[Federal Register Volume 83, Number 73 (Monday, April 16, 2018)]
[Notices]
[Pages 16364-16365]
[FR Doc No: 2018-07824]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-4764]

Policy Clarification and Premarket Notification Submissions for
Ultrasonic Diathermy Devices; Guidance for Industry and Food and Drug
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the guidance entitled ``Policy Clarification and
Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy
Devices; Guidance for Industry and Food and Drug Administration
Staff.'' This guidance clarifies FDA's policy related to compliance
with applicable performance standards and conformance to International
Electrotechnical Commission (IEC) consensus standards for ultrasonic
diathermy devices. This guidance provides recommendations for
information to provide in 510(k) submissions for ultrasonic diathermy
devices.

DATES: The announcement of the guidance is published in the Federal
Register on April 16, 2018.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-D-4764 for ``Policy Clarification and Premarket Notification
[510(k)] Submissions for Ultrasonic Diathermy Devices; Guidance for
Industry and Food and Drug Administration Staff.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff office between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be

made publicly available, submit your comments only as a written/paper
submission. You should submit two copies total. One copy will include
the information you claim to be confidential with a heading or cover
note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.''
The Agency will review this copy, including the claimed confidential
information, in its consideration of comments. The second copy, which
will have the claimed confidential information redacted/blacked out,
will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management
Staff. If you do not wish your name and contact information to be made
publicly available, you can provide this information on the cover sheet
and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Policy Clarification and Premarket Notification [510(k)] Submissions
for Ultrasonic Diathermy Devices; Guidance for Industry and Food and
Drug Administration Staff '' to the Office of the Center Director,
Guidance and Policy Development, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Jismi Johnson, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1524, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry and
FDA staff entitled ``Policy Clarification and Premarket Notification
[510(k)] Submissions for Ultrasonic Diathermy Devices; Guidance for
Industry and Food and Drug Administration Staff.'' Ultrasonic diathermy
devices are class II medical devices regulated under 21 CFR
890.5300(a), Ultrasonic diathermy. Ultrasonic therapy devices must also
comply with FDA radiation safety performance standards in 21 CFR part
1010, Performance standards for electronic products: General, and 21
CFR 1050.10, Ultrasonic therapy products. FDA recognizes that there are
several IEC standards with which other countries require conformance or
recognize for ultrasonic therapy products. This means that
manufacturers who distribute these products in the United States and
other countries might have to ensure conformance of their products to
IEC standards and comply with FDA performance standards. This may cause
manufacturers to duplicate their efforts.
    This guidance clarifies FDA's policy related to compliance with
applicable performance standards and conformance to IEC consensus
standards for ultrasonic diathermy devices. If firms provide a
declaration of conformity with the relevant provisions of the current
FDA recognized versions of the IEC 60601-2-5 and IEC 61689 standards,
FDA does not intend to consider whether firms comply with certain
requirements of 21 CFR 1050.10. This guidance also provides
recommendations for information to provide in 510(k) submissions for
ultrasonic diathermy devices.
    No comments were received on the draft guidance that was published
in the August 31, 2017, Federal Register notice (82 FR 41417).

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on policy clarification and premarket
notification (510(k)) submissions for ultrasonic diathermy devices. It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov.
Persons unable to download an electronic copy of ``Policy Clarification
and Premarket Notification [510(k)] Submissions for Ultrasonic
Diathermy Devices; Guidance for Industry and Food and Drug
Administration Staff'' may send an email request to [email protected] to receive an electronic copy of the document.
Please use the document number 1500003 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 807, subpart E have been
approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 801 have been approved under OMB control
number 0910-0485; the collections of information in 21 CFR part 820
have been approved under OMB control number 0910-0073; and the
collections of information in 21 CFR parts 1002 through 1050 are
approved under OMB control number 0910-0025.

