[Federal Register: November 9, 2005 (Volume 70, Number 216)]
[Notices]
[Page 68116-68118]
[DOCID:fr09no05-116]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 27141; 812-13216]

Frank Russell Investment Management Company, et al.; Notice of
Application

November 3, 2005.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of an application under section 6(c) of the Investment
Company Act of 1940 (``Act'') for an exemption from section 15(a) of
the Act and rule 18f-2 under the Act, as well as certain disclosure
requirements.

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    Summary of Application: Applicants request an order that would
permit them to enter into and materially amend subadvisory agreements
without shareholder approval and would grant relief from certain
disclosure requirements.
    Applicants: Frank Russell Investment Management Company
(``FRIMCo'') and Steward Funds, Inc. (the ``Company'').
    Filing Dates: The application was filed on July 20, 2005, and
amended on November 2, 2005.
    Hearing or Notification of Hearing: An order granting the
application will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by writing to the Commission's
Secretary and serving applicants with a copy of the request, personally
or by mail. Hearing requests should be received by the Commission by
5:30 p.m. on November 28, 2005, and should be accompanied by proof of
service on applicants, in the form of an affidavit or, for lawyers, a
certificate of service. Hearing requests should state the nature of the
writer's interest, the reason for the request, and the issues
contested. Persons who wish to be notified of a hearing may request
notification by writing to the Commission's Secretary.

ADDRESSES: Secretary, U.S. Securities and Exchange Commission, 100 F
St., NE., Washington, DC 20549-9303; Applicants, Gregory J. Lyons,
Esq., Frank Russell Company, 909 A Street, Tacoma, Washington 98402.

FOR FURTHER INFORMATION CONTACT: Marilyn Mann, Senior Counsel, at (202)
551-6813, or Nadya B. Roytblat, Assistant Director, at<PHONE_NUMBER>
(Division of Investment Management, Office of Investment Company
Regulation).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained for a fee at the
Commission's Public Reference Desk, 100 F St., NE., Washington, DC
20549-0102 (telephone<PHONE_NUMBER>).

Applicants' Representations

    1. The Company is organized as a Maryland corporation and is
registered under the Act as an open-end management investment company.
The Company has two operating series, neither of which will be operated
pursuant to the application. An amendment to the Company's registration
statement on Form N-1A to register shares of a third series, the
Steward Multi-Manager Equity Fund (the ``Existing Fund''), has been
filed with the Commission. When the registration statement is declared
effective, the Existing Fund will implement the manager-of-managers
structure as described in the application. Applicants also request
relief for any future series of the Company that is advised by FRIMCo
that uses the manager-of-managers arrangement described in the
application (each such series, together with the Existing Fund, a
``Fund'').\1\
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    \1\ All existing entities that currently intend to rely on the
order are named as applicants. Any entity that relies on the order
in the future will do so only in accordance with the terms and
conditions of the application. If the name of any Fund contains the
name of a Money Manager (as defined below), the name of FRIMCo
(e.g., ``Frank Russell''), or the name of an entity controlling,
controlled by, or under common control with FRIMCo that serves as
the primary adviser to the Fund, will precede the name of the Money
Manager.
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    2. FRIMCo is registered as an investment adviser under the
Investment Advisers Act of 1940 (the ``Advisers Act'') and will serve
as investment adviser to the Existing Fund pursuant to an investment
advisory agreement (``Advisory Agreement'') with the Existing Fund. The
Advisory Agreement has been approved by the Existing Fund's board of
directors (``Board''), including a majority of the directors who are
not ``interested persons,'' as defined in section 2(a)(19) of the Act,
of the Existing Fund or FRIMCo (the ``Independent Directors''), as well
as by the sole initial shareholder of the Existing Fund.
    3. Under the terms of the Advisory Agreement, FRIMCo will provide

investment advisory services to the Existing Fund, supervise the
investment program for the Existing Fund, and has the authority,
subject to Board approval, to enter into investment subadvisory
agreements (``Portfolio Management Agreements'') with one or more
subadvisers (``Money Managers''). Each Money Manager is registered
under the Advisers Act. FRIMCo will monitor and evaluate the Money
Managers and recommend to the Board their hiring, retention or
termination. Money Managers recommended to the Board by FRIMCo are
selected and approved by the Board, including a majority of the
Independent Directors. Each Money Manager has discretionary authority
to invest the assets or a portion of the assets of the Existing Fund.
FRIMCo compensates each Money Manager out of the fees paid to FRIMCo
under the Advisory Agreement.
    4. Applicants request an order that would (a) permit FRIMCo to hire
Money Managers and materially amend Portfolio Management Agreements
without obtaining shareholder approval and (b) grant relief from
certain disclosure requirements concerning fees paid to the Money
Managers. The requested relief will not extend to any Money Manager
that is an affiliated person, as defined in section 2(a)(3) of the Act,
of a Fund or FRIMCo, other than by reason of serving as a Money Manager
to one or more of the Funds (``Affiliated Money Manager'').
    5. An exemption is requested to permit a Fund to disclose (as both
a dollar amount and as a percentage of the Fund's net assets): (a) The
aggregate fees paid to FRIMCo and any Affiliated Money Managers; and
(b) the aggregate fees paid to Money Managers other than Affiliated
Money Managers (``Aggregate Fee Disclosure''). For any Fund that
employs an Affiliated Money Manager, the Fund will provide separate
disclosure of any fees paid to the Affiliated Money Manager.

Applicants' Legal Analysis

    1. Section 15(a) of the Act provides, in relevant part, that it is
unlawful for any person to act as an investment adviser to a registered
investment company except under a written contract that has been
approved by the vote of a majority of the company's outstanding voting
securities. Rule 18f-2 under the Act provides that each series or class
of stock in a series company affected by a matter must approve such
matter if the Act requires shareholder approval.
    2. Form N-1A is the registration statement used by open-end
investment companies. Item 14(a)(3) of Form N-1A requires disclosure of
the method and amount of the investment adviser's compensation.
    3. Rule 20a-1 under the Act requires proxies solicited with respect
to an investment company to comply with Schedule 14A under the
Securities Exchange Act of 1934 (``1934 Act''). Items 22(c)(1)(ii),
22(c)(1)(iii), 22(c)(8) and 22(c)(9) of Schedule 14A, taken together,
require a proxy statement for a shareholder meeting at which the
advisory contract will be voted upon to include the ``rate of
compensation of the investment adviser,'' the ``aggregate amount of the
investment adviser's fees,'' a description of the ``terms of the
contract to be acted upon,'' and, if a change in the advisory fee is
proposed, the existing and proposed fees and the difference between the
two fees.
    4. Form N-SAR is the semi-annual report filed with the Commission
by registered investment companies. Item 48 of Form N-SAR requires
investment companies to disclose the rate schedule for fees paid to
their investment advisers, including the Money Managers.
    5. Regulation S-X sets forth the requirements for financial
statements required to be included as part of investment company
registration statements and shareholder reports filed with the
Commission. Sections 6-07(2)(a), (b), and (c) of Regulation S-X require
that investment companies include in their financial statements
information about investment advisory fees.
    6. Section 6(c) of the Act provides that the Commission may exempt
any person, security, or transaction or any class or classes of
persons, securities, or transactions from any provisions of the Act, or
from any rule thereunder, if such exemption is necessary or appropriate
in the public interest and consistent with the protection of investors
and the purposes fairly intended by the policy and provisions of the
Act. Applicants state that their requested relief meets this standard
for the reasons discussed below.
    7. Applicants assert that the shareholders are relying on FRIMCo's
experience to select one or more Money Managers best suited to achieve
a Fund's investment objectives. Applicants assert that, from the
perspective of an investor in the Fund, the role of the Money Managers
is comparable to that of the individual portfolio managers employed by
traditional investment company advisory firms. Applicants state that
requiring shareholder approval of each Portfolio Management Agreement
would impose costs and unnecessary delays on the Funds, and may
preclude FRIMCo from acting promptly in a manner considered advisable
by the Board. Applicants note that the Advisory Agreement and any
Portfolio Management Agreement with an Affiliated Money Manager will
remain subject to section 15(a) of the Act and rule 18f-2 under the
Act.
    8. Applicants assert that some Money Managers use a ``posted'' rate
schedule to set their fees. Applicants state that while Money Managers
are willing to negotiate fees that are lower than those posted on the
schedule, they are reluctant to do so where the fees are disclosed to
other prospective and existing customers. Applicants submit that the
requested relief would allow FRIMCo to negotiate more effectively with
each individual Money Manager.

