[Federal Register Volume 77, Number 126 (Friday, June 29, 2012)]
[Notices]
[Pages 38871-38875]
[FR Doc No: 2012-15956]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67253; File No. SR-NASDAQ-2012-069]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Modify an Optional Depth Data Enterprise License Fee for Broker-Dealer
Distribution of Depth-of-Book Data

June 25, 2012.
    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 June 12, 2012, The NASDAQ Stock Market LLC (``NASDAQ'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I, II and III below, which Items have
been prepared by NASDAQ. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    NASDAQ proposes to modify the optional Enterprise License fee for
Non-Professional Subscribers of certain NASDAQ Depth-of-Book market
data. NASDAQ will implement the proposed revised fee on July 1, 2012.
* * * * *

7023. NASDAQ Depth-of-Book Data

    (a)-(b) No change.
    (c) Enterprise License Fees
    (1)-(2) No Change.
    (3) As an alternative to subsections (1) and (2) above, a
Distributor that is also a broker-dealer may pay a monthly fee of
$500,000 [325,000] to provide NASDAQ Level 2, NASDAQ TotalView, or
NASDAQ OpenView for Display Usage by Non-Professional Subscribers with
whom the firm has a brokerage relationship. This Enterprise License
shall not apply to relevant Level 1 or Depth Distributor fees.
    (d)-(e) No change.
* * * * *

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

    In its filing with the Commission, NASDAQ 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. NASDAQ 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
    NASDAQ is proposing a change to the Enterprise License Fee for Non-
Professional Usage of certain NASDAQ Depth-of-Book market data. NASDAQ
Rule 7023(c)(3) offers an optional Enterprise License for unlimited
Non-Professional Subscribers of NASDAQ Level 2, NASDAQ TotalView, or
NASDAQ OpenView for broker-dealers registered under the Act.
Specifically, NASDAQ proposes to increase the optional fee for
Distributors from $325,000 to $500,000 per month that covers all Non-
Professional Subscribers with whom the firm has a brokerage
relationship. This Depth-of-Book Enterprise License Fee includes Non-
Professional Subscriber fees, but does not include Distributor fees.
Non-broker-dealer vendors and application service providers are not
eligible for the Enterprise License; such firms typically pass through
the cost of market data Subscriber fees to their customers.\3\
---------------------------------------------------------------------------

    \3\ NASDAQ relies on Distributor self-reporting of usage rather
than on individual contact with each end-user Subscriber. For this
Enterprise License, NASDAQ permits Distributors to designate an
entire Subscriber population as Non-Professional provided that the
number of Professional Subscribers within that Subscriber population
does not exceed ten percent (10%) of the total population.
---------------------------------------------------------------------------

    NASDAQ continues to seek broader distribution of Depth-of-Book data
and to reduce the cost of providing Depth-of-Book data to larger
numbers of investors. In the past, NASDAQ has accomplished this goal in
part by offering similar enterprise licenses for Professional and Non-
Professional Usage of TotalView which contains the full Depth-of-Book
data for the NASDAQ Market Center Execution System. NASDAQ believes
that the adoption of enterprise licenses has led to greater
distribution of market data, particularly among Non-Professional
Subscribers.
    In addition to increased administrative flexibility, enterprise
licenses also encourage broader distribution by firms that are
currently over the fee cap as well as those that are approaching the
cap and wish to take advantage of the benefits of the program. Further,
NASDAQ believes that capping fees in this manner creates goodwill with
broker-dealers and increases transparency for retail investors.
    The Depth-of-Book Enterprise License Fee is completely optional and
does not replace existing enterprise license fee alternatives set forth
in Rule 7023. Additionally, the proposal does not impact individual
Subscriber fees for any product or raise the costs to any Subscriber of
any NASDAQ data product. The market for this Depth-of-Book information
is highly competitive and continually evolves as products develop and
change. As a result, it is proposed that the current fee be increased,
in part, due to a change in market data distribution and growing
economies of scale in the industry. Subsequent to the introduction of
the Depth-of-Book Enterprise License, there has been a substantial
change in the adoption rate and distribution of Depth-of-Book data.
Additionally, as broker/dealers consolidate and continue to grow
organically, NASDAQ needs to adjust its enterprise license pricing
model to better reflect current market conditions. The adjustment of
this fee reflects these and other market forces.
2. Statutory Basis
    NASDAQ believes that the proposed rule change is consistent with
the provisions of Section 6 of the Act,\4\ in general, and with Section
6(b)(4) of the

