[Federal Register Volume 86, Number 169 (Friday, September 3, 2021)]
[Notices]
[Page 49589]
[FR Doc No: C1-2021-16671]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-92525; File No. SR-FINRA-2020-041]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Order Approving a Proposed Rule Change, as Modified by
Amendment No. 1 and Amendment No. 2, To Adopt FINRA Rule 4111
(Restricted Firm Obligations) and FINRA Rule 9561 (Procedures for
Regulating Activities Under Rule 4111)

July 30, 2021.

Correction

    In notice document 2021-16671 appearing on page 42925 in the issue
of August 5, 2021, make the following correction:
    On page 42925, in the second column, the file number is corrected
to read as set forth above.

[FR Doc. C1-2021-16671 Filed 9-2-21; 8:45 am]
BILLING CODE 0099-10-D


[Federal Register Volume 82, Number 167 (Wednesday, August 30, 2017)]
[Notices]
[Pages 41298-41300]
[FR Doc No: 2017-18352]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81479; File No. SR-NASDAQ-2017-083]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend the Exchange's Transaction Fees at Chapter XV, Section 2 Entitled
``NASDAQ Options Market--Fees and Rebates''

August 24, 2017.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on August 16, 2017, The NASDAQ Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III, below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the Exchange's transaction fees at
Chapter XV, Section 2 entitled ``NASDAQ Options Market--Fees and
Rebates
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaq.cchwallstreet.com, at the principal office of
the Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    NOM proposes to amend the MARS subsidy program which pays a subsidy
to NOM Participants that provide certain order routing functionalities
to other NOM Participants and/or use such functionalities themselves.
Generally, under MARS, the Exchange pays participating NOM Participants
to subsidize their costs of providing routing services to route orders
to NOM. The Exchange believes that the proposed amendment to MARS will
continue to attract higher volumes of electronic equity and ETF options
volume to the Exchange from non-NOM Participants as well as NOM
Participants.
Background
    Today, to qualify for MARS, a NOM Participant's routing system
(hereinafter ``System'') is required to meet certain criteria.
Specifically the Participant's System is required to: (1) Enable the
electronic routing of orders to all of the U.S. options exchanges,
including NOM; (2) provide current consolidated market data from the
U.S. options exchanges; and (3) be capable of interfacing with NOM's
API to access current NOM match engine functionality. The NOM
Participant's System would also need to cause NOM to be one of the top
three default destination exchanges for (a) individually executed
marketable orders if NOM is at the national best bid or offer
(``NBBO''), regardless of size or time, (b) orders that establish a new
NBBO on NOM's Order Book, but allow any user to manually override NOM
as the default destination on an order-by-order basis.\3\
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    \3\ Any NOM Participant is permitted to avail itself of this
arrangement, provided that its order routing functionality
incorporates the features described herein and the Participant
satisfies NOM that it appears to be robust and reliable.
Participants remain solely responsible for implementing and
operating its System.
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    MARS Payment are made to NOM Participants that have System
Eligibility and have routed the requisite number of Eligible Contracts
daily in a month (``Average Daily Volume''), which were executed on
NOM.\4\ Today, NOM Participants that have System Eligibility and have
executed the requisite number of Eligible Contracts in a month will be
paid the following rebates: \5\
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    \4\ For the purpose of qualifying for the MARS Payment, Eligible
Contracts may include Firm, Non-NOM Market Maker, Broker-Dealer, or
Joint Back Office or ``JBO'' equity option orders that add liquidity
and are electronically delivered and executed. Eligible Contracts do
not include Mini Option orders.
    \5\ The specified MARS Payment are paid on all executed Eligible
Contracts that add liquidity, which are routed to NOM through a
participating NOM Participant's System and meet the requisite
Eligible Contracts ADV. No payment [sic] are made with respect to
orders that are routed to NOM, but not executed. Also, a Participant
is not be [sic] entitled to receive any other revenue from the
Exchange for the use of its System specifically with respect to
orders routed to NOM.

