[Federal Register Volume 85, Number 29 (Wednesday, February 12, 2020)]
[Proposed Rules]
[Pages 7899-7902]
[FR Doc No: 2020-02724]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-1109; Product Identifier MCAI-2019-00115-E]
RIN 2120-AA64

Airworthiness Directives; Rolls-Royce Deutschland Ltd & Co KG
(Type Certificate Previously Held by Rolls-Royce plc) Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain Rolls-Royce Deutschland Ltd. & Co KG (RRD) Trent XWB-75,
XWB-79, XWB-79B, and XWB-84 turbofan engines. This proposed AD was
prompted by analysis by the manufacturer of the low-pressure compressor
(LPC) outlet guide vane (OGV) assembly and LPC OGV outer mount ring
assembly. The analysis predicted that when the front engine mount is in
the fail-safe condition, the most highly stressed LPC OGV outer mount
ring assembly has a life that could be substantially less than one shop
visit interval. This proposed AD would require initial and repetitive
inspections of the OGV outer mount ring assembly and, depending on the
results of the inspections, possible replacement of the OGV outer mount
ring assembly. The FAA is proposing this AD to address the unsafe
condition on these products.

DATES: The FAA must receive comments on this proposed AD by March 30,
2020.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12 140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Rolls-
Royce Deutschland Ltd & Co KG, Eschenweg 11, 15827 Blankenfelde-Mahlow,
Germany; phone: +49 (0) 33 708 6 0; email: https://www.rolls-royce.com/contact-us.aspx. You may view this service information at the FAA,
Engine and Propeller Standards Branch, 1200 District Avenue,
Burlington, MA 01803. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2019-
1109; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this NPRM, the mandatory continuing airworthiness information (MCAI),
the regulatory evaluation, any comments received, and other
information. The street address for Docket Operations is listed above.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Stephen Elwin, Aerospace Engineer, ECO
Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: 781-
238-7236; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2019-1109;
Product Identifier MCAI-2019-00115-E'' at the beginning of your
comments. The FAA specifically invites comments on the overall
regulatory, economic, environmental, and energy aspects of this NPRM.
The FAA will consider all comments received by the closing date and may
amend this NPRM because of those comments.
    Except for Confidential Business Information as described in the
following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The FAA will also post a report summarizing each substantive
verbal contact received about this NPRM.

Confidential Business Information

    Confidential Business Information (CBI) is commercial or financial
information that is both customarily and actually treated as private by
its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552),
CBI is exempt from public disclosure. If your comments responsive to
this NPRM contain commercial or financial information that is
customarily treated as private, that you actually treat as private, and
that is relevant or responsive to this NPRM, it is important that you
clearly designate the submitted comments as CBI. Please mark each page
of your submission containing CBI as ``PROPIN.'' The FAA will treat
such marked submissions as confidential under the FOIA, and they will
not be placed in the public docket of this NPRM. Submissions containing
CBI should be sent to Stephen Elwin, Aerospace Engineer, ECO Branch,
FAA, 1200 District Avenue, Burlington, MA 01803. Any commentary that
the FAA receives which is not specifically designated as CBI will be
placed in the public docket for this rulemaking.

Discussion

    The European Union Aviation Safety Agency (EASA), which is the
Technical Agent for the Member States of the European Community, has
issued EASA AD 2019-0234, dated September 19, 2019 (referred to after
this as ``the MCAI''), to address the unsafe condition on these
products. The MCAI states:

    The purpose of the engine mount is to position the engine
relative to the pylon and to transfer all loads and rotational
moments between the engine and pylon. The front engine mount support
structure (EMSS) consists of the low pressure compressor (LPC)
outlet guide vane (OGV) assembly and OGV outer mount ring assembly.
Revised analysis of these parts, when the front engine mount (FEM)
is engaged in the fail-safe condition, has now been undertaken using
more advanced modelling techniques. This analysis predicts that,
once the FEM is in the fail-safe condition, the most highly stressed
LPC OGV has a life that could be substantially less than one shop
visit interval.
    This condition, if not detected and corrected, could lead to
failure of the EMSS, possibly resulting in engine separation and
reduced control of the aeroplane.
    To address this potential unsafe condition, Rolls-Royce
introduced inspections to protect against the FEM entering the
failsafe condition following a failure of the OGV outer mount ring
assembly lugs, and published the NMSB to provide instructions.
    For the reason described above, this [EASA] AD requires
repetitive inspections of the OGV outer mount ring assembly lug
fillet area and, depending on findings, accomplishment of applicable
corrective action(s).

    You may obtain further information by examining the MCAI in the AD
docket on the internet at https://www.regulations.gov by searching for
and locating Docket No. FAA-2019-1109.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Rolls-Royce plc (RR) Alert Non-Modification
Service Bulletin (NMSB) Trent XWB 72-AK188, Revision 2, dated December
17, 2019. The NMSB describes procedures for performing fluorescent
penetrant inspections (FPIs) of the LPC OGV outer mount ring assembly.
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.

FAA's Determination

    This product has been approved by EASA, and is approved for
operation in the United States. Pursuant to our bilateral agreement
with the European Community, EASA has notified us of the unsafe
condition described in the MCAI and service information referenced
above. The FAA is proposing this AD because it evaluated all the
relevant information provided by EASA and determined the unsafe
condition described previously is likely to exist or develop in other
products of the same type design.

Proposed AD Requirements

    This proposed AD would require initial and repetitive FPIs of the
LPC OGV outer mount ring assembly, and depending on the results of the
inspections, possible replacement of the OGV outer mount ring assembly.

Differences Between This Proposed AD and the Service Information

    RR Alert NMSB Trent XWB 72-AK188, Revision 2, dated December 17,
2019, identifies a more immediate

compliance time for RRD Trent XWB turbofan engine models with engine
serial numbers (ESNs) 21021, 21032, 21033, 21038, 21041, 21043, 21044,
21065, 21088, and 21188. This proposed AD does not include this more
immediate compliance time for these RRD Trent XWB turbofan engine
models as they are not installed on aircraft in the U.S. registry.

Costs of Compliance

    The FAA estimates that this proposed AD affects 26 engines
installed on airplanes of U.S. registry.
    The FAA estimates the following costs to comply with this proposed
AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
FPI the LPC OGV outer mount ring        3 work-hours x $85 per                $0            $255          $6,630
 assembly.                               hour = $255.
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary
replacements that would be required based on the results of the
proposed inspection. The FAA has no way of determining the number of
aircraft that might need this replacement:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                   Action                                 Labor cost                Parts cost        product
----------------------------------------------------------------------------------------------------------------
Replace the LPC OGV outer mount ring         8 work-hours x $85 per hour = $680.      $2,418,121      $2,418,801
 assembly (KH10678).
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to engines, propellers, and
associated appliances to the Manager, Engine and Propeller Standards
Branch, Policy and Innovation Division.

Regulatory Findings

    The FAA 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) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The 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):

Rolls-Royce Deutschland Ltd. & Co KG: Docket No. FAA-2019-1109;
Product Identifier MCAI-2019-00115-E.

(a) Comments Due Date

    The FAA must receive comments by March 30, 2020.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Rolls-Royce Deutschland Ltd. & Co KG (RRD)
(Type Certificate Previously Held by Rolls-Royce plc) Trent XWB-75,
XWB-79, XWB-79B, and XWB-84 turbofan engines.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7120, Engine Mount
Section.

