[Federal Register Volume 87, Number 98 (Friday, May 20, 2022)]
[Notices]
[Pages 31022-31026]
[FR Doc No: 2022-10800]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-94915; File No. SR-EMERALD-2022-16]

Self-Regulatory Organizations; MIAX Emerald, LLC; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Amend
the MIAX Emerald Fee Schedule To Adopt Fees for the High Precision
Network Time Signal Service

May 16, 2022.
    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 May 5, 2022, MIAX Emerald, LLC (``MIAX Emerald'' or ``Exchange'')
filed with the Securities and Exchange Commission (``Commission'') a
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 is filing a proposal to amend the MIAX Emerald Fee
Schedule (the ``Fee Schedule'') to adopt fees for a new service known
as the ``High Precision Network Time Signal Service.'' \3\
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    \3\ See, generally, Exchange Rule 531(d).
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    The text of the proposed rule change is available on the Exchange's
website at http://www.miaxoptions.com/rule-filings/emerald, at MIAX's
principal office, 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 provides a resilient and robust technology platform,
deterministic functionality, transparent trading platform, and a
culture of technological innovation to the U.S. options market. In
keeping with its culture of innovation, the Exchange recently
established a new service known as the ``High Precision Network Time
Signal Service'' (``HPNTSS'' or the ``Service''),\4\ which is available
for purchase by subscribers on a voluntary basis. The Exchange now
proposes to adopt fees for the Service, which is described under
Exchange Rule 531(d).\5\ In sum, Members are able to utilize the
Service to synchronize their time recording systems to those of the
Exchange at sub-nanosecond level accuracy for correlated latency
measurements between the Exchange's and the Members' systems time
measurements related to the same message or order. The Service is an
optional product available to any Member that chooses to subscribe.
However, the Exchange anticipates that latency sensitive Members would
primarily subscribe to the Service to help them measure latency in a
manner consistent with their trading behavior and the evolving pace of
trading and technology in today's markets. The Exchange anticipates
that Members that employ business models that are not latency
sensitive, such as those that only enter resting liquidity, may not
find interest in the Service and elect not to subscribe to it. The
Service may also not be useful for order routing firms that connect to
the Exchange solely as part of their best execution obligations or to
comply with the trade-through requirements under Chapter XIV of the
Exchange's Rules.\6\
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    \4\ See Securities Exchange Act Release No. 94335 (March 1,
2022), 87 FR 12756 (March 7, 2022) (SR-EMERALD-2021-38) (Notice of
Filing of Amendment No. 1 and Order Granting Accelerated Approval of
a Proposed Rule Change, as Modified by Amendment No. 1, To Amend
Exchange Rule 531 To Provide for a New Service Called the High
Precision Network Time Signal Service) (``Approval Order'').
    \5\ See Exchange Rule 531(d).
    \6\ See Amendment No. 1 at note 26 and accompanying text
available on the Commission's website at https://www.sec.gov/comments/sr-emerald-2021-38/sremerald202138-20116580-268058.pdf. See
also Chapter XIV of the Exchange's Rules, which incorporates by
reference Rule 1401, Order Protection, of the Exchange's affiliate,
Miami International Securities Exchange, LLC (``MIAX'').
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    The Exchange proposes to assess a monthly fee of $3,600 for
subscribing to the Service. As such, the Exchange proposes to amend the
Fee Schedule to adopt new Section 8), Services, to provide that
subscribers may purchase the Service for a monthly fee of $3,600.
Subscribers may cancel their subscription at any time. The Exchange
proposes to specify that for mid-month subscriptions to the Service,
new subscribers will be charged for the full calendar month for which
they subscribe. A second time signal is available with each
subscription to the Service for redundancy and disaster recovery
purposes. The Exchange initially filed the proposed fee change on March
30, 2022 with the fees being effective on April 1, 2022.\7\ The
Exchange withdrew that proposed fee change and submitted this filing on
May 5, 2022. The purpose of this revised filing is to provide
