[Federal Register Volume 83, Number 126 (Friday, June 29, 2018)]
[Notices]
[Pages 30787-30791]
[FR Doc No: 2018-13978]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83505; File No. SR-CBOE-2018-046]

Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change Relating
to Exchange Rule 6.2., Hybrid Opening (and Sometimes Closing) System
(``HOSS'')

June 25, 2018.
    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 June 15, 2018, 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 pursuant to Section 19(b)(3)(A)(iii) 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.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).

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

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Rule 6.2., Hybrid Opening (and
Sometimes Closing) System (``HOSS'').
(additions are italicized; deletions are [bracketed])
* * * * *

Cboe Exchange, Inc. Rules

* * * * *

Rule 6.2. Hybrid Opening (and Sometimes Closing) System (``HOSS'')

    (a)-(b) (No change).
    (c) Opening Rotation Period. After the System initiates the
opening rotation procedure and sends the Rotation Notice, the System
begins the opening rotation period. During the opening rotation
period for a series:
    (i)-(ii) (No change).
    (iii) After a period of time determined by the Exchange for all
classes (which period of time may be no longer than five seconds),
the System opens series of a class in [a random]the following
order[, staggered over regular intervals of time (the Exchange
determines the length and number of these intervals for all
classes).]:
    (A) ATM and OTM Series with Expirations of 29 to 31 Days. During
the initial interval (the Exchange determines the length of this
interval for all classes, the length of which may be no longer than
three seconds), the System opens:
    (I) at-the-money (``ATM'') puts and a group of out-of-the-money
(``OTM'') puts with strike prices closest to the ATM strike price,
in a random order;
    (II) ATM calls and a group of OTM calls with strike prices
closest to the ATM strike price, in a random order; and
    (III) alternating groups of further OTM puts and further OTM
calls, each in a random order.
    During this interval, the System attempts to open any ATM or OTM
series that could not open on its first attempt.
    (B) All Other Series. After the initial interval, the System
opens all other series, and any series that did not open pursuant to
subparagraph (A), in a random order, staggered over regular
intervals of time (the Exchange determines the length and number of
these intervals for all classes, the length of which intervals may
be no longer than two seconds).
    (C) Definition of ATM. For purposes of subparagraph (A), a put
(call) is ATM if its strike price equals or is the first strike
above (below) the last disseminated transaction price in the
underlying security or index value on the same trading day. If the
System begins an opening rotation for a class prior to receiving a
disseminated transaction price in the underlying security or index
value, the System will open all series in the class pursuant to
subparagraph (B).
    Subject to paragraph (d) below, the opening rotation period
(including these intervals) may not exceed [60]30 seconds.
    (d)-(h) (No change).
    . . . Interpretations and Policies:
    .01-.07 (No change).
* * * * *
    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 proposed rule change amends the order in which the System opens
series for trading. Current Rule 6.2(c)(iii) states, after a period of
time after the initiation of the opening rotation (which time is
determined by the Exchange for all classes, and may be no longer than
five seconds),\5\ the System opens series of a class in a random order,
staggered over regular intervals of time (the Exchange determines the
length and number of these intervals for all classes).\6\ The opening
rotation period (including these intervals) may not exceed 60 seconds,
except as otherwise set forth in the Rule.
---------------------------------------------------------------------------

    \5\ Currently, this time is set to two seconds. The Exchange
intends to reduce this time period to one second in June 2018.
    \6\ Currently, there are two one-second intervals.
---------------------------------------------------------------------------

    Pursuant to the proposed rule change, during an initial interval
(the Exchange determines the length of this interval for all classes,
which may be no longer than three seconds),\7\ the System will first
open at-the-money (``ATM'') and out-of-the-money (``OTM'') series with
expirations of 29 to 31 days, and then open all remaining series.
Specifically, during the first interval, the System will open:
---------------------------------------------------------------------------

    \7\ The Exchange intends to initially set the length of this
interval to 500 milliseconds.
---------------------------------------------------------------------------

     ATM puts and a group of OTM puts with strike prices
closest to the ATM strike price, in a random order;
     ATM calls and a group of OTM calls with strike prices
closest to the ATM strike price, in a random order; and
     alternating groups of further OTM puts and further OTM
calls, each in a random order.

During this interval, the System attempts to open any ATM or OTM series
that could not open on its first attempt.
    After the first interval, the System opens all other series, and
any OTM and ATM series with expirations of 29 to 31 days that did not
open during the first interval, in a random order, staggered over
regular intervals of time (the Exchange determines the length and
number of these intervals for all classes, the length of which may be
no longer than two seconds).\8\
---------------------------------------------------------------------------

    \8\ The Exchange intends to initially have 10 intervals of 100
milliseconds each.
---------------------------------------------------------------------------

    For purposes of this proposed rule change, a put (call) is ATM if
its strike price equals or is the first strike above (below) the last
disseminated transaction price in the underlying security or index
value on the same trading day. If the System begins an opening rotation
for a class prior to receiving a disseminated transaction price in the
underlying security or index value, the System will open all series in
the class pursuant to proposed subparagraph (B) (i.e., all in a random
order, staggered over regular intervals of time). Pursuant to Rule 6.2,
the opening rotation for most equity and exchange-traded product
options will begin after the System receives a disseminated opening
trade or quote in the market for the underlying security. Additionally,
the opening rotation for certain index options will begin at the later
of 8:30 a.m. and the time the System receives a disseminated index
value for classes determined by the Exchange. However, for certain
classes, the opening rotation will begin at 8:30 a.m. As a result, it
is possible the System may not have a value to determine which series
are ATM. To avoid delaying the opening of series in these classes, the
Exchange believes it is appropriate to open all series in a random
order rather than wait for such a value.
    Below are examples demonstrating the new opening sequence. For
purposes of these examples, assume the ATM strike price is 50.
Additionally, assume June expiration series are 30 days away and all
other series are more than 31 days away. There will be a one second
opening timer delay, an initial

interval of 500 milliseconds, and then 10 intervals of 100
milliseconds. Puts will be opened in groups of 4, and calls will be
opened in groups of 3 (the first put and call group will also include
the ATM strike). Class ABC consists of the following series:

