[Federal Register Volume 85, Number 180 (Wednesday, September 16, 2020)]
[Notices]
[Pages 57866-57867]
[FR Doc No: 2020-20436]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-0177]

Eosinophilic Esophagitis: Developing Drugs for Treatment;
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled
``Eosinophilic Esophagitis: Developing Drugs for Treatment.'' This
guidance is intended to describe the Agency's current thinking and
recommended approach for the development of drugs and therapeutic
biologics for the treatment of patients with eosinophilic esophagitis.
This guidance finalizes the draft guidance of the same name issued
February 6, 2019.

DATES: The announcement of the guidance is published in the Federal
Register on September 16, 2020.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-0177 for ``Eosinophilic Esophagitis: Developing Drugs for
Treatment.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Erica Lyons, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5373, Silver Spring, MD 20993-0002, 301-
796-8023.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry
entitled ``Eosinophilic Esophagitis: Developing Drugs for Treatment.''
This guidance provides FDA's current recommendations regarding clinical
trials for drugs and therapeutic biologics for the treatment of
eosinophilic esophagitis, including attributes of patients for
enrollment, trial designs, efficacy considerations, safety assessments,
and pediatric considerations.
    This guidance finalizes the draft guidance of the same name issued
February 6, 2019 (84 FR 2237). Changes to the guidance took into
consideration public comments received. Major changes included:
     Removal of the recommendation for the proton pump
inhibitor trial before patient enrollment;
     removal of the recommendation for exclusion of patients
with significant strictures;
     addition of a clarification that FDA does not recommend a
randomized withdrawal design for trials of drugs with the potential to
induce immunogenicity;
     addition of a recommendation to report eosinophil density
per square millimeter (mm\2\) as well as per high-power field;
     creation of a statistical section with recommendations on
estimands; and
     addition of a clarification on the recommendation for the
number of adolescent patients to be included in adult trials.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Eosinophilic Esophagitis: Developing Drugs
for Treatment.'' It does not establish any rights for any person and is
not binding on FDA or the public. You can use an alternative approach
if it satisfies the requirements of the applicable statutes and
regulations.

II. Paperwork Reduction Act of 1995

    This final guidance contains no collection of information.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required.
    However, this final guidance refers to previously approved
collections of information found in FDA regulations. These collections
of information are subject to review by OMB under the PRA. The
collections of information in 21 CFR part 312 (investigational new drug
applications) have been approved under OMB control number 0910-0014.
The collections of information in part 314 (new drug applications) have
been approved under OMB control number 0910-0001. The collections of
information in part 601 (biologics license applications) have been
approved under OMB control number 0910-0338. The collections of
information in parts 50 and 56 (protection of human subjects and
institutional review boards) have been approved under OMB control
number 0910-0130. The collections of information in the guidance for
industry entitled ``Expedited Programs for Serious Conditions--Drugs
and Biologics'' (available at https://www.fda.gov/media/86377/download)
have been approved under OMB control number 0910-0765.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.

    Dated: September 11, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-20436 Filed 9-15-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: July 15, 2009 (Volume 74, Number 134)]
[Notices]
[Page 34380-34383]
[DOCID:fr15jy09-130]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-60266; File No. SR-BATS-2009-022]

Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Amend
BATS Rule 11.9, Entitled ``Orders and Modifiers''

July 9, 2009.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby given
that on July 6, 2009, BATS Exchange, Inc. (the ``Exchange'' or
``BATS'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the Exchange. The Exchange has
designated this proposal as a ``non-controversial'' proposed rule
change pursuant to Section 19(b)(3)(A) of the Act \4\ and Rule 19b-
4(f)(6)(iii) thereunder,\5\ which renders it effective upon filing with
the Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
    \4\ 15 U.S.C. 78s(b)(3)(A).
    \5\ 17 CFR 240.19b-4(f)(6)(iii).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to make modifications to the existing
technology that it provides to a User that wishes to avoid trading
against orders from that same User (``Member Match Trade Prevention''
or ``MMTP''). The text of the proposed rule change is available from
the Exchange's Web site at http://www.batstrading.com, at the
Exchange's principal office, 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 parts 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 offer Member Match Trade Prevention, or
MMTP, to Exchange Users pursuant to proposed Rule 11.9(f).\6\
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    \6\ The Exchange currently offers a basic form of match
prevention by allowing a User to request a setting for their
connections that prevents incoming orders from interacting with
resting orders if both orders originate from the same MPID. The
proposed rule expands the functionality offered to Users by
providing additional options for match prevention.
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Background

    The proposed MMTP modifiers are designed to prevent two orders with
the same Unique Identifier (as defined below) from executing against
each other. The Exchange proposes adding four MMTP modifiers that will
be implemented and can be set at the market participant identifier
(``MPID''), the Exchange Member identifier or the Exchange Sponsored
Participant identifier level (any such identifier, a ``Unique
Identifier'').\7\ With one

exception, described below, the MMTP modifier on the incoming order
controls the interaction between two orders marked with MMTP modifiers
from the same Unique Identifier. The four new MMTP modifiers are
discussed more thoroughly below.
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    \7\ Any Exchange Member that has an MPID issued by FINRA is
identified in the Exchange's internal systems by that MPID. Each
Exchange Member that does not already have an MPID and each
Sponsored Participant is issued an identifier that is specific to
the Exchange and allows the Exchange to determine the User for each
order and trade.
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MMTP Cancel Newest (``MCN'')

    An incoming order marked with the MCN modifier will not execute
against opposite side resting interest marked with any MMTP modifier
originating from the same Unique Identifier. The incoming order marked
with the MCN modifier will be cancelled back to the originating User.
The resting order marked with an MMTP modifier, which otherwise would
have interacted with the incoming order from the same Unique
Identifier, will remain on the BATS Book.
    MCN Example 1: An order to buy 500 shares @ $22.00 is marked with
any of the four MMTP modifiers and becomes a resting order on the BATS
Book. Subsequently, an order to sell 500 shares @ $22.00 is entered
with the same Unique Identifier and marked with the MCN modifier.
    MCN Result 1: The incoming sell order for 500 shares @ $22.00
marked with the MCN modifier is cancelled back to the originating User.
The resting buy order for 500 shares at $22.00 marked with one of the
four MMTP modifiers remains on the BATS Book.
    MCN Example 2: An order to buy 500 shares @ $22.00 is marked with
any of the four STP modifiers and becomes a resting order on the BATS
Book. Subsequently, an order to sell 700 shares @ $22.00 is entered
with the same Unique Identifier and marked with the MCN modifier.
    MCN Result 2: The incoming sell order for 700 shares @ $22.00
marked with the MCN modifier is cancelled back to the originating User.
The resting buy order for 500 shares at $22.00 marked with one of the
four MMTP modifiers remains on the BATS Book.
    MCN Example 3: An order to buy 500 shares @ $22.00 is marked with
any of the four MMTP modifiers and becomes a resting order on the BATS
Book. Subsequently, an order to sell 400 shares @ $22.00 is entered
with the same Unique Identifier and marked with the MCN modifier.
    MCN Result 3: The incoming sell order for 400 shares @ $22.00
marked with the MCN modifier is cancelled back to the originating User.
The resting buy order for 500 shares at $22.00 marked one of the four
MMTP modifiers remains on the BATS Book.