(e) Unsafe Condition

    This AD was prompted by analysis by the manufacturer of the low-
pressure compressor (LPC) outlet guide vane (OGV) assembly and OGV
outer mount ring assembly. The analysis predicted that when the
front engine mount is in the fail-safe condition, the most highly
stressed LPC OGV outer mount ring assembly has a life that could be
substantially less than one shop visit interval. The FAA is issuing
this AD to prevent failure of the front engine mount support
structure. The unsafe condition, if not addressed, could result in
engine separation, reduced control of the airplane, and loss of the
airplane.

(f) Compliance

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

(g) Required Actions

    (1) For affected RRD Trent XWB turbofan engines with 1,700
flight cycles since new (FCSN) or greater as of the effective date
of this AD:
    (i) Within 300 flight cycles (FC) after the effective date of
this AD, perform a fluorescent penetrant inspection (FPI) of the LPC
OGV outer mount ring assembly.
    (ii) Use Accomplishment Instructions, paragraph 3.A. or 3.B., as
applicable, of Rolls-Royce plc (RR) Alert Non-Modification Service
Bulletin (NMSB) Trent XWB 72-AK188, Revision 2, dated December 17,
2019, to perform the FPI of the LPC OGV outer mount ring assembly.
    (iii) Thereafter, perform repetitive FPIs of the LPC OGV outer
mount ring assembly within 1,000 FC after the previous inspection.
    (2) For affected RRD Trent XWB turbofan engines with fewer than
1,700 FCSN as of the effective date of this AD:
    (i) Before exceeding 2,000 FCSN after the effective date of this
AD, perform an FPI of the LPC OGV outer mount ring assembly.
    (ii) Use Accomplishment Instructions, paragraph 3.A. or 3.B., as
applicable, of RR Alert NMSB 72-AK188, Revision 2, dated December
17, 2019, to perform the FPI of LPC OGV outer mount ring assembly.
    (iii) Thereafter, perform repetitive FPIs of the LPC OGV outer
mount ring assembly within 1,000 FC after the previous inspection.
    (3) If, during any FPI required by paragraph (g)(1) or (2) of
this AD, an LPC OGV outer mount ring assembly discrepancy is
detected, as defined in the Accomplishment Instructions, paragraph
3.A or 3.B, of RR Alert NMSB 72-AK188, Revision 2, dated December
17, 2019, repeat the FPI within the interval specified in
Accomplishment Instructions, paragraph 3.A. or 3.B., of RR Alert
NMSB 72-AK188, Revision 2, dated December 17, 2019.
    (4) If, during any FPI required by paragraphs (g)(1) and (2) of
this AD, an LPC OGV outer mount ring assembly is rejected as a
result of the FPI, as defined in the Accomplishment Instructions,
paragraph 3.A or 3.B, of RR Alert NMSB 72-AK188, Revision 2, dated
December 17, 2019:
    (i) Before further flight, replace the LPC OGV outer mount ring
assembly with a part eligible for installation.
    (ii) Thereafter, perform repetitive FPIs of the LPC OGV outer
mount ring assembly within 1,000 FC of the previous inspection.

(h) No Reporting Requirement

    The reporting requirements in the Accomplishment Instructions,
paragraph 3, of RR Alert NMSB Trent XWB 72-AK188, Revision 2, dated
December 17, 2019, are not required by this AD.

(i) Credit for Previous Actions

    You may take credit for the initial and repetitive FPIs that are
required by paragraphs (g)(1) and (2) of this AD if you performed
the FPIs before the effective date of this AD using RR Alert NMSB
Trent XWB 72-AK188, Revision 1, dated September 20, 2019, or Initial
Issue, dated August 13, 2019.

(j) Alternative Methods of Compliance (AMOCs)

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

(k) Related Information

    (1) For more information about this AD, contact Stephen Elwin,
Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue,
Burlington, MA 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) Refer to European Union Aviation Safety Agency (EASA) AD
2019-0234, dated September 19, 2019, for more information. You may
examine the EASA AD in the AD docket on the internet at https://www.regulations.gov by searching for and locating it in Docket No.
FAA-2019-1109.
    (3) For service information identified in this AD, contact
Rolls-Royce Deutschland Ltd & Co KG, Eschenweg 11, 15827
Blankenfelde-Mahlow, Germany; phone: +49 (0) 33 708 6 0; email:
https://www.rolls-royce.com/contact-us.aspx. You may view this
referenced service information at the FAA, Engine and Propeller
Standards Branch, 1200 District Avenue, Burlington, MA 01803. For
information on the availability of this material at the FAA, call
781-238-7759.

    Issued in Burlington, Massachusetts, on February 6, 2020.
Robert J. Ganley,
Manager, Engine and Propeller Standards Branch, Aircraft Certification
Service.
[FR Doc. 2020-02724 Filed 2-11-20; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 216 (Tuesday, November 8, 2011)]
[Proposed Rules]
[Pages 69155-69156]
[FR Doc No: 2011-28857]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-1223; Directorate Identifier 2011-NM-173-AD]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Bombardier, Inc. Model CL-600-2B16 (CL-601-3A, CL-601-3R, and
CL-604 Variants) airplanes. This proposed AD results from mandatory
continuing airworthiness information (MCAI) originated 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:

    There have been several occurrences of the air driven generator
(ADG) failure to power essential buses during functional tests of
the ADG. It was found that the low threshold setting of the circuit
protection on the ADG generator control unit (GCU) can prevent the
supply of power from the ADG to the essential buses. In the event of
an emergency, loss of power to the essential buses can prevent
continued safe flight.
* * * * *
    The proposed AD would require actions that are intended to address
the unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by December 23,
2011.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval, Qu[eacute]bec
H4S 1Y9, Canada; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>Internet http://www.bombardier.com. You
may review copies of the referenced service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
Washington. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.

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

FOR FURTHER INFORMATION CONTACT: Assata Dessaline, Aerospace Engineer,
Avionics and Flight Test Branch, ANE-172, FAA, New York Aircraft
Certification Office (ACO), 1600 Stewart Avenue, Suite 410, Westbury,
New York 11590; 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-2011-1223;
Directorate Identifier 2011-NM-173-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 we
receive about this proposed AD.

Discussion

    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued Canadian Airworthiness Directive CF-
2011-25, dated July 25, 2011 (referred to after this as ``the MCAI''),
to correct an unsafe condition for the specified products. The MCAI
states:

    There have been several occurrences of the air driven generator
(ADG) failure to power essential buses during functional tests of
the ADG. It was found that the low threshold setting of the circuit
protection on the ADG generator control unit (GCU) can prevent the
supply of power from the ADG to the essential buses. In the event of
an emergency, loss of power to the essential buses can prevent
continued safe flight.
    This directive mandates the replacement of the ADG GCU.

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

Relevant Service Information

    Bombardier, Inc. has issued Service Bulletin 605-24-003, dated
April 25, 2011; and Service Bulletin 604-24-023, dated April 25, 2011.
The actions described in this service information are intended to
correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Differences Between This AD and the MCAI or Service Information

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

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 70 products of U.S. registry. We also estimate that
it would take about 1 work-hour per product to comply with the basic
requirements of this proposed AD. The average labor rate is $85 per
work-hour. Required parts would cost about $0 per product. Where the
service information lists required parts costs that are covered under
warranty, we have assumed that there will be no charge for these parts.
Based on these figures, we estimate the cost of the proposed AD on U.S.
operators to be $5,950, or $85 per product.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this 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 adding the following new AD:

Bombardier, Inc.: Docket No. FAA-2011-1223; Directorate Identifier
2011-NM-173-AD.

Comments Due Date

    (a) We must receive comments by December 23, 2011.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Bombardier, Inc. Model CL-600-2B16 (CL-
601-3A, CL-601-3R, and CL-604 Variants) airplanes, certificated in
any category, serial numbers 5408 through 5665 inclusive, and 5701
through 5856 inclusive.

