[Federal Register Volume 82, Number 195 (Wednesday, October 11, 2017)]
[Notices]
[Pages 47316-47317]
[FR Doc No: 2017-21866]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2007-29238]

Petition for Waiver of Compliance

    Under part 211 of Title 49 Code of Federal Regulations (CFR), this
document provides the public notice that on September 19, 2017, Mount
Vernon Terminal Railway (MVT) petitioned the Federal Railroad
Administration (FRA) for a waiver of compliance from certain provisions
of the Federal railroad safety regulations contained at 49 CFR part
223. FRA assigned the petition Docket Number FRA-2007-29238.
    Specifically, MVT seeks an extension of its existing waiver of
compliance from the glazing requirements of 49 CFR 223.11, for one of
its locomotives, MVT 1200. MVT states that locomotive MVT 1200 is used
two to three times per week for a total of approximately two hours per
week at speeds not exceeding 10 miles per hour. MVT 1200 is used
exclusively for switching operations within yard limits, which includes
about 0.5 miles of main track and 0.5 miles of side tracks and spurs.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200

New Jersey Avenue SE., W12-140, Washington, DC 20590. The Docket
Operations Facility is open from 9 a.m. to 5 p.m., Monday through
Friday, except Federal Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested parties
desire an opportunity for oral comment and a public hearing, they
should notify FRA, in writing, before the end of the comment period and
specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by November 27, 2017 will be considered by
FRA before final action is taken. Comments received after that date
will be considered if practicable.
    Anyone can search the electronic form of any written communications
and comments received into any of our dockets by the name of the
individual submitting the comment (or signing the document, if
submitted on behalf of an association, business, labor union, etc.).
Under 5 U.S.C. 553(c), DOT solicits comments from the public to better
inform its processes. DOT posts these comments, without edit, including
any personal information the commenter provides, to
www.regulations.gov, as described in the system of records notice (DOT/
ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacyNotice for the
privacy notice of regulations.gov.

Robert C. Lauby,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2017-21866 Filed 10-10-17; 8:45 am]
BILLING CODE P


[Federal Register Volume 76, Number 164 (Wednesday, August 24, 2011)]
[Notices]
[Pages 53009-53012]
[FR Doc No: 2011-21657]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65165; File No. SR-NYSEAmex-2011-59]

Self-Regulatory Organizations; NYSE Amex LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Deleting the Text
of NYSE Amex Equities Rules 92, 513, 514 and Adopting New NYSE Amex
Equities Rule 5320 That Is Substantially the Same as Financial Industry
Regulatory Authority Rule 5320 To Prohibit Trading Ahead of Customer
Orders With Certain Exceptions (Commonly Known as the Manning Rule)

August 18, 2011.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on August 11, 2011, NYSE Amex LLC (the ``Exchange'' or
``NYSE Amex'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the self-regulatory
organization. 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\ 15 U.S.C. 78a.
    \3\ 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 delete the text of NYSE Amex Equities
Rules 92, 513, and 514, which limit trading ahead of customer orders,
and adopt a new NYSE Amex Equities Rule 5320 that is substantially the
same as Financial Industry Regulatory Authority (``FINRA'') Rule 5320.
The text of the proposed rule change is available at the Exchange, the
Commission's Public Reference Room, and http://www.nyse.com.

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

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

1. Purpose
    The Exchange proposes to delete the text of NYSE Amex Equities
Rules 92, 513, and 514 which limit trading ahead of customer orders,
and adopt a new NYSE Amex Equities Rule 5320 that is substantially the
same as FINRA Rule 5320.\4\ As with FINRA Rule 5320, proposed NYSE Amex
Equities Rule 5320 would prohibit trading ahead of customer orders with
certain exceptions, including large order and institutional account
exceptions, a no-knowledge exception, a riskless principal exception,
an intermarket sweep order (``ISO'') exception, and odd lot and bona
fide error transaction exceptions, discussed in detail below. Proposed
NYSE Amex Equities Rule 5320 also provides the same guidance as FINRA
Rule 5320 on minimum price improvement standards, order handling

procedures, and trading outside normal market hours.
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    \4\ See Securities Exchange Act Release No. 63895 (February 11,
2011), 76 FR 9386 (February 17, 2011) (SR-FINRA-2009-090). The
Exchange's affiliates, New York Stock Exchange LLC and NYSE Arca,
Inc., also have filed substantially similar rule filings. See SR-
NYSE-2011-42 and SR-NYSEArca-2011-57.
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Background
    NYSE Amex Equities Rule 92, which applies to Exchange-listed
securities, generally prohibits member organizations from trading on a
proprietary basis ahead of, or along with, customer orders that are
executable at the same price as the proprietary order. The Rule
contains several exceptions that make it permissible for a member or
member organization to enter a proprietary order while representing a
customer order that could be executed at the same price, provided,
among other things, that the customer order is not for an account of an
individual investor and the customer has provided express permission.
Current NYSE Amex Equities Rule 92 also permits riskless transactions
for the purpose of facilitating the execution, on a riskless principal
basis, of one or more customer orders. NYSE Amex Equities Rule 92
applies to Exchange-listed securities. NYSE Amex Equities Rules 513 and
514 impose limitations on trading ahead of customer limit orders and
market orders, respectively, with respect to Nasdaq securities that
trade on the Exchange.\5\
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    \5\ See generally NYSE Amex Equities Rules 500-525.
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Proposal To Adopt Text of FINRA Rule 5320
    In conjunction with its rules harmonization with FINRA, the
Exchange proposes to delete the text of NYSE Amex Equities Rules 92,
513, and 514 and their supplementary material and adopt the text of
FINRA Rule 5320, with certain technical changes, as NYSE Amex Equities
Rule 5320. FINRA Rule 5320 generally provides that a FINRA member that
accepts and holds an order in an equity security from its own customer
or a customer of another broker-dealer without immediately executing
the order is prohibited from trading that security on the same side of
the market for its own account at a price that would satisfy the
customer order, unless it immediately thereafter executes the customer
order up to the size and at the same or better price at which it traded
for its own account.
    Proposed NYSE Amex Equities Rule 5320 permits a member organization
to trade a security on the same side of the market for its own account
at a price that would satisfy a customer order in certain
circumstances.\6\
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    \6\ Although NYSE Amex Equities Rule 92 refers to member
organizations and members, proposed NYSE Amex Equities Rule 5320
would follow the structure of FINRA Rule 5320 and refer to member
organizations. Because all NYSE Amex members are associated with
NYSE Amex member organizations, proposed NYSE Amex Equities Rule
5320 would apply to them.
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Large Orders and Institutional Accounts
    The most notable exception to the customer order protection rule is
to allow member organizations to negotiate terms and conditions on the
acceptance of certain large-sized orders (orders of 10,000 shares or
more unless such orders are less than $100,000 in value) or orders from
institutional accounts as defined in NASD Rule 3110. Such terms and
conditions would permit the member organization to continue to trade
alongside or ahead of such customer orders if the customer agrees.
    Specifically, under the proposed rule, a member organization would
be permitted to trade a security on the same side of the market for its
own account at a price that would satisfy a customer order provided
that the member organization provides clear and comprehensive written
disclosure to each customer at account opening and annually thereafter
that (a) Discloses that the member organization may trade proprietarily
at prices that would satisfy the customer order, and (b) provides the
customer with a meaningful opportunity to opt in to the NYSE Amex
Equities Rule 5320 protections with respect to all or any portion of
its order.
    If a customer does not opt in to the protections with respect to
all or any portion of its order, the member organization may reasonably
conclude that such customer has consented to the member organization
trading a security on the same side of the market for its own account
at a price that would satisfy the customer's order.\7\
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    \7\ As is always the case, customers retain the right to
withdraw consent at any time. Therefore, a member organization's
reasonable conclusion that a customer has consented to the member
organization trading along with such customer's order is subject to
further instruction and modification from the customer.
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    In lieu of providing written disclosure to customers at account
opening and annually thereafter, the proposed rule would permit member
organizations to provide clear and comprehensive oral disclosure to,
and obtain consent from, a customer on an order-by-order basis,
provided that the member organization documents who provided such
consent and that such consent evidences the customer's understanding of
the terms and conditions of the order. In addition, where a customer
has opted in to the NYSE Amex Equities Rule 5320 protections, a member
organization may still obtain consent on an order-by-order basis to
trade ahead of or along with an order from that customer, provided that
the member organization documents who provided such consent and that
such consent evidences the customer's understanding of the terms and
conditions of the order.
No-Knowledge Exception
    The Exchange is also proposing to include a ``no-knowledge''
exception to its customer order protection rule. The proposed exception
would allow a proprietary trading unit of a member organization to
continue trading in a proprietary capacity and at prices that would
satisfy customer orders that were being held by another, separate
trading unit at the member organization. The no-knowledge exception
would be applicable with respect to NMS stocks, as defined in Rule 600
of SEC Regulation NMS. In order to avail itself of the no-knowledge
exception, a member organization must first implement and utilize an
effective system of internal controls (such as appropriate information
barriers) that operate to prevent the proprietary trading unit from
obtaining knowledge of the customer orders that are held at a separate
trading unit.
    A member organization that structures its order handling practices
in NMS stocks to permit its proprietary and/or market-making desk to
trade at prices that would satisfy customer orders held by a separate
trading unit must disclose in writing to its customers, at account
opening and annually thereafter, a description of the manner in which
customer orders are handled by the member organization and the
circumstances under which the member organization may trade
proprietarily at its market-making desk at prices that would satisfy
the customer order.
Riskless Principal Exception
    The Exchange's proposal also provides that the obligations under
this rule shall not apply to a member organization's proprietary trade
if such proprietary trade is for the purposes of facilitating the
execution, on a riskless principal basis, of another order from a
customer (whether its own customer or the customer of another broker-
dealer), provided that the member organization (a) Submits a report,
contemporaneously with the execution of the facilitated order,
identifying the trade as riskless principal to the Exchange and (b) has
written policies and procedures to ensure that riskless principal
transactions relied upon for this exception comply with applicable
Exchange rules. At a minimum these policies and procedures must require
that the customer order was received prior to the offsetting principal

