[Federal Register Volume 84, Number 234 (Thursday, December 5, 2019)]
[Notices]
[Pages 66671-66673]
[FR Doc No: 2019-26251]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2019-E-1059; FDA-2019-E-1060; and FDA-2019-E-1061]

Determination of Regulatory Review Period for Purposes of Patent
Extension; ANDEXXA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for ANDEXXA and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of patents which claims that human
biological product.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
February 3, 2020. Furthermore, any interested person may petition FDA
for a determination regarding whether the applicant for extension acted
with due diligence during the regulatory review period by June 2, 2020.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before February 3, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 3, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos.
FDA-2019-E-1059; FDA-2019-E-1060; and FDA-2019-E-1061 for
``Determination of Regulatory Review Period for Purposes of Patent
Extension; ANDEXXA.'' Received comments, those filed in a timely manner
(see ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human biological
product and continues until FDA grants permission to market the
biological product. Although only a portion of a regulatory review
period may count toward the actual amount of extension that the
Director of USPTO may award (for example, half the testing phase must
be subtracted as well as any time that may have occurred before the
patent was issued), FDA's determination of the length of a regulatory
review period for a human biological product will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(1)(B).
    FDA has approved for marketing the human biologic product ANDEXXA
(coagulation factor Xa (recombinant) inactivated-zhzo). ANDEXXA is
indicated for patients treated with rivaroxaban or apixaban, when
reversal of anticoagulation is needed, due to life-threatening or
uncontrolled bleeding. This indication is approved under accelerated
approval based on the change from baseline in anti-human Factor Xa
activity in healthy volunteers. An improvement in hemostasis has not
been established. Continued approval for this indication may be
contingent upon the results of studies to demonstrate an improvement in
hemostasis in patients.
    Subsequent to this approval, the USPTO received a patent term
restoration application for ANDEXXA (U.S. Patent Nos. 8,153,590;
8,889,129; and 9,388,401) from Portola Pharmaceuticals, Inc., and the
USPTO requested FDA's assistance in determining the patents'
eligibility for patent term restoration. In a letter dated May 13,
2019, FDA advised the USPTO that this human biological product had
undergone a regulatory review period and that the approval of ANDEXXA
represented the first permitted commercial marketing or use of the
product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
ANDEXXA is 2,171 days. Of this time, 1,302 days occurred during the
testing phase of the regulatory review period, while 869 days occurred
during the approval phase. These periods of time were derived from the
following dates:

    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: May 25,
2012. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on May 25,
2012.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): December 17, 2015. FDA has verified the
applicant's claim that the biologics license application (BLA) for
ANDEXXA (BLA 125586) was initially submitted on December 17, 2015.
    3. The date the application was approved: May 3, 2018. FDA has
verified the applicant's claim that BLA 125586 was approved on May 3,
2018.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 661 days, 693 days, or 1,066 days of patent term
extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: November 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-26251 Filed 12-4-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 78 (Thursday, April 23, 2015)]
[Notices]
[Pages 22778-22779]
[FR Doc No: 2015-09437]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[FRA Safety Advisory 2015-02]

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2015-0118, Notice No. 15-11]

Hazardous Materials: Information Requirements Related to the
Transportation of Trains Carrying Specified Volumes of Flammable
Liquids

AGENCY: Federal Railroad Administration (FRA) and Pipeline and
Hazardous Materials Safety Administration (PHMSA), DOT.

ACTION: Notice of safety advisory.

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SUMMARY: FRA and PHMSA are issuing this notice to remind railroads
operating a ``high hazard flammable train'' (HHFT)--defined as a train
comprised of 20 or more loaded tank cars of a Class 3 flammable liquid
in a continuous block, or a train with 35 or more loaded tank cars of a
Class 3 flammable liquid across the entire train--as well as the
offerors of Class 3 flammable liquids transported on such trains, that
certain information may be required by PHMSA and/or FRA personnel
during the course of an investigation immediately following an
accident.

FOR FURTHER INFORMATION CONTACT: Karl Alexy, Staff Director, Hazardous
Materials Division, Office of Technical Oversight, FRA, 1200 New Jersey
Avenue SE., Washington, DC 20590;<PHONE_NUMBER>, or via email:
<EMAIL_ADDRESS>and Richard Raksnis, Director Field Services,
Office of Hazardous Materials Safety, Pipeline and Hazardous Materials
Safety Administration, U.S. Department of Transportation, 1200 New
Jersey Ave. SE., Washington, DC 20590. Telephone<PHONE_NUMBER> or,
via-email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Due to recent derailments involving HHFTs,
FRA and PHMSA have conducted several post-accident investigations and
wish to ensure that stakeholders are fully aware of each agency's
investigative authority and cooperate with agency personnel conducting
such investigations, where time is of the essence in gathering
evidence. Therefore, PHMSA and FRA are issuing this Safety Advisory
notice to remind railroads operating HHFTs, and offerors of Class 3
flammable liquids being transported aboard those trains, of their
obligation to provide PHMSA and FRA, as expeditiously as possible, with
information agency personnel need to conduct investigations immediately
following an accident or incident.
    Federal law authorizes the Secretary of Transportation (Secretary)
to investigate rail accidents. Among other things, related to railroad
safety generally, the Department can subpoena witness testimony,
inspect track, cars, and other equipment, and require (including by
subpoena) the production of records and other evidence. 49 U.S.C.
20107, 20902 \1\ FRA's regulations set forth its general accident
investigation procedures at 49 CFR 225.31.
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    \1\ The FRA Administrator may exercise this investigative
authority pursuant to a delegation from the Secretary. 49 CFR
1.88(c), 1.89(a).
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    Federal law also authorizes the Secretary to investigate accidents
involving hazardous materials, 49 U.S.C. 5121, and in so doing require
(including by subpoena) the production of records, inspect packages,
and gather other evidence. Where Federal law requires the maintenance
of records related to hazardous materials transportation, Section 5121
obligates those responsible for maintaining such records to provide
them to DOT personnel during the course of such investigations. PHMSA
has promulgated rules at 49 CFR part 109 establishing investigative
procedures for that agency under this authority.\2\ The Secretary has
also delegated FRA the authority to investigate rail accidents and
incidents involving the transportation of hazardous material for
compliance with the Federal hazardous materials transportation law (49
U.S.C. 5101 et seq.) and its implementing regulations. See 49 CFR
1.89(j). Stakeholder cooperation with a PHMSA or FRA investigation
following an accident is critically important to transportation safety.
Thus, PHMSA and FRA issue this joint Safety Advisory to remind
stakeholders of their obligations to maintain and make available
records concerning hazardous materials transportation in accordance
with law and DOT regulations, and to explain that the following
information is likely to prove important to PHMSA and FRA personnel
during the course of an investigation--and thus should be