    Dated: April 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07824 Filed 4-13-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 85 (Thursday, May 2, 2019)]
[Notices]
[Pages 18901-18903]
[FR Doc No: 2019-08919]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85732; File No. SR-CBOE-2019-024]

Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Amend
Rule 6.49A To Eliminate the Exchange's On-Floor Position Transfer
Procedure

April 26, 2019.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on April 16, 2019, Cboe Exchange, Inc. (the ``Exchange'' or ``Cboe
Options'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the Exchange. The Exchange
filed the proposal as a ``non-controversial'' proposed rule change
pursuant to Section 19(b)(3)(A) of the Act \3\ and Rule 19b-4(f)(6)
thereunder.\4\ The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Cboe Exchange, Inc. (the ``Exchange'' or ``Cboe Options'') proposes
to amend Rule 6.49A to eliminate the Exchange's on-floor position
transfer procedure. The text of the proposed rule change is provided in
Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), at the Exchange's Office of the
Secretary, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to amend Rule 6.49A to delete the provisions
related to on-floor position transfers and amend the provision
regarding presidential exemptions. Rule 6.49A specifies the
circumstances under which Trading Permit Holders may effect transfers
of positions, both on and off the trading floor, notwithstanding the
prohibition in Rule 6.49(a).\5\ Rule 6.49A(a)(2) permits certain
position transfers to occur on the floor of the exchange or on another
options exchange. The procedures for such on-