Applicants' Conditions

    Applicants agree that any order granting the requested relief will
be subject to the following conditions:
    1. Before a Fund may rely on the order requested in the
application, the operation of the Fund in the manner described in the
application will be approved by a majority of the Fund's outstanding
voting securities, as defined in the 1940 Act, or, in the case of a
Fund whose public shareholders purchase shares on the basis of a
prospectus containing the disclosure contemplated by condition 2 below,
by the sole initial shareholder before offering the Fund's shares to
the public.
    2. The prospectus for each Fund will disclose the existence,
substance, and effect of any order granted pursuant to the application.
Each Fund will hold itself out to the public as employing the
management structure described in the application. The prospectus will
prominently disclose that FRIMCo has ultimate responsibility (subject
to oversight by the Board) to oversee the Money Managers and recommend
their hiring, termination, and replacement.
    3. Within 90 days of the hiring of a new Money Manager, the
affected Fund shareholders will be furnished all information about the
new Money Manager that would be included in a proxy statement, except
as modified to permit Aggregate Fee Disclosure. This information will
include Aggregate Fee Disclosure and any change in such disclosure
caused by the addition of the new Money Manager. To meet this
obligation, the Fund will provide shareholders within 90 days of the
hiring of a new Money Manager with an information statement meeting the
requirements of Regulation 14C, Schedule 14C and Item 22 of Schedule
14A under the 1934 Act, except as

modified by the order to permit Aggregate Fee Disclosure.
    4. FRIMCo will not enter into a Portfolio Management Agreement with
any Affiliated Money Manager without that agreement, including the
compensation to be paid thereunder, being approved by Fund
shareholders.
    5. The Board of each Fund will satisfy the fund governance
standards as defined in rule 0-1(a)(7) under the Act by the compliance
date for the rule (``Compliance Date''). Prior to the Compliance Date,
a majority of the Board will be Independent Directors, and the
nomination of new or additional Independent Directors will be at the
discretion of the then existing Independent Directors.
    6. When a Money Manager change is proposed for a Fund with an
Affiliated Money Manager, the Board, including a majority of the
Independent Directors, will make a separate finding, reflected in the
applicable Board minutes, that such change is in the best interests of
the Fund and its shareholders and does not involve a conflict of
interest from which FRIMCo or the Affiliated Money Manager derives an
inappropriate advantage.
    7. Independent legal counsel, as defined in rule 0-1(a)(6) under
the Act, will be engaged to represent the Independent Directors. The
selection of such counsel will be within the discretion of the then
existing Independent Directors.
    8. FRIMCo will provide the Board, no less frequently than
quarterly, with information about the profitability of FRIMCo on a per-
Fund basis. The information will reflect the impact on profitability of
the hiring or termination of any Money Manager during the applicable
quarter.
    9. Whenever a Money Manager is hired or terminated, FRIMCo will
provide the Board with information showing the expected impact on the
profitability of FRIMCo.
    10. FRIMCo will provide general investment management services to
each Fund, including overall supervisory responsibility for the general
management and investment of the Fund's assets, and, subject to review
and approval of the Board, will: (i) Set each Fund's overall investment
strategies, (ii) evaluate, select and recommend Money Managers to
manage all or a part of a Fund's assets, (iii) when appropriate,
allocate and reallocate a Fund's assets among multiple Money Managers,
(iv) monitor and evaluate the performance of Money Managers, and (v)
implement procedures reasonably designed to ensure that the Money
Managers comply with each Fund's investment objective, policies and
restrictions.
    11. No director or officer of a Fund, or director or officer of
FRIMCo, will own directly or indirectly (other than through a pooled
investment vehicle that is not controlled by such person) any interest
in a Money Manager, except for (a) ownership of interests in FRIMCo or
any entity that controls, is controlled by, or is under common control
with FRIMCo, or (b) ownership of less than 1% of the outstanding
securities of any class of equity or debt of a publicly traded company
that is either a Money Manager or an entity that controls, is
controlled by or is under common control with a Money Manager.
    12. Each Fund will disclose in its registration statement the
Aggregate Fee Disclosure.
    13. The requested order will expire on the effective date of rule
15a-5 under the Act, if adopted.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Jonathan G. Katz,
Secretary.
[FR Doc. 05-22332 Filed 11-8-05; 8:45 am]

BILLING CODE 8010-01-P


A statement that the results have been transmitted directly to the MDOR, and that the paper VIR may not be used for vehicle registration purposes; and

                         The statement: "This inspection is mandated by your United States Congress."

             The reciprocity waiver windshield sticker shall --  meet the same criteria as listed in paragraph (4)(A)2. of this rule.

                         Be affixed on the inside of the vehicle's front windshield in the lower left-hand corner by the motorist. A waiver indicator shall be clearly visible on the sticker. Previous windshield stickers affixed to the windshield shall be removed;

                         Be as fraud resistant as required by the contract between the department and the contractor;

                         Be valid until the next emissions inspection is required as defined in subsection (3)(B) of this rule; and

                         Contain the statement: "This inspection is mandated by your United States Congress."
             Mileage-Based Emissions-Exempt Vehicles. The VIR for the mileage- based emissions-exempt vehicle shall include:

                   A vehicle description, including the license plate number at the time of inspection, VIN, vehicle make, vehicle model, vehicle model year, fuel type, GVWR range, odometer reading at the time of the most recent safety inspection by a motor vehicle service station registered with the Missouri Secretary of State or an odometer reading verified by the department, county of registration, and the complete mailing address (street address, city, and zip code) of the vehicle owner;

                   The date that the exemption is applied for and/or the date and time that the exemption was issued;

                   The unique identification number of the licensed emissions inspector performing the safety inspection, the unique identification number and location of the inspection station, and the unique identification number of the inspection equipment;

                   The type of mileage exemption, as described in paragraphs (1)(B)7. and (1)(B)8. of this rule;

                   A statement that the results have been transmitted directly to the MDOR, and that the paper VIR may not be used for vehicle registration purposes; and

                   The statement: "This inspection is mandated by your United States Congress."