Subject

    (d) Air Transport Association (ATA) of America Code 24:
Electrical Power.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:
    There have been several occurrences of the air driven generator
(ADG) failure to power essential buses during functional tests of
the ADG. It was found that the low threshold setting of the circuit
protection on the ADG generator control unit (GCU) can prevent the
supply of power from the ADG to the essential buses. In the event of
an emergency, loss of power to the essential buses can prevent
continued safe flight.
* * * * *

Compliance

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

Actions

    (g) Within 36 months after the effective date of this AD, remove
the ADG GCU, Hamilton Sundstrand part number (P/N) 761341A
(Bombardier P/N 604-90800-7), and install a new or serviceable ADG
GCU Hamilton Sundstrand P/N 761341B (Bombardier P/N 604-90800-27) in
accordance with the Accomplishment Instructions of Bombardier
Service Bulletin 605-24-003, dated April 25, 2011 (for serial
numbers 5701 through 5856); and Bombardier Service Bulletin 604-24-
023, dated April 25, 2011 (for serial numbers 5408 through 5665); as
applicable.

Parts Installation

    (h) As of the effective date of this AD, no person may install
an ADG GCU, Hamilton Sundstrand P/N 761341A (Bombardier P/N 604-
90800-7) on any airplane.

FAA AD Differences

    Note 1:  This AD differs from the MCAI and/or service
information as follows:
    No differences.

Other FAA AD Provisions

    (i) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, NY
Aircraft Certification Office (ACO), ANE-170, 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 ACO, send it to ATTN: Program Manager, Continuing Operational
Safety, FAA, New York ACO, 1600 Stewart Avenue, Suite 410, Westbury,
New York 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. 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.

Related Information

    (j) Refer to MCAI Canadian Airworthiness Directive CF-2011-25,
dated July 25, 2011; Bombardier Service Bulletin 605-24-003, dated
April 25, 2011; and Bombardier Service Bulletin 604-24-023, dated
April 25, 2011; for related information.

    Issued in Renton, Washington, on October 27, 2011.
Kalene C. Yanamura,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2011-28857 Filed 11-7-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 36 (Monday, February 24, 2020)]
[Rules and Regulations]
[Pages 10269-10270]
[FR Doc No: 2020-03278]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.

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

Federal Register / Vol. 85, No. 36 / Monday, February 24, 2020 /
Rules and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 31296; Amdt. No. 3891]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This rule establishes, amends, suspends, or removes Standard
Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums
and Obstacle Departure Procedures (ODPs) for operations at certain
airports. These regulatory actions are needed because of the adoption
of new or revised criteria, or because of changes occurring in the
National Airspace System, such as the commissioning of new navigational
facilities, adding new obstacles, or changing air traffic requirements.
These changes are designed to provide safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective February 24, 2020. The compliance date
for each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of February 24, 2020.

ADDRESSES: Availability of matters incorporated by reference in the
amendment is as follows:

For Examination

    1. U.S. Department of Transportation, Docket Ops-M30, 1200 New
Jersey Avenue SE, West Bldg., Ground Floor, Washington, DC 20590-0001.
    2. The FAA Air Traffic Organization Service Area in which the
affected airport is located;
    3. The office of Aeronautical Navigation Products, 6500 South
MacArthur Blvd., Oklahoma City, OK 73169 or,
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

Availability

    All SIAPs and Takeoff Minimums and ODPs are available online free
of charge. Visit the National Flight Data Center at nfdc.faa.gov to
register. Additionally, individual SIAP and Takeoff Minimums and ODP
copies may be obtained from the FAA Air Traffic Organization Service
Area in which the affected airport is located.

FOR FURTHER INFORMATION CONTACT:  Thomas J. Nichols, Flight Procedures
and Airspace Group, Flight Technologies and Procedures Division, Flight
Standards Service, Federal Aviation Administration. Mailing Address:
FAA Mike Monroney Aeronautical Center, Flight Procedures and Airspace
Group, 6500 South MacArthur Blvd., Registry Bldg. 29, Room 104,
Oklahoma City, OK 73169. Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14 of the Code of
Federal Regulations, Part 97 (14 CFR part 97), by establishing,
amending, suspending, or removes SIAPS, Takeoff Minimums and/or ODPS.
The complete regulatory description of each SIAP and its associated
Takeoff Minimums or ODP for an identified airport is listed on FAA form
documents which are incorporated by reference in this amendment under 5
U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA
forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when
required by an entry on 8260-15A.
    The large number of SIAPs, Takeoff Minimums and ODPs, their complex
nature, and the need for a special format make publication in the
Federal Register expensive and impractical. Further, airmen do not use
the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead
refer to their graphic depiction on charts printed by publishers of
aeronautical materials. Thus, the advantages of incorporation by
reference are realized and publication of the complete description of
each SIAP, Takeoff Minimums and ODP listed on FAA form documents is
unnecessary. This amendment provides the affected CFR sections and
specifies the types of SIAPs, Takeoff Minimums and ODPs with their
applicable effective dates. This amendment also identifies the airport
and its location, the procedure, and the amendment number.

Availability and Summary of Material Incorporated by Reference

    The material incorporated by reference is publicly available as
listed in the ADDRESSES section.
    The material incorporated by reference describes SIAPS, Takeoff
Minimums and/or ODPS as identified in the amendatory language for part
97 of this final rule.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP, Takeoff Minimums and ODP as Amended in the
transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments
may have been issued previously by the FAA in a Flight Data Center
(FDC) Notice to Airmen (NOTAM) as an emergency action of immediate
flight safety relating directly to published aeronautical charts.
    The circumstances that created the need for some SIAP and Takeoff
Minimums and ODP amendments may require making them effective in less
than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an
effective date at least 30 days after publication is provided.
    Further, the SIAPs and Takeoff Minimums and ODPs contained in this
amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these SIAPs and
Takeoff Minimums and ODPs, the TERPS criteria were applied to the
conditions existing or anticipated at the affected airports. Because of
the close and immediate relationship between these SIAPs, Takeoff
Minimums and ODPs, and safety in air commerce, I find that notice and
public procedure under

5 U.S.C. 553(b) are impracticable and contrary to the public interest
and, where applicable, under 5 U.S.C 553(d), good cause exists for
making some SIAPs effective in less than 30 days.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26,1979); and
(3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

    Air Traffic Control, Airports, Incorporation by reference,
Navigation (Air).

    Issued in Washington, DC, on February 7, 2020.
Rick Domingo,
Executive Director, Flight Standards Service.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14,
Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by
establishing, amending, suspending, or removing Standard Instrument
Approach Procedures and/or Takeoff Minimums and Obstacle Departure
Procedures effective at 0901 UTC on the dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g), 40103, 40106, 40113,
40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:

Effective 26 March 2020

Huntsville, AL, Huntsville Intl-Carl T Jones Field, ILS OR LOC RWY
18L, Amdt 5B
Huntsville, AL, Huntsville Intl-Carl T Jones Field, ILS OR LOC RWY
36L, Amdt 11B
Harrison, AR, Boone County, ILS OR LOC RWY 36, Amdt 1
Harrison, AR, Boone County, NDB RWY 18, Amdt 6, CANCELLED
Mojave, CA, Mojave Air and Space Port, RNAV (GPS) RWY 4, Amdt 1
Mojave, CA, Mojave Air and Space Port, RNAV (GPS) RWY 22, Amdt 1
Truckee, CA, Truckee-Tahoe, RNAV (GPS) RWY 20, Amdt 1
Truckee, CA, Truckee-Tahoe, RNAV (GPS) Y RWY 20, Orig-B, CANCELLED
Denver, CO, Denver Intl, RNAV (RNP) Z RWY 7, Amdt 1
Denver, CO, Denver Intl, RNAV (RNP) Z RWY 8, Orig-B, CANCELLED
Denver, CO, Denver Intl, RNAV (RNP) Z RWY 25, Orig-B, CANCELLED
Denver, CO, Denver Intl, RNAV (RNP) Z RWY 26, Amdt 1
Gainesville, FL, Gainesville Rgnl, ILS OR LOC RWY 29, Amdt 13
Decorah, IA, Decorah Muni, RNAV (GPS) RWY 11, Amdt 1
Decorah, IA, Decorah Muni, RNAV (GPS) RWY 29, Amdt 1
Decorah, IA, Decorah Muni, VOR RWY 29, Amdt 3E, CANCELLED
Chicago, IL, Chicago O'Hare Intl, RNAV (GPS) RWY 9L, Amdt 3D
Chicago, IL, Chicago O'Hare Intl, RNAV (GPS) RWY 9R, Amdt 4B
Chicago, IL, Chicago O'Hare Intl, RNAV (GPS) RWY 10L, Amdt 5B
Preston, MN, Fillmore County, RNAV (GPS) RWY 11, Orig-D
Preston, MN, Fillmore County, RNAV (GPS) RWY 29, Amdt 1D
Sedalia, MO, Sedalia Memorial, NDB RWY 18, Amdt 8B, CANCELLED
Sedalia, MO, Sedalia Memorial, NDB RWY 36, Amdt 9A, CANCELLED
Beaufort, NC, Michael J Smith Field, RNAV (GPS) RWY 8, Amdt 2B
Roxboro, NC, Raleigh Rgnl at Person County, RNAV (GPS) RWY 6, Orig-B
Battle Mountain, NV, Battle Mountain, Takeoff Minimums and Obstacle
DP, Amdt 5
Battle Mountain, NV, Battle Mountain, VOR RWY 4, Amdt 7A
Reno, NV, Reno/Tahoe Intl, RNAV (GPS) X RWY 16L, Amdt 2
Reno, NV, Reno/Tahoe Intl, RNAV (GPS) X RWY 34R, Amdt 2
Reno, NV, Reno/Tahoe Intl, RNAV (RNP) Y RWY 16L, Amdt 1B
Aurora, OR, Aurora State, RNAV (GPS) RWY 17, Amdt 1B
North Bend, OR, Southwest Oregon Rgnl, RNAV (GPS) Y RWY 5, Amdt 1A
North Bend, OR, Southwest Oregon Rgnl, RNAV (RNP) Z RWY 5, Amdt 1A
Pendleton, OR, Eastern Oregon Rgnl at Pendleton, RNAV (GPS) RWY 8,
Amdt 1A
Pendleton, OR, Eastern Oregon Rgnl at Pendleton, RNAV (GPS) RWY 26,
Orig-E
Portland, OR, Portland Intl, ILS OR LOC RWY 10R, ILS RWY 10R (SA CAT
I), ILS RWY 10R (CAT II), ILS RWY 10R (CAT III), Amdt 35
Portland, OR, Portland-Hillsboro, ILS OR LOC RWY 13R, Amdt 11
Portland, OR, Portland-Hillsboro, NDB-B, Amdt 3A
Portland, OR, Portland-Hillsboro, RNAV (GPS) RWY 13R, Amdt 3
Portland, OR, Portland-Hillsboro, RNAV (GPS) RWY 31L, Amdt 1A
Portland, OR, Portland-Hillsboro, VOR-C, Amdt 1A
Luray, VA, Luray Caverns, Takeoff Minimums and Obstacle DP, Amdt 2A

    Rescinded: On January 27, 2020 (85 FR 4580), the FAA published
an Amendment in Docket No. 31292 Amdt No. 3887, to Part 97 of the
Federal Aviation Regulations under sections 97.29. The following
entry for Chicago, IL effective March 26, 2020, is hereby rescinded
in its entirety:

Chicago, IL, Chicago O'Hare Intl, ILS OR LOC RWY 22L, ILS RWY 22L
(SA CAT I), ILS RWY 22L (SA CAT II), Amdt 7

[FR Doc. 2020-03278 Filed 2-21-20; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 244 (Wednesday, December 19, 2012)]
[Notices]
[Pages 75230-75231]
[FR Doc No: 2012-30501]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68428; File No. SR-CBOE-2012-116]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Proposed Rule Change Related to Bylaw and Other
Changes

December 13, 2012.
    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 November 30, 2012, the Chicago Board Options Exchange,
Incorporated (``Exchange'' or ``CBOE'') filed with the Securities and
Exchange Commission (the ``Commission'') the proposed rule change as
described in Items I and II below, which Items have been prepared by
the Exchange. The 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.
---------------------------------------------------------------------------

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

    CBOE proposes to: (i) Amend its Bylaws to expressly provide that
the Representative Director Nominating Body and any petition candidate
must satisfy the compositional requirements determined by the Board
from time to time pursuant to a resolution adopted by the Board; (ii)
amend its Bylaws relating to the Board size range such that the Board
shall consist of not less than 12 and not more than 16 directors; and
(iii) make conforming changes to the CBOE Certificate of Incorporation.
The text of the proposed amendments to CBOE's Bylaws and CBOE's
Certificate of Incorporation are available on the Exchange's Web site
(http://www.cboe.org/legal), at the Exchange's Office of the Secretary
and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of those statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant parts of such
statements.

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

1. Purpose
    The purpose of this proposed rule change is to (i) Amend CBOE's
Bylaws to expressly state that the Representative Director Nominating
Body and any petition candidate must satisfy the compositional
requirements determined by the Board from time to time pursuant to a
resolution adopted by the Board; (ii) amend its Bylaws relating to the
Board size range such that the Board shall consist of not less than 12
and not more than 16 directors; and (iii) make conforming changes to
the CBOE Certificate of Incorporation.
(1) Compositional Requirements Determined by the Board
    Last year, CBOE amended its Bylaws and Certificate of Incorporation
to, among other things: (i) Eliminate the requirement that its Board of
Directors be composed of at least 30% Industry Directors, and (ii)
eliminate the requirement in Section 3.2 of the Bylaws that the
Representative Directors must be Industry Directors.\3\ In its rule
filing, CBOE noted that the changes would provide it with appropriate
flexibility as it evaluates the structure and composition of its Board
in the future.\4\ Additionally, CBOE stated that no matter what the
composition of its Board is, the Exchange intends to maintain the fair
representation of its Trading Permit Holders in the selection of its
directors and administration of its affairs consistent with Section
6(b)(3) of the Securities Exchange Act of 1934, as amended (``Act'').
In approving CBOE's rule filing, the SEC noted that it has previously
approved proposals in which an exchange's board of directors was
composed of all or nearly all non-industry directors where the process
was nevertheless designed to comply with the ``fair representation''
requirement in the selection and election of directors.\5\
---------------------------------------------------------------------------

    \3\ The Exchange notes that at all times at least 20% of the
directors serving on the Board shall be Representative Directors
nominated by the Representative Director Nominating Body as provided
in Section 3.2 of the Bylaws (or otherwise selected through the
petition process). Under Section 3.2, the Representative Director
Nominating Body provides a mechanism for Trading Permit Holders to
provide input with respect to the nominees for Representative
Directors and Trading Permit Holders are also allowed to nominate
alternative candidates by petition.
    \4\ See Securities Exchange Act Release No. 65682 (November 3,
2011), 76 FR 69780 (November 9, 2011) (noticing for comment SR-CBOE-
2011-099); Securities Exchange Act Release No. 65980 (December 15,
2011), 76 FR 79252 (December 21, 2011) (approving SR-CBOE-2011-099).
    \5\ See, e.g., Securities Exchange Act Release No. 48946
(December 17, 2003), 68 FR 74678 (December 24, 2003) (approving SR-
NYSE-2003-34).
---------------------------------------------------------------------------

