[Federal Register Volume 88, Number 32 (Thursday, February 16, 2023)]
[Notices]
[Pages 10153-10156]
[FR Doc No: 2023-03250]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-96879; File No. SR-NYSEAMER-2023-13]

Self-Regulatory Organizations; NYSE American LLC; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Modify
the NYSE American Options Fee Schedule

February 10, 2023.
    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 February 9, 2023, NYSE American LLC (``NYSE American'' or the
``Exchange'') 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 self-regulatory
organization. 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.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to modify the NYSE American Options Fee
Schedule (``Fee Schedule'') regarding the Firm Monthly Fee Cap. The
Exchange proposes to implement the fee change effective February 9,
2023.\4\ The proposed rule change is available on the Exchange's
website at www.nyse.com, at the principal office of the Exchange, and
at the Commission's Public Reference Room.
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    \4\ The Exchange previously filed to amend the Fee Schedule on
January 31, 2023 (SR-NYSEAMER-2023-10) and withdrew such filing on
February 9, 2023.
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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 self-regulatory organization
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 those 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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of this filing is to amend the Fee Schedule to modify
the Firm Monthly Fee Cap. The Exchange proposes to implement the rule
change on February 9, 2023.
    The Firm Monthly Fee Cap is set forth in Section I.I. of the Fee
Schedule.\5\ Currently, a Firm's fees associated with Manual
transactions are capped at $150,000 per month per Firm.
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    \5\ See Fee Schedule, Section I.I., Firm Monthly Fee Cap,
available at: https://www.nyse.com/publicdocs/nyse/markets/american-options/NYSE_American_Options_Fee_Schedule.pdf.
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    The Exchange proposes to raise the Firm Monthly Fee Cap to $200,000
per month per Firm. To effect this change, the Exchange proposes to
modify Section I.I. to replace references to a $150,000 cap with
references to a $200,000 cap.\6\ The Exchange also proposes to increase
the incremental service fee--which is charged for Manual transactions
once the Firm Monthly Fee Cap has been reached--from $0.01 to $0.02 and
to extend the proposed incremental service fee of $0.02 per contract to
also apply to QCC transactions entered by Floor Brokers from the
Trading Floor (i.e., manual QCC transactions). Royalty Fees and fees or
volumes associated with Strategy Executions will continue to be
excluded from the calculation of fees towards the Firm Monthly Fee Cap.
Firm Facilitation Manual trades will also continue to be executed at
the rate of $0.00 per contract regardless of whether a Firm has reached
the Firm Monthly Fee Cap.
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    \6\ The Exchange also proposes a conforming change to footnote 4
in Section I.A. (Rates for Options transactions) of the Fee
Schedule, which cross-references the Firm Monthly Fee Cap as set
forth in Section I.I. The Exchange likewise proposes to modify
footnote 4 to replace the reference to a $150,000 cap with a
reference to a $200,000 cap.
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    The Exchange believes that the proposed change, despite increasing
the amount of the Firm Monthly Fee Cap and the incremental service fee
for Manual transactions and QCC transactions, would continue to
incentivize Firms to direct order flow to the Exchange to receive the
benefits of a cap on their Manual transaction fees.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\7\ in general, and furthers the
objectives of Sections

