[Federal Register Volume 82, Number 16 (Thursday, January 26, 2017)]
[Notices]
[Pages 8551-8554]
[FR Doc No: 2017-01717]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-79845; File No. 4-631]

Joint Industry Plan; Order Approving the Twelfth Amendment to the
National Market System Plan To Address Extraordinary Market Volatility
by Bats BZX Exchange, Inc., Bats BYX Exchange, Inc., Bats EDGA
Exchange, Inc., Bats EDGX Exchange, Inc., Chicago Stock Exchange, Inc.,
Financial Industry Regulatory Authority, Inc., Investors Exchange LLC,
NASDAQ BX, Inc., NASDAQ PHLX LLC, The Nasdaq Stock Market LLC, National
Stock Exchange, Inc., New York Stock Exchange LLC, NYSE MKT LLC, and
NYSE Arca, Inc.

January 19, 2017.

I. Introduction

    On September 19, 2016, NYSE Group, Inc., on behalf of the other
parties \1\ to the National Market System Plan to Address Extraordinary
Market Volatility (the ``Plan''), filed with the Securities and
Exchange Commission (``Commission'') pursuant to Section 11A of the
Securities Exchange Act of 1934 (``Act'') \2\ and Rule 608
thereunder,\3\ a proposal to amend the Plan.\4\ The proposal represents
the twelfth amendment to the Plan, and reflects proposed changes
unanimously approved by the Participants (``Twelfth Amendment''). The
proposed Twelfth Amendment was published for comment in the Federal
Register on December 2, 2016.\5\ The Commission received two comment
letters regarding the amendment.\6\ On January 17, 2017, the
Participants submitted a letter to the Commission related to the
Twelfth Amendment, which requests that the Commission modify the
Twelfth Amendment to retain provisions in the

Plan related to Straddle States.\7\ This order approves the Twelfth
Amendment to the Plan, as modified.
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    \1\ NYSE Group, Inc. filed on behalf of the following parties to
the Plan: Bats BZX Exchange, Inc., Bats BYX Exchange, Inc., Bats
EDGA Exchange, Inc., Bats EDGX Exchange, Inc., Chicago Stock
Exchange, Inc., Financial Industry Regulatory Authority, Inc.,
Investors Exchange LLC, NASDAQ BX, Inc., NASDAQ PHLX LLC, The Nasdaq
Stock Market LLC, National Stock Exchange, Inc., New York Stock
Exchange LLC, NYSE MKT LLC, and NYSE Arca, Inc. (``Participants'').
    \2\ 15 U.S.C. 78k-1.
    \3\ 17 CFR 242.608.
    \4\ See Letter from Elizabeth King, General Counsel and
Corporate Secretary, NYSE, to Brent J. Fields, Secretary,
Commission, dated September 16, 2016.
    \5\ See Securities Exchange Act Release No. 79410 (November 28,
2016), 81 FR 87114 (``Notice'').
    \6\ See Letters from Mortimer J. Buckley, Chief Investment
Officer, Vanguard, dated December 23, 2016 (``Vanguard Letter'');
and David W. Blass, General Counsel, Investment Company Institute,
dated December 22, 2016 (``ICI Letter'') to Brent J. Fields,
Secretary, Commission.
    \7\ See Letter from Elizabeth K. King, General Counsel and
Corporate Secretary, NYSE to Brent J. Fields, Secretary, Commission,
dated January 13, 2017 (``Modification Letter'').
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II. Description of the Proposal

    In the Twelfth Amendment, the Participants propose to implement a
modified reopening process following a Trading Pause.\8\ In particular,
the Participants propose to amend the Plan to provide that a Trading
Pause will continue until the Primary Listing Exchange has reopened
trading using its established reopening procedures, even if such
reopening is more than 10 minutes after the beginning of a Trading
Pause, require that trading centers may not resume trading in an NMS
Stock following a Trading Pause without Price Bands in such NMS Stock,
and delete language made unnecessary in light of the proposed reopening
procedures.\9\ In addition, the Participants propose to address the
situation where there is no Reopening Price from the Primary Listing
Exchange due to a systems or technology issue and make related changes
regarding how the Reference Price would be determined and Price Bands
calculated and disseminated following a resumption of trading. Further,
the Participants propose to amend the Plan to provide that if an NMS
Stock is in a Trading Pause during the last ten minutes of trading
before the end of Regular Trading Hours, the Primary Listing Exchange
shall attempt to execute a closing transaction using its established
closing procedures. Finally, the Participants propose to clarify in the
Plan the limited circumstances in which a trading center may calculate
and apply Price Bands when a Reference Price is available but Price
Bands have not been disseminated by the Processor (``Synthetic Price
Bands'').
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    \8\ Unless otherwise specified, the terms used herein have the
same meaning as set forth in the Plan.
    \9\ The Primary Listing Exchanges filed proposed rule changes
pursuant to Section 19(b)(1) of the Act, 15 U.S.C. 78s(b)(1), and
Rule 19b-4 thereunder, 17 CFR 240.19b-4, relating to the changes to
the reopening procedures proposed in the Twelfth Amendment. See
Securities Exchange Act Release Nos. 79162 (October 26, 2016), 81 FR
75875 (November 1, 2016) (SR-BatsBZX-2016-61; 79158 (October 26,
2016), 81 FR 75879 November 1, 2016) (SR-NASDAQ-2016-131); and 79107
(October 18, 2016), 81 FR 73159 (October 24, 2016) (SR-NYSEArca-
2016-130). See also Securities Exchange Act Release No 79846,
(January 19, 2017) (SR-NYSEArca-2016-130).
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    Finally, in the Twelfth Amendment, the Participants propose to
remove provisions related to Straddle States. However, as described in
the Modification Letter, the Participants have requested the Commission
to modify the Twelfth Amendment to retain the provisions related to
Straddle States in the Plan.

III. Summary of Comment Letters

    The Commission received two comment letters on the proposed Twelfth
Amendment, both supporting the proposed changes to the Plan related to
the reopening process. One commenter noted that the proposed amendments
to the Plan along with the related proposed rule changes submitted by
the exchanges \10\ ``should improve the transparency of the reopening
process, allow reopening auctions to establish more accurate prices,
and make it less likely that trading in a security will be halted again
shortly after trading resumes.'' \11\ This commenter further noted that
``[I]mplementing these proposals also should increase market confidence
by reducing the likelihood of the Limit Up-Limit Down Plan creating
confusion during volatile markets, when clarity and certainty are most
important.'' \12\ This commenter urged the Commission to approve the
proposed Twelfth Amendment and corresponding rule changes, but noted
that the Twelfth Amendment ``does not address the discordance between
the rules governing clearly erroneous executions and the limit up-limit
down price bands, which contributes unnecessarily to uncertainty in the
equity markets in volatile times.'' \13\ The second commenter urged the
Commission to approve the Twelfth Amendment ``without delay'' and
before considering a change to the Plan recommended by the Equity
Market Structure Advisory Committee in which ``securities in a limit
state would not be halted pursuant to existing rules, but would be
permitted to trade within established price bands.'' \14\ This
commenter believes that ``the Twelfth Amendment is an important step
towards improving the equity markets and minimizing the likelihood of
an event like August 24, 2015.'' \15\
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    \10\ See supra note 9.
    \11\ See ICI Letter, supra note 6 at 2.
    \12\ Id.
    \13\ Id.
    \14\ See Vanguard Letter, supra note 6, at 2.
    \15\ Id.
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IV. Discussion and Commission Findings

