[Federal Register Volume 79, Number 68 (Wednesday, April 9, 2014)]
[Notices]
[Pages 19699-19702]
[FR Doc No: 2014-07891]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-71862; File No. SR-Topaz-2013-20]

Self-Regulatory Organizations; Topaz Exchange, LLC; Order
Granting Approval of Proposed Rule Change, as Modified by Amendment No.
1, to More Specifically Address the Number and Size of Counterparties
to a Qualified Contingent Cross Order

April 3, 2014.

I. Introduction

    On December 18, 2013, the Topaz Exchange, LLC (d/b/a ISE Gemini)
(the ``Exchange'' or ``Topaz'') filed with the Securities and Exchange
Commission (``Commission''), pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934 (the ``Act''),\1\ and Rule 19b-4
thereunder,\2\ a proposed rule change notice to amend Rule 715 (Types
of Orders) to more specifically address the number and size of
counterparties to a Qualified Contingent Cross Order (``QCC Order'').
The proposed rule change was published for comment in the Federal
Register on January 7, 2014.\3\ On February 18, 2014, the Commission
extended the time period for Commission action to April 7, 2014.\4\ On
April 2, 2014, the Exchange submitted an amendment to the proposed rule
change.\5\ This order approves the proposed rule change, as modified by
Amendment No. 1.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 71209 (December 31,
2013), 79 FR 867 (January 7, 2014).
    \4\ See Securities Exchange Act Release No. 71562 (February 18,
2014), 79 FR 10220 (February 24, 2014).
    \5\ The Commission notes that Amendment No. 1 is not subject to
notice and comment because it does not alter the substance of the
proposed rule change or raise any novel regulatory issues, but
rather describes how the Exchange surveils QCC Orders. See Section
III below.
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II. Background

    As originally approved on Topaz, a QCC Order was required to be
comprised of an order to buy or sell at least 1,000 contracts that is
identified as being part of a qualified contingent trade (``QCT''),
coupled with a contra-side order to buy or sell an equal number of
contracts.\6\ Following discussions regarding the QCC Order with
Commission staff, the Exchange learned that Commission staff
interpreted the Exchange's rules relating to QCC Orders to permit only
a single order on the originating side of the QCC Order and a single
order on the contra-side, with each such order comprised of a single
party and meeting the 1,000 contract minimum size requirement. In a
Regulatory Information Circular published by the Exchange on November
25, 2013, the Exchange explained that it had always interpreted the QCC
Order definition to mean that a QCC Order must be comprised of an
unsolicited order to buy or sell at least 1,000 contracts that is
identified as part of a QCT, coupled with a contra-side order that
could be made up of multiple orders, each of which could be less than
1,000 contracts.\7\ The Exchange also stated that it would seek to
amend its rules governing QCC Orders to codify its interpretation in
its rules.\8\
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    \6\ See Securities Exchange Act Release No. 70050 (July 26,
2013), 78 FR 46622 (August 1, 2013) (File No. 10-209).
    \7\ See ISE-Gemini Regulatory Information Circular 2013-021
(November 25, 2013).
    \8\ Id.
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    On December 18, 2013, the Exchange filed two proposed rule changes
with the Commission. In addition to this filing, the Exchange filed SR-
Topaz-2013-19, a proposed rule change for immediate effectiveness to
amend the definition of a QCC Order such that it must involve a single
order for at least 1,000 contracts on the originating side,\9\ but may
consist of multiple orders on the opposite, contra-side, so long as
each contra-side order is for at least

1,000 contracts.\10\ In that filing, the Exchange explained,
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    \9\ In the case of Mini Options, the minimum size is 10,000
contracts.
    \10\ See Securities Exchange Act Release No. 71181 (December 24,
2013), 78 FR 79718 (December 31, 2013) (SR-Topaz-2013-19).

    It was always the Exchange's intent and understanding when
drafting the rule text that a QCC Order could involve multiple
contra-parties of the QCC trade when the originating QCC Order
consisted of at least 1,000 contracts. However, the rule language
addressing the contra-side of a QCC Order is drafted from the
perspective of how the QCC Order gets entered into the Exchange
system. Specifically, the contra-side order to a QCC Order will
always be entered as a single order, even if that order consists of
multiple contra-parties who are allocated their portion of the trade
in a post-trade allocation. Notwithstanding the foregoing, the
literal wording of the current QCC Order rule could result in a more
limited interpretation of the rule. Therefore, the Exchange now
proposes to make it clear that a QCC Order must involve a single
order for at least 1,000 contracts on the originating side, but that
it may consist of multiple orders on the opposite, contra-side, so
long as each of the contra-side orders is for at least 1,000
contracts.\11\
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    \11\ Id. at 79719.

III. Description of the Proposed Rule Change

    In this filing, the Exchange proposes to remove the requirement
that contra-side orders of QCC Orders be for at least 1,000 contracts
each, thus permitting multiple contra-side orders on a QCC Order with a
total number of contracts equaling the originating order size, but
without any size requirement for such contra-side orders. Under this
proposal, the requirements for the QCC Order's originating order remain
unchanged, and thus would require the originating order to be a single
order for a single party of at least 1,000 contracts, and the QCC Order
must also continue to satisfy all other requirements of a QCC Order
under the Exchange's rules.
    The Exchange believes that removing the size limit placed on
contra-parties to QCC Orders may increase liquidity and, potentially,
improve the prices at which QCC Orders get executed, as the Exchange
states that the ability for market participants to provide liquidity in
response to large sized orders is directly proportional to the size and
associated risk of the resulting position. As support, the Exchange
states that smaller sized trades are often done at a better price than
larger sized trades, which convey more risk. The Exchange believes that
the ability to pool together multiple market participants to
participate on the contra-side of a trade for any size, as opposed to
only allowing market participants to participate for a minimum of 1,000
contracts, would have a direct and positive impact on the ability of
those market participants to provide the best price as they compete to
participate in the order without being compelled to provide liquidity
with a large minimum quantity. Further, the Exchange states that
allowing several participants to offer liquidity to a QCC Order serves
to ensure that the order receives the best possible price available in
the market and argues that restricting interaction to only participants
who are willing to trade a minimum of 1,000 contracts simply guarantees
an inferior price because a trade will be limited to few liquidity
providers who are taking on more risk as opposed to multiple liquidity
providers being able to share the overall risk and trade at a better
price.
    In the proposal, the Exchange stresses that the concern has always
been and should continue to be for the originating order--i.e., the
unsolicited part of the order that is seeking liquidity--and not the
professional responders and providers of liquidity. The Exchange
believes that allowing smaller orders to participate on the other side
(i.e., contra-side) of QCC Orders not only provides the best price and
opportunity for a trade to occur in a tight and liquid market, but
ensures that the highest possible number of liquidity providers are
able to participate, and states that limiting participation only to
liquidity providers who are willing to participate on the trade for
1,000 contracts conversely could result in an inferior price by
shutting out some participants due to the large size and thereby
minimizing the opportunity for competition and price improvement.
    In Amendment No. 1, the Exchange represents that it tracks and
monitors QCC Orders to determine which is the originating/agency side
of the order and which is the contra-side(s) of the order to ensure
that Members are complying with the minimum 1,000 contract size
limitation on the originating/agency side of the QCC Order. The
Exchange states that it checks to see if Members are aggregating
multiple orders to meet the 1,000 contract minimum on the originating/
agency side of the trade in violation of the requirements of the rule.
The rule requires that the originating/agency side of the trade consist
of one party who is submitting a QCC Order for at least 1,000
contracts. The Exchange represents that it enforces compliance with
this portion of the rule by checking to see if a Member breaks up the
originating/agency side of the order in a post trade allocation to
different clearing firms, allocating less than 1,000 contracts to a
party or multiple parties. For example, a Member enters a QCC Order
into the system for 1,500 contracts and receives an execution.
Subsequent to the execution, the Member allocates the originating/
agency side of the order to two different clearing firms on a post
trade allocation basis, thereby allocating 500 contracts to one
clearing firm and 1,000 contracts to another clearing firm. The
Exchange states that this type of transaction would not meet the
requirements of a QCC Order under the current rule.
    With regard to order entry, the Exchange clarifies that a Member
must mark the originating/agency side as the first order in the system
and the contra-side(s) as the second. The Exchange states that it
monitors order entries to ensure that Members are properly entering QCC
Orders into the system.

