81_FR_71806 81 FR 71605 - Order Establishing De Minimis Threshold Phase-In Termination Date

81 FR 71605 - Order Establishing De Minimis Threshold Phase-In Termination Date

COMMODITY FUTURES TRADING COMMISSION

Federal Register Volume 81, Issue 201 (October 18, 2016)

Page Range71605-71610
FR Document2016-25143

With respect to the de minimis exception to the swap dealer definition, the Commodity Futures Trading Commission (``Commission'' or ``CFTC'') is issuing an order (``Order''), pursuant to the applicable Commission regulation, to establish December 31, 2018 as the de minimis threshold phase-in termination date.

Federal Register, Volume 81 Issue 201 (Tuesday, October 18, 2016)
[Federal Register Volume 81, Number 201 (Tuesday, October 18, 2016)]
[Rules and Regulations]
[Pages 71605-71610]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-25143]


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COMMODITY FUTURES TRADING COMMISSION

17 CFR Part 1


Order Establishing De Minimis Threshold Phase-In Termination Date

AGENCY: Commodity Futures Trading Commission.

ACTION: Order.

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[[Page 71606]]

SUMMARY: With respect to the de minimis exception to the swap dealer 
definition, the Commodity Futures Trading Commission (``Commission'' or 
``CFTC'') is issuing an order (``Order''), pursuant to the applicable 
Commission regulation, to establish December 31, 2018 as the de minimis 
threshold phase-in termination date.

DATES: Issued October 13, 2016.

FOR FURTHER INFORMATION CONTACT: Eileen T. Flaherty, Director, 202-418-
5326, [email protected]; Erik Remmler, Deputy Director, 202-418-7630, 
[email protected]; Lauren Bennett, Special Counsel, 202-418-5290, 
[email protected]; Margo Dey, Special Counsel, 202-418-5276, 
[email protected]; or Rajal Patel, Special Counsel, 202-418-5261, 
[email protected], Division of Swap Dealer and Intermediary Oversight, 
Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st 
Street NW., Washington, DC 20581.

SUPPLEMENTARY INFORMATION: 

I. Background

A. Statutory and Regulatory Background

    The Dodd-Frank Wall Street Reform and Consumer Protection Act 
(``Dodd-Frank Act'') \1\ directed the CFTC and the U.S. Securities and 
Exchange Commission (``SEC'' and together with the CFTC, 
``Commissions'') to jointly further define the term ``swap dealer'' and 
to include therein a de minimis exception.\2\ The CFTC's further 
definition of swap dealer is provided in Regulation 1.3(ggg). The de 
minimis exception therein provides that a person shall not be deemed to 
be a swap dealer unless its swap dealing activity exceeds an aggregate 
gross notional amount threshold of $3 billion (measured over the prior 
12-month period), subject to a phase-in period during which the gross 
notional amount threshold is set at $8 billion.\3\ Absent further 
action by the Commission, the phase-in period would terminate on 
December 31, 2017, at which time the de minimis threshold would 
decrease to $3 billion.\4\ This would require firms to start tracking 
their swap activity beginning January 1, 2017 to determine whether 
their dealing activity over the course of that year would require them 
to register as swap dealers.
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    \1\ Public Law 111-203, 124 Stat. 1376 (2010). The text of the 
Dodd-Frank Act can be accessed on the Commission's Web site, at 
www.cftc.gov.
    \2\ See Dodd-Frank Act sections 712(d) and 721. The definition 
of ``swap dealer'' can be found in section 1a(49) of the Commodity 
Exchange Act and as further defined in Regulation 1.3(ggg). 7 U.S.C. 
1a(49) and 17 CFR 1.3(ggg). The Commodity Exchange Act is at 7 
U.S.C. 1, et seq. (2014), and is accessible on the Commission's Web 
site, at www.cftc.gov.
    \3\ See 17 CFR 1.3(ggg)(4). See also Further Definition of 
``Swap Dealer,'' ``Security-Based Swap Dealer,'' ``Major Swap 
Participant,'' ``Major Security-Based Swap Participant'' and 
``Eligible Contract Participant,'' 77 FR 30596 (May 23, 2012).
    This Order does not impact the de minimis threshold for swaps 
with ``special entities'' as defined in the Commodity Exchange Act, 
section 4s(h)(2)(C), 7 U.S.C. 6s(h)(2)(C).
    \4\ See 17 CFR 1.3(ggg)(4)(ii)(D).
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    When the $3 billion de minimis exception was established, the 
Commissions explained that the information then available regarding 
certain portions of the swap market was limited in certain respects, 
and that they expected that the implementation of swap data reporting 
may enable reassessment of the de minimis exception.\5\ Accordingly, 
the Commission adopted Regulation 1.3(ggg)(4), which directed CFTC 
staff to issue a report, after a specified period of time, on topics 
relating to the de minimis exception ``as appropriate, based on the 
availability of data and information.'' \6\ Regulation 1.3(ggg)(4) 
further provides that after giving due consideration to the report and 
any associated public comment, the Commission may issue an order to 
establish a termination date for the phase-in period or propose through 
rulemaking modifications to the de minimis exception.
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    \5\ See 77 FR at 30634, 30640.
    \6\ SEC Regulation 240.3a71-2A similarly directs SEC staff to 
prepare a report on the security-based swap dealer de minimis 
exception. 17 CFR 240.3a71-2A.
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B. Staff Reports

    Staff issued for public comment a preliminary report concerning the 
de minimis exception on November 18, 2015 (``Preliminary Report'').\7\ 
After consideration of the public comments received, and further data 
analysis, staff issued the Swap Dealer De Minimis Exception Final Staff 
Report \8\ on August 15, 2016 (``Final Report,'' and together with the 
Preliminary Report, ``Staff Reports''). The Staff Reports analyzed the 
available swap data \9\ in conjunction with relevant policy 
considerations to assess alternative de minimis threshold levels and 
other potential changes to the de minimis exception.
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    \7\ Swap Dealer De Minimis Exception Preliminary Report (Nov. 
18, 2015), available at http://www.cftc.gov/idc/groups/public/@swaps/documents/file/dfreport_sddeminis_1115.pdf.
    \8\ Swap Dealer De Minimis Exception Final Staff Report (August 
15, 2016), available at http://www.cftc.gov/idc/groups/public/@swaps/documents/file/dfreport_sddeminis081516.pdf.
    \9\ The data analysis broke down the data into the following 
asset classes: Interest rate swaps (``IRS''); credit default swaps 
(``CDS''); non-financial commodity (``Non-Financial Commodity'') 
swaps; equity (``Equity'') swaps; and foreign exchange derivatives 
(``FX Derivatives'').
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C. Swap Data Analysis

    As discussed in the Staff Reports, the lack of certain metrics 
needed for evaluating different de minimis thresholds, as well as data 
validity issues, limited the analysis of the potential impact of 
changes to the current de minimis exception.\10\ The Final Report 
further noted that, notwithstanding these data issues, the quality of 
the swap data that is reported to the Commission appears to be 
continually improving, and that the Commission is taking additional 
steps to enhance swap data quality.\11\
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    \10\ See Preliminary Report at 12-21; Final Report at 4-6, 19-
20. For example, the data reported does not indicate whether either 
counterparty to a swap is acting as a dealer, and there are 
difficulties in calculating the notional amounts for certain types 
of swaps in a uniform manner useful for data analysis.
    \11\ See Final Report at 18-19. For example, in June 2016, the 
Commission finalized amendments related to the reporting of cleared 
swaps. See Amendments to Swap Data Recordkeeping and Reporting 
Requirements for Cleared Swaps, 81 FR 41736 (June 27, 2016).
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    The data analysis in the Staff Reports provided some insights into 
the effectiveness of the de minimis exception as currently implemented. 
Staff analyzed the number of swap transactions involving at least one 
registered swap dealer, which is indicative of the extent to which 
swaps are subject to swap dealer regulation at the current $8 billion 
threshold. Data reviewed for the Final Report indicated that 
approximately 96% of all reported swap transactions involved at least 
one registered swap dealer. When considering individual swap asset 
classes, approximately 98% or more of swaps in each asset class, other 
than the Non-Financial Commodity asset class, involved at least one 
registered swap dealer. Approximately 89% of Non-Financial Commodity 
swaps involved a registered swap dealer.\12\
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    \12\ See Final Report at 22.
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    However, as discussed above, the data available was not sufficient 
to assess whether, and to what extent, specific changes to the de 
minimis threshold levels would increase or decrease the coverage of 
swaps by swap dealer regulation. In particular, the Staff Reports noted 
that reliable notional amount data was not available for Non-Financial 
Commodity, Equity, and FX Derivative swaps.
    The Commission also notes that it has not yet adopted a regulation 
on capital requirements for swap dealers, which is a significant 
component of swap dealer registration. The Commission believes it

[[Page 71607]]

is prudent to finalize the capital rule before addressing the de 
minimis threshold. In addition, the swap dealer requirements regarding 
margin for uncleared swaps, another important component of swap dealer 
registration, are currently being implemented. The Commission believes 
that a year's delay would allow it to finalize the swap dealer capital 
rule and assess the implementation of margin requirements for uncleared 
swaps. Having information on these aspects associated with swap dealer 
registration would be helpful in further assessing the impact of 
changing the de minimis threshold.
    Accordingly, the Commission believes that it is prudent to extend 
the phase-in period by one year, which may provide additional time for 
more information to become available to reassess the de minimis 
exception. Adopting this Order at this time also provides clarity to 
market participants regarding when they would need to begin preparing 
for a change to the de minimis exception.