    Rule 608 under Regulation NMS provides that the Commission shall
approve an NMS plan amendment, with such changes or subject to such
conditions as the Commission may deem necessary or appropriate, if it
finds that the plan amendment is ``necessary or appropriate in the
public interest, for the protection of investors and the maintenance of
fair and orderly markets, to remove impediments to, and perfect the
mechanism of, a national market system, or otherwise in furtherance of
the purposes of the Act.'' \16\ The Commission finds that the Twelfth
Amendment, as modified, is consistent with Section 11A of the Act \17\
and Rule 608 thereunder \18\ because, for the reasons discussed below
it is appropriate in the public interest, for the protection of
investors and the maintenance of fair and orderly markets, and that it
removes impediments to, and perfects the mechanism of, a national
market system. The Commission notes that the Participants proposed the
Twelfth Amendment to address issues experienced on August 24, 2015. In
particular, the Participants believe that the changes to the Plan set
forth in the Twelfth Amendment should reduce the number of repeat
Trading Pauses in a single NMS Stock and establish a more standardized
process across Primary Listing Exchanges in reopening trading following
a Trading Pause.
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    \16\ 17 CFR 242.608(b)(2).
    \17\ 15 U.S.C. 78k-1.
    \18\ 17 CFR 242.608.
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A. Coordinated Reopening Procedures After a Trading Pause

    The Participants propose to remove the language in Plan Section
VII(B)(3) that permits trading centers to begin trading an NMS Stock
ten minutes after declaration of a Trading Pause in an NMS Stock if the
Primary Listing Exchange has not either reported a Reopening Price or
declared a Regulatory Halt.\19\ Accordingly, Trading Pauses would
continue until a Primary Listing Market reports a Reopening Price,
except in limited circumstances discussed below. In addition, the
Participants propose to provide that trading centers may not resume
trading in an NMS Stock following a Trading Pause without Price Bands
in such NMS Stock.
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    \19\ The Participants also propose to amend Section V(C) of the
Plan to remove language, which describes the first Reference Price
in situations when a Primary Listing Market does not reopen within
ten minutes after the beginning of a Trading Pause. The Commission
believes that with the adoption of the proposed amendments described
above, the Plan text in Section V(C) is no longer necessary.
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    The Commission believes that it is appropriate in the public
interest, for the protection of investors and the maintenance of a fair
and orderly market to provide that a Trading Pause

continue until the Primary Listing Exchange has reopened trading using
its established reopening procedures, even if such reopening is more
than 10 minutes after the beginning of a Trading Pause, and to require
that trading centers may not resume trading in an NMS Stock following a
Trading Pause without Price Bands in such NMS Stock. The Commission
believes that these two provisions together support a more standardized
process for reopening trading after a Trading Pause has been declared.
Further, these provisions ensure that trading would not resume after a
Trading Pause without Price Bands.

B. Systems and Technology Issues

    The Participants propose to amend Section VII(B)(2) of the Plan to
clarify that the only time trading centers may resume trading in an NMS
Stock in the absence of a Reopening Price from the Primary Listing
Exchange is if the Primary Listing Exchange notifies the Processor that
it is unable to reopen trading due to a systems or technology issue.
The Commission believes that this change is appropriate in the public
interest, for the protection of investors and the maintenance of a fair
and orderly market because if a Primary Listing Exchange is unable to
reopen trading due to a systems or technology issue, trading should be
permitted to resume in that NMS Stock on other trading centers.
    Further, the Participants propose to add a new sentence to Section
V(C)(1) of the Plan to specify that if the Primary Listing Exchange
notifies the Processor that it is unable to reopen an NMS Stock due to
a systems or technology issue, the next Reference Price would be the
last effective Price Band that was in a Limit State before the Trading
Pause. The Participants also propose to use this process for
determining a Reference Price in situations where the Primary Listing
Exchange reopens trading with a quotation that has a zero bid or offer,
or both. The Commission believes that it is appropriate to use the last
effective Price Band as the new Reference Price in these situations. As
noted by the Participants, using the last effective Price Band that
triggered the Trading Pause should be a closer approximation of the
most recent trading in the NMS Stock, which should help to prevent
repeat Trading Pauses.
    The Participants also propose to provide that if, under Section
VII(B)(2), the Primary Listing Exchange notifies the Processor that it
is unable to reopen an NMS Stock due to a systems or technology issue
and it has not declared a Regulatory Halt, the Processor will calculate
and disseminate Price Bands by applying triple the Percentage
Parameters set forth in Appendix A to the Plan for the first 30 seconds
such Price Bands are disseminated. The Commission notes that the Plan
currently reflects that triple Percentage Parameters are applied if
trading resumes ten minutes after a Trading Pause has been declared
when the Primary Listing Exchange has not issued a Reopening Price.
Accordingly, the Commission believes that that it is appropriate to
apply triple Percentage Parameters to the new limited instances when a
Reopening Price is not disseminated.
    Finally, the Participants propose to amend Section VII(B)(4) of the
Plan to clarify that the Processor shall update the Price Bands, as set
forth in Section V(C)(1)-(2) of the Plan, after receiving notification
from the Primary Listing Exchange of a Reopening Price following a
Trading Pause (or a resume message in the case of a reopening quote
that has a zero bid or zero offer, or both), or notification that the
Primary Listing Exchange is unable to reopen trading following a
Trading Pause due to a systems or technology issue. In instances when
the Primary Listing Exchange is unable to reopen due to a systems or
technology issue, the Processor shall update the Price Bands no earlier
than ten minutes after the beginning of the Trading Pause. The
Commission believes that these changes are appropriate to clarify the
requirements of the Processor to update the Price Bands in all
situations following a Trading Pause.

C. Trading Pauses Before the End of Regular Trading Hours

    The Participants propose to amend Section VII(C)(1) of the Plan to
provide that if an NMS Stock is in a Trading Pause during the last ten
minutes of trading before the end of Regular Trading Hours, the Primary
Listing Exchange shall, rather than seek to resume trading through its
established reopening procedures, attempt to execute a closing
transaction using its established closing procedures. The Commission
believes that this change is appropriate in the public interest, for
the protection of investors and the maintenance of a fair and orderly
market to accommodate the new standardized process for reopening
trading. As noted above, all trading centers must wait to resume
trading in an NMS Stock subject to a Trading Pause until the Primary
Listing Exchange has reported a Reopening Price. It is possible that a
Trading Pause that was declared before the last ten minutes of trading
before the end of Regular Trading Hours could be extended until after
the last ten minutes of trading before the end of Regular Trading
Hours. The Commission believes that it is appropriate to amend the Plan
to reflect in such case, that trading in the NMS Stock should not
resume, and instead the Primary Listing Exchange should attempt to
execute a closing transaction using established closing procedures.

