[Federal Register Volume 83, Number 87 (Friday, May 4, 2018)]
[Notices]
[Page 19787]
[FR Doc No: 2018-09437]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2011-N-0075; FDA-2011-N-0015; FDA-2011-N-0076; FDA-
2017-N-0932; FDA-2016-N-4487; FDA-2014-N-0345; FDA-2013-N-0523; FDA-
2017-N-2428; FDA-2008-N-0312; and FDA-2014-N-1072]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration is correcting a notice
entitled ``Agency Information Collection Activities; Announcement of
Office of Management and Budget Approvals'' that appeared in the
Federal Register of April 9, 2018. The document announced a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
The document was published with an incorrect docket number. This
document corrects that error.

FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy and
Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
32, Rm. 3330, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of Tuesday, April 9,
2018 (83 FR 15152), in FR Doc. 2018-07147, on page 15152, the following
correction is made:
    1. On page 15152, in the second column, in the first line of the
list of docket numbers, ``FDA-2014-N-0075'' is corrected to read ``FDA-
2011-N-0075.''

    Dated: April 30, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-09437 Filed 5-3-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: February 4, 2010 (Volume 75, Number 23)]
[Notices]
[Page 5829-5831]
[DOCID:fr04fe10-86]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61443; File No. SR-NASDAQ-2010-007]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing of Proposed Rule Change, as Modified by Amendment No.
1, Relating To Elimination of Market Maker Requirement for Each Option
Series

January 29, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on January 14, 2009, The NASDAQ Stock Market LLC (``NASDAQ'') 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 NASDAQ. On January 26, 2009, the Exchange
filed Amendment No. 1 to the proposal. The Commission is publishing
this notice to solicit comments on the proposed rule change, as
amended, from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    NASDAQ is filing a proposal for the NASDAQ Options Market (``NOM''
or ``Exchange'') to delete from the NASDAQ rulebook Section 5, Minimum
Participation Requirement for Opening Trading of Option Series,\3\ of
Chapter IV, Securities Traded on NOM.
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    \3\ See Amendment No. 1.
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    The text of the proposed rule change is available from NASDAQ's
website at http://nasdaq.cchwallstreet.com, at NASDAQ'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 aspects of such
statements.

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

1. Purpose
    NASDAQ is proposing the elimination of a requirement that at least
one Options Market Maker be registered for trading a particular series
before it may be opened for trading on NOM.
    An Options Market Maker is a Participant \4\ registered with NASDAQ
as a Market Maker.\5\ Market Makers on NOM have certain obligations
such as maintaining two-sided markets and participating in transactions
that are ``reasonably calculated to contribute to the maintenance of a
fair and orderly market.'' \6\ To register as a Market Maker, a
Participant must file a written application with NASDAQ Regulation,
which will consider an applicant's market making ability and other
factors it deems appropriate in determining whether to approve an
applicant's registration.\7\ All Market Makers are designated as
specialists on NOM for all purposes under the Act or rules
thereunder.\8\ The NOM Rules place no limit on the number of qualifying
entities that may become Market Makers.\9\ The good standing of a
Market Maker may be suspended, terminated, or withdrawn if the
conditions for approval cease to be maintained or the Market Maker
violates any of its agreements with NASDAQ or any provisions of the NOM
Rules.\10\ A Participant that has qualified as a Market Maker may
register to make markets in individual series of options.\11\
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    \4\ The term ``Options Participant'' or ``Participant'' means a
firm, or organization that is registered with the Exchange pursuant
to Chapter II of the NOM Rules for purposes of participating in
options trading on NOM as a ``NASDAQ Options Order Entry Firm'' or
``NASDAQ Options Market Maker.''
    \5\ See NOM Rules, Chapter VII, Section 2.
    \6\ See NOM Rules, Chapter VII, Section 5(a).
    \7\ See NOM Rules, Chapter VII, Section 2(a).
    \8\ See NOM Rules, Chapter VII, Section 2.
    \9\ See NOM Rules, Chapter VII, Rule 2(c).
    \10\ See NOM Rules, Chapter VII, Section 4(b).
    \11\ See NOM Rules, Chapter VII, Section 3(a).
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    Currently Section 5 of Chapter IV of the NOM rulebook provides in
relevant part that after a particular class of options has been
approved for listing on

