[Federal Register Volume 78, Number 84 (Wednesday, May 1, 2013)]
[Notices]
[Pages 25456-25457]
[FR Doc No: 2013-10313]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0867]

Ashley Brandon Foyle: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring
Ashley Brandon Foyle for 5 years from providing services in any
capacity to a person that has an approved or pending drug product
application. FDA bases this order on a finding that Mr. Foyle was
convicted of introducing and delivering for introduction into
interstate commerce a misbranded drug, which relates to the development
or approval, including the process for development or approval, of drug
products and to the regulation of drug products under the FD&C Act. In
addition, FDA determined that the type of conduct that served as the
basis for Mr. Foyle's conviction undermines the process for the
regulation of drugs. Mr. Foyle was given notice of the proposed
debarment and an opportunity to request a hearing within the prescribed
timeframe by regulation but failed to respond. Mr. Foyle's failure to
respond constitutes a waiver of his right to a hearing concerning this
action.

DATES: This order is effective May 1, 2013.

ADDRESSES: Submit applications for termination of debarment to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kenny Shade, Office of Regulatory

Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rockville,
MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C.
335a(b)(2)(B)(i)(I)) permits FDA to debar an individual if it finds
that the individual has been convicted of a misdemeanor under Federal
law for conduct relating to the development or approval, including the
process for development or approval, of any drug product or otherwise
relating to the regulation of drug products under the FD&C Act, and if
FDA finds that the type of conduct that served as the basis for the
conviction undermines the process for the regulation of drugs.
    On May 5, 2010, Mr. Foyle pleaded guilty to a misdemeanor offense
of introducing and delivering for introduction into interstate commerce
a misbranded drug in violation of 21 U.S.C. 352(o), 331(a), and
333(a)(1). On July 7, 2011, the U.S. District Court for the District of
Nevada entered judgment against Mr. Foyle for the misdemeanor offense
of misbranding.
    FDA's finding that debarment is appropriate is based on the
misdemeanor conviction referenced herein. The factual basis for the
conviction is as follows: On July 23, 2008, Agents from Customs and
Border Protection found two express mail packages at JFK International
Mail Facility, each with a return address of Muhi Trading Corporation,
Bahadur Manzil. A border search was conducted on both packages, which
revealed 1,000 capsules labeled as the prescription drug omeprazole in
each package. The pills were in blister packs on which was written
``Omega Biotech LTD.'' Mr. Foyle and his co-defendant, David Freeman,
were the importers of record for the packages. At all relevant times,
neither Muhi Trading Corporation nor Omega Biotech LTD. were registered
to manufacture, prepare, propagate, compound, or process drugs.
    On January 20, 2009, an Agent with the Office of Criminal
Investigations at FDA (OCI) conducted an undercover purchase of
omeprazole through a Web site Mr. Foyle and Mr. Freeman used to sell
their misbranded drugs. Mr. Foyle and Mr. Freeman repackaged omeprazole
in their apartment and mailed it to the undercover Agent. Laboratory
testing of the tablets confirmed that the tablets contained omeprazole.
On February 24, 2009, OCI Agents searched Mr. Foyle and Mr. Freeman's
residence and found unapproved drugs. The omeprazole pills that Mr.
Foyle and Mr. Freeman imported, repackaged, and sold had not been
approved by or registered with FDA. At no time was Mr. Foyle and Mr.
Freeman's apartment registered as a location where drugs could be
manufactured, prepared, propagated, compounded, or processed.
    As a result of his convictions, on October 31, 2012, FDA sent Mr.
Foyle a notice by certified mail proposing to debar him for 5 years
from providing services in any capacity to a person that has an
approved or pending drug product application. The proposal was based on
a finding, under section 306(b)(2)(B)(i)(I) of the FD&C Act that Mr.
Foyle was convicted of a misdemeanor under Federal law for conduct
relating to the development or approval, including the process for
development or approval, of drug products and to the regulation of drug
products under the FD&C Act, and the conduct that served as the basis
for Mr. Foyle's conviction undermines the process for the regulation of
drugs because the introduction of misbranded drugs into interstate
commerce is prohibited by the FD&C Act. The proposal also offered Mr.
Foyle an opportunity to request a hearing, providing him 30 days from
the date of receipt of the letter in which to file the request, and
advised him that failure to request a hearing constituted a waiver of
the opportunity for a hearing and of any contentions concerning this
action. Mr. Foyle failed to respond within the timeframe prescribed by
regulation and has, therefore, waived his opportunity for a hearing and
waived any contentions concerning his debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Director, Office of Enforcement and Import
Operations, Office of Regulatory Affairs, under section
306(b)(2)(B)(i)(I) of the FD&C Act under authority delegated to him
(Staff Manual Guide 1410.35), finds that Ashley Brandon Foyle has been
convicted of a misdemeanor under Federal law for conduct relating to
the development or approval, including the process for development or
approval, of drug products and relating to the regulation of drug
products under the FD&C Act, and that the type of conduct that served
as the basis for the conviction undermines the process for the
regulation of drugs.
    As a result of the foregoing finding, Mr. Foyle is debarred for 5
years from providing services in any capacity to a person with an
approved or pending drug product application under sections 505, 512,
or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section
351 of the Public Health Service Act (42 U.S.C. 262), effective (see
DATES), (see sections 306(c)(1)(B), (c)(2)(A)(iii), and 201(dd) of the
FD&C Act (21 U.S.C. 335a(c)(1)(B), (c)(2)(A)(iii), and 321(dd))). Any
person with an approved or pending drug product application who
knowingly employs or retains as a consultant or contractor, or
otherwise uses the services of Mr. Foyle, in any capacity during Mr.
Foyle's debarment, will be subject to civil money penalties (section
307(a)(6) of the FD&C Act). If Mr. Foyle provides services in any
capacity to a person with an approved or pending drug product
application during his period of debarment he will be subject to civil
money penalties (section 307(a)(7) of the FD&C Act). In addition, FDA
will not accept or review any abbreviated new drug applications
submitted by or with the assistance of Mr. Foyle during his period of
debarment (section 306(c)(1)(B) of the FD&C Act).
    Any application by Mr. Foyle for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2012-N-0867 and sent to the Division of Dockets Management (see
ADDRESSES). All such submissions are to be filed in four copies. The
public availability of information in these submissions is governed by
21 CFR 10.20(j).
    Publicly available submissions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: April 3, 2013.
Melinda K. Plaisier,
Acting Associate Commissioner for Regulatory Affairs, Office of
Regulatory Affairs.
[FR Doc. 2013-10313 Filed 4-30-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 77, Number 201 (Wednesday, October 17, 2012)]
[Rules and Regulations]
[Pages 63725-63727]
[FR Doc No: 2012-25540]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2012-0628]
RIN 1625-AA09

Drawbridge Operation Regulation; Atlantic Intracoastal Waterway
(AIWW), Newport River, Morehead City, NC

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is temporarily changing the operating schedule
that governs the Carolina Coastal Railroad Bridge, at AIWW mile 203.8,
across Newport River in Morehead City, NC. This bridge is presently
maintained in the open position except when closure is necessary for
train crossings. This change would allow the bridge to remain closed at
night so that necessary repairs may be made while still providing for
the reasonable needs of navigation.