MMTP Cancel Oldest (``MCO'')

    An incoming order marked with the MCO modifier will not execute
against opposite side resting interest marked with any MMTP modifier
originating from the same Unique Identifier. The resting order marked
with the MMTP modifier, which otherwise would have interacted with the
incoming order by the same Unique Identifier, will be cancelled back to
the originating User. The incoming order marked with the MCO modifier
will remain on the BATS Book.
    MCO Example 1: An order to buy 500 shares @ $22.00 is marked with
any of the four MMTP modifiers and becomes a resting order in the BATS
Book. Subsequently, an order to sell 500 shares @ $22.00 is entered
with the same Unique Identifier and marked with the MCO modifier.
    MCO Result 1: The resting buy order for 500 shares at $22.00 marked
with one of the four MMTP modifiers is cancelled back to the
originating User. The incoming sell order for 500 shares @ $22.00
marked with the MCO modifier is entered in the BATS Book.
    MCO Example 2: An order to buy 500 shares @ $22.00 is marked with
any of the four MMTP modifiers and becomes a resting order in the BATS
Book. Subsequently, an order to sell 700 shares @ $22.00 is entered
with the same Unique Identifier and marked with the MCO modifier.
    MCO Result 2: The resting buy order for 500 shares at $22.00 marked
with one of the four MMTP modifiers is cancelled back to the
originating User. The incoming sell order for 700 shares @ $22.00
marked with the MCO modifier is entered on the BATS Book.
    MCO Example 3: An order to buy 500 shares @ $22.00 is marked with
any of the four MMTP modifiers and becomes a resting order in the BATS
Book. Subsequently, an order to sell 400 shares @ $22.00 is entered
with the same Unique Identifier and marked with the MCO modifier.
    MCO Result 3: The resting buy order for 500 shares at $22.00 marked
with one of the four MMTP modifiers is cancelled back to the
originating User. The incoming sell order for 400 shares @ $22.00
marked with the MCO modifier is entered on the BATS Book.

MMTP Decrement and Cancel (``MDC'')

    An incoming order marked with the MDC modifier will not execute
against opposite side resting interest marked with any MMTP modifier
originating from the same Unique Identifier. If both orders are
equivalent in size, both orders will be cancelled back to the
originating User. If the orders are not equivalent in size, the
equivalent size will be cancelled back to the originating User and the
larger order will be decremented by the size of the smaller order, with
the balance remaining on the BATS Book; provided, however, that if the
resting order is marked with any MMTP modifier other than MDC, and the
incoming order is smaller in size than the resting order, then both
orders will be cancelled back to the originating User.
    MDC Example 1: An order to buy 500 shares @ $22.00 is marked with
any of the four MMTP modifiers and becomes a resting order on the BATS
Book. Subsequently, an order to sell 500 shares @ $22.00 is entered
with the same Unique Identifier and marked with the MDC modifier.
    MDC Result 1: The resting buy order for 500 shares at $22.00 marked
with one of the four MMTP modifiers is cancelled back to the
originating User. The incoming sell order for 500 shares @ $22.00
marked with the MDC modifier is cancelled back to the originating User.
    MDC Example 2: An order to buy 500 shares @ $22.00 is marked with
any of the four MMTP modifiers and becomes a resting order in the BATS
Book. Subsequently, an order to sell 700 shares @ $22.00 is entered
with the same Unique Identifier and marked with the MDC modifier.
    MDC Result 2: The resting buy order for 500 shares at $22.00 marked
with one of the four MMTP modifiers is cancelled back to the
originating User. The equivalent portion, 500 shares, of the incoming
sell order marked with the MDC modifier is cancelled back to the
originating User. The remaining portion, 200 shares, is entered on the
BATS Book.
    MDC Example 3: An order to buy 500 shares @ $22.00 is marked with
an MDC modifier and becomes a resting order in the BATS Book.
Subsequently, an order to sell 400 shares @ $22.00 is entered with the
same Unique Identifier and marked with the MDC modifier.
    MDC Result 3: 400 of the 500 shares on the resting buy order at
$22.00 marked with one of the four MMTP modifiers are cancelled back to
the originating User. The outstanding 100 shares remain on the BATS
Book. The incoming sell order for 400 shares @ $22.00 marked with the
MDC modifier is cancelled back to the originating User.
    MDC Example 4: An order to buy 500 shares @ $22.00 is marked with
any MMTP modifier other than MDC and

becomes a resting order in the BATS Book. Subsequently, an order to
sell 400 shares @ $22.00 is entered with the same Unique Identifier and
marked with the MDC modifier.
    MDC Result 4: The resting buy order for 500 shares at $22.00 marked
with a MMTP modifier other than MDC is cancelled back to the
originating User. The incoming sell order for 400 shares @ $22.00
marked with the MDC modifier is cancelled back to the originating User.

MMTP Cancel Both (``MCB'')

    An incoming order marked with the MCB modifier will not execute
against opposite side resting interest marked with any MMTP modifier
originating from the same Unique Identifier. The entire size of both
orders will be cancelled back to the originating User.
    MCB Example 1: An order to buy 500 shares @ $22.00 is marked with
any of the four MMTP modifiers and becomes a resting order in the BATS
Book. Subsequently, an order to sell 500 shares @ $22.00 is entered
with the same Unique Identifier and marked with the MCB modifier.
    MCB Result 1: The resting buy order for 500 shares at $22.00 marked
with one of the four MMTP modifiers is cancelled back to the
originating User. The incoming sell order for 500 shares @ $22.00
marked with the MCB modifier is cancelled back to the originating User.
    MCB Example 2: An order to buy 500 shares @ $22.00 is marked with
any of the four MMTP modifiers and becomes a resting order in the BATS
Book. Subsequently, an order to sell 700 shares @ $22.00 is entered
with the same Unique Identifier and marked with the MCB modifier.
    MCB Result 2: The resting buy order for 500 shares at $22.00 marked
with one of the four MMTP modifiers is cancelled back to the
originating User. The incoming order to sell 700 shares @ $22.00 marked
with the MCB modifier is cancelled back to the originating User.
    MCB Example 3: An order to buy 500 shares @ $22.00 is marked with
any of the four MMTP modifiers and becomes a resting order in the BATS
Book. Subsequently, an order to sell 400 shares @ $22.00 is entered
with the same Unique Identifier and marked with the MCB modifier.
    MCB Result 3: The resting buy order for 500 shares at $22.00 marked
with one of the four MMTP modifiers is cancelled back to the
originating User. The incoming order to sell 400 shares @ $22.00 marked
with the MCB modifier is cancelled back to the originating User.

Additional Discussion

    MMTP modifiers are intended to prevent interaction between the same
Unique Identifier. MMTP modifiers must be present on both the buy and
the sell order in order to prevent a trade from occurring and to effect
a cancel instruction. MMTP modifiers are available for orders entered
in either an agency or principal capacity. An incoming MMTP order
cannot cancel through resting orders that have price and/or time
priority. When an order with an MMTP modifier is entered it will first
interact with all available interest in accordance with the execution
process described in Exchange Rules 11.12 and 11.13. If there is a
remaining balance on the order after trading with all orders with
higher priority, it may then interact with an opposite side MMTP order
in accordance with the rules established above. Incoming MMTP orders
that are priced through the price of a resting MMTP order may cancel
the resting order as long as no other non-MMTP orders have priority.
    The Exchange believes that adding this functionality will allow
Exchange Users to better manage order flow and prevent undesirable
executions with themselves or the potential for (or the appearance of)
``wash sales'' that may occur as a result of the velocity of trading in
today's high speed marketplace. Many Exchange Users have multiple
connections into the Exchange due to capacity and speed related
demands. Orders routed by the same User via different connections may,
in certain circumstances, trade against each other. The new MMTP
modifiers provide Users the opportunity to prevent these potentially
undesirable trades occurring under the same Unique Identifier on both
the buy and sell side of the execution. The Exchange also believes that
this functionality will allow firms to better internalize agency order
flow which in turn may decrease the costs to its customers. The
Exchange notes that the MMTP modifiers do not alleviate, or otherwise
exempt, broker-dealers from their best execution obligations. As such,
broker-dealers using the MMTP modifiers will be obligated to internally
cross agency orders at the same price, or a better price than they
would have received had the orders been executed on the Exchange.
Additionally, the MMTP modifiers will assist market participants in
complying with certain rules and regulations of the Employee Retirement
Income Security Act (``ERISA'') that preclude and/or limit managing
broker-dealers of such accounts from trading as principal with orders
generated for those accounts. Finally, the Exchange notes that offering
the MMTP modifiers will streamline certain regulatory functions by
reducing false positive results that may occur on Exchange generated
wash trading surveillance reports when orders are executed under the
same Unique Identifier. For these reasons, the Exchange believes the
MMTP modifiers offer users enhanced order processing functionality that
may prevent potentially undesirable executions without negatively
impacting broker-dealer best execution obligations.
2. Statutory Basis
    The rule change proposed in this submission is consistent with the
requirements of the Act and the rules and regulations thereunder that
are applicable to a national securities exchange, and in particular,
with the requirements of Section 6(b) of the Act.\8\ Specifically, the
proposed change is consistent with Section 6(b)(5) of the Act,\9\
because it is designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in facilitating
transactions in securities, and to remove impediments to, and perfect
the mechanism of, a free and open market and a national market system.
This functionality will allow firms to better manage order flow and
prevent undesirable executions against themselves.
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    \8\ 15 U.S.C. 78f(b).
    \9\ 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 imposes
any burden on competition.