----------------------------------------------------------------------------------------------------------------
                                                                   Average daily
                              Tiers                                   volume       MARS  payment   MARS  payment
                                                                     (``ADV'')        (penny)       (non-penny)
----------------------------------------------------------------------------------------------------------------
1...............................................................           2,500       \*\ $0.07       \*\ $0.15
2...............................................................           5,000        \*\ 0.09        \*\ 0.20
3...............................................................          10,000        \*\ 0.11        \*\ 0.30
4...............................................................          20,000        \*\ 0.15        \*\ 0.50
5...............................................................          45,000        \*\ 0.17        \*\ 0.60
----------------------------------------------------------------------------------------------------------------

    Specifically, the specified MARS Payment are paid on all executed
Eligible Contracts that add liquidity, which are routed to NOM through
a participating NOM Participant's System and meet the requisite
Eligible Contracts ADV. No payments are made with respect to orders
that are routed to NOM, but not executed.\6\
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    \6\ A Participant is not entitled to receive any other revenue
from the Exchange for the use of its System specifically with
respect to orders routed to NOM.
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Amendment to MARS Payment
    The Exchange proposes to amend the MARS Payment tiers at Chapter
XV, Section 2(6) by amending current tier 1 to require an ADV of 2,000
contracts instead of the current ADV of 2,500 contracts. The Exchange
would continue to pay a $0.07 per contract MARS Payment for Penny
Options and a $0.15 per contract rebate for Non-

Penny Options.\7\ All other tiers would remain unchanged. The Exchange
believes that the proposed change to the MARS Payment will attract
additional liquidity to NOM.
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    \7\ Today, NOM Participants that qualify for Customer and
Professional Penny Pilot Options Rebate to Add Liquidity Tier 8 in
Section 2(1) receive $0.09 per contract in addition to any MARS
Payment tier on MARS Eligible Contracts the NOM Participant
qualifies for in a given month. This would remain unchanged.
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2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\8\ in general, and furthers the objectives of Sections
6(b)(4) and 6(b)(5) of the Act,\9\ in particular, in that it provides
for the equitable allocation of reasonable dues, fees and other charges
among Participants and issuers and other persons using any facility or
system which the Exchange operates or controls, and is not designed to
permit unfair discrimination between customers, issuers, brokers, or
dealers.
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    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(4) and (5).
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    The Exchange's proposal to amend Tier 1 to lower the requisite ADV
from 2,500 to 2,000 contracts and continue to pay a MARS Payment of
$0.07 per contract for Penny Pilot Options and $0.15 per contract for
Non-Penny Pilot Options is reasonable because additional Participants
would be able to qualify for a Tier 1 rebate, because of the lower
requirement, provided the Participant has System Eligibility and
executes the requisite ADV of Eligible Contracts. The Exchange believes
this amendment may attract higher volumes of electronic equity and ETF
options volume to NOM, which would in turn benefit all NOM Participants
by offering greater price discovery, increased transparency, and an
increased opportunity to trade on the Exchange. Also, the proposal
should enhance the competitiveness of the Exchange, particularly with
respect to those exchanges that offer their own front-end order entry
system or one they subsidize in some manner. The amendment to Tier 1
may incentivize NOM Participants to participate in MARS to obtain the
rebate, provided the NOM Participant is eligible for MARS. Further, the
tier structure will continue to allow NOM Participants to price their
services at a level that will enable them to attract order flow from
market participants who would otherwise utilize an existing front-end
order entry mechanism offered by the Exchange's competitors instead of
incurring the cost in time and money to develop their own internal
systems to be able to deliver orders directly to the Exchange's System.
    The Exchange's proposal to amend Tier 1 to lower the requisite ADV
from 2,500 to 2,000 contracts and continue to pay a MARS Payment of
$0.07 per contract for Penny Pilot Options and $0.15 per contract for
Non-Penny Pilot Options is equitable and not unfairly discriminatory
because the Exchange will uniformly pay all NOM Participants the
rebates specified in the proposed MARS Payment tiers provided the NOM
Participant has executed the requisite ADV of Eligible Contracts.
Moreover, the Exchange believes that the proposed MARS Payments offered
by the Exchange are equitable and not unfairly discriminatory because
any qualifying NOM Participant that offers market access and
connectivity to the Exchange and/or utilize such functionality
themselves may earn the MARS Payment for all Eligible Contracts.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. In terms of inter-market
competition, the Exchange notes that it operates in a highly
competitive market in which market participants can readily favor
competing venues if they deem fee levels at a particular venue to be
excessive, or rebate opportunities available at other venues to be more
favorable.
    The Exchange's proposal to amend Tier 1 to lower the requisite ADV
from 2,500 to 2,000 contracts and continue to pay a MARS Payment of
$0.07 per contract for Penny Pilot Options and $0.15 per contract for
Non-Penny Pilot Options does not impose an undue burden on intra-market
competition because the Exchange will uniformly pay all NOM
Participants the MARS Payments specified in the proposed MARS Payment
tiers for Penny and Non-Penny Pilot Options provided the NOM
Participant has executed the requisite number of Eligible Contracts.