provided as expeditiously as possible, upon request:
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    \2\ The PHMSA Administrator may exercise this investigative
authority pursuant to a delegation of the Secretary. 49 CFR 1.96 and
1.97.
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     Information on the train consist, including the train
number, locomotive(s), locomotives as distributed power, end-of-train
device information, number and position of tank cars in the train, tank
car reporting marks, and the tank car specifications and relevant
attributes \3\ of the tank cars in the train.
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    \3\ Relevant attributes include information related to thermal
protection, shell and head thickness, steel specification and grade,
head shield, and pressure relief valve setting.
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     Waybill (origin and destination) information.
     The Safety Data Sheet(s) (SDS), or any other document used
to provide comprehensive emergency response and incident mitigation
information.
     Results of any product testing undertaken prior to
transportation that was used to properly characterize the Class 3
flammable liquids for transportation (initial testing).
     Results from any analysis of product samples (taken prior
to being offered into transportation) from tank car(s) involved in the
derailment.
     Date of acceptance as required to be noted on shipping
papers under 49 CFR 174.24.
     If a flammable liquid is involved, the type of liquid and
the name and location of the company extracting the material.\4\
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    \4\ For a manufactured flammable liquid, the manufacturer will
be identified on the SDS.
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     The identification of the company having initial testing
performed (sampling and analysis of material) and information on the
lab (if external) conducting the analysis.
     Name and location of the company transporting the material
from well head to loading facility or terminal.
     Name and location of the company that owns and that
operates the terminal or loading facility that loaded the product for
rail transportation.
     Name of the Railroad(s) handling the tank car(s) at any
time from point of origin to destination and a timeline of handling
changes between railroads.
    FRA and PHMSA encourage railroad industry members to take actions
that are consistent with the preceding discussion and to take other
complementary actions to help ensure the safety of the Nation's
railroads. FRA and PHMSA may modify this Safety Advisory, issue
additional safety advisories, or take other appropriate actions
necessary to ensure the highest level of safety on the Nation's
railroads, including pursuing other corrective measures under their
safety authority.

    Issued in Washington, DC on April 17, 2015.
Timothy P. Butters,
Acting Administrator, Pipeline and Hazardous Materials Safety
Administration.
Sarah E. Feinberg,
Acting Administrator, Federal Railroad Administration.
[FR Doc. 2015-09437 Filed 4-22-15; 8:45 am]
 BILLING CODE 4910-60-P


[Federal Register Volume 87, Number 28 (Thursday, February 10, 2022)]
[Notices]
[Page 7885]
[FR Doc No: 2022-02785]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-94157; File Nos. SR-MIAX-2021-59, SR-PEARL-2021-57]

Self-Regulatory Organizations; Miami International Securities
Exchange, LLC, MIAX PEARL, LLC; Notice of Withdrawal of Proposed Rule
Changes To Amend the Fee Schedules To Adopt a Tiered-Pricing Structure
for Certain Connectivity Fees

February 4, 2022.
    On December 1, 2021, Miami International Securities Exchange, LLC
(``MIAX'') and MIAX PEARL, LLC (``MIAX Pearl'') (collectively, the
``Exchanges'') each filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act''),\1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change (File Numbers SR-MIAX-2021-59 and SR-PEARL-2021-
57) to amend the MIAX Fee Schedule and MIAX Pearl Options Fee Schedule
to adopt a tiered pricing structure for certain connectivity fees. The
proposed rule changes were immediately effective upon filing with the
Commission pursuant to Section 19(b)(3)(A) of the Act.\3\ The proposed
rule changes were published for comment in the Federal Register on
December 20, 2021.\4\ On January 27, 2022, the Commission temporarily
suspended the proposed rule changes and instituted proceedings under
Section 19(b)(2)(B) of the Act \5\ to determine whether to approve or
disapprove the proposed rule changes.\6\ On February 1, 2022, the
Exchanges withdrew the proposed rule changes (SR-MIAX-2021-59 and SR-
PEARL-2021-57).
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A). A proposed rule change may take
effect upon filing with the Commission if it is designated by the
exchange as ``establishing or changing a due, fee, or other charge
imposed by the self-regulatory organization on any person, whether
or not the person is a member of the self-regulatory organization.''
15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ See Securities Exchange Act Release Nos. 93775 (December 14,
2021), 86 FR 71996 (SR-MIAX-2021-59); 93774 (December 14, 2021), 86
FR 71952 (SR-PEARL-2021-57).
    \5\ 15 U.S.C. 78s(b)(2)(B).
    \6\ See Securities Exchange Act Release No. 94088, 87 FR 5901
(February 2, 2022).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
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    \7\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-02785 Filed 2-9-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 187 (Wednesday, September 26, 2012)]
[Notices]
[Pages 59227-59231]
[FR Doc No: 2012-23633]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67894; File No. SR-BATS-2012-033]

Self-Regulatory Organizations; BATS Exchange, Inc.; Order
Granting Approval of Proposed Rule Change, as Modified by Amendment No.
1 Thereto, To List and Trade Shares of the iShares Short Maturity Bond
Fund

September 20, 2012.