NOM by NASDAQ Regulation, NASDAQ will allow trading in series of
options in that class only if there is at least one Market Maker
registered for trading that particular series. The Exchange is
proposing to eliminate this requirement in order to expand the number
of series available to investors for trading and for hedging risks
associated with securities underlying those options, as well as to
enhance markets in products which are likely to receive customer order
flow. The Exchange places a high value on its Market Makers and
believes that eliminating the listing requirement to have a Market
Maker in every series would permit Market Makers, who currently may
choose to serve as Market Makers solely to permit an options to trade
on NOM, to focus their expertise on the products that are more
consistent with their business objectives or more likely to receive
customer order flow.
    Eliminating the Market Maker listing requirement would provide the
Exchange the opportunity to trade options that may have occasional
interest but that do not necessarily require a two-sided market at all
times. The lack of a two-sided or tight market would not cause customer
orders to receive prices inferior to the best prices available across
all exchanges. In fact, NOM is designed to systematically avoid trading
through protected quotations on other options exchanges, and as such,
orders accepted into NOM in options that do not have Market Makers will
not trade at inferior prices even if there is not a two-sided market on
NOM. As a result of NOM's design, incoming orders are protected from
receiving dislocated execution prices simply by the fact that there is
robust quote competition in the exchange listed options business with
seven competing options exchanges and a multitude of competing Market
Makers and liquidity providers. Additionally, the Options Order
Protection and Locked/Crossed Market Plan requires plan participants to
``establish, maintain and enforce written policies and procedures that
are reasonably designed to prevent Trade-Throughs in that participant's
market in Eligible Options Classes.'' \12\ With the implementation of
this plan, a more robust network of private routing has been
constructed that ensures routable customer orders can access the best
prevailing prices in the market.
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    \12\ See Securities Exchange Act Release Nos. 60405 (July 30,
2009), 74 FR 39362 (August 6, 2009) (File No. 4-546) (approval order
for the Protection and Locked/Crossed Plan); and 60525 (August 18,
2009), 74 FR 43188 (August 26, 2009) (approval order for NOM's
proposed rule change to implement the Protection and Locked/Crossed
Plan).
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    Moreover, in its approval order for the proposed rule change
establishing NOM, the Commission agreed that the Act does not mandate a
particular market model for national securities exchanges, and stated
that it believed that many different types of market models could
satisfy the requirements of the Act. The Commission stated that it does
not believe that the Act requires an exchange to have Market
Makers.\13\ It noted that although Market Makers could be an important
source of liquidity on NOM, they likely would not be the only
source.\14\ It observed that, in particular, the NOM System is designed
to match buying and selling interest of all Participants on NOM. The
Exchange here is proposing simply to remove the Market Maker
participation requirement as superfluous to the existence of a vibrant
options market, nevertheless acknowledging the value Market Makers
provide to the Exchange.
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    \13\ See Securities Exchange Act Release No. 57478 (March 12,
2008), 73 FR 14521 (March 18, 2008) (File No. SR-NASDAQ-2007-004).
As the Commission noted in its approval order for the NOM market, in
its release adopting Regulation ATS, the Commission rejected the
suggestion that a guaranteed source of liquidity was a necessary
component of an exchange. See Securities Exchange Act Release No.
40760 (December 8, 1998), 63 FR 70844 (December 22, 1998)
(``Regulation ATS Release''). See also Securities Exchange Act
Release No. 44983 (October 25, 2001), 66 FR 55225 (November 1, 2001)
(File No. SR-PCX-00-25) (order approving Archipelago Exchange as the
equities trading facility of the Pacific Exchange).
    \14\ Indeed, NASDAQ believes that Market Makers are valuable
sources of liquidity and important components of a highly
competitive marketplace with various Participant types who provide
liquidity.
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    With regard to the impact on system capacity, the Exchange has
analyzed its capacity and represents that it and the Options Price
Reporting Authority have the necessary systems capacity to handle the
additional traffic associated with the listing and trading of an
expanded number of series as proposed by this filing.
    The Exchange also proposes to delete paragraph (b) of Section 5,
Chapter IV, which states that a class of options will be put into a
non-regulatory halt if at least one series for that class is not open
for trading. Originally, this provision was put in place so that the
exchange could approve underlying securities for the listing of options
but delay the listing if the Market Makers on the Exchange were not yet
ready to register in any series of options for that class. With the
elimination of the other paragraphs in Section 5 requiring a Market
Maker, the Exchange will no longer need to delay the listings of
particular series and thus will no longer need this provision.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \15\ in general, and furthers the objectives of Section
6(b)(5) of the Act \16\ in particular, in that it is designed to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general to protect investors and the public
interest, by expanding the ability of investors to hedge risks
associated with securities underlying options which are not currently
listed.
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    \15\ 15 U.S.C. 78f(b).
    \16\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act.