transaction, and that the offsetting principal transaction is at the
same price as the customer order exclusive of any markup or markdown,
commission equivalent or other fee and is allocated to a riskless
principal or customer account in a consistent manner and within 60
seconds of execution.
    Member organizations must have supervisory systems in place that
produce records that enable the member organization and the Exchange to
reconstruct accurately, readily, and in a time-sequenced manner all
orders on which a member organization relies in claiming this
exception.
ISO Exception
    The proposed rule change also provides that a member organization
shall be exempt from the obligation to execute a customer order in a
manner consistent with NYSE Amex Equities Rule 5320 with regard to
trading for its own account that is the result of an intermarket sweep
order routed in compliance with Rule 600(b)(30)(ii) of SEC Regulation
NMS where the customer order is received after the member organization
routed the ISO. Where a member organization routes an ISO to facilitate
a customer order and that customer has consented to not receiving the
better prices obtained by the ISO, the member organization also shall
be exempt with respect to any trading for its own account that is the
result of the ISO with respect to the consenting customer's order.
Odd Lot and Bona Fide Error Exception
    In addition, the Exchange proposes applying an exception for a
firm's proprietary trade that (1) Offsets a customer odd lot order
(i.e., an order less than one round lot, which is typically 100 shares)
or (2) corrects a bona fide error. With respect to bona fide errors,
member organizations would be required to demonstrate and document the
basis upon which a transaction meets the bona fide error exception.
Minimum Price Improvement Standards
    The proposed rule change establishes the minimum amount of price
improvement necessary for a member organization to execute an order on
a proprietary basis when holding an unexecuted limit order in that same
security without being required to execute the held limit order.
Order Handling Procedures
    The proposed rule change provides that a member organization must
make every effort to execute a marketable customer order that it
receives fully and promptly. A member organization that is holding a
customer order that is marketable and has not been immediately executed
must make every effort to cross such order with any other order
received by the member organization on the other side of the market up
to the size of such order at a price that is no less than the best bid
and no greater than the best offer at the time that the subsequent
order is received by the member organization and that is consistent
with the terms of the orders. In the event that a member organization
is holding multiple orders on both sides of the market that have not
been executed, the member organization must make every effort to cross
or otherwise execute such orders in a manner that is reasonable and
consistent with the objectives of the proposed rule and with the terms
of the orders. A member organization can satisfy the crossing
requirement by contemporaneously buying from the seller and selling to
the buyer at the same price.
Trading Outside Normal Market Hours
    A member organization generally may limit the life of a customer
order to the period of normal market hours of 9:30 a.m. to 4 p.m.
Eastern Time. However, if the customer and member organization agree to
the processing of the customer's order outside normal market hours, the
protections of proposed NYSE Amex Equities Rule 5320 would apply to
that customer's order(s) at all times the customer order is executable
by the member organization.
Conforming and Other Changes
    The Exchange further proposes to make a conforming change to NYSE
Amex Equities Rule 900 to delete a reference to NYSE Amex Equities Rule
92 and to delete rule text that provided that NYSE Amex Equities Rule
92 shall not preclude a member or member organization from entering in
the Off-Hours Trading Facility an aggregate-price order to buy (sell)
15 or more securities coupled with an identical order to sell (buy)
when the member or member organization holds an unexecuted closing-
price order for a component security. The Exchange has determined that,
as part of the harmonization process, it will not keep this exception
to NYSE Amex Equities Rule 92. The Exchange further notes that the NYSE
Amex Equities Rule 900 reference is no longer necessary because
proposed NYSE Amex Equities Rule 5320 does not bar the entry of an
order for a member organization's own account when holding an
unexecuted customer order; rather, if the NYSE Amex Equities Rule 5320
customer order protections are applicable, the member organization only
needs to ensure that a customer order is executed up to the size and
the same or better price at which it traded for its own account.
    The Exchange has filed a series of operative delays for NYSE Amex
Equities Rule 92(c)(3),\8\ which permits Exchange member organizations
to submit riskless principal orders to the Exchange, but requires them
to submit to a designated Exchange database a report of the execution
of the facilitated order. In extending the operative delay to September
12, 2011, the Exchange stated that it was premature to require firms to
meet the Exchange's Front End Systemic Capture reporting requirements
pending full harmonization of the respective customer order protection
rules with FINRA. In adopting NYSE Amex Equities Rule 5320 and deleting
the text of NYSE Amex Equities Rule 92 in its entirety, no additional
operative delays for NYSE Amex Equities Rule 92(c)(3) are necessary, as
the Exchange will use the FINRA model to capture riskless principal
orders.\9\
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    \8\ See Securities Exchange Act Release Nos. 59620 (Mar. 23,
2009), 74 FR 14176 (Mar. 30, 2009) (SR-NYSEALTR-2009-29); 60397
(July 30, 2009), 74 FR 39128 (Aug. 5, 2009) (SR-NYSEAmex-2009-48);
61250 (Dec. 29, 2009), 75 FR 477 (Jan. 5, 2010) (SR-NYSEAmex-2009-
92); 62540 (July 21, 2010), 75 FR 44040 (July 27, 2010) (SR-
NYSEAmex-2010-70); 63454 (December 7, 2010), 75 FR 77685 (Dec. 13,
2010) (SR-NYSEAmex-2010-111); and 64859 (July 12, 2011), 76 FR 42147
(July 18, 2011) (SR-NYSEAmex-2011-47).
    \9\ All member organizations that would be subject to proposed
NYSE Amex Equities Rule 5320 also are subject to FINRA Rule 5320 and
would therefore report riskless principal transactions as required
under the FINRA Rule. There would be no need for them to separately
report riskless principal transactions to the Exchange.
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    For consistency with Exchange rules, NYSE Amex Equities Rule 5320
will have certain differences from FINRA Rule 5320. The Exchange
proposes not to include Supplementary Material .02(b) and portions of
Supplementary Material .06, which relate to OTC equity securities, and
to change all references from ``members'' to ``member organizations.''
Implementation Date
    The Exchange proposes to implement NYSE Amex Equities Rule 5320 on
the same date that FINRA implements FINRA Rule 5320, which FINRA has
announced will be September 12, 2011.\10\ The Exchange will provide
notice of the implementation date to its