additional description and justification for the proposed fee.
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    \7\ See Securities Exchange Act Release No. 94697 (April 12,
2022), 87 FR 23000 (April 18, 2022) (SR-EMERALD-2022-12).
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    In sum, the Service enables subscribers to synchronize their own
primary clock devices to the Exchange's primary clock device, by
receiving time signals from the Exchange via a separate and dedicated 1
gigabit (``Gb'') connection that is currently offered by the Exchange
and utilized by market participants to connect to the Exchange's
System.\8\ The Service simply provides subscribers with the Exchange's
time signal at a sub-nanosecond level and nothing else. The sub-
nanosecond time signal would tell the subscriber the Exchange's time at
a sub-nanosecond level at a particular point in time. The subscriber
may then use that time signal to synchronize their own primary clock to
the Exchange's primary clock at the more acute sub-nanosecond level.\9\
Subscribers would utilize their own Enhanced PTP device \10\ to
synchronize the clocks within the subscriber's computer and network
infrastructure, as appropriate, at a sub-nanosecond level. This would
enable the subscriber to record certain times an order or message
traveled through and leaves the subscriber's system at a sub-nanosecond
level.
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    \8\ The Exchange did not provide a new connectivity option to
receive time signals via the Service. The Service is not a
connectivity product and subscribers would only need to utilize an
existing connectivity method offered by the Exchange to utilize the
Service via a dedicated connection. See Approval Order, supra note 4
at note 22 and accompanying text. See also MIAX Emerald Options
Alert, ``Update: The Introduction of the High Precision Network Time
Signal (Enhanced PTP/White Rabbit) Beginning April 1, 2022,'' March
3, 2022 (notifying potential subscribers that the Service requires a
dedicated 1Gb connection), available at https://www.miaxoptions.com/alerts/2022/03/03/miax-emerald-options-update-introduction-high-precision-network-time-signal. See Fee Schedule, Section 5, System
Connectivity Fees, for information regarding 1Gb connectivity. A
Members that subscribes to the Service would also have to pay $1,400
per month for a 1Gb connections. Id.
    \9\ See supra note 4 for a detailed description of the Service.
See also MIAX Emerald Options--Update: The Introduction of the High
Precision Network Time Signal (Enhanced PTP/White Rabbit) Beginning
April 1, 2022 (March 3, 2022), available at https://www.miaxoptions.com/alerts/2022/03/03/miax-emerald-options-update-introduction-high-precision-network-time-signal.
    \10\ An Enhanced PTP clock synchronization device captures time
and coordinates time synchronization within a network at a sub-
nanosecond level.
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    The Service is not a connectivity product and subscribers are able
to utilize an existing connectivity method (separate and dedicated 1Gb
connection) offered by the Exchange to utilize the Service. The Service
simply provides enhanced time synchronization that may be utilized by a
subscriber to adjust their own systems. The Service is not a market
data product or access/connectivity service. Subscribers may continue
to use their existing methods to connect to and send orders to the
Exchange. The Service will not include any trading data regarding the
subscriber's activity on the Exchange or include any data from other
trading activity on the Exchange.
    The Exchange established the Service in response to demand for
tighter and more accurate clock synchronization options with the
Exchange's network and requests for tools that would enable Members to
better measure traversal times between their network and that of the
Exchange at a more granular level. As described above, the Exchange
anticipates that a small subset of Members who are latency sensitive
would find the Service useful. The Service is offered to subscribers on
a completely voluntary basis in that the Exchange is not required by
any rule or regulation to make the Service available. It is a business
decision of each Member whether to subscribe to the Service and each
Member may choose to do so based on their business models and needs.
    The Exchange began to offer the Service and charge the proposed
fees on April 1, 2022. The Exchange anticipates that at most five to
six Members may find the Service useful and ultimately choose to
subscribe.