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

    No written comments were either solicited or received.

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

    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 shall: (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 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-NASDAQ-2010-007 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-NASDAQ-2010-007. 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, 100 F Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of such 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 publicly available. All
submissions should refer to File Number SR-NASDAQ-2010-007 and should
be submitted on or before February 25, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
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    \17\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-2337 Filed 2-3-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 50 (Wednesday, March 14, 2012)]
[Notices]
[Pages 15104-15105]
[FR Doc No: 2012-6178]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2012-0175; FRL-9647-1]

Environmental Laboratory Advisory Board Membership

AGENCY: U. S. Environmental Protection Agency.

ACTION: Notice Soliciting Nominations for Membership.

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SUMMARY: The EPA invites nominations from a diverse range of qualified
candidates to be considered for appointment to the Environmental
Laboratory Advisory Board (ELAB). The ELAB is a multi-stakeholder
federal advisory committee that provides independent advice and
recommendations to the EPA Administrator, Science Advisor, and Forum on
Environmental Measurements about cross-cutting issues related to
enhancing measurement programs in the EPA, and facilitating the
operation and expansion of national environmental accreditation.
    This notice solicits nominations to fill six new vacancies. To
maintain diverse representation, nominees will be selected from the
following stakeholder work force sectors:
     Academia.
     Business and industry.
     Environmental laboratory commercial, municipal, small,
other.
     Environmental laboratory suppliers of services.
     State and local government agencies.
     Tribal governments and indigenous groups.
     Trade associations.
    Within these sectors, the EPA is seeking nominees with knowledge in
methods development; measurements; monitoring and regulatory programs;
quality systems; and environmental accreditation. In an effort to
obtain nominations of diverse candidates, the EPA encourages
nominations of women and men of all racial and ethnic groups. All
nominations will be fully considered.
    Any interested person or organization may nominate qualified
persons to be considered for appointment to this advisory committee.
Individuals may self-nominate. Nominees should possess the following
qualifications:
     Demonstrated experience with environmental measurement
programs and environmental accreditation;
     Willingness to commit time to the committee, and
demonstrated ability to work constructively and effectively on
committees;
     Excellent interpersonal, oral, and written communication
and consensus-building skills; and
     Ability to serve a two-year appointment and volunteer
approximately five to seven hours per month to support the activities
of the ELAB.
    How to Submit Nominations: Nominations can be submitted in
electronic format (preferred) to Lara P. Autry, Designated Federal
Officer, US EPA, MC E243-05, 109 T. W. Alexander Drive, Research
Triangle Park, NC 27709, or emailed to<EMAIL_ADDRESS>and should be
received by April 13, 2012 for October 2012 appointment. To be
considered, all nomination packages should include:
     Current contact information for the nominee, including the
nominee's name, organization (and position within that organization),
current business

address, email address, and daytime telephone number.
     A brief statement describing the nominee's interest in
serving on the ELAB.
     A resume describing the professional and educational
qualifications of the nominee, including a list of relevant activities,
and any current or previous service on advisory committees.
     Letter(s) of recommendation from a third party supporting
the nomination.
    For further questions regarding this notice, please contact Lara P.
Autry on<PHONE_NUMBER> or<EMAIL_ADDRESS>
    Dated: March 7, 2012.
Lek Kadeli,
Acting Assistant Administrator.
[FR Doc. 2012-6178 Filed 3-13-12; 8:45 am]
BILLING CODE 6560-50-P


Docket Number:  EPA-HQ-OPP-2007-1084

 HYPERLINK "http://www.regulations.gov" www.regulations.gov

Sodium Tetrathiocarbonate

Registration Review Final Decision

September 2011

Sodium Tetrathiocarbonate

 Registration Review Final Decision

September 2011

Case Number 7009

Approved by: ______________________

		Richard P. Keigwin, Jr.

