[Federal Register Volume 79, Number 33 (Wednesday, February 19, 2014)]
[Rules and Regulations]
[Pages 9392-9395]
[FR Doc No: 2014-02997]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0210; Directorate Identifier 2012-NM-053-AD;
Amendment 39-17744; AD 2014-03-07]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are superseding Airworthiness Directive (AD) 2009-26-16 for
certain The Boeing Company Model MD-11 and MD-11F airplanes. AD 2009-
26-16 required inspecting to determine if wires touch the upper surface
of the center upper auxiliary fuel tank, and marking the location, as
necessary; inspecting all wire bundles above the center upper auxiliary
fuel tank for splices and damage; inspecting for damage to the fuel
vapor barrier seal and upper surface of the center upper auxiliary fuel
tank; and performing corrective actions, as necessary. AD 2009-26-16
also required installing nonmetallic barrier/shield sleeving, new
clamps, new attaching hardware, and a new extruded channel. This new AD
requires inspections of additional center upper auxiliary fuel tank
locations and corrective actions as necessary. This AD was prompted by
reports that identified additional locations where inspections and
corrective actions of the center upper auxiliary fuel tank are needed.
We are issuing this AD to reduce the potential of ignition sources
inside fuel tanks, which, in combination with flammable fuel vapors,
could result in fuel tank explosions and consequent loss of the
airplane.

DATES: This AD is effective March 26, 2014.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of March 26,
2014.
    The Director of the Federal Register approved the incorporation by
reference of a certain other publication listed in this AD as of
February 4, 2010 (74 FR 69249, December 31, 2009).

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
3855 Lakewood Boulevard, MC D800-0019, Long Beach, CA 90846-0001;
telephone<PHONE_NUMBER>, extension 2; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may view this referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, Washington. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2013-
0210; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The address for the Docket Office (phone: 800-647-
5527) is Docket Management Facility, U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Samuel Lee, Aerospace Engineer,
Propulsion Branch, ANM-140L, FAA, Los Angeles Aircraft Certification
Office, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: (562)
627-5262; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
Part 39 to supersede AD 2009-26-16, Amendment 39-16155 (74 FR 69249,
December 31, 2009). AD 2009-26-16 applied to certain The Boeing Company
Model MD-11 and MD-11F airplanes. The NPRM published in the Federal
Register on March 14, 2013 (78 FR 16198). The NPRM was prompted by
reports that identified additional locations where inspections and
corrective actions of the center upper auxiliary fuel tank are needed.
The NPRM proposed to continue to require inspecting to determine if
wires touch the upper surface of the center upper auxiliary fuel tank,
and marking the location, as necessary; inspecting all wire bundles
above the center upper auxiliary fuel tank for splices and damage;
inspecting for damage to the

fuel vapor barrier seal and upper surface of the center upper auxiliary
fuel tank; and performing corrective actions, as necessary. The NPRM
also proposed to continue to require installing nonmetallic barrier/
shield sleeving, new clamps, new attaching hardware, and a new extruded
channel. The NPRM also proposed to require inspections of the center
upper auxiliary fuel tank at additional locations and corrective
actions as necessary. We are issuing this AD to reduce the potential of
ignition sources inside fuel tanks, which, in combination with
flammable fuel vapors, could result in fuel tank explosions and
consequent loss of the airplane.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the proposal
(78 FR 16198, March 14, 2013) and the FAA's response to each comment.

Request for Approval of Alternative Methods of Compliance (AMOCs)

    FedEx requested that AMOCs previously approved for AD 2009-26-16,
Amendment 39-16155 (74 FR 69249, December 31, 2009), be approved as
AMOCs for the requirements of the NPRM (78 FR 16198, March 14, 2013).
FedEx also requested that Boeing Service Bulletin MD11-28-126, Revision
4, dated November 29, 2011, be revised to incorporate changes made by
seven Boeing Information Notices, which were not FAA-approved.
    We acknowledge the commenter's request. However, paragraph (k)(4)
of the NPRM (78 FR 16198, March 14, 2013) already states that AMOCs
approved for AD 2009-26-16, Amendment 39-16155 (74 FR 69249, December
31, 2009), are approved as AMOCs for the corresponding requirements of
this AD. Also, the changes in all seven Boeing Information Notices were
either incorporated or resolved in Boeing Service Bulletin MD11-28-126,
Revision 2, dated November 18, 2010, except for Boeing MD11 Service
Bulletin Information Notice MD11-28-126 IN 07, December 3, 2012, which
was issued for information only, and therefore does not affect the
requirements of this final rule. No changes have been made to this
final rule in this regard.

Request To Extend Compliance Time

    FedEx requested that the compliance time for the NPRM (78 FR 16198,
March 14, 2013) be extended from ``Within 60 months after February 4,
2010 (the effective date of AD 2009-26-16),'' for the retained
inspection and actions specified in paragraphs (g)(1) through (g)(5) of
the NPRM to 72 months, or February 4, 2016, at a minimum. FedEx stated
that work would have to be accomplished by February 4, 2015, and due to
the labor intensive nature of the work, 18 to 20 months is not enough
time to fit into a `C' check time interval.
    We do not agree with FedEx's request. In developing an appropriate
compliance time for this action, we considered not only the degree of
urgency associated with addressing the subject unsafe condition, but
the manufacturer's recommendation for an appropriate compliance time,
the availability of required parts, and the practical aspect of
installing the required modification within an interval of time that
corresponds to the typical scheduled maintenance for the majority of
affected operators. The retained inspection and corrective action were
previously required by AD 2009-26-16, Amendment 39-16155 (74 FR 69249,
December 31, 2009), so operators should have already completed or be
scheduled to have the work completed. Under the provisions of paragraph
(k) of this final rule, we may approve requests for adjustments to the
compliance time if data are submitted to substantiate that such an
adjustment would provide an acceptable level of safety.

Request To Revise Costs of Compliance

    FedEx requested that the Costs of Compliance be revised since
material costs have drastically increased. FedEx stated that Boeing
Service Bulletin MD11-28-126, Revision 4, dated November 29, 2011,
(which we referred to in the NPRM (78 FR 16198, March 14, 2013), as the
appropriate source of service information for doing the actions)
specifies a cost of $18,139 for kit part number SB11280126-11. FedEx
stated that a recent quote for this kit is $25,904. Also, the original
cost for kit SB11280126-13 was $12,268; it is now $17,568.
    We agree with the request to revise the Costs of Compliance because
current costs for kits differ greatly from when the NPRM (78 FR 16198,
March 14, 2013) was issued. The retained actions from AD 2009-26-16,
Amendment 39-16155 (74 FR 69249, December 31, 2009), had a parts cost
of $9,405 to $12,201; the revised parts cost is $15,708 to $28,005. The
parts cost for the new action was revised from $2,863 to $6,166. We
have revised the information contained in the Costs of Compliance
accordingly.

Explanation of Additional Change Made to the Costs of Compliance

    We have revised this AD to revise the Costs of Compliance, which
incorrectly specified inspection and installation costs for four Group
6 airplanes as new actions. We have revised the information contained
in the Costs of Compliance tables by removing the row containing Group
6 airplanes accordingly.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this AD as proposed except for minor editorial changes. We have
determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (78 FR 16198, March 14, 2013) for correcting the unsafe condition;
and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (78 FR 16198, March 14, 2013).