IV. Discussion and Commission Findings

    The Commission finds that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder applicable to a national securities exchange.\12\
Specifically, the Commission finds that the proposed rule change is
consistent with Section 6(b)(5) of the Act,\13\ which requires, among
other things, that the rules of a national securities exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system and, in general, to protect investors and the public
interest.
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    \12\ In approving the proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C
    \13\ 15 U.S.C. 78f(b)(5).
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    In its original approval of the QCC Order for use on the
International Securities Exchange, LLC (``ISE''), the Commission noted
the benefits of contingent trades to investors and the market as a
whole.\14\ Specifically, in providing for an exemption from certain
requirements of Regulation NMS for QCTs, the Commission recognized that
contingent trades can be ``useful trading tools for investors and other
market participants, particularly those who trade the securities of
issuers involved in mergers, different classes of shares of the same
issuer, convertible securities, and equity derivatives such as
options''

[italics added].\15\ In the Original QCC Approval Order, the Commission
also reiterated the finding from its Original QCT Exemption that those
transactions that meet the specified requirements of the QCT exemption
could be of benefit to the market as a whole and a contribution to the
efficient functioning of the securities markets and the price discovery
process.\16\
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    \14\ See Securities Exchange Act Release No. 63955 (February 24,
2011), 76 FR 11533, 11540-11541 (March 2, 2011) (SR-ISE-2010-73)
(``Original QCC Approval Order'').
    \15\ See Securities Exchange Act Release No. 54389 (August 31,
2006, 71 FR 52829, 52830 (September 7, 2006) (``Original QCT
Exemption'').
    \16\ See Original QCC Approval Order, supra note 14 at text
accompanying footnote 115.
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    In analyzing ISE's original QCC Order, the Commission weighed the
benefits of QCTs, of which QCC Orders are a subset, against the
benefits provided by the general requirement for exposure of orders in
the options markets.\17\ In the Original QCC Approval Order, the
Commission stated that the QCC Order strikes an appropriate balance for
the options market in that it is narrowly drawn and establishes a
limited exception to the general principle of exposure and retains the
general principle of customer priority in the options markets because
QCC Orders are required to be: (1) part of a QCT under Regulation NMS;
(2) for at least 1,000 contracts; (3) executed at a price at or between
the national best bid or offer; and (4) cancelled if there is a
Priority Customer Order on ISE's limit order book at the same
price.\18\ The Commission specifically noted that a QCC Order must not
only be part of a QCT by satisfying each of the six underlying
requirements of the NMS QCT Exemption, but must be for a minimum size
of 1,000 contracts, and that these requirements provide another limit
to its use by ensuring only transactions of significant size may avail
themselves of this order type.\19\ Given the requirements for QCC
Orders, the Commission also noted its belief that those customers
participating in QCC Orders would likely be sophisticated investors who
should understand that their order would not be exposed for potential
price improvement, and that these customers should be able to
themselves assess whether the net prices they are receiving for their
QCC Order are competitive.\20\ The Commission also specifically noted
that broker-dealers are subject to a duty of best execution for their
customers' orders, and that duty does not change for QCC Orders.\21\
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    \17\ Id. at 11541.
    \18\ Id.
    \19\ Id.
    \20\ Id.
    \21\ Id.
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    In considering Topaz's proposal to eliminate the minimum size
requirement for the contra-side of QCC Orders, the Commission has again
weighed whether the benefits of this order type, as proposed to be
modified, to investors and the market outweigh the benefits provided by
the general requirement for exposure of orders in the options markets.
The Commission notes that Topaz's proposal does not change the
requirements that a QCC Order must be: (1) part of a QCT under
Regulation NMS; (2) executed at a price at or between the national best
bid or offer; and (3) cancelled if there is a Priority Customer Order
on Topaz's limit order book. In addition, the changes to QCC Orders
under SR-Topaz-2013-19 \22\ permit multiple contra-side orders for QCC
Orders, so long as each such contra-side order is for at least 1,000
contracts. In this filing, the only requirement that the Exchange
proposes to change is to eliminate the requirement that contra-side
orders of a QCC Order be for at least 1,000 contracts.
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    \22\ See supra note 10.
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    The Commission believes that this change to the minimum size
requirement for the contra-side(s) of QCC Orders is narrowly tailored
and, significantly, the Exchange's rule text clearly requires that the
originating side of a QCC Order must be comprised of a single order
(i.e., a single party) for at least 1,000 contracts. The Commission
believes that retention of the requirements that the original side be
comprised of a single order from a single party and that such single
order be for at least 1,000 contracts will continue to ensure that
sophisticated investors, who are aware that their orders will not be
exposed for price improvement, and who themselves should be able to
assess whether the net prices for their QCC Orders are competitive,
will initiate QCC Orders in an effort to effectuate a complex
transaction that complies with all the requirements of the QCC Order.
    The proposed rule change will allow multiple contra-parties with
order sizes of less than 1,000 to aggregate their interest to pair
against the originating side of a QCC Order to facilitate the execution
of the QCC Order. The Commission believes that allowing smaller orders
from multiple parties to participate on the contra-side of QCC Orders
may provide a better opportunity for QCC Orders to be executed and,
potentially, at better prices. The Commission acknowledges that
limiting participation on the contra-side of a QCC Order only to
liquidity providers who are willing to participate on the trade for
1,000 contracts, could result in less interest in the trade than if
contra-side orders were not required to meet the 1,000 contract
minimum, potentially diminishing the opportunity for competition and
price improvement. The Commission believes that the proposed
modification to the definition of QCC Order is narrowly drawn in that
it does not impact the fundamental aspects of this order type, and
merely permits QCC Orders to include multiple contra-parties,
regardless of size on the contra-side, while preserving the 1,000
contract minimum on the originating side of a QCC Order. Accordingly,
the Commission finds the proposed rule consistent with the Act.\23\
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    \23\ The Commission notes that three commenters submitted
comment letters to SR-ISE-2013-72, a proposed rule change of ISE
substantively identical to, and filed contemporaneously with, SR-
Topaz-2013-20. On April 2, 2014, ISE responded to the comment
letters. See http://www.sec.gov/comments/sr-ise-2013-72/ise201372.shtml. See also Securities Exchange Act Release No. 71863
(April 3, 2014) (SR-ISE-2013-72 approval order).
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    The Commission notes that, given the differing requirements as
between the originating side and contra-side for QCC Orders, it is
essential that the Exchange be able to clearly identify and monitor--
throughout the life of a QCC Order, beginning at time of order entry on
the Exchange through the post-trade allocation process--each side of
the QCC Order and ensure that the requirements of the order type are
being satisfied including, importantly, those relating to the
originating side. The Commission believes this to be critical so that
the Exchange can ensure that market participants are not able to
circumvent the requirements of the QCC Order (as amended by this
proposed rule change), each of which the Commission continues to
believe are critical to ensuring that the QCC Order is narrowly
drawn.\24\ Further, the Commission notes that, in Amendment No. 1, the
Exchange has made certain representations regarding its enforcement and
surveillance of its Members' use of QCC Orders, including, for example,
not only at the time of

order entry, but through the post-trade allocation process as well.
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    \24\ The Commission expects the Exchange to have the capability
to enable it to surveil that such requirements are being met. Though
the Exchange has stated its ability to do so in Amendment No. 1, if
the Exchange is not able to have such monitoring at any point in
time, the Commission would expect the Exchange to take other steps
to ensure that the QCC Order cannot be improperly used. For example,
if the Exchange were not able to identify and monitor which side of
a QCC Order is the originating order, the Commission would expect
that it would require that both sides of the QCC Order meet the more
stringent requirements of the originating side, i.e., that it be for
a single order for at least 1,000 contracts.
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    For the foregoing reasons, the Commission believes that the
proposed rule change is consistent with the Act.
    It is therefore ordered, pursuant to Section 19(b)(2) of the Act
\25\ that the proposed rule change (SR-Topaz-2013-20), as modified by
Amendment No. 1, be, and it hereby is, approved.
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    \25\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\26\
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    \26\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-07891 Filed 4-8-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 124 (Wednesday, June 29, 2022)]
[Rules and Regulations]
[Pages 38651-38653]
[FR Doc No: 2022-13750]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0788; Project Identifier AD-2021-00489-T;
Amendment 39-22063; AD 2022-11-13]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain The Boeing Company Model 737-700, -800, and -900ER series
airplanes. This AD was prompted by reports of incorrectly installed
fuselage skin fasteners. This AD requires a detailed inspection of a
certain body station bulkhead, between certain stringers, for any
incorrectly installed fastener common to fuselage skin, and applicable
on-condition actions. The FAA is issuing this AD to address the unsafe
condition on these products.

DATES: This AD is effective August 3, 2022.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of August 3,
2022.