II. Conclusion and Order

    For the reasons discussed above, and pursuant to its authority 
under Regulation 1.3(ggg)(4)(ii)(C)(1), the Commission is establishing 
December 31, 2018 as the termination date for the de minimis threshold 
phase-in period. The Commission notes that prior to the termination of 
the phase-in period, the Commission may take further action regarding 
the de minimis threshold by rule amendment, order, or other appropriate 
action.\13\
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    \13\ See 17 CFR 1.3(ggg)(4)(v).
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III. Related Matters

A. Paperwork Reduction Act

    The Paperwork Reduction Act (``PRA'') \14\ imposes certain 
requirements on Federal agencies in connection with their conducting or 
sponsoring any collection of information as defined by the PRA. This 
Order does not impose any new recordkeeping or information collection 
requirements, or other collections of information that require approval 
of the Office of Management and Budget under the PRA.
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    \14\ 44 U.S.C. 3501 et seq.
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B. Cost-Benefit Considerations

    Section 15(a) of the Commodity Exchange Act (``CEA'') requires the 
Commission to consider the costs and benefits of its actions before 
promulgating a regulation under the CEA or issuing certain orders.\15\ 
Section 15(a) further specifies that the costs and benefits shall be 
evaluated in light of five broad areas of market and public concern: 
(i) Protection of market participants and the public; (ii) efficiency, 
competitiveness, and financial integrity of futures markets; (iii) 
price discovery; (iv) sound risk management practices; and (v) other 
public interest considerations. In this section, the Commission 
considers the costs and benefits resulting from its determinations with 
respect to the section 15(a) factors.
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    \15\ 7 U.S.C. 19(a).
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1. Background
    As discussed above, Regulation 1.3(ggg)(4)(i) provides an exception 
from the swap dealer definition for persons who engage in a de minimis 
amount of swap dealing activity. Currently, under Regulation 
1.3(ggg)(4)(i), a person shall not be deemed to be a swap dealer unless 
its swap dealing activity exceeds an aggregate gross notional amount 
threshold of $3 billion (measured over the prior 12-month period), 
subject to a phase-in period during which the gross notional amount 
threshold is set at $8 billion.\16\ The phase-in period would have 
terminated on December 31, 2017, and the de minimis threshold would 
have decreased to $3 billion, absent this Order.\17\ This would have 
required firms to start tracking their swap activity beginning January 
1, 2017 to determine whether their dealing activity over the course of 
that year would require them to register as swap dealers.
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    \16\ 17 CFR 1.3(ggg)(4)(i). See generally 77 FR at 30626-35. See 
also note 3, supra.
    \17\ 17 CFR 1.3(ggg)(4).
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    The $3 billion threshold, which, absent this Order, would be 
effective on December 31, 2017, sets the baseline for the Commission's 
consideration of the costs and benefits of this Order.\18\ Accordingly, 
the Commission considers the costs and benefits that will result from 
an extended phase-in period.
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    \18\ See 77 FR at 30702-14 (discussing the cost-benefit 
considerations with regard to the final swap dealer definition).
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2. General Cost and Benefit Considerations
    There are several policy objectives underlying swap dealer 
regulation and the de minimis exception to swap dealer registration. 
The primary policy objectives of swap dealer regulation include the 
reduction of systemic risk, increased counterparty protections, and 
market efficiency, orderliness, and transparency.\19\ Registered swap 
dealers are subject to a broad range of requirements, including, inter 
alia, registration, internal and external business conduct standards, 
reporting, recordkeeping, risk management, posting and collecting 
margin, and chief compliance officer designation and responsibilities. 
As noted in the Regulation 1.3(ggg) adopting release, generally, the 
lower the de minimis threshold, the greater the number of entities that 
are subject to these requirements, which could decrease systemic risk, 
increase counterparty protections, and promote swap market efficiency, 
orderliness, and transparency.\20\
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    \19\ Id. at 30628-30, 30707-08.
    \20\ Id. at 30628-30, 30703, 30707-08.
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    The Commission also considers policy objectives furthered by a de 
minimis exception, which include regulatory certainty, allowing limited 
ancillary dealing, encouraging new participants to enter the swap 
dealing market, and regulatory efficiency.\21\ Generally, the higher 
the de minimis threshold, the greater the number of entities that are 
able to engage in dealing activity without being required to register, 
which could increase competition and liquidity in the swap market.\22\ 
In addition, because competitive markets may be more efficient, a 
higher de minimis threshold might improve swap market efficiency. 
Further, the Commission notes that it has been suggested that a higher 
threshold could allow the Commission to expend its resources on 
entities with larger swap dealing activities warranting more oversight. 
An alternative view is that the de minimis threshold should be set 
based on policy independent of consideration of the Commission's 
resources.
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    \21\ Id. at 30628-30, 30707-08.
    \22\ Alternatively, the Commission notes that a lower de minimis 
threshold may lead to potential changes in market behavior, 
including, for example, product innovation.
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    Extending the phase-in period by one year will delay realization of 
the policy benefits associated with the $3 billion de minimis 
threshold, but will also extend the policy benefits associated with a 
higher de minimis threshold. The additional time to adjust to the $3 
billion de minimis threshold also would potentially increase regulatory 
certainty for some market participants. Given that the de minimis 
exception is subject to a 12-month look-back, extending the phase-in 
period to December 31, 2018 would allow entities that would potentially 
have to register as swap dealers additional time to adjust their 
activities and prepare for the compliance obligations related to swap 
dealer registration.
3. Section 15(a)
    Section 15(a) of the CEA requires the Commission to consider the 
effects of its

[[Page 71608]]

actions in light of the following five factors. This Order will delay 
the potential costs and benefits discussed below by one year.
(i) Protection of Market Participants and the Public
    Providing regulatory protections for swap counterparties who may be 
less experienced or knowledgeable about the swap products offered by 
swap dealers (particularly end-users who use swaps for hedging or 
investment purposes) is a fundamental policy goal advanced by the 
regulation of swap dealers. The Commission recognizes that the $3 
billion de minimis threshold may result in more entities being required 
to register as swap dealers compared to an $8 billion threshold, 
thereby extending counterparty protections to a greater number of 
market participants. Further, swap dealer regulation is intended to 
reduce systemic risk in the swap market. Pursuant to the Dodd-Frank 
Act, the Commission has proposed or adopted regulations for swap 
dealers--including margin and risk management requirements--designed to 
mitigate the potential systemic risk inherent in the swap market. 
Therefore, the Commission recognizes that a lower de minimis threshold 
may result in more entities being required to register as swap dealers, 
thereby potentially further reducing systemic risk.
(ii) Efficiency, Competitiveness, and Financial Integrity of Markets
    Other goals of swap dealer regulation are swap market transparency, 
orderliness, and efficiency. These benefits are achieved through 
regulations requiring, for example, swap dealers to keep trading 
records and report trades, provide counterparty disclosures about swap 
risks and pricing, and undertake portfolio reconciliation and 
compression exercises. Accordingly, the Commission notes that a lower 
de minimis threshold may have a positive effect on the efficiency and 
integrity of the markets.
    However, the Commission also recognizes that the efficiency and 
competitiveness of the swap market may be negatively impacted if the de 
minimis threshold is set too low by potentially increasing barriers to 
entry that may stifle competition and reduce swap market efficiency. 
For example, if entities choose to reduce or cease their swap dealing 
activities so that they would not need to register if the de minimis 
threshold decreases to $3 billion, the number or availability of market 
makers for swaps may be reduced, which could lead to increased costs 
for potential counterparties and end-users.
(iii) Price Discovery
    The Commission preliminarily believes that a $3 billion de minimis 
threshold may discourage participation of new swap dealers and 
ancillary dealing. If there are fewer entities engaged in dealing, 
there may be a negative effect on price discovery.
(iv) Sound Risk Management
    The Commission notes that a $3 billion de minimis threshold could 
lead to better risk management practices because a greater number of 
entities would be required by regulation to: (i) Develop and implement 
detailed risk management programs; (ii) adhere to business conduct 
standards that reduce operational and other risks; and (iii) satisfy 
margin requirements for uncleared swaps.
(v) Other Public Interest Considerations
    The Commission has not identified any other public purpose 
considerations for this Order.

C. Antitrust Considerations

    Section 15(b) of the CEA requires the Commission to take into 
consideration the public interest to be protected by the antitrust laws 
and endeavor to take the least anticompetitive means of achieving the 
objectives of the CEA, in issuing any order or adopting any Commission 
rule or regulation. The Commission does not anticipate that the Order 
discussed herein will result in anti-competitive behavior.

IV. Order

    In light of the foregoing, it is ordered, pursuant to the 
Commission's authority under Regulation 1.3(ggg)(4)(ii)(C)(1), that the 
de minimis threshold phase-in termination date shall be December 31, 
2018. Absent further action by the Commission, the phase-in period 
would terminate on December 31, 2018, at which time the de minimis 
threshold will be $3 billion.
    The Commission retains the authority to condition further, modify, 
suspend, terminate, or otherwise restrict any of the terms of the Order 
provided herein, in its discretion.

    Issued in Washington, DC, on October 13, 2016, by the 
Commission.
Christopher J. Kirkpatrick,
Secretary of the Commission.

Appendices To Order Establishing De Minimis Threshold Phase-In 
Termination Date Pursuant to Commission Regulation 
1.3(ggg)(4)(ii)(C)(1)--Commission Voting Summary, Chairman's Statement, 
and Commissioner's Statement

Appendix 1--Commission Voting Summary

    On this matter, Chairman Massad and Commissioners Bowen and 
Giancarlo voted in the affirmative. No Commissioner voted in the 
negative.