Jun ABC 62 put
Jun ABC 61 put
Jun ABC 60 put
Jun ABC 59 put
Jun ABC 58 put
Jun ABC 57 put
Jun ABC 56 put
Jun ABC 55 put
Jun ABC 54 put
Jun ABC 53 put
Jun ABC 52 put
Jun ABC 51 put
Jun ABC 50 put
Jun ABC 49 put
Jun ABC 48 put
Jun ABC 47 put
Jun ABC 46 put
Jun ABC 45 put
Jun ABC 44 put
Jun ABC 43 put
Jun ABC 42 put
Jun ABC 41 put
Jun ABC 40 put
Jun ABC 39 put
Jun ABC 38 put
Jun ABC 59 call
Jun ABC 58 call
Jun ABC 57 call
Jun ABC 56 call
Jun ABC 55 call
Jun ABC 54 call
Jun ABC 53 call
Jun ABC 52 call
Jun ABC 51 call
Jun ABC 50 call
Jun ABC 49 call
Jun ABC 48 call
Jun ABC 47 call
Jun ABC 46 call
Jun ABC 45 call
Jun ABC 44 call
Jun ABC 43 call
Jun ABC 42 call
Jun ABC 41 call
July ABC 60 put
July ABC 60 call
July ABC 59 put
July ABC 59 call
July ABC 58 put
July ABC 58 call
July ABC 57 put
July ABC 57 call
July ABC 56 put
July ABC 56 call
July ABC 55 put
July ABC 55 call
Aug ABC 60 put
Aug ABC 60 call
Aug ABC 59 put
Aug ABC 59 call
Aug ABC 58 put
Aug ABC 58 call
Aug ABC 57 put
Aug ABC 57 call
Aug ABC 56 put
Aug ABC 56 call
Aug ABC 55 put
Aug ABC 55 call
Example #1--All Series Satisfy Opening Conditions on First Attempt
    After the one-second delay, the 500-millisecond interval starts.
During that interval, the System opens in a random order the Jun ABC
50, 49, 48, 47, and 46 puts. The System then opens in a random order
the Jun ABC 50, 51, 52, and 53 calls. Then, the System opens in a
random order the Jun ABC 45, 44, 43, and 42 puts. Then, the System
opens in a random order the Jun ABC 54, 55, and 56 calls. Next, the
System opens in a random order the Jun ABC 41, 40, 39, and 38 puts. The
System then opens in a random order the Jun ABC 57, 58, and 59 calls.
After 500 milliseconds, the System opens in a random order over 10 100-
millisecond intervals the remaining Jun puts and calls and all Jul and
Aug puts and calls.
Example #2--Assume One Series Does Not Open on First Attempt but Does
Open on Second Attempt During the Initial Interval
    After the one-second delay, the 500-millisecond interval starts.
During that interval, the System opens in a random order the Jun ABC
50, 49, 48, 47, and 46 puts. The System then opens in a random order
the Jun ABC 50, 51, 52, and 53 calls. Then, the System opens in a
random order the Jun ABC 45, 44, and 43, and attempts to but cannot
open the Jun ABC 42 put. Then, the System opens in a random order the
Jun ABC 54, 55, and 56 calls. Next, the System opens in a random order
the Jun ABC 41, 40, 39, and 38 puts. The System then opens in a random
order the Jun ABC 57, 58, and 59 calls. The System then opens the Jun
ABC 42 put, which did not open on its first attempt. After 500
milliseconds, the System opens in a random order over 10 100-
millisecond intervals the remaining Jun puts and calls and all Jul and
Aug puts and calls.
Example #3--Assume One Series Does Not Satisfy Opening Conditions
During the First Interval
    After the one-second delay, the 500-millisecond interval starts.
During that interval, the System opens in a random order the Jun ABC
50, 49, 48, 47, and 46 puts. The System then opens in a random order
the Jun ABC 50, 51, 52, and 53 calls. Then, the System opens in a
random order the Jun ABC 45, 44, and 43, and attempts to but cannot
open the Jun ABC 42 put. Then, the System opens in a random order the
Jun ABC 54, 55, and 56 calls. Next, the System opens in a random order
the Jun ABC 41, 40, 39, and 38 puts. The System then opens in a random
order the Jun ABC 57 and 58 calls, and attempts to but cannot open the
Jun ABC 59 call. During the initial 500 milliseconds, the System
continues to attempt to but cannot open the Jun ABC 59 call. After 500
milliseconds, the System opens in a random order over 10 100-
millisecond intervals the Jun ABC 59 call, the remaining Jun puts and
calls, and all Jul and Aug puts and calls.
    While the System will continue to open series in a random order,
during an initial longer interval, the System will open specific groups
of series within a random order. The order in which the System opens
series for trading is generally immaterial; however, on expiration days
for volatility index derivatives, ATM and OTM series with expirations
of approximately one month are used to calculate the exercise
settlement value of expiring volatility index derivatives as part of
the modified opening procedure. The Exchange believes opening these
series first will enhance liquidity in those series on expiration days
for volatility index derivatives.
    Specifically, Market-Makers are the primary liquidity providers in
the Exchange's market. The Exchange provides Market-Makers with a tool,
the Quote Risk Monitor (``QRM'') they use to control risk of multiple,
automatic executions. A QRM event in a class will cause a Market-
Maker's quotes in all series in the class to be cancelled (certain
events may cause a Market-Maker's quotes in all classes to be
cancelled).\9\ As a result, a Market-Maker's opening transactions in
series not used to calculate an exercise settlement value may cause a
QRM event, cancelling the Market-Maker's quotes in all other series in
the class, including series used to calculate an exercise settlement
value. This reduces liquidity in these series. Similarly, the Exchange
has observed larger Market-Maker quote sizes in further OTM puts and
calls compared to sizes in less OTM puts and calls and ATM puts and
calls, which have higher weightings in the formula used to determine
the exercise settlement value of expiring volatility index derivatives
in accordance with the applicable volatility index

methodology.\10\ If the further OTM puts and calls open prior to the
less OTM puts and calls and ATM puts and calls, similar reduced
liquidity in those ATM and less OTM puts and calls from QRM events may
occur. The Exchange believes the proposed rule change will increase
liquidity in all series used to calculate exercise settlement values,
which is desirable to ensure these series open at competitive prices on
expiration days for volatility index derivatives. While liquidity is
important to open all series on the Exchange, given the potential
impact on the exercise settlement value determined for expiring
volatility index derivatives, the Exchange believes it is appropriate
to ensure a fair and orderly opening of the series used to calculate
the exercise settlement value.
---------------------------------------------------------------------------

    \9\ See Rule 8.18.
    \10\ See, e.g., the VIX methodology at http://www.cboe.com/micro/vix/vix-index-rules-and-methodology.pdf.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\11\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \12\ 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) \13\ requirement that the rules of an exchange not be
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(5).
    \13\ Id.
---------------------------------------------------------------------------

    In particular, the proposed rule change merely modifies the order
in which the System opens series for trading on the Exchange. The
System will continue to open series in a random order; however,
initially, it will open series within specific groups in a random
order. The Exchange believes the System can open series pursuant to the
proposed maximum interval times, as current interval times are under
these maximums, and because they are consistent with the proposed
maximum of 30 seconds for the entire opening process. These interval
times ensure a fast opening of all series, which will benefit
investors.
    While the order in which the System opens series is generally
immaterial (and thus why the Exchange has opened them in a random
order), the Exchange believes opening ATM and OTM series with
expirations of approximately one month will permit series used to
calculate exercise settlement values for expiring volatility index
derivatives to open as soon as possible. As discussed above, the
Exchange believes this may enhance liquidity in these series on
expiration days for volatility index derivatives, which benefits market
participants. Additionally, reducing the potential time during which
all series in all classes will open benefits all market participants,
because market participants will be able to begin trading in all series
sooner.

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

    Cboe Options 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 proposed rule change
only modifies the order in which the System will open series for
trading. The System will open groups of ATM and OTM series with
expirations of approximately one month first, but will continue to open
series within those groups in a random order, and then open all in-the-
money series in a random order (as is case today with respect to those
series). Additionally, pursuant to the proposed rule change, the
opening process must be within a shorter time period. The proposed
maximum interval times are consistent with current and proposed
interval times, and are consistent with the proposed maximum of 30
seconds for the entire opening process (which is shorter than the
current maximum). The proposed rule change applies to all classes in
the same manner, and only applies to the order in which the System will
open series for trading on the Exchange. As discussed above, the
Exchange believes this may enhance liquidity in these series on
expiration days for volatility index derivatives, which benefits market
participants. Additionally, reducing the potential time during which
all series in all classes will open benefits all market participants,
because market participants will be able to begin trading in all series
sooner.

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 comments on the
proposed rule change.