6(b)(4) and (5) of the Act,\8\ in particular, because it provides for
the equitable allocation of reasonable dues, fees, and other charges
among its members, issuers and other persons using its facilities and
does not unfairly discriminate between customers, issuers, brokers or
dealers.
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    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(4) and (5).
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The Proposed Rule Change Is Reasonable
    The Exchange operates in a highly competitive market. The
Commission has repeatedly expressed its preference for competition over
regulatory intervention in determining prices, products, and services
in the securities markets. In Regulation NMS, the Commission
highlighted the importance of market forces in determining prices and
SRO revenues and, also, recognized that current regulation of the
market system ``has been remarkably successful in promoting market
competition in its broader forms that are most important to investors
and listed companies.'' \9\
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    \9\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496, 37499 (June 29, 2005) (S7-10-04) (``Reg NMS
Adopting Release'').
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    There are currently 16 registered options exchanges competing for
order flow. Based on publicly-available information, and excluding
index-based options, no single exchange has more than 16% of the market
share of executed volume of multiply-listed equity and ETF options
trades.\10\ Therefore, no exchange possesses significant pricing power
in the execution of multiply-listed equity and ETF options order flow.
More specifically, in December 2022, the Exchange had less than 8%
market share of executed volume of multiply-listed equity and ETF
options trades.\11\
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    \10\ The OCC publishes options and futures volume in a variety
of formats, including daily and monthly volume by exchange,
available here: https://www.theocc.com/Market-Data/Market-Data-Reports/Volume-and-Open-Interest/Monthly-Weekly-Volume-Statistics.
    \11\ Based on a compilation of OCC data for monthly volume of
equity-based options and monthly volume of ETF-based options, see
id., the Exchange's market share in equity-based options was 6.77%
for the month of December 2021 and 7.11% for the month of December
2022.
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    The Exchange believes that the ever-shifting market share among the
exchanges from month to month demonstrates that market participants can
shift order flow, or discontinue or reduce use of certain categories of
products, in response to fee changes. Accordingly, competitive forces
constrain options exchange transaction fees. Stated otherwise, changes
to exchange transaction fees can have a direct effect on the ability of
an exchange to compete for order flow.
    The proposed change to the Firm Monthly Fee Cap is reasonable
because the Exchange believes the fee cap would continue to incentivize
Firms to direct order flow to the Exchange to receive the benefits of
capped fees for their Manual transactions (including manual QCC
transactions), even though the proposed change would increase the
amount of the fee cap and the incremental service charge applicable to
Manual transactions (including manual QCC transactions) after a Firm
has reached the fee cap. The Exchange also believes the proposed change
is reasonable because the proposed fee cap amount would be applicable
to all Firms and the proposed incremental service charge would be
applicable to all Manual transactions (including manual QCC
transactions) executed by a Firm once it reaches the fee cap. In
addition, although the proposed change would establish a higher fee cap
amount, it would continue to offer Firms the ability to qualify for
capped fees on Manual transactions (including manual QCC transactions),
which the Exchange believes provides Firms with a benefit not offered
by at least one other options exchange.\12\
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    \12\ See, e.g., BOX Options Fee Schedule, available at: https://boxoptions.com/fee-schedule/ (no cap on Firm manual transaction
fees).
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    To the extent that the proposed change continues to attract volume
to the Exchange, this order flow would continue to make the Exchange a
more competitive venue for order execution, which, in turn, promotes
just and equitable principles of trade and removes impediments to and
perfects the mechanism of a free and open market and a national market
system. The Exchange notes that all market participants stand to
benefit from any increase in volume, which could promote market depth,
facilitate tighter spreads and enhance price discovery, particularly to
the extent the proposed change encourages market participants to
utilize the Exchange as a primary trading venue, and may lead to a
corresponding increase in order flow from other market participants.
    Finally, to the extent the proposed change continues to attract
greater volume and liquidity, the Exchange believes the proposed change
would improve the Exchange's overall competitiveness and strengthen its
market quality for all market participants. In the backdrop of the
competitive environment in which the Exchange operates, the proposed
rule change is a reasonable attempt by the Exchange to increase the
depth of its market and improve its market share relative to its
competitors. The Exchange's fees are constrained by intermarket
competition, as market participants can choose to direct their order
flow to any of the 16 options exchanges The Exchange believes that
proposed rule change is designed to continue to incent market
participants to direct liquidity to the Exchange, and, to the extent
they continue to be incentivized to aggregate their trading activity at
the Exchange, that increased liquidity could promote market depth,
price discovery and improvement, and enhanced order execution
opportunities for all market participants.
The Proposed Rule Change Is an Equitable Allocation of Credits and Fees
    The Exchange believes the proposed rule change is an equitable
allocation of its fees and credits. The proposed change is equitable
because the increased Firm Monthly Fee Cap would be available to all
Firms equally. The proposed change is also equitable because the
increased incremental service charge would apply equally to all Firms
that achieve the fee cap and would now also apply to manual QCC
transactions executed by Firms once they have reached the fee cap. The
Exchange also believes that the proposed rule change is equitable with
respect to non-Firm market participants because the Firm Monthly Fee
Cap would not be as meaningful for Customers or Professional Customers
and because Market Makers are offered other incentives to reduce
transaction fees.\13\ The Exchange believes that the proposed changes,
although they increase the fee cap and incremental service charge
amounts, would not discourage Firms from directing order flow to the
Exchange. To the extent that the proposed change achieves its purpose
in continuing to incent Firms to aggregate their executions at the
Exchange as a primary execution venue and attracting more volume to the
Exchange, this increased order flow would continue to make the Exchange
a more competitive venue for, among other things, order execution.
Thus, the Exchange believes the proposed rule change would improve
market quality for all market participants on the Exchange and, as a
consequence, attract more order flow to the Exchange,

thereby improving market-wide quality and price discovery.
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    \13\ Customers are not subject to a fee for Manual transactions,
and neither Customers nor Professional Customers pay transaction
fees for QCC transactions. See Fee Schedule at Sections I.A. and
I.F. The Exchange offers various incentives to Market Makers,
including the Market Maker Sliding Scale and Prepayment Program. See
id. at Sections I.C. and I.D.
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The Proposed Rule Change Is Not Unfairly Discriminatory
    The Exchange believes that the modification of the Firm Monthly Fee
Cap is not unfairly discriminatory because the fee cap and incremental
service charge amounts, as proposed, would continue to be applicable to
all similarly situated Firms, any of which could continue to be
incentivized to direct order flow to the Exchange to qualify for the
fee cap. The Exchange notes that offering the Firm Monthly Fee Cap, as
proposed, to Firms but not to other market participants is not unfairly
discriminatory because the Firm Monthly Fee Cap would not be as
meaningful for Customers or Professional Customers and because Market
Makers are offered other incentives to reduce transaction fees.\14\
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    \14\ See note 13, supra.
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    Thus, to the extent the proposed change continues to attract Manual
transactions (including manual QCC transactions) to the Exchange, the
Exchange believes the proposed rule change would improve market quality
for all market participants on the Exchange and, as a consequence,
attract more order flow to the Exchange, thereby improving market-wide
quality and price discovery. The resulting increased volume and
liquidity would provide more trading opportunities and tighter spreads
to all market participants and thus would promote just and equitable
principles of trade, remove impediments to and perfect the mechanism of
a free and open market and a national market system and, in general,
protect investors and the public interest.
    Finally, the Exchange believes that it is subject to significant
competitive forces, as described below in the Exchange's statement
regarding the burden on competition.

