[Federal Register Volume 88, Number 141 (Tuesday, July 25, 2023)]
[Notices]
[Pages 47937-47940]
[FR Doc No: 2023-15655]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-97946; File No. SR-BX-2023-016]

Self-Regulatory Organizations; Nasdaq BX, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Establish Fees
for Field-Programmable Gate Array Technology as an Optional Delivery
Mechanism for BX TotalView

July 19, 2023.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on July 11, 2023, Nasdaq BX, Inc. (``BX'' or ``Exchange'') filed with
the Securities and Exchange Commission (``SEC'' or ``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

    The Exchange proposes to set fees for the purchase of field-
programmable gate array (``FPGA'') technology as an optional delivery
mechanism for BX TotalView.
    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/bx/rules, at the
principal office of the Exchange, 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 purpose of the proposed rule change is to establish a fee
schedule for the purchase of field-programmable gate array (``FPGA'')
technology as an optional delivery mechanism for BX TotalView.\3\ This
follows a recently-filed proposal to offer FPGA technology as an
optional delivery mechanism for BX TotalView.\4\
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    \3\ This Proposal was initially filed by the Exchange on May 23,
2023. See Securities Exchange Act Release No. 97627 (May 31, 2023),
88 FR 37112 (June 6, 2023) (SR-BX-2023-014). On July 7, 2023, that
filing was withdrawn and replaced by the instant filing. The instant
filing provides additional information regarding the Proposal, but
does not change it in substance.
    \4\ See SR-BX-2023-011 (``A proposal to offer field-programmable
gate array (`FPGA') technology as an optional delivery mechanism for
BX TotalView.''), available at https://listingcenter.nasdaq.com/rulebook/BX/rulefilings. A proposal to establish a fee schedule for
the use of FPGA technology for the Phlx exchange is being filed
concurrently with this proposal.
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FPGA
    FPGA is a hardware-based delivery mechanism that utilizes an
integrated circuit that is programmed to reduce ``jitter''--a technical
term of art referring to the deviation in amplitude, phase timing or
width of a signal pulse in a digital signal--that will allow data to be
processed in a more predictable, or ``deterministic,'' fashion.
Reducing jitter can be useful for certain customers due to the
variability in the timing of market data packets transmitted by an
exchange over the course of the trading day. Orders, and therefore
market data packets, typically accumulate in larger numbers at the
beginning and end of the trading day, as well as during the peaks of
activity that occur at random intervals during the day. These bursts of
activity may alter the time interval between the delivery of data
packets because software processes information at variable rates
depending on load to the system. Processing times may increase at
higher loads, and decrease during periods of lesser activity. FPGA
technology processes data packets at a constant time interval, without
regard to the number of packets processed. Higher levels of determinism
means less variable queuing, which improves the predictability of data
transfer, particularly during times of peak market activity.
    The benefits of determinism depend on the use case of the customer,
as well as the customer's specific system architecture.
    Higher determinism does not necessarily mean lower latency. The
concepts of determinism and latency are related, but distinct.
Determinism refers to predictability in the rate of data transmission;
latency refers to the time required to process data or transport it
from one location to another. Low latency is not necessarily
deterministic, and higher determinism does not necessarily mean low
latency. As such, use of FPGA technology will increase determinism, but
does not guarantee lower latency at all times.\5\
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    \5\ Because software can be impacted by workload, FPGA has lower
latency during periods of peak activity.
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    Among customers that seek a higher degree of determinism, the
benefits of FPGA technology varies, as FPGA technology is one possible
solution, among a catalog of possible solutions, for increasing the
consistency and predictability of message throughput over the course of
the trading day. Some customers are able to adequately control jitter
without using FPGA technology; other customers address jitter using
specialized software, coding or other