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\11\ in general, and furthers the
objectives of Section 6(b)(5) of the Act,\12\ in particular, in that it
is not designed to permit unfair discrimination among customers,
brokers, or dealers. The Exchange also believes that its proposal to
adopt fees for the Service is consistent with Section 6(b)(4) of the
Act \13\ because it represents an equitable allocation of reasonable
dues, fees and other charges among market participants.
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    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(5).
    \13\ 15 U.S.C. 78f(b)(4).
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    The Exchange operates in a highly competitive environment in which
16 U.S. registered equity options exchanges compete for market share.
Based on publicly available information, no single options exchange has
more than 13% of the equity options market share and currently the
Exchange represents only approximately 3.97% of the market share.\14\
The Commission has repeatedly expressed its preference for competition
over regulatory intervention in determining prices, products, and
services in the securities markets. Particularly, in Regulation NMS,
the Commission highlighted the importance of market forces in
determining prices and SRO revenues and recognized that current
regulation of the market system ``has been remarkably successful in
promoting market competition in its broader forms that are most
important to investors and listed companies.'' \15\ The Service
provides subscribing Members with a tool to assist them in
recalibrating their own models and trading strategies to improve their
overall experience on the Exchange, thereby potentially improving
execution and order fill rates. This may improve the Exchange's overall
market quality through increased liquidity and improved execution
opportunities for resting orders, enhancing the Exchange's overall
competitive position. The proposed fees are a result of the competitive
environment of the U.S. options industry as the Exchange seeks to adopt
fees to attract purchasers of the recently introduced Service.
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    \14\ See ``The Market at a Glance,'' (last visited April 26,
2022), available at https://www.miaxoptions.com/.
    \15\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496, 37499 (June 29, 2005) (``Regulation NMS Adopting
Release'').
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    If the Exchange proposed fees that market participants viewed as
excessively high, then the proposed fees would simply serve to reduce
demand for the Exchange's Service, which as noted, is entirely
optional. Other options exchanges are also free to introduce their own
comparable products with lower prices to better compete with the
Exchange's offering. The Service may not provide utility to all Members
based on their business models, and such Members may choose to use
existing time synchronization methods, or rely on other methods,
including similar products potentially offered by other exchanges, to
measure latency between the Member's system and an exchange's system or
to test their systems' performance to ensure it is operating as
intended. As such, the Exchange believes that the proposed fees are
reasonable and set at a level to compete with other options exchanges
that may choose to offer similar services. Moreover, if a market
participant views another exchange's potential service as more
attractive, then such market participant can merely choose not to
subscribe to the Exchange's Service and instead subscribe to another
exchange's similar product, which may offer similar data points, albeit
based on that other market's trading systems.
    The Exchange also believes the proposed fees are reasonable as they
would support the introduction of a new product to subscribers. As
discussed above, the Service is an optional product available to any
Member that chooses to subscribe. To date, no Member has elected to
subscribe to the Service and the Exchange anticipates that five to six
latency sensitive Members may find the Service useful and ultimately
choose to subscribe. If the Exchange prices the fees for the Service
too high, these Members may choose not to subscribe and potentially
utilize other methods to measure latency or monitor the health of their
systems. Members that employ business models that are not latency
sensitive, such as those that only enter resting liquidity and order
routing firms that connect to the Exchange solely as part of their best
execution obligations or to comply with the trade-through requirements,
may not find the Service useful for their business models and elect not
to subscribe to it regardless of the level of the fee. The Exchange
anticipates a small subset of its overall membership would find utility
in the Service and must consider this fact when pricing the Service to
encourage those Members to subscribe.
    The Exchange believes the proposed fees are reasonable in order to
support the introduction of the new Service, which may be used for
numerous optional purposes. For example, the Service would allow
subscribers to more precisely measure latency between their network and
that of the Exchange at a sub-nanosecond level, allowing subscribers to
better understand the times at which their order or message reached
certain points when traveling from their network to the Exchange. The
Service would also allow subscribers to analyze the efficiency of their
network and connections when not only routing orders to the Exchange,
but also when receiving messages back from the Exchange (including
communications regarding whether their order was accepted, rejected, or
executed). Subscribers utilizing the Service may measure message
traversal times by comparing their messages' (e.g., order, quote,
cancellation) timestamps to the Exchange's matching engine timestamps
from the Exchange-generated acknowledgement messages (e.g., order
acknowledgment, quote acknowledgment, cancellation acknowledgment).\16\
Subscribers would then be able to enhance their own systems to ensure
that they are receiving such communications in a timelier manner and to
verify that their systems are working as intended.
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    \16\ The Exchange sends subscribers an acknowledgement message
that their order or message was received by the Exchange. This
acknowledgement includes the time of receipt at a nanosecond level.
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    In addition, subscribers may utilize these enhanced latency
measurements to better analyze latencies within their own systems and
use this analysis to optimize their network, models and trading
patterns to potentially improve their interactions with the
Exchange.\17\ In particular, subscribers may use these metrics to
better assess the health of their network and that their systems are
working as intended. For example, a subscriber may use this information
when analyzing the efficacy of their various connections and whether a
connection is performing as expected or experiencing a delay. A
subscriber may then decide to rebalance the amount of orders and/or
messages over its various connections to ensure each connection is
operating with maximum efficiency. Subscribers may also use the Service
for other purposes, such as enhancing their ability to determine
compliance with certain regulatory requirements \18\ and