ADDRESSES: For service information identified in this final rule,
contact Boeing Commercial Airplanes, Attention: Contractual & Data
Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA
90740-5600; telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com. You may view this service information at the
FAA, Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>. It is also available at
https://www.regulations.gov by searching for and locating Docket No.
FAA-2021-0788.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0788; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this final rule, any
comments received, and other information. The address for Docket
Operations is U.S. Department of Transportation, Docket Operations, M-
30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue
SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Bill Ashforth, Aerospace Engineer,
Airframe Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des
Moines, WA 98198; phone and fax:<PHONE_NUMBER>; email:
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain The Boeing
Company Model 737-700, -800, and -900ER series airplanes. The NPRM
published in the Federal Register on October 13, 2021 (86 FR 56840).
The NPRM was prompted by reports of incorrectly installed fuselage skin
fasteners found at the station (STA) 727 bulkhead. This condition was
the result of incorrect procedures used to install affected fasteners
during airplane production that occurred within a certain time period.
In the NPRM, the FAA proposed to require a detailed inspection of STA
727 body station bulkhead, between stringers S-22 and S-27, for any
incorrectly installed fastener common to fuselage skin, and applicable
on-condition actions. The FAA is issuing this AD to prevent continuous
operation of the airplane with undetected incorrectly installed
fasteners, which may generate fatigue cracking that could adversely
affect the structural integrity of the airplane.

Discussion of Final Airworthiness Directive

Comments

    The FAA received comments from Boeing, United Airlines, Air Line
Pilots Association, International, and an individual commenter, who
supported the NPRM without change.
    The FAA received additional comments from two commenters, including
Aviation Partners Boeing and Delta Air Lines (DAL). The following
presents the comments received on the NPRM and the FAA's response.

Effects of Winglets on Accomplishment of the Proposed Actions

    Aviation Partners Boeing and DAL commented regarding the
installation of blended or split scimitar winglets per Supplemental
Type Certificate (STC) ST00830SE and the effect of that installation on
compliance with the proposed actions. DAL further requested a change to
paragraph (c) of the proposed AD to clarify that the installation of
STC ST00830SE does not affect the accomplishment of the manufacturer's
service instructions.
    The FAA agrees to clarify that the installation of winglets per STC
ST00830SE does not affect the accomplishment of the manufacturer's
service instructions. Therefore, the installation of STC ST00830SE does
not affect the ability to accomplish the actions required by this AD.
Operators of airplanes with these winglets do not need to request a
``change in product'' alternative method of compliance (AMOC) approval
as specified in 14 CFR 39.17. The FAA has redesignated paragraph (c) of
the proposed AD as paragraph (c)(1) of this AD, and added paragraph
(c)(2) to this AD accordingly.

Conclusion

    The FAA reviewed the relevant data, considered any comments
received, and determined that air safety requires adopting this AD as
proposed. Except for minor editorial changes, and any other changes
described previously, this AD is adopted as proposed in the NPRM. None
of the changes will increase the economic burden on any operator.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Boeing Alert Requirements Bulletin 737-53A1384 RB,
dated September 10, 2020. This service information specifies procedures
for a detailed inspection for incorrectly installed fasteners at the
STA 727 bulkhead outer chord common to the fuselage skin between
stringers S-22 and S-27 on the left and right sides, and applicable on-
condition actions. In addition to repair and replacement, on-condition
actions include repetitive inspections for cracking of the fuselage
skin between stringers S-22 and S-27; an open hole high frequency eddy
current (HFEC) inspection for cracking at all incorrectly installed
fastener locations; and external and internal general visual
inspections for repairs of the STA 727 bulkhead. On-condition actions
also include repetitive HFEC and low frequency eddy current (LFEC)
inspections in unrepaired areas for cracking of the inner skin from the
wheel well; of the outer, upper, and lower chords from the wheel well;
and of the fail-safe chord from the cargo compartment.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in ADDRESSES.

Costs of Compliance

    The FAA estimates that this AD affects 78 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                 Action                          Labor cost           Parts cost      product        operators
----------------------------------------------------------------------------------------------------------------
Inspections............................  13 work-hours x $85 per              $0          $1,105         $86,190
                                          hour = $1,105.
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary actions
that would be required based on the results of the inspection. The
agency has no way of determining the number of aircraft that might need
these on-condition actions.

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                 Action                           Labor cost            Parts cost         Cost per product
----------------------------------------------------------------------------------------------------------------
Open hole HFEC inspections..............  21 work-hours x $85 per                 $0  $1,785 per inspection
                                           hour = $85 per inspection                   cycle.
                                           cycle.
HFEC and LFEC inspections...............  36 work-hours x $85 per                  0  3,060 per inspection
                                           hour = $3,060 per                           cycle.
                                           inspection cycle.
----------------------------------------------------------------------------------------------------------------

    The FAA has received no definitive data on which to base the work-
hour estimates for the repair and replacement specified in this AD. The
cost of any required fasteners, which are operator supplied, would be
minimal.
    The FAA has included all known costs in its cost estimate.
According to the manufacturer, however, some or all of the costs of
this AD may be covered under warranty, thereby reducing the cost impact
on affected operators.

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.
    The FAA is 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

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, 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.

List of Subjects in 14 CFR Part 39

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

The Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2022-11-13 The Boeing Company: Amendment 39-22063; Docket No. FAA-
2021-0788; Project Identifier AD-2021-00489-T.

(a) Effective Date

    This airworthiness directive (AD) is effective August 3, 2022.

(b) Affected ADs

    None.

(c) Applicability

    (1) This AD applies to The Boeing Company Model 737-700, -800,
and -900ER series airplanes, certificated in any category, and
identified in Boeing Alert Requirements Bulletin 737-53A1384 RB,
dated September 10, 2020.
    (2) Installation of Supplemental Type Certificate (STC)
ST00830SE does not affect the ability to accomplish the actions
required by this AD. Therefore, for airplanes on which STC ST00830SE
is installed, a ``change in product'' alternative method of
compliance (AMOC) approval request is not necessary to comply with
the requirements of 14 CFR 39.17.

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Unsafe Condition

    This AD was prompted by reports of incorrectly installed
fuselage skin fasteners. The FAA is issuing this AD to address
incorrectly installed fasteners. This condition, if not addressed,
could result in incorrectly installed fasteners going undetected.
Continuous operation of the airplane with undetected incorrectly
installed fasteners may generate fatigue cracking that could
adversely affect the structural integrity of the airplane.

(f) Compliance

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

(g) Required Actions

    Except as specified by paragraph (h) of this AD: At the
applicable times specified in the ``Compliance'' paragraph of Boeing
Alert Requirements Bulletin 737-53A1384 RB, dated September 10,
2020, do all applicable actions identified in, and in accordance
with, the Accomplishment Instructions of Boeing Alert Requirements
Bulletin 737-53A1384 RB, dated September 10, 2020.
    Note 1 to paragraph (g): Guidance for accomplishing the actions
required by this AD can be found in Boeing Alert Service Bulletin
737-53A1384, dated September 10, 2020, which is referred to in
Boeing Alert Requirements Bulletin 737-53A1384 RB, dated September
10, 2020.

(h) Exceptions to Service Information Specifications

    (1) Where the Compliance Time column and the notes of the tables
in the ``Compliance'' paragraph of Boeing Alert Requirements
Bulletin 737-53A1384 RB, dated September 10, 2020, use the phrase
``the Original Issue date of Requirements Bulletin 737-53A1384 RB,''
this AD requires using ``the effective date of this AD.''
    (2) Where Boeing Alert Requirements Bulletin 737-53A1384 RB,
dated September 10, 2020, specifies contacting Boeing for repair
instructions or for alternative inspections: This AD requires doing
the repair, or doing the alternative inspections and applicable on-
condition actions, using a method approved in accordance with the
procedures specified in paragraph (i) of this AD.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle ACO Branch, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request
to your principal inspector or responsible Flight Standards Office,
as appropriate. If sending information directly to the manager of
the certification office, send it to the attention of the person
identified in paragraph (j) of this AD. Information may be emailed
to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the responsible Flight Standards Office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by The Boeing Company Organization Designation
Authorization (ODA) that has been authorized by the Manager, Seattle
ACO Branch, FAA, to make those findings. To be approved, the repair
method, modification deviation, or alteration deviation must meet
the certification basis of the airplane, and the approval must
specifically refer to this AD.

(j) Related Information

    For more information about this AD, contact Bill Ashforth,
Aerospace Engineer, Airframe Section, FAA, Seattle ACO Branch, 2200
South 216th St., Des Moines, WA 98198; phone and fax:<PHONE_NUMBER>;
email: [email protected].

