[Federal Register Volume 84, Number 157 (Wednesday, August 14, 2019)]
[Notices]
[Pages 40460-40464]
[FR Doc No: 2019-17383]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-86603; File No. SR-CBOE-2019-044]

Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of
Filing of a Proposed Rule Change Relating To Adopt Rule 6.49B, Off-
Floor RWA Transfers

August 8, 2019.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on August 6, 2019, Cboe Exchange, Inc. (the ``Exchange'' or ``Cboe
Options'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Cboe Exchange, Inc. (the ``Exchange'' or ``Cboe Options'') proposes
to adopt Rule 6.49B. The text of the proposed rule change is provided
in Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), at the Exchange's Office of the
Secretary, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to adopt Rule 6.49B to add an exception to
the prohibition in Rule 6.49(a) against off-floor position transfers.
Rule 6.49(a) generally requires transactions of option contracts listed
on the Exchange for a premium in excess of $1.00 to be effected on the
floor of the Exchange or on another exchange. Rule 6.49A(a) specifies
the current circumstances \3\ under which Trading Permit Holders may
effect transfers of positions off the trading floor, notwithstanding
the prohibition in Rule 6.49(a).\4\
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    \3\ The circumstances currently listed include: (1) The
dissolution of a joint account in which the remaining Trading Permit
Holder assumes the positions of the joint account; (2) the
dissolution of a corporation or partnership in which a former
nominee of the corporation or partnership assumes the positions; (3)
positions transferred as part of a Trading Permit Holder's capital
contribution to a new joint account, partnership, or corporation;
(4) the donation of positions to a not-for-profit corporation; (5)
the transfer of positions to a minor under the Uniform Gifts to
Minor law; and (6) a merger or acquisition where continuity of
ownership or management results.
    \4\ See SR-CBOE-2019-035, which proposes to amend Rule 6.49A and
is currently pending with the Securities and Exchange Commission
(the ``Commission''). The Exchange notes the proposed rule change in
this rule filing was initially included in SR-CBOE-2019-3035 [sic];
pursuant to Amendment No. 1 to that rule filing, submitted on August
6, 2019, the proposed rule change in this filing was deleted. The
Exchange proposes a virtually identical change in this rule filing.
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    Proposed Rule 6.49B is intended to facilitate the reduction of
risk-weighted assets (``RWA'') attributable to open options positions
and make other conforming changes. SEC Rule 15c3-1 (Net Capital
Requirements for Brokers or Dealers) (``Net Capital Rules'') requires
registered broker-dealers, unless otherwise excepted, to maintain
certain specified minimum levels of capital.\5\ The Net Capital Rules
are designed to protect securities customers, counterparties, and
creditors by requiring that broker-dealers have sufficient liquid
resources on hand, at all times, to meet their financial obligations.
Notably, hedged positions, including offsetting futures and options
contract positions, result in certain net capital requirement
reductions under the Net Capital Rules.\6\
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    \5\ 17 CFR 240.15c3-1.
    \6\ In addition, the Net Capital Rules permit various offsets
under which a percentage of an option position's gain at any one
valuation point is allowed to offset another position's loss at the
same valuation point (e.g. vertical spreads).
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    Subject to certain exceptions, Clearing Trading Permit Holders
(``CTPHs'') \7\ are subject to the Net Capital Rules.\8\ However, a
subset of CTPHs are subsidiaries of U.S. bank holding companies, which,
due to their affiliations with their parent U.S.-bank holding
companies, must comply with additional bank regulatory capital
requirements pursuant to rulemaking required under the Dodd-Frank Wall
Street Reform and Consumer Protection Act.\9\ Pursuant to this mandate,
the Board of Governors of the Federal Reserve System, the Office of the
Comptroller of the Currency, and the

Federal Deposit Insurance Corporation have approved a regulatory
capital framework for subsidiaries of U.S. bank holding company
clearing firms.\10\ Generally, these rules, among other things, impose
higher minimum capital and higher asset risk weights than were
previously mandated for CTPHs that are subsidiaries of U.S. bank
holding companies under the Net Capital Rules. Furthermore, the new
rules do not fully permit deductions for hedged securities or
offsetting options positions.\11\ Rather, capital charges under these
standards are, in large part, based on the aggregate notional value of
short positions regardless of offsets. As a result, in general, CTPHs
that are subsidiaries of U.S. bank holding companies must hold
substantially more bank regulatory capital than would otherwise be
required under the Net Capital Rules.
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    \7\ All CTPHs must also be clearing members of The Options
Clearing Corporation (``OCC'').
    \8\ Assuming the Commission approves the proposed rule change,
in the event federal regulators modify bank capital requirements in
the future, the Exchange will reevaluate the proposed rule change at
that time to determine whether any corresponding changes to the
proposed rule are appropriate.
    \9\ H.R. 4173 (amending section 3(a) of the Securities Exchange
Act of 1934 (the ``Act'') (15 U.S.C. 78c(a))).
    \10\ 12 CFR 50; 79 FR 61440 (Liquidity Coverage Ratio: Liquidity
Risk Measurement Standards).
    \11\ Many options strategies, including relatively simple
strategies often used by retail customers and more sophisticated
strategies used by broker-dealers, are risk-limited strategies or
options spread strategies that employ offsets or hedges to achieve
certain investment outcomes. Such strategies typically involve the
purchase and sale of multiple options (and may be coupled with
purchases or sales of the underlying securities), executed
simultaneously as part of the same strategy. In many cases, the
potential market exposure of these strategies is limited and
defined. While regulatory capital requirements have historically
reflected the risk-limited nature of carrying offsetting positions,
these positions may now be subject to higher regulatory capital
requirements.
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    The Exchange believes these higher regulatory capital requirements
may impact liquidity in the listed options market by limiting the
amount of capital CTPHs can allocate to their clients' transactions.
Specifically, the rules may cause CTPHs to impose stricter position
limits on their client clearing members. These stricter position limits
may impact the liquidity market participants may provide, including
liquidity Market-Makers may provide in their appointed classes. This
impact may be compounded when a CTPH has multiple client accounts, each
having largely risk-neutral portfolio holdings.\12\ The Exchange
believes that permitting market participants to efficiently transfer
existing options positions through an off-floor transfer process may
assist CTPHs and TPHs to address bank regulatory capital requirements
and would likely have a beneficial effect on continued liquidity in the
options market without adversely affecting market quality.
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    \12\ A number of TPHs, including Market-Makers, have informed
the Exchange that the heightened bank regulatory requirements could
impact their ability to provide consistent liquidity in the market
unless they are able to efficiently transfer their open positions
out of clearing accounts of U.S.-bank affiliated clearing firms.
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    Liquidity in the listed options market is critically important.
However, bank capital regulations that govern bank-affiliated clearing
firms are negatively impacting the ability of Trading Permit Holders,
including Market-Makers, that clear options transactions through bank-
affiliated clearing firms to provide liquidity. In order to mitigate
the potential negative effects of these additional bank regulatory
capital requirements, the proposed rule change provides market
participants with an efficient mechanism to transfer their open options
positions from one clearing account to another clearing account. The
Exchange believes the proposed rule change will increase liquidity in
the listed options market and promote more efficient capital deployment
in light of bank regulatory capital requirements.
    The Exchange has previously adopted Rules 6.56 and 6.57 to provide
Trading Permit Holders with tools to reduce RWA attributable to their
open positions in S&P 500 options (``SPX options''). However, the
procedures in those rules involve transactions that must occur on the
Exchange's trading floor to close open positions. Therefore, a market
participant must find a counterparty and be willing to close positions
to use either of these tools. As a result, these procedures are less
efficient, less flexible, and more burdensome means to reduce RWA
attributable to open options positions than an off-floor transfer of
such positions. Additionally, these tools are currently limited to SPX
options, due to the large notional size of those options, which
compounds the negative impact of bank capital requirements, and Rule
6.57 is limited to Market-Makers (Rule 6.56 is available to all Trading
Permit Holders). However, bank capital requirements apply to positions
in all listed options, and may impact all client clearing members of
clearing firms affiliated with U.S.-bank holding companies, and
clearing firms may request that Market-Makers and non-Market-Makers
reduce positions in listed options in addition to SPX. There is
currently no mechanism firms may use to transfer positions between
clearing accounts without having to effect a transaction with another
party and close a position.
    Rule 6.49A(a), as noted above, permits positions to be transferred
off the floor of the Exchange in specified limited circumstances. If a
Trading Permit Holder wanted to transfer open positions from a clearing
account it has with one a bank-affiliated clearing firm to a clearing
account it has with a non-bank-affiliated clearing firm, for example,
such a transfer would result in no change in ownership. However, the
currently permissible off-floor position transfers are non-routine,
non-recurring movements of positions, which do not permit use of the
off-floor transfer procedure to be used repeatedly or routinely in
circumvention of the normal auction market process. To comply with
clearing firms' position limits they may impose on market participants'
because they need to limit capital they may allocate for those market
participants' transactions, market participants may need to regularly
reduce open positions or limit additional positions in their accounts
with such clearing firms' to accommodate bank capital requirements.
Rule 6.49A does not permit regular transfers of positions between
accounts at different clearing firms.
    Proposed Rule 6.49B is intended to provide market participants with
an additional tool they may use to address the issues raised by bank
capital requirements for positions in all listed options in an
efficient manner that provides market participants with flexibility to
do so in accordance with their businesses and risk management
practices. Proposed Rule 6.49B provides that notwithstanding Rule 6.49,
existing positions in options listed on the Exchange of a Trading
Permit Holder or non-Trading Permit Holder (including an affiliate of a
Trading Permit Holder) may be transferred on, from, or to the books of
a CTPH off the Exchange if the transfer establishes a net reduction of
RWA attributable to those options positions (an ``RWA Transfer'').
Proposed paragraph (a) adds examples of two transfers that would be
deemed to establish a net reduction of RWA, and thus qualify as a
permissible RWA Transfer:
     A transfer of options positions from Clearing Corporation
member A to Clearing Corporation member B that net (offset) with
positions held at Clearing Corporation member B, and thus closes all or
part of those positions (as demonstrated in the example below); \13\
and
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    \13\ This transfer would establish a net reduction of RWA
attributable to the transferring Person, because there would be
fewer open positions and thus fewer assets subject to Net Capital
Rules.
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     A transfer of options positions from a bank-affiliated
Clearing Corporation member to a non-bank-affiliated Clearing
Corporation member.\14\
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    \14\ This transfer would establish a net reduction of RWA
attributable to the transferring Person, because the non-bank-
affiliated Clearing Corporation member would not be subject to Net
Capital Rules, as described above.