I. Introduction

    On July 27, 2012, BATS Exchange, Inc. (``Exchange'' or ``BATS'')
filed with the Securities and Exchange Commission (``Commission''),
pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ a proposed rule change to
list and trade shares (``Shares'') of the iShares Short Maturity Bond
Fund (``Fund''). The proposed rule change was published for comment in
the Federal Register on August 8, 2012.\3\ The Commission received no
comments on the proposal. On September 14, 2012, the Exchange filed
Amendment No. 1 to the proposed rule change.\4\ This order grants
approval of the proposed rule change, as modified by Amendment No. 1.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 67583 (August 2,
2012), 77 FR 47461 (``Notice'').
    \4\ Amendment No. 1 reflects a change to the name of the Fund,
from ``iShares Ultrashort Duration Bond Fund'' to ``iShares Short
Maturity Bond Fund,'' and a revision to the citation to the
Registration Statement, a corresponding amendment to which was filed
with the Commission on September 4, 2012. In Amendment No. 1, the
Exchange states that all other representations in the proposed rule
change remain as stated therein and no other changes are being made.
Because Amendment No. 1 is technical in nature and does not
materially alter the substance of the proposed rule change,
Amendment No. 1 is not subject to notice and comment.

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II. Description of the Proposed Rule Change

    The Exchange proposes to list and trade the Shares of the Fund
pursuant to BATS Rule 14.11(i), which governs the listing and trading
of Managed Fund Shares on the Exchange. The Shares will be offered by
iShares U.S. ETF Trust (``Trust''), which was established as a Delaware
statutory trust on June 21, 2011.\5\ BlackRock Fund Advisors is the
investment adviser (``Adviser'') to the Fund.\6\ BlackRock Financial
Management, Inc. serves as sub-adviser for the Fund (``Sub-
Adviser'').\7\ State Street Bank and Trust Company is the
administrator, custodian, and transfer agent for the Trust. BlackRock
Investments, LLC (``Distributor'') serves as the distributor for the
Trust. The Exchange represents the Adviser and Sub-Adviser are both
affiliated with multiple broker-dealers, and both the Adviser and Sub-
Adviser have implemented fire walls with respect to such broker-dealers
regarding access to information concerning the composition and/or
changes to the Fund's portfolio.\8\
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    \5\ The Trust is registered as an open-end investment company
under the Investment Company Act of 1940 (``1940 Act''). On
September 4, 2012, the Trust filed with the Commission Amendment No.
1 to Registration Statement on Form N-1A under the Securities Act of
1933 and under the 1940 Act relating to the Fund (File Nos. 333-
179904 and 811-22649) (``Registration Statement''). In addition, the
Exchange notes that the Commission has issued an order granting
certain exemptive relief to the Trust under the 1940 Act. See
Investment Company Act Release No. 29571 (January 24, 2011) (File
No. 812-13601) (``Exemptive Order'').
    \6\ BlackRock Fund Advisors is an indirect wholly owned
subsidiary of BlackRock, Inc.
    \7\ The Adviser manages the Fund's investments and its business
operations subject to the oversight of the Board of Trustees of the
Trust (``Board''). While the Adviser is ultimately responsible for
the management of the Fund, it is able to draw upon the trading,
research, and expertise of its asset management affiliates for
portfolio decisions and management with respect to portfolio
securities. The Adviser also has ongoing oversight responsibility.
The Sub-Adviser, subject to the supervision and oversight of the
Adviser and the Board, is responsible for day-to-day management of
the Fund and, as such, typically makes all decisions with respect to
portfolio holdings.
    \8\ See BATS Rule 14.11(i)(7). The Exchange represents further
that, in the event (a) the Adviser or the Sub-Adviser becomes newly
affiliated with a broker-dealer, or (b) any new adviser or sub-
adviser becomes affiliated with a broker-dealer, it will implement a
fire wall with respect to such broker-dealer regarding access to
information concerning the composition and/or changes to the
portfolio, and will be subject to procedures designed to prevent the
use and dissemination of material, non-public information regarding
such portfolio.
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Description of the Fund and the Shares

    The Fund will seek to maximize current income. To achieve its
objective, the Fund will invest, under normal circumstances,\9\ at
least 80% of its net assets in a diversified portfolio of U.S. dollar-
denominated investment grade fixed income securities (``Fixed Income
Securities''). The Fund will not be a money market fund and thus will
not seek to maintain a stable net asset value of $1.00 per Share. In
the absence of normal circumstances, the Fund may temporarily depart
from its normal investment process, provided that such departure is, in
the opinion of the portfolio management team of the Fund, consistent
with the Fund's investment objective and in the best interest of the
Fund. For example, the Fund may hold a higher than normal proportion of
its assets in cash in response to adverse market, economic, or
political conditions.
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    \9\ The term ``under normal circumstances'' includes, but is not
limited to, the absence of adverse market, economic, political, or
other conditions, including extreme volatility or trading halts in
the fixed income markets or the financial markets generally;
operational issues causing dissemination of inaccurate market
information; or force majeure type events such as systems failure,
natural or man-made disaster, act of God, armed conflict, act of
terrorism, riot, or labor disruption, or any similar intervening
circumstance.
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    The Fund will hold Fixed Income Securities of at least 13 non-
affiliated issuers.
    The Fund will not purchase the securities of issuers conducting
their principal business activity in the same industry if, immediately
after the purchase and as a result thereof, the value of the Fund's
investments in that industry would equal or exceed 25% of the current
value of the Fund's total assets, provided that this restriction does
not limit the Fund's: (i) Investments in securities of other investment
companies; (ii) investments in securities issued or guaranteed by the
U.S. government, its agencies or instrumentalities; or (iii)
investments in repurchase agreements collateralized by U.S. government
securities.
    The Fund intends to qualify each year as a regulated investment
company (``RIC'') under Subchapter M of the Internal Revenue Code of
1986, as amended. The Fund will invest its assets, and otherwise
conduct its operations, in a manner that is intended to satisfy the
qualifying income, diversification, and distribution requirements
necessary to establish and maintain RIC qualification under Subchapter
M. The Fund will not invest in non-U.S. equity securities.