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

    Because the foregoing 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, it has become
effective pursuant to Section 19(b)(3)(A)(iii) of the Act \14\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\15\
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \15\ 17 CFR 240.19b-4(f)(6). 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.
---------------------------------------------------------------------------

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-CBOE-2018-046 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-2018-046. 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-2018-046 and should be submitted on
or before July 20, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-13978 Filed 6-28-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 112 (Monday, June 11, 2018)]
[Proposed Rules]
[Pages 26877-26880]
[FR Doc No: 2018-12228]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0509; Product Identifier 2017-NM-076-AD]
RIN 2120-AA64

Airworthiness Directives; Embraer S.A. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Embraer S.A. Model ERJ 190 airplanes. This proposed AD was
prompted by reports of bushing migration and loss of nut torque on the
engine pylon lower inboard and outboard link fittings. This proposed AD
would require modification of the attaching parts of the left-hand (LH)
and right-hand (RH) pylon lower link fittings, inboard and outboard
positions. We are proposing this AD to address the unsafe condition on
these products.

DATES: We must receive comments on this proposed AD by July 26, 2018.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Embraer
S.A., Technical Publications Section (PC 060), Av. Brigadeiro Faria
Lima, 2170--Putim--12227-901 S[atilde]o Jose dos Campos--SP--Brazil;
telephone: +55 12 3927-5852 or +55 12 3309-0732; fax: +55 12 3927-7546;
email: [email protected]; internet: http://www.flyembraer.com. You
may view this service information at the FAA, Transport Standards
Branch, 2200 South 216th St., Des Moines, WA. For information on the
availability of this material at the FAA, call<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-2018-
0509; 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 NPRM, the regulatory evaluation, any comments received,
and other information. The street address for the Docket Operations
office (telephone:<PHONE_NUMBER>) is in the ADDRESSES section. Comments
will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Krista Greer, Aerospace Engineer,
International Section, Transport Standards Branch, FAA, 2200 South
216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2018-0509;
Product Identifier 2017-NM-076-AD'' at the beginning of your comments.
We specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this NPRM. We will consider all
comments received by the closing date and may amend this NPRM based on
those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this NPRM.

Discussion

    Ag[ecirc]ncia Nacional de Avia[ccedil][atilde]o Civil (ANAC), which
is the aviation authority for Brazil, has issued Brazilian AD 2017-04-
01, effective April 25, 2017 (referred to after this as the Mandatory
Continuing Airworthiness Information, or ``the MCAI''), to correct an
unsafe condition for certain Embraer S.A. Model ERJ 190 airplanes. The
MCAI states:

    This [Brazilian] AD was prompted by reports of bushing migration
and loss of nut torque on the engine pylon lower inboard and
outboard link fittings. We are issuing this [Brazilian] AD to
prevent loss of integrity of the engine pylon lower link fittings,
which could result in separation of the engine from the wing.
    This [Brazilian] AD requires modifications of the attaching
parts of the left handle (LH) and right handle (RH) pylon lower link
fittings, inboard and outboard positions.

    You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0509.

Related Service Information Under 1 CFR Part 51

    Embraer S.A. has issued Embraer Service Bulletin 190-54-0016,
Revision 04, dated December 7, 2017; and Embraer Service Bulletin
190LIN-54-0008, Revision 02, dated May 9, 2018. The service information
describes procedures for modification of the attaching parts of the LH
and RH pylon lower link fittings, inboard and outboard positions. These
documents are distinct since they apply to different airplane models.
This service information is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another

country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type designs.

Costs of Compliance

    We estimate that this proposed AD affects 85 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
            Action                   Labor cost         Parts cost      Cost per product          operators
----------------------------------------------------------------------------------------------------------------
Modification..................  Up to 270 work-hours          $3,200  Up to $26,150.......  Up to $2,222,750.
                                 x $85 per hour =
                                 $22,950.
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some of the costs of this proposed
AD may be covered under warranty, thereby reducing the cost impact on
affected individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all available costs in our
cost estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This proposed AD is issued in accordance with authority delegated
by the Executive Director, Aircraft Certification Service, as
authorized by FAA Order 8000.51C. In accordance with that order,
issuance of ADs is normally a function of the Compliance and
Airworthiness Division, but during this transition period, the
Executive Director has delegated the authority to issue ADs applicable
to transport category airplanes to the Director of the System Oversight
Division.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    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.

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

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

Embraer S.A.: Docket No. FAA-2018-0509; Product Identifier 2017-NM-
076-AD.

(a) Comments Due Date

    We must receive comments by July 26, 2018.

(b) Affected ADs

    This AD affects AD 2014-16-16, Amendment 39-17940 (79 FR 48018,
August 15, 2014) (``AD 2014-16-16'').

(c) Applicability

    This AD applies to the Embraer S.A. airplanes identified in
paragraphs (c)(1) and (c)(2) of this AD, certificated in any
category.
    (1) Model ERJ 190-100 STD, -100 LR, and -100 IGW airplanes; and
Model ERJ 190-200 STD, -200 LR, and -200 IGW airplanes; as
identified in Embraer Service Bulletin 190-54-0016, Revision 04,
dated December 7, 2017.
    (2) Model ERJ 190-100 ECJ airplanes as identified in Embraer
Service Bulletin 190LIN-54-0008, Revision 02, dated May 9, 2018.

(d) Subject

    Air Transport Association (ATA) of America Code 54, Nacelles/
pylons.

(e) Reason

    This AD was prompted by reports of bushing migration and loss of
nut torque on the engine pylon lower inboard and outboard link
fittings. We are issuing this AD to prevent loss of integrity of the
engine pylon lower link fittings, and possibly resulting in
separation of the engine from the wing.

(f) Compliance

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

(g) Definitions

    (1) Group 1 airplanes are defined as: Serial numbers 19000002,
19000004, 19000006 through 19000108 inclusive, 19000110 through
19000139 inclusive, 19000141 through 19000158 inclusive, 19000160
through 19000176 inclusive, 19000178 through 19000202 inclusive,
19000204 through 19000224 inclusive, 19000226 through 19000235
inclusive, 19000237 through 19000242 inclusive, 19000244 through
19000260 inclusive, 19000262 through 19000277 inclusive, 19000279
through 19000295 inclusive, 19000297 through 19000306 inclusive,
19000308 through 19000316 inclusive, 19000318 through 19000361
inclusive, 19000363 through 19000437 inclusive, 19000439 through
19000452 inclusive, 19000454 through 19000466 inclusive, 19000468
through 19000525 inclusive, 19000527 through 19000533 inclusive,
19000535 through 19000558 inclusive, 19000560 through 19000570
inclusive, 19000572 through 19000610 inclusive, 19000612 through
19000631 inclusive, and 19000633 through 19000636 inclusive.
    (2) Group 2 airplanes are defined as: Serial numbers 19000637
through 19000640 inclusive, 19000642 through 19000655 inclusive,
19000657 through 19000682 inclusive, 19000684 through 19000686
inclusive, 19000688, 19000689, and 19000692 through 19000694
inclusive.