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Boeing Alert Requirements Bulletin 737-53A1384 RB, dated
September 10, 2020.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-
5600; telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, [email protected], or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on May 25, 2022.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2022-13750 Filed 6-28-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 236 (Monday, December 10, 2018)]
[Notices]
[Page 63496]
[FR Doc No: 2018-26661]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Commission Staff Attendance

December 3, 2018.
    The Federal Energy Regulatory Commission (Commission) hereby gives
notice that members of the Commission's staff may attend the following
meetings related to the transmission planning activities of the New
York Independent System Operator, Inc. (NYISO):

NYISO Electric System Planning Working Group and Transmission Planning
Advisory Meeting

December 4, 2018, 10 a.m.-4 p.m. (EST)

    The above-referenced meeting will be via web conference and
teleconference.
    The above-referenced meeting is open to stakeholders.
    Further information may be found at: http://www.nyiso.com/public/committees/documents.jsp?com=bic_espwg&directory=2018-12-04.

NYISO Business Issues Committee Meeting

December 12, 2018, 10 a.m.-4 p.m. (EST)

    The above-referenced meeting will be via web conference and
teleconference.
    The above-referenced meeting is open to stakeholders.
    Further information may be found at: http://www.nyiso.com/public/committees/documents.jsp?com=bic&directory=2018-12-12.

NYISO Operating Committee Meeting

December 13, 2018, 10 a.m.-4 p.m. (EST)

    The above-referenced meeting will be via web conference and
teleconference.
    The above-referenced meeting is open to stakeholders.
    Further information may be found at: http://www.nyiso.com/public/committees/documents.jsp?com=oc&directory=2018-12-13.

NYISO Management Committee Meeting

December 19, 2018, 10 a.m.-4 p.m. (EST)

    The above-referenced meeting will be via web conference and
teleconference.
    The above-referenced meeting is open to stakeholders.
    Further information may be found at: http://www.nyiso.com/public/committees/documents.jsp?com=mc&directory=2018-12-19.
    The discussions at the meetings described above may address matters
at issue in the following proceedings:
    New York Independent System Operator, Inc., Docket No. ER15-2059.
    New York Independent System Operator, Inc., Docket No. ER17-2327.
    For more information, contact James Eason, Office of Energy Market
Regulation, Federal Energy Regulatory Commission at<PHONE_NUMBER> or
<EMAIL_ADDRESS>
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-26661 Filed 12-7-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 239 (Tuesday, December 13, 2016)]
[Notices]
[Pages 89923-89924]
[FR Doc No: 2016-29788]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Number: PR17-9-000.
    Applicants: TPL SouthTex Transmission Company LP.
    Description: Tariff filing per 284.123(b), (e)+(g): Filing Revised
Operating Statement to be effective 11/1/2016; Filing Type: 1300.
    Filed Date: 11/30/2016.
    Accession Number:<PHONE_NUMBER>68.
    Comments Due: 5 p.m. ET 12/21/16.

    284.123(g) Protests Due: 5 p.m. ET 1/30/17.

    Docket Number: PR17-10-000.
    Applicants: Magic Valley Pipeline, L.P.
    Description: Tariff filing per 284.123(e)/.224: Cancellation of
Statement of Operating Conditions to be effective 12/1/2016; Filing
Type: 800.
    Filed Date: 11/30/2016.
    Accession Number:<PHONE_NUMBER>77.

    Comments/Protests Due: 5 p.m. ET 12/21/16.

    Docket Number: PR17-11-000.
    Applicants: Public Service Company of Colorado.
    Description: Tariff filing per 284.123(b), (e)+(g): 20161201_SOR
Two GRSA Rate Changes to be effective 11/1/2016; Filing Type: 1300.
    Filed Date: 12/1/2016.
    Accession Number:<PHONE_NUMBER>28.
    Comments Due: 5 p.m. ET 12/22/16.
    284.123(g) Protests Due: 5 p.m. ET 1/30/17.

    Docket Number: PR17-12-000.
    Applicants: Columbia Gas of Maryland, Inc.
    Description: Tariff filing per 284.123(b), (e)/: CMD SOC Rates
effective 10-27-2016 to be effective 10/27/2016; Filing Type: 980.
    Filed Date: 12/1/2016.
    Accession Number:<PHONE_NUMBER>99.
    Comments/Protests Due: 5 p.m. ET 12/22/16.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP16-137-009.
    Applicants: Tallgrass Interstate Gas Transmission, L.
    Description: Compliance filing Rate Case Settlement RP16-137 to be
effective 5/1/2016.
    Filed Date: 12/5/16.
    Accession Number: 20161205-5437.
    Comments Due: 5 p.m. ET 12/19/16.

    Docket Numbers: RP17-33-001.
    Applicants: Equitrans, L.P.
    Description: Compliance filing Equitrans' October 2016 Clean-Up
Compliance Filing to be effective 11/17/2016.
    Filed Date: 12/6/16.
    Accession Number: 20161206-5121.
    Comments Due: 5 p.m. ET 12/19/16.

    Any person desiring to protest in any of the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: December 6, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-29788 Filed 12-12-16; 8:45 am]
 BILLING CODE 6717-01-P


system or piping sufficient to indicate a pressure release to the
atmosphere. Examples of these types of devices and systems include, but
are not limited to, a rupture disk indicator, magnetic sensor, motion
detector on the pressure relief valve stem, flow monitor, or pressure
monitor.
    (2) If any pressure relief device in organic HAP service releases
to atmosphere as a result of a pressure release event, the owner or
operator must calculate the quantity of organic HAP released during
each pressure release event and report this quantity as required in
Sec.  63.1417(f)(13)(iii). Calculations may be based on data from the
pressure relief device monitoring alone or in combination with process

parameter monitoring data and process knowledge.
    (d) Pressure relief devices routed to a control device, process,
fuel gas system, or drain system. If a pressure relief device in
organic HAP service is designed and operated to route all HAP emissions
from pressure releases through a closed vent system to a control device
or to a process, fuel gas system, or drain system, the owner or
operator is not required to comply with paragraphs (a), (b), or (c) (if
applicable) of this section for that pressure relief device. The fuel
gas system or closed vent system and control device (if applicable)
must meet the requirements of Sec.  63.1034, as applicable (except that
the term ``pressure relief devices'' shall apply instead of the term
``equipment leaks'' in Sec.  63.1034). The drain system (if applicable)
must meet the requirements of Sec.  63.136.

0
19. Section 63.1412 is amended by revising the last sentence of
paragraph (c) to read as follows:

Sec.  63.1412  Continuous process vent applicability assessment
procedures and methods.

* * * * *
    (c) Applicability assessment requirement. * * * Operations during
periods of malfunction shall not constitute representative conditions
for the purpose of an applicability test.
* * * * *

0
20. Section 63.1413 is amended by:
0
a. Revising paragraph (a)(2) introductory text;
0
b. Redesignating paragraph (c)(5) as paragraph (c)(6);
0
c. Adding paragraph (c)(5);
0
d. Redesignating paragraph (h) as paragraph (i);
0
e. Adding paragraph (h);
0
f. Revising newly redesignated paragraphs (i) introductory text and
(i)(4) introductory text;
0
g. Revising newly redesignated paragraphs (i)(4)(i), the first sentence
of (i)(4)(iii), and (i)(5) and (6).
    The revisions and additions read as follows:

Sec.  63.1413  Compliance demonstration procedures.