DATES: This temporary final rule is effective from 5 a.m. on October
17, 2012 to 8:30 p.m. on October 1, 2013.

ADDRESSES: Comments and related materials received from the public, as
well as documents mentioned in this preamble as being available in the
docket, are part of docket USCG-2009-0628 and are available online by
going to www.regulations.gov, and inserting USCG-2012-0628 in the
``Keyword'' box, and then clicking ``Search''. This material is also
available for inspection or copying at the Docket Management Facility
(M-30), U.S. Department of Transportation, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590, between
9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Terrance A. Knowles, Environmental Protection Specialist,
Fifth Coast Guard District, at telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
U.S.C United States Code

A. Regulatory History and Information

    On August 10, 2012, we published a notice of proposed rulemaking
(NPRM) entitled ``Drawbridge Operations; Atlantic Intracoastal Waterway
(AIWW), Newport River, Morehead City, NC.'' in the Federal Register (77
FR 47787). We received no comments on the proposed rule. No public
meeting was requested, and none was held.
    Under 5 U.S.C 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective in less than 30 days after
publication in the Federal Register. Due to these bridge repairs being
required and also being a lengthy process, it is best that this work be
done when there is the least marine activity, such as during the winter
and night time. Starting the project now will possibly shorten the 2013
summertime impacts to navigation, depending on expected project tempo/
efficiency. Also, replacement of the obsolete drive system will allow
for a safer/faster way to close the bridge during approaching
hurricanes for the 2013 storm season and beyond.

B. Basis and Purpose

    The North Carolina Department of Transportation (NCDOT), who owns
and operates this bascule-type railroad bridge, has requested a
temporary change to the existing operating regulations to facilitate
repairs of existing structural steel, strengthening of the main bascule
girders and upgrading the obsolete drive system. The current
regulations, under the general requirements set out at 33 CFR 117.5,
require that the Carolina Coastal Railroad Bridge, at AIWW mile 203.8,
across Newport River in Morehead City NC, shall open promptly and fully
for the passage of vessels when a request to open is given. However,
the drawbridge is currently maintained in the open to navigation
position at all times and closes for passing trains.
    In the closed position to vessels, this single-leaf bascule
drawbridge has a vertical clearance of 4 feet above mean high water.
    To facilitate the required repair work and to minimize the impact
on navigation, the drawbridge would operate as follows: (1) From 5 a.m.
October 17, 2012 to 8:30 p.m. on October 1, 2013 shall be maintained in
the open position to vessels and would only be closed for the passage
of trains and to perform periodic maintenance; and (2) in the closed
position to vessels, from 8:30 p.m. to 5 a.m., with one optional
opening provided at 12 a.m. (midnight) for vessels providing advance
notice before 4 p.m. on the afternoon before the requested opening.
    Vessel traffic along this part of the Atlantic Intracoastal
Waterway consists of commercial and pleasure craft including sail
boats, fishing boats, and tug and barge traffic, that transit mainly
during the daylight hours with the occasional tug and barge traffic at
night. The drawbridge is currently maintained in the open to navigation
position at all times and closes for passing trains. Consequently, the
number of mariners transiting through this section of the waterway is
not based on the amount of vessel openings but on the average number of
waterway users, which showed that there are fewer vessel transits at
night for mariners, making it a more suitable time to restrict the
operation of the drawbridge.

C. Discussion of Comments, Changes and the Final Rule

    The Coast Guard provided a comment period of 30 days and no
comments were received. The Coast Guard would temporarily revise the
operating regulations at 33 CFR 117.821 by adding a new paragraph (c).
Paragraph (c) would state from 5 a.m. on October 17, 2012 to 8:30 p.m.
on October 1, 2013, the draw of the Carolina Coastal Railroad Bridge
shall be maintained in the open position to vessels, and would only be
closed for the passage of trains and to perform periodic maintenance;
and the draw need not open from 8:30 p.m. to 5 a.m., except at 12 a.m.
(midnight) for vessels providing advance notice before 4 p.m. on the
afternoon before the requested opening.

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes or executive orders.

1. Regulatory Planning and Review

    This rule is not a ``significant regulatory action'' under section
3(f) of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Order 12866 or under
section 1 of Executive Order 13563. The Office of Management and Budget
has not reviewed it under those Orders.
    The temporary changes are expected to have minimal impact on
mariners due to the low number of vessels transiting this area at
night. Also, a midnight vessel opening would be available each night
for vessels requiring an opening provided that advance notice is given
by 4 p.m. on the afternoon before the requested opening.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard received no comments from the Small Business
Administration on this rule. The Coast Guard certifies under 5 U.S.C.
605(b) that this rule will not have a significant economic impact on a
substantial number of small entities.
    This rule will not have a significant economic impact on a
substantial number of small entities because the rule adds navigational
restrictions mainly to the movement of vessels during a time when there
is less traffic. Most commercial traffic will leave and return during
the day. The rule would possibly affect small entities such as owners/
operators of vessels due to limited drawbridge openings from 8:30 p.m.
to 5 a.m. To minimize delays, these vessels can plan their transits in
accordance with the proposed opening schedule.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section, above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agricultural Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain

about this proposed rule or any policy or action of the Coast Guard.

4. Collection of Information

    This rule would call for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this rule under that Order and have
determined that it does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the ``FOR FURTHER
INFORMATION CONTACT'' section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such expenditure, we do discuss the effects of this rule elsewhere in
this preamble.

8. Taking of Private Property

    This rule would not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and would not create an
environmental risk to health or risk to safety that might
disproportionately affect children.

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it would not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

12. Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01, and Commandant Instruction M16475.lD which
guides the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have concluded
that this action is one of a category of actions which do not
individually or cumulatively have a significant effect on the human
environment. This rule is categorically excluded under figure 2-1,
paragraph (32)(e), of the Instruction.
    Under figure 2-1, paragraph (32)(e), of the instruction, an
environmental analysis checklist and a categorical exclusion
determination are not required for this rule.