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

    The Exchange has neither solicited nor received comments on the
proposed rule change.

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

    Because the foregoing proposed rule change: (1) Does not
significantly affect the protection of investors or the public
interest; (2) does not impose any significant burden on competition;
and (3) by its terms does not become operative for 30 days after the
date of this filing, or such shorter time as the

Commission may designate if consistent with the protection of investors
and the public interest, the proposed rule change has become effective
pursuant to Section 19(b)(3)(A) of the Act \10\ and Rule 19b-4(f)(6)
thereunder.\11\
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    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative for 30 days after the date of filing. In addition,
Rule 19b-4(f)(6)(iii) requires a self-regulatory organization to
provide the Commission with 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. However, Rule 19b-4(f)(6)(iii) permits the
Commission to designate a shorter time if such action is consistent
with the protection of investors and the public interest. The Exchange
requests that the Commission waive the 30-day operative delay as well
as the five business-day pre-filing requirement so that the benefits of
this functionality to BATS market participants expected from the rule
change will not be delayed. The Commission believes that waiving the
30-day operative delay\12\ to make this functionality available without
delay is consistent with the protection of investors and the public
interest.\13\ Therefore, the Commission designates the proposal
operative upon filing.
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    \12\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
    \13\ The Commission is also waiving the five business-day pre-
filing requirement.
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    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate 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.

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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-BATS-2009-022 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BATS-2009-022. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5552, will be available for inspection and copying in the
Commission's Public Reference Room, 100 F Street, NE., Washington, DC
20549, on official business days between the hours of 10 a.m. and 3
p.m. Copies of the filing also will be available for inspection and
copying at the principal office of the Exchange. All comments received
will be posted without change; the Commission does not edit personal
identifying information from submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-BATS-2009-022 and should be submitted on
or before August 5, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
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    \14\ 14 17 CFR 200.30-3(a)(12).
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Elizabeth M. Murphy,
Secretary.
 [FR Doc. E9-16713 Filed 7-14-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 85, Number 63 (Wednesday, April 1, 2020)]
[Notices]
[Page 18328]
[FR Doc No: 2020-06788]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. 2020-11]

Petition for Exemption; Summary of Petition Received; Monar Aero
Inc.

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Federal Aviation Regulations. The
purpose of this notice is to improve the public's awareness of, and
participation in, the FAA's exemption process. Neither publication of
this notice nor the inclusion or omission of information in the summary
is intended to affect the legal status of the petition or its final
disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before April 21, 2020.

ADDRESSES: Send comments identified by docket number FAA-2019-1111
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation, 1200 New Jersey Avenue SE, Room W12-140,
West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE,
Washington, DC 20590-0001, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Jake Troutman,<PHONE_NUMBER>, Office
of Rulemaking, Federal Aviation Administration, 800 Independence Avenue
SW, Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on March 20, 2020.
Brandon Roberts,
Deputy Executive Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2019-1111.
    Petitioner: Monar Aero Inc.
    Section(s) of 14 CFR Affected: Part 21, Subpart H Sec. Sec.
45.23(b); 61.113(a) & (b); 61.133(a); 91.7(a); 91.9(b)(2); 91.103(b);
91.109; 91.119; 91.121; 91.151; 91.203(a) & (b); 91.405(a);
91.407(a)(1); 91.409(a)(2); & 91.417(a) & (b).
    Description of Relief Sought: The proposed exemption, if granted,
would allow the petitioner to operate camera-mounted unmanned aircraft
systems (UAS) weighing more than 55 pounds (lbs.), but less than 100
lbs. including payload (i.e. camera, lens, remote head) for the purpose
of closed-set filming of motion pictures, music videos, web videos,
corporate videos, television programs and commercials, and still
photography. Proposed operations would occur as close as 20 feet from
filming production personnel. Operation altitude would not exceed 400
feet above ground level.

[FR Doc. 2020-06788 Filed 3-31-20; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 79 (Tuesday, April 24, 2018)]
[Notices]
[Page 17869]
[FR Doc No: 2018-08619]

=======================================================================
-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

TIME AND DATE:  2:00 p.m. on Thursday, April 26, 2018.

PLACE:  Closed Commission Hearing Room 10800.

STATUS:  This meeting will be closed to the public.

MATTERS TO BE CONSIDERED:  Commissioners, Counsel to the Commissioners,
the Secretary to the Commission, and recording secretaries will attend
the closed meeting. Certain staff members who have an interest in the
matters also may be present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (6), (7), (8), 9(B) and (10) and 17 CFR
200.402(a)(3), (a)(5), (a)(6), (a)(7), (a)(8), (a)(9)(ii) and (a)(10),
permit consideration of the scheduled matters at the closed meeting.
    Commissioner Piwowar, as duty officer, voted to consider the items
listed for the closed meeting in closed session.
    The subject matters of the closed meeting will be:
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings; and
    Other matters relating to enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.

CONTACT PERSON FOR MORE INFORMATION:  For further information and to
ascertain what, if any, matters have been added, deleted or postponed,
please contact Brent J. Fields from the Office of the Secretary at
(202) 551-5400.

     Dated: April 19, 2018.
Brent J. Fields,
Secretary.
[FR Doc. 2018-08619 Filed 4-20-18; 11:15 am]
BILLING CODE 8011-01-P


	Standards of Performance for Coal Preparation and Processing Plants --

Final Amendments Powerpoint

	Mary Johnson

	to:

	Higgins, Cortney

	08/26/2009 02:47 PM

	Cc:

	Bill Maxwell, RobertJ Wayland, Sonja Rodman, Thomas Gillis, Cathy Coats,

Teresa Clemons

	Show Details

Hi Cortney,

I just heard that you are on vacation starting tomorrow and return to work

on September 8.  Good for you!  As promised during our August 5 phone call

regarding coal prep, I am forwarding you some powerpoint slides that

summarize issues raised by public commenters and EPA's recommendations on

those issues.  Please note that the slides are labeled  "DRAFT" and have

not been shared outside of EPA.  I would like to go ahead and schedule a

meeting with you to discuss the information/issues presented in the

slides.  Because the FR notice must be signed by September 24, I would

like to have the meeting as soon as possible after you return from

vacation.  Can you provide me with a several 1 or 1.5 hour timeslots that

you are available?  I will then schedule a meeting.  Unless I hear

otherwise from you, we will do the meeting by telephone.

Thanks and have a great vacation!

Mary

Mary Johnson

Environmental Engineer

U.S. Environmental Protection Agency

Office of Air Quality Planning and Standards

Mail Code D 243-01

Research Triangle Park, NC  27711

Phone:<PHONE_NUMBER>

Fax:<PHONE_NUMBER>


[Federal Register Volume 84, Number 130 (Monday, July 8, 2019)]
[Rules and Regulations]
[Pages 32268-32269]
[FR Doc No: 2019-14355]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 216

[Docket No. FDA-2019-D-2733]

Compliance Policy for Certain Compounding of Oral Oxitriptan (5-
HTP) Drug Products for Patients With Tetrahydrobiopterin (BH4)
Deficiency; Immediately in Effect Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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

SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is
announcing the availability of an immediately in effect guidance for
industry entitled ``Compliance Policy for Certain Compounding of Oral
Oxitriptan (5-HTP) Drug Products for Patients With Tetrahydrobiopterin
(BH4) Deficiency.'' This guidance describes FDA's policy concerning the
conditions under which the Agency does not generally intend to take
regulatory action against a licensed pharmacist in a State-licensed
pharmacy or Federal facility or a licensed physician using the bulk
drug substance oxitriptan (also known as 5-hydroxytryptophan or 5-HTP)
to compound oral drug products for patients with tetrahydrobiopterin
(BH4) deficiency. FDA developed this guidance in response to
communications from pharmacists and caregivers regarding the use of
oxitriptan to treat patients with BH4 deficiency following issuance of
a final rule that placed oxitriptan on the list of substances that
cannot be used to compound drug products in accordance with certain
compounding provisions of the Federal Food, Drug, and Cosmetic Act
(FD&C Act).

