[Federal Register Volume 77, Number 240 (Thursday, December 13, 2012)]
[Rules and Regulations]
[Pages 74116-74119]
[FR Doc No: 2012-30109]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0825; FRL-9372-1]

Extension of Tolerances for Emergency Exemptions (Multiple
Chemicals)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation extends time-limited tolerances for the
pesticides listed in this document. These actions are in response to
EPA's granting of emergency exemptions under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) authorizing use of these
pesticides. The Federal Food, Drug, and Cosmetic Act (FFDCA) requires
EPA to establish a time-limited tolerance or exemption from the
requirement for a tolerance for pesticide chemical residues in food
that will result from the use of a pesticide under an emergency
exemption granted by EPA.

DATES: This regulation is effective December 13, 2012. Objections and
requests for hearings must be received on or before February 11, 2013],
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2012-0825, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: See the table in this unit for the
name of a specific contact person. The following information applies to
all contact persons: Emergency Response Team, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

------------------------------------------------------------------------
         Pesticide/CFR citation                   Contact person
------------------------------------------------------------------------
1-Naphthaleneacetic acid 40 CFR 180.155  Keri Grinstead,
<EMAIL_ADDRESS>(703)
                                          308-8373.
Kasugamycin 40 CFR 180.614.............  Keri Grinstead,
<EMAIL_ADDRESS>(703)
                                          308-8373.
Mandipropamid 40 CFR 180.637...........  Debra Rate<EMAIL_ADDRESS><PHONE_NUMBER>.
------------------------------------------------------------------------

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2012-0825 in the subject line on the first
page of your submission. All requests must be in writing, and must be
received by the Hearing Clerk on or before February 11, 2013. Addresses
for mail and hand delivery of objections and hearing requests are
provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2012-0825, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.

Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background and Statutory Findings

    EPA published final rules in the Federal Register for each chemical
listed. The initial issuance of these final rules announced that EPA,
on its own initiative, under FFDCA section 408, 21 U.S.C. 346a, was
establishing time-limited tolerances.
    EPA established the tolerances because FFDCA section 408(l)(6)
requires EPA to establish a time-limited tolerance or exemption from
the requirement for a tolerance for pesticide chemical residues in food
that will result from the use of a pesticide under an emergency
exemption granted by EPA under FIFRA section 18. Such tolerances can be
established without providing notice or time for public comment.
    EPA received requests to extend the use of these chemicals for this
year's growing season. After having reviewed these submissions, EPA
concurs that emergency conditions exist. EPA assessed the potential
risks presented by residues for each chemical. In doing so, EPA
considered the safety standard in FFDCA section 408(b)(2), and decided
that the necessary tolerance under FFDCA section 408(l)(6) would be
consistent with the safety standard and with FIFRA section 18.
    The data and other relevant material have been evaluated and
discussed in the final rules originally published to support these
uses. Based on that data and information considered, the Agency
reaffirms that extension of these time-limited tolerances will continue
to meet the requirements of FFDCA section 408(l)(6). Therefore, each of
these time-limited tolerances is extended until the date specified
below, when each will expire and become automatically revoked. EPA will
publish a document in the Federal Register to remove the revoked
tolerances from the Code of Federal Regulations (CFR). Although these
tolerances will expire and are revoked on the date listed, under FFDCA
section 408(l)(5), residues of the pesticide not in excess of the
amounts specified in the tolerance remaining in or on the commodity
after that date will not be unlawful, provided the residue is present
as a result of an application or use of a pesticide at a time and in a
manner that was lawful under FIFRA, the tolerance was in place at the
time of the application, and the residue does not exceed the level that
was authorized by the tolerance. EPA will take action to revoke these
tolerances earlier if any experience with, scientific data on, or other
relevant information on this pesticide indicate that the residues are
not safe.
    Tolerances for the use of the following pesticide chemicals on
specific commodities are being extended:
    1-Naphthaleneacetic acid. EPA has authorized under FIFRA section 18
the use of 1-naphthaleneacetic acid on avocado tree limbs that have
been pruned or cut back to a stump to suppress excess branch growth
(suckering) in California. This regulation extends a time-limited
tolerance for the combined residues of the plant growth regulator, 1-
naphthaleneacetic acid and its conjugates calculated as 1-
naphthaleneacetic acid from the application of 1-naphthaleneacetic
acid,