trade surveillance. Subscribers may also utilize time synchronization
to assist them in better evaluating compliance with certain clock
synchronization requirements. The Exchange therefore believes the
proposed fees are reasonable because of the numerous benefits provided
to subscribers that subscribe to the Service. Selling different
products and services, such as HPNTSS, is also a means by which
exchanges compete to attract business. To the extent that the Exchange
is successful in attracting subscribers for the Service, it may earn
trading revenues and further enhance market participants' interactions
on the Exchange, which would increase value of its products and
services. If the market deems the proposed fees to be unfair or
inequitable, firms can choose not to use or discontinue their use of
the Service. The Exchange therefore believes that the proposed fees for
the Service reflect the competitive environment of U.S. exchanges and
would be properly assessed to market participants that subscribe to the
Service. The Exchange also believes the proposed fees are equitable and
not unfairly discriminatory as the fees would apply equally to all
users who choose to subscribe to the Service. It is a business decision
of each market participant that chooses to subscribe to the Service.
The Exchange's proposed fees would not differentiate between
subscribers that purchase the Service and are set at a modest level
that would allow any interested market participant to purchase the
Service based on their business needs.
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    \17\ Based on their business models and needs, Members may elect
to purchase an enhanced PTP device from a third party and use that
devise to measure latency at a sub-nanosecond level within their own
systems. In such case, the Member would be limited to time
measurements within its own system and would not be privy to the
Exchange's own sub-nanosecond timestamp.
    \18\ See, e.g., Chapter III of the Exchange's Rules, which
incorporates by reference Rule 301, Interpretation and Policy .02
(Just and Equitable Principles of Trade), of the Exchange's
affiliate, MIAX; and Financial Industry Regulatory Authority, Inc.
(``FINRA'') Rule 5320.
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    The Exchange reiterates that the decision as to whether or not to
purchase the Service is entirely optional for all potential
subscribers. Indeed, no market participant is required to purchase the
Service and the Exchange is not required to make the Service available
to all investors. It is entirely a business decision of each market
participant to subscribe to the Service. The Exchange offers the
Service as a convenience to market participants to provide them with
the ability to synchronize their own primary clock devices to the
Exchange's primary clock device at a sub-nanosecond level. A market
participant that chooses to subscribe to the Service may discontinue
the use of the Service at any time if that market participant
determines that the synchronization of its primary clock devices to the
Exchange's primary clock device is no longer useful.
    The Exchange believes it is reasonable to not pro-rate mid-month
subscriptions and to charge mid-month subscribers for the full month in
which they initially subscribe to the Service. The Exchange seeks to
encourage Members to subscribe to the Service at the beginning of each
month to ease the strain on administrative resources and synchronize
potential new subscriptions to the Service. The Exchange believes not
pro-rating mid-month subscriptions is a reasonable means to achieve
this goal. Members that elect to subscribe mid-month would be aware
that they would be liable for the full monthly fee and may elect to
wait until the first of the next month to subscribe if they wish to
receive the Service for the first full month they subscribe. Lastly,
not pro-rating mid-month subscriptions is not novel and is currently
done by the Exchange for other products and other exchanges.\19\
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    \19\ For example, the Exchange does not currently pro-rate mid-
month subscriptions to its Open-Close Report or its Liquidity Taker
Event Report. See Sections (6) and (7) of the Exchange's Fee
Schedule, available at https://www.miaxoptions.com/sites/default/files/fee_schedule-files/MIAX_Emerald_Fee_Schedule_04182022.pdf.
Cboe BZX Exchange, Inc. (``BZX'') and Cboe EDGX Exchange, Inc.
(``EDGX'') also do not pro-rate mid-month subscriptions for certain
products. See, e.g., the Market Data and Cboe LiveVol, LLC Market
Data Fees sections of BZX's options fee schedule and EDGX's options
fee schedule, available at https://www.cboe.com/us/options/membership/fee_schedule/bzx/ (last visited April 26, 2022) and
https://www.cboe.com/us/options/membership/fee_schedule/edgx/ (last
visited April 26, 2022).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act. The Exchange
made the Service available in order to keep pace with changes in the
industry and evolving customer needs and demands, and believes the
product will contribute to robust competition among national securities
exchanges. As a result, the Exchange believes this proposed rule change
permits fair competition among national securities exchanges.
    The Exchange believes the proposed fees would not cause any
unnecessary or inappropriate burden on intermarket competition as other
exchanges are free to introduce their own comparable product with lower
prices to better compete with the Exchange's offering. The Exchange
operates in a highly competitive environment, and its ability to price
the Service is constrained by the optional nature of the Service and
competition among exchanges who choose to adopt a similar product. The
Exchange must consider this in its pricing discipline in order to
compete for market share. The Exchange anticipates that most, if not
all, subscribers to the Service would be those Members whose trading
models are latency sensitive and primarily seek to remove liquidity.
These Members may increase their volume of liquidity removing orders as
a result of re-calibrating their trading models based on their use of
the Service. The increase in incoming liquidity removing orders may
result in higher execution rates for Members who are less latency
sensitive and primarily place resting orders on the Exchange's Simple
Order Book \20\ and/or Strategy Book.\21\ The proposed Service may
benefit those market participants who would receive greater fill rates,
thereby improving the Exchange's competitive standing through increased
order flow, execution rates, and enhancing the quality of the
Exchange's market.
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    \20\ The ``Simple Order Book'' is the Exchange's regular
electronic book of orders and quotes. See Exchange Rule 518(a)(15).
    \21\ The ``Strategy Book'' is the Exchange's electronic book of
complex orders and complex quotes. See Exchange Rule 518(a)(17).
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    The Exchange believes that if it were to propose fees that are
excessively higher than fees for potentially similar products, it would
simply serve to reduce demand for the Exchange's product, which as
discussed, market participants are under no obligation to utilize. In
this competitive environment, potential purchasers are free to choose
which, if any, similar product to purchase to satisfy their need for
time synchronization. As a result, the Exchange believes this proposed
rule change permits fair competition among national securities
exchanges.
    The Exchange does not believe the proposed rule change would cause
any unnecessary or inappropriate burden on intramarket competition.
Particularly, the proposed product and fees apply uniformly to any
purchaser in that the Exchange does not differentiate between
subscribers that purchase the Service. The proposed fees are set at a
modest level that would allow any interested market participant to
purchase the Service based on their business needs.