    (a)* * *
    (2) Performance tests. Performance tests shall be conducted under
such conditions as the Administrator specifies to the owner or operator
based on representative performance of the affected source for the
period being tested and in accordance with the General Provisions at
Sec.  63.7(a)(1), (a)(3), (d), (e)(2), (e)(4), (g), and (h), with the
exceptions specified in paragraph (a)(1) of this section.
Representative conditions exclude periods of startup and shutdown
unless specified by the Administrator or an applicable subpart. The
owner or operator may not conduct performance tests during periods of
malfunction. The owner or operator must record the process information
that is necessary to document operating conditions during the test and
include in such record an explanation to support that such conditions
represent normal operation. Upon request, the owner or operator shall
make available to the Administrator such records as may be necessary to
determine the conditions of performance tests. Data shall be reduced in
accordance with the EPA approved methods specified in this subpart or,
if other test methods are used, the data and methods shall be validated
according to the protocol in Method 301 of Appendix A of this part.
* * * * *
    (c) * * *
    (5) Initial and continuous compliance with the emission limit
specified in Sec.  63.1405(a)(3) shall be demonstrated following the
procedures in paragraph (h) of this section.
* * * * *
    (h) Continuous process vent compliance at existing sources. (1)
Each owner or operator complying with the mass emission limit specified
in Sec.  63.1405(a)(3) shall determine initial compliance as specified
in paragraph (h)(1)(i) of this section and continuous compliance as
specified in paragraph (h)(1)(ii) of this section.
    (i) Initial compliance. Initial compliance shall be based on the
average of the first 6 monthly average emission rate data points. The
6-month average shall be compared to the mass emission limit specified
in Sec.  63.1405(a)(3).
    (ii) Continuous compliance. For the first year of compliance,
continuous compliance shall be based on a cumulative average monthly
emission rate calculated each month based on the available monthly
emission rate data points (e.g., 7 data points after 7 months of
operation, 8 data points after 8 months of operation) beginning the
first month after initial compliance is demonstrated. The first
continuous compliance cumulative average monthly emission rate shall be
calculated using the first 7 monthly average emission rate data points.
After the first year of compliance, a 12-month rolling average monthly
emission rate shall be calculated each month based on the previous 12
monthly emission rate data points. Continuous compliance shall be
determined by comparing the cumulative average monthly emission rate or
the 12-month rolling average monthly emission rate to the mass emission
limit specified in Sec.  63.1405(a)(3).
    (2) Procedures to determine the monthly emission rate. (i) The
monthly emission rate, kilograms of organic HAP per megagram of
product, shall be determined at the end of each month using Equation 5
of this section:
[GRAPHIC] [TIFF OMITTED] TR08OC14.000

Where:

ER = Emission rate of organic HAP from continuous process vent, kg
of HAP/Mg product.
Ei = Emission rate of organic HAP from continuous process
vent i as determined using the procedures specified in paragraph
(h)(2)(ii) of this section, kg/month.
RPm = Amount of resin produced in one month as determined
using the procedures specified in paragraph (h)(2)(iii) of this
section, Mg/month.

    (ii) The monthly emission rate of organic HAP, in kilograms per
month, from an individual continuous process vent (Ei) shall
be determined. Once organic HAP emissions have been estimated, as
specified in paragraph (h)(2)(ii)(A) of this section for uncontrolled
continuous process vents or paragraphs (h)(2)(ii)(A) and (B) of this
section for continuous process vents vented to a control device or
control technology, the owner or operator may use the estimated organic
HAP emissions (Ei) until the estimated organic HAP emissions
are no longer representative due to a process change or other reason
known to the owner or operator. If organic HAP emissions
(Ei) are determined to no longer be representative, the
owner or operator shall redetermine organic HAP emissions for the
continuous process vent following the procedures in paragraph
(h)(2)(ii)(A) of this section for uncontrolled continuous process vents
or paragraphs (h)(2)(ii)(A) and (B) of this section for continuous
process vents vented to a control device or control technology.
    (A) For continuous process vents estimated through engineering
assessment, as described in Sec.  63.1414(d)(10), to emit less than 10
tons per year of uncontrolled organic HAP emissions, the owner or
operator may use the emissions determined using engineering assessment
in Equation 5 of this section or may determine organic HAP emissions
using the procedures specified in paragraph (a)(1)(i) of this section.
For continuous process vents estimated through engineering assessment,
as described in

Sec.  63.1414(d)(10), to emit 10 tons per year or greater of
uncontrolled organic HAP emissions, uncontrolled organic HAP emissions
shall be estimated following the procedures specified in paragraph
(a)(1)(i) of this section.
    (B) For continuous process vents vented to a control device or
control technology, controlled organic HAP emissions shall be
determined as follows:
    (1) Uncontrolled organic HAP emissions shall be determined
following the procedures in paragraph (h)(2)(ii)(A) of this section.
    (2) Control device or control technology efficiency shall be
determined using the procedures in paragraph (a)(1)(i) of this section
for large control devices or the procedures in paragraph (a)(1)(ii) of
this section for small control devices.
    (3) Controlled organic HAP emissions shall be determined by
applying the control device or control technology efficiency,
determined in paragraph (h)(2)(ii)(B)(2) of this section, to the
uncontrolled organic HAP emissions, determined in paragraph
(h)(2)(ii)(B)(1) of this section.
    (iii) The rate of resin produced, RPM (Mg/month), shall
be determined based on production records certified by the owner or
operator to represent actual production for the month. A sample of the
records selected by the owner or operator for this purpose shall be
provided to the Administrator in the Precompliance Report as required
by Sec.  63.1417(d).
    (i) Deviations. Paragraphs (i)(1) through (4) of this section
describe deviations from the emission limits, the operating limits, the
work practice standards, and the emission standard, respectively.
Paragraph (i)(5) of this section describes situations that are not
deviations. Paragraph (i)(6) of this section describes periods that are
excluded from compliance determinations.
* * * * *
    (4) Deviation from the emission standard. If monitoring data are
insufficient, as described in paragraphs (i)(4)(i) through (iii) of
this section, there has been a deviation from the emission standard.
    (i) The period of control device or control technology operation is
4 hours or greater in an operating day, and monitoring data are
insufficient to constitute a valid hour of data, as defined in
paragraph (i)(4)(iii) of this section, for at least 75 percent of the
operating hours;
* * * * *
    (iii) Monitoring data are insufficient to constitute a valid hour
of data, as used in paragraphs (i)(4)(i) and (ii) of this section, if
measured values are unavailable for any of the 15-minute periods within
the hour. * * *
    (5) Situations that are not deviations. If any of the situations
listed in paragraphs (i)(5)(i) or (ii) of this section occur, such
situations shall not be considered to be deviations.
    (i) Monitoring data cannot be collected during monitoring device
calibration check or monitoring device malfunction; or
    (ii) Monitoring data are not collected during periods of
nonoperation of the affected source or portion thereof (resulting in
cessation of the emissions to which the monitoring applies).
    (6) Periods not considered to be part of the period of control or
recovery device operation. The periods listed in paragraphs (i)(6)(i)
and (ii) of this section are not considered to be part of the period of
control or recovery device operation for purposes of determining
averages or periods of control device or control technology operation.
    (i) Monitoring system breakdowns, repairs, calibration checks, and
zero (low-level) and high-level adjustments; or
    (ii) Periods of nonoperation of the affected source (or portion
thereof), resulting in cessation of the emissions to which the
monitoring applies.

0
21. Section 63.1414 is amended by adding paragraph (d)(10) to read as
follows:

Sec.  63.1414  Test methods and emission estimation equations.

* * * * *
    (d) * * *
    (10) For continuous process vent emissions determined by
engineering assessment, the engineering assessment includes, but is not
limited to, the examples provided in Sec.  63.1412(k)(3).

0
22. Section 63.1415 is amended by revising the second sentence of
paragraph (b)(1)(ii)(C) to read as follows:

Sec.  63.1415  Monitoring requirements.

* * * * *
    (b) * * *
    (1) * * *
    (ii) * * *
    (C) * * * The plan shall require determination of gas stream flow
by a method which will at least provide a value for either a
representative or the highest gas stream flow anticipated in the
scrubber during representative operating conditions other than
malfunctions. * * *
* * * * *

0
23. Section 63.1416 is amended by:
0
a. Revising paragraphs (b), (c)(4), (d)(3)(iv)(B), and (e)(3)(iv)(B);
0
b. Adding paragraphs (f)(5), (f)(6), and (g)(5);
0
c. Revising the first sentence of paragraph (h)(1)(i);
0
d. Revising paragraph (h)(1)(ii);
0
e. Revising the first sentence of paragraph (h)(1)(iii);
0
f. Revising the last sentence of paragraph (h)(2)(iii); and
0
g. Revising paragraph (h)(2)(iv).
    The revisions and additions read as follows:

Sec.  63.1416  Recordkeeping requirements.