Costs of Compliance

    We estimate that this AD affects 125 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
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                                                                                Cost on U.S.
             Action                   Labor cost          Parts cost       Cost per product        operators
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Inspection/Installation           168 to 182 work-    $15,708 to $28,005  $29,988 to $43,475  $3,748,500 to
 [retained actions from AD 2009-   hours x $85 per                         per inspection      $5,434,375 per
 26-16, Amendment 39-16155 (74     hour = $14,280 to                       cycle.              inspection cycle.
 FR 69249, December 31, 2009)].    $15,470 per
                                   inspection cycle.

Inspection/installation Groups    Up to 9             $6,166............  Up to $6,931......  Up to $866,375.
 1, 2, and 5, all Configuration    work[dash]hours x
 2 airplanes [new action].         $85 per hour =
                                   $765.
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    We have received no definitive data that would enable us to provide
cost estimates for the on-condition actions specified in this AD.

Authority for This Rulemaking

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

Regulatory Findings

    We have 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 that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2009-26-16, Amendment 39-16155 (74 FR 69249, December 31, 2009), and
adding the following new AD:

2014-03-07 The Boeing Company: Amendment 39-17744; Docket No. FAA-
2013-0210; Directorate Identifier 2012-NM-053-AD.

(a) Effective Date

    This AD is effective March 26, 2014.

(b) Affected ADs

    This AD supersedes AD 2009-26-16, Amendment 39-16155 (74 FR
69249, December 31, 2009).

(c) Applicability

    This AD applies to The Boeing Company Model MD-11 and MD-11F
airplanes, certificated in any category, as identified in Boeing
Service Bulletin MD11-28-126, Revision 4, dated November 29, 2011.

(d) Subject

    Air Transport Association (ATA) of America Code 28, Fuel.

(e) Unsafe Condition

    This AD was prompted by reports that identified additional
locations where inspections and corrective actions of the center
upper auxiliary fuel tank are needed. We are issuing this AD to
reduce the potential of ignition sources inside fuel tanks, which,
in combination with flammable fuel vapors, could result in fuel tank
explosions and consequent loss of the airplane.

(f) Compliance

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

(g) Retained Inspection and Corrective Action

    This paragraph restates the requirements of paragraph (g) of AD
2009-26-16, Amendment 39-16155 (74 FR 69249, December 31, 2009),
with revised service information. For airplanes identified in Boeing
Service Bulletin MD11-28-126, Revision 1, dated June 18, 2009:
Within 60 months after February 4, 2010 (the effective date of AD
2009-26-16), do the actions specified in paragraphs (g)(1) through
(g)(5) of this AD, and do all applicable corrective actions, in
accordance with the Accomplishment Instructions of Boeing Service
Bulletin MD11-28-126, Revision 1, dated June 18, 2009; or Boeing
Service Bulletin MD11-28-126, Revision 4, dated November 29, 2011;
except as required by paragraph (j) of this AD. After the effective
date of this AD, only Boeing Service Bulletin MD11-28-126, Revision
4, dated November 29, 2011, may be used. Do all applicable
corrective actions before further flight.
    (1) Do a general visual inspection of the wire bundles between
Stations 1238.950 and 1361.000 to determine if wires touch the upper
surface of the center upper auxiliary fuel tank, and mark the
location, as applicable.
    (2) Do a detailed inspection for splices and damage of all wire
bundles above the center upper auxiliary fuel tank between Stations
1218.950 and 1381.000.
    (3) Do a detailed inspection for damage (burn marks) of the
upper surface of the center upper auxiliary fuel tank.
    (4) Do a detailed inspection for damage (burn marks) on the fuel
vapor barrier seal.
    (5) Install a nonmetallic barrier/shield sleeving, new clamps,
new attaching hardware, and a new extruded channel.

(h) New Inspections and Corrective Action for Group 1, Configuration 2;
Group 2, Configuration 2; and Group 5, Configuration 2 Airplanes

    For airplanes in Group 1, Configuration 2; Group 2,
Configuration 2; and Group 5, Configuration 2; as identified in
Boeing Service Bulletin MD11-28-126, Revision 4, dated November 29,
2011: Within 60 months after the effective date of this AD, do a
detailed inspection of wire bundles for splices and damage (chafing,
arcing, and broken insulation) and damage (burn marks) on the upper
surface of the center upper auxiliary fuel tank and fuel vapor
barrier seal; install barrier/shield sleeving and clamping; and do
all applicable corrective actions at the locations specified in
paragraphs (h)(1) through (h)(3) of this AD, in accordance with the
Accomplishment Instructions of Boeing Service Bulletin

MD11-28-126, Revision 4, dated November 29, 2011, except as required
by paragraph (j) of this AD. Do all applicable corrective actions
before further flight.
    (1) For Group 1, Configuration 2 airplanes: between Stations
1238.950 and 1381.000, Stations 1238.950 and 1256.000, and Stations
1238.950 and 1256.800, depending on passenger or freighter
configuration.
    (2) For Group 2, Configuration 2 airplanes: between Stations
1238.950 and 1275.250, and Stations 1238.950 and 1275.250, passenger
configuration only.
    (3) For Group 5, Configuration 2 airplanes: between Stations
1381.000 and 1238.950.

(i) Credit for Previous Actions

    (1) This paragraph provides credit for actions required by
paragraph (g) of this AD, if those actions were performed before the
effective date of this AD, using the service bulletins specified in
paragraphs (i)(1)(i) or (i)(1)(ii) of this AD.
    (i) Boeing Service Bulletin MD11-28-126, Revision 2, dated
November 18, 2010, which is not incorporated by reference in this
AD.
    (ii) Boeing Service Bulletin MD11-28-126, Revision 3, dated June
3, 2011, which is not incorporated by reference in this AD.
    (2) This paragraph provides credit for actions required by
paragraph (h) of this AD, if those actions were performed before the
effective date of this AD, using Boeing Service Bulletin MD11-28-
126, Revision 3, dated June 3, 2011, which is not incorporated by
reference in this AD.

(j) Repair

    Where Boeing Service Bulletin MD11-28-126, Revision 1, dated
June 18, 2009; or Boeing Service Bulletin MD11-28-126, Revision 4,
dated November 29, 2011; specifies to contact The Boeing Company for
repair instructions: Before further flight, repair the auxiliary
fuel tank in accordance with a method approved by the Manager, Los
Angeles Aircraft Certification Office (ACO), FAA. For a repair
method to be approved, the repair must meet the certification basis
of the airplane, and the approval must specifically refer to this
AD.

(k) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Los Angeles ACO, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request
to your principal inspector or local Flight Standards District
Office, as appropriate. If sending information directly to the
manager of the Los Angeles ACO, send it to the attention of the
person identified in paragraph (l) of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD if it is approved by
Structures Authorized Representative for the Boeing Commercial
Airplanes Delegation Option Authorization Organization who has been
authorized by the Manager, Los Angeles ACO, to make those findings.
For a repair method to be approved, the repair must meet the
certification basis of the airplane, and 14 CFR 25.571, Amendment
45, and the approval must specifically refer to this AD.
    (4) AMOCs approved for AD 2009-26-16, Amendment 39-16155 (74 FR
69249, December 31, 2009), are approved as AMOCs for the
corresponding requirements of this AD.