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

    Written comments were neither solicited nor 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,\22\ and Rule 19b-4(f)(2) \23\ thereunder.
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 necessary or appropriate
in the public interest, for the protection of investors, or 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.
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    \22\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \23\ 17 CFR 240.19b-4(f)(2).
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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 protected]. Please include
File Number SR-EMERALD-2022-16 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-EMERALD-2022-16. 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-EMERALD-2022-16 and should be submitted
on or before June 10, 2022.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\24\
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    \24\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-10800 Filed 5-19-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 180 (Tuesday, September 19, 2023)]
[Notices]
[Pages 64466-64467]
[FR Doc No: 2023-20162]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2006-0048]

NSF International: Grant of Expansion of Recognition

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice.

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SUMMARY: In this notice, OSHA announces the final decision to expand
the scope of recognition for NSF International as a Nationally
Recognized Testing Laboratory (NRTL).

DATES: The expansion of the scope of recognition becomes effective on
September 19, 2023.

FOR FURTHER INFORMATION CONTACT: Information regarding this notice is
available from the following sources:
    Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office
of Communications, U.S. Department of Labor, telephone:<PHONE_NUMBER>;
email: [email protected].
    General and technical information: Contact Mr. Kevin Robinson,
Director, Office of Technical Programs and Coordination Activities,
Directorate of Technical Support and Emergency Management, Occupational
Safety and Health Administration, U.S. Department of Labor, phone:
(202) 693-2300 or email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Notice of Final Decision

    OSHA hereby gives notice of the expansion of the scope of
recognition of NSF International (NSF), as a NRTL. NSF's expansion
covers the addition of one test site to the NRTL scope of recognition.
    OSHA recognition of a NRTL signifies that the organization meets
the requirements specified in 29 CFR 1910.7. Recognition is an
acknowledgment that the organization can perform independent safety
testing and certification of the specific products covered within the
scope of recognition. Each NRTL's scope of recognition includes (1) the
type of products the NRTL may test, with each type specified by the
applicable test standard and (2) the recognized site(s) that has/have
the technical capability to perform the product-testing and product-
certification activities for test standards within the NRTL's scope.
Recognition is not a delegation or grant of government authority;
however, recognition enables employers to use products approved by the
NRTL to meet OSHA standards that require product testing and
certification.
    The agency processes applications by a NRTL for initial
recognition, as well as for an expansion or renewal of recognition,
following requirements in Appendix A to 29 CFR 1910.7. This appendix
requires that the agency publish two notices in the Federal Register in
processing an application. In the first notice, OSHA announces the
application and provides the preliminary finding. In the second notice,
the agency provides the final decision on the application. These
notices set forth the NRTL's scope of recognition or modifications of
that scope. OSHA maintains an informational web page for each NRTL,
including NSF, which details that NRTL's scope of recognition. These
pages are available from the OSHA website at http://www.osha.gov/dts/otpca/nrtl/index.html.
    NSF submitted an application, dated July 21, 2020 (OSHA-2006-0048-
0016), to expand recognition as a NRTL to include one additional test
site located at: 251 Airport Industrial Drive,

Ypsilanti, Michigan 48198 (NSF Ypsilanti). OSHA staff performed an on-
site review of NSF's testing facilities at NSF Ypsilanti on May 3-4,
2023, in which assessors found some nonconformances with the
requirements of 29 CFR 1910.7. NSF has addressed these issues
sufficiently, and OSHA staff preliminarily determined that OSHA should
grant the application.
    OSHA published the preliminary notice announcing NSF's expansion
application in the Federal Register on August 16, 2023 (88 FR 55737).
The agency requested comments by August 31, 2023, but it received no
comments in response to the notice. OSHA now is proceeding with this
notice to grant expansion of NSF's scope of recognition.
    To obtain or review copies of all public documents pertaining to
the NSF expansion application, go to www.regulations/gov or contact the
Docket Office at<PHONE_NUMBER> (TTY<PHONE_NUMBER>. Docket No. OSHA-
2006-0048 contains all materials in the record containing NSF's
recognition.

II. Final Decision and Order

    OSHA staff examined NSF's expansion application, conducted a
detailed on-site assessment, and examined other pertinent information.
Based on review of this evidence, OSHA finds that NSF meets the
requirements of 29 CFR 1910.7 for expansion of recognition, subject to
the specified limitations and conditions. OSHA, therefore, is
proceeding with this final notice to grant NSF's scope of recognition.
OSHA limits the expansion of NSF's recognition to include the site at
Ypsilanti, Michigan as listed above. OSHA's recognition of the site
limits NSF to performing product testing and certifications only to the
test standards for which the site has the proper capability and
programs, and for test standards in NSF's scope of recognition. This
limitation is consistent with the recognition that OSHA grants to other
NRTLs that operate multiple sites.

A. Conditions

    In addition to those conditions already required by 29 CFR 1910.7,
NSF also must abide by the following conditions of the recognition:
    1. NSF must inform OSHA as soon as possible, in writing, of any
change of ownership, facilities, or key personnel, and of any major
change in its operations as a NRTL, and provide details of the
change(s);
    2. NSF must meet all the terms of its recognition and comply with
all OSHA policies pertaining to this recognition; and
    3. NSF must continue to meet the requirements for recognition,
including all previously published conditions on NSF's scope of
recognition, in all areas for which it has recognition.
    OSHA hereby expands the NRTL scope of recognition for NSF to
include one additional test site.

III. Authority and Signature

    James S. Frederick, Deputy Assistant Secretary of Labor for
Occupational Safety and Health, 200 Constitution Avenue NW, Washington,
DC 20210, authorized the preparation of this notice. Accordingly, the
agency is issuing this notice pursuant to 29 U.S.C. 657(g)(2),
Secretary of Labor's Order No. 8-2020 (85 FR 58393; Sept. 18, 2020),
and 29 CFR 1910.7.

    Signed at Washington, DC.
James S. Frederick,
Deputy Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2023-20162 Filed 9-18-23; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register: June 11, 2008 (Volume 73, Number 113)]
[Rules and Regulations]
[Page 33005-33007]
[DOCID:fr11jn08-11]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2008-0448]
RIN 1625-AA00

Temporary Safety Zone: Richland Regatta Hydroplane Races, Howard
Amon Park, Richland, WA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
the Richland Regatta Hydroplane Race to be held on the waters of the
Columbia River in the vicinity of Howard Amon Park, Richland, WA. The
safety zone will limit the movement of non-participating vessels in the
race area. This temporary rule is needed to provide for the safety of
life on navigable waters during the event.