DATES: The announcement of the guidance is published in the Federal
Register on July 8, 2019.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-2733 for ``Compliance Policy With Respect to Certain
Compounding of Oral Oxitriptan (5-HTP) Drug Products for Patients With
Tetrahydrobiopterin (BH4) Deficiency.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Office of Communications, Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Bldg., 4th Floor, Silver Spring, MD 20993-
0002,<PHONE_NUMBER> or<PHONE_NUMBER>; Fax:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>Send two self-addressed adhesive labels to assist
that office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Tracy Rupp, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 5171, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of an immediately in effect
guidance for industry entitled ``Compliance Policy for Certain
Compounding of Oral Oxitriptan (5-HTP) Drug Products for Patients With
Tetrahydrobiopterin (BH4) Deficiency.'' This guidance describes FDA's
policy concerning the conditions under which the Agency does not
generally intend to take regulatory action against a licensed
pharmacist in a State-licensed pharmacy or Federal facility or a
licensed physician using the bulk drug substance oxitriptan to compound
oral drug products for patients with BH4 deficiency.
    Section 503A of the FD&C Act (21 U.S.C. 353a) describes the
conditions that must be satisfied for human drug products compounded by
a licensed pharmacist in a State-licensed pharmacy or Federal facility,
or by a licensed physician to qualify for exemptions from certain
requirements of the FD&C Act related to FDA approval prior to
marketing, current good manufacturing practice requirements, and
labeling with adequate directions for use (see sections 505,
501(a)(2)(B), and 502(f)(1) of the FD&C Act (21 U.S.C. 355,
351(a)(2)(B), and 352(f)(1))). One of the conditions that must be met
for a compounded drug product to qualify for these exemptions is that a
licensed pharmacist or licensed physician compounds the drug product
using bulk drug substances that: (1) Comply with the standards of an
applicable United States Pharmacopoeia (USP) or National Formulary (NF)
monograph, if a monograph exists, and the USP chapter on pharmacy
compounding; (2) if such a monograph does not exist, are drug
substances that are components of drugs approved by FDA; or (3) if such
a monograph does not exist and the drug substance is not a component of
a drug approved by FDA, appear on a list of bulk drug substances
developed by FDA through regulation. (See section 503A(b)(1)(A)(i) of
the FD&C Act.)
    On February 19, 2019, FDA issued a final rule (84 FR 4696)
(``February 19, 2019, final rule''), which established the list of bulk
drug substances that can be used to compound drug products under
section 503A of the FD&C Act even though they are not the subject of an
applicable USP or NF monograph or a component of an FDA approved drug
product (the 503A Bulks List). (See section 503A(b)(1)(A) of the FD&C
Act.) The final rule, codified at Sec.  216.23 (21 CFR 216.23), placed
six bulk drug substances on the 503A Bulks List (Sec.  216.23(a)), and
identified four others, including oxitriptan, that cannot be used to
compound drug products under section 503A of the FD&C Act (Sec.
216.23(b)). Additional bulk drug substances nominated by the public for
inclusion on this list are currently under consideration and will be
the subject of future rulemaking.
    FDA developed this guidance in response to communications from
pharmacists and caregivers regarding the use of oxitriptan to treat
patients with BH4 deficiency following issuance of the February 19,
2019, final rule, which placed oxitriptan on the list of bulk drug
substances that cannot be used to compound drug products under section
503A of the FD&C Act. According to those communications and other
information available to the Agency, oxitriptan is the standard of care
for the treatment of BH4 deficiency, which is caused by several
different rare enzyme defects that result from gene mutations. BH4
deficiency is also known as: Primary tetrahydrobiopterin deficiency,
atypical phenylketonuria (PKU), GTP cyclohydrolase (GTPCH) deficiency,
6-pyruvoyl-tetrahydropterin synthase (6-PTPS) deficiency, and
dihydropteridine reductase (DHPR) deficiency. FDA did not consider BH4
deficiency during its initial review of this substance for the 503A
Bulks List. Thus, this guidance addresses the conditions under which
FDA does not intend to take regulatory action against a licensed
pharmacist in a State-licensed pharmacy or Federal facility or a
licensed physician for the use of bulk oxitriptan to compound oral drug
products for the treatment of identified individual patients with BH4
deficiency provided certain conditions are met. In light of the new
information regarding use of oral oxitriptan to treat BH4 deficiency,
FDA is considering whether to reevaluate the exclusion of oxitriptan
from the 503A Bulks List.
    FDA is issuing this guidance consistent with our good guidance
practices (GGP) regulation (21 CFR 10.115). We are implementing this
guidance without prior public comment because we have determined that
prior public participation is not feasible or appropriate due to the
public health need for patients with BH4 deficiency to access
compounded oxitriptan oral drug products (21 CFR 10.115(g)(2)). This
guidance does not establish any rights for any person and is not
binding on FDA or the public. Although this guidance is immediately in
effect, it remains subject to comment in accordance with FDA's GGP
regulation. This guidance is not subject to Executive Order 12866.

II. Electronic Access

    Persons with access to the internet may obtain the document at
either https://www.fda.gov/RegulatoryInformation/Guidances/default.htm
or https://www.regulations.gov. Use the FDA website listed in the
previous sentence to find the most current version of the guidance.

    Dated: July 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-14355 Filed 7-5-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: February 8, 2006 (Volume 71, Number 26)]
[Notices]
[Page 6528-6530]
[DOCID:fr08fe06-152]

=======================================================================
-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53205; File No. SR-Amex-2005-124]

Self-Regulatory Organizations; American Stock Exchange LLC;
Notice of Filing of Proposed Rule Change and Amendments No. 1, 2, and 3
Thereto Relating to Increases in the Original Listing and Annual Fees

February 1, 2006.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on December 6, 2005, the American Stock Exchange LLC (``Amex'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by Amex. On December 28,
2005, Amex filed Amendment No. 1 to the proposed rule change.\3\ On
January 23, 2006, Amex filed Amendment No. 2 to the proposed rule
change.\4\ On January 27, 2006, Amex filed Amendment No. 3 to the
proposed rule change.\5\ The Commission is publishing this notice to
solicit comments on the proposed rule change, as amended, from
interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Amendment No. 1 explains the differences in the percentage
increases in the original listing and annual fees for smaller and
larger companies and also makes technical corrections to the rule
text in Exhibit 5.
    \4\ Amendment No. 2 was withdrawn on January 31, 2006.
    \5\ Amendment No. 3 discusses the reasons why the original
listing and annual issuer fees vary depending on the size of the
company and corrects non-substantive typographical errors in the
text of the Amex Fee Schedule submitted as Exhibit 5.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Amex proposes to amend Sections 140 and 141 of the Amex Company
Guide and the Amex Fee Schedule to increase the original listing and
the annual issuer fees. The text of the proposed rule change is
available on Amex's Web site (http://www.amex.com), at the principal

office of Amex, 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, Amex included statements
concerning the purpose of and basis for the

proposed rule change. The text of these statements may be examined at
the places specified in Item IV below. Amex 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
    Amex proposes to amend Sections 140 and 141 of the Amex Company
Guide and the Amex Fee Schedule to increase the original listing and
the annual issuer fees. The Exchange believes these fee increases are
necessary to cover increased costs it has incurred in the enhancement
and development of its trading technology and improvements in the
overall level of services provided to its members and listed companies.
The Exchange's original and annual listing fees have not increased
since 2002. Should the Commission approve the proposed rule change, the
Exchange proposes to implement the increased annual fees retroactively
to January 2006 and the increased original listing fees prospectively
upon the Commission's approval of this proposal.\6\
---------------------------------------------------------------------------

    \6\ Amex clarified that the annual fees will be applied
retroactively to January 2006 and the original listing fees will be
applied prospectively. Telephone conversation between Claire
McGrath, Senior Vice President and General Counsel, Amex and Jan
Woo, Attorney, Division of Market Regulation, Commission, on
February 1, 2006.
---------------------------------------------------------------------------

    Currently the original listing fees pursuant to Section 140 of the
Amex Company Guide for stock issues range from $35,000 to $65,000
(which includes a non-refundable application processing fee of $5,000)
depending on the number of shares to be listed. Amex proposes that the
original listing fees be increased as follows:

----------------------------------------------------------------------------------------------------------------
                                                                                Percentage
                        Number of shares                           Current fee*    Proposed fee*     increase
----------------------------------------------------------------------------------------------------------------
Less than 5,000,000 shares......................................         $35,000         $45,000              28
5,000,000 to 10,000,000 shares..................................          45,000          55,000              22
10,000,001 to 15,000,000 shares.................................          55,000          60,000               9
In excess of 15,000,000 shares..................................          65,000          70,000               8
----------------------------------------------------------------------------------------------------------------
* Includes the non-refundable application-processing fee of $5,000.