Appendix 2--Statement of Chairman Timothy G. Massad

    I thank my fellow Commissioners for unanimously supporting this 
order, which extends the phase-in of the de minimis threshold for 
swap dealing by one year.
    The de minimis threshold determines when an entity's swap 
dealing activity requires registration with the CFTC. Registration 
triggers capital and margin requirements as well as other 
responsibilities, such as disclosure, recordkeeping, and 
documentation requirements. In 2012, the CFTC set the threshold 
initially at $8 billion in notional amount of swap dealing activity 
over the course of a year, and provided that it would fall to $3 
billion at the end of 2017.
    This registration requirement is a pillar of the framework for 
swap regulation mandated by the Dodd-Frank Act. Congress required 
this framework because excessive risk related to over-the-counter 
derivatives contributed to the intensity of the worst financial 
crisis since the Great Depression, one which resulted in millions of 
American families losing their jobs, their homes and their savings. 
At the same time, Congress recognized that derivatives play an 
important role in enabling businesses to hedge risk. Therefore, 
getting this framework right is very important.
    There are now more than 100 swap dealers provisionally 
registered with the CFTC, which include most of the largest global 
banking entities. Absent our action today, the threshold would have 
dropped from $8 billion to $3 billion at the end of 2017. That means 
firms would have been required to start determining whether their 
activity exceeds that lower threshold just a few months from now--in 
January of next year. Pushing back this date is a sensible and 
responsible step for several reasons.
    First, our staff has completed the study required by the rule on 
the threshold. They estimated that lowering the threshold would not 
increase significantly the percentage of interest rate swaps (IRS) 
and credit default swaps (CDS) covered by swap dealer regulation, 
but it would require many additional firms to register. This might 
include some smaller banks whose swap activity is related to their 
commercial lending

[[Page 71609]]

business. At the same time, the study notes that the data has 
certain shortcomings, particularly when it comes to nonfinancial 
commodity swaps. This market is very different than the IRS and CDS 
markets, and I know there is much concern about the threshold with 
respect to it. This delay will allow us to consider all these issues 
further.
    In addition, I believe it makes sense to adopt a rule setting 
capital requirements for swap dealers before addressing the 
threshold. This rule, which is required by Dodd-Frank, is one of the 
most important in our regulation of swap dealers, and I am hoping 
the Commission can act on a reproposal of it soon. This one-year 
delay will also allow us to more fully assess how the new margin 
requirements are working.
    These are just some of the reasons we have taken this action. I 
thank the CFTC staff for their hard work on this order and on this 
issue generally. And I again thank my fellow Commissioners for their 
support.

Appendix 3--Concurring Statement of Commissioner Sharon Y. Bowen

    While we might disagree on the details of today's order, I think 
we can all agree on one thing: Today's action is very important to 
how the swaps industry operates and our system of financial 
regulation functions. If we do not accurately and appropriately set 
the mandatory level of trading for swap dealer registration, our 
entire regulatory regime for the swaps market will be weakened.
    I know that a great deal has been said about the subject of the 
de minimis threshold, and I expect that just about everyone 
reviewing today's decision to extend the current phase-in of the $3 
billion threshold by one year is all-too familiar with its 
substance. Yet, given the amount of prior actions that the 
Commission has taken on this topic, I think we cannot fully consider 
how to view today's action without first reviewing how we got here. 
Following the 2008 financial crisis, which was exacerbated by the 
absence of regulation of the swaps market, Congress passed the Dodd-
Frank Wall Street Reform and Consumer Protection Act. Among the many 
things in that Act were a raft of robust regulatory requirements on 
the swaps market, including mandatory clearing, a system of data 
reporting, and a mandate to trade many products on Swap Execution 
Facilities (SEFs).
    Some of the most significant new regulatory requirements were 
crafted for what we now call swap dealers, those entities which had 
significant involvement in the swaps market.\1\ For instance, along 
with major swap participants, swap dealers were at the heart of our 
new regulation regarding margin for uncleared swaps and the related 
cross-border rulemaking. Swap dealers will similarly be 
substantially impacted by our upcoming rule proposal on capital.
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    \1\ See Dodd-Frank Wall Street Reform and Consumer Protection 
Act (Dodd-Frank), section 721(49)(A), available at: http://www.cftc.gov/idc/groups/public/@swaps/documents/file/hr4173_enrolledbill.pdf. That provision states that the term ``swap 
dealer'' means any person who holds itself out as a dealer in swaps; 
makes a market in swaps; regularly enters into swaps with 
counterparties as an ordinary course of business for its own 
account; or engages in any activity causing the person to be 
commonly known in the trade as a dealer or market maker in swaps, 
with the proviso that, in no event shall an insured depository 
institution be considered to be a swap dealer to the extent it 
offers to enter into a swap with a customer in connection with 
originating a loan with that customer.
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    Who has to register as a swap dealer is therefore one of the 
linchpins of the entire swaps regulatory regime. If the level of 
swap dealing activity is not sufficient to capture entities that 
should be registered as swap dealers, then many of our other rules, 
including margin and capital, will not apply to these entities, and 
the markets may not be adequately protected. On the other hand, if 
the level of swap dealing activity is too low, many entities, that 
do not pose a meaningful risk to the financial system, will be 
required to register as swap dealers, thereby unnecessarily 
burdening markets.
    It was with this concern in mind that Congress required that we 
create a threshold for swap dealer registration. Dodd-Frank requires 
that the Commission shall exempt from designation as a swap dealer 
an entity that engages in a de minimis quantity of swap dealing in 
connection with transactions with or on behalf of its customers. The 
Commission shall promulgate regulations to establish factors with 
respect to the making of this determination to exempt.\2\ We are 
thus required to give entities an exemption from swap dealer 
registration if the quantity of their swap transactions falls below 
a certain level.
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    \2\ Dodd-Frank section 721(49)(D).
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    As required, the Commission set that level in 2012. As part of a 
rulemaking released in May 2012, the Commission set the level of the 
de minimis exemption at $3 billion, with a temporary phase-in level 
of $8 billion during the first few years.\3\ The Commission also 
agreed to release a report within the next few years as more data 
from the various industry participants involved in the swaps market 
was reported to the CFTC.\4\ The Commission further committed, once 
nine months had passed after the report was published ``and after 
giving due consideration to the report and any associated public 
comment,'' to give itself three options for how to deal with the 
threshold.\5\ First, we could terminate the phase-in period and have 
the threshold immediately drop to $3 billion. Second, if we decided 
it was ``necessary or appropriate in the public interest'' to 
propose a new threshold limit, we could do so via our typical 
rulemaking authority.\6\ Third, if we failed to pursue either the 
first or second options before a date certain--December 31, 2017, 
the phase-in period would automatically and immediately end, and the 
threshold would simply be $3 billion.\7\
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    \3\ See Further Definition of ``Swap Dealer,'' ``Security-Based 
Swap Dealer,'' ``Major Swap Participant,'' ``Major Security-Based 
Swap Participant,'' and ``Eligible Contract Participant,'' 77 FR 
30596 (May 23, 2012), available at: http://www.cftc.gov/idc/groups/public/@lrfederalregister/documents/file/2012-10562a.pdf.
    \4\ Id. at 30756.
    \5\ Id.
    \6\ Id.
    \7\ Id.
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    We have now published our final staff report on the de minimis 
threshold and the nine month period of considering whether to change 
the threshold has formally begun. I am grateful for the staff for 
all their hard work and appreciate that it has not been an easy 
undertaking. I am also grateful to market participants and the 
public for the comments and opinions that they have provided on the 
first and final drafts of the report. That said, it is clear from 
the report that our staff does not have sufficient data to make a 
fully informed decision.
    Today, the Commission is augmenting our efforts to get better 
data on this issue by extending the phase-in period of the threshold 
by one year. Because of the Commission's action, the threshold will 
continue to be at $8 billion until December 31, 2018. At that point, 
absent additional action by the Commission, the phase-in period will 
end and the threshold will be $3 billion.
    I support this initiative to get additional data on this 
subject, and I do not support changing the threshold at this time. 
But I wish to make something clear: We need to see hard data backing 
up the opinions we will receive during this delay about why we 
should not just allow the threshold to be $3 billion as established 
in the rule. I know that there is a great deal of disagreement about 
this issue, and I do not think we will be able to reach a consensus 
unless we have real economic analysis and evidence to back up 
people's comments. If you believe the threshold should be changed to 
$8 billion, or some other amount, because of market conditions, 
please, provide us with supporting data. Or, if you believe that the 
threshold should be even lower, as low as the $150 million threshold 
that was once contemplated, please provide us with supporting data. 
If we stay focused on hard, economic analysis and an objective view 
about the state of the market, the final determination of the 
threshold will be more understandable and transparent. Given the 
years of existing discussion and analysis and the established 
process the Commission has created, we would do both a disservice to 
the industry and to the public to change the threshold now absent 
strong evidence for doing so.
    I am sympathetic to the concerns that there may be onerous 
impacts on the market just because of this threshold. We know that 
cleared swaps are safer than uncleared swaps, which is why we have 
tried to encourage increased clearing of swaps. As such, I think 
there is some merit to modifying the threshold in the future by 
exempting cleared swaps from being counted in calculations of 
whether a firm is above it. If market participants or observers have 
strong thoughts on this idea or other ways that we might help make 
the $3 billion threshold less arduous, I encourage you to reach out 
to my office and my staff.
    I believe we should receive empirical data that can justify 
where the threshold number needs to be. I therefore expect that, 
near the start of 2017, we will start to collect additional data 
from market participants regarding those portions of the swaps 
market for which we still lack full and detailed

[[Page 71610]]

information. Absent that, I will have no basis from which to change 
the phase-in or move the threshold to something other than $3 
billion.
[FR Doc. 2016-25143 Filed 10-17-16; 8:45 am]
 BILLING CODE 6351-01-P



                                                            Federal Register / Vol. 81, No. 201 / Tuesday, October 18, 2016 / Rules and Regulations                                             71605