(h) Left-Hand (LH) Pylon Lower Link Fitting Attaching Parts
Modification

    (1) For Group 1 airplanes as identified in paragraph (g)(1) of
this AD: Within 15,000 flight hours or 48 months after the effective
date of this AD, whichever occurs later, replace the plain bushings
of the lower inboard and outboard link fittings, install the lock
washers with the L-profile on the fuse pin's head side, and replace
the internal shear pin of the fuse pins with new ones having larger
head diameter, in accordance with ``PART I'' of the Accomplishment
Instructions of Embraer Service Bulletin 190-54-0016, Revision 04,
dated December 7, 2017.
    (2) For Group 2 airplanes as identified in paragraph (g)(2) of
this AD: Within 15,000 flight hours or 48 months after the effective
date of this AD, whichever occurs later, replace the internal shear
pin of the fuse pins with new ones having larger head diameter, in
accordance with ``PART I'' of the Accomplishment Instructions of
Embraer Service Bulletin 190-54-0016, Revision 04, dated December 7,
2017.
    (3) For airplanes identified as Group 1 in Embraer Service
Bulletin 190LIN-54-0008, Revision 02, dated May 9, 2018: Within 48
months after the effective date of this AD, replace the plain
bushings of the lower inboard and outboard link fittings, install
the lock washers with the L-profile on the fuse pin's head side, and
replace the internal shear pin of the fuse pins with new ones having
larger head diameter, in accordance with ``PART I'' of the
Accomplishment Instructions of Embraer Service Bulletin 190LIN-54-
0008, Revision 02, dated May 9, 2018.
    (4) For airplanes identified as Group 2 in Embraer Service
Bulletin Embraer Service Bulletin 190LIN-54-0008, Revision 02, dated
May 9, 2018: Within 48 months after the effective date of this AD,
replace the internal shear pin of the fuse pins with new ones having
larger head diameter, in accordance with ``PART I'' of the
Accomplishment Instructions of Embraer Service Bulletin 190LIN-54-
0008, Revision 02, dated May 9, 2018.

(i) Right-Hand (RH) Pylon Lower Link Fitting Attaching Parts
Modification

    (1) For Group 1 airplanes as identified in paragraph (g)(1) of
this AD: Within 15,000 flight hours or 48 months after the effective
date of this AD, whichever occurs later, replace the plain bushings
of the lower inboard and outboard link fittings, install the lock
washers with the L-profile on the fuse pin's head side, and replace
the internal shear pin of the fuse pins with new ones having larger
head diameter, in accordance with ``PART II'' of the Accomplishment
Instructions of Embraer Service Bulletin 190-54-0016, Revision 04,
dated December 7, 2017.
    (2) For Group 2 airplanes as identified in paragraph (g)(2) of
this AD: Within 15,000 flight hours or 48 months after the effective
date of this AD, whichever occurs later, replace the internal shear
pin of the fuse pins with new ones having larger head diameter, in
accordance with ``PART II'' of the Accomplishment Instructions of
Embraer Service Bulletin 190-54-0016, Revision 04, dated December 7,
2017.
    (3) For airplanes identified as Group 1 in Embraer Service
Bulletin Embraer Service Bulletin 190LIN-54-0008, Revision 02, dated
May 9, 2018: Within 48 months after the effective date of this AD,
replace the plain bushings of the lower inboard and outboard link
fittings, install the lock washers with the L-profile on the fuse
pin's head side, and replace the internal shear pin of the fuse pins
with new ones having larger head diameter, in accordance with ``PART
II'' of the Accomplishment Instructions of Embraer Service Bulletin
190LIN-54-0008, Revision 02, dated May 9, 2018.
    (4) For airplanes identified as Group 2 in Embraer Service
Bulletin Embraer Service Bulletin 190LIN-54-0008, Revision 02, dated
May 9, 2018: Within 48 months after the effective date of this AD,
replace the internal shear pin of the fuse pins with new ones having
larger head diameter, in accordance with ``PART II'' of the
Accomplishment Instructions of Embraer Service Bulletin 190LIN-54-
0008, Revision 02, dated May 9, 2018.

(j) Terminating Action for AD 2014-16-16

    (1) Accomplishing the actions required by paragraph (h)(1) or
(h)(2) of this AD, as applicable, terminates the requirements of
paragraphs (g)(1), (h)(1), and (i)(1) of AD 2014-16-16 for that LH
pylon lower link fitting.
    (2) Accomplishing the actions required by paragraph (h)(3) or
(h)(4) of this AD, as applicable, terminates the requirements of
paragraphs (g)(2), (h)(2), and (i)(2) of AD 2014-16-16 for that LH
pylon lower link fitting.
    (3) Accomplishing the actions required by paragraph (i)(1) or
(i)(2) of this AD, as applicable, terminates the requirements of
paragraphs (g)(1), (h)(1), and (i)(1) of AD 2014-16-16 for that RH
pylon lower link fitting.
    (4) Accomplishing the actions required by paragraph (i)(3) or
(i)(4) of this AD, as applicable, terminates the requirements of
paragraphs (g)(2), (h)(2), and (i)(2) of AD 2014-16-16 for that RH
pylon lower link fitting.

(k) Credit for Previous Actions

    (1) This paragraph provides credit for actions required by
paragraphs (h)(1), (h)(2), (i)(1), and (i)(2) of this AD, if those
actions were performed before the effective date of this AD using
Embraer Service Bulletin 190-54-0016, dated September 22, 2015;
Embraer Service Bulletin 190-54-0016, Revision 01, dated January 18,
2016; Embraer Service Bulletin 190-54-0016, Revision 02, dated
September 12, 2016; or Embraer Service Bulletin 190-54-0016,
Revision 03, dated May 18, 2017.
    (2) This paragraph provides credit for actions required by
paragraphs (h)(3), (h)(4), (i)(3), and (i)(4) of this AD, if those
actions were performed before the effective date of this AD using
Embraer Service Bulletin 190LIN-54-0008, dated October 2, 2015;
Embraer Service Bulletin 190LIN-54-0008, Revision 01, dated April
13, 2017.

(l) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Section, send it to the attention of
the person identified in paragraph (m)(2) of this AD. Information
may be emailed to: [email protected]. Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Section, Transport Standards Branch, FAA; or the Ag[ecirc]ncia
Nacional de Avia[ccedil][atilde]o Civil (ANAC); or ANAC's authorized
Designee. If approved by the ANAC Designee, the approval must
include the Designee's authorized signature.
    (3) Required for Compliance (RC): For service information that
contains steps that are labeled as RC, the provisions of paragraphs
(l)(3)(i) and (l)(3)(ii) of this AD apply.
    (i) The steps labeled as RC, including substeps under an RC step
and any figures identified in an RC step, must be done to comply
with the AD. If a step or substep is labeled ``RC Exempt,'' then the
RC requirement is removed from that step or substep. An AMOC is
required for any deviations to RC steps, including substeps and
identified figures.
    (ii) Steps not labeled as RC may be deviated from using accepted
methods in accordance with the operator's maintenance or inspection
program without obtaining approval of an AMOC, provided the RC
steps, including substeps and identified figures, can still be done
as specified, and the airplane can be put back in an airworthy
condition.

(m) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) Brazilian AD 2017-04-01, effective April 25, 2017; for
related information. This MCAI may be found in the AD docket on the
internet at http://www.regulations.gov by searching for and locating
Docket No. FAA-2018-0509.
    (2) For more information about this AD, contact Krista Greer,
Aerospace Engineer, International Section, Transport Standards
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>.
    (3) For service information identified in this AD, contact
Embraer S.A., Technical Publications Section (PC 060), Av.
Brigadeiro Faria Lima, 2170--Putim--12227-901 S[atilde]o Jose dos
Campos--SP--Brazil; telephone: +55 12 3927-5852 or +55 12 3309-0732;
fax: +55 12 3927-7546; email:

[email protected]; internet: http://www.flyembraer.com. You may
view this service information at the FAA, Transport Standards
Branch, 2200 South 216th St., Des Moines, WA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued in Des Moines, Washington, on May 31, 2018.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2018-12228 Filed 6-8-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 91 (Friday, May 10, 2013)]
[Notices]
[Page 27413]
[FR Doc No: 2013-11114]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3362-EM; Docket ID FEMA-2013-0001]

Massachusetts; Emergency and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of an
emergency for the Commonwealth of Massachusetts (FEMA-3362-EM), dated
April 17, 2013, and related determinations.

