[Federal Register Volume 88, Number 245 (Friday, December 22, 2023)]
[Notices]
[Pages 88687-88689]
[FR Doc No: 2023-28196]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-99200; File No. SR-NASDAQ-2023-035]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Order
Instituting Proceedings To Determine Whether To Approve or Disapprove a
Proposed Rule Change To List and Trade Shares of the Hashdex Nasdaq
Ethereum ETF Under Nasdaq Rule 5711(i) (Trust Units)

December 18, 2023.
    On September 20, 2023, The Nasdaq Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to list and trade shares (``Shares'') of the
Hashdex Nasdaq Ethereum ETF (``Fund'') under Nasdaq Rule 5711(i) (Trust
Units). The proposed rule change was published for comment in the
Federal Register on October 3, 2023.\3\
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 98563 (Sept. 27,
2023), 88 FR 68214 (``Notice''). The Commission has received no
comments on the proposal.
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    On November 15, 2023, pursuant to Section 19(b)(2) of the Act,\4\
the Commission designated a longer period within which to approve the
proposed rule change, disapprove the proposed rule change, or institute
proceedings to determine whether to disapprove the proposed rule
change.\5\ This order institutes proceedings under Section 19(b)(2)(B)
of the Act \6\ to determine whether to approve or disapprove the
proposed rule change.
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    \4\ 15 U.S.C. 78s(b)(2).
    \5\ See Securities Exchange Act Release No. 98948, 88 FR 81156
(Nov. 21, 2023). The Commission designated January 1, 2024, as the
date by which the Commission shall approve or disapprove, or
institute proceedings to determine whether to disapprove, the
proposed rule change.
    \6\ 15 U.S.C. 78s(b)(2)(B).
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I. Summary of the Proposal

    As described in more detail in the Notice,\7\ the Exchange proposes
to list and trade the Shares of the Fund, a series of the Tidal
Commodities Trust I (``Trust''), under Nasdaq Rule 5711(i), which
governs the listing and trading of Trust Units on the Exchange.
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    \7\ See Notice, supra note 3.
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    The investment objective of the Fund is to have the daily changes
in the net asset value (``NAV'') of the Shares reflect the daily
changes in the price of the Nasdaq Ether Reference Price (NQETH)
(``Benchmark''), less expenses from the Fund's operations.\8\ The
Benchmark is designed to track the price performance of ether.\9\ Under
normal market conditions, the Fund will invest in ether, ether futures
contracts listed on the Chicago Mercantile Exchange, Inc.
(``CME''),\10\ and in cash and cash equivalents.\11\ The Fund will use
the CME's Exchange for Physical (``EFP'') transactions to acquire and
dispose of spot ether.\12\ The Fund will be subject to investment
restrictions on spot ether which cap the Fund's exposure to the ether
spot market to a specified proportion of the Fund's NAV and restrict
the Fund's notional exposure to ether to a set proportion.\13\ The sub-
administrator of the Fund will calculate the NAV of the Fund once each
trading day, as of the earlier of the close of the Nasdaq or 4:00 p.m.
New York time.\14\ To determine the value of Ether Futures Contracts,
the Fund's sub-administrator will use the Ether Futures Contract
settlement price on the exchange on which the contract is traded,
except that the fair value of Ether Futures Contracts may be used when
Ether Futures Contracts close at their price fluctuation limit for the
day. The value of spot ether held by the Fund would be determined by
the Sponsor and by Hashdex Asset Management Ltd. (``Digital Asset
Adviser'') in good faith based on a methodology that is entirely
derived from the settlement prices of Ether Futures Contracts on the
CME and that considers all available facts and all available
information on the valuation

date.\15\ When the Fund sells or redeems its Shares, it will do so in
cash transactions with authorized participants in blocks of 10,000
Shares.\16\
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    \8\ See Notice, 88 FR at 68215. The Fund is managed and
controlled by Toroso Investments LLC (``Sponsor''). See id. at
68214.
    \9\ See id.
    \10\ According to the Exchange, the CME currently offers two
ether futures contracts: one contract representing 50 ether (``ETH
Contracts'') and another contract representing 0.10 ether (``MET
Contracts,'' and collectively, ``Ether Futures Contracts''). See id.
at 68214.
    \11\ See id. at 68214. The Fund will hold a mix of Ether Futures
Contracts, spot ether, and cash and cash equivalents, subject to
certain investment restrictions. See id. at 68219.
    \12\ See id. at 68219. According to the Exchange, EFP
transactions are a type of private agreement between two parties to
trade a futures position for the underlying asset. In an EFP
transaction, two parties exchange equivalent but offsetting
positions in an Ether Futures Contract and the underlying physical
ether. In the context of the Fund, these transactions will be used
to purchase and sell spot ether by delivering or receiving the
equivalent futures position. See id. at 68229.
    \13\ See id. at 68227-28.
    \14\ See id. at 68231. The Fund's NAV will include any
unrealized profit or loss on open ether futures contacts and any
other credit or debit accruing to the Fund but unpaid or not
received by the Fund. See id.
    \15\ See id. at 68222, 68231-32. According to the Exchange, this
``futures-based spot price'' methodology involves a calculation that
is sensitive to both the length of time (``tenor'') until each Ether
Futures Contract is due for settlement and the final settlement
price for each contract. The calculation takes into account each
contract's tenor and the tenor squared. This approach is designed to
give more importance to contracts that are due for settlement in the
near term. The calculation produces a set of weighting factors, with
each factor indicating the contribution of the corresponding Ether
Futures Contract to the estimated current spot price of ether. The
estimated spot price is the component of the result corresponding to
a tenor of zero days. The Sponsor and Digital Asset Advisor do not
use data from ether trading platforms or directly from spot ether
trading activity in determining the value of spot ether held by the
Fund. See id. at 68222-23.
    \16\ See id. at 68232-33.
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II. Proceedings To Determine Whether To Approve or Disapprove SR-
NASDAQ-2023-035 and Grounds for Disapproval Under Consideration

    The Commission is instituting proceedings pursuant to Section
19(b)(2)(B) of the Act \17\ to determine whether the proposed rule
change should be approved or disapproved. Institution of proceedings is
appropriate at this time in view of the legal and policy issues raised
by the proposed rule change, as discussed below. Institution of
proceedings does not indicate that the Commission has reached any
conclusions with respect to any of the issues involved. Rather, as
described below, the Commission seeks and encourages interested persons
to provide comments on the proposed rule change.
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    \17\ 15 U.S.C. 78s(b)(2)(B).
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    Pursuant to Section 19(b)(2)(B) of the Act,\18\ the Commission is
providing notice of the grounds for disapproval under consideration.
The Commission is instituting proceedings to allow for additional
analysis of the proposed rule change's consistency with Section 6(b)(5)
of the Act, which requires, among other things, that the rules of a
national securities exchange be ``designed to prevent fraudulent and
manipulative acts and practices'' and ``to protect investors and the
public interest.'' \19\
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    \18\ Id.
    \19\ 15 U.S.C. 78f(b)(5).
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    The Commission asks that commenters address the sufficiency of the
Exchange's statements in support of the proposal, which are set forth
in the Notice, in addition to any other comments they may wish to
submit about the proposed rule change. In particular, the Commission
seeks comment on the following questions and asks commenters to submit
data where appropriate to support their views:
    1. Given the nature of the underlying assets held by the Fund, has
the Exchange properly filed its proposal to list and trade the Shares
under Nasdaq Rule 5711(i) (Trust Units)? \20\
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    \20\ Nasdaq Rule 5711(i)(3)(B) defines the term ``Trust Units''
as a security that is issued by a trust or other similar entity that
is constituted as a commodity pool that holds investments comprising
or otherwise based on any combination of futures contracts, options
on futures contracts, forward contracts, swap contracts, commodities
and/or securities.
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    2. The Exchange raises similar arguments to support the listing and
trading of the Shares as those made in proposals to list and trade spot
bitcoin exchange-traded products (``Bitcoin ETPs''). Do commenters
agree that arguments to support the listing of Bitcoin ETPs apply
equally to the Shares? Are there particular features related to ether
and its ecosystem, including its proof of stake consensus mechanism and
concentration of control or influence by a few individuals or entities,
that raise unique concerns about ether's susceptibility to fraud and
manipulation?
    3. What are commenters' views on whether the proposed Fund and
Shares would be susceptible to manipulation? What are commenters' views
generally on whether the Exchange's proposal is designed to prevent
fraudulent and manipulative acts and practices? What are commenters'
views generally with respect to the liquidity and transparency of the
ether markets and the ether markets' susceptibility to manipulation?
    4. Based on data and analysis provided by the Exchange,\21\ what
are commenters views on whether the CME, on which CME ether futures
trade and through which the Fund intends to engage in EFP transactions
to purchase or sell spot ether, represents a regulated market of
significant size related to spot ether? \22\ What are commenters' views
on whether there is a reasonable likelihood that a person attempting to
manipulate the Shares would also have to trade on the CME to manipulate
the Shares? \23\ Do commenters agree with the Exchange that trading in
the Shares would not be the predominant influence on prices in the CME
ether futures market? \24\
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    \21\ See Notice, 88 FR at 68218, 68220-21, 68226-27.
    \22\ See id. at 68219.
    \23\ See id. at 68219-20.
    \24\ See id. at 68220-21.
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    5. The Exchange states that the Fund intends to adopt ``an
innovative approach to mitigate the risks of fraud and manipulation
that are unique to the Fund'' by ``structur[ing] the operation of the
Fund such that the regulated market of significant size in relation to
the Fund is the [CME] because it is the same market on which the Fund
trades its non-cash assets.'' \25\ The Exchange further states that the
Fund has features that underscore its significant interrelationship
with the CME, including that the Fund (i) utilizes futures-based
pricing for spot ether such that the NAV calculation for the spot ether
holdings of the Fund will be derived from the CME ether futures curve;
(ii) is subject to investment restrictions on spot ether; (iii) will
use CME EFP transactions to acquire and dispose of spot ether ``instead
of transactions on unregulated spot exchanges''; and (iv) will utilize
only cash creations and redemptions.\26\ Based on the structure and
operation of the Fund and the Fund's investments as described in the
filing, what are commenters' views on whether the CME represents a
regulated market of significant size related to spot ether? \27\
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    \25\ See id. at 68219.
    \26\ See id.
    \27\ See id.
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    6. The Fund will only use CME EFP transactions to acquire and
dispose of spot ether.\28\ The Exchange states that ``trading activity
in EFP transactions is sporadic'' but that, ``[n]onetheless, the
Sponsor believes that a large number of liquidity providers are ready
to execute this type of transaction and can provide enough liquidity to
support the [Fund's] demand.'' \29\ Do commenters agree? Why or why
not?
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    \28\ See, e.g., id. at 68229-30.
    \29\ See id. at 68230.
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    7. The value of spot ether held by the Fund would be determined
using a futures-based spot price methodology that is derived from the
settlement prices of ether futures contracts on the CME.\30\ The
Exchange presents data \31\ that it states ``strongly suggests that
[futures-based spot pricing] is a suitable choice for the NAV
calculation.'' \32\ The Exchange states that futures-based spot pricing
``could create some level of uncertainty due to the potential
divergences between the [futures-based spot price] and the spot prices
observed in unregulated markets'' but that authorized participants
``will always be in a position to hedge their exposure using
exclusively the [CME ether futures market], which will make them more
likely to provide liquidity to the Fund