its ammonium, sodium, or potassium salts, ethyl ester, and acetamide in
or on avocado at 0.05 ppm for an additional 3-year period. This
tolerance will expire and is revoked on December 31, 2015. A time-
limited tolerance was originally published in the Federal Register of
August 12, 2009 (74 FR 40513) (FRL-8428-3).
    Kasugamycin. EPA has authorized under FIFRA section 18 the use of
kasugamycin on apples for control of fire blight in Michigan. This
regulation extends a time-limited tolerance for residues of the
fungicide kasugamycin in or on apple at 0.05 ppm for an additional 3-
year period. This tolerance will expire and is revoked on December 31,
2015. A time-limited tolerance was originally published in the Federal
Register of April 14, 2010 (75 FR 19268) (FRL-8808-7).
    Mandipropamid. EPA has authorized under FIFRA section 18 the use of
mandipropamid on basil for control of downy mildew in Illinois. This
regulation extends a time-limited tolerance for the combined residues
of the fungicide mandipropamid and its metabolites in or on basil,
fresh at 20 ppm and basil, dried at 240 ppm for an additional 3-year
period. These tolerances will expire and are revoked on December 31,
2015. A time-limited tolerance was originally published in the Federal
Register of September 9, 2011 (76 FR 55799) (FRL-8886-8).

III. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for 1-naphthaleneacetic acid in
or on avocados.
    The Codex has not established a MRL for kasugamycin in or on
apples.
    The Codex has not established MRLs for mandipropamid in or on basil
commodities.

IV. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

V. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: December 7, 2012.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.155, revise the table in paragraph (b) to read as
follows:

Sec.  180.155  1-Naphthaleneacetic acid; tolerances for residues.

* * * * *
    (b) * * *

------------------------------------------------------------------------
                                    Parts per     Expiration/revocation
            Commodity                million              date
------------------------------------------------------------------------
Avocado.........................         0.05                  12/31/15
------------------------------------------------------------------------

* * * * *

0
3. In Sec.  180.614, revise the table in paragraph (b) to read as
follows:

Sec.  180.614  Kasugamycin; tolerances for residues.

* * * * *
    (b) * * *

------------------------------------------------------------------------
                                    Parts per     Expiration/revocation
            Commodity                million              date
------------------------------------------------------------------------
Apple...........................         0.05                  12/31/15
------------------------------------------------------------------------

* * * * *

0
4. In Sec.  180.637, revise the table in paragraph (b) to read as
follows:

Sec.  180.637  Mandipropamid; tolerances for residues.

* * * * *
    (b) * * *

------------------------------------------------------------------------
                                    Parts per     Expiration/revocation
            Commodity                million              date
------------------------------------------------------------------------
Basil, dried....................          240                  12/31/15
Basil, fresh....................           20                  12/31/15
------------------------------------------------------------------------

* * * * *
[FR Doc. 2012-30109 Filed 12-12-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 196 (Tuesday, October 11, 2016)]
[Notices]
[Pages 70207-70210]
[FR Doc No: 2016-24420]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-79035; File No. SR-NASDAQ-2016-124]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend Nasdaq Rule 7046

October 4, 2016.
    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 September 23, 2016, The NASDAQ Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been prepared by the
Exchange. The Commission is publishing this notice to solicit comments
on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \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

    Nasdaq is proposing to amend proposed [sic] Nasdaq Rule 7046
(Nasdaq Trading Insights) by adding the corresponding fee for the
optional Nasdaq Trading Insights product.
    The text of the proposed rule change is available at
nasdaq.cchwallstreet.com, at Nasdaq'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, 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 those 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 parts of such
statements.