member organizations via an Information Memorandum.
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    \10\ See FINRA Regulatory Notice 11-24.
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2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) \11\ of
the Act, in general, and furthers the objectives of Section 6(b)(5)
\12\ in particular in that it is designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in facilitating transactions in securities, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system and, in general, to protect investors and the
public interest. The Exchange believes that adopting the proposed rule
at the same time that FINRA implements a substantially similar rule
will contribute to investor protection by defining important parameters
by which member organizations must abide when trading proprietarily
while holding customer limit and market orders, and foster cooperation
by harmonizing requirements across self-regulatory organizations.
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    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

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

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \13\ and Rule 19b-4(f)(6) thereunder.\14\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6)(iii) thereunder.
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    \13\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \14\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under Rule 19b-4(f)(6) \15\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\16\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest.
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    \15\ 17 CFR 240.19b-4(f)(6).
    \16\ 17 CFR 240.19b-4(f)(6)(iii).
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    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSEAmex-2011-59 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEAmex-2011-59. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for 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 a.m. and 3 p.m. Copies of such 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-
NYSEAmex-2011-59 and should be submitted on or before September 14,
2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
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    \17\ 17 CFR 200.30-3(a)(12).
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Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-21657 Filed 8-23-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 85 (Wednesday, May 3, 2023)]
[Notices]
[Pages 27884-27885]
[FR Doc No: 2023-09316]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-10926-01-OA]

Public Meeting of the Science Advisory Board CASTNet Review Panel

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) Science Advisory
Board (SAB) Staff Office a public meeting of the Science Advisory Board
CASTNet Review Panel. The purpose of the public meeting is to receive
briefings from EPA on the CASTNet monitoring network, hear public
comments, ask any clarifying questions, and deliberate publicly on
charge questions regarding the Panel's review of the network and a
report from EPA's Office of Air and Radiation. Additional information,
materials, background, meeting agendas, and activities will be posted
on SAB's website at: https://sab.epa.gov.

DATES:
    Public Meetings: The Science Advisory Board CASTNet Review Panel
will hold a three-day meeting on the following dates. All times listed
are in eastern daylight time (EDT).

1. Wednesday, May 24, 2023, from 12:00 p.m. to 5:00 p.m.
2. Thursday, May 25, 2023, from 8:00 a.m. to 5:00 p.m.
3. Friday, May 26, 2023, from 8:00 a.m. to 12:00 p.m.

    Public Comments: See the section titled ``Procedures for Providing
Public Input'' under SUPPLEMENTARY INFORMATION

ADDRESSES: The public meeting will be held at AC Hotel by Marriott
Bethesda Downtown at 4646 Montgomery Ave., Bethesda, MD 20814. Please
refer to the SAB website at https://sab.epa.gov for details on how to
access the meeting, including requesting teleconference or obtaining
online simulcasting information.

FOR FURTHER INFORMATION CONTACT: Any member of the public who wants
further information concerning this notice may contact Dr. Bryan
Bloomer, Designated Federal Officer (DFO), via telephone (202) 564-
4222, or email at [email protected]. General information about the
SAB, as well as any updates concerning the meetings announced in this
notice can be found on the SAB website at https://sab.epa.gov.

SUPPLEMENTARY INFORMATION: Background: The SAB was established pursuant
to the Environmental Research, Development, and Demonstration
Authorization Act (ERDDAA), codified at 42 U.S.C. 4365, to provide
independent scientific and technical advice to the EPA Administrator on
the scientific and technical basis for agency positions and
regulations. The SAB is a Federal Advisory Committee chartered under
the Federal Advisory Committee Act (FACA), 5 U.S.C., App. 2. The SAB
will comply with the provisions of FACA and all appropriate SAB Staff
Office procedural policies. Pursuant to FACA and EPA policy, notice is
hereby given that the Science Advisory Board CASTNet Review Panel will
hold a public meeting to receive a presentation of review materials, on
the charge questions, to receive public comments, and to deliberate
upon the charge questions regarding the CASTNet monitoring network.
    Availability of Meeting Materials: All meeting materials, including
the agenda, will be available on the SAB web page at https://sab.epa.gov.
    Procedures for Providing Public Input: Public comment for
consideration by EPA's federal advisory committees and panels has a
different purpose from public comment provided to EPA program offices.
Therefore, the process for submitting comments to a federal advisory
committee is different from the process used to submit comments to an
EPA program office. Federal advisory committees and panels, including
scientific advisory committees, provide independent advice to the EPA.
Members of the public can submit relevant comments pertaining to the
committee's charge or meeting materials. Input from the public to the
SAB will have the most impact if it provides specific scientific or
technical information or analysis for the SAB to consider or if it
relates to the clarity or accuracy of the technical information.
Members of the public wishing to provide comment should follow the
instruction below to submit comments.
    Oral Statements: In general, individuals or groups requesting an
oral presentation at an in-person meeting will be limited to five
minutes. Each person making an oral statement should consider providing
written comments as well as their oral statement so that the points
presented orally can be expanded upon in writing. Persons interested in
providing oral statements should contact the DFO, in writing
(preferably via email) at the contact information noted above by May
19, 2023, to be placed on the list of registered speakers and to have
the written comments posted publicly for consideration on the SAB
website.

    Written Statements: Written statements will be accepted throughout
the advisory process; however, for timely consideration by SAB members,
statements should be submitted to the DFO by May 19, 2023. Written
statements should be supplied to the DFO at the contact information
above. Submitters are requested to provide an unsigned version of each
document because the SAB Staff Office does not publish documents with
signatures on its websites. Members of the public should be aware that
their personal contact information, if included in any written
comments, may be posted to the SAB website. Copyrighted material will
not be posted without explicit permission of the copyright holder and
should be indicated as such at the time of submission.
    Accessibility: For information on access or services for
individuals with disabilities, please contact the DFO, at the contact
information noted above, preferably at least ten days prior to the
meeting, to give the EPA as much time as possible to process your
request.

V. Khanna Johnston,
Deputy Director, Science Advisory Board Staff Office.
[FR Doc. 2023-09316 Filed 5-2-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: September 26, 2008 (Volume 73, Number 188)]
[Rules and Regulations]
[Page 55722]
[DOCID:fr26se08-6]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 47

Cape Town Treaty Implementation

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; technical amendment.

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

SUMMARY: This final rule corrects a previously published rule. In the
original document, an amendment inadvertently removed two paragraphs
relating to the registration of certain aircraft. This rule reinstates
those two paragraphs in their original form.

DATES: This rule is effective September 26, 2008.

