[Federal Register Volume 88, Number 221 (Friday, November 17, 2023)]
[Notices]
[Pages 80353-80356]
[FR Doc No: 2023-25379]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-98906; File No. SR-BOX-2023-25]

Self-Regulatory Organizations; BOX Exchange LLC; Notice of Filing
and Immediate Effectiveness of a Proposed Rule Change To Amend the Fee
Schedule for Trading on the BOX Options Market LLC Facility To Amend
Sections IV.A (Non-Auction Transactions) and IV.A.1 (Tiered Volume
Rebate for Non-Auction Transactions)

November 13, 2023.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on November 1, 2023, BOX Exchange LLC (``Exchange'') filed with the
Securities and Exchange Commission (``Commission'') the proposed rule
change as described in Items I, II, and III below, which Items have
been prepared by the Exchange. The Exchange filed the proposed rule
change pursuant to section 19(b)(3)(A)(ii) of the Act,\3\ and Rule 19b-
4(f)(2) thereunder,\4\ which renders the proposal effective upon filing
with the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange is filing with the Securities and Exchange Commission
(``Commission'') a proposed rule change to amend Section IV.A (Non-
Auction Transactions) and Section IV.A.1 (Tiered Volume Rebate for Non-
Auction Transactions) of the Fee Schedule on the BOX Options Market LLC
(``BOX'') options facility. The text of the proposed rule change is
available from the principal office of the Exchange, at the
Commission's Public Reference Room and also on the Exchange's internet
website at https://rules.boxexchange.com/rulefilings.

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

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

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

1. Purpose
    The Exchange proposes to amend Section IV.A (Non-Auction
Transactions) and Section IV.A.1 (Tiered Volume Rebate for Non-Auction
Transactions) of the BOX Fee Schedule. First, the Exchange proposes to
increase Public Customer taker fees on transactions for options
overlying the Standard and Poor's Depositary Receipts Trust (``SPY'')
in Section IV.A.\5\ Next, the Exchange proposes to reduce Tier 4
rebates and establish a new Tier 5 in the Tiered Volume Rebate for Non-
Auction Transactions for Percentage National Customer Volume in
Multiply-Listed Options Classes.
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    \5\ Options overlying Standard and Poor's Depositary Receipts/
SPDRs (``SPY'') are based on the SPDR exchange-traded fund
(``ETF''), which is designed to track the performance of the S&P 500
Index.
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Non-Auction Transactions
    In Section IV.A of the BOX Fee Schedule, fees and credits for
Electronic Non-Auction Transactions are assessed depending on three
factors: (i) the account type of the Participant submitting the order;
(ii) whether the Participant is a liquidity provider or liquidity
taker; and (iii) the account type of the contra party. Currently, when
a Public Customer SPY order is a liquidity taker contra to a
Professional Customer, Broker Dealer, or a Market Maker, the Public
Customer is assessed no fee. The Exchange now proposes to increase
Public Customer taker fees on SPY Non-Auction Transactions.
Accordingly, when a Public Customer SPY order is a liquidity taker
contra to a Professional Customer, Broker Dealer, or a Market Maker,
the Public Customer will be assessed a fee of $0.10.
Tiered Volume Rebate for Non-Auction Transactions
    The Exchange also proposes to amend Section IV.A.1 of the Fee
Schedule. Specifically, the Exchange proposes to add a Tier and to
adjust the Percentage Thresholds of National Customer Volume in
Multiply-Listed Options Classes. Currently, Public Customers

receive a per contract rebate for electronic Non-Auction Transactions
according to the Tier achieved by the Public Customer as provided in
the Percentage Thresholds of National Customer Volume in Multiply-
Listed Options Classes table in Section IV.A.1 of the BOX Fee
Schedule.\6\ Percentage thresholds are calculated on a monthly basis by
totaling the Public Customer's executed Auction and Non-Auction
transaction volume on BOX, relative to the total national customer
volume in multiply-listed options classes.
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    \6\ The Exchange notes that Public Customers do not initiate
transactions on BOX directly. BOX Participants initiate Electronic
Non-Auction Transactions on the behalf of Public Customers and are
assessed fees or provided rebates by the Exchange.
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    The Exchange notes that Non-Auction Transactions where a Public
Customer order interacts with another Public Customer order are exempt
from a per contract rebate. However, these transactions still count
toward the Public Customer's monthly volume on BOX. The current
thresholds and rebates are as follows:

----------------------------------------------------------------------------------------------------------------
                     Percentage                     Per contract rebate
                   thresholds of   -----------------------------------------------------------------------------
                 national customer   Penny interval classes      Non-penny interval                SPY
      Tier           volume in     --------------------------          classes         -------------------------
                  multiply-listed                            --------------------------
                  options classes      Maker        Taker                                  Maker        Taker
                     (monthly)                                   Maker        Taker
----------------------------------------------------------------------------------------------------------------
1..............  0.000-0.249......        $0.00        $0.00        $0.00        $0.00        $0.00        $0.00
2..............  0.250-0.499......       (0.05)       (0.15)       (0.15)       (0.27)       (0.05)         0.00
3..............  0.500-0.749......       (0.10)       (0.20)       (0.30)       (0.32)       (0.10)         0.00
4..............  0.750 and Above..       (0.27)       (0.27)       (0.60)       (0.40)       (0.27)         0.00
----------------------------------------------------------------------------------------------------------------

    The Exchange proposes to modify Tier 4 from 0.750% and Above to
0.750%-0.999% and to establish Tier 5 which will be 1.000% and Above.
The Exchange also proposes to reduce Tier 4 rebates to $0.20 and $0.22
for Maker and Taker respectively in Penny Interval Classes, $0.45 and
$0.35 for Maker and Taker respectively in Non-Penny Interval Classes,
and $0.20 and $0.00 for Maker and Taker respectively in SPY. Finally,
the Exchange proposes to establish Tier 5 rebates of $0.27 and $0.27
for Maker and Taker respectively in Penny Interval Classes, $0.60 and
$0.40 for Maker and Taker respectively in Non-Penny Interval Classes,
and $0.27 and $0.11 for Maker and Taker respectively in SPY. The
proposed rebate structure is as follows:

----------------------------------------------------------------------------------------------------------------
                     Percentage                     Per contract rebate
                   thresholds of   -----------------------------------------------------------------------------
                 national customer   Penny interval classes      Non-penny interval                SPY
      Tier           volume in     --------------------------          classes         -------------------------
                  multiply-listed                            --------------------------
                  options classes      Maker        Taker                                  Maker        Taker
                     (monthly)                                   Maker        Taker
----------------------------------------------------------------------------------------------------------------
1..............  0.000-0.249......        $0.00        $0.00        $0.00        $0.00        $0.00        $0.00
2..............  0.250-0.499......       (0.05)       (0.15)       (0.15)       (0.27)       (0.05)         0.00
3..............  0.500-0.749......       (0.10)       (0.20)       (0.30)       (0.32)       (0.10)         0.00
4..............  0.750-0.999......       (0.20)       (0.22)       (0.45)       (0.35)       (0.20)         0.00
5..............  1.000 and Above..       (0.27)       (0.27)       (0.60)       (0.40)       (0.27)       (0.11)
----------------------------------------------------------------------------------------------------------------