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

1. Purpose
    The Exchange proposes to amend Nasdaq Rule 7046 (Nasdaq Trading

Insights) by adding the corresponding fees for the optional Nasdaq
Trading Insights product.\3\ As discussed in the NTI Filing, the Nasdaq
Trading Insights product is a single optional market data service
comprised of four market data components: (a) Missed Opportunity--
Liquidity; (b) Missed Opportunity--Latency; (c) Peer Benchmarking; and
(d) Liquidity Dynamics Analysis.
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    \3\ This filing is referenced in the recently approved Nasdaq
Trading Insights filing (the ``NTI Filing'') that proposed Nasdaq
Rule 7046 (Nasdaq Trading Insights) to the Exchange rule book. See
Securities Exchange Act Release No. 78886 (Sept. 20, 2016) (SR-
NASDAQ-2016-101) (order granting approval).
---------------------------------------------------------------------------

    Upon request by a potential subscribing firm, Nasdaq will provide
the Nasdaq Trading Insights product for a 14-day period at no charge.
This waiver may be provided only once per firm. A firm will be charged
the monthly fee rate listed in Nasdaq Rule 7046(b)(2) if it does not
cancel by the conclusion of the trial offer and the fee will not be
pro-rated.
    The monthly fee rates set forth in Nasdaq Rule 7046(b), as well as
in the chart below, will apply to a firm that subscribes to the Nasdaq
Trading Insights product. The monthly fee will be based on the number
of ports the firm is subscribing to within the Nasdaq Trading Insights
product and in no case will the Nasdaq Trading Insights fees be pro-
rated. The fees for the Nasdaq Trading Insights product will be in
accordance with the following table.

------------------------------------------------------------------------
                                                 Number of     Monthly
                     Tiers                         ports       charges
------------------------------------------------------------------------
Tier 1........................................          1-5       $1,500
Tier 2........................................         6-15        2,000
Tier 3........................................        16-25        2,500
Tier 4........................................          26+        3,500
------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Act,\4\ in general, and with
Sections 6(b)(4) and (5) of the Act,\5\ in particular, in that it
provides for the equitable allocation of reasonable dues, fees, and
other charges among its members, issuers and other persons using its
facilities, and does not unfairly discriminate between customers,
issuers, brokers or dealers.
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    \4\ 15 U.S.C. 78f.
    \5\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    In adopting Regulation NMS,\6\ the Commission granted SROs and
broker-dealers (``BDs'') 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.
Nasdaq believes that its Nasdaq Trading Insights market data product is
precisely the sort of market data product that the Commission
envisioned when it adopted Regulation NMS. 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:
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    \6\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496 (June 29, 2005) (``Regulation NMS Adopting
Release'').

    [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.\7\
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    \7\ Id.