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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\10\
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    \10\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or 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-NASDAQ-2017-083 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2017-083. 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, 100 F Street NE.,

Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NASDAQ-2017-083, and should
be submitted on or before September 20, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-18352 Filed 8-29-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 215 (Monday, November 7, 2011)]
[Notices]
[Pages 68796-68797]
[FR Doc No: 2011-28719]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available from: U.S. Securities and
Exchange Commission, Office of Investor Education and Advocacy,
Washington, DC 20549-0213.

Extension:
    Rule 12f-1; OMB Control No. 3235-0128; SEC File No. 270-139.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit the
existing collection of information to the Office of Management and
Budget for extension and approval. For Rule 12f-1 (17 CFR 240.12f-1)--
Applications for permission to reinstate unlisted trading privileges.
    Rule 12f-1 (the ``Rule''), originally adopted in 1934 pursuant to
Sections 12(f) and 23(a) of the Securities Exchange Act of 1934 (15
U.S.C. 78a et seq.) (``Act''), as modified in 1995 and 2005, sets forth
the information which an exchange must include in an application to
reinstate its ability to extend unlisted trading privileges to any
security for which such unlisted trading privileges have been suspended
by the Commission, pursuant to Section 12(f)(2)(A) of the Act. An
application must provide the name of the issuer, the title of the
security, the name of each national securities exchange, if any, on
which the security is listed or admitted to unlisted trading
privileges, whether transaction information concerning the security is
reported pursuant to an

effective transaction reporting plan contemplated by Rule 601 of
Regulation NMS, the date of the Commission's suspension of unlisted
trading privileges in the security on the exchange, and any other
pertinent information. Rule 12f-1 further requires a national
securities exchange seeking to reinstate its ability to extend unlisted
trading privileges to a security to indicate that it has provided a
copy of such application to the issuer of the security, as well as to
any other national securities exchange on which the security is listed
or admitted to unlisted trading privileges.
    The information required by Rule 12f-1 enables the Commission to
make the necessary findings under the Act prior to granting
applications to reinstate unlisted trading privileges. This information
is also made available to members of the public who may wish to comment
upon the applications. Without the Rule, the Commission would be unable
to fulfill these statutory responsibilities.
    There are currently 15 national securities exchanges subject to
Rule 12f-1. The burden of complying with Rule 12f-1 arises when a
potential respondent seeks to reinstate its ability to extend unlisted
trading privileges to any security for which unlisted trading
privileges have been suspended by the Commission, pursuant to Section
12(f)(2)(A) of the Act. The staff estimates that each application would
require approximately one hour to complete. Thus each potential
respondent would incur on average one burden hour in complying with the
Rule.
    The Commission staff estimates that there could be as many as 15
responses annually and that each respondent's related cost of
compliance with Rule 12f-1 would be $168.00, or, the cost of one hour
of professional work of a paralegal needed to complete the application.
The total annual related reporting cost for all potential respondents,
therefore, is $2,520 (15 responses x $168.00 per response).
    Compliance with Rule 12f-1 is mandatory. Rule 12f-1 does not have a
record retention requirement per se. However, responses made pursuant
to Rule 12f-1 are subject to the recordkeeping requirements of Rules
17a-3 and 17a-4 of the Act. Information received in response to Rule
12f-1 shall not be kept confidential; the information collected is
public information.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimates of the burden of the proposed collection of information; (c)
ways to enhance the quality, utility, and clarity of the information on
respondents; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    The Commission may not conduct or sponsor a collection of
information unless it displays a currently valid control number. No
person shall be subject to any penalty for failing to comply with a
collection of information subject to the PRA that does not display a
valid Office of Management and Budget (OMB) control number.
    Please direct your written comments to: Thomas Bayer, Director/
Chief Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 6432 General Green Way, Alexandria, Virginia 22312 or
send an email to<EMAIL_ADDRESS>
    Dated: November 1, 2011.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2011-28719 Filed 11-4-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 196 (Thursday, October 12, 2017)]
[Notices]
[Pages 47529-47531]
[FR Doc No: 2017-22050]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0461]