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    These transfers will not result in a change in ownership, as they
must occur between accounts of the same Person.\15\ Rule 1.1 defines
``Person'' as an individual, partnership (general or limited), joint
stock company, corporation, limited liability company, trust or
unincorporated organization, or any governmental entity or agency or
political subdivision thereof. In other words, RWA transfers may only
occur between the same individual or legal entity. These are merely
transfers from one clearing account to another, both of which are
attributable to the same individual or legal entity. A market
participant effecting an RWA Transfer is analogous to an individual
transferring funds from a checking account to a savings account, or
from an account at one bank to an account at another bank--the money
still belongs to the same person, who is just holding it in a different
account for personal financial reasons.
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    \15\ See proposed paragraph (e).
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    For example, Market-Maker A clears transactions on the Exchange
into an account it has with CTPH X, which is affiliated with a U.S-bank
holding company. Market-Maker A opens a clearing account with CTPH Y,
which is not affiliated with a U.S.-bank holding company. CTPH X has
informed Market-Maker A that its open positions may not exceed a
certain amount at the end of a calendar month, or it will be subject to
restrictions on new positions it may open the following month. On
August 28, Market-Maker A reviews the open positions in its CTPH X
clearing account and determines it must reduce its open positions to
satisfy CTPH X's requirements by the end of August. It determines that
transferring out 1000 short calls in class ABC will sufficiently reduce
the RWA capital requirements in the account with CTPH X to avoid
additional position limits in September. Market-Maker A wants to retain
the positions in accordance with its risk profile. Pursuant to the
proposed rule change, on August 31, Market-Maker A transfers 1000 short
calls in class ABC to its clearing account with CTPH Y. As a result,
Market-Maker A can continue to provide the same level of liquidity in
class ABC during September as it did in previous months.
    A Trading Permit Holder must give up a CTPH for each transaction it
effects on the Exchange, which identifies the CTPH through which the
transaction will clear.\16\ A Trading Permit Holder may change the give
up for a transaction within a specified period of time.\17\
Additionally, a Trading Permit Holder may also change the CMTA \18\ for
a specific transaction.\19\ The transfer of positions from an account
with one clearing firm to the account of another clearing firm pursuant
to the proposed rule change has a similar result as changing a give up
or CMTA, as it results in a position that resulted from a transaction
moving from the account of one clearing firm to another, just at a
different time and in a different manner.\20\ In the above example, if
Market-Maker A had initially given up CTPH Y rather than CTPH X on the
transactions that resulted in the 1000 long calls in class ABC, or had
changed the give-up or CMTA to CTPH Y pursuant to Rules 6.21 or 6.67,
the ultimate result would have been the same. There are a variety of
reasons why firms give up or CMTA transactions to certain clearing
firms (and not to non-bank affiliate clearing firms) at the time of a
transaction, and the proposed rule change provides firms with a
mechanism to achieve the same result at a later time.
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    \16\ See Rule 6.21.
    \17\ See Rule 6.21(e).
    \18\ The Clearing Member Trade Assignment (``CMTA'') process at
the Options Clearing Corporation (``OCC'') facilitates the transfer
of option trades/positions from one OCC clearing member to another
in an automated fashion. Changing a CMTA for a specific transaction
would allocate the trade to a different OCC clearing member than the
one initially identified on the trade.
    \19\ See Rule 6.67(a).
    \20\ The transferred positions will continue to be subject to
OCC rules, as they will continue to be held in an account of an OCC
member.
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    Proposed paragraph (b) states RWA Transfers may occur on a routine,
recurring basis. As noted in the example above, clearing firms may
impose restrictions on the amount of open positions. Permitting
transfers on a routine, recurring basis will provide market
participants with the flexibility to comply with these restrictions
when necessary to avoid position limits on future options activity.
Additionally, proposed paragraph (f) provides that no prior written
notice to the Exchange is required for RWA Transfers. Because of the
potential routine basis on which RWA Transfers may occur, and because
of the need for flexibility to comply with the restrictions described
above, the Exchange believes it may interfere with the ability of
investors firms to comply with any CTPH restrictions describe above,
and may be burdensome to provide notice for these routine transfers.
    Proposed paragraph (c) states RWA Transfers may result in the
netting of positions. Netting is generally prohibited for off-floor
transfers.\21\ Netting occurs when long positions and short positions
in the same series ``offset'' against each other, leaving no or a
reduced position. For example, if there were 100 long calls in one
account, and 100 short calls of the same option series were added to
that account, the positions would offset, leaving no open positions.
Currently, the Exchange permits off-floor transfers on behalf of a
Market-Maker account for transactions in multiply listed options series
on different exchanges, but only if the Market-Maker nominees are
trading for the same Trading Permit Holder organization, and the
options transactions on the different options exchanges clear into
separate exchange-specific accounts because they cannot easily clear
into the same Market-Maker account at OCC. In such instances, all
Market-Maker positions in the exchange-specific accounts for the
multiply listed class would be automatically transferred on their trade
date into one central Market-Maker account (commonly referred to as a
``universal account'') at the Clearing Corporation.\22\ Positions
cleared into a universal account would automatically net against each
other.
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    \21\ See Cboe Options Regulatory Circular RG03-62 (July 24,
2003).
    \22\ Id.
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    While RWA Transfers are not occurring because of limitations
related to trading on different exchanges, similar reasoning for the
above exception applies to why netting should be permissible for the
limited purpose of reducing RWA. Firms may maintain different clearing
accounts for a variety of reasons, such as the structure of their
businesses, the manner in which they trade, their risk management
procedures, and for capital purposes. If a Market-Maker clears all
transactions into a universal account, offsetting positions would
automatically net. However, if a Market-Maker has multiple accounts
into which its transactions cleared, they would not automatically net.
While there are times when a firm may not want to close out open
positions to reduce RWA, there are other times when a firm may
determine it is appropriate to close out positions to accomplish a
reduction in RWA.
    In the example above, suppose after making the RWA Transfer
described above, Market-Maker A effects a transaction on September 25
that results in 1000 long calls in class ABC, which clears into its
account with CTPH X. If Market-Maker A had not effected its RWA
Transfer in August, the 1000 long calls would have offset against the
1000