    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 BDs at
all, it follows that the price at which such data is sold should be set
by the market as well.
    Moreover, fee liable data products such as the Nasdaq Trading
Insights product are a means by which exchanges compete to attract
order flow, and this proposal simply adds the relevant fee structure
into an Exchange rule. To the extent that exchanges are successful in
such competition, they earn trading revenues and also enhance the value
of their data products by increasing the amount of data they are able
to provide. Conversely, to the extent that exchanges are unsuccessful,
the inputs needed to add value to data products are diminished.
Accordingly, the need to compete for order flow places substantial
pressure upon exchanges to keep their fees for both executions and data
reasonable.
    The fee structure for the Nasdaq Trading Insights product,
including the 14-day trial offer, also reflects an equitable allocation
and will not be unfairly discriminatory because it is a voluntary
product designed to ensure that the amount of the charge is tailored to
the specific port usage patterns of the subscriber. Thus, for example,
a subscriber's monthly charge for receiving access to the Nasdaq
Trading Insights product for five ports is $1,500, while a subscriber's
monthly charge for receiving access to the Nasdaq Trading Insights
product for 26 ports is $3,500. The range of fee options further
ensures that subscribers are not charged a fee that is inequitably
disproportionate to the use that they make of the product.
Additionally, the 14-day trial offer provides a potential subscriber an
opportunity to try the product before signing on to receive it for a
fee.
    The proposal would not permit unfair discrimination because the
Nasdaq Trading Insights product will be available to all interested
market participants opting to subscribe, regardless of whether they
take advantage of the 14-day trial offer, and will help to protect a
free and open market by continuing to provide additional non-core data
(offered on an optional basis for a fee) to the marketplace and by
providing investors with greater choices.\8\
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    \8\ See Sec. Indus. Fin. Mkts. Ass'n (SIFMA), Initial Decision
Release No. 1015, 2016 SEC LEXIS 2278 (ALJ June 1, 2016) (finding
the existence of vigorous competition with respect to non-core
market data). See also the decision of the United States Court of
Appeals for the District of Columbia Circuit in NetCoalition v. SEC,
615 F.3d 525 (D.C. Cir. 2010) (``NetCoalition I'') (upholding the
Commission's reliance upon competitive markets to set reasonable and
equitably allocated fees for market data).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The proposed fee structure is
designed to ensure a fair and reasonable use of Exchange resources by
allowing the Exchange to recoup costs while continuing to offer its
data products at competitive rates to firms.
    The market for data products is extremely competitive and firms may
freely choose alternative venues and data vendors based on the
aggregate fees assessed, the data offered, and the value provided. The
Nasdaq Trading Insights product is part of the existing market for
proprietary market data products that is currently 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.

    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 trade executions, exchange data products cannot
exist. Moreover, data products are valuable to many end users only
insofar as they provide information that end users 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, the operation of the
exchange is characterized by high fixed costs and low marginal costs.
This cost structure is common in content and content distribution
industries such as software, where developing new software typically
requires a large initial investment (and continuing large investments
to upgrade the software), but once the software is developed, the
incremental cost of providing that software to an additional user is
typically small, or even zero (e.g., if the software can be downloaded
over the internet after being purchased).\9\ In Nasdaq's case, it is
costly to build and maintain a trading platform, but the incremental
cost of trading each additional share on an existing platform, or
distributing an additional instance of data, is very low. Market
information and executions are each produced jointly (in the sense that
the activities of trading and placing orders are the source of the
information that is distributed) and are each subject to significant
scale economies. In such cases, marginal cost pricing is not feasible
because if all sales were priced at the margin, Nasdaq would be unable
to defray its platform costs of providing the joint products.
---------------------------------------------------------------------------

    \9\ See William J. Baumol and Daniel G. Swanson, ``The New
Economy and Ubiquitous Competitive Price Discrimination: Identifying
Defensible Criteria of Market Power,'' Antitrust Law Journal, Vol.
70, No. 3 (2003).
---------------------------------------------------------------------------

    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. Nasdaq pays rebates and credits to attract orders, charges
relatively low prices for market information and charges relatively
high prices for accessing posted liquidity. Other platforms may choose
a strategy of paying lower liquidity rebates to attract orders, setting
relatively low prices for accessing posted liquidity, and setting
relatively high prices for market information. Still others may provide
most data free of charge and rely exclusively on transaction fees to
recover their costs. Finally, some platforms may incentivize use by
providing opportunities for equity ownership, which may allow them to
charge lower direct fees for executions and data.
    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. Such regulation is unnecessary because an ``excessive'' price
for one of the joint products will ultimately have to be reflected in
lower prices for other products sold by the firm, or otherwise the firm
will experience a loss in the volume of its sales that will be adverse
to its overall profitability. In other words, an increase in the price
of data will ultimately have to be accompanied by a decrease in the
cost of executions, or the volume of both data and executions will
fall.\10\
---------------------------------------------------------------------------

    \10\ Moreover, the level of competition and contestability in
the market is evident in the numerous alternative venues that
compete for order flow, including eleven 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 TRFs compete
to attract internalized transaction reports. It is common for BDs to
further and exploit this competition by sending their order flow and
transaction reports to multiple markets, rather than providing them
all to a single market. 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 MKT, NYSE Arca, and BATS/Direct Edge.
---------------------------------------------------------------------------

    The proposed charges for the Nasdaq Trading Insights product are
designed to ensure a fair and reasonable use of Exchange resources by
allowing the Exchange to recoup costs and ease administrative burden
while continuing to offer its data products at competitive rates to
firms.