Format and Content of a Risk Evaluation and Mitigation Strategy
Document; Revised Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a revised draft guidance for industry entitled
``Format and Content of a REMS Document.'' A Risk Evaluation and
Mitigation Strategy (REMS) document, which is part of a REMS that is
required by FDA, establishes the goals and requirements of the REMS.
This revised draft guidance describes a new recommended format for a
REMS document. The new format was developed based on extensive
stakeholder feedback. This guidance revises and supersedes the draft
guidance entitled ``Format and Content of Proposed Risk Evaluation and
Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS
Modifications,'' that was published by FDA on October 1, 2009.

DATES: Submit either electronic or written comments on the draft
guidance

by December 11, 2017 to ensure that the Agency considers your comment
on this draft guidance before it begins work on the final version of
the guidance.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2009-D-0461 for ``Format and Content of a REMS Document.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Gita Toyserkani, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2422, Silver Spring, MD 20993, 301-796-
1783<EMAIL_ADDRESS>or Stephen Ripley, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised draft guidance for
industry entitled ``Format and Content of a REMS Document.'' The Food
and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) created
section 505-1 of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 355-1), which authorizes FDA to require a REMS for
certain drugs if FDA determines that a REMS is necessary to ensure that
the benefits of the drug outweigh its risks (see section 505-1(a) of
the FD&C Act). A REMS is a required risk management strategy that can
include one or more elements to ensure that the benefits of a drug
outweigh its risks (see section 505-1(e) of the FD&C Act). The REMS
document includes concise information about the goals and requirements
of the REMS as they relate to the elements described under the FD&C
Act.
    In the Federal Register of October 1, 2009 (74 FR 50801), FDA
announced the availability of a draft guidance for industry entitled
``Format and Content of Proposed Risk Evaluation and Mitigation
Strategies (REMS), REMS Assessments, and Proposed REMS Modifications.''
The 2009 draft guidance described the recommended format and content
for submission of proposed REMS. It also included information and
recommendations on the content of assessments and proposed
modifications of approved REMS.
    Over the last 6 years, under the REMS Integration Initiative, FDA's
implementation of the REMS authorities has evolved. The goals of the
REMS Integration Initiative included developing guidance, improving
standardization and assessment of REMS, and improving integration of
REMS into the health care system. (More information on the REMS
Integration Initiative can be found at: https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm350852.htm).
    Through the REMS Integration Initiative and other outreach, FDA has
received feedback that specific activities and requirements for various
stakeholders (e.g., prescribers,