short calls, eliminating both positions and thus any RWA capital
requirements associated with them. At the end of August, Market-Maker A
did not want to close out the 1000 short calls when it made its RWA
Transfer. However, given changed circumstances in September, Market-
Maker A has determined it no longer wants to hold those positions. The
proposed rule change would permit Market-Maker A to effect an RWA
Transfer of the 1000 short calls from its account with CTPH Y to its
account with CTPH X (or vice versa), which results in elimination of
those positions (and a reduction in RWA associated with them). As noted
above, such netting would have occurred if Market-Maker A cleared the
September transaction directly into its account with CTPH Y, or had not
effected an RWA Transfer in August. Netting provides market
participants with appropriate flexibility to conduct their businesses
as they see fit while having the ability to reduce RWA capital
requirements when necessary.
    As is true for all other off-floor transfers permitted under Rule
6.49A, RWA Transfers may not result in preferential margin or haircut
treatment.\23\ Additionally, RWA Transfers may only be effected for
options listed on the Exchange and will be subject to applicable laws,
rules, and regulations, including rules of other self-regulatory
organizations (including OCC).\24\
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    \23\ See proposed paragraph (d); see also id.
    \24\ See proposed introductory paragraph and proposed paragraph
(g). Transfers of non-Exchange listed options and other financial
instruments are not governed by proposed Rule 6.49B. Any RWA
transfers will be subject to all applicable recordkeeping
requirements applicable to TPHs and CTPHs under the Securities
Exchange Act of 1934, and the rules and regulations thereunder (the
``Act''), such as Rule 17a-3 and 17a-4.
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2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\25\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \26\ requirements that the rules of an exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, to protect investors and the public interest. Additionally,
the Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \27\ requirement that the rules of an exchange not be
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers.
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    \25\ 15 U.S.C. 78f(b).
    \26\ 15 U.S.C. 78f(b)(5).
    \27\ Id.
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    In particular, The Exchange believes the proposed rule change to
permit RWA Transfers will remove impediments to and perfect the
mechanism of a free and open market and a national market system by
potentially mitigating the effects bank capital requirements may have
on liquidity in the listed options market. As described above, bank
capital requirements may impact capital available for options market
liquidity providers, for example due to CTPHs' imposition of stricter
position limits on firms that clear options transactions with them. The
Exchange believes providing market participants with an efficient
process to reduce RWA capital requirements attributable to open
positions in clearing accounts with U.S. bank-affiliated clearing firms
may contribute to additional liquidity in the listed options market,
which, in general, protects investors and the public interest.
    The proposed rule change, in particular the proposed changes to
permit RWA transfers to occur on a routine, recurring basis and result
in netting, also provides market participants with sufficient
flexibility to reduce RWA capital requirements at times necessary to
comply with requirements imposed on them by clearing firms. This will
permit market participants respond to then-current market conditions,
including volatility and increased volume, by reducing the RWA capital
requirements associated with any new positions they may open while
those conditions exist. Given the additional capital that may become
available to market participants as a result of the RWA Transfers,
market participants will be able to continue to provide liquidity to
the market, even during periods of increased volume and volatility,
which liquidity ultimately benefits investors. It is not possible for
market participants to predict what market conditions will exist at a
specific time, and when volatility will occur. The proposed rule change
to permit routine, recurring RWA Transfers (and to not provide prior
written notice) will provide market participants with the ability to
respond to these conditions whenever they occur. Additionally, since
firms may be subject to restrictions on positions imposed by their
clearing firms, permitting transfers on a routine, recurring basis will
provide market participants with the flexibility to comply with these
restrictions when necessary to avoid position limits on future options
activity. In addition, with respect to netting, as discussed above,
firms may maintain different clearing accounts for a variety of
reasons, such as the structure of their businesses, the manner in which
they trade, their risk management procedures, and for capital purposes.
Netting may otherwise occur with respect to a firm's positions if it
structured its clearing accounts differently, such as by using a
universal account. Therefore, the proposed rule change will permit
netting while allowing firms to continue to maintain different clearing
accounts in a manner consistent with their businesses.
    The Exchange recognizes the numerous benefits of executing options
transactions occur on an exchanges, including price transparency,
potential price improvement, and a clearing guarantee. However, the
Exchange believes it is appropriate to permit RWA Transfers to occur
off the exchange, as these benefits are inapplicable to RWA Transfers.
RWA Transfers have a narrow scope and are intended to achieve a
limited, benefit purpose. RWA Transfers are not intended to be a
competitive trading tool. There is no need for price discovery or
improvement, as the purpose of the transfer is to reduce RWA asset
capital requirements attributable to a market participants' positions.
Unlike trades on an exchange, the price at which an RWA Transfers
occurs is immaterial--the resulting reduction in RWA is the critical
part of the transfer. RWA Transfers will result in no change in
ownership, and thus they do not constitute trades with a counterparty
(and thus eliminating the need for a counterparty guarantee). The
transactions that resulted in the open positions to be transferred as
an RWA Transfer were already guaranteed by an OCC clearing member, and
the positions will continue to be subject to OCC rules, as they will
continue to be held in an account with an OCC clearing member. The
narrow scope of the proposed rule change and the limited, beneficial
purpose of RWA Transfers make allowing RWA Transfers to occur off the
floor appropriate and important to support the provision of liquidity
in the listed options market.
    The proposed rule change does not unfairly discriminate against
market