Act,\5\ in particular, in that it provides an equitable allocation of
reasonable fees among Subscribers and recipients of NASDAQ data. In
adopting Regulation NMS, the Commission granted self-regulatory
organizations and broker-dealers increased authority and flexibility to
offer new and unique market data to the public. It was believed that
this authority would expand the amount of data available to consumers,
and also spur innovation and competition for the provision of market
data.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78f.
    \5\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Commission concluded that Regulation NMS--by deregulating the
market in proprietary data--would itself further the Act's goals of
facilitating efficiency and competition:

    [E]fficiency is promoted when broker-dealers who do not need the
data beyond the prices, sizes, market center identifications of the
NBBO and consolidated last sale information are not required to
receive (and pay for) such data. The Commission also believes that
efficiency is promoted when broker-dealers may choose to receive
(and pay for) additional market data based on their own internal
analysis of the need for such data.\6\
---------------------------------------------------------------------------

    \6\ Securities Exchange Act Release No. 51808 (June 9, 2005), 70
FR 37496 (June 29, 2005).

By removing ``unnecessary regulatory restrictions'' on the ability of
exchanges to sell their own data, Regulation NMS advanced the goals of
the Act and the principles reflected in its legislative history. If the
free market should determine whether proprietary data is sold to
broker-dealers at all, it follows that the price at which such data is
sold should be set by the market as well. Level 2, TotalView and
OpenView are precisely the sort of market data products that the
Commission envisioned when it adopted Regulation NMS.
    On July 21, 2010, President Barack Obama signed into law H.R. 4173,
the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010
(``Dodd-Frank Act''), which amended Section 19 of the Act. Among other
things, Section 916 of the Dodd-Frank Act amended paragraph (A) of
Section 19(b)(3) of the Act by inserting the phrase ``on any person,
whether or not the person is a member of the self-regulatory
organization'' after ``due, fee or other charge imposed by the self-
regulatory organization.'' As a result, all SRO rule proposals
establishing or changing dues, fees, or other charges are immediately
effective upon filing regardless of whether such dues, fees, or other
charges are imposed on members of the SRO, non-members, or both.
Section 916 further amended paragraph (C) of Section 19(b)(3) of the
Act to read, in pertinent part, ``At any time within the 60-day period
beginning on the date of filing of such a proposed rule change in
accordance with the provisions of paragraph (1) [of Section 19(b)], the
Commission summarily may temporarily suspend the change in the rules of
the self-regulatory organization made thereby, 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 this title. If the Commission takes such action, the
Commission shall institute proceedings under paragraph (2)(B) [of
Section 19(b)] to determine whether the proposed rule should be
approved or disapproved.''
    The decision of the United States Court of Appeals for the District
of Columbia Circuit in NetCoalition v. SEC, No. 09-1042 (D.C. Cir.
2010), although reviewing a Commission decision made prior to the
effective date of the Dodd-Frank Act, upheld the Commission's reliance
upon competitive markets to set reasonable and equitably allocated fees
for market data. ``In fact, the legislative history indicates that the
Congress intended that the market system `evolve through the interplay
of competitive forces as unnecessary regulatory restrictions are
removed' and that the SEC wield its regulatory power `in those
situations where competition may not be sufficient,' such as in the
creation of a `consolidated transactional reporting system.' ''
NetCoalition, at 15 (quoting H.R. Rep. No. 94-229, at 92 (1975), as
reprinted in 1975 U.S.C.C.A.N. 321, 323). The court's conclusions about
Congressional intent are therefore reinforced by the Dodd-Frank Act
amendments, which create a presumption that exchange fees, including
market data fees, may take effect immediately, without prior Commission
approval, and that the Commission should take action to suspend a fee
change and institute a proceeding to determine whether the fee change
should be approved or disapproved only where the Commission has
concerns that the change may not be consistent with the Act.
    For the reasons stated above, NASDAQ believes that the proposed
fees are fair and equitable, and not unreasonably discriminatory. As
described above, the proposed fees are based on pricing conventions and
distinctions that exist in NASDAQ's current fee schedule, and the fee
schedules of other exchanges. These distinctions (top-of-book versus
Depth-of-Book, Professional versus non-Professional Subscribers, Direct
versus Indirect Access, Internal versus External Distribution) are each
based on principles of fairness and equity that have helped for many
years to maintain fair, equitable, and not unreasonably discriminatory
fees, and that apply with equal or greater force to the current
proposal.
    As described in greater detail below, if NASDAQ has calculated
improperly and the market deems the proposed fees to be unfair,
inequitable, or unreasonably discriminatory, firms can diminish or
discontinue the use of their data because the proposed fee is entirely
optional to all parties. Firms are not required to purchase Depth-of-
Book data or to utilize any specific pricing alternative if they do
choose to purchase Depth-of-Book data. NASDAQ is not required to make
Depth-of-Book data available or to offer specific pricing alternatives
for potential purchases. NASDAQ can discontinue offering a pricing
alternative (as it has in the past) and firms can discontinue their use
at any time and for any reason (as they often do), including due to
their assessment of the reasonableness of fees charged. NASDAQ
continues to establish and revise pricing policies aimed at increasing
fairness and equitable allocation of fees among Subscribers.
    NASDAQ believes that the Depth-of-Book Enterprise License promotes
increased transparency by offering a pricing option resulting in lower
fees for heavy users of Depth-of-Book data. While NASDAQ may need to
periodically adjust the Depth-of-Book Enterprise License to reflect
market forces, it continues to view the fee cap as a way for firms to
make additional information available to the firms' clients, thereby
increasing transparency of the market.