    The Exchange notes that the proposed SPY taker fees are lower than
comparable taker fees at several other exchanges.\7\ The Exchange notes
further that other exchanges employ similar incentive programs; and the
Exchange believes that the proposed changes are reasonable and
competitive when compared to incentive structures at other
exchanges.\8\
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    \7\ See e.g., Nasdaq PHLX LLC, Options 7, Section 3 Part A.
(``Simple Order'' Customer fee for removing SPY liquidity of $0.41);
Cboe C2 Exchange, Inc. Fee Schedule (``Transaction Fees'' applicable
to SPY for Public Customer Remove rates of $0.37); MIAX PEARL, LLC
Fee Schedule (``Transaction Rebates/Fees'' for Priority Customer SPY
Taker in Tier 1 of $0.46).
    \8\ See Nasdaq PHLX LLC (``Nasdaq PHLX'') Options 7, Section 2
(Customer Rebate Program) and Cboe Exchange, Inc. (``CBOE'') Fee
Schedule (Volume Incentive Program). The Exchange notes that these
programs use different tier structures, volume calculations, and
rebate amounts, however, their rebate programs operate similarly to
BOX's in that they are driven by volume and designed to incentivize
Public Customer order flow.
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2. Statutory Basis
    The Exchange believes that the proposal is consistent with the
requirements of section 6(b) of the Act, in general, and section
6(b)(4) and 6(b)(5) of the Act,\9\ in particular, in that it provides
for the equitable allocation of reasonable dues, fees, and other
charges among BOX Participants and other persons using its facilities
and does not unfairly discriminate between customers, issuers, brokers
or dealers.
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    \9\ 15 U.S.C. 78f(b)(4) and (5).
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    The Exchange notes that it operates in a highly competitive
environment. Indeed, there are currently 17 registered options
exchanges that trade options. Based on publicly available information,
no single options exchange has more than 21% of the market share and
currently the Exchange represents only approximately 7% of the market
share.\10\ The Commission has repeatedly expressed its preference for
competition over regulatory intervention in determining prices,
products, and services in the securities markets. Particularly, in
Regulation NMS, the Commission highlighted the importance of market
forces in determining prices and SRO revenues and, also, recognized
that current regulation of the market system ``has been remarkably
successful in promoting market competition in its broader forms that
are most important to investors and listed companies.'' \11\ As stated
above, the Exchange operates in a highly competitive market in which
market participants can readily direct order flow to competing venues
if they deem fee levels at a particular venue to be excessive or
incentives to be insufficient. The proposed fee changes reflect a
competitive pricing structure designed to incentivize Public Customer
electronic non-auction order flow to BOX.
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    \10\ See Cboe Global Markets U.S. Options Market Month-to-Date
Volume Summary (September 29, 2023), available at https://markets.cboe.com/us/options/market_statistics/.
    \11\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496, 37499 (June 29, 2005) (``Regulation NMS Adopting
Release'').

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Non-Auction Transactions
    The Exchange believes the proposed electronic Non-Auction
transaction taker fees for Public Customer SPY transactions are
reasonable as the proposed taker fees are lower than similar
transaction fees assessed at other exchanges.\12\ The Exchange further
believes that the proposed SPY taker fee for electronic Non-Auction
Public Customer transactions will not disincentivize Public Customer
order flow because BOX's electronic Non-Auction Transactions fee
structure is designed to attract competitive quotes and orders, which
results in liquid markets that Public Customers may find attractive.
Specifically, the Exchange assesses no fees for Public Customers that
make liquidity in SPY and, no fees for Market Makers that make
liquidity in SPY, which incentivizes competitive quotes and resting
orders. The Exchange believes that Public Customers may be willing to
pay a nominal taker fee of $0.10 to access such competitive markets.
The Exchange notes that other exchanges assess fees between $0.37 and
$0.46 for customer transactions taking liquidity in SPY.\13\
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    \12\ See supra note 7.
    \13\ See supra note 7.
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    The Exchange believes that assessing Public Customers a taker fee
of $0.10 for SPY electronic Non-Auction Transactions is equitable and
not unfairly discriminatory. The Exchange notes that Professional
Customer, Broker Dealer, and Market Maker taker fees for SPY electronic
Non-Auction Transactions are $0.50. The securities markets generally,
and BOX in particular, have historically aimed to improve markets for
investors and develop various features within the market structure for
Public Customer benefit. Accordingly, the Exchange believes that
charging a lower taker fee for Public Customers for their SPY
transactions compared to other account types on BOX is appropriate and
not unfairly discriminatory.
Tiered Volume Rebate for Non-Auction Transactions
    The Exchange believes it is reasonable, equitable and not unfairly
discriminatory to adjust certain percentage thresholds in the volume-
based thresholds for Public Customers in electronic Non-Auction
Transactions. The volume-based thresholds and applicable rebates are
designed to continue to incentivize Public Customers to direct order
flow to BOX to obtain the benefit of the rebate, which may in turn
benefit all market participants by increasing liquidity on BOX. The
Exchange proposes to amend Tier 4, which was 0.750% and Above, to
0.750%-0.999%, and to add Tier 5 with a threshold of 1.000% and Above.
This fee structure is designed to incentivize Public Customers to send
their order flow to BOX, which may result in increased trading
opportunities and executions on BOX.\14\ Further, the Exchange notes
that the proposed amendment to the percentage thresholds in the volume-
based thresholds for Public Customers in electronic Non-Auction
Transactions is not designed to benefit one firm in particular, but, as
discussed herein, is designed to further incentivize order flow to BOX.
While the Exchange proposes to decrease Tier 4 rebates, the Exchange
believes that Public Customers will still benefit from the opportunity
to obtain a rebate for their executions on BOX. The Exchange notes that
other exchanges employ similar incentive programs; and the Exchange
believes that the proposed changes are reasonable and competitive when
compared to incentive structures at other exchanges.\15\
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    \14\ The Exchange notes that BOX Participants collect rebates on
behalf of Public Customers and have independent fee arrangements
with such Public Customers.
    \15\ See supra note 8.
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    The Exchange believes that the proposed changes to the thresholds
in Tiers 4 and 5 are equitable and not unfairly discriminatory as they
are available to all Public Customers, and Public Customers may choose
whether or not to take advantage of the percentage thresholds and their
applicable rebates. The securities markets generally, and BOX in
particular, have historically aimed to improve markets for investors
and develop various features within the market structure for Public
Customer benefit. Accordingly, the Exchange believes that providing a
rebate structure for Public Customers is appropriate and not unfairly
discriminatory. Based on its review of competitor exchanges, the
Exchange believes that lowering Tier 4 rebates, and adding more
difficult to obtain Tier 5 rebates, will not disincentivize Public
Customer order flow. Rather, the Exchange believes that the proposed
rebates will continue to help attract a high level of Public Customer
order flow to the BOX, which will ultimately benefit all Participants
trading on BOX.
    The Exchange believes that the ever-shifting market share among the
exchanges from month to month demonstrates that market participants can
shift order flow and discontinue or reduce use of certain categories of
products in response to fee changes. Accordingly, competitive forces
constrain options exchange transaction fees. Stated differently,
changes to exchange transaction fees can have a direct effect on the
ability of an exchange to compete for order flow. The Exchange believes
the proposed changes are a reasonable attempt to effectively compete
for electronic Non-Auction Public Customer orders. The Exchange
believes that the proposed change may incentivize Public Customer order
flow and, in turn, may make BOX a more competitive venue for order
execution to the benefit of all Participants. Finally, the Exchange
believes the proposed changes are consistent with the Act because, to
the extent the modifications permit the Exchange to continue to attract
greater volume and liquidity, the proposed changes would improve BOX's
overall competitiveness and strengthen market quality for all market
participants.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act.
    The Exchange believes the proposed changes to Public Customer SPY
taker fees in the electronic Non-Auction Transactions fee structure
will not impose a burden on intramarket competition as BOX believes
that the changes will result in Public Customers being charged
appropriately for their SPY taker transactions. The proposed change
would apply to all similarly situated market participants and,
accordingly, the proposed change would not impose a disparate burden on
competition among Participants on BOX. The proposed change is designed
to assess Public Customers a nominal taker fee for Electronic SPY Non-
Auction Transactions. The Exchange notes that Public Customer taker
fees remain lower than Professional Customer, Broker Dealer, and Market
Maker taker fees because BOX has historically aimed to improve markets
for investors and develop various features within the market structure
for Public Customer benefit.
    The Exchange believes further the proposed changes to Public
Customer SPY taker fees in the Electronic Non-Auction Transactions fee
structure will not impose a burden on intermarket competition. The
Exchange notes that the Non-Auction Transaction fee structure as a
whole, including the proposed change, is designed to be competitive
with other options