                                           except airplanes on which Airbus                        November 25, 2014, may be used to meet this           procedures and tests that are not identified
                                           Modification 35869 has been embodied in                 reporting requirement.                                as RC may be deviated from using accepted
                                           production.                                                (1) If the inspection was done on or after         methods in accordance with the operator’s
                                             (1) Airbus Model A318–111, –112, –121,                the effective date of this AD: Submit the             maintenance or inspection program without
                                           and –122 airplanes.                                     report within 90 days after the inspection.           obtaining approval of an AMOC, provided
                                             (2) Airbus Model A319–111, –112, –113,                   (2) If the inspection was done before the          the procedures and tests identified as RC can
                                           –114, –115, –131, –132, and –133 airplanes.             effective date of this AD: Submit the report          be done and the airplane can be put back in
                                             (3) Airbus Model A320–211, –212, –214,                within 90 days after the effective date of this       an airworthy condition. Any substitutions or
                                           –231, –232, and –233 airplanes.                         AD.                                                   changes to procedures or tests identified as
                                             (4) Airbus Model A321–111, –112, –131,                                                                      RC require approval of an AMOC.
                                                                                                   (i) Other FAA AD Provisions
                                           –211, –212, –213, –231, and –232 airplanes.                                                                   (j) Related Information
                                                                                                      The following provisions also apply to this
                                           (d) Subject                                             AD:                                                      Refer to Mandatory Continuing
                                            Air Transport Association (ATA) of                        (1) Alternative Methods of Compliance              Airworthiness Information (MCAI) European
                                           America Code 25, Equipment/Furnishings.                 (AMOCs): The Manager, International                   Aviation Safety Agency (EASA)
                                                                                                   Branch, ANM–116, Transport Airplane                   Airworthiness Directive 2015–0170, dated
                                           (e) Reason                                              Directorate, FAA, has the authority to                August 18, 2015, for related information.
                                             This AD was prompted by a report of                   approve AMOCs for this AD, if requested               This MCAI may be found in the AD docket
                                           cracks found during maintenance inspections             using the procedures found in 14 CFR 39.19.           on the Internet at http://www.regulations.gov
                                           on certain lugs of the 10VU rack side fittings          In accordance with 14 CFR 39.19, send your            by searching for and locating Docket No.
                                           in the cockpit. We are issuing this AD to               request to your principal inspector or local          FAA–2015–8132.
                                           prevent reading difficulties of flight-critical         Flight Standards District Office, as                  (k) Material Incorporated by Reference
                                           information displayed to the flightcrew                 appropriate. If sending information directly
                                                                                                   to the International Branch, send it to ATTN:            (1) The Director of the Federal Register
                                           during a critical phase of flight, such as an
                                                                                                   Sanjay Ralhan, Aerospace Engineer,                    approved the incorporation by reference
                                           approach or takeoff, which could result in
                                                                                                   International Branch, ANM–116, Transport              (IBR) of the service information listed in this
                                           loss of airplane control at an altitude
                                                                                                   Airplane Directorate, FAA, 1601 Lind                  paragraph under 5 U.S.C. 552(a) and 1 CFR
                                           insufficient for recovery.                                                                                    part 51.
                                                                                                   Avenue SW., Renton, WA 98057–3356;
                                           (f) Compliance                                          telephone 425–227–1405; fax 425–227–1149.                (2) You must use this service information
                                                                                                   Information may be emailed to: 9-ANM-116-             as applicable to do the actions required by
                                             Comply with this AD within the
                                                                                                   AMOC-REQUESTS@faa.gov. Before using                   this AD, unless this AD specifies otherwise.
                                           compliance times specified, unless already
                                                                                                   any approved AMOC, notify your appropriate               (i) Airbus Service Bulletin A320–92–1087,
                                           done.
                                                                                                   principal inspector, or lacking a principal           Revision 02, dated November 25, 2014.
                                           (g) Repetitive Inspections and Repair                   inspector, the manager of the local flight               (ii) Reserved.
                                                                                                   standards district office/certificate holding            (3) For service information identified in
                                              At the later of the times specified in
                                                                                                   district office.                                      this AD, contact Airbus, Airworthiness
                                           paragraphs (g)(1) and (g)(2) of this AD: Do a
                                                                                                      (2) Contacting the Manufacturer: For any           Office—EIAS, 1 Rond Point Maurice
                                           detailed inspection for cracking of the lugs
                                                                                                   requirement in this AD to obtain corrective           Bellonte, 31707 Blagnac Cedex, France;
                                           on the 10VU rack side fittings in the cockpit,
                                                                                                   actions from a manufacturer, the action must          telephone +33 5 61 93 36 96; fax +33 5 61
                                           in accordance with the Accomplishment
                                                                                                   be accomplished using a method approved               93 44 51; email account.airworth-eas@
                                           Instructions of Airbus Service Bulletin A320–
                                                                                                   by the Manager, International Branch, ANM–            airbus.com; Internet http://www.airbus.com.
                                           92–1087, Revision 02, dated November 25,                                                                         (4) You may view this service information
                                           2014. If any crack is found, before further             116, Transport Airplane Directorate, FAA; or
                                                                                                                                                         at the FAA, Transport Airplane Directorate,
                                           flight, repair in accordance with the                   the European Aviation Safety Agency
                                                                                                                                                         1601 Lind Avenue SW., Renton, WA. For
                                           Accomplishment Instructions of Airbus                   (EASA); or Airbus’s EASA Design
                                                                                                                                                         information on the availability of this
                                           Service Bulletin A320–92–1087, Revision 02,             Organization Approval (DOA). If approved by
                                                                                                                                                         material at the FAA, call 425–227–1221.
                                           dated November 25, 2014. Repeat the                     the DOA, the approval must include the
                                                                                                                                                            (5) You may view this service information
                                           inspection thereafter at intervals not to               DOA-authorized signature.
                                                                                                                                                         that is incorporated by reference at the
                                           exceed 20,000 flight cycles or 40,000 flight               (3) Reporting Requirements: A federal
                                                                                                                                                         National Archives and Records
                                           hours, whichever occurs first. Repair of the            agency may not conduct or sponsor, and a
                                                                                                                                                         Administration (NARA). For information on
                                           10VU rack lugs does not terminate the                   person is not required to respond to, nor
                                                                                                                                                         the availability of this material at NARA, call
                                           repetitive inspections required by this                 shall a person be subject to a penalty for            202–741–6030, or go to: http://
                                           paragraph.                                              failure to comply with a collection of                www.archives.gov/federal-register/cfr/ibr-
                                              (1) Before the accumulation of 30,000 total          information subject to the requirements of            locations.html.
                                           flight cycles or 60,000 total flight hours,             the Paperwork Reduction Act unless that
                                           whichever occurs first since the airplane’s             collection of information displays a current            Issued in Renton, Washington, on
                                           first flight.                                           valid OMB Control Number. The OMB                     September 14, 2016.
                                              (2) Within 24 months after the effective             Control Number for this information                   Michael Kaszycki,
                                           date of this AD.                                        collection is 2120–0056. Public reporting for         Acting Manager, Transport Airplane
                                                                                                   this collection of information is estimated to        Directorate, Aircraft Certification Service.
                                           (h) Reporting Requirement                               be approximately 5 minutes per response,
                                                                                                                                                         [FR Doc. 2016–22837 Filed 10–17–16; 8:45 am]
                                              Submit a report of any findings (positive            including the time for reviewing instructions,
                                           and negative) of any inspection required by             completing and reviewing the collection of            BILLING CODE 4910–13–P
                                           paragraph (g) of this AD to Airbus Service              information. All responses to this collection
                                           Bulletin Reporting Online Application on                of information are mandatory. Comments
                                           Airbus World (https://w3.airbus.com/), at the           concerning the accuracy of this burden and            COMMODITY FUTURES TRADING
                                           applicable time specified in paragraph (h)(1)           suggestions for reducing the burden should            COMMISSION
                                           or (h)(2) of this AD. Where Figure A–                   be directed to the FAA at: 800 Independence
                                           FRAAA—Sheet 02, titled ‘‘Inspection                     Ave. SW., Washington, DC 20591, Attn:                 17 CFR Part 1
                                           Report,’’ of Airbus Service Bulletin A320–              Information Collection Clearance Officer,
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                                           92–1087, Revision 02, dated November 25,                AES–200.                                              Order Establishing De Minimis
                                           2014, specifies sending removed lugs to                    (4) Required for Compliance (RC): If any           Threshold Phase-In Termination Date
                                           Airbus for investigation, this AD does not              service information contains procedures or
                                           include that requirement. The form                      tests that are identified as RC, those                AGENCY: Commodity Futures Trading
                                           contained in Figure A–FRAAA—Sheet 02,                   procedures and tests must be done to comply           Commission.
                                           titled ‘‘Inspection Report,’’ of Airbus Service         with this AD; any procedures or tests that are        ACTION: Order.
                                           Bulletin A320–92–1087, Revision 02, dated               not identified as RC are recommended. Those



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                                           71606            Federal Register / Vol. 81, No. 201 / Tuesday, October 18, 2016 / Rules and Regulations