List of Subjects in 33 CFR Part 117

    Bridges.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

0
1. The authority citation for part 117 continues to read as follows:

    Authority:  33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland
Security Delegation No. 0170.1.

0
2. In Sec.  117.821, add paragraph (c) to read as follows:

Sec.  117.821  Atlantic Intracoastal Waterway, Albemarle Sound to
Sunset Beach.

* * * * *
    (c) From 5 a.m. on October 17, 2012 to 8:30 p.m. on October 1,
2013, the draw of the Carolina Coastal Railroad Bridge, at mile 203.8,
(Newport River) at Morehead City, shall operate as follows:
    (1) During the day from 5 a.m. to 8:30 p.m., shall be maintained in
the open position to vessels and would only be closed for the passage
of trains and to perform periodic maintenance.
    (2) At night, need not open 8:30 p.m. to 5 a.m. except an opening
would be provided at 12 a.m. (midnight) if advance notice is given
before 4 p.m. on the afternoon before the requested opening.

    Dated: October 5, 2012.
Lincoln D. Stroh,
Captain, U.S. Coast Guard, Acting Commander, Fifth Coast Guard
District.
[FR Doc. 2012-25540 Filed 10-16-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 78, Number 22 (Friday, February 1, 2013)]
[Rules and Regulations]
[Pages 7262-7264]
[FR Doc No: 2013-02074]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-1102; Directorate Identifier 2012-NM-062-AD;
Amendment 39-17333; AD 2013-02-12]
RIN 2120-AA64

Airworthiness Directives; EADS CASA (Type Certificate Previously
Held by Construcciones Aeron[aacute]uticas, S.A.) Airplanes

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

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for all
EADS CASA (Type Certificate previously held by Construcciones
Aeron[aacute]uticas, S.A.) Model CN-235, CN-235-100, CN-235-200, and
CN-235-300 airplanes. This AD was prompted by reports of incorrect
electrical polarity connections on engine fire extinguishing discharge
cartridges. This AD requires a one-time inspection to identify the
correct polarity for each pair of electrical connectors on each engine
fire extinguisher cartridge, and repair if necessary. We are issuing
this AD to detect and correct incorrect polarity connections, which
could prevent the actuation of the discharge cartridge in case of
automatic fire detection or manual initiation during a potential engine
fire, and could result in damage to the airplane and injury to
passengers.

DATES: This AD becomes effective March 8, 2013.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of March 8,
2013.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Shahram Daneshmandi, Aerospace
Engineer, International Branch, ANM-116, Transport Airplane
Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356;
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 October 18, 2012 (77
FR 64053). That NPRM proposed to correct an unsafe condition for the
specified products. The Mandatory Continuing Airworthiness Information
(MCAI) states:

    Reports have been received of finding wrong electrical polarity
connections of engine fire extinguishing discharge cartridges on
CASA CN-235 aeroplanes. The results of the subsequent investigation
showed that the incorrect discharge cartridge assembly was caused by
production line errors.
    This condition, if not detected and corrected, could prevent the
actuation of the discharge cartridge in case of automatic fire
detection or manual initiation in case of engine fire, possibly
resulting in damage to the aeroplane and injury to occupants.
    To address this potential unsafe condition, EADS CASA (Airbus
Military) developed instructions to identify erroneous wiring
polarity installation.
    For the reasons described above this [European Aviation Safety
Agency] AD requires a one-time inspection to verify proper
electrical polarity of wiring of each engine fire extinguisher
discharge cartridge and, depending on findings, corrective action
[accomplish the repair].

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

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (77 FR 64053, October 18,
2012) 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.

Costs of Compliance

    We estimate that this AD will affect 6 products of U.S. registry.
We also estimate that it will take about 4 work-hours per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour. Based on these figures, we estimate the cost of
this AD to the U.S. operators to be $2,040, or $340 per product.
    We have received no definitive data that would enable us to provide
cost estimates for the on-condition actions specified in this AD.

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 that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. 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 Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM (77 FR 64053, October 18,
2012), the regulatory evaluation, any comments received, and other
information. The street address for the Docket Operations 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

    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:

2013-02-12 EADS CASA (Type Certificate previously held by
Construcciones Aeron[aacute]uticas, S.A.): Amendment 39-

17333. Docket No. FAA-2012-1102; Directorate Identifier 2012-NM-062-
AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective March 8,
2013.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all EADS CASA (Type Certificate previously
held by Construcciones Aeron[aacute]uticas, S.A.) Model CN-235, CN-
235-100, CN-235-200, and CN-235-300 airplanes, certificated in any
category, all serial numbers.

(d) Subject

    Air Transport Association (ATA) of America Code 26, Fire
protection.

(e) Reason

    This AD was prompted by reports of incorrect electrical polarity
connections on engine fire extinguishing discharge cartridges. We
are issuing this AD to detect and correct incorrect polarity
connections, which could prevent the actuation of the discharge
cartridge in case of automatic fire detection or manual initiation
during a potential engine fire, and could result in damage to the
airplane and injury to passengers.

(f) Compliance

    You are responsible for having the actions required by this AD
performed within the compliance times specified, unless the actions
have already been done.

(g) Inspection

    Within 30 days after the effective date of this AD, do a one-
time inspection to identify the correct polarity for each pair of
electrical connectors on each engine fire extinguisher cartridge, in
accordance with the Instructions of Airbus Military All Operator
Letter 235-020, dated March 9, 2012.

(h) Corrective Action

    If, during the inspection required by paragraph (g) of this AD,
erroneous wiring polarity is detected: Before further flight, repair
in accordance with a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or European
Aviation Safety Agency (EASA) (or its delegated agent).

 (i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, 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 International Branch, send it to ATTN: Shahram
Daneshmandi, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
WA 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Information may be emailed to<EMAIL_ADDRESS>
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. The AMOC approval letter must specifically reference this
AD.
    (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.

(j) Related Information

    Refer to MCAI EASA Airworthiness Directive 2012-0045, dated
March 21, 2012, and Airbus Military All Operator Letter 235-020,
dated March 9, 2012, for related information.