    In connection with these changes, CBOE also amended Section 3.1 of
the Bylaws to provide that: ``[T]he Board shall determine from time to
time pursuant to resolution adopted by the Board the total number of
directors, the number of Non-Industry Directors and Industry Directors
(if any), and the number of Representative Directors that are Non-
Industry Directors and Industry Directors (if any).'' CBOE now proposes
to amend the Bylaws to expressly provide that any person nominated by
the Representative Director Nominating Body and any petition candidate
nominated pursuant to the Section 3.2 of the Bylaws shall satisfy the
compositional requirements determined by the Board pursuant to a
resolution adopted by the Board in accordance with Section 3.1
designating the number of Representative Directors that are Non-
Industry Directors and Industry Directors (if any). CBOE also proposes
to amend Section 3.5 of the Bylaws relating to the filling of vacancies
on the Board to provide that the Representative Director Nominating
Body shall only recommend individuals to fill a vacancy in a
Representative Director position who satisfy the compositional
requirements designated by the Board pursuant to resolution adopted by
the Board in accordance with Section 3.1, designating the number of
Representative Directors that are Non-Industry Directors and Industry
Directors (if any). CBOE believes that these changes are consistent
with the changes to the Bylaws that were made last year and simply
makes those changes more explicit.

(2) Board Size Range
    CBOE proposes to amend its Bylaws relating to the Board size range.
Currently, the Bylaws provide that the Board shall consist of not less
than 11 and not more than 23 directors. CBOE proposes to change the
Board size range such that the Board shall consist of not less than 12
and not more than 16 directors. CBOE believes that this new Board size
range is consistent with the current size of CBOE's Board and the Board
size range that it expects to maintain in the future.
(3) Amendment to Certificate of Incorporation
    CBOE proposes to make conforming changes to its Certificate of
Incorporation. Specifically, CBOE proposes to amend its Certificate of
Incorporation to expressly provide that any individual(s) recommended
by the Representative Director Nominating Body and any individual(s)
who are petition candidates shall satisfy the compositional
requirements determined by the Board of Directors from time to time
pursuant to a resolution adopted by the Board in accordance with
Section 3.1 of CBOE's Bylaws, designating the number of Representative
Directors that are Non-Industry Directors and Industry Directors (if
any). CBOE also proposes to include in its Certificate of Incorporation
that the Board of Directors and/or Nominating and Governance Committee,
as applicable, shall make such determinations as to whether a director
candidate satisfies applicable qualifications for election as a
director pursuant to and in accordance with Section 3.1 of the
Corporation's Bylaws, which is consistent with the current provisions
in the Bylaws.
2. Statutory Basis
    For the reasons set forth above, CBOE believes that this filing is
consistent with Section 6(b) of the Act,\6\ in general, and furthers
the objectives of Section 6(b)(1) of the Act \7\ and Section 6(b)(5) of
the Act \8\ in particular, in that (i) it enables CBOE to be so
organized as to have the capacity to be able to carry out the purposes
of the Act and to comply, and to enforce compliance by its Trading
Permit Holders and persons associated with its Trading Permit Holders,
with the provisions of the Act, the rules and regulations thereunder,
and the rules of CBOE and (ii) to prevent fraudulent and manipulative
acts and practices, to promote just and equitable principles of trade,
to remove impediments to, and perfect the mechanism of, a free and open
market and, in general, to protect investors and the public interest.
Specifically, CBOE believes that the proposed changes will enhance
CBOE's governance structure by (i) by expressly providing that any
person nominated by the Representative Director Nominating Body and any
petition candidate nominated pursuant to the Section 3.2 of the Bylaws
shall satisfy the compositional requirements determined by the Board
pursuant to a resolution adopted by the Board in accordance with
Section 3.1 designating the number of Representative Directors that are
Non-Industry Directors and Industry Directors (if any); and (ii) by
changing the Board size range from 11 to 23 directors to 12 to 16
directors. Additionally, CBOE believes that this filing is consistent
with Section 6(b)(3) of the Act in that CBOE's Bylaws will continue to
provide for the fair representation of CBOE Trading Permit Holders in
the selection of directors and the administration of the Exchange.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(1).
    \8\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

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

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

    The Exchange neither solicited nor received comments on the
proposal.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove such proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2012-116 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CBOE-2012-116. This file
number should be included on the subject line if email is used.
    To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet 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 Web site
viewing and printing in the Commission's Public Reference Room on
official business days between the hours of 10:00 a.m. and 3:00 p.m.
Copies of such filing also will be available for inspection and copying
at the principal offices of the Exchange. All comments received will be
posted without change; the Commission does not edit personal
identifying information from submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-CBOE-2012-116, and should be submitted
on or before January 9, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

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

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-30501 Filed 12-18-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 169 (Thursday, August 30, 2012)]
[Rules and Regulations]
[Pages 52610-52614]
[FR Doc No: 2012-21430]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 158

[EPA-HQ-OPP-2010-0670; FRL-9338-9]
RIN 2070-AJ80

Pesticides; Microbial Pesticide Definitions and Applicability;
Clarification and Availability of Test Guideline

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This final rule clarifies the distinction between ``isolates''
and ``strains,'' and clarifies the requirements applicable to new
isolates, which are considered to be new active ingredients under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Additional
revisions to regulatory text include several minor corrections to words
and references. Finally, EPA is announcing the availability of a final
microbial pesticide test guideline that further explains the existing
data requirement to deposit a sample in a nationally recognized culture
collection. Collectively, the final rule clarifications and revisions,
as well as the final microbial pesticide test guideline, are expected
to enhance the ability of industry to efficiently manage its microbial
pesticide registration submissions.

DATES: This final rule is effective October 29, 2012.

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2010-0670, is available either
electronically through http://www.regulations.gov or in hard copy at
the OPP Docket in the Environmental Protection Agency Docket Center
(EPA/DC), located in EPA West, Rm. 3334, 1301 Constitution Ave. NW.,
Washington, DC 20460-0001. The Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is<PHONE_NUMBER>, and the
telephone number for the OPP Docket is<PHONE_NUMBER>. Please review
the visitor instructions and additional information about the docket
available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Rose Kyprianou, Field and External
Affairs Division (7506P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>;
email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Does this action apply to me?

    You may be potentially affected by this action if you are a
producer or registrant of a microbial pesticide product. This action
also may affect any person or company who might petition EPA for a
tolerance or an exemption from the requirement of a tolerance for
residues of a microbial pesticide, holds a pesticide registration with
an existing tolerance or tolerance exemption for a microbial pesticide,
or is interested in obtaining or retaining a tolerance or tolerance
exemption in the absence of a registration (i.e., a tolerance or
tolerance exemption for an imported microbial pesticide). The North
American Industrial Classification System (NAICS) codes have been
provided to assist you and others in determining whether this action
might apply to certain entities. Potentially affected entities may
include, but are not limited to:
     Pesticide and Other Agricultural Chemical Manufacturing
(NAICS code 325320), e.g., pesticide manufacturers or formulators of
pesticide products, importers, or any person or company who seeks to
register a pesticide or to obtain a tolerance or tolerance exemption
for a pesticide.
     Crop Production (NAICS code 111).
     Animal Production (NAICS code 112).
     Food Manufacturing and Processing (NAICS code 311).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. If you have any questions regarding the applicability of this
action to a particular entity, consult the person listed under FOR
FURTHER INFORMATION CONTACT.