D. Synthetic Price Bands

    The Participants propose to amend Section V(A)(1) of the Plan to
clarify that if the Processor has not yet disseminated Price Bands, but
a Reference Price is available, a trading center may calculate and
apply Synthetic Price Bands based on the same Reference Price that the
Processor would use for calculating such Price Bands until the trading
center receives Price Bands from the Processor. The Commission believes
that this change is appropriate in the public interest, for the
protection of investors and the maintenance of a fair and orderly
market because it will make clear that, while a trading center may not
resume trading in an NMS Stock following a Trading Pause without Price
Bands in such NMS Stock, when a Reference Price is available, a trading
center is permitted to calculate and apply its own Synthetic Price
Bands before Price Bands have been received from the Processor.

E. Straddle States

    In the Twelfth Amendment, the Participants proposed to remove
provisions in the Plan related to Straddle States. In its Modification
Letter, the Participants request that the Commission approve the
Twelfth Amendment, as modified, to retain the provisions related to
Straddle States.\20\ The Participants note that they intend to further
study alternatives to eliminating Straddle States from the Plan. The
Commission deems it necessary to modify the Twelfth Amendment so that
the provisions related to Straddle States are retained. The Commission
believes that further data analysis is appropriate to evaluate
alternatives to eliminating Straddle States from the Plan.
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    \20\ See Modification Letter, supra note 7.
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    For the reasons noted above, the Commission finds that the Twelfth
Amendment to the Plan, as modified, is consistent with Section 11A of
the Act \21\ and Rule 608 thereunder.\22\
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    \21\ 15 U.S.C. 78k-1.
    \22\ 17 CFR 242.608. Consistent with their representations set
forth in the Notice, the Commission expects the Participants to
implement the Twelfth Amendment, as modified, no later than six
months after the date of this order.

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V. Conclusion

    It is therefore ordered, pursuant to Section 11A of the Act \23\
and Rule 608 thereunder,\24\ that the Twelfth Amendment to the Plan
(File No. 4-631), as modified, be, and it hereby is, approved.
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    \23\ 15 U.S.C. 78k-1.
    \24\ 17 CFR 242.608.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\25\
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    \25\ 17 CFR 200.30-3(a)(29).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-01717 Filed 1-25-17; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 178 (Thursday, September 15, 2022)]
[Notices]
[Pages 56743-56749]
[FR Doc No: 2022-20001]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2022-0353]

Airworthiness Criteria: Special Class Airworthiness Criteria for
the MissionGO MGV100 Unmanned Aircraft

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

ACTION: Notice of proposed airworthiness criteria.

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SUMMARY: The FAA announces the availability of and requests comments on
proposed airworthiness criteria for the MissionGO Model MGV100 unmanned
aircraft (UA). This document proposes the airworthiness criteria the
FAA finds to be appropriate and applicable for the UA design.

DATES: Send comments on or before October 17, 2022.

ADDRESSES: Send comments identified by docket number FAA-2022-0353
using any of the following methods:
     Federal eRegulations Portal: Go to https://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30, U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE, Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE, Washington, DC, between 9 a.m., and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: The FAA will post all comments it receives, without
change, to https://regulations.gov, including any personal information
the commenter provides. Using the search function of the docket
website, anyone can find and read the electronic form of all comments
received into any FAA docket, including the name of the individual
sending the comment (or signing the comment for an association,
business, labor union, etc.). DOT's complete Privacy Act Statement can
be found in the Federal Register published on April 11, 2000 (65 FR
19477-19478), as well as at https://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
https://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE,
Washington, DC, between 9 a.m., and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Christopher J. Richards, Emerging
Aircraft Strategic Policy Section, AIR-618, Strategic Policy Management
Branch, Policy and Innovation Division, Aircraft Certification Service,
Federal Aviation Administration, 6020 28th Avenue South, Room 103,
Minneapolis, MN 55450, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites interested people to take part in the development
of these airworthiness criteria by sending written comments, data, or
views. The most helpful comments reference a specific portion of the
airworthiness

criteria, explain the reason for any recommended change, and include
supporting data. Comments on operational, pilot certification, and
maintenance requirements would address issues that are beyond the scope
of this document.
    Except for Confidential Business Information as described in the
following paragraph, and other information as described in 14 CFR
11.35, the FAA will file in the docket all comments received, as well
as a report summarizing each substantive public contact with FAA
personnel concerning these proposed airworthiness criteria. Before
acting on this proposal, the FAA will consider all comments received on
or before the closing date for comments. The FAA will consider comments
filed late if it is possible to do so without incurring delay. The FAA
may change these airworthiness criteria based on received comments.

Confidential Business Information

    Confidential Business Information (CBI) is commercial or financial
information that is both customarily and actually treated as private by
its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552),
CBI is exempt from public disclosure. If your comments responsive to
these proposed airworthiness criteria contain commercial or financial
information that is customarily treated as private, that you actually
treat as private, and that is relevant or responsive to these proposed
airworthiness criteria, it is important that you clearly designate the
submitted comments as CBI. Please mark each page of your submission
containing CBI as ``PROPIN.'' The FAA will treat such marked
submissions as confidential under the FOIA, and they will not be placed
in the public docket of these proposed airworthiness criteria.
Submissions containing CBI should be sent to the individual listed
under For Further Information Contact. Any commentary that the FAA
receives which is not specifically designated as CBI will be placed in
the public docket for these proposed airworthiness criteria.

Background

    MissionGO applied to the FAA on November 4, 2020, for a special
class type certificate under 14 CFR 21.17(b) for the Model MGV100 UA.
    The Model MGV100 consists of a rotorcraft UA and its associated
elements (AE) including communication links and components that control
the UA. The Model MGV100 UA has a maximum gross takeoff weight of 54
pounds. It has a rotor diameter of approximately 76.5 inches. It is
approximately 66.5 inches in fuselage length and 28.5 inches in height.
The Model MGV100 UA is battery-powered using electric motors for
vertical takeoff, landing, and forward flight. The unmanned aircraft
system (UAS) operations would rely on high levels of automation and
include a single UA operated by a single pilot. MissionGO anticipates
operators will use the Model MGV100 for delivering packages. The
proposed concept of operations for the Model MGV100 identifies a
maximum operating altitude of 400 feet above ground level, a maximum
cruise speed of 38 knots, operations beyond visual line of sight of the
pilot, and operations over human beings. MissionGO has not requested
type certification for flight into known icing for the Model MGV100.