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

    NASDAQ 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, as amended. Notwithstanding its
determination that the Commission may rely upon competition to
establish fair and equitably allocated fees for market data, the
NetCoalition court found that the Commission had not, in that case,
compiled a record that adequately supported its conclusion that the
market for the data at issue in the case was competitive. NASDAQ
believes that a record may readily be established to

demonstrate the competitive nature of the market in question.
    There is intense competition between trading platforms that provide
transaction execution and routing services and proprietary data
products. Transaction execution and proprietary data products are
complementary in that market data is both an input and a byproduct of
the execution service. In fact, market data and trade execution are a
paradigmatic example of joint products with joint costs. The decision
whether and on which platform to post an order will depend on the
attributes of the platform where the order can be posted, including the
execution fees, data quality and price and distribution of its data
products. Without the prospect of a taking order seeing and reacting to
a posted order on a particular platform, the posting of the order would
accomplish little. Without trade executions, exchange data products
cannot exist. Data products are valuable to many end Subscribers only
insofar as they provide information that end Subscribers expect will
assist them or their customers in making trading decisions.
    The costs of producing market data include not only the costs of
the data distribution infrastructure, but also the costs of designing,
maintaining, and operating the exchange's transaction execution
platform and the cost of regulating the exchange to ensure its fair
operation and maintain investor confidence. The total return that a
trading platform earns reflects the revenues it receives from both
products and the joint costs it incurs. Moreover, an exchange's
customers view the costs of transaction executions and of data as a
unified cost of doing business with the exchange. A broker-dealer will
direct orders to a particular exchange only if the expected revenues
from executing trades on the exchange exceed net transaction execution
costs and the cost of data that the broker-dealer chooses to buy to
support its trading decisions (or those of its customers). The choice
of data products is, in turn, a product of the value of the products in
making profitable trading decisions. If the cost of the product exceeds
its expected value, the broker-dealer will choose not to buy it.
Moreover, as a broker-dealer chooses to direct fewer orders to a
particular exchange, the value of the product to that broker-dealer
decreases, for two reasons. First, the product will contain less
information, because executions of the broker-dealer's orders will not
be reflected in it. Second, and perhaps more important, the product
will be less valuable to that broker-dealer because it does not provide
information about the venue to which it is directing its orders. Data
from the competing venue to which the broker-dealer is directing orders
will become correspondingly more valuable.
    Thus, a super-competitive increase in the fees charged for either
transactions or data has the potential to impair revenues from both
products. ``No one disputes that competition for order flow is
`fierce'.'' NetCoalition at 24. However, the existence of fierce
competition for order flow implies a high degree of price sensitivity
on the part of broker-dealers with order flow, since they may readily
reduce costs by directing orders toward the lowest-cost trading venues.
A broker-dealer that shifted its order flow from one platform to
another in response to order execution price differentials would both
reduce the value of that platform's market data and reduce its own need
to consume data from the disfavored platform. Similarly, if a platform
increases its market data fees, the change will affect the overall cost