thus making its market price converge to its NAV.'' \33\ Do commenters
agree with the Exchange? Why or why not?
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    \30\ See id. at 68231.
    \31\ See id. at 68222-25.
    \32\ See id. at 68225.
    \33\ See id.
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    8. Some sponsors of proposed ether exchange-traded products have
made statements regarding the correlation between ether spot markets
and the CME ether futures market.\34\ What are commenters' views on the
correlation between the ether spot market and the CME ether futures
market? What are commenters' views on the extent to which a
surveillance-sharing agreement with the CME would assist in detecting
and deterring fraud and manipulation that impacts an exchange-traded
product (``ETP'') that also holds spot ether, and on whether
correlation analysis provides any evidence to this effect? What are
commenters' views on the Sponsor's own statistical analysis of the
relationship between prices in certain unregulated ether markets and
prices of CME ether futures contracts? \35\ What are commenters' views
generally on whether an ETP that holds only CME ether futures and an
ETP that also holds spot ether are similar products?
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    \34\ See, e.g., Notice of Filing of a Proposed Rule Change to
List and Trade Shares of the VanEck Ethereum ETF under BZX Rule
14.11(e)(4), Commodity-Based Trust Shares, Securities Exchange Act
Release No. 98457 (Sept. 20, 2023), 88 FR 66076 (Sept. 26, 2023),
66081 (stating that ``The Sponsor's research indicates daily
correlation between the spot ETH and the CME ETH Futures is 0.998
from the period of 9/1/22 through 9/1/23.'').
    \35\ See Notice, 88 FR at 68226-27.
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III. Procedure: Request for Written Comments

    The Commission requests that interested persons provide written
submissions of their views, data, and arguments with respect to the
issues identified above, as well as any other concerns they may have
with the proposal. In particular, the Commission invites the written
views of interested persons concerning whether the proposal is
consistent with Section 6(b)(5) or any other provision of the Act, and
the rules and regulations thereunder. Although there do not appear to
be any issues relevant to approval or disapproval that would be
facilitated by an oral presentation of views, data, and arguments, the
Commission will consider, pursuant to Rule 19b-4, any request for an
opportunity to make an oral presentation.\36\
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    \36\ Section 19(b)(2) of the Act, as amended by the Securities
Acts Amendments of 1975, Public Law 94-29 (June 4, 1975), grants the
Commission flexibility to determine what type of proceeding--either
oral or notice and opportunity for written comments--is appropriate
for consideration of a particular proposal by a self-regulatory
organization. See Securities Acts Amendments of 1975, Senate Comm.
on Banking, Housing & Urban Affairs, S. Rep. No. 75, 94th Cong., 1st
Sess. 30 (1975).
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    Interested persons are invited to submit written data, views, and
arguments regarding whether the proposed rule change should be approved
or disapproved by January 12, 2024. Any person who wishes to file a
rebuttal to any other person's submission must file that rebuttal by
January 26, 2024.
    Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's internet comment form (https://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
file number SR-NASDAQ-2023-035 on the subject line.

Paper Comments

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

All submissions should refer to file number SR-NASDAQ-2023-035. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (https://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for website viewing and
printing in the Commission's Public Reference Room, 100 F Street NE,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. Do not
include personal identifiable information in submissions; you should
submit only information that you wish to make available publicly. We
may redact in part or withhold entirely from publication submitted
material that is obscene or subject to copyright protection. All
submissions should refer to file number SR-NASDAQ-2023-035 and should
be submitted on or before January 12, 2024. Rebuttal comments should be
submitted by January 26, 2024.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\37\
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    \37\ 17 CFR 200.30-3(a)(57).
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Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-28196 Filed 12-21-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 143 (Wednesday, July 27, 2022)]
[Notices]
[Pages 45095-45096]
[FR Doc No: 2022-16120]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP15-490-000]

Delfin LNG LLC; Notice of Request for Extension of Time

    Take notice that on July 15, 2022, Delfin LNG LLC (Delfin)
requested that the Federal Energy Regulatory Commission (Commission)
grant an extension of time (2022 Extension of Time Request), until
September 28, 2023, to construct and place into service the facilities
that were authorized in the original certificate authorization issued
on September 28, 2017 (Certificate Order).\1\ The Certificate Order
authorized certain ``onshore facilities'' that would be used
exclusively to transport natural gas to Delfin's deepwater port
``offshore facilities'' (collectively, the Project) in federal waters
offshore Louisiana. The onshore facilities would be used to meet the
requirements of the customers of the offshore facilities. The
Commission subsequently has granted three, successive one-year
extensions of this in-service timing condition, with the result that
the facilities currently are required to be made available for service
by September 28, 2022.\2\
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    \1\ Delfin LNG LLC, 160 FERC ] 61,130 (2017).
    \2\ Delfin LNG LLC, Docket No. CP15-490-000 (July 8, 2019)
(delegated order) (July 2019 Extension Order)., Delfin LNG LLC,
Docket No. CP15-490-000 (July 15, 2020) (delegated order) (July 2020
Extension Order)., Delfin LNG LLC, Docket No. CP15-490-000 (June 30,
2021) (delegated order) (July 21 Extension Order).
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    In its 2022 Extension of Time Request, Delfin states that it has
made significant progress in developing the Project. Delfin asserts
that the market for LNG is strong with the current geopolitical
importance of the Ukraine invasion and the initiative of the European
Union to increase deliveries of U.S LNG to Europe. Additionally, Delfin
states that the Project remains commercially viable with a binding LNG
sale and purchase agreement with Vitol Spa for 0.5 million metric
tonnes per annum (mtpa) of LNG delivered free on-board at the Delfin
LNG deepwater port, for 15 years. Moreover, Delphin explains that it
has continued to work to develop the Project by completing the Front
End Engineering and Design for the construction of the Floating LNG
vessels (FLNGV). Delfin states the project consists of 4 separates
floating FLNGV, and only requires 2.0 to 2.5 mtpa of LNG for the long-
term off-take contracts to support a final investment (FID) and begin
construction of the first FLNGV. Moreover, Delfin affirms that FID for
the first FLNGV is on schedule for the end of the year. Accordingly,
Delfin requests an extension of time until September 28, 2023 to
complete construction of the onshore facilities and place them into
service.
    This notice establishes a 15-calendar day intervention and comment
period deadline. Any person wishing to comment on Delfin's request for
an extension of time may do so. No reply

comments or answers will be considered. If you wish to obtain legal
status by becoming a party to the proceedings for this request, you
should, on or before the comment date stated below, file a motion to
intervene in accordance with the requirements of the Commission's Rules
of Practice and Procedure (18 CFR 385.214 or 385.211) and the
Regulations under the Natural Gas Act (18 CFR 157.10).
    As a matter of practice, the Commission itself generally acts on
requests for extensions of time to complete construction for Natural
Gas Act facilities when such requests are contested before order
issuance. For those extension requests that are contested,\3\ the
Commission will aim to issue an order acting on the request within 45
days.\4\ The Commission will address all arguments relating to whether
the applicant has demonstrated there is good cause to grant the
extension.\5\ The Commission will not consider arguments that re-
litigate the issuance of the certificate order, including whether the
Commission properly found the project to be in the public convenience
and necessity and whether the Commission's environmental analysis for
the certificate complied with the National Environmental Policy Act.\6\
At the time a pipeline requests an extension of time, orders on
certificates of public convenience and necessity are final and the
Commission will not re-litigate their issuance.\7\ The OEP Director, or
his or her designee, will act on all of those extension requests that
are uncontested.
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    \3\ Contested proceedings are those where an intervenor disputes
any material issue of the filing. 18 CFR 385.2201(c)(1) (2019).
    \4\ Algonquin Gas Transmission, LLC, 170 FERC ] 61,144, at P 40
(2020).
    \5\ Id. at P 40.
    \6\ Similarly, the Commission will not re-litigate the issuance
of an NGA section 3 authorization, including whether a proposed
project is not inconsistent with the public interest and whether the
Commission's environmental analysis for the permit order complied
with NEPA.
    \7\ Algonquin Gas Transmission, LLC, 170 FERC ] 61,144, at P 40
(2020).
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    In addition to publishing the full text of this document in the
Federal Register, The Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to Commission's Public Reference
Room, due to the proclamation declaring a National Emergency concerning
the Novel Coronavirus Disease (COVID-19), issued by the President on
March 13, 2020. For assistance, contact FERC at
[email protected] or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and three copies of the protest or intervention to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426.
    Comment Date: 5:00 p.m. Eastern Time on, August 5, 2022.