exchanges and to attract order flow. The Exchange believes the
electronic Non-Auction Transactions fee structure, including the
proposed change, will remain competitive with other options exchanges
and will continue to assess lower Public Customer taker fees than
several other exchanges.\16\
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    \16\ See supra note 7.
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    The Exchange believes the proposed changes to Tier 4 and the
addition of Tier 5 in Section IV.A.1 will not impose a burden on
competition among various BOX Participants. The Exchange believes that
the proposed changes will result in Public Customers being rebated
appropriately for their transactions. The Exchange believes further
that the proposed rebates will continue to attract Public Customer
order flow to the BOX, which will ultimately benefit all Participants
trading on BOX.
    Finally, the Exchange notes that it operates in a highly
competitive market in which market participants can readily favor
competing venues. In such an environment, the Exchange must continually
review, and consider adjusting, its fees and rebates to remain
competitive with other exchanges. Because competitors are free to
modify their own fees and rebates in response, and because market
participants may readily adjust their order routing practices, the
Exchange believes that the degree to which fee or rebate changes in
this market may impose any burden on competition is extremely limited.
The Exchange notes that other exchanges provide programs to incentivize
customer order flow and that the proposed changes to the volume
thresholds remain competitive when compared to incentive structures at
other exchanges.\17\ For the reasons described above, the Exchange
believes that the proposed rule change will encourage intermarket
competition.
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    \17\ See supra note 8.
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C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to section
19(b)(3)(A)(ii) of the Exchange Act \18\ and Rule 19b-4(f)(2)
thereunder,\19\ because it establishes or changes a due, or fee.
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    \18\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \19\ 17 CFR 240.19b-4(f)(2).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend the rule
change if it appears to the Commission that the action is necessary or
appropriate in the public interest, for the protection of investors, or
would otherwise further 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 (https://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
file number SR-BOX-2023-25 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-BOX-2023-25. 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 (https://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
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. Do not
include personal identifiable information in submissions; you should
submit only information that you wish to make available publicly. We
may redact in part or withhold entirely from publication submitted
material that is obscene or subject to copyright protection. All
submissions should refer to file number SR-BOX-2023-25 and should be
submitted on or before December 8, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
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    \20\ 17 CFR 200.30-3(a)(12).
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Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-25379 Filed 11-16-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: August 18, 2009 (Volume 74, Number 158)]
[Proposed Rules]
[Page 41642-41646]
[DOCID:fr18au09-14]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-0687; Directorate Identifier 2009-NM-033-AD]
RIN 2120-AA64

Airworthiness Directives; Empresa Brasileira de Aeronautica S.A.
(EMBRAER) Model ERJ 170 and ERJ 190 Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above that would supersede an existing AD. This
proposed AD results from mandatory continuing airworthiness information
(MCAI) originated by an aviation authority of another country to
identify and correct an unsafe condition on an aviation product. The
MCAI describes the unsafe condition as: It has been found the
occurrence of two events of aircraft being dispatched with the cargo
door opened without indication. In one of the events the aircraft took
off with the cargo door opened.
    The unsafe condition is a cargo door opening during flight, which
could result in reduced structural integrity and consequent rapid
decompression of the airplane. The proposed AD would require actions
that are intended to address the unsafe condition described in the
MCAI.

DATES: We must receive comments on this proposed AD by September 17,
2009.

ADDRESSES: You may send comments 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: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-40, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Empresa Brasileira de Aeronautica S.A. (EMBRAER), Technical
Publications Section (PC 060), Av. Brigadeiro Faria Lima, 2170--Putim--
12227-901 S[atilde]o Jose dos Campos--SP--BRASIL; telephone: +55 12
3927-5852 or +55 12 3309-0732; fax: +55 12 3927-7546; e-mail:
<EMAIL_ADDRESS>Internet: http://www.flyembraer.com. You may
review copies of the referenced service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at the
FAA, call<PHONE_NUMBER> or<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, 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: Kenny Kaulia, Aerospace Engineer,
International Branch, ANM-116, FAA, Transport Airplane Directorate,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-2848; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2009-0687;
Directorate Identifier 2009-NM-033-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD 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 proposed AD.

Discussion

    On April 17, 2007, we issued AD 2007-06-53, Amendment 39-15035 (72
FR 21088, April 30, 2007). That AD requires actions intended to address
an unsafe condition on the products listed above.
    The preamble to AD 2007-06-53 specifies that we consider the
requirements ``interim action'' and that the manufacturer is developing
a modification to address the unsafe condition. That AD explains that
we might consider further rulemaking if a modification is developed,
approved, and available. The manufacturer now has developed such a
modification, and we have determined that further rulemaking is indeed
necessary; this proposed AD follows from that determination.
    The Ag[ecirc]ncia Nacional de Avia[ccedil][atilde]o Civil (ANAC),
which is the aviation authority for Brazil, has issued Brazilian
Airworthiness Directives 2007-03-01R1, effective June 9, 2008, and
2007-03-02R2, effective November 21, 2008 (referred to after this as
``the MCAI''), to correct an unsafe condition for the specified
products. The MCAI states:

    It has been found the occurrence of two events of aircraft being
dispatched with the cargo door opened without indication. In one of
the events the aircraft took off with the cargo door opened.

The unsafe condition is a cargo door opening during flight, which could
result in reduced structural integrity and consequent rapid
decompression of the airplane. Required actions include repetitive
inspections of the forward and aft cargo doors to detect signs of
interference between the lock handle and the aft edge liner assembly
and reworking the assembly; a one-time inspection for signs of damage
of the lateral roller fitting on the forward and aft cargo door frames
at the fuselage and

replacement of the roller if necessary, and modification of the cargo
door, which ends the repetitive inspections. After accomplishing the
modification, the actions include incorporating information into the
maintenance program to include the operational (OPC) and functional
(FNC) checks of the forward and aft cargo doors and accomplishing
repetitive OPC and FNC checks. You may obtain further information by
examining the MCAI in the AD docket.

Relevant Service Information

    Embraer has issued Alert Service Bulletins 170-52-A036 (for Model
ERJ 170 airplanes) and 190-52-A018 (for Model ERJ 190 airplanes); both
Revision 01, both dated March 23, 2007. Embraer Alert Service Bulletins
170-52-A036 and 190-52-A018, both dated March 12, 2007, were referred
to in the existing AD for accomplishing the required actions. No
additional work is necessary for airplanes on which the original issue
of the service information has been done.
    Embraer has also issued Service Bulletins 170-52-0041, Revision 01,
dated June 13, 2008, and 170-52-0044, dated January 18, 2008 (for Model
ERJ 170 airplanes); and Service Bulletins 190-52-0023, Revision 02,
dated March 11, 2008, and 190-52-0027 dated March 20, 2008 (for Model
ERJ 190 airplanes).
    The actions described in this service information are intended to
correct the unsafe condition identified in the MCAI.

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 design.