DATES: Effective Date: April 17, 2013.

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: Notice is hereby given that, in a letter
dated April 17, 2013, the President issued an emergency declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as
follows:

    I have determined that the emergency conditions in certain areas
of the Commonwealth of Massachusetts resulting from explosions on
April 15, 2013, are of sufficient severity and magnitude to warrant
an emergency declaration under the Robert T. Stafford Disaster
Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (``the
Stafford Act''). Therefore, I declare that such an emergency exists
in the Commonwealth of Massachusetts.
    You are authorized to provide appropriate assistance for
required emergency measures, authorized under Title V of the
Stafford Act, to save lives and to protect property and public
health and safety, and to lessen or avert the threat of a
catastrophe in the designated areas. Specifically, you are
authorized to provide assistance for emergency protective measures
(Category B), including direct Federal assistance, under the Public
Assistance program through April 22, 2013.
    Consistent with the requirement that Federal assistance is
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance will be limited to 75 percent of the total
eligible costs. In order to provide Federal assistance, you are
hereby authorized to allocate from funds available for these
purposes such amounts as you find necessary for Federal emergency
assistance and administrative expenses.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, Department
of Homeland Security, under Executive Order 12148, as amended, James N.
Russo, of FEMA is appointed to act as the Federal Coordinating Officer
for this declared emergency.
    The following areas of the Commonwealth of Massachusetts have been
designated as adversely affected by this declared emergency:

    Middlesex, Norfolk, and Suffolk Counties for emergency
protective measures (Category B), including direct federal
assistance, under the Public Assistance program at 75 percent
federal funding.

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.

W. Craig Fugate,
Administrator,
Federal Emergency Management Agency.
[FR Doc. 2013-11114 Filed 5-9-13; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 79, Number 99 (Thursday, May 22, 2014)]
[Proposed Rules]
[Pages 29387-29392]
[FR Doc No: 2014-11635]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2014-N-0440]

Microbiology Devices; Reclassification of Influenza Virus Antigen
Detection Test Systems Intended for Use Directly With Clinical
Specimens

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed order.

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

SUMMARY: The Food and Drug Administration (FDA) is proposing to
reclassify antigen based rapid influenza virus antigen detection test
systems intended to detect influenza virus directly from clinical
specimens that are currently regulated as influenza virus serological
reagents from class I into class II with special controls and into a
new device classification regulation.

DATES: Submit either electronic or written comments on the proposed
order by August 20, 2014. See section XI for the proposed effective
date of any final order that may publish based on this proposed order.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2014-
N-0440, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-2014-N-0440 for this rulemaking. All comments
received may be posted without change to http://www.regulations.gov,
including any personal information provided. For additional information
on submitting comments, see the ``Comments'' heading of the
SUPPLEMENTARY INFORMATION section.
    Docket: For access to the docket to read background documents or
comments received, go to http://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 Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Stefanie Akselrod, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5517, Silver Spring, MD 20993-0002, 301-
796-6188.

SUPPLEMENTARY INFORMATION:

I. 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), and
the Food and Drug Administration Modernization Act of 1997 (FDAMA)
(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 the FD&C Act, FDA clears or approves the three classes of
medical devices for commercial distribution in the United States
through three regulatory processes: Premarket approval (PMA), product
development protocol, and premarket notification (a premarket
notification is generally referred to as a ``510(k)'' after the section
of the FD&C Act where the requirement is found). The purpose of a
premarket notification is to demonstrate that the new device is
substantially equivalent to a legally marketed predicate device. Under
section 513(i) of the FD&C Act, a device is substantially equivalent if
it has the same intended use and technological characteristics as a
predicate device, or has different technological characteristics but
data demonstrate that the new device is as safe and effective as the
predicate device and does not raise different issues of safety or
effectiveness.
    FDA determines whether new devices are substantially equivalent to
previously offered devices by means of premarket notification
procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and
part 807 of the regulations (21 CFR part 807). Section 510(k) of the
FD&C Act and the implementing regulations in part 807, subpart E,
require a person who intends to market a medical device to submit a
premarket notification submission to FDA before proposing to begin the
introduction, or delivery for introduction into interstate commerce,
for commercial distribution of a device intended for human use.
    In accordance with section 513(f)(1) of the FD&C Act, devices that
were not in commercial distribution before May 28, 1976, the date of
enactment of the 1976 amendments, generally referred to as
postamendment devices, are classified automatically by statute into
class III without any FDA rulemaking process. These devices remain in
class III and require premarket approval, unless FDA classifies the
device into class I or class II by issuing 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 or the device is reclassified into class I or class II. 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 and part 807 of FDA's regulations.
    Section 513(f)(2) of the FD&C Act establishes procedures for ``de
novo'' risk-based review and classification of postamendment devices
automatically classified into class III by section

513(f)(1). Under these procedures, any person whose device is
automatically classified into class III by section 513(f)(1) of the
FD&C Act may seek reclassification into class I or II, either after
receipt of an order finding the device to be not substantially
equivalent, in accordance with section 513(i), to a predicate device
that does not require premarket approval, or at any time after
determining there is no legally marketed device upon which to base a
determination of substantial equivalence. In addition, under section
513(f)(3) of the FD&C Act, FDA may initiate, or the manufacturer or
importer of a device may petition for, the reclassification of a device
classified into class III under section 513(f)(1).
    On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA (126
Stat. 1056) amended section 513(e) of the FD&C Act, changing the
process for reclassifying a device from rulemaking to an administrative
order. Section 608(b) of FDASIA (126 Stat. 1056) amended section 515(b)
of the FD&C Act (21 U.S.C. 360e(b)), changing the process for requiring
premarket approval for a preamendments class III device from rulemaking
to an administrative order.

Reclassification

    FDA is publishing this document to propose the reclassification of
antigen based rapid influenza detection test (RIDT) systems intended to
detect influenza virus antigen directly from clinical specimens that
are currently regulated as influenza virus serological reagents under
Sec.  866.3330 (21 CFR 866.3330) from class I into class II with
special controls and into a new device classification regulation.
    Section 513(e) of the FD&C Act governs reclassification of
classified preamendments device types and postamendments devices that
have been classified into class I or II under section 513(f)(2) or
(f)(3) of the FD&C Act. This section provides that FDA may, by
administrative order, reclassify a device based upon ``new
information.'' FDA can initiate a reclassification under section 513(e)
of the FD&C Act or an interested person may petition FDA to reclassify
an eligible device type. The term ``new information,'' as used in
section 513(e) of the FD&C Act, 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) of the
FD&C Act must be ``valid scientific evidence,'' as defined in section
513(a)(3) and 21 CFR 860.7(c)(2). (See, e.g., General Medical Co. v.
FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens Association v. FDA,
766 F.2d 592 (D.C. Cir.), 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
520(h)(4) of the FD&C Act, added by FDAMA, provides that FDA may use,
for reclassification of a device, certain information in a PMA 6 years
after the application has been approved. This can include information
from clinical and preclinical tests or studies that demonstrate the
safety or effectiveness of the device but does not include descriptions
of methods of manufacture or product composition and other trade
secrets.
    Section 513(e)(1) of the FD&C Act sets forth the process for
issuing a final order for reclassifying a device. 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 has held a meeting of a device classification panel
described in section 513(b) of the FD&C Act with respect to rapid
influenza diagnostic tests, and therefore, has met this requirement
under section 513(e).
    FDAMA added section 510(m) to the FD&C Act. Section 510(m) of the
FD&C Act provides that a class II device may be exempted from the
premarket notification requirements under section 510(k) of the FD&C
Act, if the Agency determines that premarket notification is not
necessary to assure the safety and effectiveness of the device.