FOR FURTHER INFORMATION CONTACT: Walter Binkley, Civil Aviation
Registry, AFS-750, Mike Monroney Aeronautical Center, 6500 South
MacArthur Boulevard, Oklahoma City, OK 73169; Telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background

    On January 3, 2005, FAA published a final rule revising the
regulations concerning registering aircraft and recording security
documents (70 FR 245). These revisions were required by the Cape Town
Treaty Implementation Act of 2004. The Cape Town Treaty established a
new International Registry for registering interests against certain
aircraft and aircraft engines. The rule also made unrelated technical
changes to other portions of the regulations.
    One of the technical changes affected 14 CFR 47.35. The amendment
should have revised paragraph (a) introductory text, in order to revise
an outdated reference to an Act. However, the entire paragraph (a) was
inadvertently revised, which resulted in the loss of paragraphs (a)(1)
and (a)(2). The information in paragraphs (a)(1) and (a)(2) was still
necessary and should have remained in the section.

Technical Amendment

    This technical amendment merely reinstates paragraphs (a)(1) and
(a)(2) to 14 CFR 47.35. The text of these paragraphs remains as it was
at the time of their inadvertent removal.

Justification for Immediate Adoption

    Because this action reinstates paragraphs that were never intended
to be removed, the FAA finds that notice and public comment under 5
U.S.C. 553(b) is unnecessary. For the same reason, the FAA finds that
good cause exists under 5 U.S.C. 553(d) for making this rule effective
upon publication.

List of Subjects in 14 CFR Part 47

    Aircraft, Reporting and recordkeeping requirements.

The Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends Chapter I of Title 14, Code of Federal Regulations, part 47, as
follows:

PART 47-AIRCRAFT REGISTRATION

0
1. The authority citation for part 47 continues to read as follows:

    Authority: 4 U.S.T. 1830; Pub. L. 108-297, 118 Stat. 1095 (49
U.S.C. 40101 note, 49 U.S.C. 44101 note); 49 U.S.C. 106(g), 40113-
40114, 44101-44108, 44110-44113, 44703-44704, 44713, 45302, 46104,
46301.

0
2. Amend Sec.  47.35 by adding paragraphs (a)(1) and (a)(2) to read as
follows:

Sec.  47.35  Aircraft last previously registered in the United States.

    (a) * * *
    (1) If the applicant bought the aircraft from the last registered
owner, the conveyance must be from that owner to the applicant.
    (2) If the applicant did not buy the aircraft from the last
registered owner, he must submit conveyances or other instruments
showing consecutive transactions from the last registered owner through
each intervening owner to the applicant.
* * * * *

    Issued in Washington, DC, on September 22, 2008.
Pamela Hamilton-Powell,
Director, Office of Rulemaking.
 [FR Doc. E8-22586 Filed 9-25-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 43 (Tuesday, March 7, 2017)]
[Notices]
[Pages 12898-12899]
[FR Doc No: 2017-04388]

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

 DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2016-0384]

Qualification of Drivers; Exemption Applications; Diabetes

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of denials.

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

SUMMARY: FMCSA announces its denial of 74 applications from individuals
who requested an exemption from the Federal diabetes standard
applicable to interstate truck and bus drivers and the reasons for the
denials. FMCSA has statutory authority to exempt individuals from the
diabetes requirement if the exemptions granted will not compromise
safety. The Agency has concluded that granting these exemptions does
not provide a level of safety that will be equivalent to, or greater
than, the level of safety maintained without the exemptions for these
commercial motor vehicle (CMV) drivers.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE., Room W64-113,
Washington, DC 20590-0001. Office hours are 8:30 a.m. to 5 p.m., e.t.,
Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the Federal diabetes standard for a renewable 2-year period if it
finds ``such an exemption would likely achieve a level of safety that
is equivalent to, or greater than, the level that would be achieved
absent such an exemption.'' The procedures for requesting an exemption
are set forth in 49 CFR part 381.
    Accordingly, FMCSA evaluated 74 individual exemption requests on
their merits and made a determination that these applicants do not
satisfy the criteria eligibility or meet the terms and conditions of
the Federal exemption program. Each applicant has, prior to this
notice, received a letter of final disposition on the exemption
request. Those decision letters fully outlined the basis for the denial
and constitute final Agency action. The list published in this notice
summarizes the Agency's recent denials as required under 49 U.S.C.
31315(b)(4) by periodically publishing names and reasons for denial.
    The following 7 applicants met the diabetes requirements of 49 CFR
391.41(b)(3) and do not need an exemption:

James D. Bohanan (TN)
Dean A. Dahlheimer (MN)
James A.E. Harris (PA)
Clifford D. Humphrey (NJ)
Gary L. Knox (MN)
Brian T. McGill (UT)
John C. McGrath (WI)

    The following 33 applicants were not operating CMVs in interstate
commerce:

Epifano M. Alonzo (TX)
Henry W. Beeler (VA)
David Boutwell (NH)
Gary D. Buzzard (OK)
William J. Couch (GA)
Gladys N. Crespo (CT)
Russell L. Fortna (CO)
Glenda L. Haines (IN)
Nan W. Hendley (TX)
Phillip L. Kidney (CT)
Socrates Landestoy (NJ)
Kevin R. Loder (NJ)
Thomas W. McNeil (KY)
Rafael Mendez (CT)
Pamela J. Meziere (MS)
Edward V. Mixdorf (WI)
William C. Moore (GA)
Derek G. Norde (MO)
Alejandro Palacios (FL)
David A. Panza (OH)
Sonel Pierre-Louis (FL)
Robert B. Riley (NC)
Niguel A. Salinas (TX)
Warren A. Smith (NJ)
Donald S. Staiger (NJ)
Ernest P. Stengel (CT)
Vicki L. Stone (HI)
Zachary L.D. Tennant (WV)
Danny Thomas (PA)
Carlos F. Webb (VA)
Shane D. Weber (LA)
Charles L. Willingham (AZ)
Edward B. Wilson (VA)

    The following 8 applicants have had more than one hypoglycemic
episode requiring hospitalization or the assistance of others, or has
had one such episode but has not had one year of stability following
the episode:

Weston Arnick (MD)
Ryan L. Cox (NY)
Patricia A. Koch (AR)
Clarissa M. Olson (MO)
Silvio N. Pantaleon (NY)
Clinton W. Reynolds (VA)
Kevin G. Snyder (IN)
Hans J. Woelk (WA)

    The following 3 applicants had other medical conditions making the
applicant otherwise unqualified under the Federal Motor Carrier Safety
Regulations:

James V. Maiorana (NY)
Robert A. Shamberger (NC)
Kenny L. White (OR)

    The following applicant, Ray S. Justus (PA), did not have an
endocrinologist willing to make a statement that he is able to operate
a CMV from a diabetes standpoint.
    The following 2 applicants are unable or have not demonstrated with
willingness to properly monitor and manage his or her diabetes, whether
by a personal decision or medical inability:

Gerald W. Fitch (OH)
Tyler T. Turner (TN)

    The following 2 applicants currently reside in Canada. They are not
eligible because the Federal exemption is for drivers operating only in
the United States:

Tony J. Basaraba (SK)
Jerzy R. Rudowski (BC)

    The following applicant, Dale W. Perkins (MO), has peripheral
neuropathy or circulatory insufficiency

of the extremities likely to interfere with his ability to operate a
CMV.
    The following 5 applicants did not meet the minimum age criteria
outlined in 49 CFR 391.41(b)(1) which states that an individual must be
at least 21 years old to operate a CMV in interstate commerce:

Alex J. Erickson (ND)
Michael T. Fitzpatrick (MA)
Bradley R. Knudson (ND)
Grant A. Mason (WA)
Zachary Vanrossum (WI)

    The following 12 applicants were exempt from the diabetes standard:

Antonio Ballo (NY)
Davarus L. Bouknight (SC)
John V. Buehler (CT)
Alfred E. Canfield (OK)
Burl E. Cox (KY)
Mitchell F. Durkan (CO)
Thomas E. Fooshee (AZ)
Steven J. Hamilton (CO)
Sarah M. Harrison (PA)
Rupert N. Isaac (PA)
Larry D. Lambert (TX)
Yesimar P. Lozada (IA)

     Issued on: February 27, 2017.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2017-04388 Filed 3-6-17; 8:45 am]
 BILLING CODE 4910-EX-P


Pollutant Code Match to CAS Number ( poll2cas. sd2)

Crosswalk between the Pollutant code assigned by ERG and the pollutant CAS number.