    Dated: July 21, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-16120 Filed 7-26-22; 8:45 am]
BILLING CODE 6717-01-P


Chloropicrin: Weight of the Evidence for Use of Human Sensory Irritation Study Elissa Reaves, Ph. D.

Elissa Reaves, Ph. D.

U. S. EPA U. S. EPA Office of Pesticide Programs Office of Pesticide Programs June 27, 2006 June 27, 2006 2 Presentation Overview Presentation Overview

Key exposure pathways for soil fumigants

Chloropicrin toxicology database

Design and results of the chloropicrin human sensory irritation study

Proposed incorporation of Phase 3 of human study in risk assessment 3 Overview: Soil Fumigants Overview: Soil Fumigants

OPP is evaluating the risk from the soil fumigants:

 Methyl bromide  Methyl iodide  Chloropicrin  Telone  Metam sodium & Metam potassium ( degrade to MITC)

 Dazomet ( degrades to MITC)

Public Technical briefing for Soil Fumigants in July, 2005 4 Overview: Chloropicrin Overview: Chloropicrin

Exposure pathways  Agricultural settings, greenhouses, tree replant sites,

telephone pole applications, empty grain and potato storage fumigations  Can be used as an indicator chemical or as a warning agent when used at 2% or less in formulation  Major pathway: pre plant soil fumigant

Human Health Assessment: Acute Residential Bystander and Occupational Exposure N Cl Cl Cl O O 5 Overview: Historical use of Chloropicrin Overview: Historical use of Chloropicrin

World War I  Used for sensory irritant properties as a tearing agent and lung irritant

Incident Data  Provide support for the irritating properties of chloropicrin   Eye, skin, nose, and throat irritation, nausea, cough,

dyspnea, upper respiratory irritation, chest pain, asthma exacerbation  Insufficient exposure data prevents use of incident data in quantitative risk assessment 6 Chloropicrin: Toxicity Profile Chloropicrin: Toxicity Profile  Animal Animal

Robust database for inhalation studies  Studies varying from 30 minutes to 108 weeks  Corrosive to skin in rodent studies, held reserved for acute primary eye and dermal sensitization studies

Limited port of entry details from acute studies  only at lethal and sub lethal concentrations  No information on progression of detection to irritation

Animal data suggest port of entry effects occur at lower concentrations than systemic effects 7 Study Design: Chloropicrin Human Study Study Design: Chloropicrin Human Study

3 Phases: a total of 127 individuals

Mean age of 23 years ( range, 18 35 years)

Phase Total Subjects Males Females Repeat Participation Phase 1 62 ( odor)

63 ( eye) 32 32 30 31

Phase 2 62 32 30 14 M & 12 F ( Phase 1)

Phase 3 32 15 17 1 M ( Phase 1, 2),

1 M ( Phase 2) &

2 F ( Phase 1, 2) 8 Phase 1 Design: Chloropicrin Human Study Phase 1 Design: Chloropicrin Human Study

Objective:

 Odor detection, eye feel, or nasal feel from brief exposures  32 males, 30 females

Concentrations: 356, 533, 800, 1200 ppb

Duration:

   Sniff : 1 2 seconds, both nostrils  Eye: 25 seconds, one eye  Nose: 7 seconds, one nostril

Confidence of Feel: 1 ( very low) to 5 ( very high) 9 Phase 1 Results: Chloropicrin Human Study Phase 1 Results: Chloropicrin Human Study Odor Detection Group Analysis Detecting Subjects Only Logistic Regression Odor Median =

700 ppb Odor Median= 356 ppb EC10= 215 ppb EC50= 406 ppb Eye Detection Eye Median =

900 ppb Median between 356 & 533 ppb EC10= 38 ppb EC50= 242 ppb 10 Overall Phase 1: Chloropicrin Human Study Overall Phase 1: Chloropicrin Human Study

Strengths:

 Pertinent odor & eye threshold information  Informs variability of responses among individuals  Similar participation of males and females

Weaknesses:

 No severity scores, No physiological parameters  Length of sniff duration likely varied among subject

Not proposing Phase 1 for establishing an endpoint for risk assessment 11 Phase 2 Design: Chloropicrin Human Study Phase 2 Design: Chloropicrin Human Study

Objective:

 Feel in the eyes, nose, and/ or throat while in a walk in chamber  32 males & 30 females

Concentrations: 0, 50, 75, 100, 150 ppb

Duration:

 50 ppb for 30 minutes  75, 100 and 150 ppb for 20 minutes

Severity of feel not a parameter in Phase 2 12 Phase 2 Design: Chloropicrin Human Study Phase 2 Design: Chloropicrin Human Study

Response judgment ( score) at 30 seconds and every minute until end of exposure

Response Score:

   Yes  or   No  for the eyes, nose, and throat  Confidence of response:

  1= not certain   2= moderately certain   3= very certain

Subjects free to leave the chamber at any point 13 Hour 1 Hour 2 Hour 3 Hour 4 Hour 5 Hour 6 50 ppb 75 ppb 100 ppb 150 ppb 75 minute interval 75 minute interval 75 minute interval Phase 2 Design: Chloropicrin Human Study Phase 2 Design: Chloropicrin Human Study

Phase 2: one day schedule of exposures

Minimum of 45 minute intervals between chloropicrin exposures 14 Phase 2 Results: Chloropicrin Human Study Phase 2 Results: Chloropicrin Human Study

Feel in the eyes was more sensitive than in nose and throat  1 female left at 75 ppb, again at 150 ppb with 1 male  1 female and 1 male left at 150 ppb ( different day)

 No subjects left at 50 ppb or 100 ppb

Ocular median 75 ppb 15 Overall Phase 2: Chloropicrin Human Study Overall Phase 2: Chloropicrin Human Study

Strengths:

 More appropriate exposure scenario for acute bystander  Informs the timing of eye and nasal detection  Informs the variability of responses among individuals  Study design employed a low to high concentration  Blank period between chloropicrin exposures  Similar participation of males and females 16 Overall Phase 2: Chloropicrin Human Study Overall Phase 2: Chloropicrin Human Study

Weaknesses:

 No severity scores  No physiological parameters  Durations of exposure were not equal  Confidence scores different than in Phase 1

Not proposing Phase 2 for an endpoint in risk assessment 17 Phase 3 Design: Chloropicrin Human Study Phase 3 Design: Chloropicrin Human Study

Objective:

 Detection and severity of irritation in the eyes, nose,

and/ or throat while in a walk in chamber  15 males, 17 females

Concentrations: 0, 100, 150 ppb

Duration:

 60 minutes  4 consecutive days to same concentration

Exposures occurred in random order 18 Phase 3 Design: Chloropicrin Human Study Phase 3 Design: Chloropicrin Human Study

Physiological Parameters:

 Clinical exam of eyes, nose, throat  Pulmonary function testing   FEV1 = Forced Expiratory Volume   FVC = Forced Vital Capacity  Rhinomanometry  Nasal Cytology  Ocular Cytology  Exhaled Nitric Oxide from:

  lung ( eNO) and nose ( nNO) 19 Phase 3 Design: Chloropicrin Human Study Phase 3 Design: Chloropicrin Human Study

Symptoms rated in 3 settings:

1. While in the chamber ( scale 0 to 3);

2. Before and after exposure in the chamber and at the beginning and end of the exposure week;

3. At the beginning and end of a cycle of exposures,

via the RQLQ ( Rhinconjunctivitis Quality of Life Questionnaire) 20 Phase 3 Design: Chloropicrin Human Study Phase 3 Design: Chloropicrin Human Study

Irritation Severity Scoring:

 0 = No symptom  1 = Mild; symptom present, but minimal awareness,

easily tolerated  2 = Moderate; symptom definite and bothersome,

but tolerated  3 = Severe; symptom hard to tolerate and can interfere with activities of daily living or sleeping

Symptoms rated at 30 seconds and then every 1 minute until the end of 60 minutes 21 Phase 3 Results: Chloropicrin Human Study Phase 3 Results: Chloropicrin Human Study