Differences Between This AD and the MCAI or Service Information

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

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 145 products of U.S. registry.
    The actions that are required by AD 2007-06-53 and retained in this
proposed AD take about 1 work-hour per product, at an average labor
rate of $80 per work hour. Based on these figures, the estimated cost
of the currently required actions is $80 per product.
    We estimate that it would take about 7 work-hours per product to
comply with the new basic requirements of this proposed AD. The average
labor rate is $80 per work-hour. Required parts would cost about
$17,162 per product. Where the service information lists required parts
costs that are covered under warranty, we have assumed that there will
be no charge for these costs. As we do not control warranty coverage
for affected parties, some parties may incur costs higher than
estimated here. Based on these figures, we estimate the cost of the
proposed AD on U.S. operators to be $2,569,690, or $17,722 per product.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this 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); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

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

    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]

    2. The FAA amends Sec.  39.13 by removing Amendment 39-15035 (72 FR
21088, April 30, 2007) and adding the following new AD:

Empresa Brasileira De Aeronautica S.A. (EMBRAER): Docket No. FAA-
2009-0687; Directorate Identifier 2009-NM-033-AD.

Comments Due Date

    (a) We must receive comments by September 17, 2009.

Affected ADs

    (b) The proposed AD supersedes AD 2007-06-53, Amendment 39-
15035.

Applicability

    (c) This AD applies to EMBRAER Model ERJ 170-100 LR, -100 STD, -
100 SE, -100 SU, -200 LR, -200 STD, and -200 SU airplanes; and ERJ
190-100 STD, -100 LR, -100 IGW, -200 LR, -200 STD, and -200 IGW
airplanes; certificated in any category.

Subject

    (d) Air Transport Association (ATA) of America Code 52: Doors.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:
    It has been found the occurrence of two events of aircraft being
dispatched with the cargo door opened without indication. In one of
the events the aircraft took off with the cargo door opened.

The unsafe condition is a cargo door opening during flight, which
could result in reduced structural integrity and consequent rapid
decompression of the airplane. Required actions include repetitive
inspections of the forward and aft cargo doors to detect signs of
interference between the lock handle and the aft edge liner assembly
and reworking the assembly; a one-time inspection for signs of
damage of the lateral roller fitting on the forward and aft cargo
door frames at the fuselage and replacement of the roller if
necessary, and modification of the cargo door, which ends the
repetitive inspections. After accomplishing the modification, the
actions include incorporating information into the maintenance
program to include the operational (OPC) and functional (FNC) checks
of the forward and aft cargo doors and accomplishing repetitive OPC
and FNC checks.

Compliance

    (f) Required as indicated, unless accomplished previously.

Restatement of Requirements of AD 2007-06-53, With New Service
Information

Preflight Verification of Correct Door Closure

    (g) For Model ERJ 170-100 LR, -100 STD, -100 SE, -100 SU, -200
LR, -200 STD, and -200 SU airplanes; and ERJ 190-100 STD, -100 LR,
and -100 IGW airplanes: As of 24 hours after May 7, 2007 (the
effective date of AD 2007-06-53), before each flight after closing
the cargo doors, verify that the forward and aft cargo doors are
closed flush with the fuselage skin, and that all 4 latched and
locked indicators at the bottom of each door are green. Persons
qualified to do this verification are mechanics and flightcrew
members. If it cannot be verified that both doors are closed flush
with the fuselage skin, and that all 4 latched and locked indicators
at the bottom of each door are green, repair before further flight.
Repeat the verification before every flight until accomplishment of
the actions required by paragraph (h) of this AD.

Inspection for Interference and Damage

    (h) For Model ERJ 170-100 LR, -100 STD, -100 SE, -100 SU, -200
LR, -200 STD, and -200 SU airplanes; and ERJ 190-100 STD, -100 LR,
and -100 IGW airplanes: Within 10 days after May 7, 2007, do the
actions specified in paragraphs (h)(1), (h)(2), and (h)(3) of this
AD, in accordance with the Accomplishment Instructions of Embraer
Alert Service Bulletins 170-52-A036 (for Model ERJ 170 airplanes) or
190-52-A018 (for Model ERJ 190 airplanes), both dated March 12,
2007; or Revision 01, both dated March 23, 2007; as applicable. As
of the effective date of this AD, use Revision 01 of the service
bulletins.
    (1) Remove the roller fitting cover plate on the forward and aft
cargo door frames.
    (2) Perform a detailed inspection of the forward and aft cargo
doors to detect signs of interference between the lock handle and
the aft edge liner assembly. Then rework the aft edge liner assembly
at the applicable time specified in paragraph (h)(2)(i) or
(h)(2)(ii) of this AD.
    (i) If any sign of interference is detected: Rework the assembly
before further flight.
    (ii) If no sign of interference is detected: Rework the assembly
within 150 flight cycles after the inspection.
    (3) Perform a detailed inspection for signs of damage of the
lateral roller fitting on the forward and aft cargo door frames at
the fuselage. If any damage is found, replace the lateral roller
fitting before further flight with a new roller fitting having the
same part number, in accordance with the applicable service
bulletin.
    (4) Actions done before May 7, 2007, in accordance with Embraer
Alert Service Bulletin 170-52-A036 or 190-52-A018, both dated March
12, 2007, are acceptable for compliance with the corresponding
requirements of this AD.

    Note 1: For the purposes of this AD, a detailed inspection is:
``An intensive examination of a specific item, installation, or
assembly to detect damage, failure, or irregularity. Available
lighting is normally supplemented with a direct source of good
lighting at an intensity deemed appropriate. Inspection aids such as
mirror, magnifying lenses, etc., may be necessary. Surface cleaning
and elaborate procedures may be required.''

    Note 2: Embraer Alert Service Bulletins 170-52-A036 and 190-52-
A018 refer to Embraer Service Bulletins 170-50-0006 and 190-50-0006,
respectively, as additional sources of service information for the
rework and roller fitting cover plate removal. Embraer Service
Bulletins 170-50-0006 and 190-50-0006 are currently at Revision 01,
dated March 13, 2007.

Repetitive Inspections for Damage

    (i) For Model ERJ 170-100 LR, -100 STD, -100 SE, -100 SU, -200
LR, -200 STD, and -200 SU airplanes; and ERJ 190-100 STD, -100 LR,
and -100 IGW airplanes: Repeat the inspection specified in paragraph
(h)(3) of this AD at intervals not to exceed 150 flight cycles until
the terminating action specified in paragraph (k)(3) of this AD has
been accomplished.

Parts Installation

    (j) For Model ERJ 170-100 LR, -100 STD, -100 SE, -100 SU, -200
LR, -200 STD, and -200 SU airplanes; and ERJ 190-100 STD, -100 LR,
and -100 IGW airplanes: As of May 7, 2007, no person may install a
roller fitting cover plate on the forward and aft cargo door frames
on any airplane.