                                           SUMMARY:   With respect to the de                       terminate on December 31, 2017, at                        levels and other potential changes to the
                                           minimis exception to the swap dealer                    which time the de minimis threshold                       de minimis exception.
                                           definition, the Commodity Futures                       would decrease to $3 billion.4 This
                                                                                                                                                             C. Swap Data Analysis
                                           Trading Commission (‘‘Commission’’ or                   would require firms to start tracking
                                           ‘‘CFTC’’) is issuing an order (‘‘Order’’),              their swap activity beginning January 1,                     As discussed in the Staff Reports, the
                                           pursuant to the applicable Commission                   2017 to determine whether their dealing                   lack of certain metrics needed for
                                           regulation, to establish December 31,                   activity over the course of that year                     evaluating different de minimis
                                           2018 as the de minimis threshold phase-                 would require them to register as swap                    thresholds, as well as data validity
                                           in termination date.                                    dealers.                                                  issues, limited the analysis of the
                                           DATES: Issued October 13, 2016.                            When the $3 billion de minimis                         potential impact of changes to the
                                           FOR FURTHER INFORMATION CONTACT:                        exception was established, the                            current de minimis exception.10 The
                                           Eileen T. Flaherty, Director, 202–418–                  Commissions explained that the                            Final Report further noted that,
                                           5326, eflaherty@cftc.gov; Erik Remmler,                 information then available regarding                      notwithstanding these data issues, the
                                           Deputy Director, 202–418–7630,                          certain portions of the swap market was                   quality of the swap data that is reported
                                           eremmler@cftc.gov; Lauren Bennett,                      limited in certain respects, and that they                to the Commission appears to be
                                           Special Counsel, 202–418–5290,                          expected that the implementation of                       continually improving, and that the
                                           lbennett@cftc.gov; Margo Dey, Special                   swap data reporting may enable                            Commission is taking additional steps to
                                           Counsel, 202–418–5276, mdey@cftc.gov;                   reassessment of the de minimis                            enhance swap data quality.11
                                                                                                                                                                The data analysis in the Staff Reports
                                           or Rajal Patel, Special Counsel, 202–                   exception.5 Accordingly, the
                                                                                                                                                             provided some insights into the
                                           418–5261, rpatel@cftc.gov, Division of                  Commission adopted Regulation
                                                                                                                                                             effectiveness of the de minimis
                                           Swap Dealer and Intermediary                            1.3(ggg)(4), which directed CFTC staff to
                                                                                                                                                             exception as currently implemented.
                                           Oversight, Commodity Futures Trading                    issue a report, after a specified period of
                                                                                                                                                             Staff analyzed the number of swap
                                           Commission, Three Lafayette Centre,                     time, on topics relating to the de
                                                                                                                                                             transactions involving at least one
                                           1155 21st Street NW., Washington, DC                    minimis exception ‘‘as appropriate,
                                                                                                                                                             registered swap dealer, which is
                                           20581.                                                  based on the availability of data and
                                                                                                                                                             indicative of the extent to which swaps
                                           SUPPLEMENTARY INFORMATION:                              information.’’ 6 Regulation 1.3(ggg)(4)
                                                                                                                                                             are subject to swap dealer regulation at
                                                                                                   further provides that after giving due
                                           I. Background                                                                                                     the current $8 billion threshold. Data
                                                                                                   consideration to the report and any
                                                                                                                                                             reviewed for the Final Report indicated
                                           A. Statutory and Regulatory Background                  associated public comment, the
                                                                                                                                                             that approximately 96% of all reported
                                                                                                   Commission may issue an order to
                                             The Dodd-Frank Wall Street Reform                                                                               swap transactions involved at least one
                                                                                                   establish a termination date for the
                                           and Consumer Protection Act (‘‘Dodd-                                                                              registered swap dealer. When
                                                                                                   phase-in period or propose through
                                           Frank Act’’) 1 directed the CFTC and the                                                                          considering individual swap asset
                                                                                                   rulemaking modifications to the de
                                           U.S. Securities and Exchange                                                                                      classes, approximately 98% or more of
                                                                                                   minimis exception.
                                           Commission (‘‘SEC’’ and together with                                                                             swaps in each asset class, other than the
                                           the CFTC, ‘‘Commissions’’) to jointly                   B. Staff Reports                                          Non-Financial Commodity asset class,
                                           further define the term ‘‘swap dealer’’                                                                           involved at least one registered swap
                                           and to include therein a de minimis                        Staff issued for public comment a                      dealer. Approximately 89% of Non-
                                           exception.2 The CFTC’s further                          preliminary report concerning the de                      Financial Commodity swaps involved a
                                           definition of swap dealer is provided in                minimis exception on November 18,                         registered swap dealer.12
                                           Regulation 1.3(ggg). The de minimis                     2015 (‘‘Preliminary Report’’).7 After                        However, as discussed above, the data
                                           exception therein provides that a person                consideration of the public comments                      available was not sufficient to assess
                                           shall not be deemed to be a swap dealer                 received, and further data analysis, staff                whether, and to what extent, specific
                                           unless its swap dealing activity exceeds                issued the Swap Dealer De Minimis                         changes to the de minimis threshold
                                           an aggregate gross notional amount                      Exception Final Staff Report 8 on August                  levels would increase or decrease the
                                           threshold of $3 billion (measured over                  15, 2016 (‘‘Final Report,’’ and together                  coverage of swaps by swap dealer
                                           the prior 12-month period), subject to a                with the Preliminary Report, ‘‘Staff                      regulation. In particular, the Staff
                                           phase-in period during which the gross                  Reports’’). The Staff Reports analyzed                    Reports noted that reliable notional
                                           notional amount threshold is set at $8                  the available swap data 9 in conjunction                  amount data was not available for Non-
                                           billion.3 Absent further action by the                  with relevant policy considerations to                    Financial Commodity, Equity, and FX
                                           Commission, the phase-in period would                   assess alternative de minimis threshold                   Derivative swaps.
                                                                                                                                                                The Commission also notes that it has
                                                                                                     4 See 17 CFR 1.3(ggg)(4)(ii)(D).
                                              1 Public Law 111–203, 124 Stat. 1376 (2010). The                                                               not yet adopted a regulation on capital
                                                                                                     5 See 77 FR at 30634, 30640.
                                           text of the Dodd-Frank Act can be accessed on the                                                                 requirements for swap dealers, which is
                                           Commission’s Web site, at www.cftc.gov.                   6 SEC Regulation 240.3a71–2A similarly directs
                                              2 See Dodd-Frank Act sections 712(d) and 721.        SEC staff to prepare a report on the security-based
                                                                                                                                                             a significant component of swap dealer
                                           The definition of ‘‘swap dealer’’ can be found in       swap dealer de minimis exception. 17 CFR                  registration. The Commission believes it
                                           section 1a(49) of the Commodity Exchange Act and        240.3a71–2A.
                                           as further defined in Regulation 1.3(ggg). 7 U.S.C.       7 Swap Dealer De Minimis Exception Preliminary             10 See Preliminary Report at 12–21; Final Report

                                           1a(49) and 17 CFR 1.3(ggg). The Commodity               Report (Nov. 18, 2015), available at http://              at 4–6, 19–20. For example, the data reported does
                                           Exchange Act is at 7 U.S.C. 1, et seq. (2014), and      www.cftc.gov/idc/groups/public/@swaps/                    not indicate whether either counterparty to a swap
                                           is accessible on the Commission’s Web site, at          documents/file/dfreport_sddeminis_1115.pdf.               is acting as a dealer, and there are difficulties in
                                           www.cftc.gov.                                             8 Swap Dealer De Minimis Exception Final Staff          calculating the notional amounts for certain types
                                              3 See 17 CFR 1.3(ggg)(4). See also Further           Report (August 15, 2016), available at http://            of swaps in a uniform manner useful for data
                                           Definition of ‘‘Swap Dealer,’’ ‘‘Security-Based Swap    www.cftc.gov/idc/groups/public/@swaps/                    analysis.
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                                           Dealer,’’ ‘‘Major Swap Participant,’’ ‘‘Major           documents/file/dfreport_sddeminis081516.pdf.                 11 See Final Report at 18–19. For example, in June

                                           Security-Based Swap Participant’’ and ‘‘Eligible          9 The data analysis broke down the data into the        2016, the Commission finalized amendments
                                           Contract Participant,’’ 77 FR 30596 (May 23, 2012).     following asset classes: Interest rate swaps (‘‘IRS’’);   related to the reporting of cleared swaps. See
                                              This Order does not impact the de minimis            credit default swaps (‘‘CDS’’); non-financial             Amendments to Swap Data Recordkeeping and
                                           threshold for swaps with ‘‘special entities’’ as        commodity (‘‘Non-Financial Commodity’’) swaps;            Reporting Requirements for Cleared Swaps, 81 FR
                                           defined in the Commodity Exchange Act, section          equity (‘‘Equity’’) swaps; and foreign exchange           41736 (June 27, 2016).
                                           4s(h)(2)(C), 7 U.S.C. 6s(h)(2)(C).                      derivatives (‘‘FX Derivatives’’).                            12 See Final Report at 22.




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                                                             Federal Register / Vol. 81, No. 201 / Tuesday, October 18, 2016 / Rules and Regulations                                               71607

