A that affects or has significant potential to affect national security. Pursuant to section 564(b) of the Act (21 U.S.C. Sec.
 360bbb-3(b)), and on the basis of such determination, the Secretary of DHHS then declared an emergency justifying the authorization of the emergency use of certain oseltamivir phosphate
 products subject to the terms of any authorization issued under section 564(a) of the Act (21 U.S.C. Sec.   360bbb-3(a))

 Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. Sec.   360bbb-3(b)) are met, I am authorizing the emergency use of certain
 oseltamivir phosphate products\1\ for the treatment and prophylaxis of influenza, subject to the terms of this authorization.

 I. Criteria for Issuance of Authorization

 I have concluded that the emergency use of certain oseltamivir phosphate products for the treatment and prophylaxis of influenza meets the criteria for issuance of an authorization under
 section 564(c) of the Act, because I have concluded that:

    (1) Swine Influenza A can cause influenza, a serious or life-threatening disease or condition;

    (2) based on the totality of scientific evidence available to FDA, it is reasonable to believe that certain oseltamivir phosphate products may be effective for the treatment and
     prophylaxis of influenza, and that the known and potential benefits of certain oseltamivir phosphate products, when used for the treatment and prophylaxis of influenza, outweigh the known
     and potential risks of such products; and

    (3) there is no adequate, approved, and available alternative to the emergency use of certain oseltamivir phosphate products for the treatment and prophylaxis of influenza.\2\

 Therefore, I have concluded that the emergency use of certain oseltamivir phosphate products for the treatment and prophylaxis of influenza meets the above statutory criteria for issuance of
 an authorization.

 II. Scope of Authorization

 I have concluded, pursuant to section 564(d)(1) of the Act, that the scope of this authorization is limited to the use of authorized oseltamivir phosphate products for the treatment and
 prophylaxis of influenza for individuals exposed to Swine Influenza A. The emergency use of authorized oseltamivir phosphate products under this EUA must be consistent with, and may not
 exceed, the terms of this letter, including the scope and the conditions of authorization set forth below.

 The authorized oseltamivir phosphate products are as follows:

     Tamiflu (oseltamivir phosphate) (30 mg, 45 mg, and 75 mg) capsules

     Tamiflu (oseltamivir phosphate) oral suspension

 Oseltamivir phosphate products are approved and indicated for the treatment of uncomplicated acute illness due to influenza infections in patients 1 year and older who have been symptomatic
 for no more than 2 days. Oseltamivir phosphate products are also approved and indicated for the prophylaxis of influenza in patients 1 year and older.\3\

 1. The above oseltamivir phosphate products are authorized for use in patients less than 1 year old. Such products are also authorized for use at later time points (i.e., patients who are
 symptomatic for more than 2 days) and/or in patients sick enough to require hospitalization (i.e., patients who do not have ``uncomplicated acute illness'' per se).

 2. The above oseltamivir phosphate products labeled consistent with the manufacturer's label are authorized to be distributed under this EUA. Such products are authorized to be distributed or
 dispensed without the requisite prescription label information under section 503(b)(2) of the Act (e.g., name and address of dispenser, serial number, date of prescription or of its filling,
 name of prescriber, name of patient, if stated on prescription, directions for use and cautionary statements, if contained in the prescription).

 3. The above oseltamivir phosphate products may include products that are deployed from the Strategic National Stockpile (SNS) and that are authorized to have their expiration date extended
 under the federal government's Shelf Life Extension Program (SLEP).

 4. The above oseltamivir phosphate products are authorized to be accompanied by the following written information pertaining to the emergency use, which are authorized to be made available to
 health care providers\4\ and recipients:

         Fact Sheet for Health Care Provider
         Fact Sheet for Patients and Parents

 CDC and the appropriate state and/or local public health authority(ies) are also authorized to make available additional information relating to the emergency use of authorized oseltamivir
 phosphate products that is consistent with, and does not exceed, the terms of this letter of authorization. (See section IV).

 I have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of authorized oseltamivir phosphate products, when used for
 the treatment and prophylaxis of influenza, outweigh the known and potential risks of such products.

 I have concluded, pursuant to section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that the authorized oseltamivir
 phosphate products may be effective for the treatment and prophylaxis of influenza pursuant to section 564(c)(2)(A) of the Act. FDA has reviewed the scientific information available,
 including the information supporting the conclusions described in Section I above, and concludes that the authorized oseltamivir phosphate products, when used for the treatment and
 prophylaxis of influenza in the specified population, meet the criteria set forth in section 564(c) of the Act concerning safety and potential effectiveness.\5\

 Subject to the terms of this EUA and under the circumstances set forth in the Secretary of DHHS's determination under section 564(b)(1)(C) described above and the Secretary of DHHS's
 corresponding declaration under section 564(b)(1), the oseltamivir phosphate products described above are authorized for the treatment and prophylaxis of influenza for individuals exposed to
 Swine Influenza A.