pharmacists) are not clearly communicated in REMS documents.
Stakeholders have reported spending excessive time trying to locate,
understand, and comply with REMS requirements.
    To address the stakeholders' feedback, FDA is revising the 2009
draft guidance on the format and content of a REMS to include
information to assist applicants in drafting clear, informative, and
standardized REMS documents. This revised draft guidance provides
updated recommendations on the format and content of a REMS document
and supersedes the 2009 draft guidance. Additional and more detailed
information is provided in the template appended to this guidance.
    The new format of the REMS document, as described in this revised
draft guidance and appended template, contains substantially the same
content as described in the 2009 draft guidance; however, the
information has been reorganized. In the old format, the REMS
requirements were organized by the elements described in the statute.
In the new format, requirements are organized to describe who is
responsible for implementing the requirement, when the requirement is
to be implemented, what the required action is, and with what REMS
material(s). Additionally, the new format supports submission of REMS
documents in Structured Product Labeling (SPL) format.
    Certain information included in the 2009 draft guidance has been
revised and included in other guidances subsequently published and
therefore has been omitted from this revised draft guidance. For
example:
     Information on how FDA determines when a REMS is necessary
to ensure that the benefits of a drug outweigh its risks can be found
in the draft guidance for industry, ``FDA's Application of Statutory
Factors in Determining When a REMS Is Necessary'' (at: https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm521504.pdf).
     Information on REMS modifications can be found in the
guidance for industry, ``Risk Evaluation and Mitigation Strategies:
Modifications and Revisions'' (at: https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm441226.pdf).
    This revised guidance and appended template are being reissued in
draft form to enable the public to review and comment before
finalization.
    This revised draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The revised draft
guidance, when finalized, will represent the current thinking of FDA on
the format and content of a REMS document. It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. This guidance is not subject to
Executive Order 12866.

II. The Paperwork Reduction Act of 1995

    This revised draft guidance contains information collection
provisions that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collection of information in the guidance was approved under
OMB control numbers 0910-0001 and 0910-0338.

III. Electronic Access

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

    Dated: October 5, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-22050 Filed 10-11-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 225 (Friday, November 20, 2020)]
[Proposed Rules]
[Pages 74302-74303]
[FR Doc No: 2020-25548]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2020-1015; Airspace Docket No. 20-AEA-20]
RIN 2120-AA66

Proposed Amendment of the Class E Airspace; Bradford, PA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to amend the Class E airspace at Bradford
Regional Airport, Bradford, PA. The FAA is proposing this action as the
result of an airspace review caused by the decommissioning of the
Bradford VHF omnidirectional range (VOR) navigation aid as part of the
VOR Minimum Operational Network (MON) Program.

DATES: Comments must be received on or before January 4, 2021.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590; telephone
(202) 366-9826, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2020-1015/Airspace Docket No. 20-AEA-20, at the beginning of your
comments. You may also submit comments through the internet at https://www.regulations.gov. You may review the public docket containing the
proposal, any comments received, and any final disposition in person in
the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through
Friday, except federal holidays.
    FAA Order 7400.11E, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11E at NARA, email<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would amend the Class E surface airspace and the Class E airspace
extending upward from 700 feet above the surface at Bradford Regional
Airport, Bradford, PA, to support instrument flight rule operations at
this airport.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2020-1015/
Airspace Docket No. 20-AEA-20.'' The postcard will be date/time stamped
and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action

on the proposed rule. The proposal contained in this notice may be
changed in light of the comments received. A report summarizing each
substantive public contact with FAA personnel concerned with this
rulemaking will be filed in the docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at https://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at https://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Federal Aviation Administration, Air Traffic
Organization, Central Service Center, Operations Support Group, 10101
Hillwood Parkway, Fort Worth, TX 76177.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11E, Airspace
Designations and Reporting Points, dated July 21, 2020, and effective
September 15, 2020. FAA Order 7400.11E is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11E lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 by:
    Amending the Class E surface area airspace to within a 4.1-mile
(decreased from a 4.3-mile) radius of Bradford Regional Airport,
Bradford, PA; removing the Bradford VORTAC and the associated extension
from the airspace legal description; adding an extension to 1 mile each
side of the 134[deg] bearing from the airport extending from the 4.1-
mile radius of the airport to 4.2 miles southeast of the airport; and
replacing the outdated term ``Airport/Facility Directory'' with ``Chart
Supplement'';
    And amending the Class E airspace extending upward from 700 feet
above the surface to within a 6.6-mile (increased from a 6.5-mile)
radius of Bradford Regional Airport; removing the Bradford VORTAC and
the associated extension from the airspace legal description; removing
the BRAFO LOM and the associated extension from the airspace legal
description; and removing the city associated with the airport to
comply with changes to FAA Order 7400.2M, Procedures for Handling
Airspace Matters.
    This action is the result of an airspace review caused by the
decommissioning of the Bradford VOR, which provided navigation
information for the instrument procedures at this airport, as part of
the VOR MON Program.
    Class E airspace designations are published in paragraph 6002 and
6005, respectively, of FAA Order 7400.11E, dated July 21, 2020, and
effective September 15, 2020, which is incorporated by reference in 14
CFR 71.1. The Class E airspace designations listed in this document
will be published subsequently in the Order.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