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

    In accordance with Section 6(b)(8) of the Act, the Exchange does
not believe that the proposed rule change would impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act. Instead, as discussed above, the Exchange believes
that the proposed changes would encourage the submission of additional
liquidity to a public exchange, thereby promoting market depth, price
discovery and transparency and enhancing order execution opportunities
for all market participants. As a result, the Exchange believes that
the proposed change furthers the Commission's goal in adopting
Regulation NMS of fostering integrated competition among orders, which
promotes ``more efficient pricing of individual stocks for all types of
orders, large and small.'' \15\
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    \15\ See Reg NMS Adopting Release, supra note 9, at 37499.
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    Intramarket Competition. The proposed change is designed to
continue to attract order flow to the Exchange, which could increase
the volumes of contracts traded on the Exchange. Greater liquidity
benefits all market participants on the Exchange, and the Exchange
believes that the proposed modification of the Firm Monthly Fee Cap
(even though it would raise the amount of the fee cap and incremental
service charge) would not impose any burden on competition that is not
necessary or appropriate because it is intended to continue to
incentivize Firms to direct order flow to the Exchange to be eligible
for the benefits of capped fees on Manual transactions, thereby
promoting liquidity on the Exchange to the benefit of all market
participants.
    Intermarket Competition. The Exchange operates in a highly
competitive market in which market participants can readily favor one
of the 16 competing option exchanges if they deem fee levels at a
particular venue to be excessive. In such an environment, the Exchange
must continually adjust its fees to remain competitive with other
exchanges and to attract order flow to the Exchange. Based on publicly-
available information, and excluding index-based options, no single
exchange has more than 16% of the market share of executed volume of
multiply-listed equity and ETF options trades.\16\ Therefore, no
exchange possesses significant pricing power in the execution of
multiply-listed equity and ETF options order flow. More specifically,
in December 2022, the Exchange had less than 8% market share of
executed volume of multiply-listed equity and ETF options trades.\17\
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    \16\ See note 10, supra.
    \17\ See note 11, supra.
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    The Exchange believes that the proposed rule change reflects this
competitive environment because it modifies the Exchange's fees in a
manner designed to continue to incent market participants to direct
trading interest to the Exchange, to provide liquidity and to attract
order flow. To the extent that Firms are incentivized to utilize the
Exchange as a primary trading venue for all transactions, all of the
Exchange's market participants should benefit from the improved market
quality and increased opportunities for price improvement. The Exchange
notes that it operates in a highly competitive market in which market
participants can readily favor competing venues, including those that
do not offer a cap on Firm fees.\18\ In such an environment, the
Exchange must continually review, and consider adjusting, its fees and
credits to remain competitive with other exchanges.
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    \18\ See note 12, supra.
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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

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \19\ of the Act and subparagraph (f)(2) of Rule
19b-4 \20\ thereunder, because it establishes a due, fee, or other
charge imposed by the Exchange.
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    \19\ 15 U.S.C. 78s(b)(3)(A).
    \20\ 17 CFR 240.19b-4(f)(2).
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    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \21\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \21\ 15 U.S.C. 78s(b)(2)(B).
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-NYSEAMER-2023-13 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEAMER-2023-13. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NYSEAMER-2023-13, and should be
submitted on or before March 9, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\22\
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    \22\ 17 CFR 200.30-3(a)(12).
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Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-03250 Filed 2-15-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 81 (Thursday, April 26, 2018)]
[Notices]
[Page 18362]
[FR Doc No: 2018-08820]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736.

Extension:
    Form 1-Z, SEC File No. 270-659, OMB Control No. 3235-0723.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Form 1-Z (17 CFR 239.94) is used to report terminated or completed
offerings or to suspend the duty to file ongoing reports under
Regulation A, an exemption from registration under the Securities Act
of 1933 (15 U.S.C 77a et seq.). The purpose of the Form 1-Z is to
collect empirical data for the Commission on offerings conducted under
Regulation A that have terminated or completed, to indicate to the
Commission that issuers that have conducted Tier 2 offering are
suspending their duty to file reports under Regulation A and to provide
such information to the investing public. We estimate that
approximately 12 issuers file Form 1-Z annually. We estimate that Form
1-Z takes approximately 1.5 hours to prepare. We estimate that 100% of
the 1.5 hours per response is prepared by the company for a total
annual burden of 18 hours (1.5 hours per response x 12 responses).
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden imposed by the collection of information; (c) ways to
enhance the quality, utility, and clarity of the information collected;
and (d) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    Please direct your written comments to Pamela Dyson, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE, Washington, DC 220549; or send an email
to: [email protected].

    Dated: April 23, 2018.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-08820 Filed 4-25-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 37 (Thursday, February 25, 2016)]
[Notices]
[Page 9580]
[FR Doc No: 2016-03978]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. 2016-17]

Petition for Exemption; Summary of Petition Received; Gulfstream
Aerospace Corporation

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Title 14 of the Code of Federal
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 March 16, 2016.