of doing business with the platform, and affected broker-dealers will
assess whether they can lower their trading costs by directing orders
elsewhere and thereby lessening the need for the more expensive data.
    Analyzing the cost of market data distribution in isolation from
the cost of all of the inputs supporting the creation of market data
will inevitably underestimate the cost of the data. Thus, because it is
impossible to create data without a fast, technologically robust, and
well-regulated execution system, system costs and regulatory costs
affect the price of market data. It would be equally misleading,
however, to attribute all of the exchange's costs to the market data
portion of an exchange's joint product. Rather, all of the exchange's
costs are incurred for the unified purposes of attracting order flow,
executing and/or routing orders, and generating and selling data about
market activity. The total return that an exchange earns reflects the
revenues it receives from the joint products and the total costs of the
joint products.
    Competition among trading platforms can be expected to constrain
the aggregate return each platform earns from the sale of its joint
products, but different platforms may choose from a range of possible,
and equally reasonable, pricing strategies as the means of recovering
total costs. For example, some platform may choose to pay rebates to
attract orders, charge relatively low prices for market information (or
provide information free of charge) and charge relatively high prices
for accessing posted liquidity. Other platforms may choose a strategy
of paying lower rebates (or no rebates) to attract orders, setting
relatively high prices for market information, and setting relatively
low prices for accessing posted liquidity. In this environment, there
is no economic basis for regulating maximum prices for one of the joint
products in an industry in which suppliers face competitive constraints
with regard to the joint offering. This would be akin to strictly
regulating the price that an automobile manufacturer can charge for car
sound systems despite the existence of a highly competitive market for
cars and the availability of after-market alternatives to the
manufacturer-supplied system.
    The market for market data products is competitive and inherently
contestable because there is fierce competition for the inputs
necessary to the creation of proprietary data and strict pricing
discipline for the proprietary products themselves. Numerous exchanges
compete with each other for listings, trades, and market data itself,
providing virtually limitless opportunities for entrepreneurs who wish
to produce and distribute their own market data. This proprietary data
is produced by each individual exchange, as well as other entities, in
a vigorously competitive market.
    Broker-dealers currently have numerous alternative venues for their
order flow, including ten SRO markets, as well as internalizing BDs and
various forms of alternative trading systems (``ATSs''), including dark
pools and electronic communication networks (``ECNs''). Each SRO market
competes to produce transaction reports via trade executions, and two
FINRA-regulated Trade Reporting Facilities (``TRFs'') compete to
attract internalized transaction reports. Competitive markets for order
flow, executions, and transaction reports provide pricing discipline
for the inputs of proprietary data products.
    The large number of SROs, TRFs, BDs, and ATSs that currently
produce proprietary data or are currently capable of producing it
provides further pricing discipline for proprietary data products. Each
SRO, TRF, ATS, and BD is currently permitted to produce proprietary
data products, and many currently do or have announced plans to do so,
including NASDAQ, NYSE, NYSE Amex, NYSEArca, and BATS.
    Any ATS or BD can combine with any other ATS, BD, or multiple ATSs
or BDs to produce joint proprietary data products. Additionally, order
routers and market data vendors can facilitate single or multiple
broker-dealers' production of proprietary data products.