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 change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\11\
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

    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.

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-2016-124 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2016-124. 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, 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
such filing also will be available for inspection and copying at the
principal office of the Exchange. 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-2016-124, and should be submitted on or before
November 1, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
Robert W. Errett,
Deputy Secretary.
---------------------------------------------------------------------------

    \12\ 17 CFR 200.30-3(a)(12).
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[FR Doc. 2016-24420 Filed 10-7-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 14 (Monday, January 22, 2018)]
[Notices]
[Pages 2997-2999]
[FR Doc No: 2018-00995]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-2520]

Determination of Regulatory Review Period for Purposes of Patent
Extension; PERCEVAL SUTURELESS HEART VALVE

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for PERCEVAL SUTURELESS HEART
VALVE and is publishing this notice of that determination as required
by law. FDA has made the determination because of the submission of an
application to the Director of the U.S. Patent and Trademark Office
(USPTO), Department of Commerce, for the extension of a patent which
claims that medical device.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by March
23, 2018. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by July 23, 2018 See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before March 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of March 23, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact

information, or other information that identifies you in the body of
your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-E-2520 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; PERCEVAL SUTURELESS HEART VALVE.''
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.
     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 Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.gpo.gov/fdsys/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.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of USPTO may award (half the testing phase
must be subtracted as well as any time that may have occurred before
the patent was issued), FDA's determination of the length of a
regulatory review period for a medical device will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
    FDA has approved for marketing the medical device PERCEVAL
SUTURELESS HEART VALVE. PERCEVAL SUTURELESS HEART VALVE is indicated
for replacement of diseased, damaged, or malfunctioning native or
prosthetic aortic valves. Subsequent to this approval, the USPTO
received a patent term restoration application for PERCEVAL SUTURELESS
HEART VALVE (U.S. Patent No. 8,540,768) from Sorin Group Italia S.r.l.,
and the USPTO requested FDA's assistance in determining this patent's
eligibility for patent term restoration. In a letter dated November 10,
2016, FDA advised the USPTO that this medical device had undergone a
regulatory review period and that the approval of PERCEVAL SUTURELESS
HEART VALVE represented the first permitted commercial marketing or use
of the product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
PERCEVAL SUTURELESS HEART VALVE is 1,003 days. Of this time, 694 days
occurred during the testing phase of the regulatory review period,
while 309 days occurred during the approval phase. These periods of
time were derived from the following dates:
    1. The date an exemption under section 520(g) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360j(g)) involving this
device became effective: April 12, 2013. The applicant claims that the
investigational device exemption (IDE) required under section 520(g) of
the FD&C Act for human tests to begin became effective on February 29,
2012. However, FDA records indicate that the IDE was determined
substantially complete for clinical studies to have begun on April 12,
2013, which represents the IDE effective date.
    2. The date an application was initially submitted with respect to
the device under section 515 of the FD&C Act (21 U.S.C. 360e): March 6,
2015. The applicant claims February 27, 2015, as the date the premarket
approval application (PMA) for PERCEVAL SUTURELESS HEART VALVE (PMA
P150011) was initially submitted. However, FDA records indicate that
PMA P150011 was submitted on March 6, 2015.
    3. The date the application was approved: January 8, 2016. FDA has
verified the applicant's claim that PMA P150011 was approved on January
8, 2016.