DATES: This regulation is effective from 9 a.m. to 5 p.m. on June 14
and 15, 2008, unless canceled earlier through a broadcast notice to
mariners. The Captain of the Port Portland is taking this action to
safeguard individuals and vessels.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2008-0448 and are available online
at www.regulations.gov. They are also available for inspection or
copying at two locations: the Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays, and Coast Guard
Sector Portland, 6767 N. Basin Ave., Portland, OR 97217 between 8 a.m.
and 4 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: BM2 Joshua Lehner, c/o Captain of the
Port Portland, 6767 N. Basin Ave, Portland, OR 97217-3992, and (503)
240-9311.

Regulatory Information

    We did not publish a notice of proposed rulemaking (NPRM) for this
regulation. Under 5 U.S.C. 553(b)(B) and 5 U.S.C. 553(d)(3), the Coast
Guard finds that good cause exists for not publishing an NPRM and for
making this rule effective less than 30 days after publication in the
Federal Register. The emergent and dynamic nature of the event did not
allow previous notice. Publishing a NPRM would be contrary

to public interest since immediate action is necessary to ensure the
safety of vessels and spectators. If normal notice and comment
procedures were followed, this rule would not become effective until
after the date of the event. For this reason, following the normal
rulemaking procedures in this case would be impracticable and contrary
to the public.

Background and Purpose

    The Coast Guard is establishing a temporary safety zone to allow
for a safe racing event. This event occurs on the Columbia River in the
vicinity of Howard Amon Park in Richland, WA and is scheduled to start
at 9 a.m. and last until 5 p.m. on June 14 and 15, 2008. This event may
result in a number of recreational vessels congregating near the
hydroplane races. The hydroplane race poses several dangers to the
public including excessive noise, objects falling from any accidents,
and hydroplanes racing at high speeds in proximity to other vessels.
Accordingly, the Safety Zone is needed to protect watercraft and their
occupants from safety hazards associated with the event. This safety
zone will be enforced by representatives of the Captain of the Port
Portland. The Captain of the Port may be assisted by other federal,
state, and local agencies.

Discussion of Rule

    This temporary rule will create a safety zone to assist in
minimizing the inherent dangers associated with hydroplane races. These
dangers include, but are not limited to, excessive noise, race craft
traveling at high speed in close proximity to one another and to
spectator craft, and the risk of airborne objects from any accidents
associated with hydroplanes. In the event that hydroplanes require
emergency assistance, rescuers must have immediate and unencumbered
access to the craft. The Coast Guard, through this action, intends to
promote the safety of personnel, vessels, and facilities in the area.
Due to these concerns, public safety requires these regulations to
provide for the safety of life on the navigable waters.

Regulatory Evaluation

    This rule is not a ``significant regulatory action'' under section
3(f) of Executive Order 12866, Regulatory Planning and Review, and does
not require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order. It is not ``significant'' under the
regulatory policies and procedures of the Department of Homeland
Security (DHS). The Coast Guard expects the economic impact of this
temporary rule to be so minimal that a full Regulatory Evaluation under
the regulatory policies and procedures of DHS is unnecessary. This
expectation is based on the fact that the safety zone established by
this rule encompasses an area on the Columbia River near Howard Amon
Park in Richland, WA, rarely frequented by commercial navigation.
Additionally, the Patrol Commander may, upon request, allow the transit
of commercial vessels through the safety zone when it is safe to do so.
This regulation is established for the benefit and safety of the
recreational boating public, and any negative recreational boating
impact is offset by the benefits of allowing the hydroplanes to race.
This rule will be enforced from 9 a.m. to 5 p.m. each day on June 14
and 15, 2008. For the above reasons, the Coast Guard does not
anticipate any significant economic impact.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities. This rule will affect the following entities, some of which
may be small entities: the owners or operators of vessels intending to
transit or anchor in a portion of the Columbia River during the time
mentioned under Background and Purpose. This safety zone will not have
a significant economic impact on a substantial number of small entities
due to its short duration, small area, and the ability of the Patrol
Commander to allow commercial vessels to transit the safety zone when
safe to do so. The only vessels likely to be impacted will be
recreational boaters, small passenger vessel operators, commercial
barge operators, and a ferry that runs through the regulated area twice
a day. Because the impacts of this proposal are expected to be so
minimal, the Coast Guard certifies under 605(b) of the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.) that this temporary rule will
not have a significant economic impact on a substantial number of small
entities.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247).

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    We have analyzed this rule under Executive Order 13132 and have
determined that this rule does not have implications for federalism
under that order.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
governs the issuance of Federal regulations that require unfunded
mandates. An unfunded mandate is a regulation that requires a State,
local, or tribal government or the private sector to incur direct costs
without the Federal Government's having first provided the funds to pay
those unfunded mandate costs. This rule will not impose an unfunded
mandate.

Taking of Private Property

    This rule will not affect a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health

Risks and Safety Risks. This rule is not an economically significant
rule and does not create an environmental risk to health or risk to
safety that may disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Commandant Instruction M16475.lD,
which guides the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have concluded that there are no factors in this case that would limit
the use of a categorical exclusion under section 2.B.2 of the
Instruction. Therefore, this rule is categorically excluded, under
figure 2-1, paragraph (34)(g), of the Instruction, from further
environmental documentation because it establishes a safety zone. A
final ``Environmental Analysis Check List'' and a final ``Categorical
Exclusion Determination'' will be available in the docket where
indicated under ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, and Waterways.