Fixed Income Securities

    The Fund intends to achieve its investment objective by investing,
under normal circumstances, at least 80% of its net assets in a
diversified portfolio of U.S. dollar-denominated investment grade Fixed
Income Securities, rated a minimum of BBB- or higher by Standard &
Poor's Financial Services LLC and/or Fitch Inc., or Baa3 or higher by
Moody's Investors Service, Inc., or, if unrated, determined by the
portfolio management team of the Fund to be of equivalent quality.
    Fixed Income Securities will primarily include fixed and floating
rate debt securities of varying maturities, such as corporate \10\ and
government bonds, agency securities,\11\ instruments of non-U.S.
issuers, municipal bonds, money market instruments,\12\ and investment
companies that invest in such Fixed Income Securities. The Adviser or
its affiliates may advise the money market funds and investment
companies in which the Fund may

invest, in accordance with the 1940 Act. The Fund may invest up to 5%
of its net assets in Fixed Income Securities and instruments of issuers
that are domiciled in emerging market countries.
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    \10\ While the Fund is permitted to invest without restriction
in corporate bonds, the Adviser expects that, under normal market
conditions, the Fund will generally seek to invest in corporate bond
issuances that have at least $100 million par amount outstanding in
developed countries and at least $200 million par amount outstanding
in emerging market countries.
    \11\ While the Fund is permitted to invest without restriction
in agency securities, the Adviser expects that, under normal market
conditions, the Fund will generally not seek to invest more than 50%
of the Fund's assets in agency securities. ``Agency securities'' for
these purposes generally includes securities issued by the following
entities: Government National Mortgage Association (Ginnie Mae),
Federal National Mortgage Association (Fannie Mae), Federal Home
Loan Banks (FHLBanks), Federal Home Loan Mortgage Corporation
(Freddie Mac), Farm Credit System (FCS) Farm Credit Banks (FCBanks),
Student Loan Marketing Association (Sallie Mae), Resolution Funding
Corporation (REFCORP), Financing Corporation (FICO), and the Farm
Credit System (FCS) Financial Assistance Corporation (FAC). Agency
securities can include, but are not limited to, mortgage-backed
securities.
    \12\ While the Fund will invest at least 80% of its net assets
in a diversified portfolio of U.S. dollar-denominated investment
grade Fixed Income Securities, the Adviser expects that, under
normal circumstances, the Fund also intends to invest in money
market securities (as described below) in a manner consistent with
its investment objective in order to help manage cash flows in and
out of the Fund, such as in connection with payment of dividends or
expenses, and to satisfy margin requirements, to provide collateral
or to otherwise back investments in derivative instruments. For
these purposes, money market securities include: Short-term, high-
quality obligations issued or guaranteed by the U.S. Treasury or the
agencies or instrumentalities of the U.S. government; Short-term,
high-quality securities issued or guaranteed by non-U.S.
governments, agencies, and instrumentalities; repurchase agreements
backed by U.S. government securities; money market mutual funds;
commercial paper; and deposits and other obligations of U.S. and
non-U.S. banks and financial institutions. All money market
securities acquired by the Fund will be rated investment grade. The
Fund does not intend to invest in any unrated money market
securities. However, it may do so, to a limited extent, such as
where a rated money market security becomes unrated, if such money
market security is determined by the Adviser or the Sub-Adviser to
be of comparable quality.
---------------------------------------------------------------------------

    The Fund will invest in asset-backed and mortgage-backed Fixed
Income Securities.\13\ Asset-backed securities are fixed-income
securities that are backed by a pool of assets, usually loans such as
installment sale contracts or credit card receivables. Mortgage-backed
securities are asset-backed securities based on a particular type of
asset, a mortgage. There is a wide variety of mortgage-backed
securities involving commercial or residential, fixed-rate or
adjustable rate mortgages, and mortgages issued by banks or government
agencies. Most transactions in fixed-rate mortgage pass-through
securities occur through standardized contracts for future delivery in
which the exact mortgage pools to be delivered are not specified until
a few days prior to settlement, known as TBA transactions. The Fund may
enter into such contracts on a regular basis. The Fund, pending
settlement of such contracts, will invest the relevant assets in high-
quality, liquid short-term instruments, including shares of money
market funds affiliated with the Adviser. Collateralized mortgage
obligations (``CMOs'') are Fixed Income Securities that are backed by
cash flows from pools of mortgages. CMOs may have multiple classes with
different payment rights and protections.
---------------------------------------------------------------------------

    \13\ Although the Fund has not established a fixed limit to the
amount of asset-backed and/or mortgage-backed debt securities in
which it will invest, as noted above, at least 80% of the Fund's net
assets will be, under normal circumstances, invested in U.S. dollar-
denominated investment grade Fixed Income Securities, including
asset-backed and/or mortgage-backed debt securities. Neither high-
yield asset-backed securities nor high-yield mortgage-backed
securities are included in the Fund's principal investment
strategies. The liquidity of a security, especially in the case of
asset-backed and mortgage-backed debt securities, is a substantial
factor in the Fund's security selection process.
---------------------------------------------------------------------------