Discussion

    The FAA establishes airworthiness criteria to ensure the safe
operation of aircraft in accordance with 49 U.S.C. 44701(a) and 44704.
UA are type certificated by the FAA as special class aircraft for which
airworthiness standards have not been established by regulation. Under
the provisions of 14 CFR 21.17(b), the airworthiness standards for
special class aircraft are those the FAA finds to be appropriate and
applicable to the specific type design.
    The applicant has proposed a design with constraints upon its
operations and an unusual design characteristic: the pilot is remotely
located. The FAA developed existing airworthiness standards to
establish an appropriate level of safety for each product and its
intended use. The FAA's existing airworthiness standards did not
envision aircraft with no pilot in the flight deck and the technologies
associated with that capability.
    The FAA has reviewed the proposed design and assessed the potential
risk to the National Airspace System. The FAA considered the size of
the proposed aircraft, its maximum airspeed and altitude, and
operational limitations to address the number of unmanned aircraft per
operator and address operations in which the aircraft would operate
beyond the visual line of sight of the pilot. These factors allowed the
FAA to assess the potential risk the aircraft could pose to other
aircraft and to human beings on the ground. Using these parameters, the
FAA developed airworthiness criteria to address those potential risks
to ensure the aircraft remains reliable, controllable, safe, and
airworthy.
    The proposed criteria focus on mitigating hazards by establishing
safety outcomes that must be achieved, rather than by establishing
prescriptive requirements that must be met. This is in contrast to many
current airworthiness standards, used to certificate traditional
aircraft systems, which prescribe specific indicators and instruments
for a pilot in a flight deck that would be inappropriate for UA. The
FAA finds that the proposed criteria are appropriate and applicable for
the UA design, based on the intended operational concepts for the UA as
identified by the applicant.
    The FAA selected the particular airworthiness criteria proposed by
this notice for the following reasons:
    General: In order to determine appropriate and applicable
airworthiness standards for UA as a special class of aircraft, the FAA
determined that the applicant must provide information describing the
characteristics and capabilities of the UA and how it will be used.
    D&R.001 Concept of Operations: To assist the FAA in identifying and
analyzing the risks and impacts associated with integrating the
proposed UA design into the National Airspace System, the applicant
would be required to submit a Concept of Operations (CONOPS). The
proposed criteria would require the applicant's CONOPS to identify the
intended operational concepts for the UA and describe the UAS and its
operation. The applicant would be required to describe the information
in the CONOPS in sufficient detail to determine parameters and extent
of testing, as well as operating limitations that will be placed in the
UA Flight Manual. If the applicant requests to include collision
avoidance equipment, the proposed criteria would require the applicant
to identify such equipment in the CONOPS.
    D&R.005 Definitions: The proposed criteria include a definitions
section, distinguishing the term ``loss of flight'' from ``loss of
control.''
    Design and Construction: The FAA selected the design and
construction criteria in this section to address airworthiness
requirements where the flight testing demonstration alone may not be
sufficient to demonstrate an appropriate level of safety.
    D&R.100 UA Signal Monitoring and Transmission: To address the risks
associated with loss of control of the UA, the applicant would be
required to design the UA to monitor and transmit to the AE all
information necessary for continued safe flight and operation. Some of
the AE are located separately

from the UA, and therefore are a unique feature to UAS. As a result, no
regulatory airworthiness standards exist that directly apply to this
part of the system. The FAA based some of the proposed criteria on
existing regulations that address the information that must be provided
to a pilot in the flight deck of a manned aircraft, and modified them
as appropriate to the UAS. These proposed criteria list the specific
minimum types of information the FAA finds are necessary for the UA to
transmit for continued safe flight and operation; however, the
applicant must determine whether additional parameters are necessary.
    D&R.105 UAS AE Required for Safe UA Operations: Because safe UAS
operations depend and rely on both the UA and the AE, the FAA considers
the AE in assessing whether the UA meets the criteria that comprise the
certification basis. While the AE items themselves will be outside the
scope of the UA type design, the applicant must provide sufficient
specifications for any aspect of the AE, including the control station,
which could affect airworthiness. The proposed criteria would require a
complete and unambiguous identification of the AE and their interface
with the UA, so that their availability or use is readily apparent.
    As explained in FAA Policy Memorandum AIR600-21-AIR-600-PM01, dated
July 13, 2021, the FAA will approve either the specific AE or minimum
specifications for the AE, as identified by the applicant, as part of
the type certificate by including them as an operating limitation in
the type certificate data sheet and flight manual. The FAA may impose
additional operating limitations specific to the AE through conditions
and limitations for inclusion in the operational approval (i.e.,
waivers, exemptions, operating certificates, or a combination of
these). In this way, the FAA will consider the entirety of the UAS for
operational approval and oversight.
    D&R.110 Software: Software for manned aircraft is certified under
the regulations applicable to systems, equipment, and installations
(e.g., Sec. Sec.  23.2510, 25.1309, 27.1309, or 29.1309). There are two
regulations that specifically prescribe airworthiness standards for
software: Engine airworthiness standards (Sec.  33.28) and propeller
airworthiness standards (Sec.  35.23). The proposed UA software
criteria are based on these regulations and tailored for the risks
posed by UA software.
    D&R.115 Cyber Security: The location of the pilot separate from the
UA requires a continuous wireless connection (command and control link)
with the UA for the pilot to monitor and control it. Because the
purpose of this link is to control the aircraft, this makes the UA
susceptible to cyber security threats in a unique way.
    The current regulations for the certification of systems,
equipment, and installations (e.g., Sec. Sec.  23.2510, 25.1309,
27.1309, and 29.1309) do not adequately address potential security
vulnerabilities exploited by unauthorized access to aircraft systems,
data buses, and services. For manned aircraft, the FAA therefore issues
special conditions for particular designs with network security
vulnerabilities.
    To address the risks to the UA associated with intentional
unauthorized electronic interactions, the applicant would be required
to design the UAS's systems and networks to protect against intentional
unauthorized electronic interactions and mitigate potential adverse
effects. The FAA based the language for the proposed criteria on
recommendations in the final report dated August 22, 2016, from the
Aircraft System Information Security/Protection (ASISP) working group
under the FAA's Aviation Rulemaking Advisory Committee. Although the
recommendations pertained to manned aircraft, the FAA has reviewed the
report and determined the recommendations are also appropriate for UA.
The wireless connections used by UA make these aircraft susceptible to
the same cyber security risks, and therefore require similar criteria
as manned aircraft.
    D&R.120 Contingency Planning: The location of the pilot and the
controls for the UAS, separate from the UA, is a unique feature to UAS.
As a result, no regulatory airworthiness standards exist that directly
apply to this feature of the system.
    To address the risks associated with loss of communication between
the pilot and the UA, and thus the pilot's inability to control the UA,
the proposed criteria would require that the UA be designed to
automatically execute a predetermined action. Because the pilot needs
to be aware of the particular predetermined action the UA will take
when there is a loss of communication between the pilot and the UA, the
proposed criteria would require that the applicant identify the
predetermined action in the UA Flight Manual. The proposed criteria
would also include requirements for preventing takeoff when quality of
service is inadequate.
    D&R.125 Lightning: Because of the size and physical limitations of
this UA, it would be unlikely that this UA would incorporate
traditional lightning protection features. To address the risks that
would result from a lightning strike, the proposed criteria would
require an operating limitation in the UA Flight Manual that prohibits
flight into weather conditions conducive to lightning. The proposed
criteria would also allow design characteristics to protect the UA from
lightning as an alternative to the prohibition.
    D&R.130 Adverse Weather Conditions: Because of the size and
physical limitations of this UA, adverse weather such as rain, snow,
and icing pose a greater hazard to the UA than to manned aircraft. For
the same reason, it would be unlikely that this UA would incorporate
traditional protection features from icing. The FAA based the proposed
criteria on the icing requirements in 14 CFR 23.2165(b) and (c) and
applied them to all of these adverse weather conditions. The proposed
criteria would allow design characteristics to protect the UA from
adverse weather conditions. As an alternative, the proposed criteria
would require an operating limitation in the UA Flight Manual that
prohibits flight into known adverse weather conditions, and either also
prevent inadvertent flight into adverse weather or provide a means to
detect and to avoid or exit adverse weather conditions.
    D&R.135 Flight Essential Parts: The proposed criteria for flight
essential parts are substantively the standards for normal category
rotorcraft critical parts in Sec.  27.602, with changes to reflect UA
terminology and failure conditions. Because part criticality is
dependent on safety risk to those on board the aircraft, the term
``flight essential'' is used for those components of an unmanned
aircraft whose failure may result in loss of flight or unrecoverable
loss of UA control.
    Operating Limitations and Information: Similar to manned aircraft,
the FAA determined that the UA applicant must provide airworthiness
instructions, operating limitations, and flight and performance
information necessary for the safe operation and continued operational
safety of the UA.
    D&R.200 Flight Manual: The proposed criteria for the UA Flight
Manual are substantively the same as those in Sec.  23.2620, with minor
changes to reflect UA terminology.
    D&R.205 Instructions for Continued Airworthiness: The proposed
criteria for the Instructions for Continued Airworthiness (ICA) are
substantively the same as that in Sec.  23.1529, with