participants, as all Trading Permit Holders and non-Trading Permit
Holders with open positions in options listed on the Exchange may use
the proposed off-floor transfer process to reduce the RWA capital
requirements of CTPHs.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The purpose of the proposed
rule change to permit RWA Transfers is to alleviate the negative impact
of bank capital requirements on options market liquidity providers.
This process is not intended to be a competitive trading tool. The
Exchange does not believe that the proposed rule change will impose any
burden on intramarket competition that is not necessary or appropriate
in furtherance of the purposes of the Act, as use of the proposed
process is voluntary. All Trading Permit Holders and non-Trading Permit
Holders with open positions in options listed on the Exchange may use
the proposed off-floor transfer process to reduce the RWA capital
requirements attributable to those positions. The Exchange does not
believe that the proposed rule change will impose any burden on
intermarket competition that is not necessary or appropriate in
furtherance of the purposes of the Act. RWA Transfers have a limited
purpose, which is to reduce RWA attributable to open positions in
listed options in order to free up capital. Cboe Options believes the
proposed rule change may relieve the burden on liquidity providers in
the options market by reducing the RWA attributable to their open
positions. As a result, market participants may be able to increase
liquidity they provide to the market, which liquidity benefits all
market participants.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    The Exchange neither solicited nor received comments on the
proposed rule change.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission will:
    A. By order approve or disapprove such proposed rule change, or
    B. institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2019-044 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to File Number SR-CBOE-2019-044. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-CBOE-2019-044 and should be submitted on
or before September 4, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\28\
---------------------------------------------------------------------------

    \28\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-17383 Filed 8-13-19; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)]
[Notices]
[Pages 49089-49090]
[FR Doc No: 2018-21190]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2018-0418; FRL-9983-13]

Agency Information Collection Activities; Proposed Renewal of an
Existing Collection (EPA ICR No. 2511.02); Comment Request

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (PRA), this
document announces that EPA is planning to submit an Information
Collection Request (ICR) to the Office of Management and Budget (OMB).
The ICR, entitled: ``Reporting in the FIFRA Cooperative Agreement Work
Plan and Report Template'' and identified by EPA ICR No. 2511.02 and
OMB Control No. 2070-0198, represents the renewal of an existing ICR
that is scheduled to expire on April 30, 2019. Before submitting the
ICR to OMB for review and approval, EPA is soliciting comments on
specific aspects of the proposed information collection that is
summarized in this document. The ICR and accompanying material are
available in the docket for public review and comment.

DATES: Comments must be received on or before November 27, 2018.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2018-0418, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Carolyn Siu, Field and External
Affairs Division (7506P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. What information is EPA particularly interested in?

    Pursuant to PRA section 3506(c)(2)(A) (44 U.S.C. 3506(c)(2)(A)),
EPA specifically solicits comments and information to enable it to:
    1. Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility.
    2. Evaluate the accuracy of the Agency's estimates of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used.
    3. Enhance the quality, utility, and clarity of the information to
be collected.
    4. Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

II. What information collection activity or ICR does this action apply
to?

    Title: Reporting in the FIFRA Cooperative Agreement Work Plan and
Report Template.
    ICR number: EPA ICR No. 2511.02.
    OMB control number: OMB Control No. 2070-0198.

    ICR status: This ICR is currently scheduled to expire on April 30,
2019. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information, unless it displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the Code of Federal Regulations (CFR), after
appearing in the Federal Register when approved, are listed in 40 CFR
part 9, are displayed either by publication in the Federal Register or
by other appropriate means, such as on the related collection
instrument or form, if applicable. The display of OMB control numbers
for certain EPA regulations is consolidated in 40 CFR part 9.
    Abstract: This ICR documents the Paperwork burden of the electronic
collection of information for the pre-award burden activity for
creating a work plan and the post-award and after-the-grant award
activities related to reporting accomplishments to implement EPA's
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) State and
Tribal Assistance Grant (STAG) program (7 U.S.C. 136.u). This ICR
augments the ICR entitled ``EPA's General Regulation for Assistance
Programs ICR'' (EPA No. 0938.18; OMB No. 2030-0020) which accounts for
the current PRA burden for the minimum management requirements for all
recipients of EPA grants or cooperative agreements (assistance
agreements). This ICR renewal provides the burden assessment for the
FIFRA program specific activities associated with using a standardized
electronic format for only the STAG program reporting.
    Burden statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 46.15
hours per response. Burden is defined in 5 CFR 1320.3(b).
    The ICR, which is available in the docket along with other related
materials, provides a detailed explanation of the collection activities
and the burden estimate that is only briefly summarized here:
    Respondents/affected entities: Entities potentially affected by
this ICR are state, local governments, Indian tribes, and U.S.
territories. Entities potentially affected by this ICR are grantees of
Federal funds participating in the FIFRA and STAG program. The
corresponding North American Industry Classification System (NAICS)
Codes for respondents include: 9241--Administration of Environmental
Quality programs; 92115--American Indians and Alaska Native Tribal
Governments.
    Estimated total number of potential respondents: 81.
    Frequency of response: Biannually.
    Estimated total average number of responses for each respondent: 2.
    Estimated total annual burden hours: 26,195 hours.
    Estimated total annual costs: $2,102,179. There are no capital
investment or maintenance and operational costs.

III. Are there changes in the estimates from the last approval?

    There is no increase or decrease of the PRA burden hours in the
total estimated respondent burden compared with that identified in the
ICR currently approved by OMB. However, there is an increase in EPA's
burden cost in this ICR relative to the previous ICR due to updating
the wages (from 2012 to 2017) and using the fully loaded wage rate
replacing the unloaded wage rate used in the current ICR. This change
is a program adjustment.

IV. What is the next step in the process for this ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. EPA will issue another
Federal Register document pursuant to 5 CFR 1320.5(a)(1)(iv) to
announce the submission of the ICR to OMB and the opportunity to submit
additional comments to OMB. If you have any questions about this ICR or
the approval process, please contact the person listed under FOR
FURTHER INFORMATION CONTACT.

    Authority: 44 U.S.C. 3501 et seq.

    Dated: September 13, 2018.
Charlotte Bertrand,
Acting Principal Deputy Assistant Administrator, Office of Chemical
Safety and Pollution Prevention.
[FR Doc. 2018-21190 Filed 9-27-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 241 (Friday, December 16, 2022)]
[Notices]
[Pages 77106-77107]
[FR Doc No: 2022-27292]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL OP-OFA-048]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or https://www.epa.gov/nepa.

Weekly receipt of Environmental Impact Statements (EIS)
Filed December 5, 2022 10 a.m. EST Through December 12, 2022 10 a.m.
EST
Pursuant to 40 CFR 1506.9.
    Notice: Section 309(a) of the Clean Air Act requires that EPA make
public its comments on EISs issued by other Federal agencies. EPA's
comment letters on EISs are available at: https://cdxapps.epa.gov/cdx-enepa-II/public/action/eis/search.