(l) Related Information

    (1) For more information about this AD, contact Samuel Lee,
Aerospace Engineer, Propulsion Branch, ANM-140L, FAA, Los Angeles
Aircraft Certification Office, 3960 Paramount Boulevard, Lakewood,
CA 90712-4137; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) Service information identified in this AD that is not
incorporated by reference may be obtained at the addresses specified
in paragraphs (m)(5) and (m)(6) of this AD.

(m) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR Part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (3) The following service information was approved for IBR on
March 26, 2014.
    (i) Boeing Service Bulletin MD11-28-126, Revision 4, dated
November 29, 2011.
    (ii) Reserved.
    (4) The following service information was approved for IBR on
February 4, 2010, (74 FR 69249, December 31, 2009).
    (i) Boeing Service Bulletin MD11-28-126, Revision 1, dated June
18, 2009.
    (ii) Reserved.
    (5) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
3855 Lakewood Boulevard, MC D800-0019, Long Beach, CA 90846-0001;
telephone<PHONE_NUMBER>, extension 2; fax<PHONE_NUMBER>; Internet
https://www.myboeingfleet.com.
    (6) You may view this service information at FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, Washington. For
information on the availability of this material at the FAA, call
425-227-1221.
    (7) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on January 21, 2014.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-02997 Filed 2-18-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: July 30, 2008 (Volume 73, Number 147)]
[Notices]
[Page 44311]
[DOCID:fr30jy08-124]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Mike Monroney Aeronautical Center Environmental Assessment for
the Facilities Master Plan; Oklahoma City, OK

AGENCY: Federal Aviation Administration, DOT.

ACTION: Notice of public meeting.

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SUMMARY: The Mike Monroney Aeronautical Center (MMAC) Federal Aviation
Administration (FAA) announces a public meeting to obtain public
comment on the MMAC Site Environmental Assessment for the Facilities
Master Plan. The environmental assessment has been prepared in
accordance with the National Environmental Policy Act (40 CFR parts
1500-1508) and FAA Order 1050.1E, Environmental Impacts: Policies and
Procedures. The environmental assessment document can be reviewed at:
https://employees.faa.gov/org/centers/mmac/employee_services/amp/env/.
The public meeting will be conducted on Monday, July 28, 2008 at the
Mike Monroney Aeronautical Center (6500 S. MacArthur Blvd., Oklahoma
City, OK 73169) at 1:30 p.m. in Building 230.

FOR FURTHER INFORMATION CONTACT: Mr. Edward Connell, Federal Aviation
Administration, AMP-100, 6500 S. MacArthur Blvd., Oklahoma City, OK
73169; telephone number<PHONE_NUMBER>. Comments on the environmental
assessment should also be submitted to the above office.
    Interested persons are invited to comment on the environmental
assessment. All comments will be considered by the FAA to the extent
practicable.
    Federal Aviation Administration, Mike Monroney Aeronautical Center,
Office of Facility Management, AMP-1, 6500 S. MacArthur Blvd., Oklahoma
City, OK 73169.
    Questions may be directed to the individual named above under the
heading, FOR FURTHER INFORMATION CONTACT.

    Issued in Oklahoma City, OK, July 16, 2008.
Charles T. Sullivan,
Program Director, Office of Facility Management AMP-1.
[FR Doc. E8-17263 Filed 7-29-08; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register: March 5, 2007 (Volume 72, Number 42)]
[Notices]
[Page 9807-9810]
[DOCID:fr05mr07-90]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55346; File No. SR-NASD-2007-014]

Self-Regulatory Organizations; National Association of Securities
Dealers, Inc.; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change To Make Conforming Changes to the Rules Relating to the
NASD/NSX TRF, NASD/BSE TRF, and NASD/NYSE TRF Consistent With the New
Requirements of Regulation NMS

February 26, 2007.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on February 12, 2007, the National Association of Securities Dealers,
Inc. (``NASD'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been substantially prepared by NASD.
NASD has filed the proposal as a ``non-controversial'' rule change
pursuant to Section 19(b)(3)(A) of the Act \3\ and Rule 19b-4(f)(6)
thereunder,\4\ which renders it effective upon filing with the
Commission. 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

    NASD proposes (1) amendments to the transaction reporting rules
relating to the NASD/NSX Trade Reporting Facility (``NASD/NSX TRF''),
the NASD/BSE Trade Reporting Facility (``NASD/BSE TRF''), and the NASD/
NYSE Trade Reporting Facility (``NASD/NYSE TRF'') (collectively
referred to herein as the ``Subject TRFs'') consistent with the new
requirements of Regulation NMS under the Act;\5\ and (2) technical
amendments to conform, to the extent practicable, the reporting rules
of the Subject TRFs to the reporting rules of the NASD/Nasdaq Trade
Reporting Facility (``NASD/Nasdaq TRF'') and NASD's Alternative Display
Facility (``ADF''). The text of the proposed rule change is available
at NASD, the Commission's Public Reference Room, and http://www.nasd.com
.

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    \5\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496 (June 29, 2005) (``Regulation NMS Adopting
Release'').
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II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, NASD 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. NASD 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
Background
    On June 29, 2005, the Commission published its release adopting
Regulation NMS,\6\ which established new substantive rules designed to
modernize and strengthen the regulatory structure of the U.S. equities
markets. Pursuant to Regulation NMS, the Commission, among other
things, adopted Rule 611 (``Order Protection Rule'') to establish
protection against trade-throughs for NMS stocks.\7\
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    \6\ Id.
    \7\ NMS stock is defined in Rule 600(b)(47) of Regulation NMS as
``any NMS security other than an option.'' Rule 600(b)(46) of
Regulation NMS defines NMS security as ``any security or class of
securities for which transaction reports are collected, processed,
and made available pursuant to an effective transaction reporting
plan, or an effective national market system plan for reporting
transactions in listed options.''
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    In general, the Order Protection Rule requires a trading center
(which includes national securities exchanges, self-regulatory
organization (``SRO'') trading facilities, alternative trading systems,
OTC market makers, and block positioners) to establish, maintain, and
enforce written policies and procedures that are reasonably designed to
prevent trade-throughs on that trading center of protected quotations
and, if relying on an exception, that are reasonably designed to assure
compliance with the terms of the exception. There currently are nine
exceptions and two exemptions to the Order Protection Rule.\8\ In

addition, the Order Protection Rule requires trading centers to surveil
regularly to ascertain the effectiveness of the policies and procedures
adopted pursuant to Rule 611 of Regulation NMS and take prompt action
to remedy deficiencies in such policies and procedures.
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    \8\ See 17 CFR 242.611; Securities Exchange Act Release Nos.
54389 (August 31, 2006), 71 FR 52829 (September 7, 2006) (Order
Granting an Exemption for Qualified Contingent Trades from Rule
611(a) of Regulation NMS) and 54678 (October 31, 2006), 71 FR 65018
(November 6, 2006) (Order Exempting Certain Sub-Penny Trade-Throughs
from Rule 611 of Regulation NMS).
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    On November 6, 2006, the Commission approved the establishment of
the NASD/NSX TRF.\9\ On December 13, 2006, the Commission approved the
establishment of the NASD/BSE TRF.\10\ On February 1, 2007, NASD filed
for immediate effectiveness a proposed rule change relating to the
establishment of the NASD/NYSE TRF.\11\ The Subject TRFs provide
members additional mechanisms for reporting locked-in trades in
exchange-listed securities executed otherwise than on an exchange.
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    \9\ See Securities Exchange Act Release No. 54715 (November 6,
2006), 71 FR 66354 (November 14, 2006) (SR-NASD-2006-108). The NASD/
NSX TRF commenced operation for the reporting of over-the-counter
trades in Nasdaq-listed securities on November 27, 2006 and is
expected to expand to the reporting of over-the-counter trades in
all exchange-listed securities in the first quarter of 2007.
    \10\ See Securities Exchange Act Release No. 54931 (December 13,
2006), 71 FR 76409 (December 20, 2006) (SR-NASD-2006-115). The NASD/
BSE TRF will commence operation upon successful completion of system
testing and certification (currently anticipated to be in the first
quarter of 2007).
    \11\ See Securities Exchange Act Release No. 55325 (February 21,
2007) (SR-NASD-2007-011). The NASD/NYSE TRF will commence operation
upon successful completion of system testing and certification
(currently anticipated to be in the first quarter of 2007).
---------------------------------------------------------------------------