 This EUA will cease to be effective when the declaration of emergency is terminated under section 564(b)(2) of the Act or when the EUA is revoked under section 564(g) of the Act.

 III. Current Good Manufacturing Practice

 I am waiving current good manufacturing practice requirements with respect to the holding of authorized oseltamivir phosphate products by CDC and other public health authority(ies) for a
 period of ninety days.

 IV. Conditions of Authorization

 Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization:

 CDC

  A. CDC will verify that authorized oseltamivir phosphate products distributed to the Receive, Stage, Storage (RSS) sites are within their labeled (or SLEP-relabeled) expiration dates.

  B. CDC will ensure that the appropriate state and/or local public health authority(ies) are informed of this EUA, including the terms and conditions herein.

  C. CDC will make available to the appropriate state and/or local public health authority(ies) through appropriate means the authorized Fact Sheet for Health Care Providers, Fact Sheet for
   Patients and Parents, and at least one representative FDA-approved package insert that covers the dosage forms and strengths of authorized oseltamivir phosphate products.

  D. Only CDC may request changes to the authorized Fact Sheet for Health Care Providers and authorized Fact Sheet for Patients and Parents. Such requests will be made by contacting FDA
   concerning FDA review and approval.

 State and/or Local Public Health Authority(ies)

  E. The appropriate state and/or local public health authority(ies) will ensure that authorized oseltamivir phosphate products are distributed to recipients in accordance with applicable
   state and local laws and/or in accordance with the public health and medical emergency response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or
   dispense the covered countermeasures, and their officials, agents, employees, contractors, or volunteers following a declaration of an emergency.

  F. The appropriate state and/or local public health authority(ies) will make available through appropriate means authorized Fact Sheet for Health Care Providers, Fact Sheet for Patients and
   Parents, and at least one representative FDA-approved package insert that covers the dosage forms and strengths of authorized oseltamivir phosphate products.

 CDC and State and/or Local Public Health Authority(ies)

  G. CDC and the appropriate state and/or local public health authority(ies) are also authorized to make available additional information relating to the emergency use of authorized
   oseltamivir phosphate products that is consistent with, and does not exceed, the terms of this letter of authorization.

 The emergency use of authorized oseltamivir phosphate products as described in this letter of authorization must comply with the conditions above and all other terms of this authorization.

 V. Duration of Authorization

 This EUA will be effective until the declaration of emergency is terminated under section 564(b)(2) of the Act or the EUA is revoked under section 564(g) of the Act.

                   Joshua M. Sharfstein, M.D.
                   Principal Deputy Commissioner
                   Acting Commissioner of Food and Drugs

 \1\ FDA is authorizing the emergency use of Tamiflu (oseltamivir phosphate) (30 mg, 45 mg, and 75 mg) capsules and oral suspension for treatment and prophylaxis of influenza as described in
  the scope section of this letter (Section II). For ease of reference, this letter of authorization will use the terms ``certain oseltamivir phosphate product(s)'' and ``authorized
  oseltamivir phosphate product(s).''
\2\ No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act.
\3\ The following points should be considered before initiating treatment or prophylaxis with oseltamivir phosphate products. Oseltamivir phosphate products are not a substitute for early
  vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices. Influenza viruses change over time. Emergence of
  resistance mutations could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should
  consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use oseltamivir phosphate products.
\4\ It is possible that public health officials or other volunteers might distribute authorized oseltamivir phosphate products to recipients, if permitted, in accordance with applicable state
  and local law and/or in accordance with the public health and medical emergency response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the
  covered countermeasures, and their officials, agents, employees, contractors, or volunteers following a declaration of an emergency. For ease of reference, this letter will use the term
  ``health care provider(s)'' to refer collectively to these individuals.
\5\ Please note that with respect to authorized oseltamivir phosphate products for use in patients less than 1 year old, the conclusions above are based on limited data available for review
  under the limited timeframe given the circumstances of the emergency. The conclusions above may evolve as the emergency circumstances evolve and as more information becomes available.

    (Please note that certain written emergency use information was
also amended).

    Dated: June 30, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-18568 Filed 8-3-09; 8:45 am]

BILLING CODE 4160-01-S