Data Element Definitions POLLUTAN  Pollutant parameter POLLUTA1  Pollutant code CAS_ NUMB  Pollutant Chemical Abstract number


[Federal Register Volume 87, Number 178 (Thursday, September 15, 2022)]
[Rules and Regulations]
[Pages 56583-56589]
[FR Doc No: 2022-19954]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 516

[Docket No. FDA-2022-N-1128]
RIN 0910-AI46

Defining Small Number of Animals for Minor Use Determination;
Periodic Reassessment

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Direct final rule.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
revising the ``small number of animals'' definition for dogs and cats
in our existing regulation for new animal drugs for minor use or minor
species. The Minor Use and Minor Species Animal Health Act of 2004
(MUMS Act) provides incentives to encourage animal drug sponsors to
develop and seek FDA approval of drugs intended for use in minor animal
species or for minor uses in major animal species. Congress provided a
statutory definition of ``minor use'' that relies on the phrase ``small
number of animals'' to characterize such use. We are revising the
definition of ``small number of animals'' based on our most recent
reassessment of the small numbers, which we conducted from 2018 to
2019.

DATES: This rule is effective December 14, 2022. Either electronic or
written comments on this direct final rule or its companion proposed
rule must be submitted by November 14, 2022. If FDA receives no
significant adverse comments within the specified comment period, the
Agency intends to publish a document confirming the effective date of
the final rule in the Federal Register within 30 days after the comment
period on this direct final rule ends. If timely significant adverse
comments are received, the Agency will publish a document in the
Federal Register withdrawing this direct final rule within 30 days
after the comment period on this direct final rule ends.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 14, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.

     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2022-N-1128 for ``Defining Small Number of Animals for Minor Use
Determination; Periodic Reassessment.'' Received comments, those filed
in a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' will be
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     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.govinfo.gov/content/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,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Margaret Oeller, Center for Veterinary
Medicine (HVF-50), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>, email: [email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose and Coverage of the Direct Final Rule
    B. Summary of the Major Provisions of the Direct Final Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations and Commonly Used Acronyms in This
Document
III. Background
    A. Introduction
    B. History of Defining Small Numbers for Dogs and Cats
    C. Need for the Regulatory Action
IV. Legal Authority
V. Description of the Direct Final Rule
    A. Revisions to the ``Small Number of Animals'' Definition in
Sec.  516.3
    B. Reassessment of the Small Numbers for Dogs and Cats
VI. Direct Final Rulemaking
VII. Economic Analysis of Impacts
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With Indian Tribal Governments
XII. References

I. Executive Summary

A. Purpose and Coverage of the Direct Final Rule

    This direct final rule amends the definition of ``small number of
animals'' as it relates to dogs and cats in our regulation implementing
the MUMS Act. The term ``minor use'' is the intended use of a drug in a
major species for an indication that occurs infrequently and in only a
small number of animals, or occurs in limited geographical areas and in
only a small number of animals annually. The ``small number of
animals'' definition is used for purposes of determining whether a
particular intended use of a drug in one of the seven major species of
animals (horses, dogs, cats, cattle, pigs, turkeys, and chickens)
qualifies as a minor use. In March 2008, FDA issued a proposed rule to
establish the meaning of ``small number of animals'' as that term is
used in the definition of minor use included in the Federal Food, Drug,
and Cosmetic Act (FD&C Act). FDA finalized the rule in August 2009. The
definition for the phrase ``small number of animals'' includes a
specific upper limit number (i.e., small number) for each of the seven
major species of animals.
    In response to comments submitted to FDA regarding the 2008
proposed rule, we stated in the final rule that we would periodically
reevaluate the small numbers and update the definition if necessary.
This direct final rule is the result of our 2018-2019 reassessment of
the ``small numbers of animals.''

B. Summary of the Major Provisions of the Direct Final Rule

    Based on our 2018-2019 reassessment, we are revising the small
number for dogs included in the ``small number of animals'' definition
from 70,000 to 80,000 and the small number for cats from 120,000 to
150,000.

C. Legal Authority

    The legal authority for this direct final rule is the MUMS Act,
which amended the FD&C Act. Additional authority comes from the
``Regulations and Hearings'' section of the FD&C Act, which authorizes
FDA to issue regulations for the efficient enforcement of the FD&C Act.

D. Costs and Benefits

    Sponsors that apply for and receive conditional approval for a new
animal drug intended for a ``minor use'' in dogs or cats as a result of
the changes to the small numbers made by the direct final rule will be
able to market their drug earlier, which in turn could benefit pet
owners by improving the health of dogs and cats with uncommon diseases
or conditions. Both FDA and those sponsors receiving conditional
approval could receive cost savings from deferring costs associated
with providing FDA with substantial evidence that a new animal drug is
effective until later in the drug development process. ``Substantial
evidence'' is the effectiveness standard that must be met before a
sponsor can receive full approval for its new animal drug under the
FD&C Act. Conditional approval does not require the drug sponsor to
demonstrate effectiveness by ``substantial evidence.'' Instead, the
sponsor has to show that there is a ``reasonable expectation'' of
effectiveness. Sponsors could incur

costs to prepare and submit additional minor use determination requests
and annual designation reports to FDA. In addition, FDA will bear costs
to review any additional minor use determination requests and annual
designation reports it receives from sponsors. FDA estimates that the
annualized benefits over 20 years will range from $0 to $6.06 million
at a 7 percent discount rate, with a primary estimate of $3.03 million,
and from $0 to $7.43 million at a 3 percent discount rate, with a
primary estimate of $3.72 million. Annualized costs will range from
$3,033 to $31,741 at a 7 percent discount rate, with a primary estimate
of $17,387, and from $2,244 to $30,285 at a 3 percent discount rate,
with a primary estimate of $16,264.

II. Table of Abbreviations and Commonly Used Acronyms in This Document

------------------------------------------------------------------------
     Abbreviation/acronym                    What it means
------------------------------------------------------------------------
2013 reassessment............  Reassessment of small numbers conducted
                                by FDA in 2013, the results of which
                                were published in May 2014 (79 FR
                                28736).
AVMA.........................  American Veterinary Medical Association.
21 CFR.......................  Title 21 of the Code of Federal
                                Regulations.
Current reassessment.........  Reassessment of small numbers conducted
                                by FDA in 2018-2019.
FDA..........................  U.S. Food and Drug Administration.
FD&C Act.....................  Federal Food, Drug, and Cosmetic Act.
MUMS.........................  Minor Use and Minor Species.
MUMS Act.....................  Minor Use and Minor Species Animal Health
                                Act of 2004.
OMB..........................  Office of Management and Budget.
Pub. L.......................  Public Law.
------------------------------------------------------------------------