(k) 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 the AD specifies otherwise.
    (i) Airbus Military All Operator Letter 235-020, dated March 9,
2012.
    (ii) Reserved.
    (3) For service information identified in this AD, contact EADS-
CASA, Military Transport Aircraft Division (MTAD), Integrated
Customer Services (ICS), Technical Services, Avenida de
Arag[oacute]n 404, 28022 Madrid, Spain; telephone +34 91 585 55 84;
fax +34 91 585 55 05; email<EMAIL_ADDRESS>
Internet http://www.eads.net.
    (4) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA.
For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference 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 Renton, Washington, on January 23, 2013.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-02074 Filed 1-31-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 179 (Friday, September 14, 2018)]
[Notices]
[Pages 46745-46747]
[FR Doc No: 2018-20018]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]

Product-Specific Guidances; Draft and Revised Draft Guidances for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of additional draft and revised draft product-specific
guidances. The guidances provide product-specific recommendations on,
among other things, the design of bioequivalence (BE) studies to
support abbreviated new drug applications (ANDAs). In the Federal
Register of June 11, 2010, FDA announced the availability of a guidance
for industry entitled ``Bioequivalence Recommendations for Specific
Products'' that explained the process that would be used to make
product-specific guidances available to the public on FDA's website.
The guidances identified in this notice were developed using the
process described in that guidance.

DATES: Submit either electronic or written comments on the draft
guidance by November 13, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2007-D-0369 for ``Product-Specific Guidances; Draft and Revised
Draft Guidances for Industry.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS

CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including
the claimed confidential information, in its consideration of comments.
The second copy, which will have the claimed confidential information
redacted/blacked out, will be available for public viewing and posted
on https://www.regulations.gov. Submit both copies to the Dockets
Management Staff. If you do not wish your name and contact information
to be made publicly available, you can provide this information on the
cover sheet and not in the body of your comments and you must identify
this information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)). Submit written requests for single copies of the draft
guidances to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD
20993-0002. Send one self-addressed adhesive label to assist that
office in processing your requests. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance documents.

FOR FURTHER INFORMATION CONTACT: Wendy Good, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 4714, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products'' that explained
the process that would be used to make product-specific guidances
available to the public on FDA's website at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
    As described in that guidance, FDA adopted this process as a means
to develop and disseminate product-specific guidances and provide a
meaningful opportunity for the public to consider and comment on those
guidances. Under that process, draft guidances are posted on FDA's
website and announced periodically in the Federal Register. The public
is encouraged to submit comments on those recommendations within 60
days of their announcement in the Federal Register. FDA considers any
comments received and either publishes final guidances or publishes
revised draft guidances for comment. Guidances were last announced in
the Federal Register on July 20, 2018. This notice announces draft
product-specific guidances, either new or revised, that are posted on
FDA's website.

II. Drug Products for Which New Draft Product-Specific Guidances Are
Available

    FDA is announcing the availability of a new draft product-specific
guidances for industry for drug products containing the following
active ingredients:

     Table 1--New Draft Product-Specific Guidances for Drug Products
------------------------------------------------------------------------

-------------------------------------------------------------------------
Abemaciclib
Albuterol sulfate
Allopurinol; Lesinurad
Amantadine hydrochloride
Amphetamine aspartate; Amphetamine sulfate; Dextroamphetamine
 saccharate; Dextroamphetamine sulfate
Azelaic acid
Benznidazole
Brigatinib
Brimonidine tartrate; Timolol maleate
Chlorzoxazone
Ciprofloxacin hydrochloride
Dapagliflozin propanediol; Saxagliptin hydrochloride
Delafloxacin meglumine
Desonide
Deutetrabenazine
Diazepam
Efinaconazole
Enasidenib mesylate
Glecaprevir; Pibrentasvir
Ibuprofen; Pseudoephedrine hydrochloride
Ivermectin
Lamotrigine
Luliconazole
Midostaurin
Miltefosine
Morphine sulfate
Neratinib maleate
Olaparib
Olive oil; Soybean oil
Oxycodone hydrochloride
Penciclovir
Perflutren
Pilocarpine hydrochloride
Pitavastatin magnesium
Pitavastatin sodium
Pregabalin
Secnidazole
Sofosbuvir; Velpatasvir; Voxilaprevir
Spironolactone
Sulfur hexafluoride lipid-type a microspheres
Talc
Tavaborole
------------------------------------------------------------------------

III. Drug Products for Which Revised Draft Product-Specific Guidances
Are Available

    FDA is announcing the availability of revised draft product-
specific guidances for industry for drug products containing the
following active ingredients:

   Table 2--Revised Draft Product-Specific Guidances for Drug Products
------------------------------------------------------------------------

-------------------------------------------------------------------------
Acetazolamide
Chlorpromazine hydrochloride
Doxorubicin hydrochloride
Morphine sulfate
Nicotine polacrilex (multiple Reference Listed Drugs)
Nisoldipine
Oxycodone
Raltegravir potassium
Tacrolimus (multiple strengths)
------------------------------------------------------------------------

    For a complete history of previously published Federal Register
notices related to product-specific guidances, go to https://www.regulations.gov and enter Docket No. FDA-2007-D-0369.
    These draft guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). These draft guidances,
when finalized, will represent the current thinking of FDA on, among
other things, the product-specific design of BE studies to support
ANDAs. They do not establish any rights for any person and are not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
This guidance is not subject to Executive Order 12866.

IV. Electronic Access

    Persons with access to the internet may obtain the draft guidances
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: September 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20018 Filed 9-13-18; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: November 5, 2008 (Volume 73, Number 215)]
[Notices]
[Page 65913-65915]
[DOCID:fr05no08-105]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-58879; File No. SR-NYSEArca-2008-113]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To List and Trade
Three Series of SPDR Index Shares Funds

October 29, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on October 22, 2008, NYSE Arca, Inc. (``NYSE Arca'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared substantially by NYSE Arca.
NYSE Arca filed the proposed rule change pursuant to Section
19(b)(3)(A) of the Act \3\ and Rule 19b-4(f)(6) thereunder,\4\ which
renders it effective upon filing with the Commission. The Commission is
publishing this notice to solicit comments on the proposed rule change
from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    NYSE Arca proposes to list and trade shares (``Shares'') of the
following funds (``Funds''), which are series of SPDR Index Shares
Funds (``Trust''): SPDR S&P Emerging Markets Small Cap ETF; SPDR S&P
International Small Cap ETF; and SPDR DJ Wilshire International Real
Estate ETF.

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

    In its filing with the Commission, NYSE Arca 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. NYSE Arca has prepared summaries, set forth in Sections
A, B, and C below, of the most significant aspects of such statements.