		Director, Pesticide Re-evaluation Division

Date:		______________________

TABLE OF CONTENTS

I.	INTRODUCTION	4

II.	BACKGROUND INFORMATION	5

III.	REGISTRATION REVIEW FINAL DECISION	6

I.	INTRODUCTION

	This document is the Environmental Protection Agency’s (EPA or the
Agency) Registration Review Final Decision for sodium tetrathiocarbonate
and is being issued pursuant to 40 CFR § 155.57 and § 155.58.  A
registration review decision is the Agency’s determination whether a
pesticide meets, or does not meet, the standard for registration in the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

	FIFRA, as amended by the Food Quality Protection Act (FQPA) of 1996,
mandated the continuous review of existing pesticides.  All pesticides
distributed or sold in the United States must generally be registered by
EPA, based on scientific data showing that they will not cause
unreasonable risks to human health or the environment when used as
directed on product labeling.  The registration review program is
intended to make sure that, as the ability to assess risk evolves and as
policies and practices change, all registered pesticides continue to
meet the statutory standard of no unreasonable adverse effects to human
health or the environment.  Through the registration review program, the
Agency periodically reevaluates pesticides to make sure that as change
occurs, products in the marketplace can be safely used.  Information on
this program is provided at:   HYPERLINK
"http://www.epa.gov/oppsrrd1/registration_review/"
http://www.epa.gov/oppsrrd1/registration_review/ .

	In 2006, the Agency implemented the Registration Review program
pursuant to FIFRA Section 3(g), and will review each registered
pesticide every 15 years to determine whether it continues to meet the
FIFRA standard for registration.

	Pursuant to 40 CFR § 155.50, the Agency formally initiated
registration review for sodium tetrathiocarbonate (case 7009).  The
following timeline highlights significant events that have occurred
during the registration review of sodium tetrathiocarbonate:

December 19, 2007 – Publication of the sodium tetrathiocarbonate
Summary Document, Scoping Document, and Problem Formulation Document in
the docket (EPA-HQ-OPP-2007-1084) for a 90-day public comment period.
The Summary Document also included the preliminary work plan.

May 28, 2008 – Signature of the sodium tetrathiocarbonate Final Work
Plan and the Agency’s response to the public comments received during
the 90-day comment period on the sodium tetrathiocarbonate Summary
Document.  The one comment received did not change the work plan set out
in the Preliminary Work Plan.  The Sodium Tetrathiocarbonate Final Work
Plan was modified slightly from the Sodium Tetrathiocarbonate
Preliminary Work Plan to include additional human health data
requirements.  The document describing the updated human health data
requirements is included in the public docket (EPA-HQ-OPP-2007-1084).

November 10, 2010 – Publication of a Notice of Receipt of requests to
voluntarily cancel all remaining pesticide registrations containing
sodium tetrathiocarbonate in the Federal Register (75 FR 69073)
(FRL-8851-5).  The docket number for the receipt of the voluntary
cancellation is EPA-HQ-OPP-2009-1017.  No comments were received
regarding sodium tetrathiocarbonate during the 30-day comment period.

February 25, 2011 – Publication of the Product Cancellation Order for
all remaining pesticide registrations containing sodium
tetrathiocarbonate in the Federal Register (76 FR 10587) (FRL-8863-4).

May 4, 2011 – Publication of the sodium tetrathiocarbonate
Registration Review Proposed Final Decision Notice of Availability in
the Federal Register (76 FR, number 86, pages 25340-25342).

July 5, 2011 – Closure of the 60-day public comment period on the
proposed decision.  No comment was received.

II.	BACKGROUND INFORMATION

	Sodium tetrathiocarbonate is a soil fumigant which acts as a fungicide,
insecticide, and nematicide. Sodium tetrathiocarbonate degrades to
carbon disulfide, hydrogen sulfide, sodium hydrazide, and elemental
sulfur upon contact with water.  Carbon disulfide (PC code 016401) is
the major biologically active degradate.  Tolerances are established for
carbon disulfide from the application of sodium tetrathiocarbonate.
Carbon disulfide from the application of sodium tetrathiocarbonate is
the residue of concern for risk assessment.