design solutions in conjunction with FPGA; still others use FPGA alone.
The specific choice depends on a complex analysis of the customer's
information technology systems in the context of their particular use
cases.
    FPGA is a broadly-available, commonly-used type of programmable
circuit that can be modified to suit different use cases. It is used in
a wide spectrum of industries, including the consumer electronics,
automotive, and aerospace, as well as in a variety of industrial
applications. It is not unique to the financial services industry,\6\
or to Nasdaq.
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    \6\ See, e.g., Contrive Datum Insights, ``Field-Programmable
Gate Array (FPGA) Market is expected to reach around USD 22.10
Billion by 2030, Grow at a CAGR of 15.12% during Forecast Period
2023 to 2030,'' (February 21, 2023), available at https://www.globenewswire.com/en/news-release/2023/02/21/2612772/0/en/Field-Programmable-Gate-Array-FPGA-Market-Is-Expected-To-Reach-around-USD-22-10-Billion-by-2030-Grow-at-a-CAGR-Of-15-12-during-Forecast-Period-2023-To-2030-Data-By-Contrive-Datum-I.html (describing the
general size and state of the FPGA market in 2023).
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    FPGA technology has been offered by the Nasdaq Stock Exchange for
over a decade, and the Nasdaq Options Market for nearly as long,\7\ and
has been cited by the SEC as an example of a technology useful in the
distribution of market data products.\8\
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    \7\ See Securities Exchange Act Release No. 67297 (June 28,
2012), 77 FR 39752 (July 5, 2012) (SR-Nasdaq-2012-063) (introducing
FPGA technology); see also Nasdaq Data News 2012-13, available at
http://www.nasdaqtrader.com/TraderNews.aspx?id=dn2012-13
(introducing TotalView FPGA service as of August 1, 2012);
Securities Exchange Act Release No. 74745 (April 16, 2015), 80 FR
22588 (April 22, 2015) (SR-Nasdaq-2015-035) (establishing FPGA for
the Nasdaq Options Market); The Nasdaq Stock Market LLC Rules,
Equity 7, Section 126(c) (Hardware-Based Delivery of Nasdaq Depth
data).
    \8\ See Securities Exchange Act Release No. 90610, 86 FR 18596,
18647 (April 9, 2021) (File No. S7-03-20) (listing field
programmable gate array services as an example of a technological
innovation that could be employed by competing consolidators as part
of the Market Data Infrastructure rule).
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    The Exchange proposes to offer FPGA technology in conjunction with
the Exchange's depth of book feed, BX TotalView. BX TotalView is a
real-time market data product that provides full order depth using a
series of order messages to track the life of customer orders in the BX
market, as well as trade data for BX executions and administrative
messages such as Trading Action messages, Symbol Directory, and Event
Control messages.\9\
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    \9\ See Nasdaq BX, Inc. Rules, Equity 7, Section 123 (BX
TotalView); see also Securities Exchange Act Release No. 59307
(January 28, 2009), 74 FR 6069 (February 4, 2009) (establishing fees
for BX TotalView).
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Proposed Fees
    BX proposes internal distribution fees of $3,500 per month and
external distribution fees of $350 for FPGA hardware; customers that
elect to use FPGA hardware for both internal and external distribution
will pay both fees.\10\ These fees are in addition to Market Data
Distributor Fees,\11\ fees for BX TotalView,\12\ and other fees for
Distribution Models.\13\ Customers that elect to receive BX depth of
book data without using FPGA technology will pay no fee in addition to
the underlying fees listed above.
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    \10\ The difference in amount for external and external
distribution reflects Nasdaq's experience that the Exchange's FPGA
hardware is best employed at the point of ingestion, as the utility
of FPGA technology falls as the data moves farther from the source.
    \11\ See Nasdaq BX, Inc. Rules, Equity 7, Section 119.
    \12\ See Id., Section 123.
    \13\ See Id., Section 126.
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    The proposed fees are substantially lower than FPGA fees for the
Nasdaq exchange, which are set at $25,000 per Distributor for internal
only distribution, $2,500 for external only, and $27,500 for internal
and external distribution.\14\ The difference is based, in part, on a
comparison of peak activity at the two exchanges. As noted above, high
levels of determinism are particularly valuable during periods of peak
activity.
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    \14\ See The Nasdaq Stock Market LLC Rules, Equity 7 (Pricing
Schedule), Section 126(c) (Hardware-based delivery of Nasdaq depth
data).
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    Although there is considerable variation in the number of messages
at various peaks, as well as the duration of peak activity, the
proposed fees are roughly comparable to the differences in average peak
activity at the BX exchange relative to the Nasdaq exchange. Exchange
staff have also discussed the proposed fees with customers, and
believe, based on those discussions and their own business judgment,
that the proposed fees fairly reflect the value of FPGA technology for
the BX exchange. A number of customers provisionally agree with this
assessment, and have indicated that they are interested in testing it.
    No other exchange currently offers FPGA technology as a separate
service in conjunction with the delivery of a proprietary data feed,
and therefore there are no other fees for comparison.
    If BX is incorrect in its determination that the proposed fees
reflect the underlying value of FPGA technology, customers will not
purchase the product. FPGA technology is not necessary for a customer
to ingest and process depth of book information, and those customers
that seek a higher degree of determinism have a number of options at
their disposal to reduce jitter without using FPGA.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\15\ in general, and furthers the objectives of
Sections 6(b)(4) and 6(b)(5) of the Act,\16\ in particular, in that it
provides for the equitable allocation of reasonable dues, fees and
other charges among members and issuers and other persons using any
facility, and is not designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
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    \15\ 15 U.S.C. 78f(b).
    \16\ 15 U.S.C. 78f(b)(4) and (5).
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    The Proposal is reasonable and unlikely to burden the market
because the purchase of FPGA technology is optional for all categories
of customers. No customer and no category of customers (such as, for
example, vendors, proprietary trading firms, banks, hedge funds, market
makers, or high frequency trading firms) are required to purchase FPGA
technology for either legal or technological reasons--even a customer
that seeks to reduce jitter.\17\
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    \17\ Not all customers of depth of book information process at
sufficiently high speeds for jitter to become a concern. Neither
FPGA hardware nor its substitutes are required to ingest depth of
book information.
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    The Nasdaq exchange has over ten years of experience in selling
FPGA technology. That experience has shown that the vast majority of
Nasdaq depth customers do not find value in FPGA. The Exchange expects
such customers to continue to ingest BX TotalView as they do now.
    For those customers that may seek to increase determinism, the
purchase of FPGA technology from the BX exchange will be only one of
several options available. FPGA technology is not unique to the
Exchange or even the financial services industry. Third-party data
vendors offer FPGA technology services. Customers may also install
their own FPGA hardware for internal use. All of these are viable
options; the benefits of any particular option will depend on the
particular customer's systems and use cases.
    Customers may also choose not to address jitter using FPGA at all.
As noted above, FPGA technology processes the data at a consistently
predictable rate relative to software. This predictability in the rate
of processing may not be advantageous or optimal for all systems
receiving the exchange data feed.