    The Fund's investments will be consistent with the Fund's
investment objective and will not be used to enhance leverage. Under
normal circumstances, the effective duration of the Fund's portfolio is
expected to be one year or less, as calculated by the Adviser.\14\
---------------------------------------------------------------------------

    \14\ Effective duration is a measure of the potential
responsiveness of a bond or portfolio price to small parallel shifts
in interest rates. When measured across a portfolio, the effective
duration of a portfolio is equivalent to the average portfolio
duration.
---------------------------------------------------------------------------

Other Portfolio Holdings

    In addition to money market securities in which the Fund invests as
part of its principal investment strategies, as described above, the
Fund may invest in money market securities in a manner consistent with
its investment objective in order to help manage cash flows in and out
of the Fund, such as in connection with payment of dividends or
expenses, and to satisfy margin requirements, to provide collateral or
to otherwise back investments in derivative instruments.
    The Fund may hold up to an aggregate amount of 15% of its net
assets in illiquid securities (calculated at the time of investment),
including Rule 144A securities. The Fund will monitor its portfolio
liquidity on an ongoing basis to determine whether, in light of current
circumstances, an adequate level of liquidity is being maintained, and
will consider taking appropriate steps in order to maintain adequate
liquidity if, through a change in values, net assets, or other
circumstances, more than 15% of the Fund's net assets are held in
illiquid securities.
    Pursuant to the Exemptive Order, the Fund will not invest in swap
agreements, futures contracts, or option contracts. The Fund will also
not invest in convertible securities or preferred stock, but may invest
in currency forwards for hedging against foreign currency exchange rate
risk and/or trade settlement purposes.
    Additional information regarding the Trust, Shares, and the Fund,
including investment strategies, risks, creation and redemption
procedures, fees and expenses, portfolio holdings and disclosure
policies, distributions, taxes, and reports to be distributed to
beneficial owners of the Shares can be found in the Notice and the
Registration Statement, as applicable.\15\ Information can also be
found on the Web site for the Fund (www.iShares.com).
---------------------------------------------------------------------------

    \15\ See supra notes 3 and 5, respectively.
---------------------------------------------------------------------------

III. Discussion and Commission's Findings

    The Commission has carefully reviewed the proposed rule change and
finds that it is consistent with the requirements of Section 6 of the
Act \16\ and the rules and regulations thereunder applicable to a
national securities exchange.\17\ In particular, the Commission finds
that the proposal is consistent with Section 6(b)(5) of the Act,\18\
which requires, among other things, that the Exchange's rules be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in facilitating transactions in
securities, 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. The Commission notes that
the Fund and the Shares must comply with the requirements of BATS Rule
14.11(i) to be listed and traded on the Exchange.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78f.
    \17\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \18\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Commission finds that the proposal to list and trade the Shares
on the Exchange is consistent with Section 11A(a)(1)(C)(iii) of the
Act,\19\ which sets forth Congress' finding that it is in the public
interest and appropriate for the protection of investors and the
maintenance of fair and orderly markets to assure the availability to
brokers, dealers, and investors of information with respect to
quotations for, and transactions in, securities. Quotation and last-
sale information for the Shares will be available on the facilities of
the Consolidated Tape Association (``CTA''). The Intraday Indicative
Value (``IIV''), which will be based upon the current value for the
components of the Disclosed Portfolio, will be updated and widely
disseminated by one or more major market data vendors at least every 15
seconds during the Exchange's Regular Trading Hours.\20\ On each
business day, before commencement of trading in Shares during Regular
Trading Hours, the Fund will disclose on its Web site the Disclosed
Portfolio that will form the basis for the Fund's calculation of Net
Asset Value (``NAV'') at the end of the business day.\21\ The NAV of
the Fund's Shares generally will be calculated once daily Monday
through Friday as of the close of regular trading on the New York Stock
Exchange, generally 4:00 p.m. Eastern Time. Additionally, information
regarding market price and volume of the Shares will be continually
available on a real-time basis throughout the day on brokers' computer
screens and other electronic services. The previous day's

closing price and trading volume information for the Shares will also
be published daily in the financial section of newspapers. Intraday,
executable price quotations on Fixed Income Securities and other assets
are available from major broker-dealer firms. Such intraday price
information is also available through subscription services, such as
Bloomberg, Thomson Reuters, and International Data Corporation, which
can be accessed by authorized participants and other investors. The Web
site for the Fund will include a form of the prospectus for the Fund,
additional data relating to NAV, and other applicable quantitative
information.
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78k-1(a)(1)(C)(iii).
    \20\ According to the Exchange, several major market data
vendors display and/or make widely available IIVs published via the
CTA or other data feeds. In addition, the quotations of certain of
the Fund's holdings may not be updated during U.S. trading hours if
such holdings do not trade in the United States or if updated prices
cannot be ascertained.
    \21\ The Disclosed Portfolio will include, as applicable, the
names, quantity, percentage weighting, and market value of Fixed
Income Securities and other assets held by the Fund, and the
characteristics of such assets. The Web site information will be
publicly available at no charge.
---------------------------------------------------------------------------