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

1. Purpose
    The Exchange proposes to list and trade the Shares of the following
funds under NYSE Arca Equities Rule 5.2(j)(3), the Exchange's listing
standards for Investment Company Units (``ICUs''): \5\ SPDR S&P
Emerging Markets Small Cap ETF; SPDR S&P International Small Cap ETF;
SPDR DJ Wilshire International Real Estate ETF. The Funds are currently
listed on NYSE Alternext US LLC (``NYSE Alternext US'') (formerly,
American Stock Exchange LLC) and are traded on the Exchange pursuant to
unlisted trading privileges (``UTP''). Prior to listing on the
Exchange, the Funds would be required to satisfy the applicable
delisting procedures of NYSE Alternext US and applicable statutory and
regulatory requirements, including, without limitation, Section 12 of
Securities Exchange Act of 1934 (``Act''),\6\ relating to listing the
Funds on the Exchange.\7\
---------------------------------------------------------------------------

    \5\ An Investment Company Unit is a security that represents an
interest in a registered investment company that holds securities
comprising, or otherwise based on or representing an interest in, an
index or portfolio of securities (or holds securities in another
registered investment company that holds securities comprising, or
otherwise based on or representing an interest in, an index or
portfolio of securities). See NYSE Arca Equities Rule 5.2(j)(3)(A).
    \6\ 15 U.S.C. 78(l).
    \7\ The Exchange will seek the voluntary consent of the issuer
of the Fund to be delisted from NYSE Alternext US and listed on the
Exchange. The Exchange notes that its approval of the Fund's listing
application would be required prior to listing.
---------------------------------------------------------------------------

    The investment objective of the SPDR S&P Emerging Markets Small Cap
ETF is to provide investment results that, before fees and expenses,
correspond generally to the total return performance of an index that
tracks the small capitalization segment of global emerging market
countries. The Fund uses a passive management strategy and ``sampling''
methodology designed to track the total return performance of the S&P/
Citigroup Emerging Market US$2 billion Index (the ``Emerging Markets
Small Cap Index''). The Emerging Markets Small Cap Index is a float
adjusted market cap weighted index that represents the small
capitalization segment of emerging countries included in the BMI Global
Equity Index.
    The investment objective of the SPDR S&P International Small Cap
ETF is to replicate as closely as possible, before fees and expenses,
the total return performance of an equity index based upon the
developed world (except the U.S.) small capitalization equity markets.
The Fund uses a passive management strategy and a ``sampling''
methodology designed to track the total return performance of the S&P/
Citigroup World Ex US Cap Range < 2 Billion USD Index--a market
capitalization weighted index that defines and measures the investable
universe of publicly traded companies domiciled in developed countries
outside the U.S.
    The investment objective of the SPDR DJ Wilshire International Real
Estate ETF Fund uses a passive management strategy and ``sampling''
methodology designed to track the price and yield performance of the
Dow Jones Wilshire Ex-US Real Estate Securities Index (``DJW Ex-US RESI
Index''). The DJW Ex-US RESI Index is a float adjusted market
capitalization index designed to measure the performance of publicly
traded real estate securities in countries excluding the U.S.
    The Exchange is submitting this proposed rule change because the
underlying indexes (``Indexes'') for the Funds do not meet all of the
``generic'' listing requirements of Commentary .01(a)(B) to NYSE Arca
Equities Rule 5.2(j)(3) applicable to listing of ICUs based on
international or global indexes. The Indexes meet all such requirements
except for those set forth in Commentary .01(a)(B)(2).\8\ The Exchange
represents that: (1) Except for the requirement under Commentary
.01(a)(B)(2) to NYSE Arca Equities Rule 5.2(j)(3) that component stocks
that in the aggregate account for at least 90% of the weight of the
index each shall have a minimum monthly trading volume of at least
250,000 shares, the Shares of the Fund currently satisfy all of the
generic listing standards under NYSE Arca Equities Rule 5.2(j)(3); (2)
the continued listing standards under NYSE Arca Equities Rules
5.2(j)(3) and 5.5(g)(2) applicable to ICUs shall apply to the Shares;
and (3) the Trust is required to comply with Rule 10A-3 under the Act
\9\ for the initial and continued listing of the Shares. In addition,
the Exchange represents that the Shares will comply with all other
requirements applicable to ICUs including, but not limited to,
requirements relating to the dissemination of key information such as
the Index value and Intraday Indicative Value, rules governing the
trading of equity securities, trading hours, trading halts,
surveillance,\10\ and Information Bulletin to ETP Holders, as set forth
in Exchange rules applicable to ICUs and in prior Commission orders
approving the generic listing rules applicable to the listing and
trading of ICUs.\11\
---------------------------------------------------------------------------

    \8\ The Exchange states that the Indexes fail to meet the
requirement of Commentary .01(a)(B)(2) to NYSE Arca Equities Rule
5.2(j)(3) that component stocks that in the aggregate account for at
least 90% of the weight of the index each shall have a minimum
monthly trading volume of at least 250,000 shares. The Exchange
states that, as of October 7, 2008, for SPDR S&P Emerging Markets
Small Cap ETF, SPDR S&P International Small Cap ETF, and SPDR DJ
Wilshire International Real Estate ETF, component stocks that in the
aggregate account for 89.59%, 86.25% and 88.95% of the respective
index weights each had a minimum monthly trading volume of at least
250,000 shares.
    \9\ 17 CFR 240.10A-3.
    \10\ The Exchange may obtain information for surveillance
purposes via the Intermarket Surveillance Group (``ISG'') from other
exchanges who are members of ISG. The Exchange notes that not all
Index component stocks may trade on markets that are ISG members.
For a list of the current members of ISG, see http://
www.isgportal.org.
    \11\ See, e.g., Securities Exchange Act Release No. 55621 (April
12, 2007), 72 FR 19571 (April 18, 2007) (SR-NYSEArca-2006-86) (order
approving generic listing standards for ICUs based on international
or global indexes); Securities Exchange Act Release No. 44551 (July
12, 2001), 66 FR 37716 (July 19, 2001) (SR-PCX-2001-14) (order
approving generic listing standards for ICUs and Portfolio
Depositary Receipts); Securities Exchange Act Release No. 41983
(October 6, 1999), 64 FR 56008 (October 15, 1999) (SR-PCX-98-29)
(order approving rules for listing and trading of ICUs).
---------------------------------------------------------------------------