No subjects left the chamber prior to 60 minutes

Eye more sensitive than nose or throat

Ocular Irritation:

   30% of subjects reported no eye irritation at any time or concentration during the 60 minutes    15% to 30% of subjects varied in irritation scores of 2 ( moderate) and 3 ( severe) during the peak response period ( 30 55 minutes) at either 100 or 150 ppb  At 0 ppb, scores varied from 0, 1, and occasionally 2 22 Phase 3 Results: Chloropicrin Human Study Phase 3 Results: Chloropicrin Human Study

Perceptual effects:

 Time required for feeling irritation decreased as the concentration increased from 100 to 150 ppb  Average eye severity score increased with increased concentration

Physiological effects ( inflammation):

 Change in nasal nitric oxide ( nNO)

 Change in upper respiratory air flow 23 Phase 3 Results: Chloropicrin Human Study Phase 3 Results: Chloropicrin Human Study

1 hour after exposure, no self reported symptoms

1 hour after exposure, physiological changes present

No physiological symptoms the following day

Self reported and physiological symptoms did not progress with days/ weeks of exposure 24 Overall Phase 3: Chloropicrin Human Study Overall Phase 3: Chloropicrin Human Study

Strengths:

 Objective and subjective irritation scores  Repeated measurements

Weaknesses:

 Fewer subjects than in Phase 1 and 2  Lower concentrations as in Phase 2 not examined 25 Point of Departure ( PoD): Chloropicrin Point of Departure ( PoD): Chloropicrin Human Study Human Study

Phase 3 provides physiological parameters that support eye irritation as an appropriate endpoint for PoD

Proposing Phase 3 of human study for establishing an endpoint for risk assessment

TERA BMC Analysis:

 Utilizes Data from Phase 3 Chloropicrin Human Study  BMCL 10 = 73 ppb; based on average severity score of 1.5  Based on maximal response period ( 30 55 minutes) 26 Chloropicrin Charge to the HSRB Chloropicrin Charge to the HSRB Chloropicrin is a non selective soil fumigant whose primary toxic effect is sensory irritation in which stimulated free nerve endings mediate sensations and clinical signs in the nose, eyes, throat, and upper respiratory tract. Chloropicrin is a unique soil fumigant in that it is used as an indicator chemical or warning agent ( 2% or less by weight in formulations). The Agency is developing an assessment to estimate inhalation risk to bystanders and workers from acute exposures to chloropicrin. 27 Chloropicrin Charge to the HSRB Chloropicrin Charge to the HSRB 1. Scientific considerations:

The Agency's " Weight of Evidence" ( WOE)

document and Data Evaluation Records ( DER) for chloropicrin describe the study design of the acute inhalation human toxicity study. The Agency has concluded that the human toxicity study is appropriate for developing a point of departure for extrapolation of inhalation risk to bystanders and workers exposed to chloropicrin.

Please comment on whether the study is sufficiently sound, from a scientific perspective, to be used to estimate a safe level of inhalation exposure to chloropicrin. 28 Phase 2 Design: Chloropicrin Human Study Phase 2 Design: Chloropicrin Human Study Details of test periods and concentrations for Phase 2 Exposure Concentration: N ( Males) N ( Females) Exposure Duration " did you feel in the nose, eyes, or throat?"

blank ( air) 32 30 30 min 50 ppb chloropicrin 32 30 30 min lunch break 45 min 75 ppb chloropicrin 32 30 20 min blank ( air) 32 29 30 min 100 ppb chloropicrin 32 30 20 min blank ( air) 32 30 30 min 150 ppb chloropicrin 32 30 20 min


[Federal Register Volume 81, Number 55 (Tuesday, March 22, 2016)]
[Notices]
[Pages 15296-15297]
[FR Doc No: 2016-06370]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 1494-433]

Grand River Dam Authority; Notice of Request To Reduce Comment
Period From 60 to 30 Days on Draft Amendment Application and Soliciting
Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Request to reduce the comment period from 60
to 30 days for a draft amendment application to permanently modify the
reservoir elevation rule curve under Article 401 of the project
license.
    b. Project No: 1494-433.
    c. Date Filed: March 15, 2016.
    d. Applicant: Grand River Dam Authority (GRDA).
    e. Name of Project: Pensacola Hydroelectric Project.
    f. Location: The project is located on the Grand River in Craig,
Delaware, Mayes, and Ottawa Counties, Oklahoma.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Tamara Jahnke, Grand River Dam Authority, 226
West Dwain Willis Ave, P.O. Box 409, Vinita, OK 74301; telephone (918)
256-5545.
    i. FERC Contact: B. Peter Yarrington, telephone<PHONE_NUMBER> and
email<EMAIL_ADDRESS>or Linda Stewart, telephone (202) 502-
6680 and email linda.stewart@ferc.
    j. Deadline for filing comments, motions to intervene, and protests
is 15 days from the issuance date of this notice by the Commission. The
Commission strongly encourages electronic filing. Please file comments
using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000
characters, without prior registration, using the eComment system at
http://www.ferc.gov/docs-filing/ecomment.asp. You must include your
name and contact information at the end of your comments. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426. The first page of any filing should include the
project number (P-1494-433).
    k. Description of Request: On March 15, 2016, GRDA filed with the
Commission: (1) A draft amendment application to permanently modify the
reservoir elevation rule curve under Article 401 of the Pensacola
Project for Grand Lake O' the Cherokees, (2) a request for a temporary
variance contained in the draft amendment application, and (3) a waiver
request to reduce from 60 to 30 days the comment period for resource
agencies, Indian tribes, and other stakeholders to provide comments on
the draft amendment application mentioned above. The Commission's
regulations at 4.38(a)(7) require GRDA to provide resource agencies,
Indian tribes, and other stakeholders 60 days to provide comments on
the above draft amendment application. GRDA requests Commission
approval of a 30-day comment period instead to expedite the
Commission's review of any final application filed with the Commission.
    This notice solicits comments, motions to intervene, and protests
on GRDA's request to reduce the comment period from 60 to 30 days as
discussed above. Comments on the draft application and temporary
variance request contained in the draft application should be filed
directly with

GRDA in accordance with instructions in the draft application.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number excluding the last three digits
in the docket number field to access the document. You may also
register online at http://www.ferc.gov/docs-filing/esubscription.asp to
be notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the address in item
(h) above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents: Any filing must (1)
bear in all capital letters the title ``COMMENTS,'' ``PROTEST,'' or
``MOTION TO INTERVENE'' as applicable; (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis and otherwise comply with the requirements of 18 CFR
4.34(b). All comments, motions to intervene, or protests should relate
to project works which are the subject of the proposed amendment.
Agencies may obtain copies of the application directly from the
applicant. A copy of any protest or motion to intervene must be served
upon each representative of the applicant specified in the particular
application. If an intervener files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency. A copy of all other
filings in reference to this application must be accompanied by proof
of service on all persons listed in the service list prepared by the
Commission in this proceeding, in accordance with 18 CFR 4.34(b) and
385.2010.

    Dated: March 16, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-06370 Filed 3-21-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: May 17, 2007 (Volume 72, Number 95)]
[Notices]
[Page 27871-27874]
[DOCID:fr17my07-124]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55736; File No. SR-CBOE-2007-37]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Order Granting Accelerated Approval
of Proposed Rule Change as Modified by Amendment No. 1 to Trade the
iShares MSCI Index Funds and the S&P Europe 350 Index Fund Pursuant to
UTP

May 10, 2007.
    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 April 20, 2007, the Chicago Board Options Exchange, Incorporated
(the ``Exchange'' or ``CBOE''), filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I and II below, which Items have been substantially prepared by
the Exchange. On May 7, 2007, the Exchange filed Amendment No. 1 to the
proposed rule change. This notice and order provides notice of the
proposed rule change, as amended, and approves the proposal on an
accelerated basis.
---------------------------------------------------------------------------

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

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

    The Chicago Board Options Exchange, Incorporated proposes to trade
on its subsidiary, the CBOE Stock Exchange (``CBSX''), shares of 15
international exchange-traded funds (``ETFs'' or ``Funds'') pursuant to
unlisted trading privileges (``UTP''). The text of the proposed rule
change is available on the Exchange's Web site (http://www.cboe.org/Legal
), at the Exchange's principal office, and at the Commission's

Public Reference Room.