EIS No. 20220183, Draft, USACE, CA, Delta Conveyance Project, Comment
Period Ends: 02/14/2023, Contact: Zachary Simmons<PHONE_NUMBER>.
EIS No. 20220184, Final Supplement, USFS, MT, Telegraph Vegetation
Project, Review Period Ends: 01/17/2023, Contact: Sharon Scott 406-495-
3943.
EIS No. 20220185, Draft, NNSA, SC, Surplus Plutonium Disposition
Program, Comment Period Ends: 02/14/2023, Contact: Maxcine Maxted 803-
952-7434.
EIS No. 20220186, Final, TVA, TN, Moore County Solar, Review Period
Ends: 01/17/2023, Contact: Ashley Pilakowski<PHONE_NUMBER>.
EIS No. 20220187, Draft, BOEM, VA, Coastal Virginia Offshore Wind
Commercial Project, Comment Period Ends: 02/14/2023, Contact: Bonnie L
Houghton<PHONE_NUMBER>.
EIS No. 20220188, Draft, BOEM, NY, Sunrise Wind Project, Comment Period
Ends: 02/14/2023, Contact: Paige Foley<PHONE_NUMBER>.
Amended Notice: EIS No. 20220143, Draft, USACE, NY, Draft Integrated
Feasibility Report and Tier 1 Environmental Impact Statement, New York-
New Jersey Harbor and Tributaries Coastal Storm Risk Management
Feasibility Study, Comment Period Ends: 03/07/2023, Contact: Cheryl
Alkemeyer<PHONE_NUMBER>. Revision to FR Notice Published 10/07/2022;
Extending the Comment Period from 01/06/2023 to 03/07/2023.
EIS No. 20220158, Draft, NNSA, CA, Draft Site-Wide Environmental Impact
Statement for Continued Operation of the Lawrence Livermore National
Laboratory, Comment Period Ends: 01/18/2023, Contact: Ms. Fana
Gebeyehu-Houston<PHONE_NUMBER>. Revision to FR Notice Published 11/04/
2022; Extending the Comment Period from 01/03/2023 to 01/18/2023.
EIS No. 20220162, Draft, USDA, OR, Predator Damage Management in
Oregon, Comment Period Ends: 01/03/2023, Contact: Kevin Christensen
503-820-2751. Revision to FR Notice Published 11/10/2022; Extending the
Comment Period from 12/27/2022 to 01/03/2023.

    Dated: December 12, 2022.
Cindy S. Barger,
Director, NEPA Compliance Division, Office of Federal Activities.
[FR Doc. 2022-27292 Filed 12-15-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 130 (Tuesday, July 7, 2020)]
[Rules and Regulations]
[Pages 40584-40586]
[FR Doc No: 2020-14210]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0171; Product Identifier 2018-SW-028-AD; Amendment
39-21155; AD 2020-14-01]
RIN 2120-AA64

Airworthiness Directives; Bell Textron Inc. (Type Certificate
Previously Held by Bell Helicopter Textron Inc.) Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
Bell Textron Inc. (Bell) Model 214ST helicopters. This AD was prompted
by the discovery of bolts with nonconforming external thread root
radii. This AD requires removing the affected bolts from service and
prohibits installing an affected bolt on any helicopter. The FAA is
issuing this AD to address the unsafe condition on these products.

DATES: This AD is effective August 11, 2020.

ADDRESSES: For service information identified in this final rule,
contact Bell Textron, Inc., P.O. Box 482, Fort Worth, TX 76101;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at https://www.bellcustomer.com. You may view the referenced service information
at the FAA, Office of the Regional Counsel, Southwest Region, 10101
Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0171; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this AD, any comments received, and other information. The address for
Docket Operations is U.S. Department of Transportation, Docket
Operations, M

30, West Building Ground Floor, Room W12 140, 1200 New Jersey Avenue
SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Haytham Alaidy, Aviation Safety
Engineer, DSCO Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177;
phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to Bell Model 214ST
helicopters with certain serial-numbered spindle to yoke bolts (bolts)
part number (P/N) 214-010-262-103 installed. The NPRM published in the
Federal Register on February 26, 2020 (85 FR 11003). The NPRM was
prompted by the discovery of bolts with nonconforming external thread
root radii. The NPRM proposed to require removing the affected bolts
from service and would prohibit installing an affected bolt on any
helicopter. The FAA is issuing this AD to address the unsafe condition
on these products.
    Since the FAA issued the NPRM, Bell Helicopter Textron Inc.,
changed its name to Bell Textron Inc. This AD reflects that change and
updates the contact information.

Comments

    After the NPRM was published, the FAA received comments from the
European Union Aviation Safety Agency (EASA). The following presents
the comments received on the NPRM and the FAA's response to the
comments.

Request for the FAA To Change the Applicability

    Request: EASA requested that the FAA revise the applicability of
the AD to include all helicopters for which the affected P/N and S/N
bolts are eligible for installation. EASA stated this revision should
be made in order to fully prohibit (re)installation of the affected
bolt on any (other) helicopter. EASA further stated that the NPRM's
applicability paragraph ``excludes all helicopters that have another P/
N [bolt] installed, or the same P/N but another S/N installed, but for
which installation of that P/N (and any S/N thereof) is likely
eligible. Since the AD does not apply to those helicopters, none of the
requirements of the AD would apply either.'' According to EASA, the
prohibition in paragraph (g)(2) of the NPRM, which prohibits the
installation on any helicopter of a bolt with a P/N and S/N listed in
the applicability of the AD, could be legally disregarded by operators
of helicopters that are outside the scope of the applicability of the
AD.
    FAA Response: The FAA disagrees. Upon installation of a bolt with a
P/N and S/N listed in the applicability, the AD applies to that
helicopter, and the required actions of the AD must be complied with
prior to approving the helicopter for return to service. These required
actions include the installation prohibition in paragraph (e)(2) of the
AD. Thus, the AD prohibits the installation of an affected bolt on any
Bell Model 214ST helicopters after the effective date of the AD.

FAA's Determination

    The FAA has reviewed the relevant information, considered the
comments received, and determined that an unsafe condition exists and
is likely to exist or develop on other products of the same type design
and that air safety and the public interest require adopting the AD
requirements as proposed with the changes described previously. These
changes are consistent with the intent proposed in the NPRM for
correcting the unsafe condition and will neither increase the economic
burden on any operator nor increase the scope of the AD.

Related Service Information

    The FAA reviewed Bell Helicopter Textron Alert Service Bulletin
214ST-18-93 Revision A, dated April 17, 2019, for Model 214ST
helicopters. This service information specifies inspecting the
historical records and spare parts to determine the S/N of each bolt.
If the S/N of the bolt indicates it is a non-conforming bolt, the
service information specifies torque checking the bolt every 25 hours
until the bolt reaches its life limit.

Differences Between This AD and the Service Information

    The service information specifies torque checking the bolt every 25
hours until it is replaced upon reaching its life limit, while this AD
requires removing each bolt from service within 25 hours time-in-
service.

Costs of Compliance

    The FAA estimates that this AD affects 16 helicopters of U.S.
registry. The FAA estimates that operators may incur the following
costs in order to comply with this AD. Labor costs are estimated at $85
per work-hour.
    Replacing 1 bolt takes about 8 work-hours and parts cost about
$7,073 for an estimated replacement cost of $7,753 per helicopter.
    The FAA has no way of determining the number of bolts that might
need to be replaced.
    According to the manufacturer, some of the costs of this AD may be
covered under warranty, thereby reducing the cost impact on affected
individuals. The FAA does not control warranty coverage for affected
individuals. As a result, all costs are included in this cost estimate.

Authority for This Rulemaking

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

Regulatory Findings

    The FAA determined that this AD would not have federalism
implications under Executive Order 13132. This AD would not have a
substantial direct effect on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2020-14-01 Bell Textron Inc. (Type Certificate Previously Held by
Bell Helicopter Textron Inc.): Amendment 39-21155; Docket No. FAA-
2020-0171; Product Identifier 2018-SW-028-AD.