III. Background

A. Introduction

    The MUMS Act (Pub. L. 108-282) amended the FD&C Act to provide
incentives for the development of new animal drugs for use in minor
animal species and for minor uses in major animal species. The MUMS Act
defines ``minor use'' as the intended use of a drug in a major species
for an indication that occurs infrequently and in only a small number
of animals or in limited geographical areas and in only a small number
of animals annually (see section 201(pp) of the FD&C Act (21 U.S.C.
321(pp)). Congress charged FDA to further define the term ``small
number of animals'' for minor use purposes (see Senate Report 108-226
at 8, February 18, 2004). In the Federal Register of March 18, 2008 (73
FR 14411), we issued a proposed rule to define the term ``small number
of animals'' by establishing for each major species of animal (horses,
dogs, cats, cattle, pigs, turkeys, and chickens) an upper limit
threshold (i.e., small number) to provide a means of determining
whether any particular intended use of a new animal drug in one of
these species would qualify as a minor use under the MUMS Act.
    The ``small numbers of animals'' definition was formally
established by the final rule that was published on August 26, 2009 (74
FR 43043). In that final rule, we addressed comments from the public
regarding the 2008 proposed rule, including comments suggesting that
the Agency reevaluate the small numbers on a periodic basis. We agreed
that periodic reassessment of the small numbers is appropriate and that
such reassessments should occur approximately every 5 years.
    We conducted our initial reassessment of the small numbers in 2013
and published the results of that reassessment on May 19, 2014 (79 FR
28736) (the 2013 reassessment). At that time, we did not change the
small numbers for any of the major species.
    From 2018 to 2019, we conducted our second reassessment (current
reassessment) of the small numbers (Ref. 1). Based on the current
reassessment, we are revising (i.e., increasing) the small numbers for
dogs and cats only. Elsewhere in this issue of the Federal Register, we
are publishing a notice to announce that we are not revising the small
numbers in the ``small number of animals'' definition for the other
major species (i.e., horses, cattle, pigs, turkeys, and chickens).
Because we are only revising the ``small number of animals'' definition
as it relates to dogs and cats, the remainder of this document will
focus on those two species.

B. History of Defining Small Numbers for Dogs and Cats

    The term ``small number of animals'' is defined in Sec.  516.3(b)
(21 CFR 516.3(b)) of our regulation on new animal drugs for minor use
and minor species. For each of the seven major species of animals, the
definition specifies the greatest number of animals of that species
that could be treated annually with a new animal drug for a particular
indication and still qualify as a minor use. For dogs and cats, a
``small number of animals'' is defined as equal to or less than 70,000
dogs, or equal to or less than 120,000 cats.
    The process FDA used to establish the small numbers for the
companion animal major species (dogs, cats and horses) is outlined in
detail in the 2008 proposed rule. That process involved estimating the
development cost for an animal drug intended for each of the three
major companion animal species, estimating the amount that companion
animal owners were willing to pay for a drug to treat each of those
species, estimating the average percentage of companion animals that
would likely be treated, and estimating the uncertainty associated with
estimates of the rate of occurrence of various uncommon conditions in
companion animals. Assessment of these various factors resulted in the
formula, published in the proposed rule (73 FR 14411 at 14414), that we
use to determine the small numbers for companion animals.

C. Need for the Regulatory Action

    In the preamble to the 2009 final rule in which we first
established the definition of ``small number of animals,'' we agreed in
response to comments that we should periodically reevaluate the small
numbers and update the definition as necessary. We also agreed that
such a reevaluation should take into account the potential for changes
in the development cost of new animal drugs, changes in the amount that
animal owners are willing to pay to treat affected animals, and changes
in other factors involved in establishing a ``small number,'' such as
the total population of major animal species (74 FR 43043 at 43044).
    In a memorandum containing the results of our current reassessment,
we describe the processes that we used to reevaluate the small number
of animals (Ref. 1). Based on the current reassessment, we are
increasing the small numbers for dogs and cats only.

IV. Legal Authority

    We are issuing this direct final rule under the same legal
authorities described in the proposed and final rules we issued to
establish the ``small number of animals'' definition in 21 CFR part 516
(see 73 FR 14411 at 14415 and 74 FR 43043 at 43049). These authorities
include sections 571, 573, and 701 of the FD&C Act (21 U.S.C. 360ccc,
360ccc-2, and 371). Sections 571 and 573 of the FD&C Act were
established by the MUMS Act. Section 701(a) authorizes the Agency to
issue regulations for the efficient enforcement of the FD&C Act.

V. Description of the Direct Final Rule

A. Revisions to the ``Small Number of Animals'' Definition in Sec.
516.3

    As discussed in section III. C, when we published the final rule
defining ``small number of animals'' for minor use designation in 2009,
we agreed we should periodically reevaluate the small number of animals
to account for changes in drug development costs, changes in the amount
that animal owners are willing to pay to treat affected animals, and
other relevant factors (74 FR 43043 at 43044). Based on our current
reassessment (Ref. 1), we are revising the definition of ``small number
of animals'' in Sec.  516.3(b) to increase the small number for dogs
from 70,000 to 80,000, and to increase the small number for cats from
120,000 to 150,000.

B. Reassessment of the Small Numbers for Dogs and Cats

    For our current reassessment of the small numbers, our primary
source of information regarding costs related to dogs and cats is a
2018 report prepared by Brakke Consulting Inc., (BCI) containing
population estimates, disease incidence rates, and information about
drug development costs and treatment costs for companion animals (Ref.
2). The 2018 report is the latest update of the BCI report. We used
previous versions of the BCI report for the 2008 proposed rule and the
2013 reassessment. Our primary source of information regarding
healthcare costs for dogs and cats is the 2017-2018 edition of the
American Veterinary Medical Association (AVMA) U.S. Pet Ownership and
Demographics Sourcebook, which contains surveys of pet ownership (Ref.
3). This is an updated version of the same source we used for our 2008
proposed rule and the 2013 reassessment.
    After evaluating the relevant data from these sources and using
that information to reassess the small numbers for dogs and cats, we
determined that the small numbers for dogs and cats should be
increased. Therefore, we are revising the definition of ``small numbers
of animals'' for these two species. For a full discussion of our
current reassessment of the small numbers, see our current reassessment
memorandum (Ref. 1).

VI. Direct Final Rulemaking

    In the document entitled ``Guidance for FDA and Industry: Direct
Final Rule Procedures,'' announced in the Federal Register of November
21, 1997 (62 FR 62466), FDA describes its procedures on when and how
the Agency will employ direct final rulemaking. The guidance may be
accessed at: https://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm.
    We have determined that the subject of this rulemaking is suitable
for a direct final rule. We are revising the ``small number of
animals'' definition for dogs and cats in Sec.  516.3(b) to increase
the small numbers for these two species. This rule is intended to make
noncontroversial changes to an existing regulation. We do not
anticipate that there will be any significant adverse comments.
    Consistent with our procedures on direct final rulemaking, we are
publishing elsewhere in this issue of the Federal Register a companion
proposed rule. The companion proposed rule and this direct final rule
are substantively identical. The companion proposed rule provides the
procedural framework within which the rule may be finalized in the
event the direct final rule is withdrawn because of a significant
adverse comment. The comment period for this direct final rule runs
concurrently with the comment period for the companion proposed rule.
Any comments received in response to the companion proposed rule will
also be considered as comments regarding this direct final rule.
    We are providing a comment period for the direct final rule of 60
days after the date of publication in the Federal Register. If we
receive a significant adverse comment, we intend to withdraw this
direct final rule before its effective date by publishing a
notification in the Federal Register within 30 days after the comment
period ends. A significant adverse comment explains why the rule would
be inappropriate, including challenges to the rule's underlying premise
or approach, or would be ineffective or unacceptable without a change.
In determining whether an adverse comment is significant and warrants
withdrawing a direct final rule, we will consider whether the comment
raises an issue serious enough to warrant a substantive response in a
notice-and-comment process in accordance with section 553 of the
Administrative Procedure Act (5 U.S.C. 553).
    Comments that are frivolous, insubstantial, or outside the scope of
the rule will not be considered significant or adverse under this
procedure. A comment recommending a regulation change in addition to
those in the direct final rule would not be considered a significant
adverse comment unless the comment states why the rule would be
ineffective without the additional change. In addition, if a
significant adverse comment applies to a part of this rule and that
part can be severed from the remainder of the rule, we may adopt as
final those provisions of the rule that are not the subject of the
significant adverse comment.
    If any significant adverse comment is received during the comment
period, we will publish, before the effective date of this direct final
rule, a notification of significant adverse comment and withdraw the
direct final rule. If we withdraw the direct final rule, any comments
received will be applied to the proposed rule and will be considered in
developing a final rule using the usual notice-and-comment procedure.
If we do not receive any significant adverse comment in response to
this direct final rule during the comment period, we will publish a
document in the Federal Register confirming the effective date of the
final rule within 30 days after the comment period ends.