             GVWR-Based Emissions-Exempt Vehicles. The VIR for the GVWR-based emissions-exempt vehicle shall include:

                   A vehicle description, including the license plate number at the time of inspection, VIN, vehicle make, vehicle model, vehicle model year, fuel type, GVWR range, odometer reading at the time of the most recent safety inspection, county of registration, and the complete mailing address (street address, city, and zip code) of the vehicle owner;

                   The date and time of the vehicle's safety inspection during which the licensed inspector verified that the vehicle had a GVWR in excess of eight thousand five hundred pounds (8,500 lbs.);

                   The unique identification number of the licensed emissions inspector performing the safety inspection, the unique identification number and location of the inspection station, and the unique identification number of the inspection equipment;

             The GVWR exemption determination;
                   A statement that the results have been transmitted directly to the MDOR, and that the paper VIR may not be used for vehicle registration purposes; and

                   The statement: "This inspection is mandated by your United States Congress."

  Out-of-Area Emissions-Exempt Vehicles. The out-of-area waiver VIR shall include:

             A vehicle description, including the license plate number at the time of inspection, VIN, vehicle make, vehicle model, vehicle model year, fuel type, county of registration, and the complete name and address of the vehicle owner;

       The date and time that the out-of-area exemption is issued;

             The unique identification number of the department staff person issuing the out-of-area waiver, the location of the department staff person, and the unique identification number of the inspection equipment used to issue the out-of-area waiver;

       The county where the vehicle is being operated;

             A statement that the results have been transmitted directly to the MDOR, and that the paper VIR may not be used for vehicle registration purposes; and

             The statement: "This inspection is mandated by your United States Congress."

             Aborted Emissions Inspections. The aborted emissions VIR shall include:

                   A vehicle description, including the license plate number at the time of inspection, VIN, vehicle make, vehicle model, vehicle model year, fuel type, GVWR range, odometer reading at the time of the most recent safety inspection, county of registration, and the complete mailing address (street address, city, and zip code) of the vehicle owner;

                   The date and time that the vehicle's emissions inspection was aborted;

                   The unique identification number of the licensed emissions inspector performing the emissions inspection, the unique identification number and location of the inspection station, and the unique identification number of the inspection equipment;
             The aborted test result; and

                   The statement: "This inspection is mandated by your United States Congress."

             Beginning January 1, 2008, using a method provided by the contractor, federal, state, and local government agencies shall submit a list of vehicles, by VIN, that are operated by the government agencies and that are required to be inspected during each calendar year. Submittals are due by February 1 of each calendar year. If the first is not a business day or is a state holiday, the list shall be submitted to the contractor by the following business day. The contractor will audit these submittals by comparing the list of submitted vehicles to the database of inspected vehicles to track government fleet  public entity compliance. The contractor shall provide the department with the results of this audit by April 1 of each calendar year.

The EPA's Analysis of the Changes to Reporting and Record Keeping: Missouri updated the reference to 40 CFR 85.2223 to the latest version.
      The words "or estimate" were added because Missouri does issue both cost and estimate based waivers.
      The requirements for windshield stickers in paragraphs (4)(F)2. and (4)(I)2 were replaced with a reference to the same requirements in paragraph (4)(A)2.
      	The reference to the safety inspections was removed since safety inspections have been changed to start at the tenth year. The odometer reading will now be verified by registered service station or the department.
	Missouri replaced "government fleet" with "public entity" to clarify the meaning. The State has used "public entity" when referring to government agencies in other part of the rule.
Item 17: Test Methods
 Test Methods.

             To the extent possible, an OBD test as defined in 10 CSR 10-6.020        and the contract, shall be performed on all 1996 and later model year light duty vehicles and light duty trucks powered by gasoline and all 1997 and later model year light duty vehicles and light duty trucks powered by diesel.

             The OBD test shall follow the procedures described in 40 CFR 85.2222, which is incorporated by reference in this rule, as published by the EPA, Office of Transportation and Air Quality, 2000 Traverwood, Ann Arbor, MI 48105 on April 5, 2001. The provisions of 40 CFR 85.2222 as promulgated by the EPA on April 28, 2014, are hereby incorporated by reference in this rule, as published by the U.S. Government Publishing Office available at https://bookstore.gpo.gov/ or for mail orders print and fill out order form online and mail to: U.S. Government Publishing Office, PO Box 979050, St. Louis, MO 63197-9000. This rule does not incorporate any subsequent amendments or additions to 40 CFR 85.2222.

                   If the subject vehicle cannot be tested with the OBD test due to manufacturer design, then the subject vehicle shall be tested with only a bulb check test described in paragraph (5)(B)2. of this rule.

             Bulb check test.

                         Vehicles will fail the bulb check portion of the OBD test if the MIL is not illuminated while the key is in the on position and the engine is off (KOEO).

                         Vehicles will fail the bulb check portion of the OBD test if the MIL is illuminated while the key is in the on position and the engine is running (KOER).

                         Vehicles with keyless ignitions shall be subject to a bulb check test.
                         Vehicles that fail the KOEO bulb check portion of the OBD test described in subparagraph (5)(B)2.A. of this rule shall fail the OBD test. Repairs made to correct bulb check failures shall not be eligible for cost-based or estimate-based waivers

             Data link connector and communications tests.

                         Data link connector test. Vehicles will fail the data link connector portion of the OBD test if the DLC is inaccessible due to manufacturer design, tampered with, blocked, or not located where the manufacturer located the DLC. The emissions inspector shall determine and record the reason for this failure in the MDAS for printing on the emissions VIR.

                         Communications test. Vehicles will fail the communications portion of the OBD test if the vehicle does not maintain sufficient voltage to the DLC during OBD communication or transmit the necessary information to the inspection equipment after three (3) thirty (30) second attempts.

                               If the vehicle does not communicate after two (2) thirty- (30-)second communication attempts, inspectors shall verify  that a valid communications failure exists by the communication failure according to the lane software procedures using the MDAS OBD verification tool to verify the communication failure according to the lane software procedures.

                               If the OBD verification tool determines that the equipment is not capable of communicating with the vehicle, the MDAS shall automatically abort the OBD test and generate the emissions VIR described in subsection (4)(K) of this rule.

                               If the verification tool determines that the equipment is capable of communicating with the vehicle, inspectors shall make one (1) additional thirty (30) second communication attempt. If the vehicle does not communicate with the MDAS, the MDAS shall determine and record the reason for this failure and print this reason on the emissions VIR.

                         Vehicles that fail the DLC or communications portion of the OBD test shall fail the OBD test.

                         Repairs made to correct failures for DLCs that have been tampered with, rendered inoperative, or removed, or failures for OBD communications as described in subparagraphs (5)(B)3.A. and (5)(B)3.B. of this rule, shall not be eligible for cost-based or estimate-based waivers.
             Readiness monitor test.

                         1996 - 2000 model year gasoline-powered vehicles may pass the readiness monitor portion of the OBD test if they have no more than two (2) unset non-continuous readiness monitors.

                         2001 and newer model year gasoline-powered vehicles may pass the readiness monitor portion of the test if they have no more than one (1) unset non-continuous readiness monitor.