II. Background

    In the Federal Register of October 26, 2007 (72 FR 60988) (FRL-
8109-8), a final rule, entitled ``Pesticides; Data Requirements for
Biochemical and Microbial Pesticides,'' revised the data requirements
for biochemical and microbial pesticides--regulations that had
originally been promulgated in and had remained largely unchanged since
1984. In doing so, EPA established a distinct subpart for microbial
pesticides (i.e., 40 CFR part 158, subpart V) that provided a
definition for these particular pesticides and clearly identified the
data required to support their registration. Since 2007, however, EPA
has consistently encountered questions from industry stakeholders on
certain portions of 40 CFR part 158, subpart V, particularly with
regard to the language set forth in 40 CFR 158.2100(c)(2).
    To address these questions, in the Federal Register of April 15,
2011 (76 FR 21294) (FRL-8857-7), EPA proposed specific revisions to the
regulatory text in 40 CFR 158.2100(c)(2) for purposes of enhanced
clarity. In addition, EPA also recognized that an existing data
requirement under 40 CFR 158.2120(c) and 40 CFR 158.2171(c), deposition
of a sample in a nationally recognized culture collection, did not have
an accompanying test guideline and that there were several minor errors
in the regulatory text of 40 CFR part 158, subpart V. Therefore, with
the proposed rule, EPA also made available for public comment a draft
test guideline, entitled ``Deposition of a Sample in a Nationally
Recognized Culture Collection'' and identified as OCSPP Test Guideline
885.1250, addressing the deposition of a sample in a nationally
recognized culture collection data requirement, and proposed to make
other minor corrections to the regulations. The public comment period
for the proposed rule closed on July 14, 2011, and EPA received no
comments on the proposed rule or the draft test guideline.

III. Final Changes

A. What action is EPA taking?

    EPA is finalizing most of the changes and corrections proposed.
Although no comments were received, EPA has revised a few of the
originally proposed changes and corrections to further clarify the
regulatory text being modified. These changes are not substantive in
nature. The specific changes being promulgated with this action and the
anticipated benefits of such changes are described in this final rule
and the rationale supporting the revisions can be found in the proposed
rule (see Unit IV. of the April 15, 2011 proposed rule).
    Specifically, EPA is making several changes and corrections to the
Microbial Pesticides data requirements (40 CFR part 158, subpart V).
First, EPA is revising 40 CFR 158.2100(c)(2) to reduce confusion over
the distinction between ``isolates'' and ``strains'' and exactly how
EPA views both of these terms. To this end, EPA substitutes ``active
ingredient'' for ``strain.'' The

clarification to 40 CFR 158.2100(c)(2) also includes a requirement for
the use of a unique identifier, as part of the microbial pesticide
active ingredient taxonomic name, to allow for improved identification
of company-specific registered isolates. The clarification also
mentions the possibility for data citation, in lieu of data generation,
should sufficient similarity be established between isolates. Moreover,
after further consideration, EPA has decided against including the
proposed explanatory text (i.e., ``Because of the potential for
variation in microorganisms'') at the beginning of the first sentence
in 40 CFR 158.2100(c)(2). This phrase is not necessary or appropriate
as regulatory text because it does not add anything to the regulatory
provision.
    Second, in conjunction with the changes detailed for 40 CFR
158.2100(c)(2), EPA is announcing the availability of a final microbial
pesticide test guideline under Series 885, entitled ``Deposition of a
Sample in a Nationally Recognized Culture Collection'' and identified
as OCSPP Test Guideline 885.1250. This OCSPP test guideline is intended
to explain the existing data requirement to deposit a sample in a
nationally recognized culture collection found in the tables in 40 CFR
158.2120(c) and 40 CFR 158.2171(c). Additionally, to clarify this
microbial deposition data requirement, EPA is adding a test note to 40
CFR 158.2120(d) and 40 CFR 158.2171(d), emphasizing the need for the
continuing maintenance of a culture deposit to ensure that it remains
available for the duration of an associated registration or
experimental use permit in case EPA requests a sample. This requirement
already applies to all isolates; thus, the reference to ``new
isolates'' in the proposed rulemaking was an oversight and is just
``isolates'' in this final rule.
    Finally, to correct several minor errors, EPA is replacing ``part''
with ``subpart'' in 40 CFR 158.2100(c)(1) and removing references to a
non-existing paragraph (e) that appears in 40 CFR 158.2120 and 40 CFR
158.2171.
    The improved clarity and transparency resulting from the insertion
of this information in 40 CFR part 158, subpart V, are expected to
enhance the ability of industry to efficiently manage its microbial
pesticide registration submissions. Applicants may save time and money
from an improved understanding of the standards and interpretations of
the definitions for the data that are needed. Having all required
studies and information available to EPA at the time of application may
also reduce potential delays in the registration process, thereby
enabling registration of microbial pesticides sooner and allowing
microbial pesticide products to enter the market sooner.

B. What is EPA's authority for taking this action?

    This final rule is issued under the authority of FIFRA sections 3,
5, 10, 12, and 25 (7 U.S.C. 136 et seq.), and section 408 of the
Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 346a).

C. Electronic Access to the OCSPP Test Guidelines

    To access the OSCPP test guidelines referenced in this final rule
electronically, please go to http://www.epa.gov/ocspp and select ``Test
Methods and Guidelines.'' You may also access the test guidelines in
http://www.regulations.gov grouped by Series under Docket ID numbers:
EPA-HQ-OPPT-2009-0150 through EPA-HQ-OPPT-2009-0159 and EPA-HQ-OPPT-
2009-0576.

IV. FIFRA Review Requirements

    Pursuant to FIFRA sections 25(a) and (d), EPA has submitted a draft
of this final rule to the Committee on Agriculture in the House of
Representatives; the Committee on Agriculture, Nutrition, and Forestry
in the United States Senate; the United States Department of
Agriculture (USDA); and the FIFRA Scientific Advisory Panel (SAP).
FIFRA SAP and USDA waived review of this final rule.

V. Statutory and Executive Order Reviews

    This action only clarifies existing regulatory text to allow EPA
and stakeholders a clearer understanding of 40 CFR part 158, subpart V.
It does not otherwise impose any other requirements, involve any
significant policy or legal issues, or increase existing costs. As
such, EPA is not required to make special considerations or evaluations
under the following statutory and Executive Order review requirements.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This is not a ``significant regulatory action'' under Executive
Order 12866 (58 FR 51735, October 4, 1993) and was therefore not
reviewed by the Office of Management and Budget (OMB) under Executive
Orders 12866 and 13563 (76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act (PRA)

    This action does not impose or change any information collection
burden that requires additional review by OMB under the provisions of
PRA (44 U.S.C. 3501 et seq.). Burden is defined at 5 CFR 1320.3(b). An
agency may not conduct or sponsor, and a person is not required to
respond to a collection of information that requires OMB approval under
PRA, unless it has been approved by OMB and displays a currently valid
OMB control number. The OMB control numbers for EPA's regulations in
title 40 of the CFR, after appearing in the Federal Register, are
listed in 40 CFR part 9, and included on the related collection
instrument, or form, if applicable.
    The revisions in this final rule involve existing information
collection activities that are already approved by OMB under PRA.
Specifically, the submission of data to EPA in order to establish a
tolerance or an exemption from the requirement of a tolerance are
currently approved under OMB Control No. 2070-0024 (EPA ICR No. 0597);
the activities associated with the application for a new or amended
registration of a pesticide are currently approved under OMB Control
No. 2070-0060 (EPA ICR No. 0277); the activities associated with the
application for an experimental use permit are currently approved under
OMB Control No. 2070-0040 (EPA ICR No. 0276); and the activities
associated with the generation of data for regulatory review programs
are currently approved under OMB Control No. 2070-0174 (EPA ICR No.
2288).