    As indicated in the chart above, the percentage increase in the
original listing fees varies depending upon the number of shares to be
listed. Rather than increase each level the same percentage, the
Exchange chose to vary the percentage increases in order to remain
competitive with the original listing fees charged by other market
places. Based upon original listing fees in place at its competitors,
the Exchange determined to increase the fees by a larger percentage for
smaller companies than for larger companies. The proposed increases in
the original listing fees will not change the manner in which these
fees are applied--companies with a fewer number of shares will be
charged less than companies with a greater number of shares. The
Exchange's purpose for differentiating its original listing fees is
based on the Amex's business objective of attracting small to mid-size
companies and the recognition that the costs associated with listing
can be significant to a small or mid-size company. In addition, as a
general matter, companies with fewer shares tend to have less complex
structures, which may result in less staff time spent reviewing the
company's listing application.
    In addition, the original listing fee for non-U.S. companies listed
on a foreign stock exchange is currently 50% of the fees charged to
U.S. companies. Amex proposes that the original listing fee for non-
U.S. companies be a flat fee of $40,000, which will include the one-
time, non-refundable application-processing fee of $5,000. The original
listing fees currently paid by non-U.S. companies are significantly
lower than the rates paid by U.S. companies due to the additional costs
non-U.S. companies incur when listing in the United States. In order to
continue to recognize the costs faced by non-U.S. companies, the
Exchange chose to set a single rate that is below the lowest rate it
charges to U.S. companies, but is still competitive with rates charged
by other markets. Finally, the original listing fees for issues listed
pursuant to Sections 106 (currency and index warrants) and 107 (other
securities) of the Amex Company Guide will remain at the current rates.
    The annual fees set forth in Section 141 of the Amex Company Guide
currently range from $15,000 to $30,000 depending on the number of
shares outstanding. Amex proposes that the annual fees be increased as
follows:

----------------------------------------------------------------------------------------------------------------
                                                                                Percentage
                        Number of shares                            Current fee    Proposed fee      increase
----------------------------------------------------------------------------------------------------------------
5,000,000 shares or less........................................         $15,000         $16,500              10
5,000,001 to 10,000,000 shares..................................          17,500          19,000               9
10,000,001 to 25,000,000 shares.................................          20,000          21,500               8
25,000,001 to 50,000,000 shares.................................          22,500          24,500               9
50,000,001 to 75,000,000 shares.................................          30,000          32,500               8
In excess of 75,000,000 shares..................................          30,000          34,000              13
----------------------------------------------------------------------------------------------------------------

    As indicated in the chart above, the percentage increase in the
annual fees varies depending upon the number of shares outstanding.
Rather than increase each level the same percentage, the Exchange chose
to vary the percentage increases in order to remain competitive with
the annual fees charged by other market places. Based upon annual fees
in place at its competitors, the Exchange determined to increase the
fees by a larger percentage for its largest companies. The Exchange's
purpose for having lower annual fees for companies with fewer shares
outstanding is similarly based on its objective to retain the listings
of small to mid-size companies and a recognition that the on-going
costs associated with being a listed company have a greater impact on
the small to mid-size company. It should be noted that the Amex's
competitors also use a sliding scale

when applying original listing and annual issuer fees.
    In addition, the annual fees for issues listed pursuant to Sections
106 (currency and index warrants) and 107 (other securities) of the
Amex Company Guide will remain at their current rates.
    Finally, the Exchange is also proposing other minor technical
changes to Sections 140 and 141 of the Amex Company Guide, which will
not further alter the fees but will clarify the text of these Sections.
2. Statutory Basis
    Amex believes that the proposed rule change is consistent with
Section 6(b) of the Act \7\ in general and furthers the objectives of
Section 6(b)(4) of the Act \8\ in particular in that it is designed to
provide for the equitable allocation of reasonable dues, fees, and
other charges among its members and issuers and other persons using its
facilities. In addition, increasing original listing and annual fees
will provide the Exchange with the ability to cover increased expenses
related to enhancements in its trading technology, business services,
and regulatory programs.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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

    Amex does not believe that the proposed rule change will impose any
burden on competition.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission will:
    (A) By order approve such proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be 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, as amended, 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 e-mail to<EMAIL_ADDRESS>Please include

File No. SR-Amex-2005-124 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Amex-2005-124. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of Amex. All comments received will be posted without
change; the Commission does not edit personal identifying information
from submissions. You should submit only information that you wish to
make available publicly. All submissions should refer to File Number
SR-Amex-2005-124 and should be submitted on or before March 1, 2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Nancy M. Morris,
Secretary.
 [FR Doc. E6-1728 Filed 2-7-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: March 31, 2008 (Volume 73, Number 62)]
[Rules and Regulations]
[Page 16754-16755]
[DOCID:fr31mr08-4]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

New Animal Drugs For Use in Animal Feed; Zilpaterol

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a new animal drug application
(NADA) filed by Intervet Inc. The NADA provides for use of approved,
single-ingredient Type A medicated articles containing zilpaterol
hydrochloride and melengestrol acetate in two-way combination Type B
and Type C medicated feeds for heifers fed in confinement for
slaughter.

DATES: This rule is effective March 31, 2008.

FOR FURTHER INFORMATION CONTACT: Gerald L. Rushin, Center for
Veterinary Medicine (HFV-126), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Intervet Inc., P.O. Box 318, 29160 Intervet
Lane, Millsboro, DE 19966, filed NADA 141-284 that provides for use of
ZILMAX (zilpaterol hydrochloride) and MGA (melengestrol acetate) Type A
medicated articles to make dry and liquid two-way combination Type B
and Type C medicated feeds used for increased rate of weight gain,
improved feed efficiency, and increased carcass leanness; and for
suppression of estrus (heat) in heifers fed in confinement for
slaughter during the last 20 to 40 days on feed. The NADA is approved
as of February 29, 2008, and the regulations in 21 CFR 558.665 are
amended to reflect the approval.
    In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to support approval of
this application may be seen in the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.33(a)(2) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore,

neither an environmental assessment nor environmental impact statement
is required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
1. The authority citation for 21 CFR part 558 continues to read as
follows:

    Authority: 21 U.S.C. 360b, 371.

0
2. In Sec.  558.665, add paragraph (e)(2) to read as follows:

Sec.  558.665  Zilpaterol.

* * * * *
    (e) * * *

------------------------------------------------------------------------
Zilpaterol in  Combination in   Indications
  grams/ton       grams/ton       for use      Limitations     Sponsor
------------------------------------------------------------------------
                              * * * * * * *
------------------------------------------------------------------------
(2) 6.8 to     Melengestrol    Heifers fed    As in               057926
 provide 60     acetate to      in             paragraph
 to 90 mg/      provide 0.25    confinement    (e)(1) of
 head/day       to 0.5 mg/      for            this
                head/day        slaughter:     section; see
                                As in          paragraph
                                paragraph      Sec.  Sec.
                                (e)(1) of      558.342(d)
                                this           of this
                                section; and   chapter.
                                for            Melengestrol
                                suppression    acetate as
                                of estrus      provided by
                                (heat).        No. 000009
                                               in Sec.
                                               510.600(c)
                                               of this
                                               chapter.
------------------------------------------------------------------------
                              * * * * * * *
------------------------------------------------------------------------

    Dated: March 21, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-6601 Filed 3-28-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 76, Number 199 (Friday, October 14, 2011)]
[Proposed Rules]
[Page 63858]
[FR Doc No: 2011-26543]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2011-0932]

Drawbridge Operation Regulation; Trent River, New Bern, NC

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Commander, Fifth Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
US 70 Alfred Cunningham Bridge across the Trent River, mile 0.0, at New
Bern, NC. The deviation is necessary to accommodate racers in the three
Neuse River Bridge Runs. This deviation allows the bridge to remain in
the closed position to ensure safe passage for the racers.