ADDRESSES: Send comments identified by docket number FAA-2015-4420
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 (DOT), 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, 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, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Brent Hart<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 February 18, 2016.
James M. Crotty,
Acting Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2015-4420
    Petitioner: Gulfstream Aerospace Corporation
    Section(s) of 14 CFR Affected: 61.57(a) and (b)
    Description of Relief Sought: The petitioner is seeking an
exemption from Sec.  61.57(a) and (b) to allow pilots/operators
operating Gulfstream model G-IV, GIV-X, GV, GV-SP and GVI (G650 and
G650ER) to use any of the listed aircraft or a Level B, C, or D
simulator that represents one of the types of Gulfstream airplanes to
meet the recent takeoff and landing experience requirements of Sec.
61.57, without Gulfstream holding a 14 CFR part 142 certificate.

[FR Doc. 2016-03978 Filed 2-24-16; 8:45 am]
 BILLING CODE 4910-13-P


Comment Info: =================

General Comment:I urge you to extend the public comment period for these proposed regulations to a more reasonable 180 days.

These proposed regulations are stupid and utterly unnecessary and deeply impact my personal liberty. As a former smoker, I am outraged that you would take steps that will ultimately restrict my access to and increase the cost of a product that has in fact saved my life.

These regulations will ultimately benefit only the corporations that have an interest in restricting access to the only real, viable alternative to their products. Since the free availability of electronic cigarettes is a overwhelmingly huge net benefit to public health, I can only assume that your interest in regulating them has nothing to do with insuring a healthier public, and should they pass, I will vote with that idea in mind henceforth.


[Federal Register: May 6, 2009 (Volume 74, Number 86)]
[Notices]
[Page 20963-20964]
[DOCID:fr06my09-79]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

Transmissible Spongiform Encephalopathies Advisory Committee;
Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Transmissible Spongiform Encephalopathies
Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on June 12, 2009, from 8
a.m. to 5:45 p.m.
    Location: Holiday Inn Gaithersburg, Grand Ballroom, 2 Montgomery
Village Ave., Gaithersburg, MD.
    Contact Person: William Freas or Rosanna Harvey, Center for
Biologics Evaluation and Research (HFM-71), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-
443-0572 in the Washington, DC area), code<PHONE_NUMBER>. Please call
the Information Line for up-to-date information on this meeting. A
notice in the Federal Register about last minute modifications that
impact a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Therefore, you
should always check the agency's Web site and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
    Agenda: On June 12, 2009, the Committee will review and discuss a
recent report from the UK Health Protection Agency attributing a case
of variant Creutzfeldt-Jakob (vCJD) disease infection to treatment 11
years earlier

with a ``vCJD-implicated'' plasma-derived coagulation factor VIII
(pdFVIII) and whether this information or any other recent scientific
information about the vCJD epidemic substantially alters FDA's risk
assessment for U.S.-licensed preparations of pdFVIII products. In the
afternoon the committee will hear informational presentations on animal
models of vCJD, diagnostic test development for transmissible
spongiform encephalopathies (TSEs) and bovine spongiform encephalopathy
(BSE) surveillance and risk management.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material will be
available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on
the year 2009 and scroll down to the appropriate advisory committee
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before June
4, 2009. Oral presentations from the public will be scheduled between
approximately 10:30 a.m. and 11:15 a.m. and between 5:00 p.m. and 5:30
p.m. Those desiring to make formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before May 26, 2009. Time
allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by May 28, 2009.
    Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact William Freas or
Rosanna Harvey at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/
default.htm for procedures on public conduct during advisory committee
meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: April 28, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-10454 Filed 5-5-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register: October 24, 2007 (Volume 72, Number 205)]
[Proposed Rules]
[Page 60293-60295]
[DOCID:fr24oc07-26]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-0036; Directorate Identifier 2007-NE-22-AD]
RIN 2120-AA64

Airworthiness Directives; Rolls-Royce plc RB211-524 Series
Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above. This proposed AD results from mandatory
continuing airworthiness information (MCAI) provided by the aviation
authority of the United Kingdom to identify and correct an unsafe
condition on an aviation product. The MCAI states the following:

    Recently an RB211 HP turbine disc has been found with a crack
which had propagated further than expected from the risk model that
was used to establish the original inspection.

    We are proposing this AD to detect cracks that could cause the high
pressure (HP) turbine disc to fail and result in uncontained failure of
the engine.

DATES: We must receive comments on this proposed AD by November 23,
2007.

ADDRESSES: You may send comments by any of the following methods:
     Government-wide rulemaking Web site: Go to http://www.regulations.gov
 and follow the instructions for sending your

comments electronically.
     Mail: Docket Management Facility, U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590-0001.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    You can get the service information identified in this proposed AD
from Rolls-Royce plc, P.O. Box 31, DERBY, DE24 8BJ, UK, telephone: 44
(0) 1332 242424; fax: 44 (0) 1332 249936.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov
; or in person at the Docket Operations office

between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
the same as the Mail address provided in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Jason Yang, Aerospace Engineer, Engine
Certification Office, FAA, Engine & Propeller Directorate, 12 New
England Executive Park, Burlington, MA 01803; e-mail:
<EMAIL_ADDRESS>telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2007-0036;
Directorate Identifier 2007-NE-22-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,

economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov
, including any personal information you provide. We

will also post a report summarizing each substantive verbal contact
with FAA personnel concerning this proposed AD. Using the search
function of the Web site, anyone can find and read the comments in any
of our dockets, including, if provided, the name of the individual who
sent the comment (or signed the comment on behalf of an association,
business, labor union, etc.). You may review the DOT's complete Privacy
Act Statement in the Federal Register published on April 11, 2000 (65
FR 19477-78).