    Detailed descriptions of the Funds, the Indexes, procedures for
creating and redeeming Shares, transaction fees and expenses,
dividends, distributions, taxes, and reports to be distributed to
beneficial owners of the Shares can be found in the Trust's
Registration Statement\12\ or on the Web site for the Funds (http://
www.ssgafunds.com), as applicable.
---------------------------------------------------------------------------

    \12\ See Amendment No. 17 to the Trust's Registration Statement
for the Funds on Form N-1A, dated January 25, 2008 (Nos. 333-92106
and 811-21145). See e-mail from Michael Cavalier, Chief Counsel,
NYSE Euronext, to Brian O'Neill, Attorney, Division of Trading and
Markets, Commission, dated October 28, 2008.
---------------------------------------------------------------------------

2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Act,\13\ in general, and furthers the objectives of Section
6(b)(5),\14\ in particular, in that it is designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in facilitating transactions in securities, and to
remove impediments to and perfect the mechanisms of a free and open
market and a national market system. The proposed rule change will
allow the listing and trading of the Fund on the Exchange, which the
Exchange believes will enhance competition among market

participants, to the benefit of investors and the marketplace.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78f(b).
    \14\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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 that is 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 solicited or received with respect to the
proposed rule change.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate if consistent with
the protection of investors and the public interest, the proposed rule
change has become effective pursuant to Section 19(b)(3)(A) of the Act
\15\ and subparagraph (f)(6) of Rule 19b-4 thereunder.\16\
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78s(b)(3)(A).
    \16\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    The Exchange believes that the proposed rule change does not
significantly affect the protection of investors or the public interest
and does not impose any significant burden on competition. The Exchange
also believes that the proposed rule change is noncontroversial in that
the Indexes for the SPDR S&P Emerging Markets Small Cap ETF, SPDR S&P
International Small Cap ETF, and SPDR DJ Wilshire International Real
Estate ETF fail to meet the requirements set forth in Commentary
.01(a)(B)(2) to NYSE Arca Equities Rule 5.2(j)(3) by only small amounts
(0.41%, 3.75% and 1.05%, respectively) and the Shares currently satisfy
all of the other generic listing standards under NYSE Arca Equities
Rule 5.2(j)(3) and all other requirements applicable to ICUs, as set
forth in Exchange rules and prior Commission orders approving the
generic listing rules applicable to the listing and trading of ICUs. In
addition, the Exchange believes that it has developed adequate trading
rules, procedures, surveillance programs, and listing standards for the
continued listing and trading of the Shares.
    A proposed rule change filed under 19b-4(f)(6) normally may not
become operative prior to 30 days after the date of filing.\17\
However, Rule 19b-4(f)(6)(iii) \18\ permits the Commission to designate
a shorter time if such action is consistent with the protection of
investors and the public interest. The Exchange has requested that the
Commission waive the 30-day operative delay and designate the proposed
rule change operative upon filing to accommodate trading in the Shares
on the Exchange prior to the end of the 30-day period. The Exchange
stated that waiver of the 30-day delayed operative date is necessary to
accommodate the issuer's timeframe for listing the Shares on the
Exchange and will benefit the market and investors by permitting
listing and trading of the Shares on the Exchange prior to the 30-day
delayed operative date, thereby enhancing market competition.
---------------------------------------------------------------------------

    \17\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has this requirement.
    \18\ Id.
---------------------------------------------------------------------------

    The Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest.
Given that the Shares comply with all of the NYSE Arca Equities generic
listing standards for ICUs (except that the Indexes narrowly miss the
requirement that component stocks that in the aggregate account for at
least 90% of the weight of the index have a minimum monthly trading
volume of at least 250,000 shares), the listing and trading of the
Shares by NYSE Arca does not appear to present any novel or significant
regulatory issues or impose any significant burden on competition.
Therefore, the Commission designates the proposal operative upon
filing.\19\
---------------------------------------------------------------------------

    \19\ For purposes only of waiving the 30-day operative delay of
this proposal, the Commission has considered the proposed rule's
impact on efficiency, competition, and capital formation. 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File No. SR-NYSEArca-2008-113 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEArca-2008-113. 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, 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 NYSE Arca. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NYSEArca-2008-113 and should be submitted on or before
November 26, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
---------------------------------------------------------------------------

    \20\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-26347 Filed 11-4-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 55 (Tuesday, March 22, 2016)]
[Proposed Rules]
[Pages 15171-15173]
[FR Doc No: 2016-06373]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 81, No. 55 / Tuesday, March 22, 2016 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-3781; Directorate Identifier 2015-SW-048-AD]
RIN 2120-AA64

Airworthiness Directives; Agusta S.p.A. Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
Agusta S.p.A. (Agusta) Model A109A, A109A II, A109C, A109E, A109K2,
A109S and AW109SP helicopters. This proposed AD would require visually
inspecting the tail rotor drive shaft assembly (drive shaft) for a
crack. This proposed AD is prompted by the discovery of three cracks on
the drive shaft of a Model A109S helicopter. The proposed actions are
intended to detect a crack on the drive shaft to prevent failure of the
driveshaft, failure of the tail rotor, and subsequent loss of
helicopter control.

DATES: We must receive comments on this proposed AD by May 23, 2016.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
3781; or in person at the Docket Operations Office between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the European Aviation Safety Agency (EASA)
AD, the economic evaluation, any comments received, and other
information. The street address for the Docket Operations Office
(telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments will be
available in the AD docket shortly after receipt.
    For service information identified in this proposed rule, contact
AgustaWestland, Product Support Engineering, Via del Gregge, 100, 21015
Lonate Pozzolo (VA) Italy, ATTN: Maurizio D'Angelo; telephone 39-0331-
664757; fax 39-0331-664680; or at http://www.agustawestland.com/technical-bulletins. You may review the referenced service information
at the FAA, Office of the Regional Counsel, Southwest Region, 10101
Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177.

FOR FURTHER INFORMATION CONTACT: Martin R. Crane, Aviation Safety
Engineer, Safety Management Group, Rotorcraft Directorate, FAA, 10101
Hillwood Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to participate in this rulemaking by submitting
written comments, data, or views. We also invite comments relating to
the economic, environmental, energy, or federalism impacts that might
result from adopting the proposals in this document. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should send only one copy of written comments, or if comments are filed
electronically, commenters should submit only one time.
    We will file in the docket all comments that we receive, as well as
a report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal, we
will consider all comments we receive on or before the closing date for
comments. We will consider comments filed after the comment period has
closed if it is possible to do so without incurring expense or delay.
We may change this proposal in light of the comments we receive.