minor changes to reflect UA terminology.
    Testing: Traditional certification methodologies for manned
aircraft are based on design requirements verified at the component
level by inspection, analysis, demonstration, or test. Due to the
difference in size and complexity, the FAA determined testing
methodologies that demonstrate reliability at the aircraft (UA) level,
in addition to the design and construction criteria identified in this
proposal, will achieve the same safety objective. The proposed testing
criteria in sections D&R.300 through D&R.320 utilize these
methodologies.
    D&R.300 Durability and Reliability: The FAA intends the proposed
testing criteria in this section to cover key design aspects and
prevent unsafe features at an appropriate level tailored for this UA.
The proposed durability and reliability testing would require the
applicant to demonstrate safe flight of the UA across the entire
operational envelope and up to all operational limitations, for all
phases of flight and all aircraft configurations. The UA would only be
certificated for operations within the limitations prescribed for its
operating environment, as defined in the applicant's proposed CONOPS
and demonstrated by test. The FAA intends for this process to be
similar to the process for establishing limitations prescribed for
special purpose operations for restricted category aircraft. The
proposed criteria would require that all flights during the testing be
completed with no failures that result in a loss of flight, loss of
control, loss of containment, or emergency landing outside of the
operator's recovery zone.
    For some aircraft design requirements imposed by existing
airworthiness standards (e.g., Sec. Sec.  23.2135, 23.2600, 25.105,
25.125, 27.141, 27.173, 29.51, 29.177), the aircraft must not require
exceptional piloting skill or alertness. These rules recognize that
pilots have varying levels of ability and attention. In a similar
manner, the proposed criteria would require that the durability and
reliability flight testing be performed by a pilot with average skill
and alertness.
    Flight testing will be used to determine the aircraft's ability to
withstand flight loads across the range of operating limits and the
flight envelope. Because small UA may be subjected to significant
ground loads when handled, lifted, carried, loaded, maintained, and
transported physically by hand, the proposed criteria would require
that the aircraft used for testing endure the same worst-case ground
loads as those the UA will experience in operation after type
certification.
    D&R.305 Probable Failures: The FAA intends the proposed testing
criteria to evaluate how the UA functions after failures that are
probable to occur. The applicant will test the UA by inducing certain
failures and demonstrating that the failure will not result in a loss
of containment or control of the UA. The proposed criteria contain the
minimum types of failures the FAA finds are probable; however, the
applicant must determine the probable failures related to any other
equipment that will be addressed for this requirement.
    D&R.310 Capabilities and Functions: The proposed criteria for this
section address the minimum capabilities and functions the FAA finds
are necessary for the design of the UA and would require the applicant
to demonstrate these capabilities and functions by test. Due to the
location of the pilot and the controls for UAS, separate from the UA,
communication between the pilot and the UA is significant to the
design. Thus, the proposed criteria would require the applicant to
demonstrate the capability of the UAS to regain command and control
after a loss. As with manned aircraft, the electrical system of the UA
must have a capacity sufficient for all anticipated loads; the proposed
criteria would require the applicant to demonstrate this by test.
    The proposed criteria contain functions that would allow the pilot
to command the UA to deviate from its flight plan or from its pre-
programmed flight path. For example, in the event the pilot needs to
deconflict the airspace, the UA must respond to pilot inputs that
override any pre-programming.
    In the event an applicant requests approval for certain features,
such as geo-fencing or external cargo, the proposed criteria contain
requirements to address the associated risks. The proposed criteria in
this section would also require the design of the UA to safeguard
against unintended discontinuation of flight or release of cargo,
whether by human action or malfunction.
    D&R.315 Fatigue: The FAA intends the proposed criteria in this
section to address the risks from reduced structural integrity and
structural failure due to fatigue. The proposed criteria would require
the applicant to establish an airframe life limit and demonstrate that
loss of flight or loss of control due to structural failure will be
avoided throughout the operational life of the UA. These proposed
criteria would require the applicant to demonstrate this by test, while
maintaining the UA in accordance with the ICA.
    D&R.320 Verification of Limits: This section would evaluate
structural safety and address the risks associated with inadequate
structural design. While the proposed criteria in D&R.300 address
testing to demonstrate that the UA structure adequately supports
expected loads throughout the flight and operational envelopes, the
proposed criteria in this section would require an evaluation of the
performance, maneuverability, stability, and control of the UA with a
factor of safety.

Applicability

    These airworthiness criteria, established under the provisions of
Sec.  21.17(b), are applicable to the Model MGV100 UA. Should MissionGO
apply at a later date for a change to the type certificate to include
another model, these airworthiness criteria would apply to that model
as well, provided the FAA finds them appropriate in accordance with the
requirements of subpart D to part 21.

Conclusion

    This action affects only the airworthiness criteria for the one
model UA. It is not a standard of general applicability.

Authority Citation

    The authority citation for these airworthiness criteria is as
follows:
    Authority: 49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

Proposed Airworthiness Criteria

    The FAA proposes to establish the following airworthiness criteria
for type certification of the MissionGO Model MGV100 UA. The FAA
proposes that compliance with the following would mitigate the risks
associated with the proposed design and Concept of Operations
appropriately and would provide an equivalent level of safety to
existing rules:

General

D&R.001 Concept of Operations

    The applicant must define and submit to the FAA a concept of
operations (CONOPS) proposal describing the unmanned aircraft system
(UAS) operation in the national airspace system for which unmanned
aircraft (UA) type certification is requested. The CONOPS proposal must
include, at a minimum, a description of the following information in
sufficient detail to determine the parameters and extent of testing and
operating limitations:
    (a) The intended type of operations;

    (b) UA specifications;
    (c) Meteorological conditions;
    (d) Operators, pilots, and personnel responsibilities;
    (e) Control station, support equipment, and other associated
elements (AE) necessary to meet the airworthiness criteria;
    (f) Command, control, and communication functions;
    (g) Operational parameters (such as population density, geographic
operating boundaries, airspace classes, launch and recovery area,
congestion of proposed operating area, communications with air traffic
control, line of sight, and aircraft separation); and
    (h) Collision avoidance equipment, whether onboard the UA or part
of the AE, if requested.