II. Regulatory Background of the Device

    In the Federal Register of April 22, 1980 (45 FR 27204), FDA
published proposed regulations containing general provisions applicable
to the classification of immunology and microbiology devices and
individual proposed regulations to classify 161 immunology and
microbiology devices into one or more of three regulatory classes:
Class I (general controls), class II (performance standards), and class
III (premarket approval). These regulations included the April 22,
1980, proposed rule (45 FR 27204 at 27261) to classify influenza virus
serological reagents into class I under Sec.  866.3330 (21 CFR
866.3330) Influenza virus serological reagents. In a final rule, on
November 9, 1982 (47 FR 50814 at 50823), under the authority of the
Medical Device Amendments of 1976, FDA classified influenza virus
serological reagents into class I under Sec.  866.3330. At that time,
influenza tests conceived to fall under this regulation were laboratory
methods to detect antibodies that develop in response to influenza
infection while the detection of the influenza virus itself was done
primarily by viral culture. As enzyme immunoassay technology developed,
tests capable of detecting viral proteins (antigens) directly in human
respiratory samples began to come to FDA for clearance. Since then,
numerous influenza detection tests based on antigen-antibody binding
properties have been developed and cleared for the market. The first
RIDT for use directly from clinical specimens was cleared in 1990 and
followed by others in the late 1990s. To date, methods utilizing
antigens and antibodies as components of an influenza detection device
have been regulated under Sec.  866.3330 as class I devices exempt from
the premarket notification (510(k)) requirement subject to the
limitations in Sec.  866.9 (21 CFR 866.9). RIDTs found under Sec.
866.3330 exceed the limitations to the exemption from premarket
notification for influenza virus serological reagents under Sec.
866.9(c)(6) and thus require a 510(k) submission.
    There are approximately 12 RIDTs classified under Sec.  866.3330
actively marketed today. Because these devices are easy to use and
provide results within 15 to 30 minutes, they are widely used in point-
of-care settings where rapid diagnosis of influenza is important for
early case identification.

III. Identification

    We are proposing that RIDTs classified under Sec.  866.3330 be
identified under the new name of influenza virus antigen detection test
system. An influenza virus antigen detection test system is a device
intended for the qualitative detection of influenza viral antigens
directly from clinical specimens in patients with signs and symptoms of
respiratory infection. The test aids in the diagnosis of influenza
infection and provides epidemiological information on influenza. Due to
the propensity of the virus to mutate, new strains emerge over time
that may potentially affect the performance of these devices. Because
influenza is highly contagious and may lead to an acute respiratory
tract infection causing severe illness and even death, the accuracy of
these devices has serious public health implications.

IV. Background for Proposed Reclassification Decision

    On June 13, 2013, FDA convened a meeting of the Microbiology
Advisory Panel to discuss the regulation of RIDTs that are currently
regulated as class I devices. The primary reasons for convening the
panel to discuss this topic were continued reports of poor real world
RIDT performance by the RIDTs in the field compounded by the emergence
of new influenza strains with a potential to create a public health
emergency. The occurrence of the 2009 flu pandemic emphasized that
these RIDTs, while widely used by clinicians in point of care settings,
performed poorly resulting in misdiagnosed cases and, according to
anecdotal reports, sometimes with serious or even fatal consequences.
    The panel discussion included a discussion of the labeled
performance of the currently available RIDTs and presentations by
representatives from the Centers for Disease Control and Prevention
(CDC) and the Association of Public Health Laboratories (APHL) citing
the evidence of performance of these tests in real life settings. One
of the important issues raised was that the performance of an influenza
antigen detecting test is subject to the changes in the virus as it
mutates over time. The panel members were asked to discuss whether
there is sufficient evidence to suggest that general controls under
class I regulation are or are not sufficient to provide a reasonable
assurance that current and future RIDTs are safe and effective and
whether the addition of special controls would provide reasonable
assurance of the device's safety and effectiveness if the general
controls alone do not. Panel members provided the opinion that
sufficient data and information exist to indicate that special controls
are needed to mitigate the risks of false positive and false negative
results from RIDTs and provide a reasonable assurance of safety and
effectiveness of the device and to identify the special controls
needed. The panel members indicated that placing RIDTs into class II
with special controls was appropriate.

V. Classification Recommendation

    FDA is proposing that all RIDTs currently regulated under Sec.
866.3330 be reclassified into class II with special controls under the
new device name ``influenza virus antigen detection test system.'' FDA
believes that special controls that: (1) Identify the minimum
acceptable performance criteria; (2) identify the appropriate
comparator for establishing performance of new assays; and (3) call for
mandatory annual analytical reactivity testing of contemporary
influenza strains, including testing of newly emerging strains that
pose a danger of public health emergency, would provide reasonable
assurance of safety and effectiveness of these devices.
    Section 510(m) of the FD&C Act provides that a class II device may
be exempt from the premarket notification requirements under section
510(k), if the Agency determines that premarket notification is not
necessary to provide reasonable assurance of the safety and
effectiveness of the device. For this device, FDA believes that
premarket notification is necessary to provide reasonable assurance of
safety and effectiveness and, therefore, does not intend to exempt the
device from the premarket notification requirements.

VI. Risks to Health

    Although an RIDT is intended for use as an aid in the diagnosis of
influenza infection in conjunction with clinical symptoms and other
laboratory findings, failure of the device to perform as indicated
(producing erroneous or inaccurate results) could mislead the physician
and cause inappropriate or delayed medical treatment of a patient.
Failure of the test to produce accurate test results can also lead to
inaccurate epidemiological information that may contribute to
inappropriate public health responses and to facilitate spread of the
infection in a community. After considering the information discussed
by the Microbiology Devices Panel during the June 13, 2013, meeting in
conjunction with the published literature on the subject and the FDA
Medical Device Reporting system reports, FDA believes the following
risks are associated with RIDTs:
     A false negative result may lead to failure to provide a
correct diagnosis and the appropriate treatment of infection caused by
influenza virus and may contribute to unnecessary treatment for another
suspected condition.
     A false negative result will also provide incorrect
epidemiological information leading to failure to initiate appropriate
corrective measures to control and prevent additional infections.
     A false positive result on the other hand may lead to
delayed treatment of a respiratory infection caused by another
etiologic agent, which could potentially result in a more serious
patient outcome.
     A false positive result will also provide incorrect
epidemiological information on the presence of influenza in a
community, which may result in unnecessary patient isolation or contact
limitations and in unnecessary close contact investigations.
     A lack of result due to a device malfunction also may lead
to a delayed diagnosis and an inadequate treatment regime and, again,
lead to delayed epidemiological information on the presence of
influenza in a community, contributing to the spread of the infection.