* * * * *
    (b) Malfunction records. Records shall be kept as specified in
paragraphs (b)(1) through (3) of this section.
    (1) In the event that an affected unit fails to meet an applicable
standard, record the number of failures. For each failure record the
date, time, and duration of each failure.
    (2) For each failure to meet an applicable standard, record and
retain a list of the affected sources or equipment, an estimate of the
quantity of each regulated pollutant emitted over any emission limit,
and a description of the method used to estimate the emissions.
    (3) Record actions taken to minimize emissions in accordance with
Sec.  63.1420(h)(4), and any corrective actions taken to return the
affected unit to its normal or usual manner of operation.
    (c) * * *
    (4) Monitoring data recorded during periods identified in
paragraphs (c)(4)(i) and (ii) of this section shall not be included in
any average computed under this subpart. Records shall be kept of the
times and durations of all such periods and any other periods during
process or control device or recovery device or control technology
operation when monitors are not operating:
    (i) Monitoring system breakdowns, repairs, calibration checks, and
zero (low-level) and high-level adjustments; and
    (ii) Periods of non-operation of the affected source (or portion
thereof) resulting in cessation of the emissions to which the
monitoring applies.
* * * * *
    (d) * * *
    (3) * * *
    (iv) * * *
    (B) If there is a deviation from the mass emission limit, as
specified in Sec.  63.1413(i), the individual monthly emission rate
data points making up the cumulative average monthly emission rate or
the 12-month rolling average monthly emission rate, as appropriate.
* * * * *

    (e) * * *
    (3) * * *
    (iv) * * *
    (B) If there is a deviation from the emission limit, as specified
in Sec.  63.1413(i)(1), the individual monthly emission rate data
points making up the rolling average monthly emission rate or the 12-
month rolling average monthly emission rate, as appropriate.
* * * * *
    (f) * * *
    (5) If a continuous process vent is seeking to demonstrate
compliance with the mass emission limit specified in Sec.
63.1405(a)(3), keep records specified in paragraphs (f)(5)(i) and (ii)
of this section.
    (i) The results of the initial compliance demonstration specified
in Sec.  63.1413(h)(1)(i).
    (ii) The monthly organic HAP emissions from the continuous process
vent determined as specified in Sec.  63.1413(h)(2).
    (6) When using a flare to comply with Sec.  63.1405(a), keep the
records specified in paragraphs (f)(6)(i) through (f)(6)(iii) of this
section.
    (i) The flare design (i.e., steam-assisted, air-assisted or non-
assisted);
    (ii) All visible emission readings, heat content determinations,
flow rate measurements, and exit velocity determinations made during
the compliance determination required by Sec.  63.1413(g); and
    (iii) Periods when all pilot flames were absent during the
compliance determination required by Sec.  63.1413(g).
    (g) * * *
    (5) For pressure relief devices in organic HAP service, keep
records of the information specified in paragraphs (g)(5)(i) through
(v) of this section, as applicable.
    (i) A list of identification numbers for pressure relief devices
that vent to a fuel gas system, process, drain system, or closed-vent
system and control device, under the provisions in Sec.  63.1411(d).
    (ii) A list of identification numbers for pressure relief devices
subject to the provisions in Sec.  63.1411(a).
    (iii) A list of identification numbers for pressure relief devices
equipped with rupture disks, under the provisions in Sec.
63.1411(b)(2).
    (iv) The dates and results of the monitoring following a pressure
release for each pressure relief device subject to the provisions in
Sec.  63.1411(a) and (b). The results shall include:
    (A) The background level measured during each compliance test.
    (B) The maximum instrument reading measured at each piece of
equipment during each compliance test.
    (v) For pressure relief devices in organic HAP service subject to
Sec.  63.1411(c), keep records of each pressure release to the
atmosphere, including the following information:
    (A) The source, nature, and cause of the pressure release.
    (B) The date, time, and duration of the pressure release.
    (C) An estimate of the quantity of total HAP emitted during the
pressure release and the calculations used for determining this
quantity.
    (D) The actions taken to prevent this pressure release.
    (E) The measures adopted to prevent future such pressure releases.
    (h) * * *
    (1) * * *
    (i) The monitoring system is capable of detecting unrealistic or
impossible data during periods of operation (e.g., a temperature
reading of -200 [deg]C on a boiler) and will alert the operator by
alarm or other means. * * *
    (ii) The monitoring system generates, updated at least hourly
throughout each operating day, a running average of the parameter
values that have been obtained during that operating day or block, and
the capability to observe this running average is readily available on-
site to the Administrator during the operating day. The owner or
operator shall record the occurrence of any period meeting the criteria
in paragraphs (h)(1)(ii)(A) and (B) of this section. All instances in
an operating day or block constitute a single occurrence:
    (A) The running average is above the maximum or below the minimum
established limits; and
    (B) The running average is based on at least six 1-hour average
values.
    (iii) The monitoring system is capable of detecting unchanging data
during periods of operation, except in circumstances where the presence
of unchanging data is the expected operating condition based on past
experience (e.g., pH in some scrubbers) and will alert the operator by
alarm or other means. * * *
* * * * *
    (2) * * *
    (iii) * * * For any calendar week, if compliance with paragraphs
(h)(1)(i) through (iv) of this section does not result in retention of
a record of at least one occurrence or measured parameter value, the
owner or operator shall record and retain at least one value during a
period of operation.
    (iv) For purposes of paragraph (h)(2) of this section, a deviation
means that the daily average, batch cycle daily average, or block
average value of monitoring data for a parameter is greater than the
maximum, or less than the minimum established value.

0
24. Section 63.1417 is amended by:
0
a. Revising the first sentence of paragraph (d);
0
b. Revising paragraphs (d)(8), (d)(9), and (d)(11)(ii);
0
d. Revising paragraph (e) introductory text;
0
e. Adding paragraph (e)(10);
0
f. Revising the first sentence of paragraph (f)(1);
0
g. Revising paragraphs (f)(3)(i) and (ii) and (f)(5) introductory text;
0
h. Adding paragraph (f)(13);
0
i. Revising paragraph (g);
0
j. Revising paragraphs (h) introductory text and the first sentence of
(h)(7) introductory text;
0
k. Adding paragraph (h)(8); and
0
l. Revising paragraph (k)(3)(i)(F).
    The revisions and additions read as follows:

Sec.  63.1417  Reporting requirements.

* * * * *
    (d) Precompliance Report. Owners or operators of affected sources
requesting an extension for compliance; requesting approval to use
alternative monitoring parameters, alternative continuous monitoring
and recordkeeping, or alternative controls; requesting approval to use
engineering assessment to estimate organic HAP emissions from a batch
emissions episode as described in Sec.  63.1414(d)(6)(i)(C); wishing to
establish parameter monitoring levels according to the procedures
contained in Sec.  63.1413(a)(4)(ii); establishing parameter monitoring
levels based on a design evaluation as specified in Sec.
63.1413(a)(3); or following the procedures in Sec.  63.1413(e)(2); or
following the procedures in Sec.  63.1413(h)(2), shall submit a
Precompliance Report according to the schedule described in paragraph
(d)(1) of this section. * * *
* * * * *
    (8) If an owner or operator is complying with the mass emission
limit specified in Sec.  63.1405(a)(3), the sample of production
records specified in Sec.  63.1413(h)(2) shall be submitted in the
Precompliance Report.
    (9) If an owner or operator is complying with the mass emission
limit specified in Sec.  63.1406(a)(1)(iii) or (a)(2)(iii), Sec.
63.1407(b)(2), or Sec.  63.1408(b)(2), the sample of production records
specified in Sec.  63.1413(e)(2) shall be submitted in the
Precompliance Report.
* * * * *
    (11) * * *
    (ii) Supplements to the Precompliance Report may be submitted to
request