D&R.005 Definitions

    For purposes of these airworthiness criteria, the following
definitions apply.
    (a) Loss of Control: Loss of control means an unintended departure
of an aircraft from controlled flight. It includes control reversal or
an undue loss of longitudinal, lateral, and directional stability and
control. It also includes an upset or entry into an unscheduled or
uncommanded attitude with high potential for uncontrolled impact with
terrain. A loss of control means a spin, loss of control authority,
loss of aerodynamic stability, divergent flight characteristics, or
similar occurrence, which could generally lead to crash.
    (b) Loss of Flight: Loss of flight means a UA's inability to
complete its flight as planned, up to and through its originally
planned landing. It includes scenarios where the UA experiences
controlled flight into terrain, obstacles, or any other collision, or a
loss of altitude that is severe or non-reversible. Loss of flight also
includes deploying a parachute or ballistic recovery system that leads
to an unplanned landing outside the operator's designated recovery
zone.

Design and Construction

D&R.100 UA Signal Monitoring and Transmission

    The UA must be designed to monitor and transmit to the AE all
information required for continued safe flight and operation. This
information includes, at a minimum, the following:
    (a) Status of all critical parameters for all energy storage
systems;
    (b) Status of all critical parameters for all propulsion systems;
    (c) Flight and navigation information as appropriate, such as
airspeed, heading, altitude, and location; and
    (d) Communication and navigation signal strength and quality,
including contingency information or status.

D&R.105 UAS AE Required for Safe UA Operations

    (a) The applicant must identify and submit to the FAA all AE and
interface conditions of the UAS that affect the airworthiness of the UA
or are otherwise necessary for the UA to meet these airworthiness
criteria. As part of this requirement--
    (1) The applicant may identify either specific AE or minimum
specifications for the AE.
    (i) If minimum specifications are identified, they must include the
critical requirements of the AE, including performance, compatibility,
function, reliability, interface, operator alerting, and environmental
requirements.
    (ii) Critical requirements are those that if not met would impact
the ability to operate the UA safely and efficiently.
    (2) The applicant may use an interface control drawing, a
requirements document, or other reference, titled so that it is clearly
designated as AE interfaces to the UA.
    (b) The applicant must show the FAA the AE or minimum
specifications identified in paragraph (a) of this section meet the
following:
    (1) The AE provide the functionality, performance, reliability, and
information to assure UA airworthiness in conjunction with the rest of
the design;
    (2) The AE are compatible with the UA capabilities and interfaces;
    (3) The AE must monitor and transmit to the operator all
information required for safe flight and operation, including but not
limited to those identified in D&R.100 and
    (4) The minimum specifications, if identified, are correct,
complete, consistent, and verifiable to assure UA airworthiness.
    (c) The FAA will establish the approved AE or minimum
specifications as operating limitations and include them in the UA type
certificate data sheet and Flight Manual.
    (d) The applicant must develop any maintenance instructions
necessary to address implications from the AE on the airworthiness of
the UA. Those instructions will be included in the instructions for
continued airworthiness (ICA) required by D&R.205.

D&R.110 Software

    To minimize the existence of software errors, the applicant must:
    (a) Verify by test all software that may impact the safe operation
of the UA;
    (b) Utilize a configuration management system that tracks,
controls, and preserves changes made to software throughout the entire
life cycle; and
    (c) Implement a problem reporting system that captures and records
defects and modifications to the software.

D&R.115 Cybersecurity

    (a) UA equipment, systems, and networks, addressed separately and
in relation to other systems, must be protected from intentional
unauthorized electronic interactions that may result in an adverse
effect on the security or airworthiness of the UA. Protection must be
ensured by showing that the security risks have been identified,
assessed, and mitigated as necessary.
    (b) When required by paragraph (a) of this section, procedures and
instructions to ensure security protections are maintained must be
included in the ICA.

D&R.120 Contingency Planning

    (a) The UA must be designed so that, in the event of a loss of the
command and control (C2) link, the UA will automatically and
immediately execute a safe predetermined flight, loiter, landing, or
termination.
    (b) The applicant must establish the predetermined action in the
event of a loss of the C2 link and include it in the UA Flight Manual.
    (c) The UA Flight Manual must include the minimum performance
requirements for the C2 data link defining when the C2 link is degraded
to a level where remote active control of the UA is no longer ensured.
Takeoff when the C2 link is degraded below the minimum link performance
requirements must be prevented by design or prohibited by an operating
limitation in the UA Flight Manual.

D&R.125 Lightning

    (a) Except as provided in paragraph (b) of this section, the UA
must have design characteristics that will protect the UA from loss of
flight or loss of control due to lightning.
    (b) If the UA has not been shown to protect against lightning, the
UA Flight Manual must include an operating limitation to prohibit
flight into weather conditions conducive to lightning activity.

D&R.130 Adverse Weather Conditions

    (a) For purposes of this section, ``adverse weather conditions''
means rain, snow, and icing.
    (b) Except as provided in paragraph (c) of this section, the UA
must have design characteristics that will allow the UA to operate
within the adverse weather conditions specified in the

CONOPS without loss of flight or loss of control.
    (c) For adverse weather conditions for which the UA is not approved
to operate, the applicant must develop operating limitations to
prohibit flight into known adverse weather conditions and either:
    (1) Develop operating limitations to prevent inadvertent flight
into adverse weather conditions; or
    (2) Provide a means to detect any adverse weather conditions for
which the UA is not certificated to operate and show the UA's ability
to avoid or exit those conditions.

D&R.135 Flight Essential Parts

    (a) A flight essential part is a part, the failure of which could
result in a loss of flight or unrecoverable loss of UA control.
    (b) If the type design includes flight essential parts, the
applicant must establish a flight essential parts list. The applicant
must develop and define mandatory maintenance instructions or life
limits, or a combination of both, to prevent failures of flight
essential parts. Each of these mandatory actions must be included in
the Airworthiness Limitations Section of the ICA.

Operating Limitations and Information

D&R.200 Flight Manual

    The applicant must provide a Flight Manual with each UA.
    (a) The UA Flight Manual must contain the following information:
    (1) UA operating limitations;
    (2) UA operating procedures;
    (3) Performance information;
    (4) Loading information; and
    (5) Other information that is necessary for safe operation because
of design, operating, or handling characteristics.
    (b) Those portions of the UA Flight Manual containing the
information specified in paragraph (a)(1) of this section must be
approved by the FAA.

D&R.205 Instructions for Continued Airworthiness

    The applicant must prepare ICA for the UA in accordance with
Appendix A to part 23, as appropriate, that are acceptable to the FAA.
The ICA may be incomplete at type certification if a program exists to
ensure their completion prior to delivery of the first UA or issuance
of a standard airworthiness certificate, whichever occurs later.