    Neither NASD, generally, nor any of the NASD Trade Reporting
Facilities, specifically, qualifies as a trading center within the
meaning of Regulation NMS. Thus, the provisions of the Order Protection
Rule requiring trading centers to establish, maintain, and enforce
written policies and procedures that are reasonably designed to prevent
trade-throughs on that trading center of protected quotations in NMS
stocks are not applicable to NASD. However, NASD has a responsibility
to enforce requirements under the Act that apply to activity within its
regulatory authority. Thus, unlike exchanges that have direct
Regulation NMS obligations with respect to the SRO trading facilities,
NASD has indirect Regulation NMS obligations with respect to all over-
the-counter market activity, including post-trade regulation for
compliance with the Order Protection Rule with respect to trading
centers that trade report through an NASD Trade Reporting Facility.
Such regulation includes monitoring for whether trading centers are
reporting trades to an NASD Trade Reporting Facility that are trade-
throughs of protected quotes and whether such trade-throughs are
permissible under one of the specific exceptions and exemptions under
the Order Protection Rule.
Proposed Amendments To Align the Rules of the Subject TRFs With
Regulation NMS
    NASD proposes to amend Rule 4632C relating to the NASD/NSX TRF,
Rule 4632D relating to the NASD/BSE TRF, and Rule 4632E relating to the
NASD/NYSE TRF to require reporting members to append applicable
modifiers to last-sale transaction reports with respect to trades that
fall within the exceptions and exemptions from Rule 611 of Regulation
NMS. The proposed amendments are substantially similar to amendments to
the transaction reporting requirements relating to the ADF, which were
approved by the Commission on September 28, 2006,\12\ and the NASD/
Nasdaq TRF, which were filed for immediate effectiveness on January 8,
2007.\13\
---------------------------------------------------------------------------

    \12\ See Securities Exchange Act Release No. 54537 (September
28, 2006), 71 FR 59173 (October 6, 2006) (SR-NASD-2006-091). See
also Securities Exchange Act Release No. 55088 (January 11, 2007),
72 FR 2573 (January 19, 2007) (SR-NASD-2007-001). Unlike the ADF, an
NASD Trade Reporting Facility (e.g., the NASD/NSX TRF) is a trade
reporting mechanism only; it does not permit quoting. As such, not
all of the amendments to the ADF rules are applicable to the rules
relating to the NASD Trade Reporting Facilities.
    \13\ See Securities Exchange Act Release No. 55101 (January 12,
2007), 72 FR 2568 (January 19, 2007) (SR-NASD-2007-002).
---------------------------------------------------------------------------

    Specifically, NASD proposes to adopt new paragraph (a)(5)(C) of
Rule 4632C, paragraph (a)(5)(F) of Rule 4632D, and paragraph (a)(5)(I)
of Rule 4632E to require members to append a unique modifier, specified
by NASD, to indicate whether the trade would be a trade-through of a
protected quotation but for the trade being qualified for an exception
or exemption from Rule 611 of Regulation NMS. Further, NASD proposes to
adopt new paragraph (a)(5)(D) of Rule 4632C, paragraph (a)(5)(G) of
Rule 4632D, and paragraph (a)(5)(J) of Rule 4632E to require that, for
any trade that would be a trade-through of a protected quotation but
for the trade being qualified for an exception or exemption from Rule
611 of Regulation NMS, a member must append to the transaction report,
in addition to the modifier required under new Rule 4632C(a)(5)(C),
Rule 4632D(a)(5)(F), and Rule 4632E(a)(5)(I), respectively, a unique
modifier, specified by NASD, that identifies the specific applicable
exception or exemption from Rule 611 of Regulation NMS upon which the
member is relying.\14\ As stated in the proposed rules, these modifiers
will be used in conformity with the specifications approved by the
Operating Committee of the relevant National Market System Plans to
identify trades executed pursuant to an exception or exemption from
Rule 611 of Regulation NMS. NASD, along with the respective Subject
TRFs, will publish technical specifications regarding the specific
modifiers required under the proposed new rules.
---------------------------------------------------------------------------

    \14\ A Member using the trade report modifiers under the
proposed new rules is responsible for ensuring that the transaction
meets the criteria of the specific exemption or exception set forth
in Rule 611 of Regulation NMS.
---------------------------------------------------------------------------

    Additionally, NASD proposes to adopt new paragraph (a)(5)(E) of
Rule 4632C, paragraph (a)(5)(H) of Rule 4632D, and paragraph (a)(5)(K)
of Rule 4632E to require members to append ``[a]ny other modifier as
specified by NASD or the Securities and Exchange Commission.'' An
identical provision in the ADF rules was subject to notice and comment
and approved by the Commission pursuant to SR-NASD-2006-091 and also
was incorporated in Rule 4632 relating to the NASD/Nasdaq TRF pursuant
to SR-NASD-2007-002. Under this proposed provision, NASD will have the
authority to prescribe additional trade report modifiers by updating
the Technical Specifications for the Subject TRFs without submitting a
further proposed rule change for approval by the Commission. For
example, such authority will be used to require additional modifiers to
designate trades that qualify under two existing exemptions from the
Order Protection Rule (qualified contingent trades and certain sub-
penny trade-throughs) \15\ as well as any other exemption that the
Commission may grant in the future. This authority may also be used to
capture additional regulatory information that NASD deems necessary
(e.g., NASD will require more specific delineation of the Intermarket
Sweep Order (``ISO'') exception than is required by the National Market
System specifications).\16\ To enable members to make the necessary
systems changes, NASD would provide at least 30 days advance written
notice relating to any new modifiers.
---------------------------------------------------------------------------

    \15\ See supra note 8.
    \16\ The National Market System specifications identify both
types of ISO orders with a single modifier. NASD, however, intends
to distinguish between the ISO exceptions by requiring firms to use
a separate modifier, as defined by NASD, in instances where the
executing firm is responsible for sweeping the market.
---------------------------------------------------------------------------