    The design of data processing architecture is complex. The
ingestion of data from an exchange is just one step in the life-cycle
of trading. Customers must also generate and submit orders, evaluate
trades, and then generate new orders while interacting with multiple
exchanges. All of these steps are part of a single trading system.
Changing any one step in the process--by, for example, purchasing FPGA
technology services from one exchange (when other exchanges may not
offer FPGA)--often results in the need for changes to other aspects of
the process. As such, the decision to buy FPGA services will be based
on whether the service is compatible with their trading system as a
whole, not just on whether it may facilitate the processing of data
from a single exchange. The appropriateness of any particular solution
will depend on the customer's system architecture, and the specific use
cases for the market data consumed.
    To illustrate the choice faced by exchange customers, consider the
decisions made by the two consolidated data processors, the UTP and CTA
Plans, two different systems that use dissimilar means to achieve an
optimal solution. Both perform the same task--combining quotes and
trades from all US exchanges into a consolidated data feed with
relatively low jitter. Yet only one processor--the CTA Plan--uses FPGA
hardware, while the other--the UTP Plan--does not.
    This is because the UTP Plan's design, coding and hardware achieve
the desired level of determinism without FPGA technology. The CTA Plan,
by contrast, elected to incorporate FPGA technology into its system
design. Notwithstanding these different design decisions, both plans
achieve broadly similar levels of performance. FPGA technology is
therefore not essential to addressing jitter, but rather is one option
among many to address the issue.
    Market data customers face an array of choices to optimize
determinism, much like the UTP and CTA Plans. For example, a customer
may purchase and deploy its own FPGA hardware, without purchasing the
proposed FPGA technology service from the Exchange, after receiving
data from the Exchange. Another customer may find use of the Exchange's
FPGA technology, which lowers the level of jitter prior to the
customer's receipt of the data, to be a better fit for its system
architecture. The solution chosen will vary based on the needs and
design choices of the customer.
    The experience of the Nasdaq exchange in offering FPGA technology
shows that customers sensitive to jitter often avail themselves of
substitutes for FPGA technology, a decision that can change over time.
Over the past decade, a total of 21 current or potential users of FPGA
technology--all of which sought a higher degree of determinism--
substituted FPGA with an alternative solution. Six of these customers
were in the process of developing and testing FPGA hardware but
ultimately decided not to purchase it before completing this process.
The remaining 15 customers purchased FPGA technology, only to cancel it
after using it. Because all of these customers continued to utilize the
underlying data, these cancelations demonstrate that FPGA technology is
an optional service, even for those customers that seek to reduce
jitter.
    Moreover, as noted above, no other exchange currently offers FPGA
technology in conjunction with their proprietary data feeds as a
separate service, notwithstanding the fact that it is a widely
available technology, providing further evidence that customers have
multiple options at their disposal to address jitter.
    In the experience of the Nasdaq exchange, FPGA services are
purchased by vendors, proprietary trading firms, banks, high-frequency
trading firms, hedge funds, and market makers. The Nasdaq exchange is
aware of no systematic differences within any of these categories among
market participants that choose to use or not to use FPGA technology.
    Few customers of Nasdaq TotalView purchase FPGA services from
Nasdaq. This is because the bulk of customers consume Nasdaq TotalView
for display (i.e., human) usage. FPGA technology impacts performance at
a speed that a human cannot process, and there is no need for FPGA
technology for such usage.
    Of the customers that receive Nasdaq TotalView from Nasdaq (either
through a direct feed or an extranet connection), and are in a position
to utilize FPGA technology, only about 15 percent purchase it.
    Most strikingly, only approximately 3% of market makers at Nasdaq
purchase FPGA technology. This may seem a surprising result, given that
market makers, by definition, trade throughout the day and during
periods of peak activity, but, as noted above, customers have several
options: purchase FPGA services from a third-party vendor, implement
FPGA technology on their own, or configure their systems to process
data during peaks without the use of FPGA. The fact that only about 3%
of market makers at the Nasdaq exchange purchase FPGA demonstrates that
most customers make use of alternative solutions. As such, the
determining factor in whether to purchase FPGA is not the category of
customer, but rather the compatibility of FPGA technology with the
customer's specific systems architecture and technical requirements,
which can and do change over time as systems are modified, replaced or
updated.
    For all of these reasons, customers can discontinue the use of FPGA
technology at any time, or decide not to purchase it, for any reason,
including the level of fees.
    Customers that choose not to purchase FPGA technology are not
impacted by the proposal.
    The proposed fees will be available to all customers on a non-
discriminatory basis, and therefore are not designed to permit unfair
discrimination between customers, issuers, brokers, or dealers.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act.
    This Proposal, a response to customer demand, is a product of a
competitive marketplace. To date, lower levels of peak activity at the
BX Exchange relative to the Nasdaq exchange have been associated with
low levels of customer interest in this product. Recently, however, BX
has heard from customers interested in using FPGA technology for BX
TotalView. To address this customer demand, and to drive liquidity to
the BX Exchange by making it a more attractive trading venue, BX has
decided to offer this product.
    Approval of this Proposal will further promote competition by
providing market participants additional choices in the transmission of
depth of book data.
    Nothing in the Proposal burdens inter-market competition (the
competition among self-regulatory organizations) because approval of
the Proposal does not impose any burden on the ability of other
exchanges to compete. As noted above, FPGA technology is generally
available and any exchange has the ability to offer it if it so
chooses.
    Nothing in the Proposal burdens intra-market competition (the
competition among consumers of exchange data) because FPGA technology
is available to any customer under the same fee schedule as any other
customer, and any market participant that wishes to purchase