                         Gasoline-powered vehicles that fail the OBD test with a catalytic converter DTC (P0420 - P0439) present must have the catalyst monitor reset to pass the readiness monitor portion of the OBD retest.

                         Gasoline-powered vehicles will fail the readiness monitor portion of the OBD test if the following non-continuous monitors are not supported:

                         Oxygen sensor; and

                         Catalyst.

                         Vehicles that are on the readiness exemption table maintained by the contractor and authorized by the department shall be exempt from the readiness monitor portion of the OBD test.

                         Vehicles that fail the readiness monitor portion of the OBD test shall fail the OBD test. Vehicles must pass the readiness monitor portion of the OBD test to be eligible for a cost-based or estimate-based waiver.

                         Repairs made to correct failures for readiness monitor tampering caused by the installation of aftermarket components shall not be eligible for cost-based or estimate-based waivers.

             Diagnostic trouble code test.

                         Vehicles will fail the diagnostic trouble code test if the OBD system has stored at least one (1) mature (non-pending, non- historic) DTC that commands the MIL to be illuminated.

                         Vehicles will fail the diagnostic trouble code test if the vehicle commands the MIL to be illuminated but the OBD system has no mature (non-pending, non-historic) DTCs stored in the system.
                         The contractor shall ensure that their inspection equipment's request for DTCs does not cause the MIL to be illuminated.

                         Vehicles that fail the DTC portion of the OBD test shall fail the OBD test.

             If the subject vehicle passes the OBD test according to the OBD test standards specified in subsection (3)(I) of this rule and all of the OBD test procedures described in section (5) of this rule, then the procedures in paragraph (3)(H)3. of this rule shall be followed.

             If the subject vehicle fails the OBD test according to the OBD test standards specified in subsection (3)(I) of this rule or any of the OBD test procedures described in section (5) of this rule, then the procedures in paragraphs (3)(H)6., (3)(H)7., and (3)(J)2. of this rule shall be followed.

The EPA's Analysis of the Changes to Reporting and Record Keeping: Missouri removed references to the general definition rule, 10 CSR 10-6.020, since all the definitions have been moved to this rule.
      Missouri updated the reference to 40 CFR 85.2222 to the latest version.
	Paragraph (5)(B)3.B.(I) has been clarified.
Response to Comments
Missouri received four comments on the 2021 public notice, all from EPA. Missouri revised the exemption language in response to those comments. Missouri also changed the language in 10 CSR 10-5.381 (3)(k)5. Missouri explained why 10 CSR 10-5.381(3)(L)2. and 3. are not needed. Missouri did not change the end date to Franklin County I/M. If our final approval of this action is after the date in the rule, then I/M would be Federally required but not state-required for a time. EPA does not believe this is an approvability issue.
Missouri received ten comments on the 2019 public notice. One comment from a retail association was supportive. One comment from a real estate firm was not supportive. Missouri adequately responded.
The remaining comments were from the EPA. The EPA commented that our original 2015 Ozone designations were being litigated and a change to Jefferson County's designation could be an approval issue. Since that time, Jefferson County's designation was changed to nonattainment and become final. As a result of EPA's comment, Missouri revised the rule to only exempt Franklin County. Further in a December 6, 2021, letter, Missouri requested EPA to only act on the Franklin County portion of the 2019 SIP submittal. This adequately addresses this comment.
The EPA commented that a "bump up" or reclassification of the nonattainment status to Moderate would trigger 40 CFR 51.350(a)(4) which requires I/M in the 1990 urbanized area. Since Franklin County is not included in the 1990 urbanized area for St. Louis, any change in nonattainment status or classification will not trigger 40 CFR 51.350(a)(4) for Franklin County.
The EPA commented that in order to approve the SIP revision, the revised implementation rule, 10 CSR 10-5.381 must be included. Missouri has revised the implementation rule and will submit the rule prior to our final approval.
The EPA commented that Missouri needed to analyze the emission impacts of ending the I/M program in Franklin and Jefferson County. As described above, Missouri completed the analysis using the EPA modeling program MOVES2014. The summary of those results for Franklin County are shown above and the whole data set is available on request. Please contact Jed Wolkins,<PHONE_NUMBER><EMAIL_ADDRESS>
The EPA commented that Missouri needed to provide supplemental controls for the emissions increases resulting from I/M removal in Boles Township. As described above, in the March 2, 2022, submittal, the State provided the supplemental controls and EPA proposes to find they are satisfactory.
The EPA commented that Missouri needed to consider Regional Haze. Missouri reviewed the reductions from the I/M program and emissions from the entire state. The reductions from the I/M program are a very small fraction, under a tenth of a precent, of state-wide emissions. The State is currently working on its second round Regional Haze SIP. EPA believes given the small percentage of statewide emissions along with the use of supplemental controls for Boles township that this potential concern has been adequately addressed with the narrative provided by Missouri.
The EPA commented about possible discrepancies in Appendix 3. Missouri explained the issue was they also had conducted modeling for removing the Reformulated Fuel Standard and included all the modeling results. Missouri was working to remove I/M and the Reformulated Fuel Standard from their PM and Ozone Maintenance Plan. EPA believes this clarified the reason for the perceived discrepancies in Appendix 3.
The EPA commented that we had received the MOVES modeling files and were still in the process of reviewing them. As described above, EPA has reviewed the modeling files and believes the modeling supports the current action.

                             Record of Rulemaking
                   Missouri Department of Natural Resources
Public Hearing
December 2, 2021
Effective date of regulations
May 30, 2022
First SIP package received by EPA
November 12, 2019
Clarification for not acting on Jefferson County
December 9, 2021
Parallel Processing Request and Additional Submittal
March 2, 2022
Final State Submittal
TBD


[Federal Register Volume 78, Number 62 (Monday, April 1, 2013)]
[Notices]
[Pages 19505-19506]
[FR Doc No: 2013-07531]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[USCG-2010-0164]

National Boating Safety Advisory Council

AGENCY: Coast Guard, DHS.

ACTION: Notice of teleconference meeting.

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SUMMARY: The Strategic Planning Subcommittee of the National Boating
Safety Advisory Council (NBSAC) will meet via teleconference and online
webinar to discuss issues related to the strategic plan of the national
recreational boating safety program. This teleconference meeting will
be open to the public.

DATES: The teleconference/webinar meeting will take place on Thursday,

April 25, 2013, from 1 p.m. to 3 p.m. EST. This meeting may end early
if all business is finished before 3 p.m. If you wish to make oral
comments at the teleconference, simply notify Mr. Jeff Ludwig before
the meeting, as specified in the ADDRESSES section, or the designated
Coast Guard staff at the meeting. If you wish to submit written
comments or make a presentation, submit your comments or request to
make a presentation by April 19, 2013.