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR parts 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50
U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L.
107-295, 116 Stat. 2064; Department of Homeland Security Delegation
No. 0170.1.

0
2. A temporary section in 165.T13-031 is added to read as follows:

Sec.  165.T13-031  Safety Zone; Richland Regatta Hydroplane Races
Howard Amon Park, Richland, Washington.

    (a) Location. The following area is a safety zone:
    (1) The waters of the Columbia River from bank to bank in the
vicinity of Howard Amon Park on the Columbia River in Richland,
Washington commencing at the Interstate 182 Bridge and continuing up
river Northward 3.0 miles and terminating at the Columbia River Mile
339.
    (b) Enforcement period. This rule will be in effect from 9 a.m. to
approximately 5 p.m. on June 14, 2008 and June 15, 2008, in the
described waters of the Columbia River in Richland, Washington.
    (c) Regulations. In accordance with the general regulations in
Section 165.23 of this part, no person or vessel not participating in
the actual hydroplane race may enter or remain in this zone unless
authorized by the Captain of the Port or his designated
representatives. Vessels and persons granted authorization to enter the
safety zone shall obey all lawful orders or directions of the Captain
of the Port or his designated representatives.
    (d) Vessels wishing to request permission to enter the safety zone
may contact the official patrol on VHF Channel 16 or by calling 503-
240-9311.

    Dated: May 23, 2008.
F.G. Myer,
Captain, U.S. Coast Guard, Captain of the Port Portland.
 [FR Doc. E8-13092 Filed 6-10-08; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 77, Number 146 (Monday, July 30, 2012)]
[Proposed Rules]
[Page 44562]
[FR Doc No: 2012-18525]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 141 and 142

[FRL-9708-1]

Public Meeting: Potential Regulatory Implications of the
Reduction of Lead in Drinking Water Act of 2011

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The U.S. Environmental Protection Agency (EPA) is hosting a
public meeting on August 16, 2012, to discuss and solicit input from
States, manufacturers, drinking water systems, other interested groups
and consumers on the implementation of the Reduction of Lead in
Drinking Water Act of 2011 (``the Act''). The Act was signed on January
4, 2011, and will be effective on January 4, 2014. The Act amended
Section 1417 of the Safe Drinking Water Act (SDWA), which prohibits the
use of certain plumbing products that are not ``lead free'' (as defined
by SDWA), and makes it unlawful to introduce into commerce products
that are not ``lead free.''

DATES: The public meeting will be held at the Environmental Protection
Agency Conference Center (lobby level-room 1204). One Potomac Yard
(South Building) 2777 S. Crystal Drive, Arlington, VA 22202 on
Thursday, August 16, 2012, from 1:00 p.m. to 4:30 p.m., Eastern
Daylight Time (EDT). All attendees must go through a metal detector,
sign in with the security desk, and show government issued photo
identification to enter the building. Teleconference and webcast
attendance will be available. Instructions for registration for the
meeting are located in the SUPPLEMENTARY INFORMATION section of this
notice.

FOR FURTHER INFORMATION CONTACT: For general information about this
meeting, contact Lameka Smith, Standards and Risk Management Division,
Office of Ground Water and Drinking Water; by phone<PHONE_NUMBER> or
by email smith.lameka@epa.govmailto:. For the full text of the
Reduction of Lead in Drinking Water Act of 2011, please visit:
www.gpo.gov/fdsys/pkg/PLAW.../pdf/PLAW-111publ380.pdf. For additional
information about the Lead and Copper Rule, please visit: http://water.epa.gov/lawsregs/rulesregs/sdwa/lcr/index.cfm.

SUPPLEMENTARY INFORMATION:
    Registration: Individuals planning to attend in person, by
teleconference, or via webcast must register for the meeting by
contacting Junie Percy of IntelliTech at<PHONE_NUMBER> ext. 210, or by
email<EMAIL_ADDRESS>no later than August 15, 2012. There
is no charge for attending this public meeting, but seats and phone
lines are limited, so please register as soon as possible.
    Reduction of Lead in Drinking Water Act: The Act made several key
changes to Section 1417: First, the Act changed the definition of
``lead-free'' under SDWA by reducing the lead content to a weighted
average of not more than 0.25% in the wetted surface material. Second,
the Act also amended the definition of ``lead free'' by adding a
specific formula for calculating lead content. Third, the Act created
two separate exemptions to the prohibitions on the use and introduction
into commerce of products that are not ``lead-free.'' Some of the
changes the Act makes to SDWA Section 1417 raise implementation
challenges and issues that may warrant regulatory changes beyond
codification of the statutory changes into the Code of Federal
Regulations. EPA would make any needed regulatory changes as part of
the Lead and Copper Rule long-term revisions (LCR-LTR). However,
because the final LCR-LTR will be published after the effective date of
the Act, EPA intends to provide information to assist plumbing
manufacturers, States, water systems, plumbing retailers and other
affected parties in implementing the provisions of the Act starting in
2014. Information from this stakeholder meeting will help inform
regulatory revisions that will be included in the LCR-LTR.
    Special Accommodations: For information on access or to request
special accommodations for individuals with disabilities, please
contact Lameka Smith, Standards and Risk Management Division, Office of
Ground Water and Drinking Water, U.S. Environmental Protection Agency;
by telephone<PHONE_NUMBER> or email smith.lameka@epa.govmailto:.
Please allow at least five business days prior to the meeting to
provide EPA with time to process your request.