DATES: This deviation is effective from 6:30 a.m. through 9:30 a.m. on
October 15, 2011.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket USCG-2011-0932 and are available online
by going to http://www.regulations.gov, inserting USCG-2011-0932 in the
``Keyword'' box and then clicking ``Search''. They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or e-mail Lindsey Middleton, Coast Guard; telephone<PHONE_NUMBER>,
e-mail<EMAIL_ADDRESS>If you have questions on viewing
the docket, call Renee V. Wright, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Neuse River Bridge Run Committee on
behalf of the North Carolina Department of Transportation has requested
a temporary deviation from the current operating regulation of the US
70 Alfred Cunningham Bascule Bridge across the Trent River, mile 0.0,
at New Bern, NC. The route of the three Neuse River Bridge Run races
cross the bridge and the requested deviation is to accommodate a safe
and efficient passage across the bridge for the racers. To facilitate
this event, the draw of the bridge will be maintained in the closed-to-
navigation position from 6:30 a.m. until 9:30 a.m. on Saturday, October
15, 2011.
    The vertical clearance for this bridge in the closed position is 14
feet at Mean High Water and unlimited in the open position. The
operating regulations are set forth in 33 CFR 117.843(a) which states
that during this time of year the bridge shall open on signal.
    Vessels that can pass through the bridge in the closed position may
do so at any time. The Coast Guard will inform the waterway users of
the closure through our Local Notices to Mariners and other appropriate
local media to minimize any impact caused by the temporary deviation.
The bridge will be able to open for emergencies. Most vessel traffic
utilizing this bridge consists of recreational boaters. October is
outside of the high recreational boating season therefore, only a small
number of boaters may be affected by this temporary closure. There are
no alternate routes to the Neuse River from the Trent River.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: September 26, 2011.
Waverly W. Gregory, Jr.,
Bridge Program Manager, by direction of the Commander, Fifth Coast
Guard District.
[FR Doc. 2011-26543 Filed 10-13-11; 8:45 am]
BILLING CODE 9110-04-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

REGION III

	1650 Arch Street

	Philadelphia, Pennsylvania  19103

DATE:            August 12, 2013

SUBJECT:	Technical Support Document for the Delaware State
Implementation Plan for the Infrastructure Requirements for the 2008
Ozone National Ambient Air Quality Standards

			/s/

FROM:	Rose Quinto, Environmental Engineer

Office of Air Program Planning

TO:		File

			/s/

THRU: 	Cristina Fernandez, Associate Director

Office of Air Program Planning

A.  INTRODUCTION

The Environmental Protection Agency (EPA) is taking action on a
submittal made by the State of Delaware to meet the Clean Air Act (CAA)
section 110(a)(2) infrastructure requirements for the 2008 8-hour ozone
national ambient air quality standards (NAAQS).

B.  BACKGROUND

On March 27, 2008 (73 FR 16436), EPA promulgated a revised NAAQS for
ozone based on

8-hour average concentrations.  EPA revised the level of the 8-hour
ozone NAAQS from 0.08 parts per million (ppm) to 0.075 ppm.

Pursuant to section 110(a) of the CAA, states are required to submit
state implementation plans (SIPs) that provide for the implementation,
maintenance, and enforcement of new or revised NAAQS within three years
following the promulgation of such NAAQS.  Section 110(a) of the CAA
imposes the obligation upon states to make a SIP submission to EPA for a
new or revised NAAQS.  For the 2008 8-hour ozone NAAQS, states typically
have met many of the basic program elements required in section
110(a)(2) of the CAA through earlier SIP submissions in connection with
previous ozone standards.  Section 110(a)(2) of the CAA lists specific
elements that states must meet or continue to meet in these SIP
submissions.  The requirements include SIP infrastructure elements such
as requirements for modeling, monitoring, and emissions inventories that
are designed to assure attainment and maintenance of the NAAQS.

C.  EPA REQUIREMENTS

As discussed above, for the  2008 8-hour ozone NAAQS, states must
provide SIP submissions, or provide certification that the existing SIP
contains provisions addressing relevant infrastructure SIP elements from
sections 110(a)(2)(A) through (M) of the CAA.

D.  STATE’S SUBMITTAL

On March 27, 2013, Delaware provided a submittal to satisfy the
requirements of section 110(a)(2) of the CAA for the 2008 8-hour ozone
NAAQS.  This submittal addressed the following infrastructure elements
that EPA is proposing to approve:  Section 110(a)(2)(A), (B), (C),
(D)(i)(II), (D)(ii), (E), (F), (G), (H), (J), (K), (L), and (M) of the
CAA.

E.  EVALUATION OF STATE SUBMITTAL

1.  Section 110(a)(2)(A)

EPA has determined that Delaware has established laws and regulations
applicable to the 2008 8-hour ozone NAAQS that include enforceable
emissions limitations and other control measures, means or techniques,
as well as schedules and timetables for compliance to meet the
applicable requirements of the CAA.  The following enforceable emission
limitations and schedules are contained in Delaware’s approved SIP:  7
DE Admin. Codes 1113, 1124, 1141, 1144, 1145, 1146, and 1148.  These
regulations are identified as part of the Delaware SIP at 40 CFR
52.420(c).  Those enforceable emission limitations and schedules are
also contained in Delaware’s submitted Reasonable Further Progress
(RFP) and attainment demonstration SIPs that were approved on April 8,
2010 (75 FR 17863) and October 5, 2012 (77 FR 60914), respectively.

At present, statutory authority is set out in Title 7 “Conservation”
of the Delaware Code, Chapter 60—Delaware’s comprehensive water and
air resources conservation law.  Legislative authority giving the
Secretary of the Delaware Department of Natural Resources and
Environmental Control (DNREC) the authority to promulgate regulations is
codified at 7 Del. C., Chapter 60.  This authority is applicable to the
2008 8-hour ozone NAAQS.

In this action, EPA is not proposing to approve or disapprove any
existing Delaware provisions with regard to excess emissions during
startup, shutdown, and malfunction (SSM) of operations at a facility.
EPA believes that a number of states have SSM provisions which are
contrary to the CAA and existing EPA guidance (August 11, 1999 Steven
Herman and Robert Perciasepe Guidance Memorandum, “State
Implementation Plans: Policy Regarding Excess Emissions During
Malfunctions, Startup, and Shutdown”), and EPA plans to address such
state regulations in a separate rulemaking action.  In the meantime, EPA
encourages any state having a deficient SSM provision to take steps to
correct it as soon as possible.

Also in this action, EPA is not proposing to approve or disapprove any
existing Delaware rules with regard to director’s discretion or
variance provisions.  EPA believes that a number of states have such
provisions which are contrary to the CAA and existing EPA guidance (see
52 FR 45109, November 1987), and EPA plans to take separate rulemaking
action to address such state regulations.  In the meantime, EPA
encourages any state having director’s discretion or variance
provisions which are contrary to the CAA and EPA guidance to take steps
to correct the deficiency as soon as possible.

Based upon EPA’s review of the submittal, EPA is proposing to
determine that the State has met its obligations pursuant to
110(a)(2)(A).

2.  Section 110(a)(2)(B)

7 DE Admin. Code 1103 – “Ambient Air Quality Standards” and 7 DE
Admin. Code 1117 – “Source Monitoring, Record Keeping and
Reporting” provide for the establishment and operation of procedures
necessary to monitor, compile, and analyze data related to ambient air
quality.  These regulations are included in Delaware’s approved SIP
listed in 40 CFR 52.420(c) which applies to the 2008 8-hour ozone NAAQS.