Discussion

    The Civil Aviation Authority (CAA), which is the aviation authority
for the United Kingdom, has issued United Kingdom Airworthiness
Directive G-2006-0002, dated February 13, 2006, to correct an unsafe
condition for the specified products. The CAA AD states:

    A population of HP turbine discs that were manufactured between
1989-1999 and which were subject to possible machining anomalies,
were believed to have an increased chance of suffering from cooling
air hole cracking, compared to the general fleet population of HP
turbine discs. As a result of this risk, Rolls-Royce issued Non-
Modification Service Bulletin (NMSB) 72-C816, recommending in-
service inspections of the subject discs.
    Recently an RB211 HP turbine disc has been found with a crack
which had propagated further than expected from the risk model that
was used to establish the original inspection defined in the above
NMSB; This has led to the need for a revision of the original
inspection requirements.
    An HP turbine disc fracture would be uncontained and create a
potential unsafe condition. Accordingly, this AD introduces revised
inspection requirements to reflect the increased risk of HP turbine
disc cracking and potential disc fracture.

    You may obtain further information by examining the CAA AD in the
AD docket.

Relevant Service Information

    RR has issued Service Bulletin RB.211-72-AE718, dated January 24,
2006. The actions described in this service information are intended to
correct the unsafe condition identified in the CAA AD.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of the
United Kingdom, and is approved for operation in the United States.
Pursuant to our bilateral agreement with the United Kingdom, they have
notified us of the unsafe condition described above. We are issuing
this AD because we evaluated all the information provided by the CAA
and determined the unsafe condition exists and is likely to exist or
develop on other products of the same type design.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 72 engines installed on airplanes of U.S. registry.
We also estimate that it would take about 10.0 work-hours per product
to comply with this proposed AD, and that the average labor rate is $80
per work-hour. Required parts would cost about $15,000 per product.
Based on these figures, we estimate the total cost of the proposed AD
to U.S. operators to be $1,137,600. Our cost estimate is exclusive of
possible warranty coverage.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

    1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Rolls-Royce plc: Docket No. FAA-2007-0036; Directorate Identifier
2007-NE-22-AD.

Comments Due Date

    (a) We must receive comments by November 23, 2007.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Rolls-Royce (RR) RB211-524 series
turbofan engines with certain high pressure (HP) turbine disks,
specified by part number (P/N) and serial number (SN) listed in
Table 1 of this AD, installed. These engines are installed on, but
not limited to, Boeing 747 series and 767 series airplanes and
Lockheed L1011 series airplanes.

Reason

    (d) Recently an RB211 HP turbine disc has been found with a
crack which had propagated further than expected from the risk model
that was used to establish the original inspection defined in the
above NMSB; This has led to the need for a revision of the original
inspection requirements.
    An HP turbine disc fracture would be uncontained and create a
potential unsafe condition. Accordingly, this AD introduces revised
inspection requirements to reflect the increased risk of HP turbine
disc cracking and potential disc fracture.

Actions and Compliance

    (e) Unless already done, do the following actions.
    (f) Carry out the eddy current inspection as detailed in Section
3--Accomplishment Instructions of Rolls-Royce NMSB 72-AE718, dated
January 24, 2006, in accordance with the following schedule:
    (1) The HP disc serial numbers listed in table 1 are to be
inspected as follows:

                                 Table 1.--HP Disk Serial Numbers by Part Number
----------------------------------------------------------------------------------------------------------------
              Part No.                       Serial No.                 Part No.                Serial No.
----------------------------------------------------------------------------------------------------------------
UL29473.............................  LAQDY6043                 UL29472................  LQDY9125
UL29473.............................  LAQDY6048                 UL29472................  LQDY9554
UL29473.............................  LAQDY6079                 UL29472................  LQDY9582
UL29473.............................  LDRCZ10057                UL29472................  LQDY9895
UL29473.............................  LDRCZ10264                UL29472................  LQDY9910
UL29473.............................  LDRCZ10415                UL29472................  LQDY9947
UL29473.............................  LDRCZ11402                UL29472................  LQDY9960
UL29473.............................  LDRCZ11425                UL24994................  LQDY6777
UL29473.............................  LDRCZ11497                UL24994................  LQDY6792
UL29473.............................  LDRCZ11663                UL24994................  LQDY6859
UL29473.............................  LDRCZ11679                UL24994................  LQDY6860
UL29473.............................  LDRCZ12301                UL24994................  LQDY6866
UL29473.............................  LDRCZ12308                UL24994................  LQDY6869
UL29473.............................  LDRCZ12316                UL24994................  LQDY6934
UL29473.............................  LDRCZ12319                UL24994................  LQDY6946
UL29473.............................  LQDY6957                  UL24994................  LQDY6963
UL29473.............................  LQDY9075                  UL23166................  LQDY6745
UL29473.............................  LQDY9084                  UL23166................  LQDY6846
UL29473.............................  LQDY9557                  UL23166................  LQDY6848
UL29473.............................  LQDY9906                  UL23166................  LQDY6954
UL29473.............................  LQDY9956                  FK24790................  LDRCZ12492
UL29473.............................  LQDY9970                  FK24790................  LDRCZ12694
UL29473.............................  LQDY9985
----------------------------------------------------------------------------------------------------------------