(a) Applicability

    This AD applies to Bell Textron Inc. (Bell) Model 214ST
helicopters, certificated in any category, with a spindle to yoke
bolt (bolt) part number (P/N) 214-010-262-103 and serial number (S/
N) BH179163, BH179164, BH179169, BH179170, BH179171, BH179175,
BH179176, BH179178, BH224783, BH224751, BH224756, BH224764,
BH224765, BH383851, BH383853, BH383855, BH383856, BH383857,
BH383858, BH383860, BH383861, BH383862, BH383864, BH383865,
BH383868, BH383872, BH383873, BH383878, or BH383879 installed.

(b) Unsafe Condition

    This AD was prompted by the discovery that bolts have
nonconforming external thread root radii. The unsafe condition, if
not addressed, could result in the spindle separating from the yoke
and subsequent loss of control of the helicopter.

(c) Effective Date

    This AD is effective August 11, 2020.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    (1) Within 25 hours time-in-service, remove from service each
bolt listed in paragraph (a) of this AD.
    (2) After the effective date of this AD, do not install on any
helicopter a bolt with a P/N and S/N listed in paragraph (a) of this
AD.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, DSCO Branch, FAA, may approve AMOCs for this
AD. Send your proposal to Haytham Alaidy, Aviation Safety Engineer,
DSCO Branch, FAA, 10101 Hillwood Pkwy, Fort Worth, TX 76177; phone:
817-222-5224; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, the FAA suggests
that you notify your principal inspector, or lacking a principal
inspector, the manager of the local flight standards district office
or certificate holding district office before operating any aircraft
complying with this AD through an AMOC.

(g) Related Information

    Bell Helicopter Textron Alert Service Bulletin 214ST-18-93
Revision A, dated April 17, 2019, which is not incorporated by
reference, contains additional information about the subject of this
AD. For service information identified in this AD, contact Bell
Textron Inc., P.O. Box 482, Fort Worth, TX 76101; telephone 817-280-
3391; fax<PHONE_NUMBER>; or at https://www.bellcustomer.com. You may
view a copy of information at the FAA, Office of the Regional
Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort
Worth, TX 76177.

(h) Subject

    Joint Aircraft Service Component (JASC) Code: 6200, Main Rotor.

    Issued on June 23, 2020.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2020-14210 Filed 7-6-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: April 1, 2010 (Volume 75, Number 62)]
[Notices]
[Page 16453]
[DOCID:fr01ap10-57]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER10-914-000]

Nasdaq OMX Commodities Clearing--Finance, LLC; Supplemental
Notice That Initial Market-Based Rate Filing Includes Request for
Blanket Section 204 Authorization

March 25, 2010.
    This is a supplemental notice in the above-referenced proceeding of
Nasdaq OMX Commodities Clearing--Finance, LLC's application for market-
based rate authority, with an accompanying rate tariff, noting that
such application includes a request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is April 14, 2010.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-7295 Filed 3-31-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 91 (Thursday, May 10, 2018)]
[Rules and Regulations]
[Pages 21716-21717]
[FR Doc No: 2018-09932]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2018-0265]

Safety Zones; Annual Events in the Captain of the Port Detroit
Zone

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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ar;

SUMMARY: The Coast Guard will enforce various safety zones for annual
marine events in the Captain of the Port Detroit zone from 8:30 p.m. on
May 27, 2018 through 10:30 p.m. on September 2, 2018. Enforcement of
these zones is necessary and intended to ensure safety of life on the
navigable waters immediately prior to, during, and immediately after
these fireworks events. During the aforementioned period, the Coast
Guard will enforce restrictions upon, and control movement of, vessels
in a specified area immediately prior to, during, and immediately after
fireworks events. During each enforcement period, no person or vessel
may enter the respective safety zone without permission of the Captain
of the Port or his designated representative.

DATES: The regulations in 33 CFR 165.941 will be enforced at various
dates and times between 8:30 p.m. on May 27, 2018 through 10:30 p.m. on
September 2, 2018.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
document, call or email Tracy Girard, Prevention, Sector Detroit, Coast
Guard; telephone<PHONE_NUMBER>, or email [email protected].

SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the safety
zones listed in 33 CFR 165.941, Safety Zones; Annual Events in the
Captain of the Port Detroit Zone, at the following dates and times for
the following events:
    (1) Catawba Island Club Fireworks, Catawba Island, OH. The safety
zone listed in Sec.  165.941(a)(56) will be enforced from 8:30 p.m. to
9:30 p.m. on May 27, 2018.
    (2) Ford (formerly Target) Fireworks, Detroit, MI. The first safety
zone, listed in Sec.  165.941(a)(50)(i)(A), will be enforced from 8
a.m. on June 22, 2018 to 8 p.m. on June 25, 2018. In the case of
inclement weather on the scheduled day, this safety zone will be
enforced on June 26, 2018 until 11:59 p.m. The second safety zone,
listed in Sec.  165.941(a)(50)(i)(B), will be enforced from 7 p.m. to
11:55 p.m. on June 25, 2018. The third safety zone listed in Sec.
165.941(a)(50)(i)(C), will be enforced from 6 p.m. to 11:59 p.m. on
June 25, 2018.
    (3) Harbor Beach Fireworks, Harbor Beach, MI. The safety zone
listed in the Sec.  165.941(a)(8) will be enforced from 9:45 p.m. to 11
p.m. on July 14, 2018. In the case of inclement weather on July 14,
2018, this safety zone will be enforced from 9:45 p.m. to 11 p.m. on
July 15, 2018.
    (4) Bay City Fireworks Festival, Bay City, MI. The safety zone
listed in Sec.  165.941(a)(53), will be enforced from 10 p.m. to 10:55
p.m. on July 5, July 6, and July 7, 2018. In the case of inclement
weather on any scheduled day, this safety zone will be enforced from 10
p.m. to 10:55 p.m. on July 8, 2018.
    (5) Lexington Independence Festival Fireworks, Lexington, MI. The
safety zone listed in Sec.  165.941(a)(42), will be enforced from 10
p.m. to 10:30 p.m. on July 6, 2018. In the case of inclement weather on
July 6, 2018, this safety zone will be enforced from 10 p.m. to 10:30
p.m. on July 7, 2018.
    (6) Catawba Island Club Fireworks, Catawba Island, OH. The safety
zone listed in Sec.  165.941(a)(21) will be enforced from 9 p.m. to 10
p.m. on July 3, 2018.
    (7) Harrisville Fireworks, Harrisville, MI. The safety zone listed
in Sec.  165.941(a)(7), will be enforced from 10 p.m. to 11 p.m. on
July 7, 2018. In the case of inclement weather on July 7, 2018, this
safety zone will be enforced from 10 p.m. to 10:30 p.m. on July 8,
2018.
    (8) Red, White and Blues Bang Fireworks, Huron, OH. The safety zone
listed in Sec.  165.941(a)(22) will be enforced between from 10 p.m. to
10:45 p.m. on July 7, 2018. In the case of inclement weather on July 7,
2018, this safety zone will be enforced from 10 p.m. to 10:45 p.m. on
July 8, 2018.
    (9) Port Sanilac Fireworks, Port Sanilac, MI. The safety zone
listed in Sec.  165.941(a)(38) will be enforced from 10 p.m. to 11 p.m.
on July 7, 2018. In the case of inclement weather on July 7, 2018, this
safety zone will be enforced from 10 p.m. to 10:45 p.m. on July 8,
2018.
    (10) Oscoda Township Fireworks, Oscoda, MI. The safety zone listed
in Sec.  165.941(a)(32) will be enforced from 10 p.m. to 10:30 p.m. on
July 4, 2018. In the case of inclement weather on July 4, 2018, this
safety zone will be enforced from 10 p.m. to 10:30 p.m. on July 5,
2018.
    (11) Lakeside July 4th Fireworks, Lakeside, OH. The safety zone
listed in