    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 576 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: January 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00995 Filed 1-19-18; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 88 (Monday, May 7, 2018)]
[Notices]
[Pages 20139-20141]
[FR Doc No: 2018-09613]

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DEPARTMENT OF TRANSPORTATION

Bureau of Transportation Statistics

[Docket Number DOT-OST-2017-0043

Agency Information Collection Activity; Notice of Request for
Approval To Collect New Information: Oil and Gas Industry Safety Data
Program

AGENCY: Office of the Assistant Secretary for Research and Technology
(OST-R), Bureau of Transportation Statistics (BTS), U.S. Department of
Transportation.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the requirements of section 3506(c)(2)(A)
of Title 44 of the U.S. Code (Pub. L. 104-13, the Paperwork Reduction
Act of 1995), this notice announces the intention of BTS to request the
Office of Management and Budget (OMB) to approve a new data collection:
Oil and Gas Industry Safety Data.
    In August 2013, the Bureau of Safety and Environmental Enforcement
(BSEE) and BTS signed an Interagency Agreement to develop and implement
SafeOCS, a voluntary program for confidential reporting of `near
misses' occurring on the Outer Continental Shelf (OCS). The Oil and Gas
Industry Safety Data (ISD) program, is a component of BTS's SafeOCS
data sharing framework, that provides a trusted, proactive means for
the oil and gas industry to report sensitive and proprietary safety
information, and to identify early warnings of safety problems and
potential safety issues by uncovering hidden, at-risk conditions not
previously exposed from analysis of reportable accidents and incidents.
Companies participating in the ISD are voluntarily submitting safety
data. There is no regulatory requirement to submit such data.
    The ISD identifies a broader range of data categories to ensure
safe performance and appropriate risk management, which adds a learning
component to assist the oil and gas industry in achieving improved
safety performance. BTS will be the repository for the data, and will
analyze and aggregate information proffered under this program, and
publish reports providing identification of potential causal factors
and trends or patterns before safety is compromised, and affording
continuous improvement opportunities by focusing on repairing
impediments to safety.

DATES: Written comments should be submitted by July 6, 2018.

ADDRESSES: To ensure that your comments are not entered more than once
into the docket, submit comments by only one of the following methods:
     Federal e-Rulemaking Portal: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically. Docket Number: DOT-OST-2017-0043.
     Mail: Docket Services, U.S. Department of Transportation,
1200 New Jersey Avenue SE, West Building, Ground Floor, Room W12-140,
Washington, DC 20590-0001.
     Hand Delivery: Deliver to mail address above between 9
a.m. and 5 p.m. EST, Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Identify all transmissions with ``Docket Number DOT-OST-2017-0043''
at the beginning of each page of the document.
    Instructions: All comments must include the agency name and docket
number for this notice. Paper comments should be submitted in
duplicate. The Docket Management Facility is open for examination and
copying, at the above address from 9 a.m. to 5 p.m. EST, Monday through
Friday, except Federal holidays. If you wish to receive confirmation of
receipt of your written comments, please include a self-addressed,
stamped postcard with the following statement: ``Comments on Docket
Number DOT-OST-2017-0043.'' The Docket Clerk will date stamp the
postcard prior to returning it to you via the U.S. mail.
    Privacy Act: Anyone can search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). Please note that all
comments received including any personal information, will be posted
and will be publicly viewable, without change, at www.regulations.gov.
You may review DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (65 FR 19477-78) or you may visit
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Demetra V. Collia, Bureau of
Transportation Statistics, Office of the Assistant Secretary for
Research and Technology, U.S. Department of Transportation, Office of
Statistical and Economic Analysis, RTS-31, E36-302, 1200 New Jersey
Avenue SE, Washington, DC 20590-0001; Phone No.<PHONE_NUMBER>; Fax No.
(202) 366-3383; email: [email protected]. Office hours are from
8:30 a.m. to 5

p.m., EST, Monday through Friday, except Federal holidays.
    Data Confidentiality Provisions: The confidentiality of oil and gas
industry safety data information submitted to BTS is protected under
the BTS confidentiality statute (49 U.S.C. 6307) and the Confidential
Information Protection and Statistical Efficiency Act (CIPSEA) of 2002
(Pub. L. 107-347, Title V). In accordance with these confidentiality
statutes, only statistical (aggregated) and non-identifying data will
be made publicly available by BTS through its reports. BTS will not
release to BSEE or any other public or private entity any information
that might reveal the identity of individuals or organizations
mentioned in failure notices or reports without explicit consent of the
respondent and any other affected entities.