Delaware has established and currently operates appropriate devices,
methods, systems, and procedures necessary to monitor, compile, and
analyze data on ambient air quality, and upon request, makes such data
available to the Administrator.

Delaware maintains and operates a multi-station network of ambient
monitors throughout the State to measure ambient air quality levels
within Delaware for comparison to each NAAQS as required by 40 CFR part
58.  Seasonal (April – October) ozone monitoring is currently
performed at various locations throughout Delaware.

All data is measured using EPA approved methods as either Reference or
Equivalent monitors.  All monitors are subjected to the quality
assurance requirements of 40 CFR part 58, Appendix A, and all samplers
are located at sites that have met the minimum siting requirements of 40
CFR part 58, Appendix E.  The data is submitted to EPA’s Air Quality
System (AQS) in a timely manner in accordance with the schedule
prescribed by EPA in 40 CFR part 58.

In order to keep EPA informed of changes to the sampling network, DNREC
provides EPA Region III with prior notification of any planned changes
to the network.  As needed, details of these changes and anticipated
approvals of the changes are communicated to EPA.  On an annual basis,
Delaware sends EPA a monitoring network plan as required by 40 CFR part
58, section 10 (Annual Monitoring Network Plan and Periodic Network
Assessment).  EPA approved Delaware’s 2012 Annual Air Quality
Monitoring Network Design Plan on February 21, 2013.  This plan contains
all required information including site and monitor description,
analysis methods, operating schedule, monitoring objectives and scale of
representativeness, as well as information on any planned changes.
DNREC submits data to the AQS system, in a timely manner, pursuant to
the schedule prescribed by the EPA in 40 CFR part 58.

Based upon EPA’s review of the submittal, EPA is proposing to
determine that the State has met its obligations pursuant to
110(a)(2)(B).

3.  Section 110(a)(2)(C)

Delaware has established and currently operates a program to provide for
the enforcement of the enforceable emission limitations and other
control measures, means, or techniques, as well as schedules and time
tables for the compliance, as may be necessary or appropriate, to meet
the applicable requirements of the CAA and to regulate modification and
construction of any stationary source within areas covered by its SIP as
necessary to assure the NAAQS are achieved. Aspects of Delaware’s
program for enforcement are found in those SIP-approved provisions of

7 DE Admin. Codes 1102 and 1125.

At present, Delaware as part of its Division of Air Quality function
exercises its programmatic authority to utilize the enforcement powers
set out in 7 Del. C. section 6005 entitled, “Enforcement; civil and
administrative penalties; expenses,” 7 Del. C., section 6013 entitled
“Criminal penalties,” and 7 Del. C. section 6018 entitled “Cease
and desist order.”

Delaware implements its Construction and Operation Permit Program
requirements under 7 DE Admin. Codes 1102 and 1125.  These existing
permitting programs which are part of the federally-approved SIP ensure
that the construction and modification of both major and minor
stationary sources do not cause or contribute to a violation of the
ozone NAAQS.

SIP approved 7 DE Admin. Code 1102 provides for the evaluation and
necessary regulation of any stationary source that emits equal to or
greater than 0.2 pounds of any air contaminant, including ozone, in any
one day.

SIP approved 7 DE Admin. Code 1125 governs preconstruction review and
permitting of any new or modified major stationary sources of air
pollutants as required in Part C of Title I of the CAA.

Based upon EPA’s review of the submittal, EPA is proposing to
determine that the State has met its obligations pursuant to
110(a)(2)(C).

4.  Section 110(a)(2)(D)

Section 110(a)(2)(D)(i)(I)

In accordance with the decision of the U.S. Court of Appeals for the
District of Columbia (D.C. Circuit Court), EPA at this time is not
treating the 110(a)(2)(D)(i)(I) SIP submission from Delaware as a
required SIP submission.  See EME Homer City Generation, LP v. EPA, 696
F.3d 7 (D.C. Cir. 2012), cert granted, 2013 U.S. App. LEXIS 48101
(2013).  On June 24, 2013, the Supreme Court granted the petitions of
the United States and others and agreed to review this D.C. Circuit
Court decision.  However, at this time the D.C. Circuit Court decision
remains in place and unless it is reversed or otherwise modified by the
Supreme Court, states are not required to submit 110(a)(2)(D)(i)(I) SIP
revisions until EPA has quantified their obligations under that section.
Delaware’s March 27, 2013 infrastructure SIP submission for the 2008
8-hour ozone NAAQS included information related to section
110(a)(2)(D)(i)(I). EPA will address this element in a separate action.

Section 110(a)(2)(D)(i)(II)

For all areas of Delaware, a SIP- approved PSD program (7 DE Admin. Code
1125) is in place.  See 40 CFR 52.420(c).  See additional discussion
under 110(a)(2)(C).  Based upon EPA’s review of the submittal, EPA is
proposing to determine that Delaware has met its obligations pursuant to
110(a)(2)(D)(i)(II) for the part C permit program.

Prong 4 of section 110(a)(2)(D)(i)(II) requires that SIPs include
provisions prohibiting any source or other type of emissions activity in
one state from interfering with measures to protect visibility required
to be included in another state’s SIP.  Delaware’s regional haze SIP
was approved on July 19, 2011 (76 FR 42557) and prohibits emission
sources in Delaware from emitting air pollutants which would interfere
with measures which protect visibility.

Based upon EPA’s review of the submittal, EPA is proposing to
determine that the State has met its obligations pursuant to
110(a)(2)(D)(i)(II).

Section 110(a)(2)(D)(ii)

Neither Delaware nor any facility in Delaware is subject to a section
126 rule.  Delaware has no currently pending obligations pursuant to CAA
126(b) or (c).  In Delaware’s March 27, 2013 submittal, Delaware
demonstrated that it has adequate provisions insuring future compliance
with the requirements of sections 126 and 115 of the CAA.  Based upon
EPA’s review of the submittal, EPA is proposing to determine that the
State has met its obligations pursuant to 110(a)(2)(D)(ii).

5.  Section 110(a)(2)(E)

For section 110(a)(2)(E)(i), Delaware has adequate authority under state
law pursuant to

7 Del. C. Chapter 60 to carry out its SIP obligations with respect to
the 2008 8-hour ozone NAAQS.  DNREC will continue to have, through the
State of Delaware General Fund and through the Title V fee program,
funding to carry out its SIP obligations.  Furthermore, Delaware’s
funding sources are sufficient to provide adequate personnel for those
purposes.

At present, Delaware states it fulfills this obligation by virtue of
having adequate personnel and funding through the CAA section 105 grant
process (Federal grant funds), the State of Delaware general fund (state
tax revenues), and appropriated special funds collected by the State of
Delaware from application fees, permit fees, renewal fees, and civil or
administrative penalties or fines under 7 Del. C. Chapter 60.  The
Division of Air Quality is responsible for developing, implementing and
enforcing the SIP.

Delaware complies with the requirements of section 110(a)(2)(E)(ii)
through compliance with the applicable requirements of 29 Del C.,
Chapter 58, “Laws Regulating the Conduct of Officers and Employees of
the State,” which EPA approved as a SIP revision on April 17, 2013 (78
FR 22785).

The requirements of section 110(a)(2)(E)(iii) are not applicable to
Delaware because Delaware does not rely on localities for specific SIP
implementation.  Based upon EPA’s review of the submittal, EPA is
proposing to determine that Delaware has met its obligations pursuant to
110(a)(2)(E).

6.  Section 110(a)(2)(F)

Specific monitoring and emissions reporting requirements are found
throughout the State of Delaware’s regulations governing the control
of air pollution, including 7 DE Admin. Codes 1103 and 1117.  These
regulations are included in Delaware’s approved SIP and are listed in
40 CFR 52.420(c) and also apply to the 2008 8-hour ozone NAAQS.

Delaware’s SIP requires that owners or operators of stationary sources
monitor and submit periodic reports on the nature and amounts of ozone
emissions and emissions related-data emissions from the sources.  This
may include the installation, maintenance and replacement of equipment,
where appropriate.  This information submitted to DNREC is available to
the public at reasonable times for public inspection pursuant to
Delaware law.  Delaware has stated it will continue to require reporting
of emissions.