VII. Economic Analysis of Impacts

    We have examined the impacts of the direct final rule under
Executive Order 12866, Executive Order 13563, the Regulatory
Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform
Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us
to assess all costs and benefits of available regulatory alternatives
and, when regulation is necessary, to select regulatory approaches that
maximize net benefits (including potential economic, environmental,
public health and safety, and other advantages; distributive impacts;
and equity). We believe that this direct final rule is not a
significant regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because net costs of the direct final rule are less than 0.32
percent of average annual revenues for the smallest firms

in the industry, we certify that the direct final rule will not have a
significant economic impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``any rule that includes
any Federal mandate that may result in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $165
million, using the most current (2021) Implicit Price Deflator for the
Gross Domestic Product. This direct final rule would not result in an
expenditure in any year that meets or exceeds this amount.
    By expanding incentives for new animal drug development under the
MUMS Act as a result of increasing the small numbers for dogs and cats,
the direct final rule could benefit pet owners by improving the health
of dogs and cats with uncommon diseases or conditions. These health
improvements could result from the earlier marketing of new animal
drugs by sponsors that apply for and receive conditional approval as a
result of the direct final rule. The direct final rule also could
result in cost savings to new animal drug sponsors and FDA. Sponsors
that receive conditional approval have the ability to market their new
animal drug for up to 5 years, subject to annual renewals, before
providing substantial evidence that it is effective, as required for
full approval. This would defer costs to sponsors and FDA associated
with a demonstration of substantial evidence of effectiveness until
later in the development process.
    Because the direct final rule could increase the number of uncommon
diseases or conditions in dogs and cats that qualify for minor use drug
development incentives, including user fee waivers, exclusive marketing
rights, grants, and eligibility for conditional approval, sponsors
could incur costs to prepare and submit additional minor use
determination requests and, for those sponsors that pursue designation
for their new animal drug, annual designation reports to FDA. FDA will
bear costs to review any additional minor use determination requests
and annual designation reports. Potential sponsors of new animal drugs
for minor uses in dogs or cats will also incur a one-time cost to read
and understand the direct final rule.
    We additionally estimate potential within-industry transfers from
sponsors receiving user fee waivers as a result of the direct final
rule to fee-paying sponsors, and transfers from government to industry
in the form of grants to support safety and effectiveness testing.
    We summarize the annualized benefits and costs of the rule in table
1. We estimate that the annualized benefits over 20 years will range
from $0 to $6.06 million at a 7 percent discount rate, with a primary
estimate of $3.03 million, and from $0 to $7.43 million at a 3 percent
discount rate, with a primary estimate of $3.72 million. Annualized
costs will range from $3,033 to $31,741 at a 7 percent discount rate,
with a primary estimate of $17,387, and from $2,244 to $30,285 at a 3
percent discount rate, with a primary estimate of $16,264.

                                       Table 1--Summary of Benefits, Costs, and Distributional Effects of the Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Units
                                                                           ------------------------------------
               Category                   Primary       Low        High                               Period                      Notes
                                         estimate    estimate    estimate      Year      Discount     covered
                                                                              dollars    rate (%)     (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized ($m/year)....       $3.03       $0.00       $6.06        2021           7          20  These include benefits to pet owners and
                                              3.72        0.00        7.43        2021           3          20   cost savings to industry and FDA.
                                       ------------------------------------------------------------------------
    Annualized Quantified.............

    Qualitative.

--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized ($m/year)....       0.017       0.003       0.032        2021           7          20
                                             0.016       0.002       0.030        2021           3          20
                                       ------------------------------------------------------------------------
    Annualized Quantified.............

    Qualitative.

--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers: \1\
    Federal Annualized Monetized ($m/         0.43        0.00        0.86        2021           7          20
     year).                                   0.48        0.00        0.97        2021           3          20
                                       -----------------------------------------------------------------------------------------------------------------
                                        From: Government
                                        To: Industry
                                       -----------------------------------------------------------------------------------------------------------------
    Other Annualized Monetized ($m/           0.47        0.00        0.94        2021           7          20
     year).                                   0.57        0.00        1.14        2021           3          20
                                       -----------------------------------------------------------------------------------------------------------------
                                        From: Industry
                                        To: Industry
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local, or Tribal Government: None............................................................................................................
    Small Business: Quantified effects of less than 0.32 percent of average annual revenues for the smallest firms......................................
    Wages: None.........................................................................................................................................
    Growth: None........................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Transfers are monetary payments between persons or groups that do not affect the total resources available to society.

    We have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of the direct final rule. The full analysis of
economic impacts is available in the docket for this direct final rule
(Ref. 4) and at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

VIII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IX. Paperwork Reduction Act of 1995

    This direct final rule 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. 3501-3521). A
description of these provisions is given in the Description section of
this document with an estimate of the annual recordkeeping burden.
Included in the estimate is the time for reviewing instructions,
searching existing data sources, gathering and maintaining the data
needed, and completing and reviewing each collection of information.
    Title: Designated New Animal Drugs for Minor Use and Minor Species;
OMB control number 0910-0605--Revision.
    Description: The direct final rule revises the ``small number of
animals'' definition for dogs and cats in our existing regulation at
Sec.  516.3(b) for new animal drugs for minor use and minor species.
The small numbers for dogs and cats are increased. The MUMS Act
provides incentives to encourage animal drug sponsors to develop and
seek FDA approval of drugs intended for use in minor species or for
minor uses in major animal species. Congress provided a statutory
definition of ``minor use'' that relies on the phrase ``small number of
animals'' to characterize such use. The ``small number of animals''
definition is used for purposes of determining whether a particular
intended use of a drug in one of the major species of animals qualifies
as a minor use.
    Description of Respondents: Pharmaceutical companies that sponsor
new animal drugs.
    We estimate the burden of this information collection as follows:

                                                    Table 2--Estimated One-time Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
                   Activity                       Number of      records per    Total annual        Average burden per recordkeeping        Total hours
                                                recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reading and Understanding the Rule...........             474               1             474  0.683 (41 minutes).......................             323
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Using the number of active sponsors of new animal drug applications
and active sponsors of abbreviated new animal drug applications, we
estimate there are 237 sponsors affected by this rule. We estimate two
recordkeepers per sponsor.
    We expect that new animal drug sponsors will incur a one-time
burden associated with reading and understanding the rule and a nominal
increase in the overall annual burden associated with reporting
requirements resulting from a potential increase in submissions of
minor use determination requests and annual designation reports to FDA.
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3507(d)), we have submitted the information collection provisions of
this direct final rule to OMB for review. Before the effective date of
this direct final rule, FDA will publish a notice in the Federal
Register announcing OMB's decision to approve, modify, or disapprove of
the information collections of this direct final rule.
    An Agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number.

X. Federalism

    We have analyzed this direct final rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
the direct final rule does not contain policies that have substantial
direct effects 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. Accordingly,
we conclude that the rule does not contain policies that have
federalism implications as defined in the Executive order and,
consequently, a federalism summary impact statement is not required.

XI. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this direct final rule in accordance with the
principles set forth in Executive Order 13175. We have determined that
the direct final rule does not contain policies that would have a
substantial direct effect on one or more Indian Tribes, on the
relationship between the Federal Government and Indian Tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian Tribes. Accordingly, we conclude that the direct
final rule does not contain policies that have tribal implications as
defined in the Executive order and, consequently, a tribal summary
impact statement is not required.

XII. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.