Discussion

    EASA, which is the aviation authority for Italy, has issued AD No.
2015-0054, dated March 27, 2015, to correct an unsafe condition for
Model A109A with retrofit kit part number 109-0820-27-101 installed,
and Model A109A II, A109C, A109E, A109K2, A109LUH, A109S, and AW109SP
helicopters.
    EASA advises that during scheduled maintenance on a Model A109S
helicopter, three cracks were found on the drive shaft. An
investigation could not determine the cause of the cracking but
concluded it could not have been caused by fatigue. This condition, if
not detected and corrected, could lead to tail rotor failure, possibly
resulting in loss of helicopter control, EASA advises. EASA AD No.
2015-0054 consequently requires a one-time inspection of the drive
shaft, and replacing the drive shaft if cracks are found.

FAA's Determination

    These helicopters have been approved by the aviation authority of
Italy and are approved for operation in the United States. Pursuant to
our bilateral agreement with Italy, EASA, its technical representative,
has notified us of the unsafe condition described in its AD. We are
proposing this AD because we evaluated all known relevant information
and determined that an unsafe condition is likely to exist or develop
on other products of the same type design.

Related Service Information Under 1 CFR Part 51

    We reviewed AgustaWestland Bollettino Tecnico (BT) No. 109-147 for
Model A109A helicopters with retrofit kit P/N 109-0820-27-101
installed, Model A109A II, and Model A109C helicopters; BT No. 109EP-
143 for Model A109E helicopters; BT No. 109K-68 for Model A109K2
helicopters; BT No. 109S-067 for Model A109S

helicopters; and BT No. 109SP-094 for Model AW109SP helicopters. All of
the BTs are dated March 25, 2015. AgustaWestland reports that during a
scheduled servicing of an A109S helicopter, three cracks were found on
drive shaft P/N 109-8412-02-1. The BTs prescribe a one-time drive shaft
inspection for cracks.
    This service information 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.

Proposed AD Requirements

    This proposed AD would require, within 50 hours time-in-service,
visually inspecting the drive shaft for a crack and replacing the drive
shaft if it is cracked.

Differences Between This Proposed AD and the EASA AD

    The EASA AD applies to Agusta Model A109LUH helicopters. This
proposed AD would not because that model does not have an FAA type
certificate.

Interim Action

    We consider this proposed AD to be an interim action. The design
approval holder has not determined the cause of the unsafe condition
identified in this proposed AD. If a cause is determined and actions
developed to address the cause, we might consider additional
rulemaking.

Costs of Compliance

    We estimate that this proposed AD would affect 142 helicopters of
U.S. Registry and that labor costs average $85 per work-hour. Based on
these estimates, we expect the following costs:
     Inspecting the drive shaft would require 9 work-hours and
no parts. The estimated cost would be $765 per helicopter and $108,630
for the U.S. fleet.
     Replacing the drive shaft would not require additional
labor hours. Parts would cost $6,082 per helicopter.
    According to Agusta service information, some of the costs of this
proposed AD may be covered under warranty, thereby reducing the cost
impact on affected individuals. We do not control warranty coverage by
Agusta. Accordingly, we have included all costs in our cost estimate.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed, I certify this proposed regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska to the extent that
it justifies making a regulatory distinction; and
    4. 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 an economic evaluation of the estimated costs to comply
with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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 (AD):

Agusta S.p.A.: Docket No. FAA-2015-3781; Directorate Identifier
2015-SW-048-AD.

(a) Applicability

    This AD applies to Agusta S.p.A. Model A109A, A109A II, A109C,
A109E, A109K2, A109S, and AW109SP helicopters with a tail rotor
drive shaft assembly (drive shaft), part number 109-8412-02-1 or
109-8412-02-3, installed, certificated in any category.

(b) Unsafe Condition

    This AD defines the unsafe condition as a crack in a drive
shaft. This condition could result in failure of a drive shaft,
failure of the tail rotor, and subsequent loss of helicopter
control.

(c) Comments Due Date

    We must receive comments by May 23, 2016.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    Within 50 hours time-in-service:
    (1) Visually inspect each drive shaft in accordance with the
Compliance Instructions, paragraph 4, of AgustaWestland Bollettino
Tecnico (BT) No. 109-147, dated March 25, 2015; BT No. 109EP-143,
dated March 25, 2015; BT No. 109K-68, dated March 25, 2015; BT No.
109S-067, dated March 25, 2015; or BT No. 109SP-094, dated March 25,
2015, as applicable for your model helicopter.
    (2) If there is a crack, replace the drive shaft before further
flight.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs
for this AD. Send your proposal to: Martin R. Crane, Aviation Safety
Engineer, Safety Management Group, Rotorcraft Directorate, FAA,
10101 Hillwood Pkwy, Fort Worth, TX 76177; telephone<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office before operating any aircraft
complying with this AD through an AMOC.

(g) Additional Information

    The subject of this AD is addressed in European Aviation Safety
Agency (EASA) AD No. 2015-0054, dated March 27, 2015. You may view
the EASA AD on the Internet at http://www.regulations.gov by
searching for and locating it in Docket No. FAA-2015-3781.

(h) Subject

    Joint Aircraft Service Component (JASC) Code: 6510, Tail Rotor
Drive Shaft.

    Issued in Fort Worth, Texas, on March 15, 2016.
Scott A. Horn,
Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2016-06373 Filed 3-21-16; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: May 12, 2010 (Volume 75, Number 91)]
[Proposed Rules]
[Page 26681-26683]
[DOCID:fr12my10-14]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-28077; Directorate Identifier 2007-NE-20-AD]
RIN 2120-AA64

Airworthiness Directives; Turbomeca S.A. Arriel 2B and 2B1
Turboshaft Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to revise an existing airworthiness directive (AD)
for the products listed above. This proposed 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: Since issuance of AD 2007-0109, Turbom[eacute]ca has
released modification TU166 which consists in inserting HP blade
dampers between the HP disc and the HP blade platform. Introduction of
these dampers has demonstrated to limit axial displacement of the HP
blade relative to the disk in case of blade lock rupture or opening,
therefore eliminating the need for inspection and replacement.
    We are proposing this AD to prevent an uncommanded in-flight engine
shutdown which could result in an emergency autorotation landing or an
accident.