VII. Summary of the Reasons for Reclassification

    Due to the mounting evidence and reports from the scientific
community about the poor sensitivity of the RIDTs currently on the
market and the corresponding risks to health associated with low
sensitivity in combination with a rapidly evolving influenza genome
with the potential for a public health emergency, FDA convened a
meeting of the Microbiology Devices Panel of the Medical Devices
Advisory Committee in order to discuss a proposal to reclassify RIDTs
in Sec.  866.3330 from class I to class II with special controls.
Consistent with the opinions expressed by the experts on the panel, FDA
believes that the establishment of special controls, in addition to
general controls, is necessary to mitigate the risks to health not
mitigated by the general controls and provide a reasonable assurance of
safety and effectiveness for these devices. While we believe that
general controls continue to adequately address the risk to health
caused by a lack of result due to a device malfunction we believe
special controls, in addition to general controls, are needed to
control

the other risks of this device, which are: (1) A false negative result
may lead to failure to provide a correct diagnosis and the appropriate
treatment of infection caused by influenza virus and may contribute to
unnecessary treatment for another suspected condition; (2) a false
negative result will also provide incorrect epidemiological information
leading to failure to initiate appropriate corrective measures to
control and prevent additional infections; (3) a false positive result
on the other hand may lead to delayed treatment of a respiratory
infection caused by another etiologic agent, which could potentially
result in a more serious patient outcome; and (4) a false positive
result will also provide incorrect epidemiological information on the
presence of influenza in a community, which may result in unnecessary
patient isolation or contact limitations and in unnecessary close
contact investigations.

VIII. Special Controls

    FDA believes that the following special controls are necessary, in
addition to general controls, to mitigate the risks to health described
in section VI.
    1. The device's sensitivity and specificity performance
characteristics must meet one of the following two minimum clinical
performance criteria in order to be cleared for marketing and to remain
on the market:
     If the manufacturer chooses to compare the device to viral
culture:
    [cir] The sensitivity estimate for the device when testing for
Influenza A must be at least at the 90 percent point estimate with a
lower bound of the 95 percent confidence interval that is greater than
or equal to 80 percent. The sensitivity estimate for the device when
testing for Influenza B must be at least at the 80 percent point
estimate with a lower bound of the 95 percent confidence interval that
is greater than or equal to 70 percent.
    [cir] The specificity estimate for the device when testing for
Influenza A and Influenza B must be at least at the 95 percent point
estimate with a lower bound of the 95 percent confidence interval that
is greater than or equal to 90 percent.
     If the manufacturer chooses to compare the device to an
appropriate molecular comparator method:
    [cir] The positive percent agreement for the device when testing
for Influenza A and Influenza B must be at least at the 80 percent
point estimate with a lower bound of the 95 percent confidence interval
that is greater than or equal to 70 percent.
    [cir] The negative percent agreement for the device when testing
for Influenza A and Influenza B must be at least at the 95 percent
point estimate with a lower bound of the 95 percent confidence interval
that is greater than or equal to 90 percent.
    2. When performing testing to demonstrate the device meets the
requirements in paragraph 1 of this section, a currently appropriate
and FDA accepted comparator method must be used to establish assay
performance in clinical studies.
    3. Annual analytical reactivity testing of the device must be
performed with contemporary influenza strains. This annual analytical
reactivity testing must meet the following criteria:
     The appropriate strains to be tested will be identified by
FDA in consultation with CDC and sourced from CDC or a CDC-designated
source. If the annual strains are not available from CDC, FDA will
identify an alternative source for obtaining the requisite strains.
    [cir] The testing must be conducted according to a standardized
protocol considered and determined by FDA to be acceptable and
appropriate.
    [cir] By July 31 of each calendar year, the results of the last 3
years of annual analytical reactivity testing must be included as part
of the device's labeling. If a device has not been on the market long
enough for 3 years of annual reactivity testing since the device was
given marketing authorization, then the results of every designated
annual reactivity testing since the device was given marketing
authorization by FDA, including the results of annual analytical
reactivity testing performed on the viral strains provided that
calendar year, must be included. The results must be presented as part
of the device's labeling in a tabular format, which includes the
detailed information for each virus tested as described in the
certificate of authentication, either by:
    [cir] Placing the results directly in the device's Sec.  809.10(b)
(21 CFR 809.10(b)) compliant labeling in a section of the labeling
devoted to annual analytical reactivity testing; or
    [cir] Providing a hyperlink in a section of the device's labeling
to the manufacturer's public Web site where the annual analytical
reactivity testing data can be found. If this option is chosen, the
manufacturer's home page must publicly provide a hyperlink, which can
easily be found and executed, to the annual analytical reactivity
testing results and the Web page containing those annual analytical
reactivity testing results must allow unrestricted viewing access. This
includes being easy to locate the results from the primary part of the
manufacturer's Web site that discusses the device.
    4. If an emergency, or a potential emergency, is declared by the
Secretary of Health and Human Services (HHS) for an influenza viral
strain:
     Within 30 days from the date that FDA notifies
manufacturers that characterized viral samples are available for test
evaluation, the manufacturer must have testing performed on the device
with that viral strain in accordance with a standardized protocol
considered and determined by FDA to be acceptable and appropriate. The
procedure and location of testing may depend on the nature of the
emerging virus.
     Within 60 days from the date that CDC first makes
characterized viral samples available to manufacturers and continuing
until the emergency, or potential emergency, is declared by the
Secretary of HHS to be over, the results of the influenza emergency
analytical reactivity testing, including the detailed information for
the virus tested as described in the certificate of authentication,
must be included as part of the device's labeling in a tabular format,
either by:
    [cir] Placing the table directly in the device's Sec.  809.10(b)
compliant labeling in the section of the labeling devoted to annual
analytical reactivity testing and influenza emergency analytical
reactivity testing but separate from the annual analytical reactivity
testing tables; or
    [cir] Providing a hyperlink in a section of the device's labeling
devoted to annual analytical reactivity testing and influenza emergency
analytical reactivity testing to a part of the manufacturer's public
Web site where the annual and the emergency analytical reactivity
testing data can be found. If this option is chosen, the manufacturer's
home page must publicly provide a hyperlink, which can easily be found
and executed, to the analytical reactivity and emergency testing
results and the Web page containing those annual analytical reactivity
testing results must allow unrestricted viewing access.
    Table 1 shows the special controls set forth in this order that are
needed to address the identified risks for this device not sufficiently
addressed by the general controls to provide a reasonable assurance of
safety and effectiveness of the device.

  Table 1--Identified Risks to Health and Required Mitigation Measures
------------------------------------------------------------------------
     Identified risks to health          Required mitigation measures
------------------------------------------------------------------------
1. A false negative result may lead  Special Controls 1-4.
 to failure to provide a correct
 diagnosis and the appropriate
 treatment of infection caused by
 influenza virus and may contribute
 to unnecessary treatment for
 another suspected condition..
2. A false negative result will      Special Controls 1-4.
 also provide incorrect
 epidemiological information
 leading to failure to initiate
 appropriate corrective measures to
 control and prevent additional
 infections..
3. A false positive result on the    Special Controls 1-4.
 other hand may lead to delayed
 treatment of a respiratory
 infection caused by another
 etiologic agent, which could
 potentially result in a more
 serious patient outcome..
4. A false positive result will      Special Controls 1-4.
 also provide incorrect
 epidemiological information on the
 presence of influenza in a
 community, which may result in
 unnecessary patient isolation or
 contact limitations and in
 unnecessary close contact
 investigations..
------------------------------------------------------------------------

    If this proposed order is finalized, RIDTs in Sec.  866.3330 will
be reclassified into class II with special controls in a new
classification regulation at 21 CFR 866.3328. Adherence to the special
controls, when finalized, in addition to the general controls, is
necessary to provide a reasonable assurance of the safety and
effectiveness of the device.