    The Commission further believes that the proposal to list and trade
the Shares is reasonably designed to promote fair disclosure of
information that may be necessary to price the Shares appropriately and
to prevent trading when a reasonable degree of transparency cannot be
assured. The Commission notes that the Exchange will obtain a
representation from the issuer of the Shares that the NAV per Share
will be calculated daily and that the NAV and the Disclosed Portfolio
will be made available to all market participants at the same time.\22\
Trading in the Shares also will be subject to BATS Rule
14.11(i)(4)(B)(iv), which sets forth circumstances under which Shares
of the Fund may be halted.\23\ The Exchange may halt trading in the
Shares if trading is not occurring in the securities and/or the
financial instruments comprising the Disclosed Portfolio of the Fund,
or if other unusual conditions or circumstances detrimental to the
maintenance of a fair and orderly market are present.\24\ Further, the
Commission notes that the Reporting Authority that provides the
Disclosed Portfolio must implement and maintain, or be subject to,
procedures designed to prevent the use and dissemination of material,
non-public information regarding the actual components of the
portfolio.\25\ The Exchange states that it prohibits the distribution
of material, non-public information by its employees. The Exchange also
states that the Adviser and Sub-Adviser are both affiliated with
multiple broker-dealers, and both the Adviser and Sub-Adviser have
implemented fire walls with respect to such broker-dealers regarding
access to information concerning the composition and/or changes to the
Fund's portfolio.\26\ Moreover, the Exchange represents that it is able
to obtain information via the Intermarket Surveillance Group (``ISG'')
from other exchanges that are members of ISG or with which the Exchange
has in place a comprehensive surveillance sharing agreement.
---------------------------------------------------------------------------

    \22\ See BATS Rule 14.11(i)(4)(A)(ii).
    \23\ See BATS Rule 14.11(i)(4)(B)(iv).
    \24\ See BATS Rule 14.11(i)(4)(B)(iii) (providing additional
considerations for the suspension of trading in or removal from
listing of Managed Fund Shares on the Exchange). With respect to
trading halts, the Exchange may consider all relevant factors in
exercising its discretion to halt or suspend trading in the Shares
of the Fund. The Exchange will halt trading in the Shares under the
conditions specified in BATS Rule 11.18. Trading also may be halted
because of market conditions or for reasons that, in the view of the
Exchange, make trading in the Shares inadvisable.
    \25\ See BATS Rule 14.11(i)(4)(B)(ii)(B).
    \26\ See supra note 8 and accompanying text. The Commission
notes that an investment adviser to an open-end fund is required to
be registered under the Investment Advisers Act of 1940 (``Advisers
Act''). As a result, the Adviser, Sub-Adviser, and their related
personnel are subject to the provisions of Rule 204A-1 under the
Advisers Act relating to codes of ethics. This Rule requires
investment advisers to adopt a code of ethics that reflects the
fiduciary nature of the relationship to clients as well as
compliance with other applicable securities laws. Accordingly,
procedures designed to prevent the communication and misuse of non-
public information by an investment adviser must be consistent with
Rule 204A-1 under the Advisers Act. In addition, Rule 206(4)-7 under
the Advisers Act makes it unlawful for an investment adviser to
provide investment advice to clients unless such investment adviser
has (i) adopted and implemented written policies and procedures
reasonably designed to prevent violation, by the investment adviser
and its supervised persons, of the Advisers Act and the Commission
rules adopted thereunder; (ii) implemented, at a minimum, an annual
review regarding the adequacy of the policies and procedures
established pursuant to subparagraph (i) above and the effectiveness
of their implementation; and (iii) designated an individual (who is
a supervised person) responsible for administering the policies and
procedures adopted under subparagraph (i) above.
---------------------------------------------------------------------------

    The Exchange further represents that the Shares are deemed to be
equity securities, thus rendering trading in the Shares subject to the
Exchange's existing rules governing the trading of equity securities.
In support of this proposal, the Exchange has made representations,
including:
    (1) The Shares will be subject to BATS Rule 14.11(i), which sets
forth the initial and continued listing criteria applicable to Managed
Fund Shares.
    (2) The Exchange has appropriate rules to facilitate transactions
in the Shares during all trading sessions.
    (3) The Exchange's surveillance procedures applicable to derivative
products, which include Managed Fund Shares, are adequate to properly
monitor the trading of the Shares on the Exchange during all trading
sessions and to deter and detect violations of Exchange rules and
applicable federal securities laws.
    (4) Prior to the commencement of trading, the Exchange will inform
its members in an Information Circular (``Circular'') of the special
characteristics and risks associated with trading the Shares.
Specifically, the Circular will discuss the following: (a) The
procedures for purchases and redemptions of Shares in Creation Units
(and that Shares are not individually redeemable); (b) BATS Rule 3.7,
which imposes suitability obligations on Exchange members with respect
to recommending transactions in the Shares to customers; (c) how
information regarding the IIV is disseminated; (d) the risks involved
in trading the Shares during the Pre-Opening \27\ and After Hours
Trading Sessions \28\ when an updated IIV will not be calculated or
publicly disseminated; (e) the requirement that members deliver a
prospectus to investors purchasing newly issued Shares prior to or
concurrently with the confirmation of a transaction; and (f) trading
information.
---------------------------------------------------------------------------

    \27\ The Pre-Opening Session is from 8:00 a.m. to 9:30 a.m.
Eastern Time.
    \28\ The After Hours Trading Session is from 4:00 p.m. to 5:00
p.m. Eastern Time.
---------------------------------------------------------------------------

    (5) For initial and/or continued listing, the Fund must be in
compliance with Rule 10A-3 under the Act.\29\
---------------------------------------------------------------------------

    \29\ See 17 CFR 240.10A-3.
---------------------------------------------------------------------------

    (6) The Fund may hold up to an aggregate amount of 15% of its net
assets in illiquid securities (calculated at the time of investment),
including Rule 144A securities. The Fund will monitor its portfolio
liquidity on an ongoing basis to determine whether, in light of current
circumstances, an adequate level of liquidity is being maintained, and
will consider taking appropriate steps in order to maintain adequate
liquidity if, through a change in values, net assets, or other
circumstances, more than 15% of the Fund's net assets are held in
illiquid securities.
    (7) Pursuant to the Exemptive Order, the Fund will not invest in
swap agreements, futures contracts, or option contracts.
    (8) The Fund's investments will be consistent with the Fund's
investment objective and will not be used to enhance leverage.
    (9) The Fund will not invest in non-U.S. equity securities.
    (10) A minimum of 100,000 Shares will be outstanding at the
commencement of trading on the Exchange.