The potential sources of proprietary products are virtually limitless.
    The fact that proprietary data from ATSs, BDs, and vendors can by-
pass SROs is significant in two respects. First, non-SROs can compete
directly with SROs for the production and sale of proprietary data
products, as BATS and Arca did before registering as exchanges by
publishing Depth-of-Book data on the Internet. Second, because a single
order or transaction report can appear in an SRO proprietary product, a
non-SRO proprietary product, or both, the data available in proprietary
products is exponentially greater than the actual number of orders and
transaction reports that exist in the marketplace.
    Market data vendors provide another form of price discipline for
proprietary data products because they control the primary means of
access to end Subscribers. Vendors impose price restraints based upon
their business models. For example, vendors such as Bloomberg and
Thomson Reuters that assess a surcharge on data they sell may refuse to
offer proprietary products that end Subscribers will not purchase in
sufficient numbers. Internet portals, such as Google, impose a
discipline by providing only data that will enable them to attract
``eyeballs'' that contribute to their advertising revenue. Retail
broker-dealers, such as Schwab and Fidelity, offer their customers
proprietary data only if it promotes trading and generates sufficient
commission revenue. Although the business models may differ, these
vendors' pricing discipline is the same: they can simply refuse to
purchase any proprietary data product that fails to provide sufficient
value. NASDAQ and other producers of proprietary data products must
understand and respond to these varying business models and pricing
disciplines in order to market proprietary data products successfully.
    In addition to the competition and price discipline described
above, the market for proprietary data products is also highly
contestable because market entry is rapid, inexpensive, and profitable.
The history of electronic trading is replete with examples of entrants
that swiftly grew into some of the largest electronic trading platforms
and proprietary data producers: Archipelago, Bloomberg Tradebook,
Island, RediBook, Attain, TracECN, BATS Trading and Direct Edge. A
proliferation of dark pools and other ATSs operate profitably with
fragmentary shares of consolidated market volume.
    Regulation NMS, by deregulating the market for proprietary data,
has increased the contestability of that market. While broker-dealers
have previously published their proprietary data individually,
Regulation NMS encourages market data vendors and broker-dealers to
produce proprietary products cooperatively in a manner never before
possible. Multiple market data vendors already have the capability to
aggregate data and disseminate it on a profitable scale, including
Bloomberg, and Thomson Reuters.
    The court in NetCoalition concluded that the Commission had failed
to demonstrate that the market for market data was competitive based on
the reasoning of the Commission's NetCoalition order because, in the
court's view, the Commission had not adequately demonstrated that the
Depth-of-Book data at issue in the case is used to attract order flow.
NASDAQ believes, however, that evidence not before the court clearly
demonstrates that availability of data attracts order flow. For
example, as of July 2010, 92 of the top 100 broker-dealers by shares
executed on NASDAQ consumed NQDS and 80 of the top 100 broker-dealers
consumed TotalView. During that month, the NQDS-Subscribers were
responsible for 94.44% of the orders entered into NASDAQ and TotalView
Subscribers were responsible for 92.98%.
    Competition among platforms has driven NASDAQ continually to
improve its platform data offerings and to cater to customers' data
needs. For example, NASDAQ has developed and maintained multiple
delivery mechanisms (IP, multi-cast, and compression) that enable
customers to receive data in the form and manner they prefer and at the
lowest cost to them. NASDAQ offers front end applications such as its
``Bookviewer'' to help customers utilize data. NASDAQ has created new
products like TotalView Aggregate to complement TotalView ITCH and/
NQDS, because offering data in multiple formatting allows NASDAQ to
better fit customer needs. NASDAQ offers data via multiple extranet
providers, thereby helping to reduce network and total cost for its
data products. NASDAQ has developed an online administrative system to
provide customers transparency into their data feed requests and
streamline data usage reporting. NASDAQ has also expanded its
Enterprise License options that reduce the administrative burden and
costs to firms that purchase market data.
    Despite these enhancements and a dramatic increase in message
traffic, NASDAQ's fees for market data have remained flat. In fact, as
a percent of total Subscriber costs, NASDAQ data fees have fallen
relative to other data usage costs--including bandwidth, programming,
and infrastructure--that have risen. The same holds true for execution
services; despite numerous enhancements to NASDAQ's trading platform,
absolute and relative trading costs have declined. Platform competition
has intensified as new entrants have emerged, constraining prices for
both executions and for data.
    The vigor of competition for Depth-of-Book information is
significant and the Exchange believes that this proposal itself clearly
evidences such competition. NASDAQ is offering a new pricing model in
order to keep pace with changes in the industry and evolving customer
needs. It is entirely optional and is geared towards attracting new
customers, as well as retaining existing customers.
    The Exchange has witnessed competitors creating new products and
innovative pricing in this space over the course of the past year.
NASDAQ continues to see firms challenge its pricing on the basis of the
Exchange's explicit fees being higher than the zero-priced fees from
other competitors such as BATS. In all cases, firms make decisions on
how much and what types of data to consume on the basis of the total
cost of interacting with NASDAQ or other exchanges. Of course, the
explicit data fees are but one factor in a total platform analysis.
Some competitors have lower transactions fees and higher data fees, and
others are vice versa. The market for this Depth-of-Book information is
highly competitive and continually evolves as products develop and
change.