IX. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of 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.

X. Paperwork Reduction Act of 1995

    This proposed administrative order establishes special controls
that refer to previously approved collections of information found in
other 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 part 807, subpart E, regarding premarket notification
submissions have been approved under OMB control number 0910-0120; and
the collections of information in 21 CFR part 801 and 21 CFR 809.10
have been approved under OMB control number 0910-0485.

XI. Proposed Effective Date

    FDA proposes that any final order based on this proposed order
become effective 1 year after its date of publication in the Federal
Register.

XII. Comments

    Interested persons may submit either electronic comments regarding
this document or the associated Special Controls guideline to http://www.regulations.gov or written comments to the Division of Dockets
Management (see ADDRESSES). It is only necessary to send one set of
comments. Identify comments with the docket number found in brackets in
the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at http://www.regulations.gov.

XIII. Reference

    The following reference has been placed on display in the Division
of Dockets Management (see ADDRESSES) and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday, and is
available electronically at http://www.regulations.gov. (FDA has
verified the Web site address in this reference section, but we are not
responsible for any subsequent changes to the Web site after this
document publishes in the Federal Register.)
    1. Transcript of FDA's Microbiology Devices Panel Meeting, June 13,
2013. (Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/MicrobiologyDevicesPanel/UCM359554.pdf.)

List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 866 be amended as follows:

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

0
1. The authority citation for part 866 continues to read as follows:

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

0
2. Add Sec.  866.3328 to subpart D to read as follows:

Sec.  866.3328  Influenza virus antigen detection test system.

    (a) Identification. An influenza virus antigen detection test
system is a device intended for the qualitative detection of influenza
viral antigens directly from clinical specimens in patients with signs
and symptoms of respiratory infection. The test aids in the diagnosis
of influenza infection and provides epidemiological information on
influenza. Due to the propensity of the virus to mutate, new strains
emerge over time which may potentially affect the performance of these
devices. Because influenza is highly contagious and may lead to an
acute respiratory tract infection causing severe illness and even
death, the accuracy of these devices has serious public health
implications.
    (b) Classification. Class II. The special controls for this device
are:
    (1) The device's sensitivity and specificity performance
characteristics must meet one of the following two minimum clinical
performance criteria in order to be cleared for marketing and to remain
on the market:
    (i) If the manufacturer chooses to compare the device to viral
culture:
    (A) The sensitivity estimate for the device when testing for
Influenza A must be at least at the 90 percent point estimate with a
lower bound of the 95 percent confidence interval that is greater than
or equal to 80 percent. The sensitivity estimate for the device when
testing for Influenza B must be at least at the 80 percent point
estimate with a lower bound of the 95 percent confidence interval that
is greater than or equal to 70 percent.
    (B) The specificity estimate for the device when testing for
Influenza A and Influenza B must be at least at the 95 percent point
estimate with a lower bound of the 95 percent confidence interval that
is greater than or equal to 90 percent.
    (ii) If the manufacturer chooses to compare the device to an
appropriate molecular comparator method:

    (A) The positive percent agreement for the device when testing for
Influenza A and Influenza B must be at least at the 80 percent point
estimate with a lower bound of the 95 percent confidence interval that
is greater than or equal to 70 percent.
    (B) The negative percent agreement estimate for the device when
testing for Influenza A and Influenza B must be at least at the 95
percent point estimate with a lower bound of the 95 percent confidence
interval that is greater than or equal to 90 percent.
    (2) When performing testing to demonstrate the device meets the
requirements in paragraph (b)(1) of this section, a currently
appropriate and FDA accepted comparator method must be used to
establish assay performance in clinical studies.
    (3) Annual analytical reactivity testing of the device must be
performed with contemporary influenza strains. This annual analytical
reactivity testing must meet the following criteria:
    (i) The appropriate strains to be tested will be identified by FDA
in consultation with the Centers for Disease Control and Prevention
(CDC) and sourced from CDC or a CDC-designated source. If the annual
strains are not available from CDC, FDA will identify an alternative
source for obtaining the requisite strains.
    (ii) The testing must be conducted according to a standardized
protocol considered and determined by FDA to be acceptable and
appropriate.
    (iii) By July 31 of each calendar year, the results of the last 3
years of annual analytical reactivity testing must be included as part
of the device's labeling. If a device has not been on the market long
enough for 3 years of annual reactivity testing since the device was
given marketing authorization, then the results of every designated
annual reactivity testing since the device was given marketing
authorization by FDA, including the results of annual analytical
reactivity testing performed on the viral strains provided that
calendar year, must be included. The results must be presented as part
of the device's labeling in a tabular format, which includes the
detailed information for each virus tested as described in the
certificate of authentication, either by:
    (A) Placing the results directly in the device's Sec.  809.10(b) of
this chapter compliant labeling in a section of the labeling devoted to
annual analytical reactivity testing; or
    (B) Providing a hyperlink in a section of the device's labeling to
the manufacturer's public Web site where the annual analytical
reactivity testing data can be found. If this option is chosen, the
manufacturer's home page must publicly provide a hyperlink, which can
easily be found and executed, to the annual analytical reactivity
testing results and the Web page containing those annual analytical
reactivity testing results must allow unrestricted viewing access. This
includes being easy to locate the results from the primary part of the
manufacturer's Web site that discusses the device.
    (4) If an emergency, or a potential emergency, is declared by the
Secretary of Health and Human Services (HHS) for an influenza viral
strain:
    (i) Within 30 days from the date that FDA notifies manufacturers
that characterized viral samples are available for test evaluation, the
manufacturer must have testing performed on the device with that viral
strain according to a standardized protocol considered and determined
by FDA to be acceptable and appropriate. The procedure and location of
testing may depend on the nature of the emerging virus.
    (ii) Within 60 days from the date that CDC first makes
characterized viral samples available to manufacturers and continuing
until the emergency, or potential emergency, is declared by the
Secretary of HHS to be over, the results of the influenza emergency
analytical reactivity testing, including the detailed information for
the virus tested as described in the certificate of authentication,
must be included as part of the device's labeling in a tabular format,
either by:
    (A) Placing the table directly in the device's Sec.  809.10(b) of
this chapter compliant labeling in the section of the labeling devoted
to annual analytical reactivity testing and influenza emergency
analytical reactivity testing but separate from the annual analytical
reactivity testing tables; or
    (B) Providing a hyperlink in a section of the device's labeling
devoted to annual analytical reactivity testing and influenza emergency
analytical reactivity testing to a part of the manufacturer's public
Web site where the annual and the emergency analytical reactivity
testing data can be found. If this option is chosen, the manufacturer's
home page must publicly provide a hyperlink, which can easily be found
and executed, to the analytical reactivity and emergency testing
results and the Web page containing those annual analytical reactivity
testing results must allow unrestricted viewing access.

    Dated: May 14, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-11635 Filed 5-21-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: April 24, 2006 (Volume 71, Number 78)]
[Notices]
[Page 21005]
[DOCID:fr24ap06-50]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ES06-31-000]

Detroit Edison Company; Notice of Filing

April 13, 2006.
    Take the notice that March 31, 2006, Detroit Edison Company filed
an application pursuant to section 204 of the Federal Power Act seeking
authorization to issue from time to time long-term debt securities in
an aggregate principal amount not to exceed $1.0 billion.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

    Comment Date: 5 p.m. Eastern Time on April 19, 2006.

Magalie R. Salas,
Secretary.
[FR Doc. E6-6035 Filed 4-21-06; 8:45 am]

BILLING CODE 6717-01-P