    NASD also proposes to amend Rules 4632C, 4632D, and 4632E to
expressly

provide that, in the event that the rules require multiple modifiers on
any given trade report, members are to report in accordance with
guidance published by NASD regarding priorities among modifiers, if
such guidance is provided. A Member that reports in accordance with
such guidance would not be in violation of the trade reporting rules
for failing to use a particular modifier.
    NASD believes that the proposed rule change is necessary to ensure
that there is transparency relating to trades that are exempt from the
trade-through rule and to enhance NASD's ability to examine for
compliance with the Order Protection Rule.
Proposed Amendments to Rules of the Subject TRFs To Conform to NASD/
Nasdaq TRF and ADF Rules
    NASD proposes changes to conform, to the extent practicable, the
reporting rules of the Subject TRFs to the NASD/Nasdaq TRF and ADF
reporting rules. Specifically, NASD proposes to reorganize Rule 4632C
relating to the NASD/NSX TRF, Rule 4632D relating to the NASD/BSE TRF,
and Rule 4632E relating to the NASD/NYSE TRF and renumber paragraphs
(a)(3) and (a)(5) of Rule 4632C, paragraphs (a)(3) and (a)(6) of Rule
4632D, and paragraphs (a)(3) and (a)(6) of Rule 4632E, without amending
the text of those provisions. NASD also proposes to renumber paragraphs
(a)(4), (a)(6), and (a)(8) of Rule 4632C, paragraphs (a)(5), (a)(8),
and (a)(10) of Rule 4632D and paragraphs (a)(5), (a)(8), and(a)(10) of
Rule 4632E, and amend the text of those provisions to conform to the
text of the equivalent provisions in Rule 4632 relating to the NASD/
Nasdaq TRF.
    Additionally, NASD proposes to adopt new Rules 4632C(a)(5),
4632D(a)(5), and 4632E(a)(5) to require members to use trade report
modifiers designated by NASD for certain enumerated transactions. As
with the NASD/Nasdaq TRF and ADF, members will be required to include
such modifiers on all trade reports, including reports of ``as/of''
trades.\17\ Consistent with SR-NASD-2007-001 and SR-NASD-2007-002, the
proposed amendments to Rules 4632C, 4632D, and 4632E would delete the
labels (e.g., .T or .W) for the modifiers that members are required to
use when reporting the enumerated transactions. Thus, Rules 4632C,
4632D, and 4632E would identify the types of transactions that must
have a unique identifier associated with them, and such modifiers would
be labeled in the system technical specifications rather than in the
rules.
---------------------------------------------------------------------------

    \17\ The NASD/NSX TRF currently does not accept ``as/of''trade
reports and the rules for the NASD/BSE TRF, which have been approved
by the Commission but are not yet effective, also do not permit the
submission of ``as/of'' trade reports. NASD will file a separate
proposed rule change to reflect the reporting of ``as/of'' trades to
the NASD/NSX TRF and NASD/BSE TRF. Thus, upon the operative date of
this proposed rule change, members will be required to append all
applicable trade report modifiers to ``as/of'' trade reports
submitted to the NASD/NSX TRF and the NASD/BSE TRF. NASD reminds
members that they should mark any ``as/of'' trade report for
publication if that trade would have been for publication had it
been reported on trade date.
---------------------------------------------------------------------------

    It should be noted that, because of differences in functionality,
not all of the rules relating to NASD's Trade Reporting Facilities are
identical. For example, unlike the NASD/Nasdaq TRF, the NASD/BSE TRF,
and the NASD/NYSE TRF, pursuant to current Rule 4632C(a)(7), the NASD/
NSX TRF does not accept trade reports for Stop Stock Transactions (as
such term is defined in Rule 4200C), transactions occurring at prices
based on average-weighting or other special pricing formulae, or
transactions that reflect a price different from the current market
when the execution price is based on a prior reference point in time.
In this proposed rule change, NASD proposes to renumber Rule
4632C(a)(7) as 4632C(a)(8) without amending the text of the rule.
    In addition, neither the NASD/NSX TRF nor the NASD/BSE TRF will
accept trades reported as other than regular way settlement (see Rules
6130C(a) and 6130D(a), respectively). Thus, unlike Rule 4632(a)(5)
relating to the NASD/Nasdaq TRF and Rule 4632E(a)(5) relating to the
NASD/NYSE TRF, proposed Rules 4632C(a)(5) and 4632D(a)(5) do not
include provisions pertaining to trade report modifiers for Seller's
Option, Cash, or Next Day transactions.
    As discussed in footnote 17 above, the NASD/NSX TRF and NASD/BSE
TRF rules currently do not provide for the submission of ``as/of''
trade reports; however, once the necessary system changes have been
made, NASD will file a separate proposed rule change proposing
amendments to Rules 4632C(a)(2)(B) and (D) and 4632D(a)(2)(B) and (D)
that are consistent with Rule 4632(a)(2)(B) and (D) and proposed Rule
4632E(a)(2)(B) and (D).
    NASD has filed the proposed rule change for immediate
effectiveness. In accordance with the Regulation NMS compliance dates
established by the Commission,\18\ NASD proposes to make the proposed
rule change operative on the Pilot Stocks Phase Date, which is
currently anticipated to be July 9, 2007. However, members may begin
submitting trade reports to the Subject TRFs in compliance with the
proposed rule change after the Trading Phase Date, which is currently
anticipated to be March 5, 2007. This does not change in any way a
member's responsibilities under the Regulation NMS compliance
dates.\19\
---------------------------------------------------------------------------

    \18\ See Securities Exchange Act Release No. 55160 (January 24,
2007), 72 FR 4202 (January 30, 2007).
    \19\ NASD notes that, although the proposed rule change will not
be operative until the Pilot Stocks Phase Date, members may be
required to meet the Regulation NMS message format requirements for
reporting to the Subject TRFs prior to that date. NASD will notify
members of the date of mandatory compliance with Regulation NMS
message formatting requirements for the Subject TRFs and on such
date, members will be required to report in accordance with the new
systems requirements, although the specific new modifiers proposed
herein would continue to be voluntary until the Pilot Stocks Phase
Date.
---------------------------------------------------------------------------

2. Statutory Basis
    NASD believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\20\ which requires, among
other things, that NASD rules be designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest. NASD believes that the proposed rule change
facilitates the goals articulated in Regulation NMS, including
providing an effective mechanism and regulatory framework for reporting
over-the-counter transactions to NASD.
---------------------------------------------------------------------------

    \20\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

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

    NASD does not believe that the proposed rule change will result in
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

    Written comments were neither solicited nor received.

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

    The foregoing proposed rule change is subject to Section
19(b)(3)(A)(iii) of the Act \21\ and Rule 19b-4(f)(6) thereunder \22\
because the proposal: (i) Does not significantly affect the protection
of investors or the public interest; (ii) does not impose any
significant burden on competition; and (iii) does not become operative
prior to 30 days after the date

of filing or such shorter time as the Commission may designate if
consistent with the protection of investors and the public interest;
provided that NASD has given the Commission 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.\23\
---------------------------------------------------------------------------

    \21\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \22\ 17 CFR 240.19b-4(f)(6).
    \23\ NASD has satisfied the five-day pre-filing requirement.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change the Commission may summarily abrogate 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-NASD-2007-014 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASD-2007-014. 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 inspection and
copying in the Commission's Public Reference Room. Copies of the filing
also will be available for inspection and copying at the principal
office of NASD. 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-
NASD-2007-014 and should be submitted on or before March 26, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\24\
---------------------------------------------------------------------------

    \24\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-3744 Filed 3-2-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 87, Number 234 (Wednesday, December 7, 2022)]
[Notices]
[Pages 75058-75059]
[FR Doc No: 2022-26544]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4673-DR; Docket ID FEMA-2022-0001]

Florida; Amendment No. 12 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Florida (FEMA-4673-DR), dated September 29, 2022, and
related determinations.