ADDRESSES: The Subcommittee will meet via teleconference and online
webinar. To participate by phone and view the webinar, contact the
Alternate Designated Federal Officer (ADFO) listed below in the FOR
FURTHER INFORMATION CONTACT section to obtain teleconference/webinar
information. Note the number of teleconference lines is limited and
will be available on a first-come, first-served basis. To join those
participating in this teleconference from U.S. Coast Guard
Headquarters, come to Room 5-0624, U.S. Coast Guard Headquarters
Building, 2100 Second Street SW., Washington, DC 20593. You must
present a valid, government-issued photo identification to gain
entrance to the Coast Guard Headquarters building.
    If you want to make a presentation, send your request by April 19,
2013, to Mr. Jeff Ludwig, NBSAC ADFO, telephone<PHONE_NUMBER>,
Commandant (CG-BSX-2), 2100 Second Street SW Stop 7581, Washington, DC
20593-7581 or by fax to<PHONE_NUMBER>. To facilitate public
participation we are inviting public comment on the issues to be
considered by the committee as listed in the ``Agenda'' section below.
You may submit a written comment on or before April 19, 2013 or make an
oral comment during the public comment portion of the meeting.
    To submit a comment in writing, use one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov
    Follow the instructions for submitting comments.
     Email<EMAIL_ADDRESS>Include the docket
number (USCG-2010-0164) on the subject line of the message.
     Fax:<PHONE_NUMBER> Include the docket number (USCG-2010-
0164) on the subject line of the fax.
     Mail: Docket Management Facility (M-30), U.S. Department
of Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: Same as mail address above, between 9 a.m.
and 5 p.m., Monday through Friday, except Federal holidays. The
telephone number is<PHONE_NUMBER>.
    Instructions: Include the words ``Department of Homeland Security''
and the docket number of this notice in your submission. All comments
submitted will be posted on www.regulations.gov without alteration and
will contain personal information you provided. You may review a
Privacy Act notice regarding our public dockets in the January 17,
2008, issue of the Federal Register (73 FR 3316).
    Docket: For access to the docket to read documents or comments
related to this NBSAC meeting, go to www.regulations.gov, insert
``USCG-2010-0164'' in the ``Search'' box and then click ``Search.''

FOR FURTHER INFORMATION CONTACT: Mr. Jeff Ludwig, USCG, NBSAC ADFO,
telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>If you have
any questions on viewing or submitting material to the docket, call
Barbara Hairston, Program Manager, Docket Operations, telephone 202-
366-9826.

SUPPLEMENTARY INFORMATION: We are publishing this meeting notice under
provisions of the Federal Advisory Committee Act (FACA), 5 U.S.C.
Appendix. NBSAC provides advice and recommendations to the Department
of Homeland Security on matters relating to recreational boating
safety. See 33 U.S.C. 13110.

Agenda of Meeting

    The agenda for April 25, 2013 includes:
    (1) Discussion of progress made on the objectives and strategies of
the 2012-2016 national recreational boating safety program strategic
plan.
    (2) Public comment.
    A final agenda will be available on http://homeport.uscg.mil/NBSAC
NLT April 11, 2013.

Public Participation

    We have scheduled the last fifteen minutes of the meeting, from
2:45 to 3 p.m., for oral comments from the public. If you wish to make
an oral comment, please contact Mr. Jeff Ludwig, listed in the FOR
FURTHER INFORMATION CONTACT section, either before the meeting or at
the meeting when the members of the audience are requested to state
their interest in commenting. We request that you limit your oral
comments to 3 minutes. Please note that this public comment period may
start before 2:45 p.m. if all other agenda items have been covered and
may end before 3 p.m. if all of those wishing to comment have done so.
    For information on facilities or services for individuals with
disabilities or to request special assistance at the teleconference,
please contact the individuals listed in the FOR FURTHER INFORMATION
CONTACT section, as soon as possible.

    Dated: March 26, 2013.
David S. Fish,
Captain, U.S. Coast Guard, Acting Director of Inspections and
Compliance.
[FR Doc. 2013-07531 Filed 3-29-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 202 (Thursday, October 18, 2018)] [Rules and Regulations] [Pages 52754-52756] [FR Doc No: 2018-22148]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0586; Product Identifier 2017-NM-151-AD; Amendment

39-19445; AD 2018-20-11]

RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc., Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of

Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain

Bombardier, Inc., Model DHC-8-300 series airplanes. This AD was

prompted by reports indicating that a certain emergency exit door could

not be opened during maintenance. This AD requires a detailed

inspection of the ball bearings of an emergency exit, replacement of

bearings if necessary, application of corrosion inhibiting compound

(CIC), and revision of the maintenance or inspection program, as

applicable. We are issuing this AD to address the unsafe condition on

these products.

DATES: This AD is effective November 23, 2018.

    The Director of the Federal Register approved the incorporation by

reference of certain publications listed in this AD as of November 23,

2018.

ADDRESSES: For service information identified in this final rule,

contact Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt

Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone<PHONE_NUMBER>;

fax<PHONE_NUMBER>; email [email protected]; internet

http://www.bombardier.com. You may view this service information at the

FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA.

For information on the availability of this material at the FAA, call

206-231-3195. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-

0586.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-

0586; or in person at Docket Operations between 9 a.m. and 5 p.m.,

Monday through Friday, except Federal holidays. The AD docket contains

this final rule, the regulatory evaluation, any comments received, and

other information. The address for Docket Operations (phone: 800-647-

5527) is U.S. Department of Transportation, Docket Operations, M-30,

West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE,

Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Darren Gassetto, Aerospace Engineer,

Airframe and Propulsion Section, FAA, New York ACO Branch, 1600 Stewart

Avenue, Suite 410, Westbury, NY 11590; telephone<PHONE_NUMBER>; fax 516-

794-5531; email [email protected].

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR

part 39 by adding an AD that would apply to certain Bombardier, Inc.,

Model DHC-8-300 series airplanes. The NPRM published in the Federal

Register on July 6, 2018 (83 FR 31496). The NPRM was prompted by

reports indicating that a certain emergency exit door could not be

opened during maintenance. The NPRM proposed to require a detailed

inspection of the ball bearings of an emergency exit, replacement of

bearings if necessary, application of CIC, and revision of the

maintenance or inspection program, as applicable.

    We are issuing this AD to address corrosion of the emergency exit

door ball bearings, which could result in the inability to open the

emergency exit door during an emergency evacuation and consequently

impede airplane egress.

    Transport Canada Civil Aviation (TCCA), which is the aviation

authority for Canada, has issued Canadian Airworthiness Directive CF-

2017-30, dated August 30, 2017 (referred to after this as the Mandatory

Continuing Airworthiness Information, or ``the MCAI''), to correct an

unsafe condition for certain Bombardier, Inc., Model DHC-8-300 series

airplanes. The MCAI states:

    An operator has reported the inability to open the Forward Right

Hand Type I emergency exit door with either the internal or external

handle during maintenance. Investigation has determined that the

handle was found to be jammed due to corroded center and lower shaft

ball bearings. Condensation has been found to be the root cause of

the Forward Right Hand Type I emergency exit door hardware

corrosion. Other Forward Right Hand Type I emergency exit door ball

bearings are also susceptible to corrosion. Inability to open the

Forward Right Hand Type I emergency exit door during an emergency

evacuation may impede aircraft egress.

    This [Canadian] AD mandates the inspection for corrosion and

replacement, as required, of all Forward Right Hand Type I emergency

exit door ball bearings, and the application of corrosion inhibiting

compound (CIC), to ensure that the Forward Right Hand Type I

emergency exit door can be opened when required.

    You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-

0586.

Comments

    We gave the public the opportunity to participate in developing

this final rule. We have considered the comment received. The Air Line

Pilots Association, International (ALPA) indicated its support for the

NPRM.