FPGA technology can do so on a non-discriminatory basis.

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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\18\
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    \18\ 15 U.S.C. 78s(b)(3)(A)(ii).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (https://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
file number SR-BX-2023-016 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-BX-2023-016. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (https://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for website viewing and
printing in the Commission's Public Reference Room, 100 F Street NE,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. Do not
include personal identifiable information in submissions; you should
submit only information that you wish to make available publicly. We
may redact in part or withhold entirely from publication submitted
material that is obscene or subject to copyright protection. All
submissions should refer to file number SR-BX-2023-016 and should be
submitted on or before August 15, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\19\
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    \19\ 17 CFR 200.30-3(a)(12).
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Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-15655 Filed 7-24-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 72 (Thursday, April 14, 2022)]
[Notices]
[Pages 22200-22201]
[FR Doc No: 2022-07986]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG22-90-000.
    Applicants: Laurel Mountain Interconnection, LLC.
    Description: Laurel Mountain Interconnection, LLC submits Notice of
Self-Certification of Exempt Wholesale Generator Status.
    Filed Date: 4/7/22.
    Accession Number: 20220407-5167.
    Comment Date: 5 p.m. ET 4/28/22.

    Take notice that the Commission received the following Complaints
and Compliance filings in EL Dockets:

    Docket Numbers: EL22-50-000.
    Applicants: East Kentucky Power Cooperative, Inc.
    Description: Petition of East Kentucky Power Cooperative, Inc. for
Enforcement of PURPA.
    Filed Date: 4/8/22.
    Accession Number: 20220408-5112.
    Comment Date: 5 p.m. ET 4/29/22.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER20-1633-001.
    Applicants: Silver Run Electric, LLC, PJM Interconnection, L.L.C.
    Description: Compliance filing: Silver Run Electric, LLC submits
tariff filing per 35: Silver Run Electric Amendment to Order No. 864
Compliance Filing to be effective 5/25/2020.
    Filed Date: 4/8/22.
    Accession Number: 20220408-5080.
    Comment Date: 5 p.m. ET 4/29/22.