floor position transfers are set forth in Rule 6.49A(b) and (c), as
well as Interpretations and Policies .01 through .03. The Exchange no
longer wants to make available on-floor transfers of positions, so the
proposed rule change deletes paragraphs (a)(2), (b), and (c), and
Interpretations and Policies .01 through .03 \6\ from Rule 6.49A.\7\
The on-floor position transfer procedure is administratively burdensome
on the Exchange, and is currently used by Trading Permit Holders on a
limited basis. As the Exchange noted when the rule was adopted, the
Exchange's ``on-floor'' procedure was intended to help ensure that
Trading Permit Holders with a need to transfer positions in bulk as
part of a sale or disposition of all or substantially all of a Trading
Permit Holder's assets or options positions were able to get the best
possible price for the positions while also ensuring that other Trading
Permit Holders have an adequate opportunity to make bids and offers on
the positions that are being transferred.\8\ In addition, the Exchange
noted the ``on-floor'' position transfer procedure could be used by
Market-Makers that, for reasons other than a forced liquidation, such
as an extended vacation, wished to liquidate their entire, or nearly
their entire, open positions in a single set of transactions, subject
to certain restrictions.\9\
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    \5\ Rule 6.49 generally requires transactions of option
contracts listed on the Exchange for a premium in excess of $1.00 to
be effected on the floor of the Exchange or on another exchange.
    \6\ The Exchange proposes to move the provision in
Interpretation and Policy .03 that states the on-floor transfer
procedure is not to be used repeatedly or routinely in circumvention
of the normal auction market process to proposed paragraph (g), as
that provision applies to both the current on-floor and off-floor
position transfer procedures.
    \7\ The proposed rule change makes conforming changes to the
paragraph lettering and numbering in current subparagraph (a)(1)
(proposed subparagraph (a)). Because, as proposed, Rule 6.49A will
only relate to off-floor transfers, the proposed rule change renames
Rule 6.49A and adds a heading to proposed paragraph (a).
    \8\ See Exchange Act Release No. 36647 (December 28, 1995), 61
FR 566 (January 8, 1996) (Order Approving and Notice of Filing and
Order Granting Accelerated Approval of Amendments No. 1 and 2 to a
Proposed Rule Change Relating to the Transfer of Positions on the
Floor of the Exchange in Cases of Dissolution and other Situations)
(SR-CBOE-95-36).
    \9\ Id. Among other restrictions, repeated and frequent use of
the on-floor procedure in Rule 6.49A by a TPH is not permitted.
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    For example, the Exchange's on-floor transfer of positions rule was
also intended to address the common situation in which a Designated
Primary Market-Maker (``DPM'') sold its business or in which a Market-
Maker, for reasons other than a forced liquidation, such as an extended
vacation, wished to liquidate its entire, or nearly entire, position in
a single set of transactions.\10\ Currently, because DPMs have been
largely consolidated in the hands of firms rather than individuals,
such transfers are, for the most part unnecessary; if an individual
takes an extended vacation, another member of the firm handles the
firm's book. Accordingly, the Exchange believes that the on-floor
transfer of positions procedure no longer serves the uses for which is
was originally adopted. The Exchange also notes that at least one other
options exchange with a trading floor and a transfer of positions rule
does not offer an on-floor transfer procedure.\11\
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    \10\ Id.
    \11\ See, e.g., Nasdaq OMX PHLX LLC (``Phlx'') 1058.
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    Current paragraph (d) (proposed paragraph (b)) contains exemptions
to Rule 6.49A(a) that are approved by the Exchange's president.\12\ The
proposed rule change permits the President or a designee to grant an
exemption to the Rule 6.49(a) prohibition if, in his or her judgment,
allowing the off-floor transfer is necessary or appropriate for the
maintenance of a fair and orderly market and the protection of
investors and is in the public interest, including due to unusual or
extraordinary circumstances such as the market value of the Person's
positions will be comprised by having to comply with the requirement to
trade on the Exchange pursuant to the normal auction process or, when
in the judgment of President or his or her designee, market conditions
make trading on the Exchange impractical. The proposed rule change
updates language consistent with the change to only permit off-floor
transfers. Additionally, the additional circumstances in which the
President or a designee may grant an exemption are similar to those
that the President or a designee may consider when taking action under
emergency conditions pursuant to Rule 6.17.
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    \12\ Similar to the rules of other exchanges, the proposed rule
change also lets a designee of the Exchange president grant an
exemption. See, e.g., Arca Rule 6.78-O(f).
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    The proposed rule change makes no changes to permissible off-floor
position transfers.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Act and the rules and regulations thereunder applicable to the
Exchange and, in particular, the requirements of Section 6(b) of the
Act.\13\ Specifically, the Exchange believes the proposed rule change
is consistent with the Section 6(b)(5) \14\ requirements that the rules
of an exchange be 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 regulating,
clearing, settling, processing information with respect to, and
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.
Additionally, the Exchange believes the proposed rule change is
consistent with the Section 6(b)(5) \15\ requirement that the rules of
an exchange not be designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
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    \13\ 15 U.S.C. 78f(b).
    \14\ 15 U.S.C. 78f(b)(5).
    \15\ Id.
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    The Exchange believes that the proposed rule change to eliminate
the on-floor position transfer procedure promotes just and equitable
principles of trade, helps remove impediments to and perfect the
mechanism of a free and open market and a national market system, and
promotes efficient administration of the Exchange, as it eliminates a
complex procedure that is of limited use to Trading Permit Holders
today but still imposes an administrative burden on the Exchange. The
proposed rule change removes impediments to and perfects the mechanism
of a free and open market, because it is similar to rules of other
options exchanges. The Exchange also notes that at least one other
options exchange with a trading floor and a transfer of positions rule
does not offer an on-floor transfer procedure,\16\ and at least one
other options exchange lets a designee of the Exchange president grant
an exemption.\17\ Additionally, the additional circumstances in which
the President or a designee may grant an exemption are similar to those
that the President or a designee may consider when taking action under
emergency conditions pursuant to Rule 6.17, and thus the proposed rule
change does not significantly expand the Exchange's President's
authority to take action when necessary or appropriate for the
maintenance of a fair and orderly market and to protect investors.
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    \16\ See, e.g., Nasdaq OMX PHLX LLC (``Phlx'') 1058.
    \17\ See, e.g., NYSE Arca, Inc. (``Arca'') Rule 6.78-O(f).
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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. The