New Requirements of This AD: Actions and Compliance

    (k) Unless already done, do the following actions.
    (1) For Model ERJ 190-200 LR, -200 STD, and -200 IGW airplanes:
As of 24 hours after the effective date of this AD, before each
flight after closing the cargo doors, verify that the forward and
aft cargo doors are closed flush with the fuselage skin, and that
all 4 latched and locked indicators at the bottom of each door are
green. Persons qualified to do this verification are mechanics and
flightcrew members. If it cannot be verified that both doors are
closed flush with the fuselage skin, and that all 4 latched and
locked indicators at the bottom of each door are green, repair
before further flight. Repeat the verification before every flight
until accomplishment of the actions required by paragraph (k)(2) of
this AD.
    (2) For Model ERJ 190-200 LR, -200 STD, and -200 IGW airplanes:
Within 10 days after the effective date of this AD, do the actions
specified in paragraphs (k)(2)(i), (k)(2)(ii), and (k)(2)(iii) of
this AD, in accordance with the Accomplishment Instructions of
Embraer Alert Service Bulletin 190-52-A018, Revision 01, dated March
23, 2007. Repeat the inspection specified in paragraph (k)(2)(iii)
of this AD at intervals not to exceed 150 flight cycles until the
terminating action specified in paragraph (k)(3) of this AD has been
accomplished.
    (i) Remove the roller fitting cover plate on the forward and aft
cargo door frames.
    (ii) Perform a detailed inspection of the forward and aft cargo
doors to detect signs of interference between the lock handle and
the aft edge liner assembly. Then rework the aft edge liner assembly
at the applicable time specified in paragraph (k)(2)(ii)(A) or
(k)(2)(ii)(B) of this AD.
    (A) If any sign of interference is detected: Rework the assembly
before further flight.
    (B) If no sign of interference is detected: Rework the assembly
within 150 flight cycles after the inspection.
    (iii) Perform a detailed inspection for signs of damage of the
lateral roller fitting on the forward and aft cargo door frames at
the fuselage. If any damage is found, replace the lateral roller
fitting before further flight with a new roller fitting having the
same part number, in accordance with Embraer Alert Service Bulletin
190-52-A018, Revision 01, dated March 23, 2007.
    (3) For all airplanes: Within 5,000 flight cycles after the
effective date of this AD, do the actions specified in paragraphs
(k)(3)(i) and (k)(3)(ii) of this AD on the forward and aft cargo
doors. Accomplishing the actions in this paragraph terminates the
repetitive inspections required by paragraphs (i) and (k)(2) of this
AD.
    (i) Relocate the cargo door closed indication sensor in
accordance with the Accomplishment Instructions of Embraer Service
Bulletin 170-52-0041, Revision 01, dated June 13, 2008; or 190-52-
0023, Revision 02, dated March 11, 2008; as applicable.
    (ii) Modify the cargo door lock handle mechanism and replace the
forward and aft cargo door roller fittings having part number (P/N)
170-92569-401 and 170-85452-401 with new fittings having P/N 170-
92569-403 and 170-85452-403, as applicable. Do the modification in
accordance with the Accomplishment Instructions of Embraer Service
Bulletins 170-52-0044, dated January 18, 2008; or 190-52-0027, dated
March 20, 2008; as applicable.
    (4) Actions done before the effective date of this AD in
accordance with Embraer

Service Bulletin 170-52-0041, dated September 6, 2007; or 190-52-
0023, dated September 6, 2007, or Revision 01, dated December 6,
2007; as applicable; are acceptable for compliance with the
corresponding requirements of this AD.
    (5) Within 12 months after the effective date of this AD or 12
months after accomplishing the modification required by paragraph
(k)(3) of this AD, whichever occurs later: Incorporate information
into the maintenance program to include the operational (OPC) and
functional (FNC) checks of the forward and aft cargo doors; in
accordance with a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or the
Ag[ecirc]ncia Nacional de Avia[ccedil][atilde]o Civil (or its
delegated agent). Within 6,000 flight hours after doing the actions
required by paragraph (k)(3) of this AD, do the OPC and FNC checks
and repeat the checks thereafter at intervals not to exceed 6,000
flight hours.

    Note 3: Guidance on the OPC and FNC checks specified in
paragraph (k)(5) of this AD can be found in Table 1 of this AD, as
applicable.

                                          Table 1--OPC and FNC Guidance
----------------------------------------------------------------------------------------------------------------
               Manual--                                  Task--                                Date--
----------------------------------------------------------------------------------------------------------------
Embraer 170 Aircraft Maintenance       52-31-00-710-801-A/500....................  July 15, 2008.
 Manual.
                                       52-31-20-720-801-A/500....................  July 15, 2008.
                                       52-32-00-710-801-A/500....................  July 15, 2008.
                                       52-32-20-720-801-A/500....................  July 15, 2008.
Embraer 190 Aircraft Maintenance       52-31-00-710-801-A/500....................  July 15, 2008.
 Manual.
                                       52-31-20-720-801-A/500....................  July 15, 2008.
                                       52-32-00-710-801-A/500....................  July 15, 2008.
                                       52-32-20-720-801-A/500....................  July 15, 2008.
----------------------------------------------------------------------------------------------------------------

    Note 4: For the purposes of this AD, a functional check (FNC)
is: ``A quantitative check to determine if one or more functions of
an item perform within specified limits.''

    Note 5: For the purposes of this AD, an operational check (OPC)
is: ``A task to determine if an item is fulfilling its intended
purpose. Since it is a failure finding task, it does not require
quantitative tolerances.''

FAA AD Differences

    Note 6: This AD differs from the MCAI and/or service information
as follows: Where the MCAI includes a compliance time of ``after
accomplishment of the modification'' for revising the maintenance
program for Model ERJ-170 airplanes, we have determined that a
compliance time of ``within 12 months after the effective date of
the AD or within 12 months after accomplishment of the modification,
whichever occurs later'' is appropriate. This compliance time is
equivalent to the compliance time required for Model ERJ-190
airplanes. The manufacturer and ANAC agree with this compliance
time.

Other FAA AD Provisions

    (l) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, FAA, has the authority to approve AMOCs for
this AD, if requested using the procedures found in 14 CFR 39.19.
Send information to ATTN: Kenny Kaulia, Aerospace Engineer,
International Branch, ANM-116, FAA, Transport Airplane Directorate,
1601 Lind Avenue, SW., Renton, Washington 98055-4056; telephone
(425) 227-2848; fax<PHONE_NUMBER>. Before using any approved AMOC
on any airplane to which the AMOC applies, notify your principal
maintenance inspector (PMI) or principal avionics inspector (PAI),
as appropriate, or lacking a principal inspector, your local Flight
Standards District Office. The AMOC approval letter must
specifically reference this AD. AMOCs approved previously in
accordance with AD 2007-06-53, are approved as AMOCs for the
corresponding provisions of paragraph (i) of this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act, the
Office of Management and Budget (OMB) has approved the information
collection requirements and has assigned OMB Control Number 2120-
0056.

Related Information

    (m) Refer to Brazilian Airworthiness Directives 2007-03-01R1,
dated June 9, 2008, and 2007-03-02R2, dated November 21, 2008; and
the service information contained in Table 2 of this AD for related
information.

                      Table 2--Service Information
------------------------------------------------------------------------
       Service Bulletin            Revision               Date
------------------------------------------------------------------------
Embraer Alert Service                       01  March 23, 2007.
 Bulletin 170-52-A036.
Embraer Alert Service                       01  March 23, 2007.
 Bulletin 190-52-A018.
Embraer Service Bulletin 170-               01  June 13, 2008.
 52-0041.
Embraer Service Bulletin 170-         Original  January 18, 2008.
 52-0044.
Embraer Service Bulletin 190-               02  March 11, 2008.
 52-0023.
Embraer Service Bulletin 190-         Original  March 20, 2008.
 52-0027.
------------------------------------------------------------------------

    Issued in Renton, Washington, on August 7, 2009.
Stephen P. Boyd,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E9-19655 Filed 8-17-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register: September 3, 2009 (Volume 74, Number 170)]
[Rules and Regulations]
[Page 45553-45554]
[DOCID:fr03se09-5]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2008-0763; Airspace Docket No. 08-AAL-22]

Establishment of Class E Airspace; Quinhagak, AK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action establishes Class E airspace at Quinhagak, AK to
provide adequate controlled airspace to contain aircraft executing
Standard Instrument Approach Procedures (SIAPs). Two Standard
Instrument Approach Procedures (SIAPs) are being developed for the
Quinhagak Airport at Quinhagak, AK. Additionally, one textual Obstacle
Departure Procedure (ODP) is being developed. Also, this action makes a
minor correction to the geographic coordinates for the airport. This
action establishes Class E airspace upward from 700 feet (ft.) above
the surface at Quinhagak Airport, Quinhagak, AK.