                                           is prudent to finalize the capital rule                 benefits shall be evaluated in light of                recordkeeping, risk management,
                                           before addressing the de minimis                        five broad areas of market and public                  posting and collecting margin, and chief
                                           threshold. In addition, the swap dealer                 concern: (i) Protection of market                      compliance officer designation and
                                           requirements regarding margin for                       participants and the public; (ii)                      responsibilities. As noted in the
                                           uncleared swaps, another important                      efficiency, competitiveness, and                       Regulation 1.3(ggg) adopting release,
                                           component of swap dealer registration,                  financial integrity of futures markets;                generally, the lower the de minimis
                                           are currently being implemented. The                    (iii) price discovery; (iv) sound risk                 threshold, the greater the number of
                                           Commission believes that a year’s delay                 management practices; and (v) other                    entities that are subject to these
                                           would allow it to finalize the swap                     public interest considerations. In this                requirements, which could decrease
                                           dealer capital rule and assess the                      section, the Commission considers the                  systemic risk, increase counterparty
                                           implementation of margin requirements                   costs and benefits resulting from its                  protections, and promote swap market
                                           for uncleared swaps. Having                             determinations with respect to the                     efficiency, orderliness, and
                                           information on these aspects associated                 section 15(a) factors.                                 transparency.20
                                           with swap dealer registration would be                                                                            The Commission also considers
                                                                                                   1. Background                                          policy objectives furthered by a de
                                           helpful in further assessing the impact
                                           of changing the de minimis threshold.                      As discussed above, Regulation                      minimis exception, which include
                                              Accordingly, the Commission believes                 1.3(ggg)(4)(i) provides an exception from              regulatory certainty, allowing limited
                                           that it is prudent to extend the phase-                 the swap dealer definition for persons                 ancillary dealing, encouraging new
                                           in period by one year, which may                        who engage in a de minimis amount of                   participants to enter the swap dealing
                                           provide additional time for more                        swap dealing activity. Currently, under                market, and regulatory efficiency.21
                                           information to become available to                      Regulation 1.3(ggg)(4)(i), a person shall              Generally, the higher the de minimis
                                           reassess the de minimis exception.                      not be deemed to be a swap dealer                      threshold, the greater the number of
                                           Adopting this Order at this time also                   unless its swap dealing activity exceeds               entities that are able to engage in
                                           provides clarity to market participants                 an aggregate gross notional amount                     dealing activity without being required
                                           regarding when they would need to                       threshold of $3 billion (measured over                 to register, which could increase
                                           begin preparing for a change to the de                  the prior 12-month period), subject to a               competition and liquidity in the swap
                                           minimis exception.                                      phase-in period during which the gross                 market.22 In addition, because
                                                                                                   notional amount threshold is set at $8                 competitive markets may be more
                                           II. Conclusion and Order                                billion.16 The phase-in period would                   efficient, a higher de minimis threshold
                                              For the reasons discussed above, and                 have terminated on December 31, 2017,                  might improve swap market efficiency.
                                           pursuant to its authority under                         and the de minimis threshold would                     Further, the Commission notes that it
                                           Regulation 1.3(ggg)(4)(ii)(C)(1), the                   have decreased to $3 billion, absent this              has been suggested that a higher
                                           Commission is establishing December                     Order.17 This would have required firms                threshold could allow the Commission
                                           31, 2018 as the termination date for the                to start tracking their swap activity                  to expend its resources on entities with
                                           de minimis threshold phase-in period.                   beginning January 1, 2017 to determine                 larger swap dealing activities warranting
                                           The Commission notes that prior to the                  whether their dealing activity over the                more oversight. An alternative view is
                                           termination of the phase-in period, the                 course of that year would require them                 that the de minimis threshold should be
                                           Commission may take further action                      to register as swap dealers.                           set based on policy independent of
                                           regarding the de minimis threshold by                      The $3 billion threshold, which,                    consideration of the Commission’s
                                           rule amendment, order, or other                         absent this Order, would be effective on               resources.
                                           appropriate action.13                                   December 31, 2017, sets the baseline for                  Extending the phase-in period by one
                                                                                                   the Commission’s consideration of the                  year will delay realization of the policy
                                           III. Related Matters
                                                                                                   costs and benefits of this Order.18                    benefits associated with the $3 billion
                                           A. Paperwork Reduction Act                              Accordingly, the Commission considers                  de minimis threshold, but will also
                                              The Paperwork Reduction Act                          the costs and benefits that will result                extend the policy benefits associated
                                           (‘‘PRA’’) 14 imposes certain                            from an extended phase-in period.                      with a higher de minimis threshold. The
                                           requirements on Federal agencies in                     2. General Cost and Benefit                            additional time to adjust to the $3
                                           connection with their conducting or                     Considerations                                         billion de minimis threshold also would
                                           sponsoring any collection of                                                                                   potentially increase regulatory certainty
                                                                                                      There are several policy objectives                 for some market participants. Given that
                                           information as defined by the PRA. This
                                                                                                   underlying swap dealer regulation and                  the de minimis exception is subject to
                                           Order does not impose any new
                                                                                                   the de minimis exception to swap dealer                a 12-month look-back, extending the
                                           recordkeeping or information collection
                                                                                                   registration. The primary policy                       phase-in period to December 31, 2018
                                           requirements, or other collections of
                                                                                                   objectives of swap dealer regulation                   would allow entities that would
                                           information that require approval of the
                                                                                                   include the reduction of systemic risk,                potentially have to register as swap
                                           Office of Management and Budget under
                                                                                                   increased counterparty protections, and                dealers additional time to adjust their
                                           the PRA.
                                                                                                   market efficiency, orderliness, and                    activities and prepare for the
                                           B. Cost-Benefit Considerations                          transparency.19 Registered swap dealers                compliance obligations related to swap
                                             Section 15(a) of the Commodity                        are subject to a broad range of                        dealer registration.
                                           Exchange Act (‘‘CEA’’) requires the                     requirements, including, inter alia,
                                                                                                   registration, internal and external                    3. Section 15(a)
                                           Commission to consider the costs and
                                           benefits of its actions before                          business conduct standards, reporting,                    Section 15(a) of the CEA requires the
                                           promulgating a regulation under the                                                                            Commission to consider the effects of its
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                                                                                                     16 17 CFR 1.3(ggg)(4)(i). See generally 77 FR at
                                           CEA or issuing certain orders.15 Section                30626–35. See also note 3, supra.                        20 Id.at 30628–30, 30703, 30707–08.
                                           15(a) further specifies that the costs and                17 17 CFR 1.3(ggg)(4).                                 21 Id.at 30628–30, 30707–08.
                                                                                                     18 See 77 FR at 30702–14 (discussing the cost-         22 Alternatively, the Commission notes that a
                                             13 See 17 CFR 1.3(ggg)(4)(v).                         benefit considerations with regard to the final swap   lower de minimis threshold may lead to potential
                                             14 44 U.S.C. 3501 et seq.                             dealer definition).                                    changes in market behavior, including, for example,
                                             15 7 U.S.C. 19(a).                                      19 Id. at 30628–30, 30707–08.                        product innovation.



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                                           71608            Federal Register / Vol. 81, No. 201 / Tuesday, October 18, 2016 / Rules and Regulations

                                           actions in light of the following five                  costs for potential counterparties and                  Issued in Washington, DC, on October 13,
                                           factors. This Order will delay the                      end-users.                                            2016, by the Commission.
                                           potential costs and benefits discussed                                                                        Christopher J. Kirkpatrick,
                                           below by one year.                                      (iii) Price Discovery                                 Secretary of the Commission.
                                           (i) Protection of Market Participants and                 The Commission preliminarily                        Appendices To Order Establishing De
                                           the Public                                              believes that a $3 billion de minimis                 Minimis Threshold Phase-In
                                                                                                   threshold may discourage participation                Termination Date Pursuant to
                                              Providing regulatory protections for                 of new swap dealers and ancillary                     Commission Regulation
                                           swap counterparties who may be less                                                                           1.3(ggg)(4)(ii)(C)(1)—Commission
                                                                                                   dealing. If there are fewer entities
                                           experienced or knowledgeable about the                                                                        Voting Summary, Chairman’s
                                                                                                   engaged in dealing, there may be a
                                           swap products offered by swap dealers                                                                         Statement, and Commissioner’s
                                                                                                   negative effect on price discovery.
                                           (particularly end-users who use swaps                                                                         Statement
                                           for hedging or investment purposes) is                  (iv) Sound Risk Management
                                           a fundamental policy goal advanced by                                                                         Appendix 1—Commission Voting
                                           the regulation of swap dealers. The                       The Commission notes that a $3                      Summary
                                           Commission recognizes that the $3                       billion de minimis threshold could lead                 On this matter, Chairman Massad and
                                           billion de minimis threshold may result                 to better risk management practices                   Commissioners Bowen and Giancarlo voted
                                           in more entities being required to                      because a greater number of entities                  in the affirmative. No Commissioner voted in
                                           register as swap dealers compared to an                 would be required by regulation to: (i)               the negative.
                                           $8 billion threshold, thereby extending                 Develop and implement detailed risk                   Appendix 2—Statement of Chairman
                                           counterparty protections to a greater                   management programs; (ii) adhere to                   Timothy G. Massad
                                           number of market participants. Further,                 business conduct standards that reduce
                                           swap dealer regulation is intended to                                                                            I thank my fellow Commissioners for
                                                                                                   operational and other risks; and (iii)
                                           reduce systemic risk in the swap                                                                              unanimously supporting this order, which
                                                                                                   satisfy margin requirements for                       extends the phase-in of the de minimis
                                           market. Pursuant to the Dodd-Frank Act,                 uncleared swaps.                                      threshold for swap dealing by one year.
                                           the Commission has proposed or                                                                                   The de minimis threshold determines
                                           adopted regulations for swap dealers—                   (v) Other Public Interest Considerations              when an entity’s swap dealing activity
                                           including margin and risk management                                                                          requires registration with the CFTC.
                                                                                                     The Commission has not identified
                                           requirements—designed to mitigate the                                                                         Registration triggers capital and margin
                                           potential systemic risk inherent in the                 any other public purpose considerations               requirements as well as other
                                           swap market. Therefore, the                             for this Order.                                       responsibilities, such as disclosure,
                                           Commission recognizes that a lower de                                                                         recordkeeping, and documentation
                                                                                                   C. Antitrust Considerations                           requirements. In 2012, the CFTC set the
                                           minimis threshold may result in more                                                                          threshold initially at $8 billion in notional
                                           entities being required to register as                     Section 15(b) of the CEA requires the              amount of swap dealing activity over the
                                           swap dealers, thereby potentially further               Commission to take into consideration                 course of a year, and provided that it would
                                           reducing systemic risk.                                 the public interest to be protected by the            fall to $3 billion at the end of 2017.
                                                                                                   antitrust laws and endeavor to take the                  This registration requirement is a pillar of
                                           (ii) Efficiency, Competitiveness, and                                                                         the framework for swap regulation mandated
                                           Financial Integrity of Markets                          least anticompetitive means of
                                                                                                   achieving the objectives of the CEA, in               by the Dodd-Frank Act. Congress required
                                              Other goals of swap dealer regulation                                                                      this framework because excessive risk related
                                                                                                   issuing any order or adopting any                     to over-the-counter derivatives contributed to
                                           are swap market transparency,                           Commission rule or regulation. The                    the intensity of the worst financial crisis
                                           orderliness, and efficiency. These                      Commission does not anticipate that the               since the Great Depression, one which
                                           benefits are achieved through                           Order discussed herein will result in                 resulted in millions of American families
                                           regulations requiring, for example, swap                anti-competitive behavior.                            losing their jobs, their homes and their
                                           dealers to keep trading records and                                                                           savings. At the same time, Congress
                                           report trades, provide counterparty                     IV. Order                                             recognized that derivatives play an important
                                           disclosures about swap risks and                                                                              role in enabling businesses to hedge risk.
                                           pricing, and undertake portfolio                          In light of the foregoing, it is ordered,           Therefore, getting this framework right is
                                                                                                   pursuant to the Commission’s authority                very important.
                                           reconciliation and compression                                                                                   There are now more than 100 swap dealers
                                           exercises. Accordingly, the Commission                  under Regulation 1.3(ggg)(4)(ii)(C)(1),
                                                                                                                                                         provisionally registered with the CFTC,
                                           notes that a lower de minimis threshold                 that the de minimis threshold phase-in
                                                                                                                                                         which include most of the largest global
                                           may have a positive effect on the                       termination date shall be December 31,                banking entities. Absent our action today, the
                                           efficiency and integrity of the markets.                2018. Absent further action by the                    threshold would have dropped from $8
                                              However, the Commission also                         Commission, the phase-in period would                 billion to $3 billion at the end of 2017. That
                                           recognizes that the efficiency and                      terminate on December 31, 2018, at                    means firms would have been required to
                                                                                                   which time the de minimis threshold                   start determining whether their activity
                                           competitiveness of the swap market may                                                                        exceeds that lower threshold just a few
                                           be negatively impacted if the de                        will be $3 billion.
                                                                                                                                                         months from now—in January of next year.
                                           minimis threshold is set too low by                       The Commission retains the authority                Pushing back this date is a sensible and
                                           potentially increasing barriers to entry                to condition further, modify, suspend,                responsible step for several reasons.
                                           that may stifle competition and reduce                  terminate, or otherwise restrict any of                  First, our staff has completed the study
                                           swap market efficiency. For example, if                                                                       required by the rule on the threshold. They
                                                                                                   the terms of the Order provided herein,
                                           entities choose to reduce or cease their                                                                      estimated that lowering the threshold would
                                                                                                   in its discretion.
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                                           swap dealing activities so that they                                                                          not increase significantly the percentage of
                                                                                                                                                         interest rate swaps (IRS) and credit default
                                           would not need to register if the de                                                                          swaps (CDS) covered by swap dealer
                                           minimis threshold decreases to $3                                                                             regulation, but it would require many
                                           billion, the number or availability of                                                                        additional firms to register. This might
                                           market makers for swaps may be                                                                                include some smaller banks whose swap
                                           reduced, which could lead to increased                                                                        activity is related to their commercial lending