* 1. FDA Memorandum, ``2018-2019 Reassessment of Small Numbers of
Animals for Minor Use Determination'', 2021.
* 2. Brakke Consulting, Inc., Update of Population Estimates,
Disease Incidence Rates, Drug Development Costs and Treatment Costs
for Companion Animals,'' October 22, 2018.
3. American Veterinary Medical Association, ``Pet Ownership and
Demographics Sourcebook,'' 2017-2018 Edition, October 2018. Accessed
November 09, 2021. https://www.avma.org/news/press-releases/avma-releases-latest-stats-pet-ownership-and-veterinary-care and https://www.avma.org/sites/default/files/resources/AVMA-Pet-Demographics-Executive-Summary.pdf.
* 4. FDA, ``Final Regulatory Impact Analysis, Final Regulatory
Flexibility Analysis, Unfunded Mandates Reform Act Analysis'', 2021.

List of Subjects in 21 CFR Part 516

    Administrative practice and procedure, Animal drugs, Confidential

business information, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
516 is amended as follows:

PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES

0
1. The authority citation for part 516 continues to read as follows:

    Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371.

0
2. Amend Sec.  516.3(b) by revising the definition for ``Small number
of animals'' to read as follows:

Sec.  516.3  Definitions.

* * * * *
    (b) * * *
    Small number of animals means equal to or less than 50,000 horses;
80,000 dogs; 150,000 cats; 310,000 cattle; 1,450,000 pigs; 14,000,000
turkeys; and 72,000,000 chickens.
* * * * *

    Dated: August 31, 2022.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2022-19954 Filed 9-14-22; 8:45 am]
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[Federal Register: May 20, 2009 (Volume 74, Number 96)]
[Rules and Regulations]
[Page 23617-23618]
[DOCID:fr20my09-4]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-0035; Directorate Identifier 2008-NM-096-AD;
Amendment 39-15909; AD 2009-10-13]
RIN 2120-AA64

Airworthiness Directives; Saab AB, Saab Aerosystems Model 340A
(SAAB/SF340A) and SAAB 340B Airplanes

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

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD results from mandatory continuing
airworthiness information (MCAI) 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:

    Field experiences have revealed cracks in the frames and closing
angle on the forward engine cowl door * * *.
    In case of a damaged frame and/or closing angle, the forward
engine cowl door can loosen during flight and depart from the
aircraft.

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

DATES: This AD becomes effective June 24, 2009.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of June 24,
2009.

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

FOR FURTHER INFORMATION CONTACT: Shahram Daneshmandi, Aerospace
Engineer, International Branch, ANM-116, Transport Airplane
Directorate, FAA, 1601 Lind Avenue, SW., Renton, Washington 98057-3356;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on February 17, 2009
(74 FR 7384). That NPRM proposed to correct an unsafe condition for the
specified products. The MCAI states:

    Field experiences have revealed cracks in the frames and closing
angle on the forward engine cowl door NS STA [nacelle station] 203
and 250.
    In case of a damaged frame and/or closing angle, the forward
engine cowl door can loosen during flight and depart from the
aircraft.
    This AD is issued to require a detailed inspection to find out
if there are any cracks [or deformations or wear damage] in the
frames and/or the closing angles. The inspection is on four points
on each of the forward engine cowl doors.

The corrective action depends on if the crack, deformation, or wear
damage is within or outside certain defined limits, and includes doing
a repair either in accordance with the specified service information,
or contacting Saab for repair instructions and doing the repair. You
may obtain further information by examining the MCAI in the AD docket.

Comments

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

Conclusion

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

Differences Between This AD and the MCAI or Service Information

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

Costs of Compliance

    We estimate that this AD will affect 141 products of U.S. registry.
We also estimate that it will take about 2 work-hours per product to
comply with the basic requirements of this AD. The average labor rate
is $80 per work-hour. Based on these figures, we estimate the cost of
this AD to the U.S. operators to be $22,560, or $160 per product.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under 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 AD and placed it in the AD docket.

Examining the AD Docket

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2009-10-13 Saab AB, Saab Aerosystems: Amendment 39-15909. Docket No.
FAA-2009-0035; Directorate Identifier 2008-NM-096-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective June 24,
2009.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Saab AB, Saab Aerosystems Model 340A
(SAAB/SF340A) airplanes, serial numbers (S/Ns) 004 through 159
inclusive, and Model SAAB 340B airplanes, S/Ns 160 through 459
inclusive; certificated in any category.

Subject

    (d) Air Transport Association (ATA) of America Code 71:
Powerplant.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:
    Field experiences have revealed cracks in the frames and closing
angle on the forward engine cowl door NS STA [nacelle station] 203
and 250.
    In case of a damaged frame and/or closing angle, the forward
engine cowl door can loosen during flight and depart from the
aircraft.
    This AD is issued to require a detailed inspection to find out
if there are any cracks [or deformations or wear damage] in the
frames and/or the closing angles. The inspection is on four points
on each of the forward engine cowl doors.

The corrective action depends on if the crack, deformation, or wear
damage is within or outside certain defined limits, and includes
doing a repair either in accordance with the specified service
information, or contacting Saab for repair instructions and doing
the repair.

Actions and Compliance

    (f) Unless already done, do the following actions.
    (1) Within 1,000 flight hours after the effective date of this
AD, do a detailed inspection for cracking, deformation, or wear
damage of the frame and closing angle on the forward engine cowl
door, in accordance with the Accomplishment Instructions of Saab
Service Bulletin 340-71-060, dated February 8, 2008.
    (2) If any crack, deformation, or wear damage is found during
the inspection required by paragraph (f)(1) of this AD, before
further flight, do all applicable corrective actions in accordance
with the Accomplishment Instructions of Saab Service Bulletin 340-
71-060, dated February 8, 2008.
    (3) Submit a report of the findings of the inspection required
by paragraph (f)(1) of this AD to Saab at the address specified in
Saab Service Bulletin 340-71-060, dated February 8, 2008. Submit the
report at the applicable time specified in paragraph (f)(3)(i) or
(f)(3)(ii) of this AD. The report must include the information
specified in the ``Inspection Result Formula'' form in the service
bulletin.
    (i) If the inspection was done after the effective date of this
AD: Submit the report within 30 days after the inspection.
    (ii) If the inspection was accomplished before the effective
date of this AD: Submit the report within 30 days after the
effective date of this AD.

FAA AD Differences

    Note 1: 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,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. Send information to ATTN:
Shahram Daneshmandi, Aerospace Engineer, International Branch, ANM-
116, Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW.,
Renton, Washington 98057-3356; telephone<PHONE_NUMBER>; fax (425)
227-1149. Before using any approved AMOC on any airplane to which
the AMOC applies, notify your appropriate principal inspector (PI)
in the FAA Flight Standards District Office (FSDO), or lacking a PI,
your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act, the
Office of Management and Budget (OMB) has approved the information
collection requirements and has assigned OMB Control Number 2120-
0056.

Related Information

    (h) Refer to MCAI European Aviation Safety Agency (EASA)
Airworthiness Directive 2008-0069, dated April 11, 2008; and Saab
Service Bulletin 340-71-060, dated February 8, 2008; for related
information.

Material Incorporated by Reference

    (i) You must use Saab Service Bulletin 340-71-060, dated
February 8, 2008, to do the actions required by this AD, unless the
AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact Saab
Aircraft AB, SAAB Aerosystems, SE-581 88, Link[ouml]ping, Sweden;
telephone +46 13 18 5591; fax +46 13 18 4874; e-mail
<EMAIL_ADDRESS>Internet http://
www.saabgroup.com.
    (3) You may review copies of the 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>.
    (4) You may also review copies of the 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/code_of_federal_regulations/
ibr_locations.html.

    Issued in Renton, Washington, on May 6, 2009.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E9-11279 Filed 5-19-09; 8:45 am]

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