approval to use alternative monitoring parameters, as specified in
paragraph (j) of this section; to use alternative continuous monitoring
and recordkeeping, as specified in paragraph (k) of this section; to
use alternative controls, as specified in paragraph (d)(5) of this
section; to use engineering assessment to estimate organic HAP
emissions from a batch emissions episode, as specified in paragraph
(d)(6) of this section; or to establish parameter monitoring levels
according to the procedures contained in Sec.  63.1413(a)(4)(ii) or
(a)(3), as specified in paragraph (d)(7) of this section.
    (e) Notification of Compliance Status. For existing and new
affected sources, a Notification of Compliance Status shall be
submitted within 150 days after the compliance dates specified in Sec.
63.1401. For equipment leaks, the Notification of Compliance Status
shall contain the information specified in 40 CFR part 63, subpart UU.
For storage vessels, continuous process vents, batch process vents, and
aggregate batch vent streams, the Notification of Compliance Status
shall contain the information listed in paragraphs (e)(1) through (9)
of this section. For pressure relief devices subject to the
requirements of Sec.  63.1411(c), the owner or operator shall also
submit the information listed in paragraph (e)(10) of this section in a
supplement to the Notification of Compliance Status within 150 days
after the first applicable compliance date for pressure relief device
monitoring.
* * * * *
    (10) For pressure relief devices in organic HAP service, a
description of the device or monitoring system to be implemented,
including the pressure relief devices and process parameters to be
monitored (if applicable), and a description of the alarms or other
methods by which operators will be notified of a pressure release.
    (f) * * *
    (1) Except as specified in paragraph (f)(12) of this section, a
report containing the information in paragraph (f)(2) of this section
or containing the information in paragraphs (f)(3) through (11) and
(13) of this section, as appropriate, shall be submitted semiannually
no later than 60 days after the end of each 180 day period. * * *
* * * * *
    (3) * * *
    (i) All information specified in 40 CFR part 63, subpart WW and
subpart SS for storage vessels; 40 CFR part 63, subpart SS for
continuous process vents required to comply with subpart SS; Sec.
63.1416(d)(3)(ii) for batch process vents; and Sec.  63.1416(e) for
aggregate batch vent stream.
    (ii) The daily average values, batch cycle daily average values, or
block average values of monitored parameters for deviations, as
specified in Sec.  63.1413(i), of operating parameters. In addition,
the periods and duration of periods when monitoring data were not
collected shall be specified.
* * * * *
    (5) If there is a deviation from the mass emission limit specified
in Sec.  63.1405(a)(3), Sec.  63.1406(a)(1)(iii) or (a)(2)(iii), Sec.
63.1407(b)(2), or Sec.  63.1408(b)(2), the following information, as
appropriate, shall be included:
* * * * *
    (13) For pressure relief devices, Periodic Reports must include the
information specified in paragraphs (f)(13)(i) through (iii) of this
section.
    (i) For pressure relief devices in organic HAP service subject to
Sec.  63.1411, report confirmation that all monitoring to show
compliance was conducted within the reporting period.
    (ii) For pressure relief devices in organic HAP gas or vapor
service subject to Sec.  63.1411(b), report any instrument reading of
500 ppm above background or greater, more than 5 days after the relief
device returns to organic HAP gas or vapor service after a pressure
release.
    (iii) For pressure relief devices in organic HAP service subject to
Sec.  63.1411(c), report each pressure release to the atmosphere,
including the following information:
    (A) The source, nature, and cause of the pressure release.
    (B) The date, time, and duration of the pressure release.
    (C) An estimate of the quantity of total HAP emitted during the
pressure release and the method used for determining this quantity.
    (D) The actions taken to prevent this pressure release.
    (E) The measures adopted to prevent future such pressure releases.
    (g) Reports of Malfunctions. If a source fails to meet an
applicable standard, report such events in the Periodic Report. Report
the number of failures to meet an applicable standard. For each
instance, report the date, time and duration of each failure. For each
failure the report must include a list of the affected sources or
equipment, an estimate of the quantity of each regulated pollutant
emitted over any emission limit, and a description of the method used
to estimate the emissions.
    (h) Other reports. Other reports shall be submitted as specified in
paragraphs (h)(1) through (8) of this section.
* * * * *
    (7) Whenever a continuous process vent becomes subject to control
requirements under Sec.  63.1405(a), as a result of a process change,
the owner or operator shall submit a report within 60 days after the
performance test or applicability assessment, whichever is sooner. * *
*
* * * * *
    (8) Electronic reporting. Within 60 days after the date of
completing each performance test (as defined in Sec.  63.2), the owner
or operator must submit the results of the performance tests, including
any associated fuel analyses, required by this subpart according to the
methods specified in paragraphs (h)(8)(i) or (ii) of this section.
    (i) For data collected using test methods supported by the EPA-
provided software, the owner or operator shall submit the results of
the performance test to the EPA by direct computer-to-computer
electronic transfer via EPA-provided software, unless otherwise
approved by the Administrator. Owners or operators, who claim that some
of the information being submitted for performance tests is
confidential business information (CBI), must submit a complete file
using EPA-provided software that includes information claimed to be CBI
on a compact disc, flash drive, or other commonly used electronic
storage media to the EPA. The electronic media must be clearly marked
as CBI and mailed to U.S. EPA/OAPQS/CORE CBI Office, Attention: WebFIRE
Administrator, MD C404-02, 4930 Old Page Rd., Durham, NC 27703. The
same file with the CBI omitted must be submitted to the EPA by direct
computer-to-computer electronic transfer via EPA-provided software.
    (ii) For any performance test conducted using test methods that are
not compatible with the EPA-provided software, the owner or operator
shall submit the results of the performance test to the Administrator
at the appropriate address listed in Sec.  60.4.
* * * * *
    (k) * * *
    (3) * * *
    (i) * * *
    (F) If the daily average is not a deviation, as defined in Sec.
63.1413(i), from the operating parameter, the data for that operating
day may be converted to hourly average values, and the four or more
individual records for each hour in the operating day may be discarded.
* * * * *

0
25. Table 1 to Subpart OOO is amended by:
0
a. Removing entries 63.1(a)(6)-63.1 (a)(8) and 63.1(a)(9);

0
b. Adding entries 63.1(a)(6) and 63.1(a)(7)-63.1(a)(9);
0
c. Revising entries 63.1(c)(4), 63.6(e), 63.6(e)(1)(i), and
63.6(e)(1)(ii);
0
d. Adding entry 63.6(e)(3);
0
e. Removing entries 63.6(e)(3)(i), 63.6(e)(3)(i)(A), 63.6(e)(3)(i)(B),
63.6(e)(3)(i)(C), 63.6(e)(3)(ii), 63.6(e)(3)(iii), 63.6(e)(3)(iv),
63.6(e)(3)(v), 63.6(e)(3)(vi), 63.6(e)(3)(vii), 63.6(e)(3)(vii)(A),
63.6(e)(3)(vii)(B), 63.6(e)(3)(vii)(C), 63.6(e)(3)(viii), and
63.6(e)(3)(ix);
0
f. Revising entries 63.6(f)(1), 63.7(e)(1), 63.8(c)(1)(i),
63.8(c)(1)(ii), 63.8(c)(1)(iii), and 63.10(d)(5); and
0
g. Removing footnote a.
    The revisions and additions read as follows:

     Table 1 to Subpart OOO of Part 63--Applicability of General Provisions to Subpart OOO Affected Sources
----------------------------------------------------------------------------------------------------------------
                Reference                    Applies to subpart OOO                   Explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
63.1(a)(6)..............................  Yes........................  .........................................
63.1(a)(7)-63.1(a)(9)...................  No.........................  [Reserved].

                                                  * * * * * * *
63.1(c)(4)..............................  No.........................  [Reserved].

                                                  * * * * * * *
63.6(e).................................  Yes........................  Except as otherwise specified in this
                                                                        table.
63.6(e)(1)(i)...........................  No.........................  See Sec.   63.1400(k)(4) for general duty
                                                                        requirement.
63.6(e)(1)(ii)..........................  No.........................  .........................................

                                                  * * * * * * *
63.6(e)(3)..............................  No.........................  .........................................
63.6(f)(1)..............................  No.........................  .........................................

                                                  * * * * * * *
63.7(e)(1)..............................  No.........................  See Sec.   63.1413(a)(2).

                                                  * * * * * * *
63.8(c)(1)(i)...........................  No.........................  .........................................
63.8(c)(1)(ii)..........................  No.........................  .........................................
63.8(c)(1)(iii).........................  No.........................  .........................................

                                                  * * * * * * *
63.10(d)(5).............................  No.........................  See Sec.   63.1417(g) for malfunction
                                                                        reporting requirements.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

0
26. Table 5 to Subpart OOO is amended by removing entry 63.1417(g) and
adding entry 63.1417(h)(8) to read as follows:

                                           Table 5 to Subpart OOO of Part 63--Reports Required by This Subpart
--------------------------------------------------------------------------------------------------------------------------------------------------------
                Reference                      Description of report                                         Due date
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
63.1417(h)(8)............................  Electronic reporting........  Within 60 days after completing performance test.
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2014-23099 Filed 10-7-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 113 (Monday, June 13, 2016)]
[Notices]
[Pages 38198-38199]
[FR Doc No: 2016-13815]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2016-0002; Internal Agency Docket No. FEMA-B-1621]

Proposed Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: Comments are requested on proposed flood hazard
determinations, which may include additions or modifications of any
Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area
(SFHA) boundary or zone designation, or regulatory floodway on the
Flood Insurance Rate Maps (FIRMs), and where applicable, in the
supporting Flood Insurance Study (FIS) reports for the communities
listed in the table below. The purpose of this notice is to seek
general information and comment regarding the preliminary FIRM, and
where applicable, the FIS report that the Federal Emergency Management
Agency (FEMA) has provided to the affected communities. The FIRM and
FIS report are the basis of the floodplain management measures that the
community is required either to adopt or to show evidence of having in
effect in order to qualify or remain qualified for participation in the
National Flood Insurance Program (NFIP). In addition, the FIRM and FIS
report, once effective, will be used by insurance agents and others to
calculate appropriate flood insurance premium rates for new buildings
and the contents of those buildings.