    (2) For all RB211-524 engine marks except RB211-524D4 variants:
    (i) If the HP turbine disc cycles are greater than 6150 cycles
since new on the effective date of this AD, inspect the HP turbine
disc within 500 cycles after the effective date of this AD.
    (ii) If the HP turbine disc cycles are less than 6150 cycles
since new on the effective date of this AD, inspect the disc by
whichever is the soonest of the conditions below:
    (A) Prior to reaching 6650 cycles since new. The HP turbine disc
life at inspection must be greater than 700 cycles since new.
    (B) At next shop visit where the HP turbine rotor is removed
from the Combustor Outer Case and the HP turbine disc life is
greater than 700 cycles since new. If a HP turbine disc that meets
these cyclic life criteria is currently at shop visit, and if, at
the effective date of this Airworthiness Directive, it has not yet
been reinstalled into the Combustion Outer Case, then the HP turbine
disc must be inspected in accordance with the requirements of this
Airworthiness Directive at the current shop visit.
    (3) For all RB211-524D4 engine mark variants:
    (i) If the HP turbine disc cycles are greater than 5000 cycles
since new on the effective date of this AD, inspect the HP turbine
disc within 500 cycles after the effective date of this AD.
    (ii) If the HP turbine disc cycles were less than 5000 cycles
since new on the effective date of this AD, inspect the HP turbine
disc by whichever is the soonest of the conditions below:
    (A) Prior to reaching 5500 cycles since new. The HP turbine disc
life at inspection must be greater than 700 cycles since new.
    (B) At the next shop visit where the HP turbine rotor is removed
from the Combustor Outer Case and the HP turbine disc life is
greater than 700 cycles since new. If a HP turbine disc that meets
these cyclic life criteria is currently at shop visit, and if, at
the effective date of this Airworthiness Directive, it has not yet
been reinstalled into the Combustion Outer Case, then the HP turbine
disc must be inspected in accordance with the requirements of this
Airworthiness Directive at the current shop visit.
    (4) For all other HP turbine discs specified in the
Applicability of this Directive but not listed in Table 1 on page 2:
    (i) Inspect the HP turbine disc at next shop visit where the HP
turbine rotor is removed from the Combustor Outer Case and the HP
turbine disc life is greater than 700 cycles since new. If a HP
turbine disc that meets these cyclic life criteria is currently at
shop visit, and if, at the effective date of this Airworthiness
Directive, it has not yet been reinstalled into the Combustion Outer
Case, then the HP turbine disc must be inspected in accordance with
the requirements of this Airworthiness Directive at the current shop
visit.
    (ii) If a HP turbine disc has previously passed the inspection
to Rolls-Royce NMSB 72-C816 or the focused inspection carried out in
accordance with Rolls-Royce TS594-J Overhaul Process Manual Task 70-
00-00-200-223 at greater than 700 cycles since new, then either of
these inspections meets the requirements of this Airworthiness
Directive.

FAA AD Differences

    (g) Wherever the MCAI AD specifies 24 November 2005, this AD
specifies the effective date of this AD.

Other FAA AD Provisions

    (h) Alternative Methods of Compliance (AMOCs): The Manager,
Engine Certification Office, FAA, has the authority to approve AMOCs
for this AD, if requested using the procedures found in 14 CFR
39.19.

Related Information

    (i) Refer to the Civil Aviation Authority Airworthiness
Directive G-2006-0002, dated February 13, 2006, and RR Nonmandatory
Service Bulletin RB.211-72-AE718, dated January 24, 2006, for
related information.
    (j) Contact Jason Yang, Aerospace Engineer, Engine Certification
Office, FAA, Engine & Propeller Directorate, 12 New England
Executive Park, Burlington, MA 01803; e-mail<EMAIL_ADDRESS>
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>, for more information
about this AD.

    Issued in Burlington, Massachusetts, on October 17, 2007.
Peter A. White,
Acting Manager, Engine and Propeller Directorate, Aircraft
Certification Service.
[FR Doc. E7-20923 Filed 10-23-07; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register: November 6, 2009 (Volume 74, Number 214)]
[Notices]
[Page 57503-57504]
[DOCID:fr06no09-64]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0319]

Guidance for Industry and Food and Drug Administration Staff; In
Vitro Diagnostic 2009 H1N1 Tests for Use in the 2009 H1N1 Emergency;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``In Vitro Diagnostic 2009 H1N1
Tests for Use in the 2009 H1N1 Emergency.'' FDA is issuing this
guidance to inform industry and agency staff of its recommendations for
the type of information and data FDA believes needs to be included in
an Emergency Use Authorization Request (EUA) for in vitro diagnostic
(IVD) devices intended for use in diagnosing 2009 H1N1 Influenza virus
infections during the emergency involving Swine Influenza A\1\. The
Secretary of the Department of Health and Human Services (HHS) declared
the emergency on April 26, 2009, in accordance with the Federal Food,
Drug, and Cosmetics Act (the Act).
---------------------------------------------------------------------------

    \1\ Swine Influenza A is now known as 2009 H1N1 Influenza (2009
H1N1).