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

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

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

1. Purpose
    The purpose of the proposed rule change is to trade on CBSX shares
of 15 international ETFs (the ``Shares'') pursuant to UTP. These Funds
are:

 iShares MSCI Australia Index Fund
 iShares MSCI Brazil Index Fund
 iShares MSCI EAFE Index Fund
 iShares MSCI Emerging Markets Index Fund
 iShares MSCI Germany Index Fund
 iShares MSCI Hong Kong Index Fund
 iShares MSCI Malaysia Index Fund
 iShares MSCI Mexico Index Fund
 iShares MSCI Pacific ex-Japan Index Fund
 iShares MSCI Singapore Index Fund
 iShares MSCI South Africa Index Fund
 iShares MSCI South Korea Index Fund
 iShares MSCI Taiwan Index Fund
 iShares MSCI United Kingdom Index Fund
 iShares S&P Europe 350 Index Fund

    The Exchange deems the Shares to be equity securities, thus
rendering trading in the Shares subject to existing CBSX rules
governing the trading of equity securities.
a. Description of the Funds
    The following funds are listed on the American Stock Exchange
(``Amex''):

 iShares MSCI Australia Index Fund
 iShares MSCI Brazil Index Fund
 iShares MSCI Germany Index Fund
 iShares MSCI Hong Kong Index Fund
 iShares MSCI Malaysia Index Fund
 iShares MSCI Mexico Index Fund
 iShares MSCI Singapore Index Fund
 iShares MSCI South Korea Index Fund
 iShares MSCI Taiwan Index Fund
 iShares MSCI United Kingdom Index Fund
 iShares S&P Europe 350 Index Fund

    The following funds are listed on the New York Stock Exchange
(``NYSE''):\3\
---------------------------------------------------------------------------

    \3\ Effective February 16, 2007, the iShares MSCI Index Funds
for EAFE, Emerging Markets, Pacific ex-Japan, and South Africa
transferred their primary listing to the NYSE and are no longer
listed on Amex. See Supplement dated February 16, 2007 to the
Prospectus dated January 1, 2007 for the iShares MSCI Series, and
Supplement dated February 16, 2007 to the Prospectus dated December
1, 2006 for the iShares Goldman Sachs Series and the iShares MSCI
EAFE Series.

 iShares MSCI EAFE Index Fund
 iShares MSCI Emerging Markets Index Fund
 iShares MSCI Pacific ex-Japan Index Fund
 iShares MSCI South Africa Index Fund

    In addition to being listed on the Amex or NYSE, the Shares \4\ are
traded on those and other securities exchanges and in the over-the-
counter market.\5\ The information below is intended to provide a
description of how the Shares were created and are traded.\6\
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    \4\ The Funds (with the exception of the MSCI EAFE and S&P
Europe 350 Funds) were formerly known as World Equity Benchmark
Shares or WEBS. An initial series of WEBS, including the iShares
MSCI Australia, Germany, Hong Kong, Malaysia, Mexico, Singapore, and
United Kingdom Index Funds were initially approved for listing and
trading on Amex in 1996. See Securities Exchange Act Release No.
36947 (March 8, 1996), 61 FR 10606 (March 14, 1996) (SR-Amex-95-43).
Additional WEBS series were approved for listing and trading in
2000, including iShares MSCI Brazil, iShares MSCI Taiwan, iShares
MSCI South Africa and iShares MSCI South Korea. See Securities
Exchange Act Release No. 42748 (May 2, 2000), 65 FR 30155 (May 10,
2000) (SR-Amex-98-49). iShares MSCI EAFE and iShares S&P Europe 350,
issued by iShares Trust, were approved for Amex listing and trading
in, respectively, in 2001. See Securities Exchange Release No. 44700
(August 14, 2001), 66 FR 43927 (August 21, 2001) (SR-Amex-2001-34);
Securities Exchange Act Release No. 42786 (May 15, 2000), 65 FR
33586 (May 24, 2000) (SR-Amex-99-49) (collectively, ``Listing
Approval Orders'').
    \5\ See, e.g., Securities Exchange Act Release No. 50142 (August
3, 2004), 69 FR 48539 (August 10, 2004) (SR-NYSE-2004-27) (approving
trading of the Shares pursuant to UTP).
    \6\ Much of the information in this filing was taken from the
Prospectuses and Statements of Additional Information of iShares,
Inc. dated January 1, 2007, the Prospectus of iShares S&P Europe
350, dated August 1, 2006, the Prospectus of iShares Trust MSCI
EAFE, dated December 1, 2006, and the Web sites of Amex (http://www.amex.com), the NYSE (http://www.nyse.com), and iShares (http://

http://www.ishares.com). Fund information relating to net asset value

(``NAV''), returns, dividends, component stock holdings, and the
like is updated on a daily basis on the Web sites.
---------------------------------------------------------------------------

    The Shares are issued by iShares, Inc., except for iShares MSCI
EAFE and S&P Europe 350, which are issued by iShares Trust. iShares,
Inc. and iShares Trust are open-ended management investment companies.
Each Fund seeks investment results that correspond generally to the
price and yield performance, before fees and expenses, of the
applicable

underlying index. The Funds utilize representative sampling to invest
in a representative sample of securities in the applicable underlying
index. Barclays Global Fund Advisors (``BGFA''), a subsidiary of
Barclays Global Investors, N.A. (``BGI''), is the investment advisor
for each Fund. BGI is a wholly owned indirect subsidiary of Barclays
Bank PLC of the United Kingdom. BGFA and its affiliates are not
affiliated with the index providers (MSCI and Standard & Poor's).
Investors Bank and Trust Company serves as administrator, custodian,
and transfer agent for the Funds, and SEI Investments Distribution Co.
is distributor for the Funds. The distributor is not affiliated with
BGFA.
b. MSCI and S&P Indexes
    The MSCI Indexes are calculated by MSCI for each trading day in the
applicable foreign exchange markets based on official closing prices in
such exchange markets. For each trading day, MSCI publicly disseminates
the MSCI Index values for the previous day's close. The S&P Europe 350
Index is calculated by Standard & Poor's (``S&P''), and is publicly
disseminated by S&P for the previous day's close. The indexes are
reported periodically in major financial publications, and the intra-
day values of the Indexes, disseminated every 15 seconds throughout the
trading day, are available through vendors of financial information as
further described in the Listing Approval Orders.
c. Tracking Error
    The Funds have chosen to pursue a representative sampling strategy
that, by its very nature, entails some risk of tracking error. (It
should also be noted that Fund expenses, the timing of cash flows, and
other factors all contribute to tracking error.) The Web site for the
Funds, http://www.iShares.com, contains detailed information on the

performance and tracking error for each Fund.
d. Availability of Information Regarding Funds
    The Web site for the Funds (http://www.iShares.com) contains the

prior business day's NAV and the reported closing price, and a
calculation of the premium or discount of such price against NAV; and
data in chart format displaying the frequency distribution of discounts
and premiums of the daily closing price against the NAV.
    The intra-day values of the indexes will be disseminated every 15
seconds throughout the trading day by organizations authorized by the
index providers and are available through major financial information
vendors.
    The intraday indicative value (``IIV'') of each Fund will be
disseminated every 15 seconds throughout the trading day by the
national securities exchange on which the Fund is listed or by other
information providers or market data vendors. The IIV likely will not
reflect the value of all securities included in the applicable indexes.
In addition, the IIV will not necessarily reflect the precise
composition of the current portfolio of securities held by the Funds at
a particular moment. The IIV disseminated throughout the trading day
should not be viewed as a real-time update of the NAV of the Funds,
which is calculated only once a day. It is expected, however, that
during the trading day the IIV will closely approximate the value per
share of the portfolio of securities for the Funds, except under
unusual circumstances.
    For the iShares MSCI Australia, Hong Kong, Malaysia, Pacific ex-
Japan, Singapore, South Korea, and Taiwan Funds, there is no overlap in
trading hours between the foreign and U.S. markets. Therefore, for each
of these Funds, the IIV calculator utilizes closing prices (denominated
in the applicable foreign currency) in the principal foreign market for
securities in the applicable Fund's portfolio and converts the price to
U.S. dollars. This IIV is updated every 15 seconds, during the trading
hours of the national securities exchange on which the Fund is listed,
to reflect changes in currency exchange rates between the U.S. dollar
and the applicable foreign currency. The IIV also includes the
estimated cash component for each Fund.
    For the iShares MSCI Brazil, EAFE, Germany, Mexico, South Africa,
and United Kingdom Funds, and the S&P Europe 350 Fund, there is an
overlap in trading hours between the foreign and U.S. markets.
Therefore, the IIV calculator updates the applicable IIV every 15
seconds to reflect price changes in the applicable foreign market or
markets and converts such prices into U.S. dollars based on the
currency exchange rate. When a relevant foreign market is closed but
the U.S. markets are open, the IIV is updated every 15 seconds to
reflect changes in currency exchange rates after the foreign market
closes. The IIV also includes the applicable cash component for each
Fund.
e. Information Circular
    In connection with the trading of the Shares, the Exchange will
inform members and member organizations in an Information Circular of
certain characteristics of certain Funds, as discussed below. The
circular will discuss the special characteristics and risks of trading
this type of security. Specifically, the circular, among other things,
will discuss what the Funds are, how they are created and redeemed, the
requirement that members and member firms deliver a prospectus or
Product Description to investors purchasing Shares prior to or
concurrently with the confirmation of a transaction, applicable
Exchange rules, dissemination information, trading information, and the
applicability of suitability rules.\7\
---------------------------------------------------------------------------

    \7\ The Commission issued an order (``Order'') granting the
Funds an exemption from Section 24(d) of the Investment Company Act
of 1940. See, e.g., Investment Company Act Release No. 25623 (June
25, 2002). Any Product Description used in reliance on the Section
24(d) exemptive order will comply with all representations made and
all conditions contained in the Application for the Order.
---------------------------------------------------------------------------