DATES: Effective Date: 0901 UTC, October 22, 2009. The Director of the
Federal Register approves this

incorporation by reference action under title 1, Code of Federal
Regulations, part 51, subject to the annual revision of FAA Order
7400.9 and publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Gary Rolf, AAL-538G, Federal Aviation
Administration, 222 West 7th Avenue, Box 14, Anchorage, AK 99513-7587;
telephone number<PHONE_NUMBER>; fax:<PHONE_NUMBER>; e-mail:
<EMAIL_ADDRESS>Internet address: http://www.faa.gov/about/
office_org/headquarters_offices/ato/service_units/systemops/fs/
alaskan/rulemaking/.

SUPPLEMENTARY INFORMATION:

History

    On Thursday, May 28, 2009, the FAA published a notice of proposed
rulemaking in the Federal Register to establish Class E airspace at
Quinhagak, AK (74 FR 25460). Subsequent to publication, the FAA found
an error in the geographic coordinates for Quinhagak Airport. This
action corrects that error.
    Interested parties were invited to participate in this rulemaking
proceeding by submitting written comments on the proposal to the FAA.
No comments were received. The rule, with corrected coordinates, is
adopted as proposed.
    The Class E airspace areas designated as 700/1,200 ft. transition
areas are published in paragraph 6005 of FAA Order 7400.9S, Airspace
Designations and Reporting Points, signed October 3, 2008, and
effective October 31, 2008, which is incorporated by reference in 14
CFR 71.1. The Class E airspace designations listed in this document
will be published subsequently in the Order.

The Rule

    This amendment to 14 CFR part 71 establishes Class E airspace at
the Quinhagak Airport, AK. This Class E airspace is established to
accommodate aircraft executing new instrument procedures, and will be
depicted on aeronautical charts for pilot reference. The intended
effect of this rule is to provide adequate controlled airspace for
Instrument Flight Rules (IFR) operations at the Quinhagak Airport,
Quinhagak, AK.
    The FAA has determined that this 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. Because this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this rule 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 United States 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 1, Section 40103, Sovereignty and use of
airspace. Under that section, the FAA is charged with prescribing
regulations to ensure the safe and efficient use of the navigable
airspace. This regulation is within the scope of that authority because
it creates Class E airspace sufficient in size to contain aircraft
executing instrument procedures for the Quinhagak Airport and
represents the FAA's continuing effort to safely and efficiently use
the navigable airspace.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR part 71 as follows:

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

0
1. The authority citation for 14 CFR 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]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.9S, Airspace Designations and Reporting
Points, signed October 3, 2008, and effective October 31, 2008, is
amended as follows:

Paragraph 6005 Class E Airspace Extending Upward from 700 feet or
More Above the Surface of the Earth.
* * * * *

AAL AK E5 Quinhagak, AK [New]

Quinhagak, Quinhagak Airport, AK
    (Lat. 59[deg]45[min]18[sec] N., long. 161[deg]50[min]43[sec] W.)

    That airspace extending upward from 700 feet above the surface
within a 6.4-mile radius of the Quinhagak Airport, AK.
* * * * *

    Issued in Anchorage, AK, on August 20, 2009.
James L. Krause,
Acting Manager, Alaska Flight Services Information Area Group.
[FR Doc. E9-21059 Filed 9-2-09; 8:45 am]

BILLING CODE 4910-13-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

DATE:	12/20/06

	SUBJECT:	Foramsulfuron: Human Health Risk Assessment for the Proposed
uses in/on

	Sweet Corn and Popcorn.  PC code: 122020, Petition No. 5E7004, DP
Barcode: 324201

FROM:	Karlyn J. Bailey, Toxicologist and Risk Assessor

	Registration Action Branch 2

Health Effects Division (7509P)

THRU:	Richard Loranger, Branch Senior Scientist

	Christina Swartz, Branch Chief

	Registration Action Branch 2

Health Effects Division (7509P)

TO:	James Tompkins/Ching-Tsen, Team 25

		Herbicide Branch

		Registration Division (7505P)

The Health Effects Division (HED) of the Office of Pesticide Programs
(OPP) is charged with estimating the risk to human health from exposure
to pesticides.  The Registration Division (RD) of OPP has requested that
HED evaluate hazard and exposure data and conduct dietary, occupational,
residential and aggregate exposure assessments, as needed, to estimate
the risk to human health that will result from proposed uses of
foramsulfuron in/on sweet corn and popcorn.

In a previous risk assessment (D273636, Y. Donovan), HED evaluated
foramsulfuron hazard and exposure data for use on corn.  HED concluded
that the toxicology and residue chemistry data submitted for
foramsulfuron supported a tolerance exemption, due to its lack of
toxicity [40 CFR § 180.1219].  It was concluded that a human health
risk assessment was not needed.

For the proposed uses on sweet corn and popcorn, HED also recommends a
tolerance exemption due to the absence of toxicity in the database;
therefore, a human health risk assessment is not needed for the proposed
uses.

Recommendation for Tolerances and Registration for Use In/On Sweet Corn
and Popcorn

HED concludes that the toxicology and residue chemistry data support a
tolerance exemption for foramsulfuron in/on sweet corn and popcorn.  Due
to its lack of toxicity, a human health risk assessment is not needed
for this chemical.  The 40 CFR § 180.1219 should be modified to include
sweet corn (K+ CWHR) and popcorn, grain.

Hazard AND DIETARY/non-dietary exposure

HED previously determined that the toxicological profile of
foramsulfuron supports a tolerance exemption for this chemical, as no
adverse effects were observed in the submitted toxicological studies
regardless of the route of exposure (HED Doc. No. 014671, 09/19/01).
The tolerance exemption recommendation of the HIARC removed all residue
chemistry data requirements (D267582, Y. Donovan).  Thus, no dietary,
occupational, residential or aggregate exposure assessments are needed
for HED to conclude with reasonable certainty that dietary and
non-dietary exposures to foramsulfuron do not pose a significant human
health risk.

Drinking Water assessment

The Environmental Fate and Effects Division (EFED) completed an
evaluation of the section 3 New Use request for the addition of sweet
corn and popcorn to the Option label for foramsulfuron.  EFED reviewed
the proposed label (3264-685) and found the proposed conditions
(application rate, number of applications, etc.) consistent with those
evaluated in a previous EFED risk assessment (D267565).  In addition,
EFED evaluated the relative geographic extent of sweet corn and popcorn
acreage and found them consistent with field corn previously assessed.

The previous assessment evaluated both ecological risk and drinking
water exposure for both aerial and ground applications and EFED believes
that the potential ecological risks and drinking water exposure values
communicated in the earlier assessment do not need to be repeated and
should be used by RD in determining whether to grant this petition
(memo, D324203).

In summary, EFED’s previous assessment predicted the following
drinking water exposure concentrations:

PRZM/EXAMS-Index Reservoir

(Two aerial applications per year, each at 0.0365 lb a.i./acre and 14
days apart).

Acute (yearly peak upper 10%): 			1 µg/L (parts per billion, or ppb)

Chronic, non-cancer (yearly avg. upper 10%): 	0.3 µg/L (parts per
billion, or ppb)

Chronic, cancer (yearly average): 		0.2 µg/L (parts per billion, or
ppb)

SCI-GROW 2-Ground Water

Acute and Chronic:				0.05 µg/L (parts per billion, or ppb)

Cumulative Exposure

Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency consider
"available information concerning the cumulative effects” of a
particular pesticide's residues and "other substances that have a common
mechanism of toxicity.”