DATES: We must receive comments on this proposed AD by June 28, 2010.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Contact Turbomeca, 40220 Tarnos, France; telephone 33 05 59 74 40
00, fax 33 05 59 74 45 15 for the service information identified in
this proposed AD.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
the same as the Mail address provided in

the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

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

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2007-
28077; Directorate Identifier 2007-NE-20-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact
with FAA personnel concerning this proposed AD. Using the search
function of the Web site, anyone can find and read the comments in any
of our dockets, including, if provided, the name of the individual who
sent the comment (or signed the comment on behalf of an association,
business, labor union, etc.). You may review the DOT's complete Privacy
Act Statement in the Federal Register published on April 11, 2000 (65
FR 19477-78).

Discussion

    On April 16, 2009, the FAA issued AD 2009-09-03, Amendment 39-15889
(74 FR 18981, April 27, 2009). That AD requires performing an initial
and repetitive borescope inspection of the engine for rearward
displacement of the high-pressure turbine (HP) blades.

Actions Since AD 2009-09-03 Was Issued

    Since that AD was issued, the European Aviation Safety Agency
(EASA), which is the Technical Agent for the Member States of the
European Community, has issued EASA Airworthiness Directive 2007-
0109R1, dated November 9, 2009 (referred to after this as ``the
MCAI''), to correct an unsafe condition for the specified products. The
MCAI states:

    Since issuance of AD 2007-0109, Turbom[eacute]ca has released
modification TU166 which consists in inserting HP blade dampers
between the HP disc and the HP blade platform. Introduction of these
dampers has demonstrated to limit axial displacement of the HP blade
relative to the disk in case of blade lock rupture or opening,
therefore eliminating the need for inspection and replacement.
    Therefore, this AD revises AD 2007-0109 by retaining the same
requirements of AD 2007-0109 except that applicability is limited to
ARRIEL 2B, 2B1 and 2B1A engines which do not incorporate
modification TU166.

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

Relevant Service Information

    Turbomeca S.A. has issued Mandatory Service Bulletin No. 292 72
2825, Version B, dated September 21, 2009. The actions described in
this service information are intended to correct the unsafe condition
identified in the EASA AD.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of France,
and is approved for operation in the United States. Pursuant to our
bilateral agreement with France, they have notified us of the unsafe
condition described in the EASA AD and service information referenced
above. We are proposing this AD because we evaluated all information
provided by EASA, and determined the unsafe condition exists and is
likely to exist or develop on other products of the same type design.
This proposed AD would require inspecting for HP blade rearward
displacement.

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 required different actions
in this AD from those in the MCAI in order to follow FAA policies. Any
such differences are described in a separate paragraph of the AD. These
requirements take precedence over the actions copied from the MCAI.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 248 products of U.S. registry. We also estimate that
it would take about 2 work-hours per product to comply with this
proposed AD. The average labor rate is $85 per work-hour. Based on
these figures, we estimate the cost of the proposed AD on U.S.
operators to be $42,160.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by removing Amendment 39-15889 and
adding the following new AD:

Turbomeca S.A.: Docket No. FAA-2007-28077; Directorate Identifier
2007-NE-20-AD.

Comments Due Date

    (a) We must receive comments by June 28, 2010.

Affected Airworthiness Directives (ADs)

    (b) This AD revises AD 2009-09-03, Amendment 39-15889.

Applicability

    (c) This AD applies to Turbomeca S.A. Arriel 2B and 2B1
turboshaft engines that don't incorporate modification TU166. These
engines are installed on, but not limited to, Eurocopter AS 350 B3
and EC 130 B4 helicopters.

Reason

    (d) This AD results from:

    Since issuance of AD 2007-0109, Turbom[eacute]ca has released
modification TU166 which consists in inserting HP blade dampers
between the HP disc and the HP blade platform. Introduction of these
dampers has demonstrated to limit axial displacement of the HP blade
relative to the disk in case of blade lock rupture or opening,
therefore eliminating the need for inspection and replacement.

We are issuing this AD to prevent an uncommanded in-flight engine
shutdown which could result in an emergency autorotation landing or
an accident.

Actions and Compliance

    (e) Unless already done, do the following actions:

Initial Inspection

    (1) Perform an initial high-pressure (HP) turbine borescope
inspection according to Turbomeca S.A. Mandatory Service Bulletin
(MSB) No. 292 72 2825, Version B, dated September 21, 2009, or
earlier version as follows:
    (i) For engines with fewer than 500 hours and 450 cycles since
new or since the last HP turbine borescope inspection, inspect
before reaching 600 hours or 500 cycles whichever occurs first.
Replace HP turbine modules with rearward turbine blade displacement
greater than 0.5 mm.
    (ii) For the remaining engines, inspect within the next 100
hours. Replace HP turbine modules with rearward turbine blade
displacement greater than 0.5 mm.

Repetitive Inspections

    (2) Perform repetitive HP turbine borescope inspections
according to Turbomeca S.A. MSB No. 292 72 2825, Version B, dated
September 21, 2009 or earlier version:
    (i) Within 600 hours or 500 cycles from the previous inspection,
whichever occurs first, if the rearward displacement of the turbine
blades was less than 0.2 mm. Replace HP turbine modules with
rearward turbine blade displacement greater than 0.5 mm.
    (ii) Within 100 hours of the previous inspection if the rearward
displacement of the turbine blades was between 0.2 mm and 0.5 mm.
Replace HP turbine modules with rearward turbine blade displacement
greater than 0.5 mm.

Optional Terminating Action

    (f) Incorporating modification TU166 terminates the repetitive
inspection requirements of paragraphs (e)(2)(i) and (e)(2)(ii) of
this AD.

FAA AD Differences

    (g) For clarification, we restructured the actions and
compliance wording of this AD.
    (h) We deleted the Turbomeca reporting requirement from the AD.
    (i) Although EASA Airworthiness Directive 2007-0109R1, dated
November 9, 2009, applies to the Arriel 2B1A engine, this AD does
not apply to that model because it has no U.S. type certificate.

Alternative Methods of Compliance (AMOCs)

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

Related Information

    (k) Refer to EASA Airworthiness Directive 2007-0109R1, dated
November 9, 2009, and Turbomeca S.A. MSB No. 292 72 2825, Version B,
dated September 21, 2009, or earlier version, for related
information.
    (l) Contact Kevin Dickert, Aerospace Engineer, Engine
Certification Office, FAA, Engine and Propeller Directorate, 12 New
England Executive Park, Burlington, MA 01803; e-mail:
<EMAIL_ADDRESS>telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>.

    Issued in Burlington, Massachusetts, on May 5, 2010.
Peter A. White,
Assistant Manager, Engine and Propeller Directorate, Aircraft
Certification Service.

[FR Doc. 2010-11324 Filed 5-11-10; 8:45 am]
BILLING CODE 4910-13-P