    In addition, the circular will note Exchange responsibilities,
including that before an Exchange member, member organization, or
employee thereof recommends a transaction in the Shares, a
determination must be made that the recommendation is in compliance
with all applicable Exchange and federal rules and regulations. The
circular will also discuss exemptive, no-action, and interpretive
relief granted by the Commission from Section 11(d)(1) and certain
rules under the Act, including Rule 10a-1, Rule 10b-10, Rule 14e-5,
Rule 10b-17, Rule 11d1-2, Rules 15c1-5 and 15c1-6, and Rules 101 and
102 of Regulation M under the Act.
    The NAV for the iShares MSCI Malaysia, South Korea, and Taiwan
Index Funds will be calculated every day that the listing exchange is
open for trading, normally as of 10 a.m. Central Time. This is in
contrast to the other Funds, for which the NAV is normally calculated
at 3 p.m. Central Time.
f. Other Issues
i. Surveillance Procedures
    The Exchange intends to utilize its existing surveillance
procedures applicable to equity securities to monitor trading in the
Shares. The Exchange represents that these procedures are adequate to
monitor Exchange trading of the Shares.
ii. Trading Hours
    The trading hours for the Shares on CBSX will be 8:15 a.m. until
3:15 p.m. Central Time (unless the value of a Fund is not being
calculated and widely disseminated before 8:30 a.m., in which case
trading in that Fund will begin at 8:30 a.m.; and unless the original
listing

exchange closes trading of a Fund at 3 p.m., in which case trading in
that Fund will end at 3 p.m.).
iii. Trading Halts
    The Exchange proposes to modify its Rule 52.3 to provide that (i)
From 8:15 to 8:30 Central Time, if a security described in Rules 54.1,
54.2, and 54.3 (an ``ETF'') (the Shares are among the securities
covered by this provision) begins trading on CBSX and subsequently a
temporary interruption occurs in the calculation or wide dissemination
of the IIV or the value of the underlying index, as applicable, to such
ETF, by a major market data vendor, CBSX may continue to trade the ETF
for the remainder of the 8:15 to 8:30 session; and, (ii) during normal
market hours, if a temporary interruption occurs in the calculation or
wide dissemination of the applicable IIV or value of the underlying
index by a major market data vendor and the listing market halts
trading in the ETF, CBSX, upon notification by the listing market of
such halt due to such temporary interruption, also shall immediately
halt trading in the ETF on CBSX.
2. Statutory Basis
    CBOE believes that the proposed rule change is consistent with the
Act and the rules and regulations thereunder applicable to a national
securities exchange. Specifically, the Exchange believes the proposed
rule change is consistent with the Section 6(b)(5) \8\ requirements
that an exchange have rules that are designed to promote just and
equitable principles of trade, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and
to protect investors and the public interest. In addition, CBOE
believes that the proposal is consistent with Rule 12f-5 under the Act
\9\ because it deems each Share to be an equity security, thus
rendering trading in each Fund subject to the Exchange's existing rules
governing the trading of equity securities.\10\
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78(f)(b)(5).
    \9\ 17 CFR 240.12f-5.
    \10\ See e-mail dated May 8, 2007 from Brian Jung, Law Clerk,
CBOE, to Geoffrey Pemble, Special Counsel, Division of Market
Regulation, Commission.
---------------------------------------------------------------------------

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

    CBOE 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.

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

    The Exchange neither solicited nor received comments on the
proposal.

III. 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 e-mail to<EMAIL_ADDRESS>Please include

File Number SR-CBOE-2007-37 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CBOE-2007-37. This file
number should be included on the subject line if e-mail 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 inspection and
copying in the Commission's Public Reference Room. 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-CBOE-2007-37 and should be submitted on or before June
7, 2007.

IV. Commission's Findings and Order Granting Accelerated Approval of
the Proposed Rule Change

    After careful review, the Commission finds that the proposed rule
change, as amended, is consistent with the requirements of the Act and
the rules and regulations thereunder applicable to a national
securities exchange.\11\ In particular, the Commission finds that the
proposed rule change is consistent with Section 6(b)(5) of the Act,\12\
which requires that an exchange have rules designed, among other
things, to promote just and equitable principles of trade, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system, and in general to protect investors and the
public interest. The Commission believes that this proposal should
benefit investors by increasing competition among markets that trade
the Shares.
---------------------------------------------------------------------------

    \11\ In approving this rule change, the Commission notes that it
has considered the proposal's impact on efficiency, competition, and
capital formation. See 15 U.S.C. 78c(f).
    \12\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    In addition, the Commission finds that the proposal is consistent
with Section 12(f) of the Act,\13\ which permits an exchange to trade,
pursuant to UTP, a security that is listed and registered on another
exchange.\14\ The Commission notes that it previously approved the
listing and trading of each of the Shares on either Amex or the
NYSE.\15\ The Commission also finds that the proposal is consistent
with Rule 12f-5 under the Act,\16\ which provides that an exchange
shall not extend UTP to a security unless the exchange has in effect a
rule or rules providing for transactions in the class or type of
security to which the exchange extends UTP. The Exchange has
represented that it meets this requirement because it deems the Shares
to be equity securities, thus rendering trading in the Shares subject
to the Exchange's existing rules governing the trading of equity
securities.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78l(f).
    \14\ Section 12(a) of the Act, 15 U.S.C. 78l(a), generally
prohibits a broker-dealer from trading a security on a national
securities exchange unless the security is registered on that
exchange pursuant to Section 12 of the Act. Section 12(f) of the Act
excludes from this restriction trading in any security to which an
exchange ``extends UTP.'' When an exchange extends UTP to a
security, it allows its members to trade the security as if it were
listed and registered on the exchange even though it is not so
listed and registered.
    \15\ See supra notes 3-5.
    \16\ 17 CFR 240.12f-5.
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    The Commission further believes that the proposal is consistent
with Section

11A(a)(1)(C)(iii) of the Act,\17\ which sets forth Congress's finding
that it is in the public interest and appropriate for the protection of
investors and the maintenance of fair and orderly markets to assure the
availability to brokers, dealers, and investors of information with
respect to quotations for and transactions in securities. Quotations
for and last-sale information regarding the Shares are disseminated
through the facilities of the CTA and the Consolidated Quotation
System. In addition, the IIV of each Fund is disseminated every 15
seconds throughout the trading day by the national securities exchange
on which the Fund is listed or by other information providers or market
data vendors.
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78k-1(a)(1)(C)(iii).
---------------------------------------------------------------------------

    Furthermore, the Commission believes that the proposal is
reasonably designed to preclude trading of the Shares when transparency
is impaired. New CBOE Rule 52.3 sets forth trading halt procedures when
CBOE trades an ETF pursuant to UTP. Under this rule, if the listing
market halts trading when the IIV is not being calculated or
disseminated, CBOE also would halt trading in the Shares. This rule is
substantially similar to those recently adopted by other exchanges and
found by the Commission to be consistent with the Act.\18\
---------------------------------------------------------------------------

    \18\ See e.g., NYSE Arca Equities Rule 7.34; Securities Exchange
Act Release No. 54997 (December 21, 2006), 71 FR 78501 (December 29,
2006).
---------------------------------------------------------------------------

    The Commission notes that, if the Shares should be delisted by the
listing market, the Exchange would no longer have authority to trade
the Shares pursuant to this order.
    In support of this proposal, the Exchange has made the following
representations:
    1. The Exchange's surveillance procedures are adequate to properly
monitor Exchange trading of the Shares and to deter and detect
violations of Exchange rules.
    2. Prior to the commencement of trading, the Exchange would inform
its members and member organizations in an Information Circular of the
special characteristics and risks associated with trading the Shares.
    3. The Information Circular would include the requirement that
members and member firms deliver a prospectus to investors purchasing
newly issued Shares prior to or concurrently with the confirmation of a
transaction.
    This approval order is conditioned on the Exchange's adherence to
these representations.
    The Commission finds good cause for approving this proposal before
the thirtieth day after the publication of notice thereof in the
Federal Register. As noted previously, the Commission previously found
that the listing and trading of the Shares on either Amex or the NYSE
is consistent with the Act. The Commission presently is not aware of
any regulatory issue that should cause it to revisit that finding or
would preclude the trading of the Shares on the Exchange pursuant to
UTP. Therefore, accelerating approval of this proposal should benefit
investors by creating, without undue delay, additional competition in
the market for the Shares.