Sodium tetrathiocarbonate is registered for pre-plant and post-plant
soil applications on almonds, grapes, lemons, oranges, peaches, prunes,
and plums.  It provides control of soil nematodes (e.g., ring,
root-knot), diseases (e.g., phytophthora, armillaria) and insects (e.g.,
grape phylloxera).  It cannot be used in greenhouses and other enclosed
areas.  There are no registered residential uses.  Sodium
tetrathiocarbonate is currently labeled for use only in Arizona,
California, Oregon, and Washington.  The most recent environmental fate
and ecological risk assessments for sodium tetrathiocarbonate were
completed in 1995 and 1996 in support of the proposed new uses on
almonds, peaches, and prunes.  The most recent human health assessments
were also completed in 1995 and 1996 in support of the same proposed new
uses.

	After the Final Work Plan was signed in May 2008 as part of the
registration review process for sodium tetrathiocarbonate, the technical
and end-use product registrant, Arysta Lifescience North America, LLC,
informed the Agency that they were requesting to voluntarily cancel all
of their sodium tetrathiocarbonate product registrations.  These were
the last remaining products registered in the U.S. containing sodium
tetrathiocarbonate.  A Notice of Receipt of requests to voluntarily
cancel all pesticide registrations containing sodium tetrathiocarbonate
published in the Federal Register on November 10, 2010.  There were no
comments submitted regarding sodium tetrathiocarbonate during the 30-day
comment period.  The Agency then issued the product cancellation order
on February 25, 2011 for all remaining sodium tetrathiocarbonate product
registrations.  (Copies of those documents are included in the docket
for this registration review.)  As specified in the Cancellation Order,
registrants are prohibited from selling or distributing end-use products
containing sodium tetrathiocarbonate as of February 25, 2012.  After
February 25, 2012, persons other than the registrants may sell,
distribute, or use existing stocks of products containing sodium
tetrathiocarbonate until existing stocks are exhausted, provided that
such sale, distribution, or use is consistent with the terms of the
previously approved labeling on, or that accompanies, the cancelled
products.

III.	REGISTRATION REVIEW FINAL DECISION

	As stated in the Preliminary Work Plan for sodium tetrathiocarbonate,
the Agency had intended to revise the existing risk assessments for
sodium tetrathiocarbonate.  However, due to the cancellation order
issued affecting all sodium tetrathiocarbonate product registrations in
the United States, the Agency found that it is not necessary to conduct
new risk assessments for sodium tetrathiocarbonate and, therefore,
issued a proposed decision pursuant to 40 CFR Part 155.53(c)(2) and 40
CFR Part 155.58.  The voluntary cancellation of all remaining U.S.
sodium tetrathiocarbonate registrations will become effective prior to
the previously planned completion dates for the revised sodium
tetrathiocarbonate risk assessments.  The Registration Review Timeline
introduced in the Sodium Tetrathiocarbonate Preliminary Work Plan
proposed that the Agency would issue the preliminary risk assessments by
September 2012 and issue the revised risk assessments by March 2013,
with a final registration review decision scheduled for completion by
September 2013.

The existing stocks sales and distribution deadlines included in the
February 25, 2011 cancellation order ensure that sodium
tetrathiocarbonate sale, distribution, and use will decline and
eventually cease entirely in the United States in the future.  During
this period, the Agency believes that existing stocks of sodium
tetrathiocarbonate products may be used until depleted without causing
unreasonable risk to human health and the environment.  Pursuant to 40
CFR § 155.57 and 155.58, the Agency is issuing the registration review
final decision, thus concluding the sodium tetrathiocarbonate
registration review for the reasons discussed above.  The affected
product registrations are subject to the terms and conditions of the
February 25, 2011 cancellation order.

 PAGE

 PAGE   5


[Federal Register Volume 75, Number 44 (Monday, March 8, 2010)]
[Notices]
[Page 10549]
[FR Doc No: 2010-4871]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Request Revision From the Office of
Management and Budget of a Currently Approved Information Collection
Activity, Request for Comments; Report of Inspections Required by
Airworthiness Directives, Part 39

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: The FAA invites public comments about our intention to request
the Office of Management and Budget (OMB) to approve a current
information collection. Airworthiness directives are regulations issued
to require correct corrective action to correct unsafe conditions in
aircraft, engines, propellers, and appliances. Reports of inspections
are often needed when emergency corrective action is taken to determine
if the action was adequate to correct the unsafe condition. The
respondents are aircraft owners and operators.