Conclusion

    We reviewed the relevant data, considered the comment received, and

determined that air safety and the public interest require adopting

this final rule as proposed, except for minor editorial changes. We

have determined that these minor changes:

     Are consistent with the intent that was proposed in the

NPRM for addressing the unsafe condition; and

     Do not add any additional burden upon the public than was

already proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    Bombardier has issued the following service information:

     Service Bulletin 8-52-65, dated July 26, 2017, which

describes procedures for a detailed inspection of the forward right-

hand type I emergency exit door ball bearings for corrosion, seal

damage, and loss of lubricant; applying CIC; and replacing emergency

exit door ball bearings if necessary.

     de Havilland Inc. Dash 8 Series 300 MaintenanceTask Card

Task Number 5220/12 (``Servicing of Forward RH Emergency Exit

Mechanisms''), dated March 15, 2017, which describes procedures for

servicing the forward right-hand emergency exit door mechanisms.

     Temporary Revision (TR) 54-042, dated April 10, 2018, to

the DHC-8-300 Aircraft Maintenance Manual (AMM), which describes

procedures for servicing the type I emergency exit door mechanisms.

    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.

Costs of Compliance

    We estimate that this AD affects 16 airplanes of U.S. registry.

    We estimate the following costs to comply with this AD:

                                      Estimated Costs for Required Actions

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

                                                                                Cost per       Cost on U.S.

                          Labor cost                              Parts cost        product         operators

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

3 work-hours x $85 per hour = $255...........................              $0             $255           $4,080

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

    We have determined that revising the maintenance or inspection

program takes an average of 90 work-hours per operator, although we

recognize that this number may vary from operator to operator. In the

past, we have estimated that this action takes 1 work-hour per

airplane. Since operators incorporate maintenance or inspection program

changes for their affected fleet(s), we have determined that a per-

operator estimate is more accurate than a per-airplane estimate.

Therefore, we estimate the total cost per operator to be $7,650 (90

work-hours x $85 per work-hour).

    We estimate the following costs to do any necessary on-condition

actions that would be required based on the results of any required

actions. We have no way of determining the number of aircraft that

might need these on-condition actions:

                 Estimated Costs of On-Condition Actions

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

                                                             Cost per

              Labor cost                   Parts cost        product

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

6 work-hours x $85 per hour = $510....            $586           $1,096

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

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.

    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 transport category airplanes and

associated appliances to the Director of the System Oversight Division.

Regulatory Findings

    This AD will not have federalism implications under Executive Order

13132. This AD will not have a substantial direct effect on the States,

on the relationship between the national government and the States, or

on the distribution of power and responsibilities among the various

levels of government.

    For the reasons discussed above, I certify that this AD:

    (1) Is not a ``significant regulatory action'' under Executive

Order 12866,

    (2) Is not a ``significant rule'' under the DOT Regulatory Policies

and Procedures (44 FR 11034, February 26, 1979),

    (3) Will not affect intrastate aviation in Alaska, and

    (4) Will not have a significant economic impact, positive or

negative, on a substantial number of small entities under the criteria

of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by

reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the

Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0

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

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

Sec.  39.13  [Amended]

0

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

directive (AD):

2018-20-11 Bombardier, Inc.: Amendment 39-19445; Docket No. FAA-

2018-0586; Product Identifier 2017-NM-151-AD.

(a) Effective Date

    This AD is effective November 23, 2018.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Bombardier, Inc., Model DHC-8-301, -311, and

-315 airplanes, certificated in any category, serial numbers 100

through 672 inclusive.

(d) Subject

    Air Transport Association (ATA) of America Code 52, Doors.

(e) Reason

    This AD was prompted by reports indicating that the forward

right-hand type I emergency exit door could not be opened during

maintenance. An investigation determined that the exit door handle

was jammed due to corroded center and lower shaft ball bearings. We

are issuing this AD to address corrosion of the emergency exit door

ball bearings, which could result in the inability to open the

emergency exit door

during an emergency evacuation and consequently impede airplane

egress.

(f) Compliance

    Comply with this AD within the compliance times specified,

unless already done.

(g) Revision of Maintenance or Inspection Program

    Within 60 days after the effective date of this AD: Revise the

maintenance or inspection program, as applicable, to incorporate de

Havilland Inc. Dash 8 Series 300 Maintenance Task Card Task Number

5220/12 (``Servicing of Forward RH Emergency Exit Mechanisms''),

dated March 15, 2017; and Temporary Revision 54-042, dated April 10,

2018, to the DHC-8-300 Aircraft Maintenance Manual (AMM). The

initial compliance time for doing the task is at the time specified

in de Havilland Inc. Dash 8 Series 300 Maintenance Task Card Task

Number 5220/12 (``Servicing of Forward RH Emergency Exit

Mechanisms''), dated March 15, 2017, or within 60 days after the

effective date of this AD, whichever occurs later.

(h) Inspection and Replacement

    Within 5,000 flight hours or 36 months, whichever occurs first,

after the effective date of this AD: Do a detailed inspection of all

ball bearings of the forward right-hand type I emergency exit for

corrosion, seal damage, and loss of lubricant; replace bearings as

applicable; and apply corrosion inhibiting compound (CIC); in

accordance with the Accomplishment Instructions of Bombardier

Service Bulletin 8-52-65, dated July 26, 2017. Do all applicable

replacements before further flight.

(i) No Alternative Actions or Intervals

    After the maintenance or inspection program has been revised as

required by paragraph (g) of this AD, no alternative actions (e.g.,

inspections) or intervals may be used unless the actions and

intervals are approved as an alternative method of compliance (AMOC)

in accordance with the procedures specified in paragraph (j)(1) of

this AD.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:

    (1) Alternative Methods of Compliance (AMOCs): The Manager, New

York ACO 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 certification

office, send it to ATTN: Program Manager, Continuing Operational

Safety, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,

Westbury, NY 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.

    (2) Contacting the Manufacturer: For any requirement in this AD

to obtain corrective actions from a manufacturer, the action must be

accomplished using a method approved by the Manager, New York ACO

Branch, FAA; or Transport Canada Civil Aviation (TCCA); or

Bombardier, Inc.'s TCCA Design Approval Organization (DAO). If

approved by the DAO, the approval must include the DAO-authorized

signature.

(k) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information

(MCAI) Canadian Airworthiness Directive CF-2017-30, dated August 30,

2017, for related information. This MCAI may be found in the AD

docket on the internet at http://www.regulations.gov by searching

for and locating Docket No. FAA-2018-0586.

    (2) For more information about this AD, contact Darren Gassetto,

Aerospace Engineer, Airframe and Propulsion Section, FAA, New York

ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590;

telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email [email protected].

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the

incorporation by reference (IBR) of the service information listed

in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.

    (2) You must use this service information as applicable to do

the actions required by this AD, unless this AD specifies otherwise.

    (i) Bombardier Service Bulletin 8-52-65, dated July 26, 2017.

    (ii) de Havilland Inc. Dash 8 Series 300 Maintenance Task Card

Task Number 5220/12 (``Servicing of Forward RH Emergency Exit

Mechanisms''), dated March 15, 2017.