V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\19\ that the proposed rule change (SR-CBOE-2007-37), as modified
by Amendment No. 1 thereto, be and it hereby is, approved on an
accelerated basis.
---------------------------------------------------------------------------

    \19\ 19 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\20\
---------------------------------------------------------------------------

    \20\ 20 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Lynn Taylor,
Assistant Secretary.
 [FR Doc. E7-9465 Filed 5-16-07; 8:45 am]

BILLING CODE 8010-01-P


ESA STAKEHOLDER WORKSHOP (JUNE 29-30, 2016):
Breakout Sessions: Improving Aquatic Modeling
Breakout Session AQUATIC 1: Changes to Conceptual Models and Mathematical Approaches Incorporated into Bins 3 and 4 (Flowing Waters):
In the draft Biological Evaluations (BEs), effect determinations are made at the individual scale of biological organization.  Consequently, the goal is to accurately predict maximum pesticide concentrations that may occur in different aquatic habitats utilized by listed species and are spatially and temporally relevant to the listed species.  The modeling approach presented in the draft BEs leveraged EPA's current generic aquatic modeling approach by using the Pesticide in Water Calculator (PWC) shell, a combination of field-scale models (PRZM5/VVWM), to generate estimated exposure concentrations (EECs) for three generic flowing water bins of varying volumes and flow rates (Bins 2, 3, and 4).  The Bin 2 estimates are intended to represent lower-flow habitats, such as first-order streams.  When considered in relation to field-scale monitoring data, such as those obtained from edge-of-field (EOF) studies, model results should provide confidence in EECs for this bin.  There is expected to be less confidence in applying this approach for deriving estimates for Bins 3 and 4, because processes that affect larger-scale concentration dynamics (e.g., longitudinal dispersion) are not accounted for.   The EECs derived for these higher-flow habitats in the draft BEs are extremely high and seem to defy both professional judgement and typical patterns seen in contaminant monitoring data.
In the context of watershed hydrodynamics, the three flowing bins represent aquatic habitats which would ideally be representative, for example, of streams that are sequentially connected within a watershed.  While runoff and drift from a field adjacent to a Bin 3 and/or 4 waterbody can directly contribute loading, the EECs generated from these types of events are being characterized with Bin 2 EECs, as these EECs may be reflective of concentrations occurring before complete mixing within the Bin 3 and/or 4 waterbody had occurred.  Initial modeling generated Bin 3 and 4 EECs that exceed those generated for Bin 2, which runs counter to expectations based on standard transport dynamics, e.g., dispersive dampening of chemographic peak maxima as a pulse of contaminant moves downstream.  Given the apparently unreasonably high EECs for Bins 3 and 4, a qualitative approach was considered in the draft BEs for use in assessing these bins.  The approach relied on monitoring data to demonstrate a downward trend in the magnitude of peak exposures.  Consistent with published studies showing a reduction in exposures as one moves down a watershed network, the approach showed a 5-fold reduction in exposure from Bin 3-like streams and a 10-fold reduction from Bin 3-like streams to Bin 4-like streams.  The draft BE also applied a qualitative comparison of volumes and flowrates to suggest a reasonably conservative magnitude of exposure expected in Bins 3 and 4 as a separate line of evidence.
Charge Questions:
 EPA explored several factors in using the PWC, including incorporation of a baseflow and use of the daily average instead of the instantaneous peak EEC. What are the strengths and weaknesses of these modifications? Are there other modifications that can be made and what are their strengths and weaknesses?
 How appropriate are the methods used in the draft BEs to develop field/watershed sizes and waterbody lengths for these Bins? What reasonable alternatives could be used to model watershed processes that allow for accurate estimation of possible exposure concentrations (including the maximum) in these flowing bins based on product labeling?
 For the bins (3 and 4) that represent larger flowing systems, what ways of incorporating the effects of dispersive mixing and/or peak desynchronization into concentration estimates are reasonable?
 What are the strengths and weaknesses of alternative mechanistic or regression-based watershed models such as the Soil and Watershed Assessment Tool (SWAT), the Hydrological Simulation Program-Fortran (HSPF) and the Watershed Regressions for Pesticides (WARP) for simulating aquatic pesticide concentrations at the temporal resolution and national scales required for ESA assessment? Are there other watershed models that should be considered?
 What is the desired and appropriate spatial scale for EECs for Bins 3 and 4? Specific PWC EECs were developed for HUC2 regions. Can or should the EECs for Bins 3 and 4 be at a finer spatial scale given a nationwide consultation?

Breakout Session AQUATIC 2: Evaluating Watershed Model Results:
In the Draft BEs, EPA employed an approach for flowing waters in an effort to approximate watershed processes.  Regardless of the model employed, the EECs from any model need to be conservative (i.e, protective of the species of concern) and scientifically defensible in order to be used for risk assessment purposes.  Typically, for EPA's use of PRZM5/VVWM as a field-scale model for vulnerable waters (e.g., headwater streams), this would be done by comparing model outputs to field monitoring data (i.e., edge of field runoff studies), where pesticide monitoring data is associated with pesticide-applications under well-described conditions (i.e., application rates, field characteristics, water characteristics, and meteorological conditions).  However, for watershed modeling, which aggregates exposure across a larger area, field-scale monitoring data, and the associated well-described conditions for all locations in the watershed, can be extremely difficult to obtain and, as a watershed model aggregates exposure, it may not be necessary.
Available literature documents have evaluated watershed models, including the NAS-recommended model SWAT, using general and targeted watershed monitoring data that is focused on known high pesticide-use areas, provided the data are collected at a high enough frequency to adequately capture the peak exposure concentration along with variations in concentration in the receiving stream.  Unlike field monitoring data, general monitoring data (i.e., sometimes described as ambient monitoring data) often lacks background information on application rates and field conditions and can be problematic when used for comparisons to model-generated EECs.  They may, however, provide a lower bound for model-generated EECs.  Targeted watershed monitoring (e.g., studies at a watershed scale that are targeted to areas of known high pesticide use, with a sampling frequency targeted to the timing of use and subsequent runoff events) has been proposed as a means to provide more than a lower bound, especially when such monitoring spans multiple years and can be tied to factors that drive pesticide transport from field to water bodies.  Such data are used to complement the results from modeling, not as a substitute for modeling.
In the Exposure chapter of the 2013 NAS report, the NAS noted that "If pesticides are to be used without jeopardizing the survival of listed species and their habitats, the estimated environmental concentrations (EECs) to which the organisms and their habitats will be exposed need to be determined. Chemical fate and transport models are the chief tools used to accomplish that task." (p. 49) The NAS further went on to describe a stepwise approach to fate and transport modeling, commenting on the use of various models such as AgDRIFT, PRZM, and EXAMS (p. 52-54).  The NAS then cautioned that "in evaluating models, general monitoring data and field studies need to be distinguished.  General monitoring studies provide information on pesticide concentrations in surface water or ground water on the basis of monitoring of specific locations at specific times.  The monitoring reports, however, are not associated with specific applications of pesticides under well-described conditions, such as application rate, field characteristics, water characteristics, and meteorological conditions.  General monitoring data cannot be used to estimate pesticide concentrations after a pesticide application or to evaluate the performance of fate and transport models." (p. 54) Though not as abundant as general monitoring data, field-scale monitoring studies are available for many pesticides, including the three OPs.  However, monitoring data with this type of supporting information are generally lacking at the watershed scale.  Additionally, the general monitoring data, specifically at the watershed scale, sometimes include data sets which are spatially and temporally targeted to varying degrees with pesticide applications.  Lastly, the NAS noted that "pesticide fate and transport models do not provide information on the watershed scale; they are intended only to predict pesticide concentrations in bodies of water at the edge of a field on which a pesticide was applied." (p. 54) The NAS also noted that "different hydrodynamic models are required to predict how pesticide loadings immediately below a field are propagated through a watershed or how inputs from multiple fields (or multiple applications) aggregate throughout a watershed." The NAS report did not provide additional discussion on the monitoring data requirements (e.g., metadata such as use rates, location, and timing) needed to evaluate watershed models.
Given the distinctions above between field-scale and watershed-scale models, the question arises "how does one evaluate the results generated from a watershed model?" EPA is proposing to use of the following multiple lines of evidence to evaluate the range of scientifically-defensible EECs for each flowing bin: consideration of available edge-of-field monitoring data and edge-of-field modeled estimates from PRZM5; incorporation of results from multiple watershed models, as appropriate; and consideration of statistical approaches to estimate confidence bounds around general monitoring data that were collected at a greater than a daily time step (i.e., SEAWAVE Q and bias factors).
Charge Questions:
 In what ways are a "multiple lines of evidence" approach appropriate for evaluating the results from a watershed model? What would be the "lines of evidence" and sources of information?
 How can different types of monitoring data be distinguished? What metadata requirements (e.g., use info, sample frequency, etc.) can be used to distinguish types of monitoring data?
 What roles can the various types of monitoring data play in the evaluation of results from a watershed model (e.g., general monitoring doesn't predict maximum but has other roles)?
 What other approaches are available for evaluating results from watershed models?
 To what extent can we rely on historical monitoring data when product labeling has changed and application-specific information is lacking?
 Are there new or different types of monitoring that could be employed to further our understanding of aquatic modeling estimates?


[Federal Register Volume 81, Number 78 (Friday, April 22, 2016)]
[Notices]
[Pages 23708-23709]
[FR Doc No: 2016-09373]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]

Scientific Evidence in Development of Human Cells, Tissues, and
Cellular and Tissue-Based Products Subject to Premarket Approval;
Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

SUMMARY: The Food and Drug Administration (FDA), Center for Biologics
Evaluation and Research (CBER) is announcing a public workshop entitled
``Scientific Evidence in Development of Human Cells, Tissues, and
Cellular and Tissue-Based Products (HCT/Ps) Subject to Premarket
Approval. The purpose of the public workshop is to identify and discuss
scientific considerations and challenges to help inform the development
of HCT/Ps subject to premarket approval, including stem cell-based
products.

DATES: The public workshop will be held on September 8, 2016, from 8:30
a.m. to 5 p.m. See the SUPPLEMENTARY INFORMATION section for
registration date and information.

ADDRESSES: The public workshop will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room,
Silver Spring, MD 20993-0002. Entrance for the public workshop
participants (non-FDA employees) is through Building 1, where routine
security check procedures will be performed. For parking and security
information, please refer to http://www.fda.gov/aboutfda/workingatfda/buildingsandfacilities/whiteoakcampusinformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Lori Jo Churchyard, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-
402-7911.