Regulatory Notices and Analyses

    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, is
non-controversial and unlikely to result in adverse or negative
comments. 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. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11E,
Airspace Designations and Reporting Points, dated July 21, 2020, and
effective September 15, 2020, is amended as follows:

Paragraph 6002 Class E Airspace Areas Designated as Surface Areas.

* * * * *

AEA PA E2 Bradford, PA [Amended]

Bradford Regional Airport, PA
    (Lat. 41[deg]48'11'' N, long. 78[deg]38'24'' W)

    Within a 4.1-mile radius of the Bradford Regional Airport, and
within 1 mile each side of the 134[deg] bearing from the airport
extending from the 4.1-mile radius to 4.2 miles southeast of the
airport. This Class E airspace area is effective during the specific
dates and times established in advance by a Notice to Airmen. The
effective date and time will thereafter be continuously published in
the Chart Supplement.

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

AEA PA E5 Bradford, PA [Amended]

Bradford Regional Airport, PA
    (Lat. 41[deg]48'11'' N, long. 78[deg]38'24'' W)
HIVIT Waypoint
    (Lat. 41[deg]57'51'' N, long. 78[deg]39'15'' W)

    That airspace extending upward from 700 feet above the surface
of the Earth within a 6.6-mile radius of the Bradford Regional
Airport, and within a 6-mile radius of the HIVIT Waypoint serving
the University of Pittsburgh.

    Issued in Fort Worth, Texas, on November 16, 2020.
Martin A. Skinner,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2020-25548 Filed 11-19-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: April 6, 2009 (Volume 74, Number 64)]
[Proposed Rules]
[Page 15399-15401]
[DOCID:fr06ap09-14]

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

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

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-0310; Directorate Identifier 2009-NM-012-AD]
RIN 2120-AA64

Airworthiness Directives; Bombardier Model CL-600-2B19 (Regional
Jet Series 100 & 440) Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above. 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:

    During the Acceptance Test Procedure (ATP) of returned Inboard
Flap Actuators * * * an excessive wear condition was identified
regarding endplay between the flap actuator and ball screw.
Excessive wear of the screw and ball nut could potentially lead to a
flap system jam. * * *

* * * * *
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 May 6, 2009.

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 W12-40, 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>; e-mail
<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> or<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: Fabio Buttitta, Aerospace Engineer,
Airframe and Propulsion Branch, ANE-171, FAA, New York Aircraft
Certification Office, 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-2009-0310;
Directorate Identifier 2009-NM-012-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-
2008-33R1, dated January 9, 2009 (referred to after this as ``the
MCAI''), to correct an unsafe condition for the specified products. The
MCAI states:

    During the Acceptance Test Procedure (ATP) of returned Inboard
Flap Actuators Part Number (PN) 601R93101-19, an excessive wear
condition was identified regarding endplay between the flap actuator
and ball screw. Excessive wear of the screw and ball nut could
potentially lead to a flap system jam. A Temporary Revision (TR) has
been made to the Bombardier CL-600-2B19 Maintenance Requirements
Manual (MRM), Appendix A, ``Certification Maintenance Requirements''
(CMR) to ensure that unacceptable wear on the nut and ball screw is
detected and corrected.
    Revision 1 of this directive introduces a new phase-in schedule
for performing a new CMR task C27-50-300-01.