    (iii) Temporary Revision (TR) 54-042, dated April 10, 2018, to

the DHC-8-300 Aircraft Maintenance Manual (AMM).

    (3) For service information identified in this AD, contact

Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt

Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone<PHONE_NUMBER>;

fax<PHONE_NUMBER>; email [email protected]; internet

http://www.bombardier.com.

    (4) You may view this service information at the FAA, Transport

Standards Branch, 2200 South 216th St., Des Moines, WA. For

information on the availability of this material at the FAA, call

206-231-3195.

    (5) You may view this service information that is incorporated

by reference at the National Archives and Records Administration

(NARA). For information on the availability of this material at

NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Des Moines, Washington, on September 20, 2018.

John P. Piccola,

Acting Director, System Oversight Division, Aircraft Certification

Service.

[FR Doc. 2018-22148 Filed 10-17-18; 8:45 am]

 BILLING CODE 4910-13-P


[Federal Register: December 22, 2009 (Volume 74, Number 244)]
[Notices]
[Page 68068-68069]
[DOCID:fr22de09-47]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0013]

International Conference on Harmonisation; Guidance on Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the
International Conference on Harmonisation Regions; Annex 8 on Sterility
Test General Chapter; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``Q4B Evaluation and Recommendation
of Pharmacopoeial Texts for Use in the ICH Regions; Annex 8: Sterility
Test General Chapter.'' The guidance was prepared under the auspices of
the International Conference on Harmonisation of Technical Requirements
for Registration of Pharmaceuticals for Human Use (ICH). The guidance
provides the results of the ICH Q4B evaluation of the Sterility Test
General Chapter harmonized text from each of the three pharmacopoeias
(United States, European, and Japanese) represented by the
Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition
of the three pharmacopoeial methods by the three ICH regulatory regions
and provides specific information regarding the recognition. The
guidance is intended to recognize the interchangeability between the
local regional pharmacopoeias, thus avoiding redundant testing in favor
of a common testing strategy in each regulatory region. In the Federal
Register of February 21, 2008 (73 FR 9575), FDA made available a
guidance on the Q4B process entitled ``Q4B Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.''

DATES: Submit written or electronic comments on agency guidance at any
time.

ADDRESSES: Submit written requests for single copies of the guidance to
the Division of Drug Information (HFD-240), Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002; or the Office of
Communication, Outreach and Development (HFM-40), Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville, MD 20852-1448. The guidance may
also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-
1800. Send two self-addressed adhesive labels to assist the office in
processing your requests. Requests and comments should be identified
with the docket number found in brackets in the heading of this
document. Submit written comments on the guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION
section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Robert H. King, Sr., Center for Drug
Evaluation and Research (HFD-003), Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 51, rm. 4150, Silver Spring, MD 20993-0002,
301-796-1242; or Christopher Joneckis, Center for Biologics Evaluation
and Research (HFM-25), Food and Drug Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD 20852-1448,<PHONE_NUMBER>.
    Regarding the ICH: Michelle Limoli, Office of International
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance harmonization and is
committed to seeking scientifically based harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for drug development among regulatory agencies.
    ICH was organized to provide an opportunity for tripartite
harmonization initiatives to be developed with input from both
regulatory and industry representatives. FDA also seeks input from
consumer representatives and others. ICH is concerned with
harmonization of technical requirements for the registration of
pharmaceutical products among three regions: The European Union, Japan,
and the United States. The six ICH sponsors are the European
Commission; the European Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of Health, Labour, and Welfare; the
Japanese Pharmaceutical Manufacturers Association; the Centers for Drug
Evaluation and Research and Biologics Evaluation and Research, FDA; and
the Pharmaceutical Research and Manufacturers of America. The ICH
Secretariat, which coordinates the preparation of documentation, is
provided by the International Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
    The ICH Steering Committee includes representatives from each of
the ICH sponsors and the IFPMA, as well as observers from the World
Health Organization, Health Canada, and the European Free Trade Area.
    In the Federal Register of February 17, 2009 (74 FR 7446), FDA
published a notice announcing the availability of a draft tripartite
guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial
Texts for Use in the ICH Regions; Annex 8: Sterility Test General
Chapter.'' The notice gave interested persons an opportunity to submit
comments by April 20, 2009.
    After consideration of the comments received and revisions to the
guidance, a final draft guidance entitled ``Q4B Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions;
Annex 8: Sterility Test General Chapter'' was submitted to the ICH
Steering Committee and endorsed by the three participating regulatory
agencies in June 2009.
    The guidance provides the specific evaluation outcome from the ICH
Q4B process for the Sterility Test General Chapter harmonization
proposal originating from the three-party PDG. This guidance is in the
form of an annex to the core ICH Q4B guidance. When implemented, the
annex will provide guidance for industry and regulators on the use of
the specific pharmacopoeial texts evaluated by the ICH Q4B process.
Following receipt of comments on the draft, no substantive changes were
made to the annex.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on this topic. It does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach

satisfies the requirements of the applicable statutes and regulations.

II. Comments

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

III. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.regulations.gov, http://www.fda.gov/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
http://www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    Dated: December 16, 2009.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning, and Budget.
[FR Doc. E9-30326 Filed 12-21-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 83, Number 200 (Tuesday, October 16, 2018)]
[Rules and Regulations]
[Pages 52135-52137]
[FR Doc No: 2018-21965]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0415; Product Identifier 2017-NM-149-AD; Amendment
39-19466; AD 2018-21-08]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for all The
Boeing Company Model 737-100, -200, -200C, -300, -400, -500 series
airplanes. This AD was prompted by the results of a fleet survey that
revealed cracking in the bulkhead frame web at a certain body station.
This AD requires repetitive inspections of the bulkhead frame web at a
certain station, and applicable on-condition actions. We are issuing
this AD to address the unsafe condition on these products.

DATES: This AD is effective November 20, 2018.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of November 20,
2018.

ADDRESSES: For service information identified in this final rule,
contact Boeing Commercial Airplanes, Attention: Contractual & Data
Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA
90740-5600; telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com. You may view this service information at the
FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA.
For information on the availability of this material at the FAA, call
206-231-3195. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0415.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0415; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, the regulatory evaluation, any comments received, and
other information. The address for Docket Operations (phone: 800-647-
5527) is U.S. Department of Transportation, Docket Operations, M-30,
West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: George Garrido, Aerospace Engineer,
Airframe Section, FAA, Los Angeles ACO Branch, 3960 Paramount
Boulevard, Lakewood, CA 90712-4137; phone:<PHONE_NUMBER>; fax: 562-627-
5210; email: [email protected].

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to all The Boeing Company
Model 737-100, -200, -200C, -300, -400, -500 series airplanes. The NPRM
published in the Federal Register on May 25, 2018 (83 FR 24242). The
NPRM was prompted by the results of a fleet survey that revealed
cracking in the bulkhead frame web at a certain body station. The NPRM
proposed to require repetitive inspections of the bulkhead frame web at
a certain station, and repair if necessary.
    We are issuing this AD to address cracking in the station (STA)
259.5 bulkhead frame web from the first stiffener above stringer S-10
to S-13. Such cracking could result in reduced structural integrity of
the airplane.

Comments

    We gave the public the opportunity to participate in developing
this final rule. The following presents the comments received on the
NPRM and the FAA's response to each comment.