Sec.  165.941(a)(20) will be enforced from 9:20 p.m. to 10:10 p.m. on
July 4, 2018. In the case of inclement weather on July 4, 2018, this
safety zone will be enforced from 9:20 p.m. to 10:10 p.m. on July 5,
2018.
    (12) Grosse Pointe Yacht Club 4th of July Fireworks, Grosse Pointe
Shores, MI. The safety zone listed in Sec.  165.941(a)(41) will be
enforced from 10 p.m. to 10:30 p.m. on July 4, 2018. In the case of
inclement weather on July 4, 2018, this safety zone will be enforced
from 10 p.m. to 10:30 p.m. on July 5, 2018.
    (13) Belle Maer Harbor 4th of July Fireworks, Harrison Township,
MI. The safety zone listed in Sec.  165.941(a)(46) will be enforced
from 10 p.m. to 10:30 p.m. on July 4, 2018. In the case of inclement
weather on July 4, 2018, this safety zone will be enforced from 10 p.m.
to 10:30 p.m. on July 5, 2018.
    (14) Port Austin Fireworks, Port Austin, MI. The safety zone listed
in Sec.  165.941(a)(33), will be enforced from 10 p.m. to 10:30 p.m. on
July 4, 2018. In the case of inclement weather on July 4, 2018, this
safety zone will be enforced from 10 p.m. to 10:30 p.m. on July 5,
2018.
    (15) City of St. Clair Fireworks, St. Clair, MI. The safety zone
listed in Sec.  165.941(a)(31) will be enforced from 10 p.m. to 10:45
p.m. on July 4, 2018. In the case of inclement weather on July 4, 2018,
this safety zone will be enforced from 10 p.m. to 10:45 p.m. on July 5,
2018.
    (16) Tawas City 4th of July Fireworks, Tawas City, MI. The safety
zone listed in Sec.  165.941(a)(47) will be enforced from 10 p.m. to 11
p.m. on July 4, 2018. In the case of inclement weather on July 4, 2018,
this safety zone will be enforced from 10 p.m. to 11 p.m. on July 5,
2018.
    (17) Huron River fest Fireworks, Huron, OH. The safety zone listed
in Sec.  165.941(a)(23) will be enforced between from 9:45 p.m. until
10:30 p.m. on July 13, 2018. In the case of inclement weather on July
13, 2018, this safety zone will be enforced from 9:45 p.m. to 10:30
p.m. on July 14, 2018.
    (18) Au Gres City Fireworks, Au Gres, MI. The safety zone listed in
Sec.  165.941(a)(3) will be enforced from 10 p.m. to 10:45 p.m. on June
30, 2018. In the case of inclement weather on June 30, 2018, this
safety zone will be enforced from 10 p.m. to 10:45 p.m. on July 1,
2018.
    (19) Catawba Island Club Fireworks, Catawba Island, OH. The safety
zone listed in Sec.  165.941(a)(28) will be enforced from 8:30 p.m. to
9:30 p.m. on September 2, 2018.
    (20) Lakeside Labor Day Fireworks, Lakeside, OH. The safety zone
listed in Sec.  165.941(a)(27) will be enforced from 9 p.m. to 9:50
p.m. on September 1, 2018. In the case of inclement weather on
September 1, 2018, this safety zone will be enforced from 9 p.m. to
9:50 p.m. on September 2, 2018.
    (21) Trenton Fireworks, Trenton, MI. The safety zone listed in
Sec.  165.941(a)(45) will be enforced from 10 p.m. to 10:30 p.m. on
July 4, 2018.
    (22) Put-In-Bay Fourth of July Fireworks, Put-In-Bay, OH. The
safety zone listed in Sec.  165.941(a)(5) will be enforced from 9 p.m.
to 10:30 p.m. on July 4, 2018.
    (23) Caseville Fireworks, Caseville, MI. The safety zone listed in
the Sec.  165.941(a)(36) will be enforced from 9:45 p.m. to 10:30 p.m.
on July 3, 2018.
    (24) Ecorse Fireworks, Ecorse, MI. The safety zone listed in the
Sec.  165.941(a)(43) will be enforced from 9:30 p.m. to 10:30 p.m. on
July 7, 2018. In the case of inclement weather on July 7, 2018, this
safety zone will be enforced from 9:30 p.m. to 10:30 p.m. on July 8,
2018.
    Under the provisions of Sec.  165.23, entry into, transiting, or
anchoring within these safety zones during the enforcement period is
prohibited unless authorized by the Captain of the Port Detroit or his
designated representative. Vessels that wish to transit through the
safety zones may request permission from the Captain of the Port
Detroit or his designated representative. Requests must be made in
advance and approved by the Captain of Port before transits will be
authorized. Approvals will be granted on a case by case basis. The
Captain of the Port may be contacted via U.S. Coast Guard Sector
Detroit on channel 16, VHF-FM or by calling<PHONE_NUMBER>. The Coast
Guard will give notice to the public via Local Notice to Mariners and
VHF radio broadcasts that the regulation is in effect.
    This document is issued under authority of Sec.  165.941 and 5
U.S.C. 552(a). If the Captain of the Port determines that any of these
safety zones need not be enforced for the full duration stated in this
document, he may suspend such enforcement and notify the public of the
suspension via a Broadcast Notice to Mariners.

    Dated: May 4, 2018.
Jeffrey W. Novak,
Captain, U.S. Coast Guard, Captain of the Port Detroit.
[FR Doc. 2018-09932 Filed 5-9-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 87, Number 207 (Thursday, October 27, 2022)]
[Notices]
[Pages 65085-65088]
[FR Doc No: 2022-23383]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2480]

Rare Disease Endpoint Advancement Pilot Meeting Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The seventh iteration of the Prescription Drug User Fee
Amendments (PDUFA VII) included as part of the FDA User Fee
Reauthorization Act of 2022 highlights the goal of advancing and
facilitating the development and timely approval of drugs and
biological products for rare diseases, including rare diseases in
children. The Food and Drug Administration (FDA or Agency) is
announcing the Rare Disease Endpoint Advancement Pilot Meeting Program
(RDEA Pilot Program) established under the seventh iteration of PDUFA
that affords sponsors who are admitted into the RDEA Pilot Program
additional engagement opportunities with the Agency to discuss efficacy
endpoint development in rare disease drug and

biological product development programs. Meetings under the program
will be conducted by FDA's Center for Drug Evaluation and Research
(CDER) or Center for Biologics Evaluation and Research (CBER) during
fiscal years (FYs) 2023 to 2027. For each sponsor whose RDEA program
proposal (RDEA proposal or proposal) is admitted into the program, up
to four meetings that will provide an opportunity for medical product
developers to discuss rare disease endpoint development will be held
between the sponsor and CDER or CBER. To promote innovation and
evolving science, novel endpoints developed through the RDEA Pilot
Program may be presented by FDA (e.g., in a guidance or public workshop
or on a public-facing website) as case studies, including novel
endpoints for drugs that have not yet been approved or biological
products that have not yet been licensed by FDA for a given indication.

DATES: The RDEA Pilot Program will proceed from October 1, 2022,
through September 30, 2027. Sponsors may submit RDEA program proposals
beginning July 1, 2023, through June 30, 2027. Submit either electronic
or written comments about this program by December 27, 2022.