This approval order is based on all of the Exchange's representations
and description of the Fund, including those set forth above and in the
Notice.
    For the foregoing reasons, the Commission finds that the proposed

rule change is consistent with Section 6(b)(5) of the Act \30\ and the
rules and regulations thereunder applicable to a national securities
exchange.
---------------------------------------------------------------------------

    \30\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\31\ that the proposed rule change (SR-BATS-2012-033), as modified
by Amendment No. 1 thereto, be, and it hereby is, approved.
---------------------------------------------------------------------------

    \31\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\32\
---------------------------------------------------------------------------

    \32\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-23633 Filed 9-25-12; 8:45 am]
BILLING CODE 8011-01-P


                             Prohexadione (112600)
                     Screening Level Usage Analysis (SLUA)
                             Date: March 30, 2012

What is a Screening Level Usage Analysis (SLUA)?
      * Available estimates of pesticide usage data for a particular active ingredient that is used on agricultural crops in the United States.
      * Pesticide usage data obtained from various sources.  The data are then merged, averaged, and rounded so that the presented information is not proprietary, business confidential, or trade secret.
What does it contain?
      * Pesticide usage data for a single active ingredient only.
      * Agricultural use sites (crops) that the pesticide is reported to be used on.
      * Available pesticide usage information from U.S. states that produce 80% or more of a crop, in most cases, or less than 80%, in rare cases, depending on the scope of the survey and available resources.
      * Annual percent of crop treated (average & maximum) for each agricultural crop.
      * Average annual pounds of the pesticide applied for each agricultural crop (i.e., for the states surveyed, not for the entire United States).
What assumptions can I make about the reported data?
      * Average pounds of active ingredient applied - Values are calculated by merging pesticide usage data sources together; averaging across all observations, then rounding.  Note:  If the estimated value is less than 500, then that value is labeled <500.  Estimated values between 500 & <1,000,000 are rounded to 1 significant digit.  Estimated values of 1,000,000 or greater are rounded to 2 significant digits.)
      * Average percent of crop treated - Values are calculated by merging data sources together; averaging by year, averaging across all years, & rounding to the nearest multiple of 5.  Note:  If the estimated value is less than 2.5, then the value is labeled <2.5.  If the estimated value is less than 1, then the value is labeled <1.
      * Maximum percent of crop treated - Value is the single maximum value reported across all data sources, across all years, & rounded up to the nearest multiple of 5.  Note:  If the estimated value is less than 2.5, then the value is labeled <2.5.
What are the data sources used?
      * USDA-NASS (United States Department of Agriculture's National Agricultural Statistics Service)  -  pesticide usage data from 2003 to 2009.
      * Private pesticide market research  -  pesticide usage data from 2003 to 2010.
      * California Department of Pesticide Regulation (DPR) Pesticide Use Reporting (PUR) data for 2000 to 2009.
What are the limitations to the data?
      * Additional registered uses may exist but are not included because the available surveys do not report usage (e.g., small acreage crops).
      * Lack of reported usage data for the pesticide on a crop does not imply zero usage.
      * Usage data on a particular site may be noted in data sources, but not quantified.  In these instances, the site would not be reported in the SLUA.
      * Non-agricultural use sites (e.g., turf, post-harvest, mosquito control, etc.) are not reported in the SLUA.  A separate request must be made to receive these estimates.
      * Some sites show some use, even though they are not on the label.  This usage could be due to various factors, including, but not limited to Section 18 requests, existing stocks of the chemical, data collection errors, and experimental use permits (EUPs).

                                March 30, 2012

    Screening Level Estimates of Agricultural Uses of Prohexadione (112600)
                             Sorted Alphabetically

                               Percent Crop Ttd.

Crop
                                   Lbs. A.I.
                                     Avg.
                                     Max.
                                                                              1
Apples
                                    10,000
                                      10
                                      25

SLUA data sources include:
  USDA-NASS (United States Department of Agriculture's National Agricultural Statistics Service)
Private Pesticide Market Research

These results reflect amalgamated data developed by the Agency and are releasable to the public.


[Federal Register: August 13, 2008 (Volume 73, Number 157)]
[Rules and Regulations]
[Page 47039-47041]
[DOCID:fr13au08-5]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0626 Directorate Identifier 2008-CE-035-AD;
Amendment 39-15637; AD 2008-16-19]
RIN 2120-AA64

Airworthiness Directives; Pilatus Aircraft Ltd. Model PC-6
Airplanes

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

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD results from mandatory continuing
airworthiness information (MCAI) issued by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as:

    This Airworthiness Directive (AD) is prompted due to the
discovery of loose self-locking stop nuts Part Number (P/N)
9<IP_ADDRESS> in the tail landing gear fastener assemblies of some
PC-6 aircraft.
    It is believed that this occurrence could also exist in other
fastener assemblies using nuts P/N 9<IP_ADDRESS> at various
identified locations in the aircraft.
    If left uncorrected, the identified assemblies may become loose
and not function as designed and could lead to hazardous situations.

We are issuing this AD to require actions to correct the unsafe
condition on these products.

DATES: This AD becomes effective September 17, 2008.
    On September 17, 2008, the Director of the Federal Register
approved the incorporation by reference of certain publications listed
in this AD.