C. Regulatory Flexibility Act (RFA)

    Pursuant to RFA section 605(b) (5 U.S.C. 601 et seq.), EPA hereby
certifies that this final rule does not have a significant adverse
economic impact on a substantial number of small entities. Under RFA,
small entities include small businesses, small organizations, and small
governmental jurisdictions. In making this determination, the impact of
concern is any significant adverse economic impact on small entities
because the primary purpose of regulatory flexibility analysis is to
identify and address regulatory alternatives ``which minimize any
significant economic impact of the rule on small entities.'' 5 U.S.C.
603 and 604. Thus, an agency may certify under RFA when the rule
relieves regulatory burden, or otherwise has no expected economic
impact on small entities subject to the rule.
    This action only clarifies existing regulatory text to allow EPA
and stakeholders a clearer understanding of

40 CFR part 158, subpart V. It does not otherwise amend or impose any
other requirements. As such, this final rule will not have any adverse
economic impact on any entities, large or small.

D. Unfunded Mandates Reform Act (UMRA)

    State, local, and Tribal governments are rarely pesticide
applicants or registrants, so this final rule is not expected to affect
these governments and is not expected to adversely affect the private
sector. Accordingly, pursuant to Title II of UMRA (2 U.S.C. 1531-1538),
EPA has determined that this action is not subject to the requirements
in UMRA sections 202 and 205 because it does not contain a Federal
mandate that may result in expenditures of $100 million or more for
State, local, and Tribal governments, in the aggregate, or for the
private sector in any 1 year. In addition, this action does not
significantly or uniquely affect small governments or impose a
significant intergovernmental mandate, as described in UMRA sections
203 and 204.

E. Executive Order 13132: Federalism

    This action will not have federalism implications because it is not
expected to have a substantial direct effect on 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, as specified in Executive Order 13132 (64 FR 43255, August
10, 1999). Thus, Executive Order 13132 does not apply to this action.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    EPA is not aware of any Tribal governments that are pesticide
registrants. This action will not, therefore, have Tribal implications
because it is not expected to have substantial direct effects on Indian
Tribes, will not significantly or uniquely affect the communities of
Indian Tribal governments, and does not involve or impose any
requirements that affect Indian Tribes, as specified in Executive Order
13175 (65 FR 67249, November 9, 2000). Accordingly, the requirements of
Executive Order 13175 do not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997)
as applying only to those regulatory actions that concern health or
safety risks, such that the analysis required under section 5-501 of
the Executive Order has the potential to influence the regulation. This
action is not subject to Executive Order 13045 because it does not
establish an environmental standard intended to mitigate health or
safety risks, nor is it an ``economically significant regulatory
action'' as defined by Executive Order 12866.

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 (66 FR 28355,
May 22, 2001) because it is not a significant regulatory action under
Executive Order 12866, nor will it affect energy supply, distribution,
or use.

I. National Technology Transfer and Advancement Act (NTTAA)

    This action does not involve technical standards that would require
the consideration of voluntary consensus standards pursuant to NTTAA
section 12(d) (15 U.S.C. 272 note).

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    This action does not have disproportionately high and adverse human
health or environmental effects on minority or low-income populations
because it does not affect the level of protection provided to human
health or the environment. Therefore, this action does not involve
special consideration of environmental justice-related issues as
specified in Executive Order 12898 (59 FR 7629, February 16, 1994).

VI. Congressional Review Act (CRA)

    Pursuant to CRA (5 U.S.C. 801 et seq.), EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of the rule in the Federal Register.
This action is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 158

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: August 24, 2012.
James Jones,
Acting Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.

    Therefore, 40 CFR chapter I is amended as follows:

PART 158--[AMENDED]

0
1. The authority citation for part 158 continues to read as follows:

    Authority:  7 U.S.C. 136-136y; 21 U.S.C. 346a.

0
2. In Sec.  158.2100, revise paragraphs (c)(1) and (2) to read as
follows:

Sec.  158.2100  Microbial pesticides definition and applicability.

* * * * *
    (c) * * *
    (1) This subpart applies to microbial pesticides as specified in
paragraphs (c)(2), (c)(3), and (c)(4) of this section.
    (2) Each new isolate of a microbial pesticide is a new active
ingredient and must be registered independently of any similarly
designated and already registered microbial pesticide active
ingredient. Each new isolate for which registration is sought must have
a unique identifier following the taxonomic name of the microorganism,
and the registration application must be supported by data required in
this subpart. This does not preclude the possibility of using data from
another isolate, provided sufficient similarity is established, to
support registration.
* * * * *

0
3. In Sec.  158.2120:
0
a. Revise paragraphs (a), (b), and (c).
0
b. Redesignate in paragraph (d), test notes 1 through 4 as test notes 2
through 5 and add new test note 1.
    The amendments read as follows:

Sec.  158.2120  Microbial pesticides product analysis data requirements
table.

    (a) General. Sections 158.100 through 158.130 describe how to use
this table to determine the product analysis data requirements and the
substance to be tested for a particular microbial pesticide. Notes that
apply to an individual test and include specific conditions,
qualifications, or exceptions to the designated test are identified in
paragraph (d) of this section.
    (b) Key. R = Required; CR = Conditionally required; NR = Not
required; MP = Manufacturing-use product; EP = End-use product; TEP =
Typical end-use product; TGAI = Technical grade of the active
ingredient; All = All of the above.
    (c) Table. The table in this paragraph shows the data requirements
for microbial pesticides product analysis.

The test notes are shown in paragraph (d) of this section.

                         Table--Microbial Pesticides Product Analysis Data Requirements
----------------------------------------------------------------------------------------------------------------
                                                                             Test substance
 Test guideline No.       Data requirement          All use     ----------------------------------------   Test
                                                   patterns              MP                  EP           notes
----------------------------------------------------------------------------------------------------------------
                                        Product Chemistry and Composition
----------------------------------------------------------------------------------------------------------------
885.1100............  Product identity.......  R                 MP................  EP................  .......
885.1200............  Manufacturing process..  R                 TGAI and MP.......  TGAI and EP.......  .......
885.1250............  Deposition of a sample   R                 TGAI..............  TGAI..............        1
                       in a nationally
                       recognized culture
                       collection.
885.1300............  Discussion of formation  R                 TGAI and MP.......  TGAI and EP.......  .......
                       of unintentional
                       ingredients.
----------------------------------------------------------------------------------------------------------------
                                          Analysis and Certified Limits
----------------------------------------------------------------------------------------------------------------
885.1400............  Analysis of samples....  R                 TGAI and MP.......  TGAI and EP.......        2
885.1500............  Certification of limits  R                 MP................  EP................  .......
----------------------------------------------------------------------------------------------------------------
                                      Physical and Chemical Characteristics
----------------------------------------------------------------------------------------------------------------
830.6302............  Color..................  R                 TGAI..............  TGAI..............  .......
830.6303............  Physical state.........  R                 TGAI..............  TGAI..............  .......
830.6304............  Odor...................  R                 TGAI..............  TGAI..............  .......
830.6313............  Stability to normal and  R                 TGAI..............  TGAI..............  .......
                       elevated temperatures,
                       metals, and metal ions.
830.6317............  Storage stability......  R                 TGAI and MP.......  TGAI and EP.......  .......
830.6319............  Miscibility............  R                 MP................  EP................        3
830.6320............  Corrosion                R                 MP................  EP................        4
                       characteristics.
830.7000............  pH.....................  R                 TGAI..............  TGAI..............  .......
830.7100............  Viscosity..............  R                 MP................  EP................        5
830.7300............  Density/relative         R                 TGAI..............  TGAI..............  .......
                       density/bulk density
                       (specific gravity).
----------------------------------------------------------------------------------------------------------------