Relevant Service Information

    Bombardier has issued Temporary Revision 2A-41, dated November 7,
2007, to Appendix A of the Airworthiness Requirements, Part 2, of the
Bombardier CL-600-2B19 Maintenance Requirements Manual. 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 668 products of U.S. registry. We also estimate that it
would take about 3 work-hours per product to comply with the basic
requirements of this proposed AD. The average labor rate is $80 per
work-hour. Based on these figures, we estimate the cost of the proposed
AD on U.S. operators to be $160,320, or $240 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. (Formerly Canadair): Docket No. FAA-2009-0310;
Directorate Identifier 2009-NM-012-AD.

Comments Due Date

    (a) We must receive comments by May 6, 2009.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Bombardier Model CL-600-2B19 (Regional
Jet Series 100 & 440) airplanes, all serial numbers, certificated in
any category.

    Note 1: This AD requires revisions to certain operator
maintenance documents to include new inspections. Compliance with
these inspections is required by 14 CFR 91.403(c). For airplanes
that have been previously modified, altered, or repaired in the
areas addressed by these inspections, the operator may not be able
to accomplish the inspections described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must
request approval for an alternative method of compliance according
to paragraph (g)(1) of this AD. The request should include a
description of changes to the required inspections that will ensure
the continued operational safety of the airplane.

Subject

    (d) Air Transport Association (ATA) of America Code 27: Flight
Controls.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    During the Acceptance Test Procedure (ATP) of returned Inboard
Flap Actuators Part Number (PN) 601R93101-19, an excessive wear
condition was identified regarding endplay between the flap actuator
and ball screw. Excessive wear of the screw and ball nut could
potentially lead to a flap system jam. A Temporary Revision (TR) has
been made to the Bombardier CL-600-2B19 Maintenance Requirements
Manual (MRM), Appendix A, ``Certification Maintenance Requirements''
(CMR) to ensure that unacceptable wear on the nut and ball screw is
detected and corrected.
    Revision 1 of this directive introduces a new phase-in schedule
for performing a new CMR task C27-50-300-01.

Actions and Compliance

    (f) Unless already done, within 30 days after the effective date
of this AD, revise the Airworthiness Requirements section of
Bombardier Model CL-600-2B19 MRM to include the information in
Bombardier TR 2A-41, dated November 7, 2007, to Appendix A of the
Airworthiness Requirements, Part 2, of the Bombardier CL-600-2B19
Maintenance Requirements Manual (MRM). The initial compliance time
with the new CMR task must be done within 500 flight hours after the
effective date of this AD.

    Note 2: The actions required by paragraph (f) of this AD may be
done by inserting a copy of Bombardier TR 2A-41, dated November 7,
2007, to Appendix A of the Airworthiness Requirements, Part 2, of
the Bombardier CL-600-2B19 MRM. When this TR has been included in
general revisions of the MRM, the general revisions may be inserted
in the MRM, provided the relevant information in the general
revision is identical to that in Bombardier TR 2A-41.

FAA AD Differences

    Note 3: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office (ACO), FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. Send information to ATTN: Fabio Buttitta, Aerospace
Engineer, Airframe and Propulsion Branch, ANE-171, FAA, New York
ACO, 1600 Stewart Avenue, Suite 410, Westbury, New York 11590;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Before using any
approved AMOC on any airplane to which the AMOC applies, notify your
principal maintenance inspector (PMI) or principal avionics
inspector (PAI), as appropriate, or lacking a principal inspector,
your local Flight Standards District Office.

    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act, the
Office of Management and Budget (OMB) has approved the information
collection requirements and has assigned OMB Control Number 2120-
0056.

Related Information

    (h) Refer to MCAI Canadian Airworthiness Directive CF-2008-33R1,
dated January 9, 2009; and Bombardier Temporary Revision 2A-41,
dated November 7, 2007, to Appendix A of the Airworthiness
Requirements, Part 2, of the Bombardier CL-600-2B19 Maintenance
Requirements Manual; for related information.

    Issued in Renton, Washington, on March 30, 2009.
Stephen P. Boyd,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E9-7643 Filed 4-3-09; 8:45 am]

BILLING CODE 4910-13-P