ADDRESSES: You may examine the AD docket on the Internet at http://
www.regulations.gov or in person at Document Management Facility, 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: Doug Rudolph, Aerospace Engineer, FAA,
Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on June 9, 2008 (73 FR
32497). That NPRM proposed to correct an unsafe condition for the
specified products. The MCAI states:

    This Airworthiness Directive (AD) is prompted due to the
discovery of loose self-locking stop nuts Part Number (P/N)
9<IP_ADDRESS> in the tail landing gear fastener assemblies of some
PC-6 aircraft.
    It is believed that this occurrence could also exist in other
fastener assemblies using nuts P/N 9<IP_ADDRESS> at various
identified locations in the aircraft.
    If left uncorrected, the identified assemblies may become loose
and not function as designed and could lead to hazardous situations.
    In order to prevent those conditions, the present AD requires
you to replace self-locking stop nuts P/N 9<IP_ADDRESS> from the
Tail Landing Gear Assembly, the Parachute Cable Assembly, the Water
Tank Assembly, the Cable Tensioner Assembly, the Fuel Filter
Assembly, the Hydraulic Pump Assembly and the Engine Mounts Assembly
in accordance with Pilatus PC-6 Service Bulletin No. 53-002 Revision
2.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM or on the determination of
the cost to the public.

Conclusion

    We reviewed the available data and determined that air safety and
the public interest require adopting the AD as proposed.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a NOTE within the AD.

Costs of Compliance

    Based on the service information, we estimate that this AD will
affect 50 products of U.S. registry. We also estimate that it will take
about 7 work-hours per product to comply with basic requirements of
this AD. The average labor rate is $80 per work-hour. Required parts
will cost about $310 per product.
    Based on these figures, we estimate the cost of this AD to the U.S.
operators to be $43,500, or $870 per product.

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 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 this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866;
    (2) Is not a ``significant rule'' under 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 AD and placed it in the AD Docket.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Office (telephone<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
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 AD:

2008-16-19 Pilatus Aircraft Ltd.: Amendment 39-15637; Docket No.
FAA-2008-0626; Directorate Identifier 2008-CE-035-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective
September 17, 2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to PC-6, PC-6-H1, PC-6-H2, PC-6/350, PC-6/
350-H1, PC-6/350-H2, PC-6/A, PC-6/A-H1, PC-6/A-H2, PC-6/B-H2, PC-6/
B1-H2, PC-6/B2-H2, PC-6/B2-H4, PC-6/C-H2, and PC-6/C1-H2 airplanes,
manufacturer serial numbers (MSN) MSN 101 through MSN 949 and MSN
2001 through MSN 2092, certificated in any category.

    Note 1: These airplanes may also be identified as Fairchild
Republic Company PC-6 airplanes, Fairchild Heli Porter PC-6
airplanes, or Fairchild-Hiller Corporation PC-6 airplanes.

Subject

    (d) Air Transport Association of America (ATA) Code 53:
Fuselage.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:
    This Airworthiness Directive (AD) is prompted due to the
discovery of loose self-locking stop nuts Part Number (P/N)
9<IP_ADDRESS> in the tail landing gear fastener assemblies of some
PC-6 aircraft.
    It is believed that this occurrence could also exist in other
fastener assemblies using nuts P/N 9<IP_ADDRESS> at various
identified locations in the aircraft.
    If left uncorrected, the identified assemblies may become loose
and not function as designed and could lead to hazardous situations.
    In order to prevent those conditions, the present AD requires
you replace self-locking stop nuts P/N 9<IP_ADDRESS> from the Tail
Landing Gear Assembly, the Parachute Cable Assembly, the Water Tank
Assembly, the Cable Tensioner Assembly, the Fuel Filter Assembly,
the Hydraulic Pump Assembly and the Engine Mounts Assembly in
accordance with Pilatus PC-6 Service Bulletin No. 53-002 Revision 2.

Actions and Compliance

    (f) Unless already done, do the following actions:
    (1) Within the next 12 months after September 17, 2008 (the
effective date of this AD), inspect and modify the fastener
assemblies as instructed in paragraph 3 of Pilatus Aircraft Ltd.
Pilatus PC-6 Service Bulletin No. 53-002, Revision No. 2, dated
September 24, 2007.
    (2) As of September 17, 2008 (the effective date of this AD), no
person shall install on any PC-6 series aircraft, water tank
assemblies and hydraulic pump assemblies, unless they have been
previously modified following paragraph 4 of Pilatus Aircraft Ltd.
Pilatus PC-6 Service Bulletin No. 53-002, Revision No. 2, dated
September 24, 2007.

FAA AD Differences

    Note 2: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Doug Rudolph, Aerospace Engineer, FAA, Small
Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106;

telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>. Before using any
approved AMOC on any airplane to which the AMOC applies, notify your
appropriate principal inspector (PI) in the FAA Flight Standards
District Office (FSDO), or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.), the Office of Management and Budget (OMB) has
approved the information collection requirements and has assigned
OMB Control Number 2120-0056.

Related Information

    (h) Refer to MCAI European Aviation Safety Agency EASA AD No.:
2008-0083, dated May 5, 2008; and Pilatus Aircraft Ltd. Pilatus PC-6
Service Bulletin No. 53-002, Revision No. 2, dated September 24,
2007, for related information.

Material Incorporated by Reference

    (i) You must use Pilatus Aircraft Ltd. Pilatus PC-6 Service
Bulletin No. 53-002, Revision No. 2, dated September 24, 2007, to do
the actions required by this AD, unless the AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Pilatus Aircraft Ltd., Customer Liaison Manager, CH-6371 STANS,
Switzerland; telephone: +41 41 619 65 80; fax: +41 41 619 65 76; e-
mail<EMAIL_ADDRESS>    (3) You may review copies at the FAA, Central Region, Office of
the Regional Counsel, 901 Locust, Room 506, Kansas City, Missouri
64106; or at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-
register/cfr/ibr-locations.html.

    Issued in Kansas City, Missouri, on August 1, 2008.
James E. Jackson,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E8-18236 Filed 8-12-08; 8:45 am]

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