DATES: Please submit comments by May 7, 2010.

FOR FURTHER INFORMATION CONTACT: Carla Mauney on<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Federal Aviation Administration (FAA)

    Title: Report of Inspections Required by Airworthiness Directives,
Part 39.
    Type of Request: Extension without change of an approved
collection.
    OMB Control Number: 2120-0056.
    Forms(s): There are no FAA forms associated with this collection.
    Affected Public: A total of 1,120 Respondents.
    Frequency: The information is collected on occasion.
    Estimated Average Burden per Response: Approximately 5 minutes per
response.
    Estimated Annual Burden Hours: An estimated 2,800 hours annually.
    Abstract: Airworthiness directives are regulations issued to
require correct corrective action to correct unsafe conditions in
aircraft, engines, propellers, and appliances. Reports of inspections
are often needed when emergency corrective action is taken to determine
if the action was adequate to correct the unsafe condition. The
respondents are aircraft owners and operators.

ADDRESSES: Send comments to the FAA at the following address: Ms. Carla
Mauney, Room 712, Federal Aviation Administration, IT Enterprises
Business Services Division, AES-200, 800 Independence Ave., SW.,
Washington, DC 20591.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimates of the burden of
the proposed information collection; ways to enhance the quality,
utility and clarity of the information to be collected; and ways to
minimize the burden of the collection of information on respondents,
including the use of automated collection techniques or other forms of
information technology.

    Issued in Washington, DC, on February 25, 2010.
Carla Mauney,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, AES-200.
[FR Doc. 2010-4871 Filed 3-5-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 174 (Thursday, September 8, 2016)]
[Notices]
[Pages 62123-62124]
[FR Doc No: 2016-21614]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 70

[Regional Docket No. II-2016-01; FRL-9952-01-Region 2]

Petition To Reopen State Operating Permit; NY; Seneca Energy II,
LLC

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of final action.

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SUMMARY: Pursuant to Clean Air Act (CAA) section 505(b)(2) and 40 CFR
70.8(d), the Environmental Protection Agency (EPA) Administrator signed
an Order, dated July 29, 2016, denying a petition filed by Finger Lakes
Zero Waste Coalition, Inc., dated February 8, 2016, asking the EPA to
``reopen'' the Title V operating permit, Permit No. 8-3244-00040/00002,
issued by the New York State Department of Environmental Conservation
(DEC) to Seneca Energy II, LLC (Seneca) relating to the Ontario County
Landfill Gas-to-

Energy Facility in western New York. The process by which the EPA may
initiate the reopening process for such a title V permit is explained
at 40 CFR 70.7(g)(1).

DATES: Any such petition for review of this Order filed under the CAA
must be received by November 7, 2016 pursuant to section 307 of the
CAA.

ADDRESSES: You may review copies of the final Order, the petitions, and
other supporting information during normal business hours at EPA Region
2, 290 Broadway, New York, New York. If you wish to examine these
documents, you should make an appointment at least 24 hours before the
visiting day.

FOR FURTHER INFORMATION CONTACT: Steven Riva, Chief, Permitting
Section, Air Programs Branch, Clean Air and Sustainability Division,
EPA, Region 2, 290 Broadway, 25th Floor, New York, New York 10007,
telephone<PHONE_NUMBER>, email address<EMAIL_ADDRESS>or the
above EPA Region 2 address.

SUPPLEMENTARY INFORMATION: In the context of a petition to reopen, the
threshold determination is the Administrator's ``find[ing] that cause
exists to terminate, modify, or revoke and reissue a permit'' pursuant
to 40 CFR 70.7(f). If, and only if, the Administrator makes that
finding, the EPA ``will notify'' the relevant entities to initiate the
reopening process. In light of the discretionary threshold finding
applicable to reopening for cause by the EPA, a petition to reopen a
title V permit should present evidence (e.g., factual information,
citation, analysis) explaining why there is cause to reopen the title V
permit pursuant to 40 CFR 70.7(f). In this instance, the Petitioner has
not presented sufficient evidence that the title V permit fails to
comply with the CAA, or that it should be reopened for cause pursuant
to 40 CFR 70.7(f).