Unlike other pesticides for which EPA has followed a cumulative risk
approach based on a common mechanism of toxicity, EPA has not made a
common mechanism of toxicity finding as to foramsulfuron and any other
substances, and foramsulfuron does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that foramsulfuron has
a common mechanism of toxicity with other substances.  For information
regarding EPA’s efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see the policy statements released by EPA’s Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a common
mechanism on EPA’s website at   HYPERLINK
"http://www.epa.gov/pesticides/cumulative/"
http://www.epa.gov/pesticides/cumulative/ .

Conclusion

HED concludes that the toxicology and residue chemistry data support a
tolerance exemption for foramsulfuron.  Due to its lack of toxicity, a
human health risk assessment is not needed.

REFERENCES

FQPA Human Health Risk Assessment for the Use of Foramsulfuron on Corn.
Y. Donovan, D273636. 02/26/02.

Ecological Risk Assessment and Drinking Water Assessment for the
Proposed Addition of Sweet Corn and Popcorn to the Option Label Use of
Foramsulfuron on Corn. M. Corbin, D324203 and D324283.  09/21/06.

Foramsulfuron: Report of the Hazard Identification Assessment Review
Committee. A. Levy, HED DOC.NO. 014671. 09/19/01.

Evaluation of Residue Chemistry Data to Support Tolerances for Use of
Foramsulfuron on Field Corn. Y. Donovan, D267582.  03/05/02

Page   PAGE  3  of   NUMPAGES  3


[Federal Register Volume 84, Number 50 (Thursday, March 14, 2019)]
[Rules and Regulations]
[Pages 9226-9228]
[FR Doc No: 2019-04719]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2019-N-0360]

Medical Devices; Immunology and Microbiology Devices;
Classification of the Device To Detect and Identify Microorganisms and
Associated Resistance Marker Nucleic Acids Directly in Respiratory
Specimens

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the device to detect and identify microorganisms and associated
resistance marker nucleic acids directly in respiratory specimens into
class II (special controls). The special controls that apply to the
device type are identified in this order and will be part of the
codified language for the device to detect and identify microorganisms
and associated resistance marker nucleic acids directly in respiratory
specimens classification. We are taking this action because we have
determined that classifying the device into class II (special controls)
will provide a reasonable assurance of safety and effectiveness of the
device. We believe this action will also enhance patients' access to
beneficial innovative devices, in part by reducing regulatory burdens.

DATES: This order is effective March 14, 2019. The classification was
applicable on April 3, 2018.

FOR FURTHER INFORMATION CONTACT: Dina Jerebitski, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4450, Silver Spring, MD 20993-0002, 301-
796-4221<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the device to detect and identify
microorganisms and associated resistance marker nucleic acids directly
in respiratory specimens as class II (special controls), which we have
determined will provide a reasonable assurance of safety and
effectiveness. In addition, we believe this action will enhance
patients' access to beneficial innovation, in part by reducing
regulatory burdens by placing the device into a lower device class than
the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act to a predicate device that does not require
premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new
device is substantially equivalent to a predicate by means of the
procedures for premarket notification under section 510(k) (21 U.S.C.
360(k)) of the FD&C

Act and Part 807 (21 CFR part 807) respectively.
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically within
class III, the De Novo classification is considered to be the initial
classification of the device.
    We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval application in order to market a substantially
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial
equivalence''). Instead, sponsors can use the 510(k) process, when
necessary, to market their device.

II. De Novo Classification

    On September 11, 2017, Curetis GmbH submitted a request for De Novo
classification of the Unyvero LRT Application. FDA reviewed the request
in order to classify the device under the criteria for classification
set forth in section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on April 3, 2018, FDA issued an order to the requester
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 866.3985. We have named
the generic type of device ``device to detect and identify
microorganisms and associated resistance marker nucleic acids directly
in respiratory specimens,'' and it is identified as an in vitro
diagnostic device intended for the detection and identification of
microorganisms and associated resistance markers in respiratory
specimens collected from patients with signs or symptoms of respiratory
infection. The device is intended to aid in the diagnosis of
respiratory infection in conjunction with clinical signs and symptoms
and other laboratory findings. These devices do not provide
confirmation of antibiotic susceptibility since mechanisms of
resistance may exist other than those detected by the device.
    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

  Table 1--Device To Detect and Identify Microorganisms and Associated
 Resistance Marker Nucleic Acids Directly in Respiratory Specimens Risks
                         and Mitigation Measures
------------------------------------------------------------------------
       Identified risks                   Mitigation measures
------------------------------------------------------------------------
Incorrect identification or    General Controls and Special Controls (1)
 lack of identification of a    (21 CFR 866.3985(b)(1)), (2) (21 CFR
 pathogenic microorganism by    866.3985(b)(2)), (3) (21 CFR
 the device can lead to         866.3985(b)(3)), and (4) (21 CFR
 improper patient management.   866.3985(b)(4)).
Failure to correctly           General Controls and Special Controls (1)
 interpret test results.        (21 CFR 866.3985(b)(1)), (2)(iii) (21
                                CFR 866.3985(b)(2)(iii)), (2)(iv) (21
                                CFR 866.3985(b)(2)(iv)), (2)(v) (21 CFR
                                866.3985(b)(2)(v)), (2)(vi) (21 CFR
                                866.3985(b)(2)(vi)), (2)(vii) (21 CFR
                                866.3985(b)(2)(vii)), (2)(viii) (21 CFR
                                866.3985(b)(2)(viii)), and (3) (21 CFR
                                866.3985(b)(3)).
Failure to correctly operate   General Controls and Special Controls (1)
 the instrument.                (21 CFR 866.3985(b)(1)), (2)(i) (21 CFR
                                866.3985(b)(2)(i)), (4)(ii) (21 CFR
                                866.3985(b)(4)(ii)), (4)(iii) (21 CFR
                                866.3985(b)(4)(iii)), and (4)(iv) (21
                                CFR 866.3985(b)(4)(iv)).
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. In order for a device to fall
within this classification, and thus avoid automatic classification in
class III, it would have to comply with the special controls named in
this final order. The necessary special controls appear in the
regulation codified by this order. This device is subject to premarket
notification requirements under section 510(k).

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. 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 the guidance document ``De Novo
Classification Process (Evaluation of Automatic Class III
Designation)'' have been approved under OMB control number 0910-0844;
the collections of information in part 814, subparts A through E,
regarding premarket approval, have been approved under OMB control
number 0910-0231; the collections of information in part 807, subpart
E, regarding premarket notification submissions, have been approved
under OMB control number 0910-0120; the collections of information in
part 820, regarding quality system regulation, have been approved under
OMB control number 0910-0073; and the collections of information in 21
CFR parts 801 and 809, regarding labeling, have been approved under OMB
control number 0910-0485.

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, 21 CFR part
866 is 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, 360l, 371.

0
2. Add Sec.  866.3985 to subpart D to read as follows:

Sec.  866.3985  Device to detect and identify microorganisms and
associated resistance marker nucleic acids directly in respiratory
specimens.