SUPPLEMENTARY INFORMATION:

I. The Data Collection

    The Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35; as
amended) and 5 CFR part 1320 require each Federal agency to obtain OMB
approval to initiate an information collection activity. BTS is seeking
OMB approval to collect the following new data:
    Title: Oil and Gas Industry Safety Data (ISD) Program.
    OMB Control Number:
    Type of Review: Approval of data collection. This information
collection for Oil and Gas Industry Safety Data is to ensure the safe
performance and appropriate risk management within the oil and gas
industry, including but not limited to exploration and production.
    Respondents: Oil and gas industry companies involved in the
exploration and/or production working in the Gulf of Mexico (GOM).
Responsibility for establishing the actual scope and burden for this
collection resides with BTS.
    Number of Potential Responses: One hundred.
    Estimated Time per Response: 40 hours.
    Frequency: Annual.
    Total Annual Burden: 400 hours.
    Abstract: The Confidential Information Protection and Statistical
Efficiency Act of 2002 (CIPSEA) (44 U.S.C. 3501 note), can provide
strong confidentiality protection for information acquired for
statistical purposes under a pledge of confidentiality. CIPSEA Guidance
from the Office of Management and Budget advises that a non-statistical
agency or unit (BSEE) that wishes to acquire information with CIPSEA
protection, may consider entering an agreement with a Federal
statistical agency or unit (BTS). BTS and BSEE have determined that it
is in the public interest to collect, and process ISD reports and any
other data deemed necessary to administer the Oil and Gas Industry
Safety Data Program under a pledge of confidentiality for statistical
purposes only.
    Working with subject matter experts BTS will then aggregate and
further analyze these reports to identify potential causal factors and
trends. All data reviewers would be subject to non-disclosure
requirements mandated by CIPSEA. The results of these aggregated
analyses will be distributed by BTS through public reports, workshops,
and other forms. Periodic industry workshops may be scheduled by BSEE/
industry to discuss the data analysis and trend results, as well as
share ideas and process improvements for preventing recurrence.