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                                                             Federal Register / Vol. 81, No. 201 / Tuesday, October 18, 2016 / Rules and Regulations                                                  71609

                                           business. At the same time, the study notes              major swap participants, swap dealers were                    We have now published our final staff
                                           that the data has certain shortcomings,                  at the heart of our new regulation regarding               report on the de minimis threshold and the
                                           particularly when it comes to nonfinancial               margin for uncleared swaps and the related                 nine month period of considering whether to
                                           commodity swaps. This market is very                     cross-border rulemaking. Swap dealers will                 change the threshold has formally begun. I
                                           different than the IRS and CDS markets, and              similarly be substantially impacted by our                 am grateful for the staff for all their hard
                                           I know there is much concern about the                   upcoming rule proposal on capital.                         work and appreciate that it has not been an
                                           threshold with respect to it. This delay will               Who has to register as a swap dealer is                 easy undertaking. I am also grateful to market
                                           allow us to consider all these issues further.           therefore one of the linchpins of the entire               participants and the public for the comments
                                              In addition, I believe it makes sense to              swaps regulatory regime. If the level of swap              and opinions that they have provided on the
                                           adopt a rule setting capital requirements for            dealing activity is not sufficient to capture              first and final drafts of the report. That said,
                                           swap dealers before addressing the threshold.            entities that should be registered as swap                 it is clear from the report that our staff does
                                           This rule, which is required by Dodd-Frank,              dealers, then many of our other rules,                     not have sufficient data to make a fully
                                           is one of the most important in our regulation           including margin and capital, will not apply               informed decision.
                                           of swap dealers, and I am hoping the                     to these entities, and the markets may not be                 Today, the Commission is augmenting our
                                           Commission can act on a reproposal of it                 adequately protected. On the other hand, if                efforts to get better data on this issue by
                                           soon. This one-year delay will also allow us             the level of swap dealing activity is too low,             extending the phase-in period of the
                                           to more fully assess how the new margin                  many entities, that do not pose a meaningful               threshold by one year. Because of the
                                           requirements are working.                                risk to the financial system, will be required             Commission’s action, the threshold will
                                              These are just some of the reasons we have            to register as swap dealers, thereby                       continue to be at $8 billion until December
                                           taken this action. I thank the CFTC staff for            unnecessarily burdening markets.                           31, 2018. At that point, absent additional
                                           their hard work on this order and on this                   It was with this concern in mind that                   action by the Commission, the phase-in
                                           issue generally. And I again thank my fellow             Congress required that we create a threshold               period will end and the threshold will be $3
                                           Commissioners for their support.                         for swap dealer registration. Dodd-Frank                   billion.
                                                                                                    requires that the Commission shall exempt                     I support this initiative to get additional
                                           Appendix 3—Concurring Statement of                       from designation as a swap dealer an entity                data on this subject, and I do not support
                                           Commissioner Sharon Y. Bowen                             that engages in a de minimis quantity of swap              changing the threshold at this time. But I
                                                                                                    dealing in connection with transactions with               wish to make something clear: We need to
                                              While we might disagree on the details of             or on behalf of its customers. The
                                           today’s order, I think we can all agree on one                                                                      see hard data backing up the opinions we
                                                                                                    Commission shall promulgate regulations to                 will receive during this delay about why we
                                           thing: Today’s action is very important to               establish factors with respect to the making
                                           how the swaps industry operates and our                                                                             should not just allow the threshold to be $3
                                                                                                    of this determination to exempt.2 We are thus              billion as established in the rule. I know that
                                           system of financial regulation functions. If             required to give entities an exemption from
                                           we do not accurately and appropriately set                                                                          there is a great deal of disagreement about
                                                                                                    swap dealer registration if the quantity of
                                           the mandatory level of trading for swap                                                                             this issue, and I do not think we will be able
                                                                                                    their swap transactions falls below a certain
                                           dealer registration, our entire regulatory                                                                          to reach a consensus unless we have real
                                                                                                    level.
                                           regime for the swaps market will be                                                                                 economic analysis and evidence to back up
                                                                                                       As required, the Commission set that level
                                           weakened.                                                in 2012. As part of a rulemaking released in               people’s comments. If you believe the
                                              I know that a great deal has been said about          May 2012, the Commission set the level of                  threshold should be changed to $8 billion, or
                                           the subject of the de minimis threshold, and             the de minimis exemption at $3 billion, with               some other amount, because of market
                                           I expect that just about everyone reviewing              a temporary phase-in level of $8 billion                   conditions, please, provide us with
                                           today’s decision to extend the current phase-            during the first few years.3 The Commission                supporting data. Or, if you believe that the
                                           in of the $3 billion threshold by one year is            also agreed to release a report within the next            threshold should be even lower, as low as the
                                           all-too familiar with its substance. Yet, given          few years as more data from the various                    $150 million threshold that was once
                                           the amount of prior actions that the                     industry participants involved in the swaps                contemplated, please provide us with
                                           Commission has taken on this topic, I think              market was reported to the CFTC.4 The                      supporting data. If we stay focused on hard,
                                           we cannot fully consider how to view today’s             Commission further committed, once nine                    economic analysis and an objective view
                                           action without first reviewing how we got                months had passed after the report was                     about the state of the market, the final
                                           here. Following the 2008 financial crisis,               published ‘‘and after giving due                           determination of the threshold will be more
                                           which was exacerbated by the absence of                  consideration to the report and any                        understandable and transparent. Given the
                                           regulation of the swaps market, Congress                 associated public comment,’’ to give itself                years of existing discussion and analysis and
                                           passed the Dodd-Frank Wall Street Reform                 three options for how to deal with the                     the established process the Commission has
                                           and Consumer Protection Act. Among the                   threshold.5 First, we could terminate the                  created, we would do both a disservice to the
                                           many things in that Act were a raft of robust            phase-in period and have the threshold                     industry and to the public to change the
                                           regulatory requirements on the swaps market,             immediately drop to $3 billion. Second, if we              threshold now absent strong evidence for
                                           including mandatory clearing, a system of                decided it was ‘‘necessary or appropriate in               doing so.
                                           data reporting, and a mandate to trade many              the public interest’’ to propose a new                        I am sympathetic to the concerns that there
                                           products on Swap Execution Facilities                    threshold limit, we could do so via our                    may be onerous impacts on the market just
                                           (SEFs).                                                  typical rulemaking authority.6 Third, if we                because of this threshold. We know that
                                              Some of the most significant new                      failed to pursue either the first or second                cleared swaps are safer than uncleared
                                           regulatory requirements were crafted for                 options before a date certain—December 31,                 swaps, which is why we have tried to
                                                                                                    2017, the phase-in period would                            encourage increased clearing of swaps. As
                                           what we now call swap dealers, those entities
                                                                                                    automatically and immediately end, and the                 such, I think there is some merit to modifying
                                           which had significant involvement in the
                                                                                                    threshold would simply be $3 billion.7                     the threshold in the future by exempting
                                           swaps market.1 For instance, along with
                                                                                                                                                               cleared swaps from being counted in
                                              1 See Dodd-Frank Wall Street Reform and               to enter into a swap with a customer in connection         calculations of whether a firm is above it. If
                                                                                                    with originating a loan with that customer.                market participants or observers have strong
                                           Consumer Protection Act (Dodd-Frank), section               2 Dodd-Frank section 721(49)(D).
                                           721(49)(A), available at: http://www.cftc.gov/idc/                                                                  thoughts on this idea or other ways that we
                                                                                                       3 See Further Definition of ‘‘Swap Dealer,’’
                                           groups/public/@swaps/documents/file/hr4173_                                                                         might help make the $3 billion threshold less
                                           enrolledbill.pdf. That provision states that the term    ‘‘Security-Based Swap Dealer,’’ ‘‘Major Swap               arduous, I encourage you to reach out to my
                                           ‘‘swap dealer’’ means any person who holds itself        Participant,’’ ‘‘Major Security-Based Swap
                                                                                                    Participant,’’ and ‘‘Eligible Contract Participant,’’ 77
                                                                                                                                                               office and my staff.
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                                           out as a dealer in swaps; makes a market in swaps;                                                                     I believe we should receive empirical data
                                           regularly enters into swaps with counterparties as       FR 30596 (May 23, 2012), available at: http://
                                                                                                    www.cftc.gov/idc/groups/public/@lrfederalregister/         that can justify where the threshold number
                                           an ordinary course of business for its own account;
                                           or engages in any activity causing the person to be
                                                                                                    documents/file/2012-10562a.pdf.                            needs to be. I therefore expect that, near the
                                           commonly known in the trade as a dealer or market
                                                                                                       4 Id. at 30756.                                         start of 2017, we will start to collect
                                           maker in swaps, with the proviso that, in no event
                                                                                                       5 Id.                                                   additional data from market participants
                                           shall an insured depository institution be                  6 Id.                                                   regarding those portions of the swaps market
                                           considered to be a swap dealer to the extent it offers      7 Id.                                                   for which we still lack full and detailed