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.\7\ 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.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(a)(ii). [sic]
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2012-069 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2012-069. 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 Web site (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 Web site
viewing and printing in the Commission's Public Reference Room on
official business days between the hours of 10:00 a.m. and 3:00 p.m.
Copies of such filing also will be available for inspection and copying
at the principal offices of NASDAQ. All comments received will be
posted without change; the Commission does not edit personal
identifying information from submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NASDAQ-2012-069, and should be submitted
on or before July 20, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
Kevin M. O'Neill,
Deputy Secretary.
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

[FR Doc. 2012-15956 Filed 6-28-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 67 (Friday, April 9, 2021)]
[Notices]
[Pages 18541-18542]
[FR Doc No: 2021-07332]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0039]

Electronic Submissions; Update to the Specifications for
Preparing and Submitting Postmarket Individual Case Safety Reports for
Vaccines; Technical Specification

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) Center for
Biologics Evaluation and Research (CBER) is announcing the availability
of version 2.2 of the Specifications for Preparing and Submitting
Postmarket Individual Case Safety Reports (ICSRS) for Vaccines
(Specifications). The version update is not applicable to CBER-
regulated drug products marketed for human use with approved New Drug
Applications (NDAs) and Abbreviated New Drug Applications (ANDAs);
CBER-regulated therapeutic biological products marketed for human use
with approved Biologic License Applications (BLAs); Whole Blood or
blood components; and human cells, tissues, and cellular and tissue-
based products (HCT/Ps) regulated solely under the Public Health
Service Act.