II. Background

    The goal of the Oil and Gas Industry Safety Data program is to
provide BTS with essential information about accident precursors and
other hazards associated with Outer Continental Shelf (OCS) oil and gas
operations including but not limited to exploration and production
(E&P.) This program collects voluntarily reported safety data.
    A related goal of the ISD is to provide a mechanism whereby
participating companies can submit safety data in whatever format they
currently use to minimize incremental effort on the company's part. To
realize the optimum benefits from an industrywide framework, all
organizations associated with offshore E&P operations (operators,
contractors, subcontractors, suppliers/OEMs) and/or regulatory agencies
are encouraged to submit data voluntarily. BTS is conducting an
Industry Safety Data (ISD) program pilot, in 2017-2018 with data from
nine companies.
    The value proposition of the ISD program is its focus on the
continual improvement in safety performance, and its implementation of
lessons learned from incidents and events that occur within the oil and
gas industry. This is particularly important for major hazards and
associated prevention/mitigation barriers. Several key aspects of this
effort includes:
     Providing a solution for a central repository for
collection, collaboration, and sharing of lessons learned from
collected safety-related data,
     Identifying the type of data that will provide valuable
information,
     Gaining alignment on incident and indicator definitions,
     Utilizing a secure process for collection and analysis of
the data,
     Implementing a robust methodology for identifying systemic
issues,
     Disseminating the results to stakeholders who can then
take actions to reduce or eliminate the risk of recurrence through
greater barrier integrity,
     Providing opportunities for stakeholders to network and
benchmark performance, both individually and as an organization, and
     Establishing a framework wherein adverse actions cannot
legally be taken against data submitters nor can raw data be used for
regulatory development purposes.
    One other related goal of the ISD program is to provide a mechanism
whereby participating companies can submit safety data in whatever
format they currently use to minimize incremental effort on the
company's part.
    One of the key benefits associated with submitting safety data
directly to BTS for review and analysis, is that it addresses concerns
related to protection of the data source. SafeOCS, including the ISD,
operates under a Federal law, the Confidential Information Protection
and Statistical Efficiency Act of 2002 (CIPSEA), which requires the
program to protect the identity of the reporter and treat reports
confidentially. Information submitted under CIPSEA is also protected
from release to other government agencies, Freedom of Information Act
(FOIA) requests, and subpoena. Even regulatory agencies, such as BSEE,
cannot have access to the identity of those submitting reports under
the program. In addition, the information from individual records
cannot be used for enforcement purposes. CIPSEA is subject to strict
criminal and civil penalties for noncompliance.
    Once data is aggregated, BTS will analyze safety data reports
submitted by companies involved in OCS activities. BTS will also work
with subject matter experts to further analyze these reports to
identify potential causal factors and trends. The results of these
aggregated analyses will be distributed by BTS through public reports.
Industry workshops may then be scheduled to allow operators, service
companies, drilling contractors, regulators, and other stakeholders to
discuss the results and share lessons learned.
    This data collection will provide participating members within the
oil and gas industry, a trusted means to report sensitive proprietary
and safety information related to operations in the OCS, and to foster
trust in the confidential collection, handling, and storage of the raw
data. BTS will use the

data collected to establish a comprehensive source of the safety
related data for statistical purposes. With input from subject matter
experts, BTS will process and analyze information on Safety Data and
associated metadata, and publish the results of such analyses in public
reports. These reports will provide the industry, all OCS stakeholders
and BSEE with essential information about critical safety issues for
offshore operations and production.
    The BTS Director or Deputy Director will review all analyses and
reports, and issue approval for publication. While BTS's direct
involvement will end after the aggregated trends report is published,
the ISD program may form a committee to address the analytical
findings.

III. Request for Public Comment

    BTS requests comments on any aspects of this information collection
request, including: (1) Ways to enhance the quality, usefulness, and
clarity of the collected information; and (2) ways to minimize the
collection burden without reducing the quality of the information
collected, including additional use of automated collection techniques
or other forms of information technology.

Patricia Hu,
Director, Bureau of Transportation Statistics, Office of the Assistant
Secretary for Research and Technology, U.S. Department of
Transportation.
[FR Doc. 2018-09613 Filed 5-4-18; 8:45 am]
 BILLING CODE 4910-9X-P


[Federal Register: June 29, 2006 (Volume 71, Number 125)]
[Notices]
[Page 37130-37131]
[DOCID:fr29jn06-87]

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SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

In the Matter of Rudy 45; Order of Suspension of Trading

June 26, 2006.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Rudy 45 (``RDYF'') because the company has failed to make required
periodic corporate filings and/or has made inadequate or incomplete
periodic corporate filings since December 2004, because of questions
raised regarding the accuracy and adequacy of publicly disseminated
information concerning, among other things, an acquisition announced by
Rudy 45, and because of possible manipulative conduct

occurring in the market for the company's stock.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed company.
    Therefore, it is ordered, pursuant to Section 12(k) of the
Securities Exchange Act of 1934, that trading in the above-listed
company is suspended for the period from 9:30 a.m. EDT, on June 26,
2006 through 11:59 p.m. EDT, on July 10, 2006.

    By the Commission.
Nancy M. Morris,
Secretary.
[FR Doc. 06-5791 Filed 6-26-06; 11:51 am]

BILLING CODE 8010-01-P