Request To Clarify Corrective Actions

    Boeing requested that the Summary section and Related Service
Information paragraph in the NPRM be revised to clarify that the
corrective actions include more than just repairs. Boeing stated that
the service information does not describe defined repairs but indicates
that if any crack is found, contact Boeing for repair instructions and
do the repair and repeat the instructions.
    We agree with the commenter's request for the reasons provided by
the commenter. We have revised the Summary section of this final rule
by changing ``repair if necessary'' to ``applicable on-condition
actions.'' We have revised the ``Related Service Information under 1
CFR part 51'' paragraph of this final rule by clarifying the
description of the service information to ``. . . low frequency eddy
current inspections of the STA 259.5 bulkhead frame web from the first
stiffener above stringer S-10 to S-13, on the left and right sides of
the airplane and applicable on-condition actions.''

Request To Include Group 1 Airplanes as Specified in the Service
Information

    Boeing requested that Group 1 airplanes, as specified in Boeing
Alert Requirements Bulletin 737-53A1369 RB, dated October 12, 2017, be
addressed in the body of the proposed AD. Boeing stated that this
change would allow operators with airplanes that are not subject to the
limit of validity a means to comply with the requirements specified in
the proposed AD.
    We agree with the commenter's request for the reasons provided by
the commenter. Group 1 airplanes are those having line numbers 1
through 291 that have accumulated flight cycles beyond the limit of
validity of the maintenance program. We have revised paragraph (g) of
this AD to address Group 1 airplanes, added paragraph (h) of this AD to
address Group 2 and 3 airplanes, and redesignated the subsequent
paragraphs accordingly.

Effect of Winglets on Accomplishment of the Proposed Actions

    Aviation Partners Boeing stated that accomplishing the Supplemental
Type Certificate (STC) ST01219SE does not affect the ability to
accomplish the actions specified in the NPRM.
    We concur with the commenter. We have redesignated paragraph (c) of
the proposed AD as (c)(1) and added paragraph (c)(2) to this AD to
state that installation of STC ST01219SE does not affect the ability to
accomplish the actions required by this final rule. Therefore, for
airplanes on which STC ST01219SE is installed, a ``change in product''
alternative method of compliance (AMOC) approval request is not
necessary to comply with the requirements of 14 CFR 39.17.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this final rule with the changes described previously and minor
editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of this final
rule.

Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Requirements Bulletin 737-53A1369 RB,
dated October 12, 2017. The service information describes procedures
for repetitive high frequency eddy current inspections and low
frequency eddy current inspections of the STA 259.5 bulkhead frame web
from the first stiffener above stringer S-10 to S-13, on the left and
right sides of the airplane and applicable on-condition actions. 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.

Costs of Compliance

    We estimate that this AD affects 411 airplanes of U.S. registry. We
estimate the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
          Action                   Labor cost           Parts cost      Cost per product          operators
----------------------------------------------------------------------------------------------------------------
Inspections..............  57 work-hours x $85 per                $0  $4,845 per            $1,991,295 per
                            hour = $4,845 per                          inspection cycle.     inspection cycle.
                            inspection cycle.
----------------------------------------------------------------------------------------------------------------

    We have received no definitive data that would enable us to provide
cost estimates for the on-condition actions specified in this AD.

Authority for This Rulemaking

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

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

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

Sec.  39.13  [Amended]

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

2018-21-08 The Boeing Company: Amendment 39-19466; Docket No. FAA-
2018-0415; Product 2017-NM-149-AD.

(a) Effective Date

    This AD is effective November 20, 2018.

(b) Affected ADs

    None.

(c) Applicability

    (1) This AD applies to all The Boeing Company Model 737-100, -
200, -200C, -300, -400, and -500 series airplanes, certificated in
any category.
    (2) Installation of Supplemental Type Certificate (STC)
ST01219SE does not affect the ability to accomplish the actions
required by this AD. Therefore, for airplanes on which STC ST01219SE
is installed, a ``change in product'' alternative method of
compliance (AMOC) approval request is not necessary to comply with
the requirements of 14 CFR 39.17.

(d) Subject

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

(e) Unsafe Condition

    This AD was prompted by the results of a fleet survey that
revealed cracking in the bulkhead frame web at a certain body
station. We are issuing this AD to address cracking in the station
(STA) 259.5 bulkhead frame web from the first stiffener above
stringers S-10 to S-13. Such cracking could result in reduced
structural integrity of the airplane.

(f) Compliance

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

(g) Required Actions for Group 1 Airplanes

    For airplanes identified as Group 1 in Boeing Alert Requirements
Bulletin 737-53A1369 RB, dated October 12, 2017: Within 120 days
after the effective date of this AD, inspect the airplane and do all
applicable on-condition actions using a method approved in
accordance with the procedures specified in paragraph (j) of this
AD.

(h) Required Actions for Group 2 and 3 Airplanes

    For airplanes identified as Group 2 and 3 in Boeing Alert
Requirements Bulletin 737-53A1369 RB, dated October 12, 2017: Except
as required by paragraph (i) of this AD, at the applicable times
specified in the ``Compliance'' paragraph of Boeing Alert
Requirements Bulletin 737-53A1369 RB, dated October 12, 2017, do all
applicable actions identified in, and in accordance with, the
Accomplishment Instructions of Boeing Alert Requirements Bulletin
737-53A1369 RB, dated October 12, 2017.

    Note 1 to paragraph (h) of this AD: Guidance for accomplishing
the actions required by this AD is included in Boeing Alert Service
Bulletin 737-53A1369, dated October 12, 2017, which is referred to
in Boeing Alert Requirements Bulletin 737-53A1369 RB, dated October
12, 2017.

(i) Exceptions to Service Information Specifications

    (1) For purposes of determining compliance with the requirements
of this AD: Where Boeing Alert Requirements Bulletin 737-53A1369 RB,
dated October 12, 2017, uses the phrase ``the original issue date of
Requirements Bulletin 737-53A1369,'' this AD requires using the
effective date of this AD.
    (2) Where Boeing Alert Requirements Bulletin 737-53A1369 RB,
dated October 12, 2017, specifies contacting Boeing, this AD
requires repair using a method approved in accordance with the
procedures specified in paragraph (j) of this AD.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Los Angeles ACO 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 certification office, send it to the attention of
the person identified in paragraph (k) of this AD. Information may
be emailed to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by the Boeing Commercial Airplanes Organization
Designation Authorization (ODA) that has been authorized by the
Manager, Los Angeles ACO Branch, FAA, to make those findings. To be
approved, the repair method, modification deviation, or alteration
deviation must meet the certification basis of the airplane, and the
approval must specifically refer to this AD.

(k) Related Information

    For more information about this AD, contact George Garrido,
Aerospace Engineer, Airframe Section, FAA, Los Angeles ACO Branch,
3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-
5232; fax:<PHONE_NUMBER>; email: [email protected].

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Boeing Alert Requirements Bulletin 737-53A1369 RB, dated
October 12, 2017.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-
5600; telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com.
    (4) You may view this service information at the FAA, Transport
Standards Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call
206-231-3195.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Des Moines, Washington, on September 20, 2018.
John P. Piccola,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2018-21965 Filed 10-15-18; 8:45 am]
 BILLING CODE 4910-13-P