DATES: This amendment was issued November 10, 2022.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Florida is hereby amended to include the following
area among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of September 29, 2022.

    Martin County for debris removal [Category A] and permanent work
[Categories C-G] (already designated for emergency protective
measures [Category B], including direct

federal assistance, under the Public Assistance program).
    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2022-26544 Filed 12-6-22; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 80, Number 197 (Tuesday, October 13, 2015)]
[Rules and Regulations]
[Pages 61298-61302]
[FR Doc No: 2015-25923]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 890

[Docket No. FDA-2012-N-0378]

Physical Medicine Devices; Reclassification of Shortwave
Diathermy for All Other Uses, Henceforth To Be Known as Nonthermal
Shortwave Therapy

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order; technical correction.

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

SUMMARY: The Food and Drug Administration (FDA) is issuing a final
order to reclassify shortwave diathermy (SWD) for all other uses, a
preamendments class III device, into class II (special controls), and
to rename the device ``nonthermal shortwave therapy'' (SWT). FDA is
also making a technical correction in the regulation for the carrier
frequency for SWD and SWT devices.

DATES: This order is effective on October 13, 2015. See further
discussion in Section IV, ``Implementation Strategy.''

FOR FURTHER INFORMATION CONTACT: Michael J. Ryan, Center for Devices
and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 1615,
Silver Spring, MD 20993,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended
by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L.
94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the
Food and

Drug Administration Modernization Act of 1997 (Pub. L. 105-115), the
Medical Device User Fee and Modernization Act of 2002 (Pub. L. 107-
250), the Medical Devices Technical Corrections Act (Pub. L. 108-214),
the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-
85), and the Food and Drug Administration Safety and Innovation Act
(FDASIA) (Pub. L. 112-144), among other amendments, established a
comprehensive system for the regulation of medical devices intended for
human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established
three categories (classes) of devices, reflecting the regulatory
controls needed to provide reasonable assurance of their safety and
effectiveness. The three categories of devices are class I (general
controls), class II (special controls), and class III (premarket
approval).
    Under section 513(d) of the FD&C Act, devices that were in
commercial distribution before the enactment of the 1976 amendments,
May 28, 1976 (generally referred to as preamendments devices), are
classified after FDA has: (1) Received a recommendation from a device
classification panel (an FDA advisory committee); (2) published the
panel's recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
    Devices that were not in commercial distribution prior to May 28,
1976 (generally referred to as ``postamendments devices''), are
automatically classified by section 513(f) of the FD&C Act into class
III without any FDA rulemaking process. Those devices remain in class
III and require premarket approval unless, and until, the device is
reclassified into class I or II or FDA issues an order finding the
device to be substantially equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate device that does not require
premarket approval. The Agency determines whether new devices are
substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and 21 CFR part 807.
    A preamendments device that has been classified into class III and
devices found substantially equivalent by means of premarket
notification (510(k)) procedures to such a preamendments device or to a
device within that type (both the preamendments and substantially
equivalent devices are referred to as preamendments class III devices)
may be marketed without submission of a premarket approval application
(PMA) until FDA issues a final order under section 515(b) of the FD&C
Act (21 U.S.C. 360e(b)) requiring premarket approval.
    On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA
amended section 513(e) of the FD&C Act, changing the mechanism for
reclassifying a device from rulemaking to an administrative order.
    Section 513(e) of the FD&C Act provides that FDA may, by
administrative order, reclassify a device based upon ``new
information.'' FDA can initiate a reclassification under section 513(e)
or an interested person may petition FDA to reclassify a preamendments
device. The term ``new information,'' as used in section 513(e),
includes information developed as a result of a reevaluation of the
data before the Agency when the device was originally classified, as
well as information not presented, not available, or not developed at
that time. (See, e.g., Holland-Rantos Co. v. United States Department
of Health, Education, and Welfare, 587 F.2d 1173, 1174 n.1 (D.C. Cir.
1978); Upjohn v. Finch, 422 F.2d 944 (6th Cir. 1970); Bell v. Goddard,
366 F.2d 177 (7th Cir. 1966).)
    Reevaluation of the data previously before the Agency is an
appropriate basis for subsequent action where the reevaluation is made
in light of newly available authority (see Bell, 366 F.2d at 181;
Ethicon, Inc. v. FDA, 762 F.Supp. 382, 388-391 (D.D.C. 1991); or, in
light of changes in ``medical science,'' Upjohn, 422 F.2d at 951).
Whether data before the Agency are old or new data, the ``new
information'' to support reclassification under section 513(e) must be
``valid scientific evidence'' as defined in section 513(a)(3) of the
FD&C Act and 21 CFR 860.7(c)(2). (See, e.g., Gen. Medical Co. v. FDA,
770 F.2d 214 (D.C. Cir. 1985); Contact Lens Mfrs. Ass'n v. FDA, 766
F.2d 592 (D.C. Cir. 1985), cert. denied, 474 U.S. 1062 (1986).)
    FDA relies upon ``valid scientific evidence'' in the classification
process to determine the level of regulation for devices. To be
considered in the reclassification process, the ``valid scientific
evidence'' upon which the Agency relies must be publicly available.
Publicly available information excludes trade secret and/or
confidential commercial information, e.g., the contents of a pending
PMA. (See section 520(c) of the FD&C Act (21 U.S.C. 360j(c)).)
    Section 513(e)(1) of the FD&C Act sets forth the process for
issuing a final reclassification order. Specifically, prior to the
issuance of a final order reclassifying a device, the following must
occur: (1) Publication of a proposed order in the Federal Register; (2)
a meeting of a device classification panel described in section 513(b)
of the FD&C Act; and (3) consideration of comments to a public docket.
FDA published a proposed order to reclassify this device in the Federal
Register of February 20, 2014 (79 FR 9671). FDA has held a meeting of a
device classification panel described in section 513(b) of the FD&C Act
to discuss shortwave diathermy for all other uses, and therefore, has
met this requirement under section 513(e)(1) of the FD&C Act. As
explained further in section II of the proposed order, a meeting of a
device classification panel described in section 513(b) of the FD&C Act
took place on May 21, 2013. FDA received and has considered several
comments on this proposed order, as discussed in Section II.

II. Public Comments in Response to the Proposed Order

    In response to the February 20, 2014, proposed order to reclassify
shortwave diathermy for all other uses and to rename the device
``nonthermal shortwave therapy,'' FDA received 40 comments from
industry, a patient advocacy group, and consumers of SWT devices. Of
those, 35 comments were received from users of specific devices who
support the use and availability of those devices in the United States.
Several of these comments also supported reclassification into class
II. This final order reclassifies into class II SWT devices intended
for adjunctive use in the palliative treatment of postoperative pain
and edema of soft tissue by means other than the generation of deep
heat within body tissues and establishes special controls that are
intended to mitigate risks to health of SWT devices in order to provide
a reasonable assurance of their safety and effectiveness. These special
controls are meant to protect patients from unsafe or ineffective SWT
devices.
    Six of the comments from users also requested that the prescription
use restriction be removed from the proposed regulation so that SWT
devices could be available over-the-counter (OTC). This final order
applies only to SWT devices for the indications and uses that have been
previously cleared for marketing. To date, FDA has not cleared an SWT
device for OTC use and, as a result, has limited the reclassification
in this final order to prescription use devices. However, if FDA
receives a marketing application in the future for an SWT device
indicated