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                                           71610            Federal Register / Vol. 81, No. 201 / Tuesday, October 18, 2016 / Rules and Regulations

                                           information. Absent that, I will have no basis          commercial distribution before May 28,                FD&C Act, FDA issued an order on May
                                           from which to change the phase-in or move               1976 (the date of enactment of the                    18, 2012, classifying the DEKA Arm
                                           the threshold to something other than $3                Medical Device Amendments of 1976),                   System into class III, because it was not
                                           billion.                                                generally referred to as postamendments               substantially equivalent to a device that
                                           [FR Doc. 2016–25143 Filed 10–17–16; 8:45 am]
                                                                                                   devices, are classified automatically by              was introduced or delivered for
                                           BILLING CODE 6351–01–P
                                                                                                   statute into class III without any FDA                introduction into interstate commerce
                                                                                                   rulemaking process. These devices                     for commercial distribution before May
                                                                                                   remain in class III and require                       28, 1976, or a device which was
                                           DEPARTMENT OF HEALTH AND                                premarket approval, unless and until                  subsequently reclassified into class I or
                                           HUMAN SERVICES                                          the device is classified or reclassified              class II.
                                                                                                   into class I or II, or FDA issues an order               On June 15, 2012, DEKA Integrated
                                           Food and Drug Administration                            finding the device to be substantially                Solutions Corporation submitted a
                                                                                                   equivalent, in accordance with section                request for classification of the DEKA
                                           21 CFR Part 890                                         513(i), to a predicate device that does               Arm System under section 513(f)(2) of
                                           [Docket No. FDA–2016–N–2829]                            not require premarket approval. The                   the FD&C Act. In accordance with
                                                                                                   Agency determines whether new                         section 513(f)(2) of the FD&C Act, FDA
                                           Medical Devices; Physical Medicine                      devices are substantially equivalent to               reviewed the request in order to classify
                                           Devices; Classification of the Upper                    predicate devices by means of                         the device under the criteria for
                                           Extremity Prosthesis Including a                        premarket notification procedures in                  classification set forth in section
                                           Simultaneously Powered Elbow and/or                     section 510(k) of the FD&C Act (21                    513(a)(1). FDA classifies devices into
                                           Shoulder With Greater Than Two                          U.S.C. 360(k)) and part 807 (21 CFR part              class II if general controls by themselves
                                           Simultaneous Powered Degrees of                         807) of the regulations.                              are insufficient to provide reasonable
                                           Freedom and Controlled by Non-                             Section 513(f)(2) of the FD&C Act, as              assurance of safety and effectiveness,
                                           Implanted Electrical Components                         amended by section 607 of the Food and                but there is sufficient information to
                                                                                                   Drug Administration Safety and                        establish special controls to provide
                                           AGENCY:    Food and Drug Administration,                Innovation Act (Pub. L. 112–144),                     reasonable assurance of the safety and
                                           HHS.                                                    provides two procedures by which a                    effectiveness of the device for its
                                           ACTION:   Final order.                                  person may request FDA to classify a                  intended use. After review of the
                                           SUMMARY:    The Food and Drug                           device under the criteria set forth in                information submitted in the request,
                                           Administration (FDA) is classifying the                 section 513(a)(1). Under the first                    FDA determined that the device can be
                                           Upper Extremity Prosthesis Including a                  procedure, the person submits a                       classified into class II with the
                                           Simultaneously Powered Elbow and/or                     premarket notification under section                  establishment of special controls. FDA
                                           Shoulder with Greater Than Two                          510(k) of the FD&C Act for a device that              believes these special controls, in
                                           Simultaneous Powered Degrees of                         has not previously been classified and,               addition to general controls, will
                                           Freedom and Controlled by Non-                          within 30 days of receiving an order                  provide reasonable assurance of the
                                           Implanted Electrical Components into                    classifying the device into class III                 safety and effectiveness of the device.
                                                                                                   under section 513(f)(1), the person                      Therefore, on May 9, 2014, FDA
                                           class II (special controls). The special
                                                                                                   requests a classification under section               issued an order to the requestor
                                           controls that will apply to the device are
                                                                                                   513(f)(2) of the FD&C Act. Under the                  classifying the device into class II. FDA
                                           identified in this order and will be part                                                                     is codifying the classification of the
                                                                                                   second procedure, rather than first
                                           of the codified language for the upper                                                                        device by adding 21 CFR 890.3450.
                                                                                                   submitting a premarket notification
                                           extremity prosthesis including a                                                                                 Following the effective date of this
                                                                                                   under section 510(k) and then a request
                                           simultaneously powered elbow and/or                                                                           final classification order, any firm
                                                                                                   for classification under the first
                                           shoulder with greater than two                                                                                submitting a premarket notification
                                                                                                   procedure, the person determines that
                                           simultaneous powered degrees of                                                                               (510(k)) for an upper extremity
                                                                                                   there is no legally marketed device upon
                                           freedom and controlled by non-                                                                                prosthesis including a simultaneously
                                                                                                   which to base a determination of
                                           implanted electrical components’                                                                              powered elbow and/or shoulder with
                                                                                                   substantial equivalence and requests a
                                           classification. The Agency is classifying               classification under section 513(f)(2) of             greater than two simultaneous powered
                                           the device into class II (special controls)             the FD&C Act. If the person submits a                 degrees of freedom and controlled by
                                           in order to provide a reasonable                        request to classify the device under this             non-implanted electrical components
                                           assurance of safety and effectiveness of                second procedure, FDA may decline to                  will need to comply with the special
                                           the device.                                             undertake the classification request if               controls named in this final order. The
                                           DATES: This order is effective October                  FDA identifies a legally marketed device              device is assigned the generic name
                                           18, 2016. The classification was                        that could provide a reasonable basis for             upper extremity prosthesis including a
                                           applicable on May 9, 2014.                              review of substantial equivalence with                simultaneously powered elbow and/or
                                           FOR FURTHER INFORMATION CONTACT:                        the device or if FDA determines that the              shoulder with greater than two
                                           Michael Hoffmann, Center for Devices                    device submitted is not of ‘‘low-                     simultaneous powered degrees of
                                           and Radiological Health, Food and Drug                  moderate risk’’ or that general controls              freedom and controlled by non-
                                           Administration, 10903 New Hampshire                     would be inadequate to control the risks              implanted electrical components, and it
                                           Ave., Bldg. 66, Rm. 2640, Silver Spring,                and special controls to mitigate the risks            is identified as a prescription device
                                           MD, 20993–0002, 301–796–6476,                           cannot be developed.                                  intended for medical purposes, and
                                           Michael.Hoffmann@fda.hhs.gov.                              In response to a request to classify a             intended to replace a partially or fully
                                           SUPPLEMENTARY INFORMATION:                              device under either procedure provided                amputated or congenitally absent upper
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                                                                                                   by section 513(f)(2) of the FD&C Act,                 extremity. It uses electronic inputs
                                           I. Background                                           FDA shall classify the device by written              (other than simple, manually controlled
                                              In accordance with section 513(f)(1) of              order within 120 days. This                           electrical components such as switches)
                                           the Federal Food, Drug, and Cosmetic                    classification will be the initial                    to provide greater than two independent
                                           Act (the FD&C Act) (21 U.S.C.                           classification of the device. In                      and simultaneously powered degrees of
                                           360c(f)(1)), devices that were not in                   accordance with section 513(f)(1) of the              freedom and includes a simultaneously


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Document Created: 2016-10-17 23:52:20
Document Modified: 2016-10-17 23:52:20
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionOrder.
DatesIssued October 13, 2016.
ContactEileen T. Flaherty, Director, 202-418- 5326, [email protected]; Erik Remmler, Deputy Director, 202-418-7630, [email protected]; Lauren Bennett, Special Counsel, 202-418-5290, [email protected]; Margo Dey, Special Counsel, 202-418-5276, [email protected]; or Rajal Patel, Special Counsel, 202-418-5261, [email protected], Division of Swap Dealer and Intermediary Oversight, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street NW., Washington, DC 20581.
FR Citation81 FR 71605 

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