Testing

D&R.300 Durability and Reliability

    The UA must be designed to be durable and reliable when operated
under the limitations prescribed for its operating environment, as
documented in its CONOPS and included as operating limitations on the
type certificate data sheet and in the UA Flight Manual. The durability
and reliability must be demonstrated by flight test in accordance with
the requirements of this section and completed with no failures that
result in a loss of flight, loss of control, loss of containment, or
emergency landing outside the operator's recovery area.
    (a) Once a UA has begun testing to show compliance with this
section, all flights for that UA must be included in the flight test
report.
    (b) Tests must include an evaluation of the entire flight envelope
across all phases of operation and must address, at a minimum, the
following:
    (1) Flight distances;
    (2) Flight durations;
    (3) Route complexity;
    (4) Weight;
    (5) Center of gravity;
    (6) Density altitude;
    (7) Outside air temperature;
    (8) Airspeed;
    (9) Wind;
    (10) Weather;
    (11) Operation at night, if requested;
    (12) Energy storage system capacity; and
    (13) Aircraft to pilot ratio.
    (c) Tests must include the most adverse combinations of the
conditions and configurations in paragraph (b) of this section.
    (d) Tests must show a distribution of the different flight profiles
and routes representative of the type of operations identified in the
CONOPS.
    (e) Tests must be conducted in conditions consistent with the
expected environmental conditions identified in the CONOPS, including
electromagnetic interference (EMI) and high intensity radiated fields
(HIRF).
    (f) Tests must not require exceptional piloting skill or alertness.
    (g) Any UAS used for testing must be subject to the same worst-case
ground handling, shipping, and transportation loads as those allowed in
service.
    (h) Any UA used for testing must use AE that meet, but do not
exceed, the minimum specifications identified under D&R.105. If
multiple AE are identified, the applicant must demonstrate each
configuration.
    (i) Any UAS used for testing must be maintained and operated in
accordance with the ICA and UA Flight Manual. No maintenance beyond the
intervals established in the ICA will be allowed to show compliance
with this section.
    (j) If cargo operations or external-load operations are requested,
tests must show, throughout the flight envelope and with the cargo or
external-load at the most critical combinations of weight and center of
gravity, that--
    (1) The UA is safely controllable and maneuverable; and
    (2) The cargo or external-load is retainable and transportable.

D&R.305 Probable Failures

    The UA must be designed such that a probable failure will not
result in a loss of containment or control of the UA. This must be
demonstrated by test.
    (a) Probable failures related to the following equipment, at a
minimum, must be addressed:
    (1) Propulsion systems;
    (2) C2 link;
    (3) Global Positioning System (GPS);
    (4) Flight control components with a single point of failure;
    (5) Control station; and
    (6) Any other AE identified by the applicant.
    (b) Any UA used for testing must be operated in accordance with the
UA Flight Manual.
    (c) Each test must occur at the critical phase and mode of flight,
and at the highest aircraft-to-pilot ratio.

D&R.310 Capabilities and Functions

    (a) All of the following required UAS capabilities and functions
must be demonstrated by test:
    (1) Capability to regain command and control of the UA after the C2
link has been lost.
    (2) Capability of the electrical system to power all UA systems and
payloads.
    (3) Ability for the pilot to safely discontinue the flight.
    (4) Ability for the pilot to dynamically re-route the UA.
    (5) Ability to safely abort a takeoff.
    (6) Ability to safely abort a landing and initiate a go-around.
    (b) The following UAS capabilities and functions, if requested for
approval, must be demonstrated by test:
    (1) Continued flight after degradation of the propulsion system.
    (2) Geo-fencing that contains the UA within a designated area, in
all operating conditions.
    (3) Positive transfer of the UA between control stations that
ensures only one control station can control the UA at a time.
    (4) Capability to release an external cargo load to prevent loss of
control of the UA.
    (5) Capability to detect and avoid other aircraft and obstacles.
    (c) The UA must be designed to safeguard against inadvertent
discontinuation of the flight and inadvertent release of cargo or
external load.

D&R.315 Fatigue

    The structure of the UA must be shown to withstand the repeated
loads expected during its service life without failure. A life limit
for the airframe must be established, demonstrated by test, and
included in the ICA.

D&R.320 Verification of Limits

    The performance, maneuverability, stability, and control of the UA
within the flight envelope described in the UA Flight Manual must be
demonstrated at a minimum of 5% over maximum gross weight with no loss
of control or loss of flight.

    Issued in Washington, DC, on September 9, 2022.
Ian Lucas,
Manager, Policy Implementation Section, Policy and Innovation Division,
Aircraft Certification Service.
[FR Doc. 2022-20001 Filed 9-14-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: March 18, 2009 (Volume 74, Number 51)]
[Notices]
[Page 11535-11536]
[DOCID:fr18mr09-41]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PR09-16-000]

Enogex, LLC; Notice of Filing

March 11, 2009.
    Take notice that on February 27, 2009, Enogex, LLC (Enogex) filed
pursuant to section 284.123(e) of the Commission's regulations, a
revised Statement of Operating Conditions (SOC) proposing to implement
a new firm transportation service on its East Zone effective April 1,
2009. Enogex states that it is making the revisions to its SOC in
advance of a rate petition which will seek to establish new firm
section 311 transportation rates on its East Zone and to revise its
existing interruptible rates on its East and West Zones.
    Any person desiring to participate in this rate proceeding must
file a motion 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 and 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 date as indicated below. Anyone filing an
intervention or protest must serve a copy of that document on the
Applicant. Anyone filing an intervention or protest on or before the
intervention or protest date need not 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 Wednesday, March 24, 2009.

Kimberly D. Bose,
Secretary.
 [FR Doc. E9-5773 Filed 3-17-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 9 (Tuesday, January 14, 2014)]
[Notices]
[Pages 2449-2450]
[FR Doc No: 2014-00519]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1430]

Draft Guidance for Industry on Fulfilling Regulatory Requirements
for Postmarketing Submissions of Interactive Promotional Media for
Prescription Human and Animal Drugs and Biologics; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Fulfilling
Regulatory Requirements for Postmarketing Submissions of Interactive
Promotional Media for Prescription Human and Animal Drugs and
Biologics.'' This draft guidance responds to stakeholder requests for
specific guidance on FDA's current views on how manufacturers, packers,
and distributors (firms), that may either be the applicant or acting on
behalf of the applicant, of prescription human and animal drug and
biological products (drugs) can fulfill regulatory requirements for
postmarketing submissions of interactive promotional media for their
FDA-approved products. This draft guidance clarifies FDA's policies on
what the Agency considers to be interactive promotional media.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comments on
this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 14, 2014. General comments on Agency guidance
documents are welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002; or to
the Office of Communication, Outreach and Development (HFM-40), Center
for Biologics Evaluation and Research, Food and Drug Administration,
1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448; or to the
Communications Staff (HFV-12), Center for Veterinary Medicine, Food and
Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:
    Regarding human prescription drugs: Barbara Chong, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Silver Spring, MD 20993,<PHONE_NUMBER>.
    Regarding prescription human biological products: Stephen Ripley,
Center for Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-
1448,<PHONE_NUMBER>.