    Docket Numbers: ER22-496-001.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Tariff Amendment: 2022-04-08_Deficiency Response to
Minimum Capacity Obligation Filing to be effective 9/1/2022.
    Filed Date: 4/8/22.
    Accession Number: 20220408-5128.
    Comment Date: 5 p.m. ET 4/29/22.

    Docket Numbers: ER22-1101-001.
    Applicants: Cascade Energy Storage, LLC.
    Description: Tariff Amendment: Second Supplement to Application for
Market-Based Rate Authority to be effective 2/24/2022.
    Filed Date: 4/7/22.
    Accession Number: 20220407-5173.
    Comment Date: 5 p.m. ET 4/18/22.

    Docket Numbers: ER22-1102-001.
    Applicants: Sierra Energy Storage, LLC.
    Description: Tariff Amendment: Second Supplement to Application for
Market-Based Rate Authority to be effective 2/24/2022.
    Filed Date: 4/7/22.
    Accession Number: 20220407-5174.
    Comment Date: 5 p.m. ET 4/18/22.

    Docket Numbers: ER22-1103-001.
    Applicants: BRP Capital & Trade LLC.
    Description: Tariff Amendment: Second Supplement to Application for
Market-Based Rate Authority to be effective 4/25/2022.

    Filed Date: 4/7/22.
    Accession Number: 20220407-5179.
    Comment Date: 5 p.m. ET 4/18/22.

    Docket Numbers: ER22-1602-000.
    Applicants: Midcontinent Independent System Operator, Inc.,
Cooperative Energy.
    Description: Sec.  205(d) Rate Filing: Midcontinent Independent
System Operator, Inc. submits tariff filing per 35.13(a)(2)(iii): 2022-
04-07_ROE Married Sheets to be effective 10/1/2016.
    Filed Date: 4/7/22.
    Accession Number: 20220407-5184.
    Comment Date: 5 p.m. ET 4/28/22.

    Docket Numbers: ER22-1603-000.
    Applicants: Alabama Power Company, Georgia Power Company,
Mississippi Power Company.
    Description: Sec.  205(d) Rate Filing: Alabama Power Company
submits tariff filing per 35.13(a)(2)(iii): Crimson Solar (Enterprise
Solar) LGIA Filing to be effective 3/25/2022.
    Filed Date: 4/8/22.
    Accession Number: 20220408-5122.
    Comment Date: 5 p.m. ET 4/29/22.

    Docket Numbers: ER22-1604-000.
    Applicants: California Independent System Operator Corporation.
    Description: Sec.  205(d) Rate Filing: 2022-04-08 Central
Procurement Entities Tariff Amendment to be effective 8/15/2022.
    Filed Date: 4/8/22.
    Accession Number: 20220408-5137.
    Comment Date: 5 p.m. ET 4/29/22.

    Docket Numbers: ER22-1605-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Tariff Amendment: Termination of Shelter Cove WPA (SA
382) to be effective 6/7/2022.
    Filed Date: 4/8/22.
    Accession Number: 20220408-5139.
    Comment Date: 5 p.m. ET 4/29/22.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: April 8, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-07986 Filed 4-13-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 1 (Thursday, January 2, 2014)]
[Notices]
[Pages 180-181]
[FR Doc No: 2013-31396]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2013-08]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of 14 CFR. The purpose of this notice is to
improve the public's awareness of, and participation in, this aspect of
FAA's regulatory activities. Neither publication of this notice nor the
inclusion or omission of information in the summary is intended to
affect the legal status of the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number involved and must be received on or before January 22, 2014.

ADDRESSES: You may send comments identified by Docket Number FAA-2013-
0810 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Theresa White, ANM-113,
Standardization Branch, Transport Airplane Directorate, Federal
Aviation Administration, 1601 Lind Avenue SW., Renton, WA 98057; email:
<EMAIL_ADDRESS>(425) 227-2956; Sandra Long, ARM-201, Office
of Rulemaking, Federal Aviation

Administration, 800 Independence Avenue SW., Washington, DC 20591;
email<EMAIL_ADDRESS>(202) 493-5245.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on December 27, 2013.
Lirio Liu,
Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2013-0810.
    Petitioner: Embraer.
    Section of 14 CFR Affected: 14 CFR Sec.  25.562(b), at Amendment
64; Sec.  25.785(b) at Amendment 88; and Special Conditions 25-495-SC,
number 2(e).
    Description of Relief Sought: The Petitioner request relief from
the regulatory requirements and special conditions, to allow for the
installation of lateral single and multiple side-facing seats in the
initial 55 production EMB-550 airplanes without meeting the new
criteria for side-facing seats.