for OTC use, FDA would make its classification decision regarding such
use at that time.
    One public comment FDA received requested that SWT devices remain
classified in class III, and that FDA call for PMAs. FDA disagrees that
SWT devices should remain in class III and require PMA approval. On May
21, 2013, FDA held a meeting of the Orthopedic and Rehabilitation
Devices Panel (the 2013 Panel), to discuss the classification of SWT
devices (Ref. 1). The 2013 Panel reached consensus that SWT devices did
not fit the statutory definition of a class III device. Section
513(a)(1)(C) of the FD&C Act provides that a device is class III if (a)
the device is life supporting or life sustaining, of substantial
importance in preventing impairment to human health, or presents a
potential unreasonable risk of illness or injury, and (b) the device
cannot be classified in class I or II because insufficient information
exists to determine that general controls or general and special
controls would provide reasonable assurance of the safety and
effectiveness of the device. The 2013 Panel agreed that SWT devices are
not life supporting or life sustaining, or of substantial importance to
preventing impairment to human health. The 2013 Panel was concerned
about the potential unreasonable risk of illness or injury resulting
from the use of SWT devices in certain instances, such as treatments
around the eye. Moreover, the 2013 Panel concluded that the information
presented to the panel was sufficient to establish special controls
that are necessary to provide reasonable assurance of safety and
effectiveness of SWT. Thus, the consensus of the 2013 Panel was to
recommend that SWT be reclassified into class II (special controls).
    FDA agrees with the 2013 Panel's recommendation for
reclassification. The Agency believes, as stated in the proposed order,
that the risks of SWT devices are sufficiently understood based on
valid scientific evidence, and a review of the clinical literature
indicates that few relevant adverse events have been reported for these
devices. FDA further believes that the risks of SWT devices with the
special controls identified in this final order will be nominal.
    One of the public comments, received from industry, requested
removal of the special control requiring clinical data, stating that it
was unnecessary and there was already sufficient evidence of
effectiveness. This comment did not cite new data, but requested that
FDA reconsider the data that was previously presented to the 2013
Panel. The available scientific evidence on the effectiveness of SWT
was presented to the 2013 Panel by both FDA and industry, and there was
panel consensus that the existing data was very limited and that
clinical data should be required as a special control. When asked to
consider the benefits of SWT based on the information presented to it
by FDA and industry, the 2013 Panel consensus was that there may be a
certain subset of patients who may benefit from SWT; however, the 2013
Panel had ``very serious concerns involving both the veracity and the
scientific methodology of the data presented.'' Thus, although the
limited data reviewed by the Agency and by the 2013 Panel suggest that
SWT could potentially be effective, particularly for management of
postoperative pain, the 2013 Panel members indicated a need for
clinical data demonstrating effectiveness from statistically powered,
well-controlled studies with quantified outcomes. The 2013 Panel agreed
with FDA that clinical studies should consider the following
attributes: Randomization, utilization of sham controls, blinding,
well-defined cohorts, well-defined treatment parameters, clinically
relevant and validated measures, adequate power, appropriate and
defined methods of statistics, predefined hypotheses, and systematic
collection of adverse events. The 2013 Panel believed that clinical
studies incorporating these basic design elements should be feasible to
conduct, and are important in demonstrating an appropriate level of
effectiveness for specific devices. FDA agrees with the 2013 Panel's
assessment and has determined that the special controls identified in
this final order, including clinical performance data, are necessary to
provide a reasonable assurance of safety and effectiveness of SWT.
    Two comments from sponsors of currently marketed SWT devices
supported reclassification, but requested 2 years from the effective
date of the final order to submit a 510(k), rather than the 60 days FDA
proposed in the proposed order. The comments suggested that if clinical
data are necessary, it will be difficult to plan and conduct a clinical
trial and submit the data within 60 days of the effective date of the
final order. One comment suggested that it will be beneficial to
interact with the Agency prior to a clinical trial and submission of
the data to FDA, and that 60 days may not be adequate to accomplish
such. FDA would like to encourage interaction with the Agency prior to
a clinical study and submission of the data to FDA, and therefore
grants these requests to provide more time for currently legally
marketed SWT devices to comply with the special controls identified in
this order. The special controls will be effective on the date of
publication of this final order. However, FDA does not intend to
enforce compliance with the special controls with respect to currently
legally marketed SWT devices until 1 year after the date of publication
of this final order. Please see Section IV, ``Implementation
Strategy.'' The Agency also notes that when indicated for adjunctive
use in the palliative treatment of postoperative pain and edema, SWT
devices may not be considered significant risk devices, per 21 CFR
812.3(m), and therefore clinical studies conducted in the United States
involving SWT devices with those indications for use may not require an
application for Investigational Device Exemption (U.S. studies
involving such devices would, however, require approval by an
institutional review board; see 21 CFR 812.2(b)(1)). Alternatively, SWT
devices with indications for use different from adjunctive use in the
palliative treatment of postoperative pain and edema of soft tissue, or
that specify the types of postoperative pain or edema, may be
considered significant risk devices. We encourage interaction with FDA
through the presubmission process to address any questions regarding
whether such a device is significant risk.
    One industry comment challenged FDA's authority to require new
510(k)s for SWT devices that have already been legally marketed to
demonstrate that the SWT devices meet the special controls. FDA has
considered this comment, and will not require manufacturers of
currently legally marketed SWT devices to submit a new 510(k)
notification. However, manufacturers must comply with the special
controls implemented by this order; if the special controls are not met
then the device may be considered adulterated under section
501(f)(1)(B) of the FD&C Act (21 U.S.C. 351(f)(1)(B). In order to
ensure compliance with these special controls, FDA is requiring that
manufacturers of currently marketed SWT devices submit an amendment to
their previously cleared 510(k) demonstrating compliance with the
special controls. Such amendment will be added to the 510(k) file but
will not serve as a basis for a new substantial equivalence review. An
amendment to a 510(k) in this context will be used solely to submit
information demonstrating to

FDA that an SWT device is in compliance with the special controls.
    As discussed above, the special controls will be effective on the
date of publication of this final order. However, FDA does not intend
to enforce compliance with the special controls with respect to
currently legally marketed SWT devices until 1 year after the date of
publication. Please see Section IV, ``Implementation Strategy.'' If an
amendment to a 510(k) that demonstrates compliance with the special
controls for the device is not submitted as required in Section IV or
if FDA determines after review of the amendment that the device is not
in compliance with the special controls, the device may be considered
adulterated and sale of the device would have to cease.
    In reviewing the proposed order, the comments received, and the
2013 Panel's recommendations, FDA is also making a few modifications to
the identification and special controls for SWT devices. The
identification has been revised from ``intended for the treatment of
medical conditions except for the treatment of malignancies'' to
``intended for adjunctive use in the palliative treatment of
postoperative pain and edema of soft tissue,'' as the latter statement
more closely captures the current intended uses of existing SWT
devices. The special control that specifies saline gel test loads has
been revised to allow for testing in saline gel test load or other
appropriate models to allow for flexible characterization approaches.
The special control ``Documented clinical performance testing must
demonstrate safe and effective use of the device'' has been revised to
``A detailed summary of the clinical testing pertinent to use of the
device to demonstrate the effectiveness of the device in its intended
use.'' This revision clarifies the information that FDA would expect to
see under this special control. Finally, labeling for SWT devices must
include output characteristics of the device and recommended treatment
regimes, including duration of use, in addition to a detailed summary
of the clinical testing pertinent to the use of the device and a
summary of the adverse events and complications. This revision
clarifies the type of information that FDA would expect to see in
labeling for SWT devices. FDA believes these revisions provide
additional clarification and flexibility for SWT device manufacturers.

