Via Email<EMAIL_ADDRESS>
March 5, 2007

Ms. Kim Teal

Environmental Protection Specialist

U.S. EPA/OAR/OAQPS/SPPD/NRCG

E143-03

Research Triangle Park, NC  27711

Re:  Paper, Film & Foil CTGs

Dear Ms. Teal:

The Flexible Packaging Association (FPA) would like to provide the
following input concerning the development of CTGs for paper, film and
foil surface coatings, particularly because we have become concerned
with your note last Friday that EPA may be modeling the CTG closely on
the Paper and Other Web Coating MACT (40 CFR Part 63, Subpart JJJJ). As
you know, FPA is a national trade association, representing businesses
in the paper, foil, plastic and film converting industry.  FPA members
use multiple printing and coating materials and processes to meet
ever-changing technical product demands and regulatory requirements for
the packaging of foods, pharmaceuticals, household goods, garden
supplies, cosmetics and other industrial, institutional and agricultural
applications.  Flexible packaging is an over $21 billion industry in the
United States and is the second largest segment of the U.S. packaging
market.

FPA’s members understand the tight timeframe that the Court has
imposed on the Agency with respect to this project.  We feel that we
could be helpful in providing data to EPA on the industry and our
processes and available controls, and therefore are requesting that you
share a draft of the CTG, and if that is not possible, that you arrange
a meeting as soon as possible to discuss data needs and questions
relating to the industry that have arisen as the CTG is being drafted.
A similar dialogue appeared particularly helpful to both EPA and the
industry with drafting and expediting the analysis of the printing and
publishing alternative §183(b) determination.  We are also including
the following discussion to provide additional technical information and
to amplify our concern about modeling the CTG too closely on the POWC
MACT.

FPA is aware that the relationship between HAPs and VOCs used in
industry are sometimes misunderstood, particularly with respect to the
interchangeability of HAPs with VOCs and the notion that a HAP
requirement will have an equivalent reduction in VOCs.  For certain
industries, that rely heavily on HAP utilization, there may be merit to
this understanding, but for other industries, like flexible packaging,
this understanding is incorrect.  The mechanism overwhelmingly used by
flexible packaging manufacturers to comply with both subpart JJJJ and KK
was through elimination of HAPs by substitution with non-HAP VOCs.  The
industry has expended huge amounts of time and money on research &
development efforts to eliminate utilization of hazardous air pollutants
from our manufacturing operations.  Today only a very few HAPs remain in
use in our industry and typically only in low quantities.  However,
substitution of VOCs with non-VOCs is not technically feasible or
economically available.

The flexible packaging industry utilizes a wide array of coatings,
including high solids, high VOC and high water content.  Solids content
in a coating at application can vary from virtually 100% to less than
1%.  The type of coating ultimately used is totally dependent on
functionality and performance.  There is no one technology that can
accommodate all of our manufacturing needs.  This industry has a vested
interest in avoiding VOC use where possible.  For example, certain high
performance resins cannot be applied at 100 % solids and are not
dispersible for fluid application in water or other non-VOC solvents.
Consequently while we have some latitude in finding alternatives to
HAPs, there are applications that require the use of VOC solvents.  For
these applications we commonly use control devices; importantly, the
control efficiencies achieved on many of these lines could not meet
subpart JJJJ requirements.

To better evaluate the impact of using subpart JJJJ criteria as a
replacement for currently RACT, we should look at a few illustrations
involving solvent-based coatings and water- based coatings.  The current
Paper Coating RACT typically sets out a limit of 2.9 pounds of VOC per
gallon of coating applied minus water.  This would equate to a solvent
based coating at roughly 60% solids/ 40% solvent by volume (≈66.6%
solids by weight).  In terms of the NESHAP limit, current RACT would
equate to ≈0.5 pounds VOC per pound of solids.  Conversely, the POWC
sets out HAP limits of 0.2 pounds HAP per pound of solids for existing
sources and 0.08 pounds of HAP per pound of solids for new sources.
These represent further reductions over the current RACT by 60 to 84%.
The upper bound for gravure application of solvent based coatings is
typically 40% solids by weight.  At current RACT, a 40% solids coating
would need to be controlled to 67% efficiency to meet the limit.
However, the same coating at the POWC limits would require control
efficiencies of 87 to 95%.  This level of efficiency would necessitate
the installation of total enclosures on all such applications.  This is
a significant change that would not be either technologically or
economically feasible in many cases and would certainly not fall within
the technological and economic feasibility assessments that were
conducted for the POWC MACT development.

Another helpful illustration is provided by looking at water-based
coatings.  The original RACT did not handle water-based coatings well
because of a misperception that an entity could just continually add
water to make a non-compliant coating compliant.  Unfortunately, the
POWC approach compounds that problem.  Since the original RACT ignored
water, a water-based coating needed to meet the same 66.6% solids/33.4%
VOC (2/1) ratio as a solvent based coating.  However for any existing
operation where the coating VOC was above 4%, the solids to VOC ratio
would now become 5/1 to meet a POWC based RACT.  And for any new
operation where the coating VOC was above 1.6%, the solids to VOC ratio
would need to be 12.5/1.  Consequently a coating with 5% VOC and 85%
water would need to be controlled to meet a RACT limit based on the 0.2
POWC limit.

These illustrations of the problems with a RACT based on POWC limits
underscore our concern that the Agency would model the CTG it is
developing on the Subpart JJJJ MACT rule.  Such a CTG would create an
enormous hardship on the industry and would without question make
manufacture of a number of commercial products infeasible.  While we
have concerns that there may be other issues in the current RACT draft
document that we could help to clarify, we cannot stress strongly enough
that there is no transferability of the POWC based HAP limit to VOC
RACT.

FPA is willing to assist the EPA in any way possible to avoid lengthy
delays in developing appropriate guidance to meet court-imposed
deadlines on the Agency.  The most expeditious way for us to provide
your project team input, of course, would be to be able to review drafts
as they are developed.  If that is not possible, then we request that
you schedule a meeting with us prior to submission of the draft CTG for
OMB review.

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Please call me at<PHONE_NUMBER> to arrange such a meeting and to discuss
any questions that you have for us.

Sincerely,

Ram K. Singhal

Director, Regulatory & Government Relations.

Cc:  Bruce Moore (US EPA)

       Heather Brown (EC/R Incorporated)

 PAGE

 PAGE   2

971 Corporate Boulevard (  Suite 403 (  Linthicum, Maryland 21090

phone:<PHONE_NUMBER> (  fax:<PHONE_NUMBER> (  e-mail<EMAIL_ADDRESS>(
web: www.flexpack.org


[Federal Register: September 28, 2007 (Volume 72, Number 188)]
[Notices]
[Page 55255-55257]
[DOCID:fr28se07-129]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. IC-27976; 812-13417]

WisdomTree Investments, Inc., et al.; Notice of Application

September 21, 2007.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of application to amend a prior order under section 6(c)
of the Investment Company Act of 1940 (``Act'') for an exemption from
sections 2(a)(32), 5(a)(1), 22(d), 22(e), and 24(d) of the Act and rule
22c-1 under the Act, under sections 6(c) and 17(b) of the Act for an
exemption from sections 17(a)(1) and 17(a)(2) of the Act, and under
section 12(d)(1)(J) for an exemption from sections 12(d)(1)(A) and
12(d)(1)(B) of the Act.

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

Summary of Application: Applicants request an order (``Order'') to
amend a prior order that permits: (a) An open-end management investment
company, whose series track the performance of certain domestic and
international equity securities indexes developed by the parent company
of the series' investment adviser, to issue shares (``Shares'')
redeemable only in large aggregations; (b) secondary market
transactions in Shares to occur at negotiated prices; (c) dealers to
sell Shares to purchasers in the secondary market unaccompanied by a
prospectus when prospectus delivery is not required by the Securities
Act of 1933 (``Securities Act''); (d) certain affiliated persons of the
series to deposit securities into, and receive securities from, the
series in connection with the purchase and redemption of aggregations
of the series' Shares; (e) under certain circumstances, the series that
track certain foreign equity securities indexes to pay redemption
proceeds more than seven days after the tender of Shares; and (f)
certain management investment companies and unit investment trusts
outside of the same group of investment companies as the series to
acquire Shares (the ``Prior Order'').\1\ Applicants seek to amend the
Prior Order in order to offer additional series based on certain fixed
income securities indexes (the ``New Funds''). In addition, the Order
would delete a condition related to future relief in the Prior Order.
---------------------------------------------------------------------------

    \1\ WisdomTree Investments, Inc., et al., Investment Company Act
Release Nos. 27324 (May 18, 2006) (notice) and 27391 (June 12, 2006)
(order).

Applicants: WisdomTree Investments, Inc. (``WTI''), WisdomTree Asset
Management, Inc. (the ``Advisor''), and WisdomTree Trust (the
---------------------------------------------------------------------------
``Trust'').

Filing Dates: The application was filed on August 13, 2007 and amended
on September 19, 2007.

Hearing or Notification of Hearing: An order granting the requested
relief will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by writing to the Commission's
Secretary and serving applicants with a copy of the request, personally
or by mail. Hearing requests should be received by the Commission by
5:30 p.m. on October 16, 2007, and should be accompanied by proof of
service on applicants, in the form of an affidavit or, for lawyers, a
certificate of service. Hearing requests should state the nature of the
writer's interest, the reason for the request, and the issues
contested. Persons who wish to be notified of a hearing may request
notification by writing to the Commission's Secretary.

ADDRESSES: Secretary, U.S. Securities and Exchange Commission, 100 F
Street, NE., Washington, DC 20549-1090. Applicants: 48 Wall Street,
Suite 1100, New York, NY 10005.

FOR FURTHER INFORMATION CONTACT: Courtney S. Thornton, Senior Counsel,
at<PHONE_NUMBER>, or Mary Kay Frech, Branch Chief, at<PHONE_NUMBER>
(Division of Investment Management, Office of Investment Company
Regulation).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained for a fee at the
Commission's Public Reference Branch, 100 F Street, NE., Washington, DC
20549-0102 (tel.<PHONE_NUMBER>).

Applicants' Representations

    1. The Trust, a Delaware statutory trust registered under the Act
as an open-end management investment company, is organized as a series
fund with multiple series (the ``Equity Funds''). WTI, a Delaware
corporation with its principal offices in New York City, is the sole
shareholder of the Advisor. WTI has developed and maintains the
proprietary indexes that serve or will serve as the basis for the
Equity Funds and the New Funds. The Advisor is a Delaware corporation
that is registered as an investment adviser under the Investment
Advisers Act of 1940 (``Advisers Act''). The Advisor serves as
investment adviser to the Equity Funds, and the Advisor, or an entity
controlled by or under common control with the Advisor, will serve as
investment adviser to the New Funds and any future series of the Trust
(``Future Funds''). The Advisor and the Trust intend to hire one or
more subadvisers (``Subadvisers'') for the New Funds, each of which
will be registered as an investment adviser under the Advisers Act and
will not otherwise be an affiliated person, or an affiliated person of
an affiliated person, of the Trust, the Advisor, or WTI. ALPS
Distributors, Inc. (``Distributor''), a broker-dealer registered under
the Securities Exchange Act of 1934 (``Exchange Act''), acts as
distributor and principal underwriter of the Equity Funds and may
perform such services for the New Funds and any Future Funds.
    2. The Trust is currently permitted to offer the Equity Funds,
which track equity securities indexes developed by WTI, in reliance on
the Prior Order. Applicants seek to amend the Prior Order to permit the
Trust to offer the New Funds, as well as Future Funds (together with
the Equity Funds and the New Funds, the ``Funds'') that are advised by
the Advisor or an entity controlled by or under common control with the
Advisor and that comply with the terms and conditions of the Prior
Order, as modified by the requested relief.
    3. The investment objective of each New Fund will be to provide
investment results that correspond generally to the price and yield
performance of its underlying index (``Underlying Index'') by investing
in a portfolio of securities generally consisting of the component
securities (``Component Securities'') of the Underlying Index.\2\ The
Underlying Index for each New Fund tracks fixed income securities and
will be rebalanced monthly.\3\ The Underlying Indexes for the New
Funds, as well as the Underlying Indexes for the Equity Funds, have
been created by WTI, an affiliated person, as defined in section
2(a)(3) of the Act, of the Advisor and the Trust. Future Funds may be
based on Underlying Indexes created, compiled, sponsored, or maintained
by WTI or another index provider that is controlled by or under common
control with WTI (a ``WTI Index Provider'') or on Underlying Indexes
created, compiled, sponsored, or maintained by an entity that is not an
affiliated person, or an affiliated person of an affiliated person, of
the Fund, the Advisor, the Distributor, promoter, or any Subadviser to
a Fund (a ``Non-Affiliated Index Provider''). Because Funds based on
Underlying Indexes created by a WTI Index Provider could introduce
potential conflicts of interest, the Prior Order contains certain
representations and undertakings relating to the transparency of the
methodology for those Underlying Indexes, and the establishment of
certain policies and procedures to limit communication between index
personnel and employees of the Advisor and any Subadviser. Applicants
believe that these conflicts of interest do not exist where the index
creator is a Non-Affiliated Index Provider. Applicants therefore seek
to amend the Prior Order to provide that the relevant representations
and undertakings in the application for the Prior Order should not
apply to a Fund based on an Underlying Index created by a Non-
Affiliated Index Provider.
---------------------------------------------------------------------------

    \2\ The Underlying Indexes for the New Funds are the WisdomTree
International Government ex Japan Bond Index and the WisdomTree
Government Strategies Index.
    \3\ The application for the Prior Order specified that
Underlying Indexes created, compiled, sponsored, or maintained by a
WTI Index Provider (as defined below) would be reconstituted no more
frequently than quarterly. Applicants seek to amend the Prior Order
to allow such Underlying Indexes to be reconstituted as frequently
as monthly, which applicants indicate is a common methodology for
fixed income indexes.
---------------------------------------------------------------------------

    4. The applicants state that the Component Securities of the
WisdomTree International Government ex Japan Bond Index include liquid
investment grade government bonds denominated in developed market
currencies other than the U.S. dollar and the Japanese yen, with a
primary focus on fixed-rate coupon bonds in developed markets maturing
between 3 and 10 years, and exclude securities with embedded options,
floating-rate coupons, and zero coupons. The Component Securities of
the WisdomTree Government Strategies Index include U.S. Treasury
securities, obligations of U.S. government agencies and quasi-
government corporations, and U.S. mortgage-backed securities.\4\ Each
New Fund may fully replicate its Underlying Index, but each New Fund
currently intends to use a ``representative sampling'' strategy. Under
a representative sampling strategy, a New Fund will hold a basket of
the Component Securities of its Underlying Index, but may not hold all
of the Component Securities of its Underlying Index. Each New Fund
generally will invest at least 80% of its total assets in the Component
Securities of the relevant Underlying Index. However, a New Fund may
also at times invest up to 20 percent of its total assets in certain
futures, options and swap contracts, and cash and cash equivalents,
including money market funds, as well as securities not included in its
Underlying Index, but which the Advisor believes will help the New Fund
to track its Underlying Index. At all times, a New Fund and any Future
Fund will hold in the aggregate at least 80% of its total assets in
Component Securities and investments that have economic characteristics
that are substantially identical to the economic characteristics of the
Component Securities of its Underlying Index.\5\ Applicants expect that
each New Fund will have a tracking error relative to the performance of
its respective

Underlying Index of no more than 5 percent.
---------------------------------------------------------------------------

    \4\ The Trust intends to substitute a cash-in-lieu amount to
replace any Deposit Security or Fund Security (each as defined
below) that is a ``to-be-announced transaction'' or ``TBA
Transaction.'' A TBA Transaction is a method of trading mortgage-
backed securities where the buyer and seller agree upon general
trade parameters such as agency, settlement date, par amount, and
price. The actual pools delivered are determined two days prior to
settlement date. The amount of substituted cash in the case of TBA
Transactions will be equivalent to the value of the TBA Transaction
listed as a Deposit Security or Fund Security.
    \5\ Applicants anticipate that investments that have economic
characteristics substantially identical to those of the Component
Securities of an Underlying Index will encompass securities such as
depository receipts based on Component Securities and TBA
Transactions.
---------------------------------------------------------------------------

    5. Applicants state that the New Funds will comply with the federal
securities laws in accepting a deposit of a portfolio of securities
designated by the Advisor to correspond generally to the price and
yield performance of the New Fund's Underlying Index (``Deposit
Securities'') and satisfying redemptions with portfolio securities of
the New Funds (``Fund Securities''), including that the Deposit
Securities and Fund Securities are sold in transactions that would be
exempt from registration under the Securities Act.\6\
---------------------------------------------------------------------------

    \6\ In accepting Deposit Securities and satisfying redemptions
with Fund Securities that are restricted securities eligible for
resale pursuant to rule 144A under the Securities Act, the New Funds
will comply with the conditions of rule 144A, including in
satisfying redemptions with such rule 144A eligible restricted Fund
Securities. The prospectus for each New Fund will also state that an
authorized participant that is not a ``Qualified Institutional
Buyer,'' as defined in rule 144A under the Securities Act, will not
be able to receive, as part of a redemption, restricted securities
eligible for resale under rule 144A.
---------------------------------------------------------------------------

    6. Applicants state that the New Funds will operate in a manner
identical to the operation of the Equity Funds under the Prior Order,
except as specifically noted by applicants (and summarized in this
notice), and will comply with all of the terms, provisions and
conditions of the Prior Order, as amended by the present application.
Applicants believe that the requested relief continues to meet the
necessary exemptive standards.

Future Relief

    7. Applicants also seek to amend the Prior Order to modify the
terms under which the Trust may offer Future Funds. The Prior Order is
currently subject to a condition that does not permit applicants to
register the shares of any Future Fund by means of filing a post-
effective amendment to the Trust's registration statement or by any
other means, unless applicants have requested and received with respect
to such Future Fund, either exemptive relief from the Commission or a
no-action letter from the Division of Investment Management of the
Commission, or if the Future Fund could be listed on a national
securities exchange (``Exchange'') without the need for a filing
pursuant to rule 19b-4 under the Exchange Act.
    8. The order would amend the Prior Order to delete this condition.
Any Future Fund will (a) be advised by the Advisor or an entity
controlled by or under common control with the Advisor; (b) track
Underlying Indexes that are created, compiled, sponsored or maintained
by a WTI Index Provider or a Non-Affiliated Index Provider; and (c)
comply with the respective terms and conditions of the Prior Order, as
amended by the present application.
    9. Applicants believe that the modification of the future relief
available under the Prior Order would be consistent with sections 6(c)
and 17(b) of the Act and that granting the requested relief will
facilitate the timely creation of Future Funds and the commencement of
secondary market trading of such Future Funds by removing the need to
seek additional exemptive relief. Applicants submit that the terms and
conditions of the Prior Order have been appropriate for the existing
series of the Trust and would remain appropriate for Future Funds.
Applicants also submit that tying exemptive relief under the Act to the
ability of a Future Fund to be listed on an Exchange without the need
for a rule 19b-4 filing under the Exchange Act is not necessary to meet
the standards under sections 6(c) and 17(b) of the Act.

Applicants' Conditions

    Applicants agree that any Order granting the requested relief will
be subject to the same conditions as those imposed by the Prior Order,
except for condition 1 to the Prior Order, which will be deleted.

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.
Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-19148 Filed 9-27-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 86, Number 241 (Monday, December 20, 2021)]
[Rules and Regulations]
[Pages 71830-71831]
[FR Doc No: 2021-27433]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2021-0353; FRL-8916-02-R1]

Air Plan Approval; Connecticut; 2015 Ozone NAAQS Interstate
Transport Requirements

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is approving a State
Implementation Plan (SIP) revision submitted by the State of
Connecticut as meeting the Clean Air Act (CAA) requirement that each
State's SIP contain adequate provisions to prohibit emissions that will
significantly contribute to nonattainment or interfere with maintenance
of the 2015 8-hour ozone national ambient air quality standards (NAAQS)
in any other state. This action is being taken in accordance with the
CAA.

DATES: This rule is effective on January 19, 2022.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R01-OAR-2021-0353. All documents in the docket
are listed on the https://www.regulations.gov website. Although listed
in the index, some information is not publicly available, i.e., CBI or
other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
internet and will be publicly available only in hard copy form.
Publicly available docket materials are available at https://www.regulations.gov or at the U.S. Environmental Protection Agency, EPA
Region 1 Regional Office, Air and Radiation Division, 5 Post Office
Square--Suite 100, Boston, MA. EPA requests that if at all possible,
you contact the contact listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m.,
excluding legal holidays and facility closures due to COVID-19.

FOR FURTHER INFORMATION CONTACT: Alison C. Simcox, Air Quality Branch,
U.S. Environmental Protection Agency, EPA Region 1, 5 Post Office
Square--Suite 100, (Mail code 05-2), Boston, MA 02109-3912, tel. (617)
918-1684, email [email protected].

SUPPLEMENTARY INFORMATION:
    Throughout this document whenever ``we,'' ``us,'' or ``our'' is
used, we mean EPA.

Table of Contents

I. Background and Purpose
II. Final Action
III. Statutory and Executive Order Reviews

I. Background and Purpose

    On August 30, 2021, EPA published a Notice of Proposed Rulemaking
(NPRM) for the State of Connecticut. See 86 FR 48357. The NPRM proposed
approval of a Connecticut SIP revision that addresses the CAA
requirement prohibiting emissions from the state that significantly
contribute to nonattainment or interfere with maintenance of the 2015
8-hour ozone NAAQS in other states. See CAA section 110(a)(2)(D)(i)(I)
(the ``good neighbor provision''). The SIP revision was submitted to
EPA by Connecticut on December 6, 2018. The rationale for EPA's
proposed action is given in the NPRM and will not be repeated here. EPA
received no public comments on the NPRM.

II. Final Action

    EPA is approving a Connecticut SIP revision, which was submitted on
December 6, 2018. This submission is approved as meeting CAA section
110(a)(2)(D)(i)(I) requirements that Connecticut's SIP includes
adequate provisions prohibiting any source or other type of emissions
activity within the state from emitting any air pollutant in amounts
that will contribute significantly to nonattainment or interfere with
maintenance of the 2015 ozone NAAQS in any other state.

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register.

This action is not a ``major rule'' as defined by 5 U.S.C. 804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by February 18, 2022. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

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

    Dated: December 13, 2021.
Deborah Szaro,
Acting Regional Administrator, EPA Region 1.
    Part 52 of chapter I, title 40 of the Code of Federal Regulations
is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart H--Connecticut

0
2. Section 52.370 is amended by adding paragraph (c)(126) to read as
follows:

 Sec.  52.370  Identification of plan

* * * * *
    (c) * * *
    (126) Revisions to the State Implementation Plan submitted by the
Connecticut Department of Energy and Environmental Protection on
December 6, 2018.
    (i) [Reserved]
    (ii) Additional materials.
    (A) The Connecticut Department of Energy and Environmental
Protection document, ``Connecticut Good Neighbor SIP for the 2015 Ozone
National Ambient Air Quality Standard.'' Final, December 6, 2018.
    (B) [Reserved]
* * * * *

0
3. Section 52.386 is amended by adding paragraph (f) to read as
follows:

Sec.  52.386  Section 110(a)(2) infrastructure requirements.

* * * * *
    (f) The Connecticut Department of Energy and Environmental
Protection submitted the following infrastructure SIP on this date:
2015 ozone NAAQS--December 6, 2018 (CAA Sec.  110(a)(2)(D)(i)(I)
transport provisions). This infrastructure SIP is approved.

[FR Doc. 2021-27433 Filed 12-17-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: November 20, 2007 (Volume 72, Number 223)]
[Proposed Rules]
[Page 65246-65248]
[DOCID:fr20no07-14]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

18 CFR Parts 141 and 385

[Docket No. RM07-18-000]

Elimination of FERC Form No. 423

November 2, 2007.
AGENCY: Federal Energy Regulatory Commission, DOE.

ACTION: Notice of proposed rulemaking.

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SUMMARY: In this Notice of Proposed Rulemaking, the Federal Energy
Regulatory Commission (Commission) is proposing to amend its
regulations to eliminate the FERC Form No. 423, Monthly Report of Cost
and Quality of Fuels for Electric Plants. The Commission's infrequent
use of the information no longer justifies the burden and cost of
collecting it. Conversely, the Energy Information Administration has
expressed a need for this information and, upon cessation of the
Commission's collection, proposes to collect the information, as part
of its newly proposed EIA-923.

DATES: Comment deadline: Comments are due December 20, 2007.

ADDRESSES: You may submit comments identified by Docket No. RM07-18-
000, by one of the following methods:
     eFiling: From the Commission's Web site: http://www.ferc.gov
, follow the instructions for submitting comments

electronically found by selecting eFiling under the Documents & Filing
heading.
     Mail: Commenters unable to file comments electronically
must mail or hand deliver an original and 14 copies of their comments
to the Federal Energy Regulatory Commission, Secretary of the
Commission, 888 First Street, NE., Washington, DC 20426.
    Please refer to the Comment Procedures section for additional
information.

FOR FURTHER INFORMATION CONTACT: Lawrence Greenfield (Legal
Information), Office of the General Counsel--Energy Markets, Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426,

Telephone:<PHONE_NUMBER>, E-mail<EMAIL_ADDRESS>    Patricia W. Morris (Technical Information), Division of
Administration, Budget and Strategic Planning, Office of Energy Market
Regulation, Federal Energy Regulatory Commission, 888 First Street,
NE., Washington, DC 20426, Telephone:<PHONE_NUMBER>, E-mail:
<EMAIL_ADDRESS>
    James Krug (Technical Information), Division of Administration,
Budget and Strategic Planning, Office of Energy Market Regulation,
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, Telephone:<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:
    1. In this Notice of Proposed Rulemaking, the Commission is
proposing to amend its regulations, 18 CFR 141.61, to eliminate its
Form No. 423, Monthly Report of Cost and Quality of Fuels for Electric
Plants (OMB No. 1902-0024). The Commission's infrequent use of the
information no longer justifies the burden and cost of collecting it.
While the Commission is proposing to eliminate the Form 423, the Energy
Information Administration (EIA) has expressed a need for this
information and, upon cessation of the Commission's collection, has
proposed to collect the information, as part of its newly proposed EIA-
923 survey.\1\
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    \1\ Energy Information Administration Electric Power Survey, OMB
Control No. 1905-0129, Supporting Statement A, (submitted to the
Office of Management and Budget for review on October 4, 2007),
available at: http://www.reginfo.gov/public/do/PRAViewDocument?ref_nbr=200709-1905-003
.

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Background

    2. Form 423 gathers information on the cost and quality of fuels
delivered to steam electric generating plants of 50 MW or greater. This
information has been used over the years for a variety of purposes,
including: (1) To conduct fuel reviews under Federal Power Act (FPA)
sections 205(a) and (e); \2\ (2) to address fuel costs and fuel
purchase practices affecting public utility rates under FPA sections
205 and 206; \3\ and (3) to detect abnormally high fuel costs in public
utility fuel purchases indicative of affiliate preference under FPA
sections 205 and 206.\4\
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    \2\ 16 U.S.C. 824d(a), (e).
    \3\ 16 U.S.C. 824d, 824e.
    \4\ Id.
---------------------------------------------------------------------------

    3. Form 423 is submitted electronically on a monthly basis by
approximately 190 utilities for their 569 steam electric generating
plants.

Discussion

    4. The issuance of Order No. 888 \5\ and the public utility
industry's increasing reliance on market-based rates have created a
diminished need for the Form 423 information; greater use of market-
based rates has resulted in less reliance on cost-based rates and less
need to evaluate rates by reference to the utility's costs. In short,
there are fewer public utilities with cost-based rates \6\ and
particularly with fuel adjustment clauses as part of their rates. This,
in turn, has resulted in fewer rate cases and fewer complaints filed
with the Commission. Moreover, should the Commission have a need for
information concerning fuel costs and purchases, it can obtain such
information on a case-by-case basis through special reports,
investigations, or in formal proceedings.\7\
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    \5\ Promoting Wholesale Competition Through Open Access Non-
discriminatory Transmission Services by Public Utilities; Recovery
of Stranded Costs by Public Utilities and Transmitting Utilities,
Order No. 888, 61 FR 21540 (May 10, 1996), FERC Stats. & Regs. ]
31,036 (1996), order on reh'g, Order No. 888-A, 62 FR 12274 (Mar.
14, 1997), FERC Stats. & Regs. ] 31,048 (1997), order on reh'g,
Order No. 888-B, 81 FERC ] 61,248 (1997), order on reh'g, Order No.
888-C, 82 FERC ] 61,046 (1998), aff'd in relevant part sub nom.
Transmission Access Policy Study Group v. FERC, 225 F.3d 667 (D.C.
Cir. 2000), aff'd sub nom. New York v. FERC, 535 U.S. 1 (2002).
    \6\ A review of data from the Electric Quarterly Reports for
calendar year 2006 indicates that market-based power sales
constituted ninety percent of jurisdictional power sales (reported
as energy sales and booked out transactions). Five percent were at
cost-based rates, and the other five percent could not be readily
categorized given the information reported.
    \7\ See, e.g., 16 U.S.C. 825e, 825f.
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    5. The Commission's infrequent use of the information collected
through Form 423, in sum, no longer justifies the burden of collecting
it. The Commission therefore proposes to cease to collect the Form 423
information ending with the December 2007 information, due February 15,
2008.
    6. In contrast to the Commission's lack of need for the
information, the EIA, in a collection statement to the Office of
Management and Budget (OMB), states that EIA has multiple uses for it
and request approval to collect it. Presently, EIA collects similar
information from nonutility generators and, as explained in EIA's
collection statement to OMB, adding to it information from Commission-
jurisdictional public utilities would, for the first time, capture all
such data on one form for the entire industry. EIA further proposes to
merge the combined data collection with information from three other
existing EIA collections: EIA-906, EIA-920 and EIA-767, in an effort to
improve data quality, consistency and reporting efficiency. The result,
EIA states, will be a new survey, the EIA-923, Power Plant Operations
Report.
    7. The Commission proposes to collect Form 423 information ending
with the December 2007 report, due February 15, 2008, to coordinate
with the initiation of EIA's collection of that information. However,
if EIA is not prepared to collect the information at that time, to
prevent a gap in data continuity, the Commission will continue to
collect the information, until such time as EIA is prepared to begin
collection, but not beyond the December 2008 report, due in February
2009.
    8. The annual estimated $385,128 cost to filers to provide the Form
423 information, added to the $193,869 cost to the Commission to
collect it, means eliminating the collection would save $578,997. The
added burden on EIA to collect the FERC Form 423 data, EIA states in
its OMB submission, is offset by the added efficiencies of reorganizing
their data collections.

Solicitation of Comments

    9. The Commission seeks comments both on its proposal to eliminate
the Form 423, and on the date the Commission proposes to eliminate the
Form 423.

Information Collection Statement

    10. OMB regulations require OMB to approve certain information
collection requirements imposed by an agency.\8\ Here, the Commission
is proposing to cease collecting certain information. Nevertheless, OMB
has been notified of the Commission's actions in this case. The
Commission will submit a copy of the Notice of Proposed Rulemaking
(NOPR) to OMB for information purposes only.
---------------------------------------------------------------------------

    \8\ 5 CFR 1320.11.
---------------------------------------------------------------------------

    11. Interested persons may obtain information on the elimination of
these reporting requirements by contacting the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426
[Attn: Michael Miller, Information Services Division<PHONE_NUMBER>,
fax:<PHONE_NUMBER>]. Comments also can be sent to the Office of
Information and Regulatory Affairs of OMB [Attn: Desk Officer for the
Federal Energy Regulatory Commission; phone,<PHONE_NUMBER>, fax: (202)
395-7285, e-mail<EMAIL_ADDRESS>Comments regarding
EIA's collection of information now collected on Form 423 should be
addressed to OMB at the above address.

Environmental Analysis

    12. Commission regulations require that an Environmental Assessment
or an Environmental Impact Statement be prepared for any Commission
action that may have a significant adverse effect on the human
environment.\9\ The Commission has categorically excluded certain
actions from this requirement as not having a significant adverse
effect on the human environment. No environmental consideration is
necessary for the promulgation of a rule concerning information
gathering, analysis or dissemination.\10\ Because this NOPR concerns
the elimination of an information collection, no environmental
consideration is necessary.
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    \9\ Regulations Implementing the National Environmental Policy
Act, Order No. 486, 52 FR 47897 (Dec. 17, 1987), FERC Stats. & Regs.
] 30,783 (1987) (codified at 18 CFR Part 380).
    \10\ 18 CFR 380.4(a)(5).
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Regulatory Flexibility Act Certification

    13. The Regulatory Flexibility Act of 1980 (RFA) \11\ generally
requires either a description and analysis of a rule that will have a
significant economic impact on a substantial number of small entities
or a certification that the rule will not have a significant economic
impact on a substantial number of small entities. Most utilities to
which this proposed rule applies would not fall within the RFA's
definition of small entity.\12\ Consequently, the Commission certifies
that this NOPR, if adopted, will not have a significant economic impact
on a substantial number of small entities. Moreover, elimination of the
Form 423 will reduce the burden on all entities, including small
entities.
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    \11\ 5 U.S.C. 601-12.
    \12\ 5 U.S.C. 601(3), citing to section 3 of the Small Business
Act, 15 U.S.C. 632. Section 3 of the Small Business Act defines a
``small business concern'' as a business that is independently owned
and operated and that is not dominant in its field of operation. The
Small Business Size Standards component of the North American
Industry Classification System (NAICS) defines a small electric
utility as one that, including its affiliates, is primarily engaged
in the generation, transmission, and/or distribution of electric
energy for sale and whose total electric output for the preceding
fiscal year did not exceed four million MWh. 13 CFR 121.201.
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Comment Procedures

    14. The Commission invites interested persons to submit comments on
the changes proposed in this NOPR to be adopted, including any related
matters or alternative proposals that commenters may wish to discuss.
Comments are due December 20, 2007. Comments must refer to Docket No.
RM07-18-000, and must include, in the comments, the commenter's name,
the organization represented, if applicable, and the address. Comments
may be filed either in electronic or paper format.
    15. Comments may be filed electronically via the eFiling link found
under the Documents & Filings heading on the Commission's Web site at
http://www.ferc.gov. The Commission accepts most standard word

processing formats, but requests commenters to submit comments in a
text-searchable format rather than a scanned image format. Commenters
filing electronically do not need to make a paper filing. Commenters
that are not able to file comments electronically must send an original
and 14 copies of their comments to: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE.,
Washington, DC 20426.
    16. All comments will be placed in the Commission's public files
and may be viewed, printed, or downloaded remotely as described in the
Document Availability section below. Commenters on this proposal are
not required to serve copies of their comments on other commenters.

Document Availability

    17. 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) and

in the Commission's Public Reference Room during normal business hours
(8:30 a.m. to 5 p.m. Eastern time) at 888 First Street, NE., Room 2A,
Washington, DC 20426.
    18. From the Commission's Home Page on the Internet, the full text
of this document is available in the Commission's document management
system, eLibrary, in PDF and Microsoft Word format for viewing,
printing, and downloading. To access this document in eLibrary, type
the docket number (excluding the last three digits of the docket
number), in the Docket Number field.
    19. User assistance is available for eLibrary and the Commission's
Web site during normal business hours. For assistance, please contact
FERC Online Support at<PHONE_NUMBER> (toll-free at 1-866-208-3676), e-
mail<EMAIL_ADDRESS>or contact the Public Reference Room
at<PHONE_NUMBER>, TTY<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>

List of Subjects

18 CFR Part 141

    Electric power, Reporting and recordkeeping requirements.

18 CFR Part 385

    Administrative practice and procedure, Electric power, Penalties,
Pipelines, Reporting and recordkeeping requirements

    By direction of the Commission.
Kimberly D. Bose,
Secretary.
    In consideration of the foregoing, the Commission proposes to amend
parts 141 and 385, Chapter I, Title 18, Code of Federal Regulations, as
follows:

PART 141--STATEMENTS AND REPORTS (SCHEDULES)

    1. The authority citation for part 141 continues to read as
follows:

    Authority: 15 U.S.C. 79; 16 U.S.C. 791a-828c, 2601-2645; 31
U.S.C. 9701; 42 U.S.C. 7101-7352.

Sec.  141.61  [Removed and reserved]

    2. Section 141.61 is removed and reserved.

PART 385--RULES OF PRACTICE AND PROCEDURE

    3. The authority citation for part 385 continues to read as
follows:

    Authority: 5 U.S.C. 551-557; 15 U.S.C. 717-717z, 3301-3432; 16
U.S.C.791a-825v, 2601-2645; 28 U.S.C. 2461; 31 U.S.C. 3701, 9701; 42
U.S.C. 7101-7352, 16441, 16451-16463; 49 U.S.C. 60502; 49 App.
U.S.C. 1-85 (1988).

Sec.  385.2011  [Amended]

    4. Section 385.2011, paragraph (a)(8) is removed and reserved.

[FR Doc. E7-22550 Filed 11-19-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 54 (Tuesday, March 20, 2018)]
[Notices]
[Pages 12218-12221]
[FR Doc No: 2018-05562]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82872; File No. SR-CboeBZX-2017-011]

Self-Regulatory Organizations; CboeBZX Exchange, Inc.; Order
Granting Approval of a Proposed Rule Change To List and Trade the
Common Shares of Beneficial Interest of the PowerShares Income Builder
Portfolio, a Series of PowerShares Exchange-Traded Fund Trust II

March 14, 2018.

I. Introduction

    On December 1, 2017, CboeBZX Exchange, Inc. (``Exchange'' or
``BZX'') 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 the common shares of beneficial
interest of the PowerShares Income Builder Portfolio (``Fund''), a
series of PowerShares Exchange-Traded Fund Trust II (``Trust''), under
BZX Rule 14.11(c)(3). The proposed rule change was published for
comment in the Federal Register on December 20, 2017.\3\ On January 22,
2018, 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\ On
March 6, 2018, the Exchange filed Amendment No. 1 to the proposed rule
change.\6\ The Commission has received no comments on the proposal. The
Commission is approving the proposed rule change, as modified by
Amendment No. 1.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 82328 (Dec. 14,
2017), 82 FR 60443 (Dec. 20, 2017).
    \4\ 15 U.S.C. 78s(b)(2).
    \5\ See Securities Exchange Act Release No. 82559 (Jan. 22,
2018), 83 FR 3820 (Jan. 26, 2018).
    \6\ In Amendment No. 1, which amended and replaced the proposed
rule change in its entirety, the Exchange: (1) Corrected certain
references to its rules; (2) supplemented information regarding
requirements applicable to investment advisers, including
information with respect to firewalls and procedures designed to
prevent the use and dissemination of material, nonpublic information
regarding the Fund's portfolio; (3) corrected the definition and
usage of certain defined terms; (4) clarified that the Fund will not
be a leveraged or inverse-leveraged fund and will not use derivative
instruments to enhance leverage; (5) conformed its representations
regarding the calculation and dissemination of the Underlying Index
(as defined herein) and information relating to trading halts in
accordance with applicable BZX rules; (6) supplemented information
regarding pricing availability with respect to holdings in non-
exchange-listed securities of other investment companies; and (7)
made other technical, non-substantive, and conforming changes.
Because Amendment No. 1 does not materially alter the substance of
the proposed rule change or raise unique or novel regulatory issues,
it is not subject to notice and comment. Amendment No. 1 is
available at: https://www.sec.gov/comments/sr-cboebzx-2017-011/cboebzx2017011-3206088-162013.pdf.
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II. Exchange's Description of the Proposal \7\
---------------------------------------------------------------------------

    \7\ A more detailed description of the Trust, the Fund, and the
Shares, as well as information regarding the methodology of the
Underlying Index (as defined herein), the Fund's portfolio holdings,
and the Fund's investment restrictions are included in Amendment No.
1 to the proposed rule change and Registration Statement (as defined
herein). See Amendment No. 1, supra note 6; Registration Statement,
infra note 8 and accompanying text.
---------------------------------------------------------------------------

    The Exchange proposes to list and trade the Shares under BZX Rule
14.11(c)(5), which governs the listing and trading of Index Fund Shares
based on equity and fixed income securities. The Fund will be a
passively managed, index-based exchange-traded fund (``ETF''), and it
is a series of the Trust. The Trust is registered with the Commission
as an open-end management investment company and has filed a post-
effective amendment to its registration statement on Form N-1A
(``Registration Statement'') with the Commission.\8\ Invesco
PowerShares Capital Management LLC will be the investment adviser
(``Adviser''), and Invesco Advisers, Inc. will be the investment sub-
adviser (``Sub-Adviser''), to the Fund. The Adviser and the Sub-Adviser
are affiliated with a broker-dealer and have implemented, and will
maintain, a fire wall with respect to the broker-dealer affiliate
regarding access to information concerning the composition of, or
changes to, the Fund's portfolio.
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    \8\ See Registration Statement on Form N-1A for the Trust, filed
on July 31, 2017 (File Nos. 333-138490 and 811-21977). According to
the Exchange, the Commission has issued an order granting certain
exemptive relief (``Exemptive Order'') with respect to the Trust
under the Investment Company Act of 1940 (``1940 Act''). See
Investment Company Act Release No. 27841 (May 25, 2007) (File No.
812-13335).
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    The Fund's investment objective is to seek to track the investment
results (before fees and expenses) of the Goldman Sachs Bond Buyers
Equity Basket Index (``Underlying Index''). The Underlying Index is
designed to measure the performance of a hypothetical portfolio of
common equity stocks with an overlay of fully-collateralized written
put options on those stocks. Solactive AG (``Calculation Agent'')
maintains, calculates, and publishes the value of the Underlying Index
on each business day. The Calculation Agent is not registered as an
investment adviser or broker-dealer and is not affiliated with any
broker-dealers. The Calculation Agent also has implemented and will
maintain procedures designed to prevent the use and dissemination of
material, nonpublic information regarding the Underlying Index as
required under BZX Rule 14.11(c)(5)(A)(iii).
    The Exchange states that it has submitted the proposed rule change
because the Underlying Index for the Fund does not meet all of the
listing requirements of BZX Rule 14.11(c)(5), which applies to Index
Fund Shares based on an index that consists of both equity securities
and fixed income securities. BZX Rule 14.11(c)(5) requires that the
equity and fixed income component securities separately meet the
criteria set forth in BZX Rules 14.11(c)(3) and (4), applicable to
equity and fixed income securities indexes,

respectively. Specifically, the Fund does not meet all of the listing
requirements of BZX Rule 14.11(c)(5) because the Underlying Index
partially consists of put options, in addition to equity and fixed
income securities.

A. Description of the Underlying Index

    The Underlying Index will consist of a mixture of: (1) 100 U.S.
exchange-listed, large capitalization common stocks that have listed
options traded on a U.S. exchange (``Stock Component''); (2) put
options that are sold (``written'') on those same 100 stocks that make
up the Stock Component (``Options Strategy''); and (3) Treasury bills
(``Collateral''), which are intended to collateralize the Options
Strategy. The selection of common stocks for the Stock Component, the
selection of strike prices of the fully-collateralized put options for
the Options Strategy, and the asset allocation between the Stock
Component and Collateral are determined pursuant to the Underlying
Index's methodology.\9\ According to the Exchange, the Underlying Index
is designed to obtain yield from three sources: (1) The dividends and
returns on the common stocks in the Stock Component; (2) the premiums
received from the put options sold via the Options Strategy; \10\ and
(3) the yield from Treasury bills serving as Collateral.\11\
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    \9\ A more detailed description of the methodology of the
Underlying Index can be found in Amendment No. 1 to the proposed
rule change and Registration Statement. See supra note 7.
    \10\ A put option seller will incur a loss if the put option
expires in-the-money at the expiration date or if the in-the-money
put option is exercised by the option holder and, in each case, the
in-the-money amount is greater than the purchase price of the put
option (``premium'') collected by the put option seller. A put
option seller will recognize a realized gain if the put option
expires ``out of the money'' (i.e., the underlying stock price is
below the put option strike price).
    \11\ The amount of the premiums received from selling options
largely involves the level of implied volatility of the underlying
reference security: the measurement of how much the market price of
the underlying reference security historically varied from day to
day over a specific period of time. The higher the implied
volatility, the more likely the underlying reference security will
experience large price changes. Another factor bearing on the put
option premium is the time value of the options. The more time that
remains until the expiration date of the option, the greater the
amount of time that an option trade has to become profitable due to
a favorable move in the underlying reference security. As a result,
investors are willing to pay a higher premium for more time until
the expiration date of an option (and conversely, as the expiration
date of an option approaches, the market price of the option
decreases, and down to zero if the option remains out-of-the-money
on the expiration date of the option).
---------------------------------------------------------------------------

    The Options Strategy writes or sells put options on the 100 stocks
included in the Stock Component. Those put options are standardized
options listed and traded on U.S. exchanges and will have terms of at
least six but no more than eighteen months as of each quarterly
rebalance date. The strike price for each put option will be selected,
in accordance with the Underlying Index's methodology, at an amount
that will generate a premium that (when annualized) is as close as
possible to the expected return of the underlying stock. The put
options related to the Options Strategy will have expirations between
six and eighteen months. All put options in the Underlying Index are
fully collateralized with Treasury bills in an amount equal to the
outstanding notional value of the put options. The Collateral may also
include the premiums collected on the put options.
    The Underlying Index is rebalanced quarterly in March, June,
September, and December, typically on the Friday before the third
Saturday of the month (``rebalance date''). The 100 common stocks to be
included in the Stock Component are made available one week prior to
the rebalance date. The put option strike prices and weights of the
Underlying Index's components will be made available prior to the end
of the business day on the rebalance date.

B. Description of the Fund

    Under normal market conditions,\12\ the Fund will seek to achieve
its investment objective by generally investing at least 90% of its
total assets in the components of the Underlying Index.\13\ The Fund
will use an ``indexing'' investment approach to seek to achieve its
investment objective. The Adviser will seek a correlation over time of
0.95 or better between the Fund's performance and the performance of
the Underlying Index (a correlation of 1.00 would represent perfect
correlation).\14\ The Fund generally will employ a ``full replication''
methodology, meaning that generally it will seek to invest in all of
the components of the Underlying Index (i.e., all of the stocks in the
Stock Component, the Options Strategy, and the Collateral for the put
options) in proportion to their weightings in the Underlying Index.
However, under various circumstances, it may not be possible or
practicable for the Fund to purchase all of the components of the
Underlying Index in the same weightings as the Underlying Index. In
those circumstances, the Fund may purchase a representative sample of
securities in the Underlying Index in pursuing its investment
objective.\15\
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    \12\ The term ``normal market conditions'' includes, but is not
limited to, the absence of trading halts in the applicable financial
markets generally; operational issues causing dissemination of
inaccurate market information or system failures; or force majeure
type events such as natural or man-made disaster, act of God, armed
conflict, act of terrorism, riot or labor disruption, or any similar
intervening circumstance.
    \13\ The Fund will operate as an index fund and will not be
actively managed. Therefore, the Fund will not adopt temporary
defensive strategies. It will continue to invest at least 90% of its
assets in the components of the Underlying Index, in accordance with
the terms of its Exemptive Order, even during unusual market
conditions, including extreme volatility or trading halts in the
financial markets generally.
    \14\ Another means of evaluating the relationship between the
returns of the Fund and the Underlying Index is to assess the
``tracking error'' between the two. Tracking error means the
variation between the Fund's annual return and the return of the
Underlying Index, expressed in terms of standard deviation. The Fund
seeks to have a tracking error of less than 5%, measured on a
monthly basis over a one-year period by taking the standard
deviation of the difference in the Fund's returns versus the
Underlying Index's returns.
    \15\ A ``sampling'' methodology means that the Adviser (or Sub-
Adviser) will use a quantitative analysis to select component
securities of the Underlying Index for the Fund's portfolio that are
a representative sample of securities that have, in the aggregate,
investment characteristics similar to the Underlying Index in terms
of key risk factors, performance attributes and other
characteristics. These include industry weightings, market
capitalization, return variability, earnings valuation, yield and
other financial characteristics of securities. When employing a
sampling methodology, the Adviser (or Sub-Adviser) bases the
quantity of holdings in the Fund on a number of factors, including
asset size of the Fund, and generally expects the Fund to hold less
than the total number of securities in the Underlying Index.
However, the Adviser (or Sub-Adviser) reserves the right to invest
the Fund in as many securities as it believes necessary to achieve
the Fund's investment objective.
---------------------------------------------------------------------------

    After investing at least 90% of its total assets in components of
the Underlying Index, the Fund may invest up to 10% of its total assets
in the following: (i) Exchange-traded U.S. equity securities not
included in the Underlying Index, but which the Adviser or Sub-Adviser
believes will help the Fund to track the Underlying Index; \16\ (ii)
high quality securities issued or guaranteed by the U.S. government (in
addition to Treasury bills) and non-U.S. governments, and each of their
agencies and instrumentalities; (iii) money market instruments,
including repurchase agreements or other funds which invest exclusively
in money market instruments (subject to applicable limitations under
the 1940 Act, or exemptions therefrom); \17\ (iv)

convertible securities; (v) structured notes;\18\ (vi) securities of
other investment companies (including affiliated and unaffiliated
funds, such as open-end or closed-end management investment companies,
and other ETFs) beyond the limits permitted under the 1940 Act, subject
to certain terms and conditions set forth in a Commission exemptive
order issued to the Trust pursuant to Section 12(d)(1)(J) of the 1940
Act; and (vii) over-the-counter (``OTC'') options.\19\
---------------------------------------------------------------------------

    \16\ For example, there may be instances in which the Adviser or
Sub-Adviser may choose to purchase or sell securities not in the
Underlying Index which the Adviser or Sub-Adviser believes are
appropriate to substitute for one or more Underlying Index
components in seeking to replicate, before fees and expenses, the
performance of the Underlying Index.
    \17\ The Fund may invest in repurchase agreements with
commercial banks, brokers or dealers to generate income from its
excess cash balances and to invest securities lending cash
collateral.
    \18\ Structured notes are derivative securities for which the
amount of principal repayment or interest payments is based on the
movement of one or more factors, including but not limited to,
currency exchange rates, interest rates (such as the prime lending
rate or LIBOR), referenced bonds, and stock indices.
    \19\ The Fund may use OTC options, together with positions in
cash and money market instruments, to simulate full investment in
the Underlying Index. The Fund will only enter into OTC options with
counterparties that the Adviser or Sub-Adviser reasonably believes
are capable of performing under the contract, and the Fund will post
collateral as required by the counterparty and applicable
regulations. The Adviser or Sub-Adviser will attempt to mitigate the
Fund's respective credit risk by transacting, where possible, with
large, well-capitalized institutions using measures designed to
determine the creditworthiness of the counterparty. The Adviser and
Sub-Adviser will evaluate the creditworthiness of counterparties on
a regular basis. In addition to information provided by credit
agencies, the Adviser and Sub-Adviser will review approved
counterparties using various factors, which may include the
counterparty's reputation, the Adviser's or Sub-Adviser's past
experience with the counterparty, and the price and market actions
of debt of the counterparty. The Fund may also use various
techniques to minimize credit risk, including early termination or
reset and payment, using different counterparties, and limiting the
net amount due from any individual counterparty. However, the risk
of losses to the Fund resulting from counterparty default is still
possible.
---------------------------------------------------------------------------

    The Fund may hold up to an aggregate amount of 15% of its net
assets (calculated at the time of investment) in assets deemed illiquid
by the Adviser or Sub-Adviser.\20\ The Fund will monitor its portfolio
liquidity on an ongoing basis to determine whether, in light of current
circumstances, an adequate level of liquidity is being maintained, and
will consider taking appropriate steps in order to maintain adequate
liquidity if, through a change in values, net assets, or other
circumstances, more than 15% of the Fund's net assets are held in
illiquid securities or other illiquid assets. The Fund will not be a
leveraged or inverse leveraged fund and will not use derivative
instruments to enhance leverage.\21\
---------------------------------------------------------------------------

    \20\ In reaching liquidity decisions, the Adviser or Sub-Adviser
may consider the following factors: The frequency of trades and
quotes for the security; the number of dealers wishing to purchase
or sell the security and the number of other potential purchasers;
dealer undertakings to make a market in the security; and the nature
of the security and the nature of the marketplace in which it trades
(e.g., the time needed to dispose of the security, the method of
soliciting offers and the mechanics of transfer).
    \21\ The Exchange states that the Fund's investments will be
consistent with the Fund's investment objective. The Fund does not
presently intend to engage in any form of borrowing for investment
purposes, and will not be operated as a ``leveraged ETF'' or
``inverse leveraged ETF,'' i.e., it will not be operated in a manner
designed to seek a multiple or an inverse multiple of the
performance of an underlying reference index.
---------------------------------------------------------------------------

III. Discussion and Commission Findings

    After careful review, the Commission finds that the proposed rule
change, as modified by Amendment No. 1, is consistent with the Act and
the rules and regulations thereunder applicable to a national
securities exchange.\22\ In particular, the Commission finds that the
proposal is consistent with Section 6(b)(5) of the Act,\23\ which
requires, among other things, that the Exchange's rules be designed to
prevent fraudulent and manipulative acts and practices, 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.
---------------------------------------------------------------------------

    \22\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \23\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    Under the proposal, the Exchange represents that, under normal
market conditions, the Fund will hold a substantial amount (at least
90%) of its net assets in the components of the Underlying Index, which
includes: (1) The Stock Component, consisting of 100 U.S. exchange-
listed, large capitalization common stocks that have listed options
traded on a U.S. exchange; (2) the Options Strategy, consisting of
standardized put options listed and traded on U.S. exchanges and that
are sold on those same 100 stocks that make up the Stock Component; and
(3) Collateral consisting of Treasury bills intended to collateralize
the Options Strategy. According to the Exchange, the Shares will be
listed and traded on the Exchange pursuant to the listing criteria in
BZX Rule 14.11(c)(5) and will therefore comply with all of the
requirements therein, except that the Underlying Index will consist, in
part, of U.S. exchange listed written put options based on U.S.
exchange-listed equity securities.
    The Exchange represents that the Stock Component and the Collateral
component will satisfy the applicable listing requirements under BZX
Rule 14.11(c), including BZX Rules 14.11(c)(3) and (4) relating to
equity and fixed income securities index components, respectively. The
Commission notes that, with respect to the Options Strategy, all of the
standardized put options will be listed and traded on U.S. exchanges,
all of which are members of the Intermarket Surveillance Group
(``ISG''). In addition, all of the equity securities included in the
Stock Component will be listed and traded on U.S. exchanges, all of
which are members of ISG. The Commission further notes that, according
to the proposal, the Fund will be subject to the other requirements as
set forth in Exchange rules applicable to Index Fund Shares, including,
but not limited to, requirements relating to the dissemination of key
information such as the Net Asset Value, the Intraday Indicative Value,
rules governing the trading of equity and fixed income securities,
firewalls, trading hours, and trading halts.
    Under the proposal, the value of the Underlying Index will be
calculated and widely disseminated at least once every 15 seconds
during Regular Trading Hours \24\ and will be available from major
market data vendors, provided however, that with respect to the fixed
income components of the Underlying Index, the impact on the Underlying
Index will be updated and widely disseminated at least once daily.\25\
Further, an Intraday Indicative Value will be based upon the current
value for the components of the Disclosed Portfolio and will be updated
and widely disseminated by one or more major market data vendors and
broadly displayed at least every 15 seconds during the Exchange's
Regular Trading Hours. The Fund's portfolio holdings will be disclosed
on the Fund's website daily after the close of trading on the Exchange
and prior to the opening of trading on the Exchange the following
day.\26\
---------------------------------------------------------------------------

    \24\ The Exchange's ``Regular Trading Hours'' are between 9:30
a.m. and 4:00 p.m. Eastern Time. See BZX Rule 1.5(w).
    \25\ See BZX Rule 14.11(c)(5)(A)(ii).
    \26\ See BZX Rule 14.11(c)(1)(B)(iv).
---------------------------------------------------------------------------

    Quotation and last-sale information for U.S. exchange-listed
options contracts cleared by The Options Clearing Corporation will be
available via the Options Price Reporting Authority. Intraday, closing,
and settlement prices of common stocks and other exchange-listed
instruments will be readily available from the exchanges trading such
securities as well as automated quotation systems, published or other
public sources, or online information services such as Bloomberg

or Reuters. Quotation information from brokers and dealers or pricing
services will be available for U.S. government obligations, high
quality securities issued or guaranteed by the U.S. government (in
addition to Treasury bills) and non-U.S. governments, and each of their
agencies and instrumentalities, money market instruments, convertible
securities, structured notes, non-exchange-listed securities of other
investment companies, and OTC options.
    The Commission also believes that the proposal is designed to
prevent trading when a reasonable degree of transparency cannot be
assured. The Exchange states that trading in the Shares may be halted
for market conditions or for reasons that, in the view of the Exchange,
make trading inadvisable. Similarly, trading in the Shares will be
halted if an interruption to the dissemination of either of the
Intraday Indicative Value or the value of the Underlying Index persists
past the trading day in which it occurred. The Exchange will obtain a
representation from the issuer of the Shares that the NAV per Share
will be calculated daily and made available to all market participants
at the same time.\27\ If the Exchange becomes aware that the NAV for
the Shares is not being disseminated to all market participants at the
same time or the daily public website disclosure of portfolio holdings
does not occur, the Exchange will halt trading in the Shares.\28\
---------------------------------------------------------------------------

    \27\ See BZX Rule 14.11(c)(9)(A)(ii).
    \28\ See BZX Rule 14.11(c)(1)(b)(iv).
---------------------------------------------------------------------------

    The Exchange has represented that its surveillance procedures are
adequate to properly monitor the trading of the Shares on the Exchange
during all trading sessions and to deter and detect violations of
Exchange rules and the applicable federal securities laws. The Exchange
has also represented that it may obtain information regarding trading
in the Shares and other exchange-traded securities and instruments held
by the Fund via the ISG from other exchanges that are members of the
ISG or with which the Exchange has entered into a comprehensive
surveillance sharing agreement.
    The Exchange has represented that all statements and
representations made in this filing regarding the Underlying Index
composition; the description of the portfolio or reference assets;
limitations on portfolio holdings or reference assets; dissemination
and availability of the Underlying Index, reference asset, and intraday
indicative values; and the applicability of Exchange rules specified in
this filing shall constitute continued listing requirements for the
Shares.
    The issuer has represented to the Exchange that it will advise the
Exchange of any failure by the Fund to comply with the continued
listing requirements, and, pursuant to its obligations under Section
19(g)(1) of the Act, the Exchange will surveil for compliance with the
continued listing requirements. If the Fund is not in compliance with
the applicable listing requirements, the Exchange will commence
delisting procedures under BZX Rule 14.12. This approval order is based
on all of the Exchange's statements and representations, including
those set forth above and in Amendment No. 1 to the proposed rule
change.
    For the foregoing reasons, the Commission finds that the proposed
rule change, as modified by Amendment No. 1, is consistent with Section
6(b)(5) of the Act \29\ and the rules and regulations thereunder
applicable to a national securities exchange.
---------------------------------------------------------------------------

    \29\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\30\ that the proposed rule change (SR-CboeBZX-2017-011), as
modified by Amendment No. 1 be, and it hereby is, approved.
---------------------------------------------------------------------------

    \30\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\31\
---------------------------------------------------------------------------

    \31\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-05562 Filed 3-19-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 124 (Thursday, June 29, 2017)]
[Notices]
[Pages 29569-29570]
[FR Doc No: 2017-13609]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-3199]

Program for Enhanced Review Transparency and Communication for
Original 351(k) Biologics License Applications in Biosimilar User Fee
Act II

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the statement of work for an
assessment of the Program for Enhanced Review Transparency and
Communication for original biologics license applications (BLAs)
(351(k)s) submitted under the Public Health Service Act (hereafter
referred to as 351(k) applications) (hereafter referred to as the
Program). The Program is part of the FDA performance commitments under
the proposed reauthorization of the Biosimilar User Fee Act (BsUFA),
which, if enacted into law, will allow FDA to collect user fees for the
review of 351(k) applications for fiscal years (FYs) 2018-2022. As part
of the FDA performance commitments described in this document, the
Program will be evaluated by an independent contractor in an interim
and final assessment.

DATES: FDA is providing a period of 30 days for public comment on the
statement of work before beginning the assessment. The statement of
work can be accessed at https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM559341.pdf. Public comments will be
accepted through July 31, 2017. See ADDRESSES section below for
information about submitting comments to the public docket.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before July 31, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of July 31, 2017. Comments received by
mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''

    Instructions: All submissions received must include the Docket No.
FDA-2017-N-3199 for ``Program for Enhanced Review Transparency and
Communication for Original 351(k) Biologics License Applications in
BsUFA II.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Azada Hafiz, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1148, Silver Spring, MD 20993, 240-402-
6073, Fax:<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The timely review of 351(k) applications is central to FDA's
mission to protect and promote the public health. The BsUFA was first
enacted by Congress in 2012 and authorizes FDA to collect user fees for
351(k) applications. FDA dedicates BsUFA user fees to the efficient
review of 351(k) applications and to facilitate the development of safe
and effective biosimilar biological products for the American public.
FDA dedicates the additional fee resources to hire reviewers and
support staff and upgrade its information technology systems. With the
availability of these additional fee resources, FDA was able to agree
to certain review performance goals, including a complete review of
351(k) applications and taking regulatory action within specified
timeframes. The current authorization of the program (BsUFA I) expires
in September 2017.
    As directed by statute, FDA prepared recommendations for the
reauthorization of BsUFA for a new 5-year period by conducting
negotiations with the regulated industry and holding regular
consultations with public stakeholders including patient advocates,
consumer advocates, and healthcare professionals. Following these
discussions, related public meetings, and Agency requests for public
comment, FDA transmitted proposed recommendations for BsUFA II for
fiscal years 2018-2022. FDA's BsUFA II recommendations include an FDA
commitment to implement a new review program for 351(k) applications to
promote the efficiency and effectiveness of the first-cycle review
process and minimize the number of review cycles necessary for approval
of these complex applications. The Program is described in detail in
section I.B of the document entitled ``Biosimilar Biological Product
Reauthorization Performance Goals and Procedures Fiscal Years 2018
Through 2022'' available at https://www.fda.gov/downloads/forindustry/userfees/biosimilaruserfeeactbsufa/ucm521121.pdf.

II. BsUFA II Program for Enhanced Review Transparency and Communication
for Original 351(k) BLAs

    FDA recognizes that increasing communication between the Agency and
applicants during FDA's review has the potential to increase efficiency
in the review process. To enhance review transparency and improve
communication between the FDA review team and the applicant, FDA has
proposed for BsUFA II a new review model (the Program), for the review
of all 351(k) applications. The Program will allow for additional
communication between FDA review teams and the applicants of biosimilar
biological products in the form of a Biological Product Development
Type 4 (pre-351(k) BLA) meetings, mid-cycle communications, and late-
cycle meetings. To accommodate this increased interaction during
regulatory review and to address the need for additional time to review
these complex applications, FDA's review clock will begin after the 60-
day administrative filing review period for applications reviewed under
the Program.
    The goal of the Program is to improve the efficiency and
effectiveness of the first-cycle review process by increasing
communications during application review. This will provide sponsors
with the opportunity to clarify previous submissions and provide
additional data and analyses that are readily available, potentially
avoiding the need for an additional review cycle when concerns can be
promptly resolved without compromising FDA's standards for approval.

    Dated: June 23, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-13609 Filed 6-28-17; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 179 (Monday, September 20, 2021)]
[Notices]
[Pages 52142-52143]
[FR Doc No: 2021-20271]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 3509-042]

Little Falls Hydroelectric Associates, LP; Notice of Application
Tendered for Filing With The Commission and Establishing Procedural
Schedule for Licensing and 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 Major License.
    b. Project No.: 3509-042.
    c. Date Filed: August 31, 2021.
    d. Applicant: Little Falls Hydroelectric Associates, LP.
    e. Name of Project: Little Falls Hydroelectric Project (Little
Falls Project).
    f. Location: The existing project is located on the Mohawk River,
in the City of Little Falls, Herkimer County, New York. The project
does not occupy federal land.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791 (a)-825 (r).
    h. Applicant Contact: David H. Fox, Director, Licensing and
Compliance, Little Falls Hydroelectric Associates, LP, Eagle Creek
Renewable Energy, 7315 Wisconsin Avenue, Suite 1100W, Bethesda, MD
20814, [email protected]; Jody J. Smet, Vice President,
Regulatory Affairs, Little Falls Hydroelectric Associates, LP, Eagle
Creek Renewable Energy, 7315 Wisconsin Avenue, Suite 1100W, Bethesda,
MD 20814, [email protected]

    i. FERC Contact: Monir Chowdhury at<PHONE_NUMBER> or email at
<EMAIL_ADDRESS>    j. This application is not ready for environmental analysis at this
time.
    k. Project Description: The Little Falls Project consists of: (1)
Two state-owned dams (i.e., North State Dam and South State Dam) joined
by an island, and equipped with 1-foot-high flashboards and flow
control gates, with a total length of 594 feet and a height of about
6.25 feet; (2) a reservoir with a storage capacity of 800 acre-feet at
a normal surface elevation of 363.8 feet; \1\ (3) a 45-foot-wide, 300-
foot-long navigation lock (Lock 17); (4) a 55-foot-wide, 73-foot-long
concrete intake structure with two roller head gates to control flow
through the intake; (5) two 14-foot-diameter, 90-foot-long steel
penstocks; (6) a 65-foot-wide by 99-foot-long concrete powerhouse
containing two-turbine-generator units each with a capacity of 6.8
megawatts; (7) two sets of 4.16-kilovolt (kV), 60-foot-long generator
leads that run from the powerhouse to a switchyard containing a 4.16/
46-kV transformer; (8) a 46-kV, 50-foot-long transmission line from the
switchyard to a nearby interconnection point that connects the project
with the National Grid; and (9) appurtenant facilities.
---------------------------------------------------------------------------

    \1\ All elevations refer to Barge Canal Datum which is 0.8 foot
higher than elevations in National Geodetic Vertical Datum of 1929.
---------------------------------------------------------------------------

    There are several structures inside the project boundary that are
not considered part of the project: A flood gate structure owned by the
New York State Canal Corporation to protect the canal during periods of
high headwater; the Middle Dam, with sixty percent of the dam currently
breached, located in the bypassed reach of the Mohawk River, and built
as part of a hydropower plant that was decommissioned in 1962; and the
Gilbert Dam located also in the bypassed reach approximately 700 feet
upstream of the powerhouse to measure flow through the Mohawk River and
to assure minimum flow conditions are met in the river.
    l. In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested individuals an
opportunity to view and/or print the contents of this document and the
full license application via the internet through the Commission's Home
Page (www.ferc.gov) using the ``eLibrary'' link. At this time, the
Commission has suspended access to the Commission's Public Access 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_ADDRESS>or
call toll-free,<PHONE_NUMBER> or TTY,<PHONE_NUMBER>.
    m. 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.
    n. Procedural schedule: The application will be processed according
to the following preliminary Hydro Licensing Schedule. Revisions to the
schedule may be made as appropriate.

------------------------------------------------------------------------
               Milestone                           Target date
------------------------------------------------------------------------
Issue Deficiency Letter (if necessary).  September 2021.
Request Additional Information.........  October 2021.
Notice of Acceptance/Notice of Ready     February 2022.
 for Environmental Analysis.
------------------------------------------------------------------------

    o. 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: September 14, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-20271 Filed 9-17-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: May 6, 2009 (Volume 74, Number 86)]
[Rules and Regulations]
[Page 20867]
[DOCID:fr06my09-2]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2008-1076; Airspace Docket No. 08-ANE-102]

Amendment to Class E Airspace; Rutland, VT

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Direct final rule, confirmation of effective date.

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SUMMARY: This action confirms the effective date of a direct final rule
that amends the Class E Airspace at Rutland-Southern Vermont Regional
(RUT); Rutland, VT to provide adequate controlled airspace for those
aircraft using Instrument Approach Procedures to the airport. The
action became necessary due to the decommissioning of the IRA NDB and
new Standard Instrument Approach Procedures (SIAPs) being developed for
Rutland-Southern Vermont Regional Airport. This rule also imparts a
technical amendment to change the name of the airport from Rutland
State Airport to Rutland-Southern Vermont Regional.

DATES: Effective Date: 0901 UTC, May 6, 2009. The Director of the
Federal Register approves this incorporation by reference action under
Title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA Order 7400.9 and publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Melinda Giddens, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320: telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Confirmation of Effective Date

    The FAA published this direct final rule with a request for
comments in the Federal Register on December 15, 2008 (73 FR 75936),
Docket No. FAA-2008-1076; Airspace Docket No. 08-ANE-102. The FAA uses
the direct final rulemaking procedure for a non-controversial rule
where the FAA believes that there will be no adverse public comment.
This direct final rule advised the public that no adverse comments were
anticipated, and that unless a written adverse comment, or a written
notice of intent to submit such an adverse comment, were received
within the comment period, the regulation would become effective on
March 12, 2009. No adverse comments were received, and thus this notice
confirms that effective date.

    Issued in College Park, Georgia, on April 22, 2009.
Barry A. Knight,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. E9-10372 Filed 5-5-09; 8:45 am]

BILLING CODE 4910-13-P