[FR Doc. 2013-31396 Filed 12-31-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 88 (Thursday, May 7, 2015)]
[Notices]
[Pages 26280-26281]
[FR Doc No: 2015-11013]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]

Joint Meeting of the Bone, Reproductive, and Urologic Drugs
Advisory Committee, and the Drug Safety and Risk Management Advisory
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of two public advisory
committees of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committees: Bone, Reproductive, and Urologic Drugs Advisory
Committee, and the Drug Safety and Risk Management Advisory Committee.
    General Function of the Committees: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on June 4, 2015, from 8
a.m. to 5 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions

including information regarding special accommodations due to a
disability, visitor parking, and transportation may be accessed at:
http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    Contact Person: Kalyani Bhatt, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, Rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX: 301-847-
8533, email<EMAIL_ADDRESS>or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area). A
notice in the Federal Register about last minute modifications that
impact a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    Agenda: The committees will discuss new drug application (NDA)
022526, flibanserin 100 milligram (mg) tablets, submitted by Sprout
Pharmaceuticals Inc., proposed for the treatment of hypoactive sexual
desire disorder (HSDD) in premenopausal women.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before May
20, 2015. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. Those individuals interested in making
formal oral presentations should notify the contact person and submit a
brief statement of the general nature of the evidence or arguments they
wish to present, the names and addresses of proposed participants, and
an indication of the approximate time requested to make their
presentation on or before May 12, 2015. Time allotted for each
presentation may be limited. If the number of registrants requesting to
speak is greater than can be reasonably accommodated during the
scheduled open public hearing session, FDA may conduct a lottery to
determine the speakers for the scheduled open public hearing session.
The contact person will notify interested persons regarding their
request to speak by May 13, 2015.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Kalyani Bhatt at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: May 4, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-11013 Filed 5-6-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 4 (Friday, January 6, 2023)]
[Rules and Regulations]
[Pages 975-977]
[FR Doc No: 2023-00010]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2022-N-3189]

Medical Devices; Cardiovascular Devices; Classification of the
Hardware and Software for Optical Camera-Based Measurement of Pulse
Rate, Heart Rate, Breathing Rate, and/or Respiratory Rate

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
classifying the hardware and software for optical camera-based
measurement of pulse rate, heart rate, breathing rate, and/or
respiratory rate into class II (special controls). The special controls
that apply to the device type are identified in this order and will be
part of the codified language for the hardware and software for optical
camera-based measurement of pulse rate, heart rate, breathing rate,
and/or respiratory rate's classification. We are taking this action
because we have determined that classifying the device into class II
(special controls) will provide a reasonable assurance of safety and
effectiveness of the device. We believe this action will also enhance
patients' access to beneficial innovative devices.

DATES: This order is effective January 6, 2023. The classification was
applicable on April 1, 2021.

FOR FURTHER INFORMATION CONTACT: Jennifer Kozen, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2272, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the hardware and software for
optical camera-based measurement of pulse rate, heart rate, breathing
rate, and/or respiratory rate as class II (special controls), which we
have determined will provide a reasonable assurance of safety and
effectiveness. In addition, we believe this action will enhance
patients' access to beneficial innovation, in part by placing the
device into a lower device class than the automatic class III
assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device
that does not require premarket approval. We determine whether a new
device is substantially equivalent to a predicate device by means of
the procedures for premarket notification under section 510(k) of the
FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 (Pub. L. 105-115) established the first procedure for De
Novo classification. Section 607 of the Food and Drug Administration
Safety and Innovation Act (Pub. L. 112-144) modified the De Novo
application process by adding a second procedure. A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    When FDA classifies a device into class I or II via the De Novo
process, the device can serve as a predicate for future devices of that
type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C
Act). As a result, other device sponsors do not have to submit a De
Novo request or premarket approval application to market a
substantially equivalent device (see section 513(i) of the FD&C Act,
defining ``substantial equivalence''). Instead, sponsors can use the
less-burdensome 510(k) process, when necessary, to market their device.

II. De Novo Classification

    On June 12, 2020, FDA received ContinUse Biometrics Ltd.'s request
for De Novo classification of the Gili Pro BioSensor. FDA reviewed the
request in order to classify the device under the criteria for
classification set forth in section 513(a)(1) of the FD&C Act.