III. The Final Order

    Under section 513(e) of the FD&C Act, FDA is adopting its findings
as published in the preamble to the proposed order with the
modifications discussed in Section II of this final order. FDA is
issuing this final order to reclassify shortwave diathermy (SWD) for
adjunctive use in the palliative treatment of postoperative pain and
edema in superficial soft tissue by means other than the generation of
deep heat within body tissues from class III to class II, rename the
device ``nonthermal shortwave therapy'' (SWT), and establish special
controls by revising part 890 (21 CFR part 890). As described in the
proposed order, FDA is also making a technical correction in the
regulation for the carrier frequency for SWD and SWT devices from ``13
megahertz (MHz) to 27.12 MHz'' to ``13.56 MHz or 27.12 MHz.'' The
identification for Sec.  890.5290 has been revised to provide the name
change of the device under paragraph (b) and a more accurate
description of the devices in this classification section. SWT devices
must comply with the special controls identified in this order (see
Section IV, ``Implementation Strategy'').
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act if FDA determines that premarket notification is
not necessary to provide reasonable assurance of the safety and
effectiveness of the devices. FDA has determined that premarket
notification is necessary to provide reasonable assurance of safety and
effectiveness of SWT and, therefore, this device type is not exempt
from premarket notification requirements.
    Following the effective date of this final order, firms marketing
SWT devices must comply with the special controls set forth in this
order (see Section IV, ``Implementation Strategy'').

IV. Implementation Strategy

    The special controls identified in this final order are effective
October 13, 2015. For models of SWT devices that have not been legally
marketed prior to October 13, 2015, or models that have been legally
marketed but are required to submit a new 510(k) under Sec.
807.81(a)(3) because the device is about to be significantly changed or
modified, manufacturers must obtain 510(k) clearance, among other
relevant requirements, and demonstrate compliance with the special
controls included in this final order, before marketing the new or
changed device.
    FDA does not intend to enforce compliance with the special controls
for currently legally marketed SWT devices until October 13, 2016. For
those manufacturers who wish to continue to offer currently legally
marketed devices for sale, FDA expects them to submit a 510(k)
amendment for those devices by October 13, 2016 demonstrating
compliance with the special controls included in this final order. If a
510(k) amendment is not submitted by this date for the device or if FDA
determines that the amendment does not demonstrate compliance with the
special controls, the device may be considered adulterated under
section 501(f)(1)(B) of the FD&C Act as of the date of FDA's
determination of noncompliance or October 13, 2016, whichever is
sooner, and sale of the device would have to cease.

V. Environmental Impact, No Significant Impact

    The Agency has determined under 21 CFR 25.34(b) 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.

VI. Paperwork Reduction Act of 1995

    This final order 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 812 have been approved under
OMB control number 0910-0078; 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 814, subpart B,
have been approved under OMB control number 0910-0231; and the
collections of information under 21 CFR part 801 have been approved
under OMB control number 0910-0485.

VII. Codification of Orders

    Prior to the amendments by FDASIA, section 513(e) of the FD&C Act
provided for FDA to issue regulations to reclassify devices. Although
section 513(e) of the FD&C Act as amended requires FDA to issue final
orders rather than regulations, FDASIA also provides for FDA to revoke
previously issued regulations by order. FDA will continue to codify
classifications and reclassifications in the Code of Federal
Regulations (CFR). Changes resulting from final orders will appear in
the CFR as changes to codified classification determinations or as
newly codified orders. Therefore, under section 513(e)(1)(A)(i) of the
FD&C Act, as amended by FDASIA, in this final order

we are revoking the requirements in Sec.  890.5290(b) related to the
classification of SWT as class III devices and codifying the
reclassification of SWT into class II (special controls).

VIII. Reference

    FDA has placed the following reference on display in the Division
of Dockets Management (HFA-305) Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852. Interested persons may see
it between 9 a.m. and 4 p.m., Monday through Friday, and online at
http://www.regulations.gov.
    1. FDA's Orthopedic and Rehabilitation Devices Panel transcript and
other meeting materials are available on FDA's Web site at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/ucm352525.htm.

List of Subjects in 21 CFR Part 890

    Medical devices, Physical medicine devices.

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

PART 890--PHYSICAL MEDICINE DEVICES

0
1. The authority citation for 21 CFR part 890 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Section 890.5290 is amended by revising paragraphs (a)(1) and (b)
and removing paragraph (c).
    The revisions read as follows:

Sec.  890.5290  Shortwave diathermy.

    (a) Shortwave diathermy for use in applying therapeutic deep heat
for selected medical conditions--(1) Identification. A shortwave
diathermy for use in applying therapeutic deep heat for selected
medical conditions is a device that applies to specific areas of the
body electromagnetic energy in the radiofrequency (RF) bands of 13.56
megahertz (MHz) or 27.12 MHz and that is intended to generate deep heat
within body tissues for the treatment of selected medical conditions
such as relief of pain, muscle spasms, and joint contractures, but not
for the treatment of malignancies.
* * * * *
    (b) Nonthermal shortwave therapy--(1) Identification. A nonthermal
shortwave therapy is a prescription device that applies to the body
pulsed electromagnetic energy in the RF bands of 13.56 MHz or 27.12 MHz
and that is intended for adjunctive use in the palliative treatment of
postoperative pain and edema of soft tissue by means other than the
generation of deep heat within body tissues as described in paragraph
(a) of this section.
    (2) Classification: Class II (special controls). The device is
classified as class II. The special controls for this device are:
    (i) Components of the device that come into human contact must be
demonstrated to be biocompatible.
    (ii) Appropriate analysis/testing must demonstrate that the device
is electrically safe and electromagnetically compatible in its intended
use environment.
    (iii) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use. Non-
clinical performance testing must characterize the output waveform of
the device and demonstrate that the device meets appropriate output
performance specifications. The output characteristics and the methods
used to determine these characteristics, including the following, must
be determined:
    (A) Peak output power;
    (B) Pulse width;
    (C) Pulse frequency;
    (D) Duty cycle;
    (E) Characteristics of other types of modulation that may be used;
    (F) Average measured output powered into the RF antenna/applicator;
    (G) Specific absorption rates in saline gel test load or other
appropriate model;
    (H) Characterization of the electrical and magnetic fields in
saline gel test load or other appropriate model for each RF antenna and
prescribed RF antenna orientation/position; and
    (I) Characterization of the deposited energy density in saline gel
test load or other appropriate model.
    (iv) A detailed summary of the clinical testing pertinent to use of
the device to demonstrate the effectiveness of the device in its
intended use.
    (v) Labeling must include the following:
    (A) Output characteristics of the device;
    (B) Recommended treatment regimes, including duration of use; and
    (C) A detailed summary of the clinical testing pertinent to the use
of the device and a summary of the adverse events and complications.
    (vi) Nonthermal shortwave therapy devices marketed prior to the
effective date of this reclassification must submit an amendment to
their previously cleared premarket notification (510(k)) demonstrating
compliance with these special controls.

    Dated: October 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25923 Filed 10-9-15; 8:45 am]
BILLING CODE 4164-01-P