    Dated: July 24, 2012.
Pamela S. Barr,
Acting Director, Office of Ground Water and Drinking Water.
[FR Doc. 2012-18525 Filed 7-27-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 39 (Monday, February 29, 2016)]
[Notices]
[Pages 10260-10261]
[FR Doc No: 2016-04227]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-0631]

Requirements for Transactions With First Responders Under Section
582 of the Federal Food, Drug, and Cosmetic Act--Compliance Policy;
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION:  Notice of availability.

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

SUMMARY:  The Food and Drug Administration (FDA or we) is announcing
the availability of a guidance for industry entitled ``Requirements for
Transactions with First Responders under Section 582 of the Federal
Food, Drug, and Cosmetic Act--Compliance Policy.'' This guidance
describes FDA's compliance policy regarding certain requirements in the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) for trading
partners engaged in transactions with first responders. This compliance
policy is in effect until further notice by FDA.

DATES:  Effective February 29, 2016. For information about enforcement
dates, please see the SUPPLEMENTARY INFORMATION section.

ADDRESSES:  You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2016-D-0631 for ``Requirements for Transactions with First
Responders under Section 582 of the Federal Food, Drug, and Cosmetic
Act--Compliance Policy; Guidance for Industry.'' Received comments will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.

     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT:  Office of Compliance, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry
entitled ``Requirements for Transactions with First Responders under
Section 582 of the Federal Food, Drug, and Cosmetic Act--Compliance
Policy.'' We are issuing this guidance consistent with our good
guidance practices regulation (21 CFR 10.115). We are implementing this
guidance without prior public comment because we have determined that
prior public participation is not feasible or appropriate (21 CFR
10.115(g)(2)). We made this determination because this guidance
document provides information pertaining to compliance with certain
statutory requirements described in this document that are currently in
effect. In addition, because FDA's compliance policy regarding the
provisions to provide, capture, and maintain product tracing
information under section 582(d)(1) of the FD&C Act (21 U.S.C. 360eee-
1(d)(1)) will expire on March 1, 2016 (see 80 FR 67408, November 2,
2015), it is important that FDA provide this information before that
date to avoid potential disruptions in the supply chain. Although this
guidance document is immediately in effect, it remains subject to
comment in accordance with the Agency's good guidance practices (21 CFR
10.115(g)(3)). FDA is particularly interested in comments related to
the scope of this guidance. FDA will consider any comments received and
may revise the scope of the enforcement policy described in this
guidance as appropriate.
    On November 27, 2013, the Drug Supply Chain Security Act (DSCSA)
(Title II of Pub. L. 113-54) was signed into law. Section 202 of DSCSA
adds sections 581 and 582 to the FD&C Act (21 U.S.C. 360eee and 360eee-
1), which set forth new definitions and requirements for the tracing of
products through the pharmaceutical distribution supply chain. Starting
in 2015, certain trading partners (manufacturers, wholesale
distributors, dispensers, and repackagers) generally were required
under sections 582(b)(1), (c)(1), (d)(1), and (e)(1) of the FD&C Act to
exchange product tracing information when engaging in transactions
involving certain prescription drugs. These trading partners were also
generally required under sections 582(b)(4), (c)(4), (d)(4) and (e)(4)
to have systems in place to enable the verification of suspect and
illegitimate product. Furthermore, sections 582(b)(3), (c)(3), (d)(3),
and (e)(3) specify that the trading partners of manufacturers,
wholesale distributors, dispensers, and repackagers must be
``authorized'' within the meaning of section 581(2) of the FD&C Act.
    For dispensers, requirements for the tracing of products through
the pharmaceutical distribution supply chain under section 582(d)(1) of
the FD&C Act took effect on July 1, 2015. FDA published a notice of
availability for a revised guidance document on November 2, 2015,
stating that it does not intend to take action against dispensers who,
prior to March 1, 2016, accept ownership of product without receiving
the product tracing information, as required by section 582(d)(1)(A)(i)
of the FD&C Act, or do not capture and maintain the product tracing
information, as required by section 582(d)(1)(A)(iii) of the FD&C Act
(80 FR 67408).
    As described in the guidance, FDA understands that transactions
between dispensers and first responders may present challenges related
to compliance with certain requirements in section 582 of the FD&C Act
related to the exchange of product tracing information, conducting
business only with authorized trading partners, and having verification
systems in place. To minimize possible disruptions to the activities of
first responders, FDA does not intend to take action against certain
trading partners and first responders as described in the guidance.
This compliance policy is in effect until further notice by FDA.
    The guidance represents the current thinking of FDA on this topic.
It does not establish any rights for any person and is not binding on
FDA or the public. You can use an alternative approach if it satisfies
the requirements of the applicable statutes and regulations.

II. Electronic Access

    Persons with access to the Internet may obtain the guidance
document at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
http://www.regulations.gov.

    Dated: February 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04227 Filed 2-26-16; 8:45 am]
 BILLING CODE 4164-01-P