DATES: Comments are to be submitted on or before September 12, 2016.

ADDRESSES: The Preliminary FIRM, and where applicable, the FIS report
for each community are available for inspection at both the online
location and the respective Community Map Repository address listed in
the tables below. Additionally, the current effective FIRM and FIS
report for each community are accessible online through the FEMA Map
Service Center at www.msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-1621, to
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance
and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC
20472,<PHONE_NUMBER>, or (email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
500 C Street SW., Washington, DC 20472,<PHONE_NUMBER>, or (email)
<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard
determinations for each community listed below, in accordance with
section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4104, and 44 CFR 67.4(a).
    These proposed flood hazard determinations, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own or pursuant to policies
established by other Federal, State, or regional entities. These flood
hazard determinations are used to meet the floodplain management
requirements of the NFIP and also are used to calculate the appropriate
flood insurance premium rates for new buildings built after the FIRM
and FIS report become effective.
    The communities affected by the flood hazard determinations are
provided in the tables below. Any request for reconsideration of the
revised flood hazard information shown on the Preliminary FIRM and FIS
report that satisfies the data requirements outlined in 44 CFR 67.6(b)
is considered an appeal. Comments unrelated to the flood hazard
determinations also will be considered before the FIRM and FIS report
become effective.
    Use of a Scientific Resolution Panel (SRP) is available to
communities in support of the appeal resolution process. SRPs are
independent panels of experts in hydrology, hydraulics, and other
pertinent sciences established to review conflicting scientific and
technical data and provide recommendations for resolution. Use of the
SRP only may be exercised after FEMA and local communities have been
engaged in a collaborative consultation process for at least 60 days
without a mutually acceptable resolution of an appeal. Additional
information regarding the SRP process can be found online at http://floodsrp.org/pdfs/srp_fact_sheet.pdf.
    The watersheds and/or communities affected are listed in the tables
below. The Preliminary FIRM, and where applicable, FIS report for each
community are available for inspection at both the online location and
the respective Community Map Repository address listed in the tables.
For communities with multiple ongoing Preliminary studies, the studies
can be identified by the unique project number and Preliminary FIRM
date listed in the tables. Additionally, the current effective FIRM and
FIS report for each community are accessible online through the FEMA
Map Service Center at www.msc.fema.gov for comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: May 31, 2016.
Roy E. Wright,
Deputy Associate Administrator for Insurance and Mitigation, Department
of Homeland Security, Federal Emergency Management Agency.
    I. Non-watershed-based studies:

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
             Yavapai County, Arizona, and Incorporated Areas
------------------------------------------------------------------------
      Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
------------------------------------------------------------------------
          Project: 16-09-1388S Preliminary Date: April 1, 2016
------------------------------------------------------------------------
City of Prescott.......................  Public Works Department, 201
                                          South Cortez Street, Prescott,
                                          AZ 86303.
Unincorporated Areas of Yavapai County.  Yavapai County Flood Control
                                          District Office, 1120 Commerce
                                          Drive, Prescott, AZ 86305.
------------------------------------------------------------------------
            Delaware County, Indiana, and Incorporated Areas
------------------------------------------------------------------------
      Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
------------------------------------------------------------------------
          Project: 14-05-6087S Preliminary Date: July 22, 2015
------------------------------------------------------------------------
City of Muncie.........................  Delaware County Building, 100
                                          West Main Street, Room 206,
                                          Muncie, IN 47305.
Town of Yorktown.......................  Yorktown Town Hall, 9800 West
                                          Smith Street, Yorktown, IN
                                          47396.
Unincorporated Areas of Delaware County  Delaware County Building, 100
                                          West Main Street, Room 206,
                                          Muncie, IN 47305.
------------------------------------------------------------------------
           Tippecanoe County, Indiana, and Incorporated Areas
------------------------------------------------------------------------
      Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
------------------------------------------------------------------------
          Project: 14-05-6086S Preliminary Date: April 17, 2015
------------------------------------------------------------------------
City of Lafayette......................  City Hall, 20 North 6th Street,
                                          Lafayette, IN 47901.
Town of Shadeland......................  Shadeland Town Hall, 3125 South
                                          175 West, Lafayette, IN 47909.
Unincorporated Areas of Tippecanoe       Tippecanoe County Office, 20
 County.                                  North 3rd Street, Lafayette,
                                          IN 47901.
------------------------------------------------------------------------
              Humboldt County, Iowa, and Incorporated Areas
------------------------------------------------------------------------
      Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
------------------------------------------------------------------------
          Project: 15-07-0903S Preliminary Date: July 30, 2015
------------------------------------------------------------------------
City of Bradgate.......................  City Hall, 202 South Garfield
                                          Street, Bradgate, IA 50520.
City of Dakota City....................  City Hall, 26 5th Street South,
                                          Dakota City, IA 50529.
City of Humboldt.......................  City Hall, 29 5th Street South,
                                          Humboldt, IA 50548.
City of Livermore......................  City Hall, 401 4th Avenue,
                                          Livermore, IA 50558.
City of Lu Verne.......................  City Hall, 109 Dewitt Street,
                                          Lu Verne, IA 50560.
City of Rutland........................  City Hall, 201 Sheridan Avenue,
                                          Rutland, IA 50582.
City of Thor...........................  City Hall, 223 North Ann
                                          Street, Thor, IA 50591.
Unincorporated Areas of Humboldt County  Humboldt County Courthouse, 203
                                          Main Street, Dakota City, IA
                                          50529.
------------------------------------------------------------------------

[FR Doc. 2016-13815 Filed 6-10-16; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 77, Number 11 (Wednesday, January 18, 2012)]
[Notices]
[Pages 2556-2557]
[FR Doc No: 2012-846]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

Ethical and Regulatory Challenges in the Development of Pediatric
Medical Countermeasures; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

    The Food and Drug Administration (FDA), Office of Pediatric
Therapeutics, is announcing a public workshop entitled ``Ethical and
Regulatory Challenges in the Development of Pediatric Medical
Countermeasures.'' There is a critical need for pediatric research on
medical countermeasures to ensure that these products are safe and
effective in the pediatric population. The challenges to developing and
evaluating drugs, biologics, and devices for children in the medical
countermeasure context are complex

and need to be better understood by ethicists, researchers,
policymakers, and the general public. The purpose of the public
workshop is to provide a forum for careful consideration of scientific,
ethical, and regulatory issues confronting FDA and other stakeholders
in the area of medical countermeasures and public health preparedness.
    Date and Time: The public workshop will be held on February 15,
2012, from 8:30 a.m. to 5 p.m. and February 16, 2012, from 8:30 a.m. to
3 p.m.
    Location: The public workshop will be held at the Rockville Hilton
Hotel, 1750 Rockville Pike, Rockville, MD 20852.
    Contact Person: Cindy de Sales,<PHONE_NUMBER>, FAX: (240) 316-
3201, email<EMAIL_ADDRESS>    Registration: Please use the following Web site to register online:
http://www.contractmeetings.com. Alternatively, you can email or fax
your registration information (including name, title, firm name,
address, telephone and fax numbers) to the contact person by February
1, 2012. There is no registration fee for the public workshop. Early
registration is recommended because seating is limited. Registration on
the day of the public workshop will be provided on a space available
basis beginning at 8 a.m.
    If you need special accommodations due to a disability, please
contact Cindy de Sales (see Contact Person) at least 7 days in advance.

SUPPLEMENTARY INFORMATION: The workshop will include plenaries and
breakout sessions on the ethical and regulatory challenges in the
development of medical countermeasures for the pediatric population.
Topics of the breakout sessions will include: (1) Institutional Review
Board preparedness to review study protocols relevant to pediatric
medical countermeasures; (2) potential scientific and ethical
justifications for conducting pre-event pediatric medical
countermeasures research; (3) leveraging new technologies to develop
pediatric medical countermeasures; and (4) risk communication related
to pediatric treatment and research during public health emergencies.
The workshop also will include discussion of a number of case studies
to facilitate discussion of the challenges of pediatric medical
countermeasure development and deployment.
    Transcripts: Transcripts of the public workshop may be requested in
writing from the Division of Freedom of Information (ELEM-1029), Food
and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville,
MD 20857, approximately 15 working days after the public workshop at
the cost of 10 cents per page. A transcript of the public workshop will
be available on the Internet at http://www.regulations.gov, Docket No.
FDA-2011-N-0002. Transcripts may also be viewed at the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: January 12, 2012.
David Dorsey,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2012-846 Filed 1-17-12; 8:45 am]
BILLING CODE 4160-01-P