SUPPLEMENTARY INFORMATION: The purpose of the public workshop is to
identify and discuss scientific considerations and challenges to help
inform the development of HCT/Ps subject to premarket approval,
including stem cell-based products.
    Elsewhere in this issue of the Federal Register, FDA is announcing
the rescheduling of a part 15 public hearing to September 12 and 13,
2016, to obtain input on four issued draft guidance

documents relating to the regulation of HCT/Ps. FDA will provide a
summary of the workshop at the part 15 public hearing.
    Registration: Persons (including FDA employees) seeking to view the
public workshop via Adobe Connect or who wish to attend in person must
register at http://www.eventbrite.com/o/food-amp-drug-administration-fda-6730245227 on or before August 1, 2016, and provide complete
contact information, including name, title, affiliation, email, and
phone number. There is no registration fee for the public workshop.
Early registration is recommended because seating is limited and is on
a first-come, first-served basis. There will be no onsite registration.
    If you need special accommodations due to a disability and/or have
registration questions, please contact Tasha Johnson or Pauline
Cottrell at<EMAIL_ADDRESS>(Subject line: FDA SEDHC
workshop).
    Transcripts: Please be advised that as soon as possible after a
transcript of the public workshop is available, it will be accessible
at: http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm492499.htm.

    Dated: April 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-09373 Filed 4-21-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 40 (Friday, February 28, 2014)]
[Notices]
[Pages 11455-11456]
[FR Doc No: 2014-04418]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2013-0047; OMB No. 1660-NEW]

Agency Information Collection Activities: Submission for OMB
Review; Comment Request; The SalesForce Customer Relationship
Management System Webform Allowing an Individual To Submit
Correspondence to FEMA

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: The Federal Emergency Management Agency (FEMA) will submit the
information collection abstracted below to the Office of Management and
Budget for review and clearance in accordance with the requirements of
the Paperwork Reduction Act of 1995. The submission will describe the
nature of the information collection, the categories of respondents,
the estimated burden (i.e., the time, effort and resources used by
respondents to respond) and cost, and the actual data collection
instruments FEMA will use.

DATES: Comments must be submitted on or before March 31, 2014.

ADDRESSES: Submit written comments on the proposed information
collection

to the Office of Information and Regulatory Affairs, Office of
Management and Budget. Comments should be addressed to the Desk Officer
for the Department of Homeland Security, Federal Emergency Management
Agency, and sent via electronic mail to<EMAIL_ADDRESS>or
faxed to<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Requests for additional information or
copies of the information collection should be made to Director,
Records Management Division, 1800 South Bell Street, Arlington, VA
20598-3005, facsimile number<PHONE_NUMBER>, or email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Collection of Information

    Title: The SalesForce Customer Relationship Management System Web-
form allowing an Individual to Submit Correspondence to FEMA.
    Type of information collection: New information collection.
    OMB Number: 1660--NEW.
    Form Titles and Numbers: None.
    Abstract: FEMA correspondence teams respond to questions from
individuals covering various topics. Depending on the topic searched,
the Customer Relationship Management queries the database of pre-
approved questions and answers. If the search result does not provide
the desired answer, the citizen is provided a link to the web-form to
submit their inquiry (i.e. question/comment) to the proper component
(i.e. program office) for a response. In general, a citizen's inquiry
may range from publications requests, how to apply for grants, or
reimbursement criterion. The minimal collection of Personally
Identifiable Information is necessary for FEMA correspondence teams to
carry out their mission of responding to citizens who seek assistance.
    Affected Public: Individuals or households; Business or other for-
profit; Not-for-profit institutions; Farms; Federal Government; State,
Local, Tribal Government.
    Estimated Number of Respondents: 25,000.
    Estimated Total Annual Burden Hours: 833 hours.
    Estimated Cost: The estimated annual cost to respondents for the
hour burden is $25,664.73. There are no annual costs to respondents
operations and maintenance costs for technical services. There is no
annual start-up or capital costs. The cost to the Federal Government is
$645,008.00.

    Dated: February 20, 2014.
Charlene D. Myrthil,
Director, Records Management Division, Mission Support Bureau, Federal
Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2014-04418 Filed 2-27-14; 8:45 am]
BILLING CODE 9111-22-P


[Federal Register Volume 87, Number 243 (Tuesday, December 20, 2022)]
[Notices]
[Pages 77827-77828]
[FR Doc No: 2022-27587]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 3240-040]

Briar Hydro Associates; Notice of Application Tendered for Filing
With the Commission and Soliciting Additional Study Requests and
Establishing Procedural Schedule for Relicensing and a Deadline for
Submission of Final Amendments

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: New License.
    b. Project No.: 3240-040.
    c. Date Filed: November 30, 2022.
    d. Applicant: Briar Hydro Associates.
    e. Name of Project: Rolfe Canal Hydroelectric Project.
    f. Location: On the Contoocook River, in the City of Concord,
Merrimack County New Hampshire. No federal lands are located within the
project boundary.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)-825(r)
    h. Applicant Contact: Andrew J. Locke, Essex Hydro Associates, LLC,
55 Union Street, Boston, MA 02108;<PHONE_NUMBER>, email_
[email protected]
    i. FERC Contact: Jeanne Edwards at<PHONE_NUMBER>; or
[email protected].
    j. Cooperating agencies: Federal, state, local, and tribal agencies
with jurisdiction and/or special expertise with respect to
environmental issues that wish to cooperate in the preparation of the
environmental

document should follow the instructions for filing such requests
described in item l below. Cooperating agencies should note the
Commission's policy that agencies that cooperate in the preparation of
the environmental document cannot also intervene. See, 94 FERC ] 61,076
(2001).
    k. Pursuant to section 4.32(b)(7) of 18 CFR of the Commission's
regulations, if any resource agency, Indian Tribe, or person believes
that an additional scientific study should be conducted in order to
form an adequate factual basis for a complete analysis of the
application on its merit, the resource agency, Indian Tribe, or person
must file a request for a study with the Commission not later than 60
days from the date of filing of the application, and serve a copy of
the request on the applicant.
    l. Deadline for filing additional study requests and requests for
cooperating agency status: January 29, 2023.
    The Commission strongly encourages electronic filing. Please file
additional study requests and requests for cooperating agency status
using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. For assistance, please contact FERC Online Support
at [email protected],<PHONE_NUMBER> (toll free), or (202)
502-8659 (TTY). In lieu of electronic filing, you may submit a paper
copy. Submissions sent via the U.S. Postal Service must be addressed
to: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission,
888 First Street NE, Room 1A, Washington, DC 20426. Submissions sent
via any other carrier must be addressed to: Kimberly D. Bose,
Secretary, Federal Energy Regulatory Commission, 12225 Wilkins Avenue,
Rockville, Maryland 20852. All filings must clearly identify the
project name and docket number on the first page: Rolfe Canal Project
(P-3240-040).
    m. The application is not ready for environmental analysis at this
time.
    n. The Rolfe Canal Project diverts water from the York Dam into the
Rolfe Canal and consists of the following existing facilities: (1) York
impoundment with a surface area of 50-acres, at elevation of 342.5 feet
National Geodetic Vertical Datum 1929 (NGVD29); (2) a 300-foot-long,
10-foot-high diversion dam (York Dam); (3) a 50-foot-wide concrete
gated intake structure; (4) a 7,000-foot-long, 75-foot-wide, and 9-
foot-deep power canal; (5) an additional impoundment (created by York
Dam at the end of the power canal) with surface area of 3-acres, at
elevation of 342.5 feet NGVD29, and a negligible storage capacity; (6)
a 130-foot-long, 17-foot-high granite block intake dam; (7) a 950-foot-
long underground penstock; (8) a 32-foot-wide by 90-foot-long, concrete
powerhouse containing one Kaplan turbine-generating unit with a
capacity of 4.285 megawatts; (9) a 1,200-foot-long tailrace; (10)
transmission facilities consisting of a three-phase 4.16/34.5- kilovolt
(kV) transformer; and a 34.5-kV, 650-foot-long transmission line; and
(11) other appurtenances. The project has a 4,000-foot-long bypassed
reach.
    The project operates in a run-of-river mode with a minimum flow of
338 cubic feet per second (cfs), or inflow, whichever is less, into the
York impoundment, a minimum flow of 50 cfs into the York bypass, and a
minimum flow of 5 cfs into a historic channel that bypasses the
penstock. The project had an average annual generation of 19,585,884
kilowatt-hours between 2014 and 2018. Briar Hydro proposes to increase
the minimum flow into the York bypass to 100 cfs.
    o. Copies of the application may be viewed on the Commission's
website at http://www.ferc.gov using the ``eLibrary'' link. Enter the
docket number excluding the last three digits in the docket number
field to access the document (P-3240). For assistance, contact FERC
Online Support at [email protected] or call toll-free, (866)
208-3676 or<PHONE_NUMBER> (TTY).
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    p. Procedural schedule and final amendments: The application will
be processed according to the following preliminary schedule. Revisions
to the schedule will be made as appropriate.

Issue Deficiency Letter (if necessary) February 2023
Request Additional Information (if necessary) March 2023
Issue Acceptance Letter May 2023
Issue Scoping Document 1 for comments May 2023
Issue Scoping Document 2 (if necessary) August 2023
Issue Notice of Ready for Environmental Analysis August 2023

    q. Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of the notice
of ready for environmental analysis.

    Dated: December 14, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-27587 Filed 12-19-22; 8:45 am]
BILLING CODE 6717-01-P