DATES: Submit written or electronic comments on this guidance at any
---------------------------------------------------------------------------
time. General comments on agency guidelines are welcome at any time.

ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``In Vitro Diagnostic 2009 H1N1 Tests for Use in the
2009 H1N1 Emergency'' to the Division of Small Manufacturers,
International, and Consumer Assistance, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993. Send one self-
addressed adhesive label to assist that office in processing your
request, or fax your request to<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the
guidance.
    Submit written comments concerning this guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.regulations.gov. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Sally Hojvat, Center for Devices and
Radiological Health WO/66, rm. 5552, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance document provides recommendations on the types of
information and data that FDA believes needs to be included in an
Emergency Use Authorization Request (EUA) for in vitro diagnostic (IVD)
devices intended for use in diagnosing 2009 H1N1 Influenza virus
infections during the emergency involving Swine Influenza A. While FDA
encourages the submission of premarket notifications (510(k)s) for all
2009 H1N1 tests, the agency is aware that during a declared emergency,
it may not be possible for manufacturers of 2009 H1N1 tests to submit a
510(k) prior to distributing or offering a test. For example, during
the initial phase of the emergency, positive clinical specimens may not
be readily available for use in device evaluations. The identification
of acute test capacity need may limit the ability to test the usual
number of specimens needed for a 510(k). Additionally, appropriate
validation specimens may not be available in certain areas at the time
the test is needed. If manufacturers of 2009 H1N1 tests are unable to
submit a premarket notification and there is a continued public health
need for 2009 H1N1 tests during this declared emergency, manufacturers
should submit an EUA request to FDA. Public participation is not
feasible or appropriate since the agency must act immediately to
protect the public health during the declared emergency concerning 2009
H1N1 Influenza. This guidance applies to 2009 H1N1 tests during the
time that the declaration of emergency concerning 2009 H1N1 Influenza
is in effect.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on in vitro diagnostic 2009 H1N1 tests for
use in the 2009 H1N1 emergency. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the

public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
using the Internet. To receive ``In Vitro Diagnostic 2009 H1N1 Tests
for Use in the 2009 H1N1 Emergency,'' you may either send an e-mail
request to<EMAIL_ADDRESS>to receive an electronic copy of the
document or send a fax request to<PHONE_NUMBER> to receive a hard copy.
Please use the document number 1706 to identify the guidance you are
requesting.
    CDRH maintains an entry on the Internet for easy access to
information including text, graphics, and files that may be downloaded
to a personal computer with Internet access. Updated on a regular
basis, the CDRH home page includes device safety alerts, Federal
Register reprints, information on premarket submissions (including
lists of approved applications and manufacturers' addresses), small
manufacturer's assistance, information on video conferencing and
electronic submissions, Mammography Matters, and other device-oriented
information. The CDRH web site may be accessed at http://www.fda.gov/
cdrh. A search capability for all CDRH guidance documents is available
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also
available at http://www.regulations.gov.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations and guidance documents. These
collections of information are subject to review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). The collections of information in 21 CFR part
814 have been approved under OMB Control No. 0910-0231; the collections
of information in 21 CFR part 807 Subpart E have been approved under
OMB Control No. 0910-0120; the collections of information in 21 U.S.C.
360bbb-3(b) have been approved under OMB Control No. 0910-0584; the
collections of information in 21 CFR part 812 have been approved under
OMB Control No. 0910-0078; the collections in 21 CFR 493.17 have been
approved under OMB Control No. 0910-0607; the collections of
information in 21 CFR part 56 have been approved under OMB Control No.
0910-0130; the collections of information in Section 564(b)(1) of the
FD&C Act have been approved under OMB Control No. 0910-0595; the
collections of information in 21 CFR part 820 have been approved under
OMB Control No. 0910-0073; and the collections of information in 21 CFR
809.10 have been approved under OMB Control No. 0910-0485.

V. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), written or electronic comments regarding this
document. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. Comments are to be identified with the docket number found
in brackets in the heading of this document. Received comments may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.

    Dated: November 2, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-26737 Filed 11-5-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 83, Number 176 (Tuesday, September 11, 2018)]
[Notices]
[Pages 45922-45923]
[FR Doc No: 2018-19695]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Number: PR18-81-000.
    Applicants: Agua Blanca, LLC.
    Description: Tariff filing per 284.123(b),(e)/: compliance to 1 to
be effective 7/1/2018.
    Filed Date: 8/30/18.
    Accession Number: 20180830-5199.
    Comments/Protests Due: 5 p.m. ET 9/20/18.

    Docket Numbers: RP18-1131-000.
    Applicants: Equitrans, L.P.
    Description: Tariff Cancellation: Terminate Non-conforming
Negotiated Rate Gathering Agreement to be effective 8/1/2018.
    Filed Date: 9/4/18.
    Accession Number: 20180904-5069.
    Comments Due: 5 p.m. ET 9/17/18.

    Docket Numbers: RP18-1132-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 090418 Negotiated Rates--Twin
Eagle Resource Management, LLC R-7300-08 to be effective 11/1/2018.
    Filed Date: 9/4/18.
    Accession Number: 20180904-5070.
    Comments Due: 5 p.m. ET 9/17/18.