    Regarding animal prescription drugs: Dorothy McAdams, Center for
Veterinary Medicine (HFV-216), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Fulfilling Regulatory Requirements for Postmarketing
Submissions of Interactive Promotional Media for Prescription Human and
Animal Drugs and Biologics.''
    On November 12-13, 2009, FDA held a 21 CFR part 15 public hearing
entitled ``Promotion of Food and Drug Administration-Regulated Medical
Products Using the Internet and Social Media Tools'' to provide an
opportunity for broad public participation and comment on the following
questions that relate specifically to promotional issues:
    1. For what online communications are manufacturers, packers, or
distributors accountable?
    2. How can manufacturers, packers, or distributors fulfill
regulatory requirements (e.g., fair balance, disclosure of indication
and risk information, and postmarketing submission requirements) in
their internet and social media promotion, particularly when using
tools that are associated with space limitations and tools that allow
for real-time communications (e.g., microblogs and mobile technology)?
    3. What parameters should apply to the posting of corrective
information on Web sites controlled by third parties?
    4. When is the use of links appropriate?

Subsequent to the live testimony heard at the part 15 public hearing,
FDA received 72 comments to the docket.
    This draft guidance provides FDA's recommendations to drug firms on
fulfilling the regulatory requirements under 21 CFR 314.81(b)(3)(i), 21
CFR 601.12(f)(4), and 21 CFR 514.80(b)(5)(ii) for postmarketing
submissions of interactive promotional media for their FDA-approved
products. For the purposes of this draft guidance, the phrase
``interactive promotional media'' includes tools and technologies that
often allow for real-time communications and interactions (e.g., blogs,
microblogs, social networking sites, online communities, live podcasts,
etc.), which firms use to promote their drugs. FDA's regulation of
prescription drug product promotion extends both to promotional
activities that are carried out by the firm itself, and to promotion
conducted on the firm's behalf. In determining whether the firm is
accountable for a communication about its product(s), the Agency
considers whether the firm, or anyone acting on its behalf, is
influencing or controlling the product promotional activity or
communication in whole or part.
    Firms may have a variety of options for how much control they exert
over activities that utilize interactive promotional media, regardless
of whether the promotional activity occurs on firm sponsored venues or
on third-party venues. For example, a firm may promote its products
through product Web sites, discussion boards, chat rooms, or other
public electronic forums that it maintains and over which it has full
control. In addition, third-party sites (i.e., Web sites and other
venues that are either entirely independent of a firm's control and
influence or not fully controlled by a firm) also may promote a firm's
products. This draft guidance outlines considerations FDA takes into
account in determining when product communications using interactive
technologies are subject to substantive influence by firms that market
the product, therefore triggering postmarketing submission
requirements.
    In addition, this draft guidance provides FDA's recommendations for
how firms can fulfill the regulatory requirement to submit
postmarketing promotional materials to FDA in a practical manner to
address the potential volume of real-time information that is
continuously posted and shared through various interactive promotional
media platforms.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). When finalized, it will
represent the Agency's current thinking on fulfilling the regulatory
requirements for postmarketing submissions of interactive promotional
media for drugs. It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the requirements of the
applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collection of information in 21 CFR 314.81(b)(3)(i), 21 CFR
601.12(f)(4), and 21 CFR 514.80(b)(5)(ii) including Forms FDA 2253 and
FDA 2301, have been approved under OMB control numbers 0910-0001, 0910-
0338, and 0910-0284.

III. Comments

    Interested persons may submit either electronic comments regarding
this document 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, or http://www.regulations.gov.

    Dated: January 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-00519 Filed 1-13-14; 8:45 am]
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[Federal Register: July 31, 2009 (Volume 74, Number 146)]
[Proposed Rules]
[Page 38145-38146]
[DOCID:fr31jy09-16]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2009-0539; Airspace Docket No. 09-AGL-14]

Proposed Amendment of Class E Airspace; Winona, MN

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend Class E airspace at Winona, MN.
Additional controlled airspace is necessary to accommodate new Standard
Instrument Approach Procedures (SIAPs) at Winona Municipal Airport-Max
Conrad Field, Winona, MN. The FAA is taking this action to enhance the
safety and management of Instrument Flight Rules (IFR) operations for
SIAPs at Winona Municipal Airport-Max Conrad Field.

DATES: 0901 UTC. Comments must be received on or before September 14,
2009.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue, SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590-0001. You
must identify the docket number FAA-2009-0539/Airspace Docket No. 09-
AGL-14, at the beginning of your comments. You may also submit comments
through the Internet at http://www.regulations.gov. You may review the
public docket containing the proposal, any comments received, and any
final disposition in person in the Dockets Office between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The Docket Office
(telephone 1-800-647-5527), is on the ground floor of the building at
the above address.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone: (817) 321-
7716.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2009-0539/
Airspace Docket No. 09-AGL-14.'' The postcard will be date/time stamped
and returned to the commenter.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://
www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_
amendments/.
    Additionally, any person may obtain a copy of this notice by
submitting a request to the Federal Aviation Administration (FAA),
Office of Air Traffic Airspace Management, ATA-400, 800 Independence
Avenue, SW., Washington, DC 20591, or by calling<PHONE_NUMBER>.
Communications must identify both docket numbers for this notice.
Persons interested in being placed on a mailing list for future NPRMs
should contact the FAA's Office of Rulemaking<PHONE_NUMBER>, to
request a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    This action proposes to amend Title 14, Code of Federal Regulations
(14 CFR), part 71 by adding additional Class E airspace extending
upward from 700 feet above the surface for SIAPs operations at Winona
Municipal Airport-Max Conrad Field, Winona, MN. Controlled airspace is
needed for the safety and management of IFR operations at the airport.
    Class E airspace areas are published in Paragraph 6005 of FAA Order
7400.9S, dated October 3, 2008, and effective October 31, 2008, which
is incorporated by reference in 14 CFR 71.1. The Class E airspace
designation listed in this document would be published subsequently in
the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106 describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would add additional controlled airspace at Winona Municipal
Airport-Max Conrad Field, Winona, MN.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR Part 71 as follows:

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

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

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

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of FAA Order
7400.9S, Airspace Designations and Reporting Points, dated October 3,
2008, and effective October 31, 2008, is amended as follows:

Paragraph 6005 Class E Airspace areas extending upward from 700
feet or more above the surface of the earth

* * * * *

AGL MN E5 Winona, MN [Amended]

Winona Municipal Airport--Max Conrad Field, MN
    (Lat. 44[deg]04[min]38[sec] N., long. 91[deg]42[min]30[sec] W.)

    That airspace extending upward from 700 feet above the surface
within a 7-mile radius of Robertson Field Airport and within 8 miles
southwest and 4 miles northeast of the 121[deg] bearing from the
airport extending from the 7-mile radius to 21 miles southeast of
the airport, excluding that airspace within the La Crosse, WI Class
D airspace area.
* * * * *

    Issued in Fort Worth, TX on July 22, 2009.
Anthony D. Roetzel,
Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. E9-18239 Filed 7-30-09; 8:45 am]

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