    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on April 1, 2021, FDA issued an order to the requester
classifying the device into class II. In this final order, FDA is
codifying the classification of the device by adding 21 CFR
870.2786.\1\ We have named the generic type of device hardware and
software for optical camera-based measurement of pulse rate, heart
rate, breathing rate, and/or respiratory rate, and it is identified as
a device that uses an optical sensor system and software algorithms to
obtain and analyze video signal and estimate pulse rate, heart rate,
breathing rate, and/or respiratory rates. This device is not intended
to independently direct therapy.
---------------------------------------------------------------------------

    \1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
---------------------------------------------------------------------------

    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

 Table 1--Hardware and Software for Optical Camera-Based Measurement of
  Pulse Rate, Heart Rate, Breathing Rate, and/or Respiratory Rate Risks
                         and Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Delayed or incorrect treatment due to    Software verification,
 erroneous output as a result of device   validation, and hazard
 malfunction or algorithm error.          analysis; Cybersecurity
                                          assessment; Clinical data; and
                                          Labeling.
Delayed or incorrect treatment due to    Human factors assessment, and
 user misinterpretation.                  Labeling.
Eye damage, burns, and related safety    Non-clinical performance
 concerns due to illuminating optics.     testing, and Labeling.
------------------------------------------------------------------------

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

III. Analysis of Environmental Impact

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

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections
of information in 21 CFR part 860, subpart D, regarding De Novo
classification have been approved under OMB control number 0910-0844;
the collections of information in 21 CFR part 814, subparts A through
E, regarding premarket approval, have been approved under OMB control
number 0910-0231; the collections of information in part 807, subpart
E, regarding premarket notification submissions, have been approved
under OMB control number 0910-0120; the collections of information in
21 CFR part 820, regarding quality system regulation, have been
approved under OMB control number 0910-0073; and the collections of
information in 21 CFR part 801, regarding labeling, have been approved
under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 870

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
870 is amended as follows:

PART 870--CARDIOVASCULAR DEVICES

0
1. The authority citation for part 870 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  870.2786 to subpart C to read as follows:

Sec.  870.2786  Hardware and software for optical camera-based
measurement of pulse rate, heart rate, breathing rate, and/or
respiratory rate.

    (a) Identification. The device uses an optical sensor system and
software algorithms to obtain and analyze video signal and estimate
pulse rate, heart rate, breathing rate, and/or respiratory rates. This
device is not intended to independently direct therapy.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) A software description and the results of verification and
validation testing based on a comprehensive hazard analysis and risk
assessment must include:
    (i) A full characterization of the software technical parameters,
including algorithms;
    (ii) A description of all mitigations for user error or failure of
any subsystem components (including signal detection, signal analysis,
data display, and storage) on output accuracy; and
    (iii) Software documentation must include a cybersecurity
vulnerability and management process to assure software functionality.
    (2) Performance testing must demonstrate the safety of any
illuminating optics.
    (3) Clinical data must be provided. This assessment must fulfill
the following:

    (i) The clinical data must be representative of the intended use
population for the device. Any selection criteria or sample limitations
must be fully described and justified.
    (ii) The assessment must demonstrate output consistency using the
expected range of data sources and data quality encountered in the
intended use population and environment.
    (iii) The assessment must compare device output with a clinically
accurate patient-contacting relevant comparator device in an accurate
and reproducible manner.
    (4) A human factors and usability engineering assessment must be
provided that evaluates the risk of improper measurement.
    (5) Labeling must include:
    (i) A description of what the device measures and outputs to the
user;
    (ii) Warnings identifying sensor acquisition factors or subject
conditions or characteristics (garment types/textures, motion, etc.)
that may impact measurement results;
    (iii) Guidance for interpretation of the measurements, including a
statement that the output is adjunctive to other physical vital sign
parameters and patient information;
    (iv) The expected performance of the device for all intended use
populations and environments; and
    (v) Robust instructions to ensure correct system setup.

    Dated: January 3, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-00010 Filed 1-5-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 115 (Wednesday, June 15, 2016)]
[Notices]
[Pages 39053-39054]
[FR Doc No: 2016-14139]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0853]

Tobacco Product Manufacturing Facility Visits

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA), Center for Tobacco
Products (CTP) is announcing an invitation for participation in its
Tobacco Product Manufacturing Facility Visits. This program is intended
to give FDA staff an opportunity to visit facilities involved in the
manufacturing of newly deemed tobacco products and their components and
parts, including any related laboratory testing, and to observe the
manufacturing operations of the tobacco industry. The purpose of this
document is to invite parties interested in participating in Tobacco
Product Manufacturing Facility Visits to submit requests to CTP.

DATES: Submit either an electronic or written request for participation
by August 15, 2016. See section IV of this document for information on
requests for participation.