    Docket Numbers: RP18-1133-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 090418 Negotiated Rates--Twin
Eagle Resource Management, LLC R-7300-09 to be effective 11/1/2018.
    Filed Date: 9/4/18.
    Accession Number: 20180904-5072.
    Comments Due: 5 p.m. ET 9/17/18.

    Docket Numbers: RP18-1134-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 090418 Negotiated Rates--Twin
Eagle Resource Management, LLC R-7300-10 to be effective 11/1/2018.
    Filed Date: 9/4/18.
    Accession Number: 20180904-5073.
    Comments Due: 5 p.m. ET 9/17/18.

    Docket Numbers: RP18-1135-000.
    Applicants: Equitrans, L.P.
    Description: Tariff Cancellation: Terminate Negotiated Rate Service
Agreement--Hayden Harper to be effective 1/10/2018.
    Filed Date: 9/4/18.
    Accession Number: 20180904-5075.
    Comments Due: 5 p.m. ET 9/17/18.

    Docket Numbers: RP18-1136-000.
    Applicants: Equitrans, L.P.
    Description: Sec.  4(d) Rate Filing: Negotiated Capacity Release
Agreements--9/1/2018 to be effective 9/1/2018.
    Filed Date: 9/4/18.
    Accession Number: 20180904-5076.
    Comments Due: 5 p.m. ET 9/17/18.

    Docket Numbers: RP18-1137-000.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Non-Conforming Negotiated Rate
Agreement Filing (SoCal Nov 18) to be effective 11/1/2018.
    Filed Date: 9/4/18.
    Accession Number: 20180904-5077.
    Comments Due: 5 p.m. ET 9/17/18.

    Docket Numbers: RP18-1138-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 090418 Negotiated Rates--DTE
Energy Trading, Inc. R-1830-15 to be effective 11/1/2018.
    Filed Date: 9/4/18.
    Accession Number: 20180904-5081.
    Comments Due: 5 p.m. ET 9/17/18.

    Docket Numbers: RP18-1139-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 090418 Negotiated Rates--DTE
Energy Trading, Inc. R-1830-16 to be effective 11/1/2018.
    Filed Date: 9/4/18.
    Accession Number: 20180904-5082.
    Comments Due: 5 p.m. ET 9/17/18.

    Docket Numbers: RP18-1140-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 090418 Negotiated Rates--
Freepoint

Commodities LLC R-7250-22 to be effective 11/1/2018.
    Filed Date: 9/4/18.
    Accession Number: 20180904-5102.
    Comments Due: 5 p.m. ET 9/17/18.

    Docket Numbers: RP18-1141-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 090418 Negotiated Rates--
Direct Energy Business Marketing, LLC R-7465-07 to be effective 11/1/
2018.
    Filed Date: 9/4/18.
    Accession Number: 20180904-5110.
    Comments Due: 5 p.m. ET 9/17/18.

    Docket Numbers: RP18-1142-000.
    Applicants: Guardian Pipeline, L.L.C.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate PAL
Agreements--Wisconsin Public Service Corporation to be effective 9/1/
2018.
    Filed Date: 9/4/18.
    Accession Number: 20180904-5120.
    Comments Due: 5 p.m. ET 9/17/18.

    Docket Numbers: RP18-1143-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 090418 Negotiated Rates--
Macquarie Energy LLC R-4090-17 to be effective 11/1/2018.
    Filed Date: 9/4/18.
    Accession Number: 20180904-5121.
    Comments Due: 5 p.m. ET 9/17/18.

    Docket Numbers: RP18-1144-000.
    Applicants: Alliance Pipeline L.P.
    Description: Sec.  4(d) Rate Filing: Horizon Delivery Point to be
effective 10/1/2018.
    Filed Date: 9/4/18.
    Accession Number: 20180904-5124.
    Comments Due: 5 p.m. ET 9/17/18.

    Docket Numbers: RP18-1145-000.
    Applicants: NEXUS Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: NEXUS Non-Conforming
Agreements Filing to be effective 10/1/2018.
    Filed Date: 9/4/18.
    Accession Number: 20180904-5148.
    Comments Due: 5 p.m. ET 9/17/18.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: September 5, 2018.
 Nathaniel J. Davis, Sr.,
 Deputy Secretary.
[FR Doc. 2018-19695 Filed 9-10-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 248 (Tuesday, December 27, 2011)]
[Notices]
[Page 80958]
[FR Doc No: 2011-33035]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1999-DR; Docket ID FEMA-2011-0001]

Texas; Amendment No. 6 to Notice of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster for the
State of Texas (FEMA-1999-DR), dated July 1, 2011, and related
determinations.

DATES: Effective Date: December 13, 2011.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that the incident
period for this declared disaster is now April 6, 2011, through and
including August 29, 2011.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households in
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant).

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-33035 Filed 12-23-11; 8:45 am]
BILLING CODE 9111-23-P


                      Notes from Meeting with Bob Spurgin

Attended by:
Spurgin and Associates:	Bob Spurgin

EPA Staff:		Kristin Fitzgerald

Date:				June 25, 2013

EPA had a call with Bob Spurgin. He discussed the variation in what sorts of pharmaceutical wastes that publicly owned treatment works (POTWs) will accept from healthcare facilities.  He mentioned that one POTW in San Francisco is allowing aqueous pharmaceuticals to be discharged to it.  He also discussed the typical management of "fully-dosed" (or empty) syringes.