ADDRESSES: You may submit comments about the RDEA Pilot Program as
follows. Please note that late, untimely filed comments will not be
considered. The https://www.regulations.gov electronic filing system
will accept comments until 11:59 p.m. Eastern Time December 27, 2022.
Comments received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are received on or
before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked, and identified
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2022-N-2480 for ``Rare Disease Endpoint Advancement Pilot
Program.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Mary Jo Salerno, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected], with the subject line ``RDEA Pilot Meeting
Program for CDER'' or Julienne Vaillancourt, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7252, Silver Spring, MD 20993-0002, 301-
796-1827, [email protected], with the subject line ``RDEA Pilot
Meeting Program for CBER.'' Additional information is available on the
RDEA Pilot Program web page: https://www.fda.gov/drugs/development-resources/rare-disease-endpoint-advancement-pilot-program.

SUPPLEMENTARY INFORMATION:

I. Background

    In connection with the seventh iteration of PDUFA, FDA committed to
conduct a pilot program to advance rare disease drug development
programs by providing a mechanism for sponsors to collaborate with FDA
throughout the efficacy endpoint development process (see ``PDUFA
Reauthorization Performance Goals and Procedures Fiscal Years 2023
Through 2027,'' section I.K.4.a, https://www.fda.gov/media/151712/download).
    FDA is announcing this pilot program to satisfy the above-mentioned
commitment. The goals of the early meeting discussions granted under
this program are to provide advice on how a proposed novel endpoint can
be used in a specific rare disease drug development program and to
promote innovation by allowing FDA to publicly present the proposed
novel endpoints (or natural history studies in which the proposed
endpoint is intended to be studied) considered through the program,
including novel endpoints for drugs or biological products that have

not yet been approved or licensed by FDA for a given indication. FDA
has committed to accepting a limited number of qualified proposals for
admission into the RDEA Pilot Program that increases after the first
year of PDUFA VII. For FY 2023, sponsors may submit RDEA proposals
beginning in the fourth quarter, and FDA will accept a maximum of one
proposal. For FYs 2024 through 2027, FDA will accept up to one RDEA
proposal per quarter with a maximum of three proposals per year.
    Complete RDEA proposals may be submitted throughout the quarter on
a rolling basis; however, only those received by the quarterly closing
date, which will be the last day of each quarter of the fiscal year
(i.e., December 31, March 31, June 30, September 30), will be
considered for selection in the following quarter. Within 60 days after
the quarterly closing date, FDA will review the RDEA proposals, select
a proposal to proceed to disclosure discussions, and notify sponsors of
their proposal status. When FDA and the sponsor agree on the
information that FDA may share publicly, FDA will notify the sponsor of
admission into the program.
    Sponsors admitted to the RDEA Pilot Program may participate in up
to four focused meetings with relevant FDA staff to discuss endpoint
development. FDA's advice provided during and between RDEA meetings
does not constitute a regulatory decision and is considered nonbinding.
Being admitted into the RDEA Pilot Program and completing four RDEA
meetings does not guarantee approval for a regulatory submission that
includes efficacy endpoints discussed during RDEA meetings. Likewise,
being denied admission into the RDEA Pilot Program does not mean that
the proposed novel endpoint is unacceptable for regulatory decision
making.
    After completion of four RDEA meetings, the sponsor can request
additional input on their novel endpoint from FDA, as needed, through
other formal meeting mechanisms, such as Type B, Type C, Type C
Surrogate Endpoint, or Type D meetings. Sponsors that do not
participate in the RDEA Pilot Program will have an opportunity to
interact with the Agency through traditional channels.
    The listed eligibility and selection factors outlined in this
notice reflect the current thinking at the time of publication.
Information about the process for applying to and participating in the
RDEA pilot meeting program will be communicated on the following web
page: https://www.fda.gov/drugs/development-resources/rare-disease-endpoint-advancement-pilot-program.

II. General, Eligibility, and Disclosure Information for the RDEA Pilot
Program

A. General Information

    The RDEA Pilot Program will be jointly administered by the
following Centers:
     CDER: CDER's Rare Diseases Team, in the Office of New
Drugs, Division of Rare Diseases and Medical Genetics, which is the
point of contact for RDEA Pilot Program communications for CDER
products.
     CBER: CBER's Rare Disease Liaison, in the Office of the
Director, Policy Staff, which is the point of contact for RDEA Pilot
Program communications for CBER products.

B. Eligibility and Selection Information

    To be eligible for the RDEA Pilot Program:
     The associated development program should be active and
address a rare disease, with an active investigational new drug
application (IND) or pre-IND for the rare disease.
    [cir] Sponsors that do not yet have an active development program
but have, or are initiating, a natural history study where the proposed
endpoint is intended to be studied are also eligible to apply.
    [cir] FDA may also consider accepting a proposal for a development
program for a common disease that includes innovative or novel endpoint
elements, including the specific endpoint and/or the methodology being
developed if there is sufficient justification that the proposal could
be applicable to a rare disease.
     The proposed endpoint is a novel efficacy endpoint
intended to establish substantial evidence of effectiveness for a rare
disease treatment. An endpoint is considered novel if it has never been
used to support drug approval or if it has been substantially modified
from previous use to support drug approval.
    Preference will be given to proposals:
     That have the potential to impact drug development more
broadly, such as one that uses a novel approach to develop an efficacy
endpoint or an endpoint that could potentially be relevant to other
diseases.
     That collectively reflect a range of different types of
endpoints.
     That have novel approaches for collecting additional
clinical data in the premarket stage to advance validation of the
endpoint for a surrogate endpoint proposal. If the sponsor is proposing
to develop a surrogate endpoint as part of a rare disease application,
participation in a prior Type C Surrogate Endpoint meeting is
encouraged.

C. Disclosure

    To promote innovation in this area, novel efficacy endpoints
developed through the RDEA Pilot Program may be presented by FDA (e.g.,
in a guidance, at public workshops and conferences, or on FDA's
website) as case studies, including while the drug studied in the trial
has not yet been approved by FDA. Accordingly, before FDA grants the
initial meeting under the program, FDA and the sponsor must agree on
the information that FDA may include in these public case studies. The
specific information to be disclosed will depend on the content of each
novel efficacy endpoint and associated natural history study if
applicable. FDA intends to focus on information that is beneficial to
advancing efficacy endpoint development for drugs that treat rare
diseases and those elements relevant to understanding the novel
efficacy endpoint and its potential use in a clinical trial intended to
support regulatory approval.
    Sponsors wishing to participate in the program should identify
aspects of the proposed novel endpoint and associated natural history,
if applicable, that they consider nondisclosable and provide a
rationale for withholding the information. Participation in the
program, including any agreement on information disclosure, will be
voluntary and at the discretion of the sponsor. Sponsors that do not
wish to make such disclosures may seek regulatory input through other
existing channels.

IV. Paperwork Reduction Act of 1995

    While this notice contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521) is not required
for this notice. The previously approved collections of information are
subject to review by OMB under the PRA. The collections of information
in 21 CFR part 312 for INDs and clinical trials have been approved
under OMB control number 0910-0014. The collections of information in
21 CFR part 601 for biologic new drug applications (NDAs) have been
approved under OMB control number 0910-0338. The collections of
information in 21 CFR part 314 for the submission of NDAs and for
requesting meetings with FDA about drug development programs have been

approved under OMB control number 0910-0001. The collections of
information relating to rare disease drug and biological product
development programs have been approved under OMB control number 0910-
0765.

    Dated: October 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23383 Filed 10-26-22; 8:45 am]
BILLING CODE 4164-01-P