     (d) * * *
    1. Required for each isolate of a microbial pesticide. Isolates
must be deposited with an agreement to ensure that the sample will be
maintained and will not be discarded for the duration of the associated
registration(s).
* * * * *

0
4. In Sec.  158.2171:
0
a. Revise paragraphs (a), (b), and (c).
0
b. Redesignate in paragraph (d), test notes 3 through 6 as test notes 4
through 7 and add new test note 3.
    The amendments read as follows:

Sec.  158.2171  Experimental use permit microbial pesticides product
analysis data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use
this table to determine the product analysis data requirements and the
substance to be tested for a particular microbial pesticide. Notes that
apply to an individual test and include specific conditions,
qualifications, or exceptions to the designated test are identified in
paragraph (d) of this section.
    (b) Key. R = Required; CR = Conditionally required; NR = Not
required; MP = Manufacturing-use product; EP = End-use product; TEP =
Typical end-use product; TGAI = Technical grade of the active
ingredient; All = All of the above.
    (c) Table. The table in this paragraph shows the data requirements
for experimental use permit microbial pesticides product analysis. The
test notes are shown in paragraph (d) of this section.

                       Table--EUP Microbial Pesticides Product Analysis Data Requirements
----------------------------------------------------------------------------------------------------------------
                                                                             Test substance
 Test guideline No.       Data requirement     All use patterns ----------------------------------------   Test
                                                                         MP                  EP           notes
----------------------------------------------------------------------------------------------------------------
                                        Product Chemistry and Composition
----------------------------------------------------------------------------------------------------------------
885.1100............  Product identity.......  R                 MP................  EP................  .......
885.1200............  Manufacturing process..  R                 TGAI and MP.......  TGAI and EP.......     1, 2
885.1250............  Deposition of a sample   R                 TGAI..............  TGAI..............        3
                       in a nationally
                       recognized culture
                       collection.
885.1300............  Discussion of formation  R                 TGAI and MP.......  TGAI and EP.......        2
                       of unintentional
                       ingredients.
----------------------------------------------------------------------------------------------------------------
                                          Analysis and Certified Limits
----------------------------------------------------------------------------------------------------------------
885.1400............  Analysis of samples....  R                 TGAI and MP.......  TGAI and EP.......     2, 4
885.1500............  Certification of limits  R                 MP................  EP................  .......
----------------------------------------------------------------------------------------------------------------

                                      Physical and Chemical Characteristics
----------------------------------------------------------------------------------------------------------------
830.6302............  Color..................  R                 TGAI..............  TGAI..............  .......
830.6303............  Physical state.........  R                 TGAI..............  TGAI..............  .......
830.6304............  Odor...................  R                 TGAI..............  TGAI..............  .......
830.6313............  Stability to normal and  R                 TGAI..............  TGAI..............  .......
                       elevated temperatures,
                       metals, and metal ions.
830.6317............  Storage stability......  R                 TGAI and MP.......  TGAI and EP.......  .......
830.6319............  Miscibility............  R                 MP................  EP................        5
830.6320............  Corrosion                R                 MP................  EP................        6
                       characteristics.
830.7000............  pH.....................  R                 TGAI..............  TGAI..............  .......
830.7100............  Viscosity..............  R                 MP................  EP................        7
830.7300............  Density/relative         R                 TGAI..............  TGAI..............  .......
                       density/bulk density
                       (specific gravity).
----------------------------------------------------------------------------------------------------------------

     (d) * * *
    3. Required for each isolate of a microbial pesticide. Isolates
must be deposited with an agreement to ensure that the sample will be
maintained and will not be discarded for the duration of the associated
experimental use permit(s).
* * * * *
[FR Doc. 2012-21430 Filed 8-29-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: February 11, 2009 (Volume 74, Number 27)]
[Notices]
[Page 6901-6902]
[DOCID:fr11fe09-60]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA2008E0091; Docket No. FDA2008E0099; Docket No.
FDA2008E0204]

Determination of Regulatory Review Period for Purposes of Patent
Extension; MACROPLASTIQUE IMPLANTS

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) has determined the
regulatory review period for MACROPLASTIQUE IMPLANTS and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of Patents and Trademarks, Department of Commerce, for the extension of
patents which claim that medical device.

ADDRESSES:  Submit written comments and petitions to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:  Beverly Friedman, Office of
Regulatory Policy, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 6222, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Public Law 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of Patents and Trademarks may award (half
the testing phase must be subtracted as well as any time that may have
occurred before the patent was issued), FDA's determination of the
length of a regulatory review period for a medical device will include
all of the testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
    FDA recently approved for marketing the medical device
MACROPLASTIQUE IMPLANTS. MACROPLASTIQUE IMPLANTS are indicated for
transurethral injection in the treatment of adult women diagnosed with
stress urinary incontinence (SUI) primarily due to intrinsic sphincter
deficiency (ISD). Subsequent to this approval, the Patent and Trademark
Office received patent term restoration applications for MACROPLASTIQUE
IMPLANTS (U.S. Patent Nos. 5,258,028;. 5,336,263; and 5,571,182) from
Uroplasty, Inc., and the Patent and Trademark Office requested FDA's
assistance in determining these patents' eligibilities for patent term
restoration. In a letter dated May 6, 2008, FDA advised the Patent and
Trademark Office that this medical device had undergone a regulatory
review period and that the approval of MACROPLASTIQUE IMPLANTS
represented the first permitted commercial marketing or use of the
product. Thereafter, the Patent and Trademark Office requested that FDA
determine the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for
MACROPLASTIQUE IMPLANTS is 2,651 days. Of this time, 1,973 days
occurred during the testing phase of the

regulatory review period, while 678 days occurred during the approval
phase. These periods of time were derived from the following dates:
    1. The date an exemption under section 520(g) of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(g)) involving this
device became effective: July 30, 1999. The applicant claims that the
investigational device exemption (IDE) required under section 520(g) of
the act for human tests to begin became effective on June 30, 1999.
However, FDA records indicate that the IDE was determined substantially
complete for clinical studies to have begun on July 30, 1999, which
represents the IDE effective date.
    2. The date an application was initially submitted with respect to
the device under section 515 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360e): December 22, 2004. The applicant claims December
21, 2004, as the date the premarket approval application (PMA) for
MACROPLASTIQUE IMPLANTS (PMA P040050) was initially submitted. However,
FDA records indicate that PMA P040050 was submitted on December 22,
2004.
    3. The date the application was approved: October 30, 2006. FDA has
verified the applicant's claim that PMA P040050 was approved on October
30, 2006.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 1,640 days of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) written or electronic comments and ask for a redetermination
by April 13, 2009. Furthermore, any interested person may petition FDA
for a determination regarding whether the applicant for extension acted
with due diligence during the regulatory review period by August 10,
2009. To meet its burden, the petition must contain sufficient facts to
merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d
sess., pp. 41-42, 1984.) Petitions should be in the format specified in
21 CFR 10.30.
    Comments and petitions should be submitted to the Division of
Dockets Management. Three copies of any mailed information are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Comments and petitions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

    Dated: January 17, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E9-2903 Filed 2-10-09; 8:45 am]

BILLING CODE 4160-01-S