ADDRESSES: If your facility is interested in participating in Tobacco
Product Manufacturing Facility Visits, please submit a request either
electronically to http://www.regulations.gov or in writing to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Matthew Brenner, Center for Tobacco
Products, Food and Drug Administration, Document Control Center, Bldg.
71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
877-287-1373, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On June 22, 2009, the Family Smoking Prevention and Tobacco Control
Act (Pub. L. 111-31; 123 Stat. 1776) was signed into law, amending the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) and giving FDA
authority to regulate tobacco product manufacturing, distribution, and
marketing. The new provisions include, among other things, the
authority to issue regulations related to tobacco product manufacturing
practice in order to protect the public health and to assure that
tobacco products are in compliance with the FD&C Act. Specifically,
section 906(e) of the FD&C Act (21 U.S.C. 387f(e)) provides that in
applying manufacturing restrictions to tobacco, the Secretary shall
prescribe regulations (which may differ based on the type of tobacco
product involved) requiring that the methods used in, and the
facilities and controls used for, the manufacture, preproduction design
validation (including a process to assess the performance of a tobacco
product), packing, and storage of a tobacco product conform to current
good manufacturing practice, or hazard analysis and critical control
point methodology.
    CTP is instituting Tobacco Product Manufacturing Facility Visits to
provide FDA staff with the opportunity to:
     Observe tobacco product manufacturing operations--from the
receipt of raw materials to the distribution of newly deemed tobacco
products, and
     Learn about the manufacturing practices and processes
unique to your facility and newly deemed tobacco products.
    This program will also inform FDA staff as they implement the
tobacco provisions of the FD&C Act.

II. Description of the Tobacco Product Manufacturing Facility Visits

    In this program, groups of FDA staff plan to observe the following
facilities and their operations:
     Manufacturing facilities, including establishments that
process, package, label, and distribute different types of newly deemed
tobacco products (e.g., dissolvable products, gels, cigars, pipe
tobacco, waterpipe tobacco products, and electronic nicotine delivery
systems (ENDS) (including e-cigarettes, e-hookah, e-cigars, vape pens,
advanced refillable personal vaporizers, and electronic pipes) and
liquid nicotine and flavors) (see 81 FR 28973, May 10, 2016),
     Laboratory facilities that perform tobacco testing
(whether third-party or in-house), and
     Manufacturing facilities for tobacco products for further
manufacturing into finished tobacco products (including, but not
limited to, components, parts, flavors, casings, e-liquids).
    Please note that Tobacco Product Manufacturing Facility Visits are
not intended to include or replace official FDA inspections of
facilities to determine compliance with the FD&C Act; rather, these
facility visits are meant to educate FDA staff and improve their
understanding of the tobacco industry and its manufacturing operations.

III. Site Selection

    CTP plans to select sites from one or more of each of the following
categories:
     Dissolvable products,
     Gels,
     Cigars,
     Pipe tobacco,
     Waterpipe tobacco products,
     ENDS (including e-cigarettes, e-hookah, e-cigars, vape
pens, advanced refillable personal vaporizers, and electronic pipes)
and liquid nicotine and flavors,
     Tobacco laboratories,
     Importers of finished tobacco products,
     Distributors and wholesalers of regulated tobacco
products, and/or
     Manufacturers of tobacco products for further
manufacturing into finished tobacco products (including, but not
limited to, components, parts, flavors, casings, e-liquids).
    Final site selections will be based on the availability of CTP
funds and resources for the relevant fiscal year, as well as the
following factors, as applicable: (1) Compliance status of the
requesting facility and affiliated firm; (2) whether the requesting
facility or affiliated firm, if applicable, has a significant request
or marketing application or submission pending with FDA; and (3)
whether the requesting facility will be engaged in active manufacturing
or processing during the proposed time of the visit. All travel
expenses associated with Tobacco Product Manufacturer Facility Visits
will be the responsibility of CTP.

IV. Requests for Participation

    The request for participation should include the following
identification information:
     The name and contact information (including address, phone
number, and email) of your point of contact for the request;

     The physical address(es) of the site(s) for which you are
submitting a request;
     The type of processes (e.g., manufacturing, laboratory
practices, mixing, packaging, labeling, and distribution activities)
performed at your facility;
     The type of tobacco products tested, processed, or
manufactured at your facility; and
     A proposed program agenda.
    Identify requests for participation with the docket number found in
brackets in the heading of this document. Received requests are
available for public examination in the Division of Dockets Management
(see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: June 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14139 Filed 6-14-16; 8:45 am]
BILLING CODE 4164-01-P