    (a) Identification. A device to detect and identify microorganisms
and associated resistance marker nucleic acids directly from
respiratory specimens is an in vitro diagnostic device intended for the
detection and identification of microorganisms and associated
resistance markers in respiratory specimens collected from patients
with signs or symptoms of respiratory infection. The device is intended
to aid in the diagnosis of respiratory infection in conjunction with
clinical signs and symptoms and other laboratory findings. These
devices do not provide confirmation of antibiotic susceptibility since
mechanisms of resistance may exist other than those detected by the
device.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The intended use for the 21 CFR 809.10 labeling must include a
detailed description of what the device detects, the type of results
provided to the user, the clinical indications appropriate for test
use, and the specific population(s) for which the device is intended.
    (2) The 21 CFR 809.10(b) labeling must include:
    (i) A detailed device description, including all device components,
control elements incorporated into the test procedure, instrument
requirements, ancillary reagents required but not provided, and a
detailed explanation of the methodology, including all pre-analytical
methods for processing of specimens.
    (ii) Performance characteristics from analytical studies,
including, but not limited to, limit of detection, inclusivity,
reproducibility, cross reactivity, interfering substances, competitive
inhibition, carryover/cross contamination, specimen stability, and
linearity, as applicable.
    (iii) A limiting statement that the device is intended to be used
in conjunction with clinical history, signs and symptoms, and results
of other diagnostic tests, including culture and antimicrobial
susceptibility testing.
    (iv) A detailed explanation of the interpretation of test results
for clinical specimens and acceptance criteria for any quality control
testing.
    (v) A limiting statement that negative results for microorganisms
do not preclude the possibility of infection, and should not be used as
the sole basis for diagnosis, treatment, or other patient management
decisions.
    (vi) If applicable, a limiting statement that detected
microorganisms may not be the cause of lower respiratory tract
infection and may be indicative of colonizing or normal respiratory
flora.
    (vii) If applicable, a limiting statement that detection of
resistance markers cannot be definitively linked to specific
microorganisms and that the source of a detected resistance marker may
be an organism not detected by the assay, including colonizing flora.
    (viii) If applicable, a limiting statement that detection of
antibiotic resistance markers may not correlate with phenotypic gene
expression.
    (3) The 21 CFR 809.10(b) labeling and any test report generated by
the device must include a limiting statement that negative results for
resistance markers do not indicate susceptibility of detected
microorganisms.
    (4) Design verification and validation must include:
    (i) Performance characteristics from clinical studies that include
prospective (sequential) samples and, if appropriate, additional
characterized samples. The study must be performed on a study
population consistent with the intended use population and compare the
device performance to results obtained from an FDA accepted reference
method and/or FDA accepted comparator method, as appropriate. Results
from the clinical studies must include the clinical study protocol
(including predefined statistical analysis plan, if applicable),
clinical study report, and results of all statistical analyses.
    (ii) A detailed device description including the following:
    (A) Thorough description of the assay methodology including, but
not limited to, primer/probe sequences, primer/probe design, and
rationale for target sequence selection, as applicable.
    (B) Algorithm used to generate a final result from raw data (e.g.,
how raw signals are converted into a reported result).
    (iii) A detailed description of device software, including, but not
limited to, validation activities and outcomes.
    (iv) As part of the risk management activities, an appropriate end
user device training program must be offered as an effort to mitigate
the risk of failure from user error.

    Dated: March 8, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-04719 Filed 3-13-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 43 (Tuesday, March 5, 2019)]
[Notices]
[Pages 7906-7908]
[FR Doc No: 2019-03901]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0560]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance on Informed Consent for In Vitro Diagnostic
Device Studies Using Leftover Human Specimens That Are Not Individually
Identifiable

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection associated with
the guidance on informed consent for in vitro diagnostic (IVD) device
studies using leftover human specimens that are not individually
identifiable.

DATES: Submit either electronic or written comments on the collection
of information by May 6, 2019.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before May 6, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 6, 2019. Comments received by
mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2012-N-0560 for ``Guidance on Informed Consent for In Vitro
Diagnostic Device Studies Using Leftover Human Specimens That Are Not
Individually Identifiable.'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20

and other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Guidance on Informed Consent for In Vitro Diagnostic Device Studies
Using Leftover Human Specimens That Are Not Individually Identifiable

OMB Control Number 0910-0582--Extension

    FDA's investigational device regulations are intended to encourage
the development of new, useful devices in a manner that is consistent
with public health, safety, and compliant with ethical standards.
Investigators should have freedom to pursue the least burdensome means
of accomplishing this goal. However, to ensure that the balance is
maintained between product development and the protection of public
health, safety, and ethical standards, FDA has established human
subject protection regulations addressing requirements for informed
consent and institutional review board (IRB) review that apply to all
FDA-regulated clinical investigations involving human subjects. In
particular, informed consent requirements further both safety and
ethical considerations by allowing potential subjects to consider both
the physical and privacy risks they face if they agree to participate
in a trial.
    Under FDA regulations, clinical investigations using human
specimens conducted in support of premarket submissions to FDA are
considered human subject investigations (see 21 CFR 812.3(p)). Many
investigational device studies are exempt from most provisions of part
812, Investigational Device Exemptions, under 21 CFR 812.2(c)(3), but
FDA's regulations for the protection of human subjects (21 CFR parts 50
and 56) apply to all clinical investigations that are regulated by FDA
(see 21 CFR 50.1, 21 CFR 56.101, 21 U.S.C. 360j(g)(3)(A), and 21 U.S.C.
360j(g)(3)(D)).
    FDA regulations do not contain exceptions from the requirements of
informed consent on the grounds that the specimens are not identifiable
or that they are remnants of human specimens collected for routine
clinical care or analysis that would otherwise have been discarded. Nor
do FDA regulations allow IRBs to decide whether or not to waive
informed consent for research involving leftover or unidentifiable
specimens.
    In the document entitled ``Guidance on Informed Consent for In
Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are
Not Individually Identifiable,'' issued under the Good Guidances
Practices regulation (21 CFR 10.115), FDA outlines the circumstances in
which it intends to exercise enforcement discretion as to the informed
consent regulations for clinical investigators, sponsors, and IRBs.
    The recommendations of the guidance impose a minimal burden on
industry. FDA estimates that 700 studies will be affected annually.
Each study will result in one annual record, estimated to take 4 hours
to complete. This results in a total recordkeeping burden of 2,800
hours (700 x 4 = 2,800).
    FDA estimates the burden of this collection of information as
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                       Average burden
                              Activity                                  Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recordkeeping regarding leftover human specimens that are not                   700                1              700                4            2,800
 individually identifiable that are used in certain IVD studies....
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.

    Dated: February 27, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-03901 Filed 3-4-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 174 (Friday, September 9, 2022)]
[Notices]
[Page 55420]
[FR Doc No: 2022-19476]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 6951-018]

Tallassee Shoals, LLC; Notice of Waiver Period for Water Quality
Certification Application

    On August 22, 2022, Tallassee Shoals, LLC. submitted to the Federal
Energy Regulatory Commission (Commission) a copy of its application for
a Clean Water Act section 401(a)(1) water quality certification filed
with Georgia Environmental Protection Division, in conjunction with the
above captioned project. Pursuant to 40 CFR 121.6 and section
[4.34(b)(5), 5.23(b), 153.4, or 157.22] of the Commission's
regulations,\1\ we hereby notify the Georgia Environmental Protection
Division of the following:
---------------------------------------------------------------------------

    \1\ 18 CFR [4.34(b)(5)/5.23(b)/153.4/157.22].
---------------------------------------------------------------------------

    Date of Receipt of the Certification Request: August 12, 2022.
    Reasonable Period of Time to Act on the Certification Request: One
year August 12, 2023.
    If Georgia Environmental Protection Division fails or refuses to
act on the water quality certification request on or before the above
date, then the agency certifying authority is deemed waived pursuant to
section 401(a)(1) of the Clean Water Act, 33 U.S.C. 1341(a)(1).

    Dated: September 2, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-19476 Filed 9-8-22; 8:45 am]
BILLING CODE 6717-01-P