    Dated: August 29, 2016.
Catherine McCabe,
Acting Regional Administrator, Region 2.
[FR Doc. 2016-21614 Filed 9-7-16; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 183 (Wednesday, September 21, 2016)]
[Notices]
[Pages 64916-64917]
[FR Doc No: 2016-22708]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1530]

Reporting of Computational Modeling Studies in Medical Device
Submissions; Guidance for Industry and Food and Drug Administration
Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the guidance entitled ``Reporting of Computational
Modeling Studies in Medical Device Submissions.'' The purpose of this
guidance document is to provide recommendations to industry on the
formatting, organization, and content of reports of computational
modeling and simulation (CM&S) studies that are used as valid
scientific evidence to support medical device submissions, and to
assist FDA staff in the review of computational modeling and simulation
studies by improving the consistency and predictability of the review
of CM&S and facilitating full interpretation and complete review of
those studies.

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2013-D-1530] for ``Reporting of Computational Modeling Studies in
Medical Device Submissions.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management 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 http://www.regulations.gov. Submit both copies to the Division of
Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Reporting of Computational Modeling Studies in Medical Device
Submissions'' to the Office of the Center Director, Guidance and Policy
Development, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Tina Morrison, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 62, Rm. 2204, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry and
FDA staff entitled ``Reporting of Computational Modeling Studies in
Medical Device Submissions.'' This guidance is intended to provide
recommendations to industry on the formatting, organization, and
content of reports for CM&S studies that are used as valid scientific
evidence to support medical device submissions.
    In the Federal Register on January 17, 2014 (79 FR 3211), FDA
announced the availability of the draft guidance document. Interested
persons were invited to comment by April 17, 2014.

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
current thinking of FDA on ``Reporting of Computational Modeling
Studies in Medical Device Submissions''. 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.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the Internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. Persons
unable to download an electronic copy of ``Reporting of Computational
Modeling Studies in Medical Device Submissions'' may send an email
request to<EMAIL_ADDRESS>to receive an electronic copy of
the document. Please use the document number 1807 to identify the
guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. 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 807, subpart E have been
approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 812 have been approved under OMB control
number 0910-0078; the collections of information in 21 CFR part 814,
subparts A through E have been approved under OMB control number 0910-
0231; and the collections of information in 21 CFR part 814, subpart H
have been approved under OMB control number 0910-0332.

    Dated: September 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22708 Filed 9-20-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 225 (Friday, November 26, 2021)]
[Rules and Regulations]
[Pages 67312-67313]
[FR Doc No: 2021-25687]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0693; Project Identifier MCAI-2020-01666-R;
Amendment 39-21788; AD 2021-22-15]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Airbus Helicopters Model AS332L2 and EC225LP helicopters. This
AD was prompted by a design deficiency. This AD requires modifying the
hoist control power supply, as specified in a European Union Aviation
Safety Agency (EASA) AD, which is incorporated by reference. The FAA is
issuing this AD to address the unsafe condition on these products.

DATES: This AD is effective January 3, 2022.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of January 3,
2022.

ADDRESSES: For material incorporated by reference (IBR) in this AD,
contact the EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
telephone +49 221 8999 000; email [email protected]; internet
www.easa.europa.eu. You may find this material on the EASA website at
https://ad.easa.europa.eu. You may view this material at the FAA,
Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy.,
Room 6N-321, Fort Worth, TX 76177. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>. It is also available
in the AD docket at https://www.regulations.gov by searching for and
locating Docket No. FAA-2021-0693.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0693; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this final rule, any
comments received, and other information. The address for Docket
Operations is U.S. Department of Transportation, Docket Operations, M-
30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue
SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Ronnea Derby, Aerospace Engineer,
Denver ACO Branch, Compliance & Airworthiness Division, FAA, 26805 E
68th Ave., Mail Stop: Room 214, Denver, CO 80249; telephone (303) 342-
1093; email [email protected].