ADDRESSES: You may submit either electronic or written comments at any
time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-N-0039 for ``Electronic Submissions; Update to the
Specifications for Preparing and Submitting Postmarket Individual Case
Safety Reports for Vaccines; Technical Specification''. Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure laws. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Victoria Wagman, Center for Biologics
Evaluation and Research, Food and Drug Administration, Bldg. 71, Rm.
7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    CBER is announcing the availability of version 2.2 of the
Specifications for Preparing and Submitting Postmarket ICSRs for
Vaccines (available at https://www.fda.gov/industry/about-esg/cber-vaccine-icsr-implementation). The version update has been prepared to
accommodate the submission of certain reports for combination products
required by an FDA rule, ``Postmarketing Safety Reporting for
Combination Products'', published in the Federal Register of December
20, 2016 (81 FR 92603) (available at https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products). In addition, version 2.2 includes
updated business rules (Appendix I of the Specifications) which provide
details on data field specifications as well as updated sample
Extensible Markup Language (XML) ICSR test files (available at https://www.fda.gov/industry/about-esg/cber-vaccine-icsr-implementation). The
version update is not applicable to CBER-regulated drug products
marketed for human use with approved NDAs and ANDAs; CBER-regulated
therapeutic biological products marketed for human use with approved
BLAs); Whole Blood or blood components; and HCT/Ps regulated solely
under section 361 of the Public Health Service Act (42 U.S.C. 264).
    Vaccine manufacturers and others responsible for reporting ICSRs
for vaccines can now transition to reporting in the updated version
2.2. Instructions to transition are available at https://www.fda.gov/vaccines-blood-biologics/getting-started-icsr-submission-fdas-electronic-vaccine-adverse-event-reporting-system-evaers. Manufacturers
can contact the CBER ICSR Submissions Coordinator
<EMAIL_ADDRESS>to inform of their intent to
transition to version 2.2 of the Specifications for Preparing and
Submitting Postmarket Individual Case Safety Reports for Vaccines.
Although manufacturers are encouraged to transition to the updated
version 2.2, CBER continues to accept reports in version 1.0 until
further notice.

    Dated: April 5, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-07332 Filed 4-8-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 112 (Thursday, June 11, 2015)]
[Proposed Rules]
[Page 33222]
[FR Doc No: 2015-14088]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2015-0358; FRL-9928-89-Region-7]

Approval and Promulgation of Air Quality Implementation Plans;
Iowa; Grain Vacuuming Best Management Practices (BMPs) and Rescission
Rules

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) proposes to approve
the State Implementation Plan (SIP) revision submitted by the State of
Iowa to amend Best Management Practices (BMPs) for grain vacuuming
operations at Group 1 grain elevators. Additional revisions to the SIP
include revised definitions, revised requirements for Department forms,
and rescinding rule requirements and references for conditional
permits.

DATES: Comments on this proposed action must be received in writing by
July 13, 2015.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R07-
OAR-2015-0358, by mail to Heather Hamilton, Environmental Protection
Agency, Air Planning and Development Branch, 11201 Renner Boulevard,
Lenexa, Kansas 66219. Comments may also be submitted electronically or
through hand delivery/courier by following the detailed instructions in
the ADDRESSES section of the direct final rule located in the rules
section of this Federal Register.

FOR FURTHER INFORMATION CONTACT: Heather Hamilton, Environmental
Protection Agency, Air Planning and Development Branch, 11201 Renner
Boulevard, Lenexa, Kansas 66219 at<PHONE_NUMBER>, or by email at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the final rules section of this Federal
Register, EPA is approving the state's SIP revision as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial revision amendment and anticipates no relevant adverse
comments to this action. A detailed rationale for the approval is set
forth in the Technical Support Document that is part of this rulemaking
docket. If no relevant adverse comments are received in response to
this action, no further activity is contemplated in relation to this
action. If EPA receives relevant adverse comments, the direct final
rule will be withdrawn and all public comments received will be
addressed in a subsequent final rule based on this proposed action. EPA
will not institute a second comment period on this action. Any parties
interested in commenting on this action should do so at this time.
Please note that if EPA receives adverse comment on part of this rule
and if that part can be severed from the remainder of the rule, EPA may
adopt as final those parts of the rule that are not the subject of an
adverse comment. For additional information, see the direct final rule
which is located in the rules section of this Federal Register.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: May 28, 2015.
Mark Hague,
Acting Regional Administrator, Region 7.
[FR Doc. 2015-14088 Filed 6-10-15; 8:45 am]
BILLING CODE 6560-50-P