Except as specifically exempted by the Delaware Freedom of Information
Act, 29 Del. C. Chapter 100, Delaware makes all records, reports or
information obtained by DNREC or referred to at public hearings
available to the public pursuant to the provisions of the Delaware
Freedom of Information Act, 29 Del. C. Chapter 100.

Other aspects of Delaware’s program for requiring installation and
maintenance of monitoring equipment, and periodic emissions reporting,
are found in the source monitoring, source testing and test methods, and
recordkeeping and reporting provisions of 7 DE Admin. Codes 1112, 1123,
1124, 1126, 1131, 1137, 1139, 1140, 1141, 1142 and others in the
approved Delaware SIP, which is identified at 40 CFR 52.420(c).

Based upon EPA’s review of the submittal, EPA is proposing to
determine that the State has met its obligations pursuant to
110(a)(2)(F).

7.  Section 110(a)(2)(G)

Delaware has authority comparable to that in section 303 of the CAA and
adequate contingency plans to implement such authority.

At present, 7 Del. C. section 6003(a)(1) requires a permit from the
Secretary prior to discharging any air contaminant.  7 Del. C. section
6002(2) defines air contaminant essentially as any substance other than
uncombined water.  7 Del. C. section 6005 allows the Secretary to seek a
preliminary or permanent injunction or temporary restraining order for
discharge of an air contaminant without a permit, and to issue a cease
and desist order for violations (7 Del. C. section 6018).  Therefore, if
any discharge of an air contaminant, including ozone, would cause
imminent and substantial endangerment to the health, safety and welfare
of the people of the State of Delaware or the environment, the Secretary
may seek an injunction or temporary restraining order to halt the
violation.

Delaware’s SIP contains an emergency episode plan found in 7 DE Admin.
Code 1115, Air Pollution Alert and Emergency Plan, that is currently
approved in the SIP and identified at 40 CFR 52.420(c).

Based upon EPA’s review of the submittal, EPA is proposing to
determine that the State has met its obligations pursuant to
110(a)(2)(G).

8.  Section 110(a)(2)(H)

Through its SIP submission, Delaware has demonstrated that it has
adequate authority under the Delaware Code, Chapter 60, Title 7
“Conservation” to revise the SIP.  This submission also provides EPA
with adequate assurances that Delaware will review and revise its SIP
from time to time as may be necessary to take account of revisions of
such primary or secondary NAAQS or the availability of improved or more
expeditious methods of attaining such standards and, whenever the
Administrator finds, on the basis of information available to the
Administrator, that the plan is substantially inadequate to attain the
NAAQS which it implements, or to otherwise comply with any additional
requirements established under the CAA.

Based upon EPA’s review of the submittal, EPA is proposing to
determine that the State has met its obligations pursuant to
110(a)(2)(H).

9.  Section 110(a)(2)(I)

EPA does not expect infrastructure SIP submissions to address this
element.  Nonattainment area plans required under part D of Title I of
the CAA are required on a different schedule from section 110(a)(2)
infrastructure elements of the CAA and thus, will be reviewed and acted
upon through a separate process.

10.  Section 110(a)(2)(J)

Section 121 (relating to consultation).  7 DE Admin. Code 1132,
Transportation Conformity of the State of Delaware Governing the Control
of Air Pollution, provides a legal platform for the various consultation
procedures that have been developed between DNREC, the Delaware
Department of Transportation (DELDOT), and the Metropolitan Planning
Organizations (MPOs).  The MPOs provide the forum for consultation with
local governments.  Delaware’s MPOs are:  WILMAPCO, Kent County MPO,
and the Salisbury-Wicomoco MPO.  Regional planning organizations provide
the forum for inter-state consultations.  7 DE Admin. Code 1132 is
included in the Delaware SIP.  Additionally, consultations with Federal
Land Managers are always ongoing in accordance with EPA rules (such as
in the Regional Haze regulations).

Section 127 (relating to public notification).  All SIP revisions and
new/amended regulations undergo public notice and hearing, pursuant to 7
Del. C. Chapters 29 and 60, which provides for  publication in the
newspapers and in the Delaware Register, and for comment by both the
public and local political subdivisions.  The public notice and hearing
processes also fulfill the section 121 consultation process.  Approved
regulations in the Delaware SIP specify the organizations responsible
for implementing and enforcing the plans.  In addition, DNREC makes real
time and historical air quality information available on its web site.

PSD requirements necessary to implement the 2008 8-hour ozone NAAQS are
SIP approved and implemented through the requirements of 7 DE Admin.
Code 1125, Preconstruction Review.  The latest Delaware PSD SIP was
approved on October 2, 2012 (77 FR 60053).

With regard to visibility protection, there are no new applicable
visibility protection obligations under section 110(a)(2)(J) as a result
of the 2008 8-hour ozone NAAQS.  Delaware is complying with, and will
continue to comply with the visibility protection and regional haze
program requirements under part C of the CAA.  EPA approved the Delaware
regional haze SIP on July 19, 2011 (76 FR 42557).

Based upon EPA’s review of the submittal, EPA is proposing to
determine that the State has met its obligations pursuant to
110(a)(2)(J).

11.  Section 110(a)(2)(K)

Delaware has the authority and technical capability to conduct air
quality modeling in order to assess the effect on ambient air quality
relevant pollutant emissions and will continue to perform modeling.
Delaware will continue to submit to EPA the air quality modeling data as
part of Delaware’s relevant SIP submissions, permit actions, and
through Federal grant commitments or in other ways that EPA may request.

Based upon EPA’s review of the submittal, EPA is proposing to
determine that the State has met its obligations pursuant to
110(a)(2)(K).

12.  Section 110(a)(2)(L)

Delaware’s submissions adequately address this requirement by
explaining that consistent with Delaware law, Delaware will continue to
require the owner or operator of each major stationary source to pay to
the permitting authority, as a condition of any permit required under
the CAA, a fee sufficient to cover (i) the reasonable costs of reviewing
and acting upon any application for such a permit, and (ii) if the owner
or operator receives a permit for such source, the reasonable costs of
implementing and enforcing the terms and conditions of any such permit
(not including any court costs or other costs associated with any
enforcement action), until such fee requirement is superseded with
respect to such sources by the Administrator’s approval of a fee
program under Title V pursuant to Delaware law.  Delaware currently
fulfills this under the enabling authority of 7 Del. C., sections 6095
to 6099, and fee legislation that currently is renewed every three
years.

Delaware also has a fully approved Title V operating permits program.
See paragraphs (b) and (c) under “Delaware” in Appendix A to 40 CFR
part 70—Approval Status of State and Local Operating Permits Programs.

Based upon EPA’s review of the submittal, EPA is proposing to
determine that the State has met its obligations pursuant to
110(a)(2)(L).

13.  Section 110(a)(2)(M)

In the March 27, 2013 SIP submittal, Delaware stated it will continue to
provide for consultation and participation by local political
subdivisions affected by the SIP pursuant to the public notice laws
found in 7 Del. C., sections 6006 and 6010, and 29 Del. C. Chapters
10003, 10004, and 10115, as applicable.  Furthermore, Delaware stated
all Delaware SIP revisions undergo public notice and hearing which have
allowed for comment by the public which includes local political
subdivisions.  The public notice and hearing processes fulfill the
requirements for consultation with local political subdivisions affected
by the SIP.

Based upon EPA’s review of the submittal, EPA is proposing to
determine that the State has met its obligations pursuant to
110(a)(2)(M).

F.  CONCLUSIONS AND RECOMMENDED AGENCY ACTION

EPA’s analysis of Delaware’s infrastructure submittal for the 2008
8-hour ozone NAAQS concludes that Delaware’s submittal meets the
requirements of section 110(a)(2)(A), (B), (C), (D)(i)(II), (D)(ii),
(E), (F), (G), (H), (J), (K), (L), and (M) of the CAA, as identified
above.  It is recommended that a notice of proposed rulemaking be
prepared approving Delaware’s infrastructure submittal for the 2008
8-hour ozone NAAQS.

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