SUPPLEMENTARY INFORMATION:

Background

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2020-0281, dated December 16, 2020
(EASA AD 2020-0281), to correct an unsafe condition for certain serial-
numbered Airbus Helicopters (AH), formerly Eurocopter, Eurocopter
France, Aerospatiale Model AS 332 L2 and EC 225 LP helicopters.
    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain serial-numbered
Airbus Helicopters Model AS332L2 and EC225LP helicopters. The NPRM
published in the Federal Register on August 25, 2021 (86 FR 47420). The
NPRM was prompted by a design deficiency involving the incorrect wiring
routing of the electrical hoist installation. The affected wiring was
not protected by the circuit breaker that was intended to provide
electrical protection for that wiring. The NPRM proposed to require
modifying the hoist control power supply, as specified in EASA AD 2020-
0281.
    The FAA is issuing this AD to correct the electrical hoist
installation wiring routing. See EASA AD 2020-0281 for additional
background information.

Discussion of Final Airworthiness Directive

Comments

    The FAA gave the public the opportunity to participate in
developing this final rule. The FAA received no comments on the NPRM or
on the determination of the cost to the public.

Conclusion

    The FAA reviewed the relevant data and determined that air safety
and the public interest require adopting this final rule as proposed.

Related Service Information Under 1 CFR Part 51

    EASA AD 2020-0281 requires modifying the hoist control power
supply.
    This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

Costs of Compliance

    The FAA estimates that this AD affects 5 helicopters of U.S.
Registry. Labor rates are estimated at $85 per work-hour. Based on
these numbers, the FAA estimates the following costs to comply with
this AD.
    Modifying the electrical hoist control power supply takes about 4
work-hours and parts cost about $10, for an estimated cost of $350 per
helicopter and $1,750 for the affected U.S. fleet.

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.
    The FAA is 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

    This AD will not have federalism implications under Executive Order
13132. This AD will 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 that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, 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.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

0
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]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

2021-22-15 Airbus Helicopters: Amendment 39-21788; Docket No. FAA-
2021-0693; Project Identifier MCAI-2020-01666-R.

(a) Effective Date

    This airworthiness directive (AD) is effective January 3, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus Helicopters Model AS332L2 and EC225LP
helicopters, certificated in any category, as identified in European
Union Aviation Safety Agency (EASA) AD 2020-0281, dated December 16,
2020 (EASA AD 2020-0281).

(d) Subject

    Joint Aircraft Service Component (JASC) Code: 2500, Cabin
Equipment/Furnishings.

(e) Unsafe Condition

    This AD was prompted by a design deficiency. The FAA is issuing
this AD to correct the electrical hoist installation wiring routing.
The unsafe condition, if not addressed, could result in a short
circuit of the hoist control electrical harness and subsequent hoist
shear command and hoisted load loss, possibly resulting in injury to
a person being lifted or injury to persons on the ground.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, EASA AD 2020-0281.

(h) Exceptions to EASA AD 2020-0281

    (1) Where EASA AD 2020-0281 requires compliance within 30 days
after its effective date, this AD requires compliance within 30
hours time-in-service after the effective date of this AD.
    (2) This AD does not require the ``Remarks'' section of EASA AD
2020-0281.

(i) No Reporting Requirement

    Although the service information referenced in EASA AD 2020-0281
specifies to submit certain information to the manufacturer, this AD
does not include that requirement.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, International Validation Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the International Validation Branch, send
it to the attention of the person identified in paragraph (k) of
this AD. Information may be emailed to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(k) Related Information

    For more information about this AD, contact Ronnea Derby,
Aerospace Engineer, Denver ACO Branch, Compliance & Airworthiness
Division, FAA, 26805 E 68th Ave., Mail Stop: Room 214, Denver, CO
80249; telephone<PHONE_NUMBER>; email [email protected].

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) European Union Aviation Safety Agency (EASA) AD 2020-0281,
dated December 16, 2020.
    (ii) [Reserved]
    (3) For EASA AD 2020-0281, contact the EASA, Konrad-Adenauer-
Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
[email protected]; internet www.easa.europa.eu. You may find this
EASA AD on the EASA website at https://ad.easa.europa.eu.
    (4) You may view this service information at the FAA, Office of
the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room
6N-321, Fort Worth, TX 76177. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>. This material may be
found in the AD docket at https://www.regulations.gov by searching
for and locating Docket No. FAA-2021-0693.
    (5) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
[email protected], or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on October 15, 2021.
Lance T. Gant,
Director,Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-25687 Filed 11-24-21; 8:45 am]
BILLING CODE 4910-13-P