Exchange does not believe the proposed rule change will impose any
burden on intramarket competition, as the current on-floor position
transfer procedure is of limited use to Trading Permit Holders today
but still imposes an administrative burden on the Exchange. The
proposed elimination of the on-floor position transfer promotes
efficient administration of the Exchange, as it eliminates this complex
procedure that is limited in application. Market participants will
still be able to effect transactions on the Exchange pursuant to the
normal auction process if an off-floor transfer is not permissible.
    The Exchange does not believe the proposed rule change will impose
any burden on intermarket competition. As discussed above, at least one
other options exchange with a trading floor and a transfer of positions
rule does not offer an on-floor transfer procedure,\18\ and at least
one other options exchange lets a designee of the Exchange president
grant an exemption.\19\ Additionally, the additional circumstances in
which the President or a designee may grant an exemption are similar to
those that the President or a designee may consider when taking action
under emergency conditions pursuant to Rule 6.17, and thus the proposed
rule change does not significantly expand the Exchange's President's
authority to take action when necessary or appropriate for the
maintenance of a fair and orderly market and to protect investors.
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    \18\ See, e.g., Nasdaq OMX PHLX LLC (``Phlx'') 1058.
    \19\ See, e.g., NYSE Arca, Inc. (``Arca'') Rule 6.78-O(f).
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C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    The Exchange neither solicited nor received written comments on 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) of the Act \20\ and Rule 19b-4(f)(6) thereunder.\21\
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 for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6) thereunder.\22\
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    \20\ 15 U.S.C. 78s(b)(3)(A).
    \21\ 17 CFR 240.19b-4(f)(6).
    \22\ In addition, Rule 19b-4(f)(6)(iii) requires a self-
regulatory organization to give the Commission written notice of its
intent to file the proposed rule change, along with a brief
description and text of the proposed rule change, at least five
business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission. The
Exchange has satisfied this requirement.
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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. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \23\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \23\ 15 U.S.C. 78s(b)(2)(B).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2019-024 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CBOE-2019-024. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (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 website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-CBOE-2019-024 and should be submitted on
or before May 23, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\24\
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    \24\ 17 CFR 200.30-3(a)(12).
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Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-08919 Filed 5-1-19; 8:45 am]
 BILLING CODE 8011-01-P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on September 23, 2002

NOTICE OF ACTION TAKEN -- DOCKET OST 1998-3483

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant:  AEROTRANSPORTES PRIVADOS, S.A. de C.V.
             Date Filed: September 3, 2002

Relief requested:  Exemption from 49 USC section 41301 to permit the
applicant to continue to conduct passenger charter operations between
Mexico and the United States, and other passenger charter operations in
accordance with 14 CFR Part 212, using small equipment.

If renewal, date and citation of last action:  September 26, 2001

Applicant representative(s):  Julio Gonzalez Santos, 011-52-81-8319-7784

Responsive pleadings:  None.

	DISPOSITION

Action:  Approved.
         Action date:  September 23, 2002

Effective dates of authority granted:  September 23, 2002, through
September 26, 2003.

Basis for approval (bilateral agreement/reciprocity):  United
States-Mexico Air Transport Services Agreement of August 15, 1960, as
amended and extended (Agreement).

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations indicated:  Standard exemption
conditions.

Special conditions/Partial grant/Denial basis/Remarks:  In the conduct
of these operations, the carrier must adhere to all applicable
provisions of the U.S.-Mexico Agreement.  In the conduct of these
operations, the carrier may only use aircraft capable of carrying no
more than 60 passengers and having a maximum payload capacity of no more
than 18,000 pounds (small equipment).  The above grant includes
authority to conduct Third and Fourth Freedom charter operations.  While
we have subjected, consistent with the provisions of the Agreement,
Mexican carriers conducting charter operations with large aircraft to
prior approval or submission of notice for their Third and Fourth
Freedom charters, we determined that any such requirement was not
necessary on public interest grounds in this case, since the carrier
will be conducting these operations solely with small aircraft.  (Other
charter operations to/from the United States under this authority,
however, are subject to prior approval under 14 CFR Part 212.)  Further,
we are continuing to allow Mexican carriers conducting passenger
charters using small equipment to make stopovers in the United States in
the conduct of such operations.

Action taken by:   Paul L. Gretch, Director

		      Office of International Aviation

________________________________________________________________________
________________________________________________________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) the applicant was qualified to perform its proposed
operations; (3) grant of the authority was consistent with the public
interest; and (4) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted/deferred/dismissed, we denied all requests in
the referenced Docket.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp