[Federal Register Volume 79, Number 148 (Friday, August 1, 2014)]
[Notices]
[Pages 44782-44785]
[FR Doc No: 2014-18197]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1048]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device Labeling Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
associated with the medical device labeling regulations.

DATES: Submit either electronic or written comments on the collection
of information by September 30, 2014.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Medical Device Labeling Regulations--21 CFR 800, 801, and 809 (OMB
Control Number 0910-0485)--Extension

    Section 502 of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 352), among other things, establishes requirements for
the label or labeling of a medical device so that it is not misbranded
and subject to a regulatory action. Certain provisions under section
502 require manufacturers, importers, and distributors of medical
devices to disclose information about themselves or the devices, on the
labels or labeling for the devices.
    Section 502(b) of the FD&C Act requires that for packaged devices,
the label must bear the name and place of business of the manufacturer,
packer, or distributor as well as an accurate statement of the quantity
of the contents. Section 502(f) of the FD&C Act requires that the
labeling for a device must contain adequate directions for use. FDA may
however, grant an exemption, if the Agency determines that the adequate
directions for use labeling requirements are not necessary for the
particular case, as it relates to protection of the public health.
    FDA regulations under parts 800, 801, and 809 (21 CFR parts 800,
801, and 809) require disclosure of specific information by
manufacturers, importers, and distributors of medical devices about
themselves or the devices, on the label or labeling for the devices to
health professionals and consumers. FDA issued these regulations under
the authority of sections 201, 301, 502, and 701 of the FD&C Act (21
U.S.C. 321, 331, 352, and 371). Most of the regulations under parts
800, 801, and 809 are derived from requirements of section 502 of the
FD&C Act, which provides in part, that a device shall be misbranded if,
among other things, its label or labeling fails to bear certain
required information concerning the device, is false or misleading in
any particular way, or fails to contain adequate directions for use.

Recordkeeping Burden

    Section 801.150(a)(2) establishes recordkeeping requirements for
manufacturers of devices to retain a copy of the agreement containing
the specifications for the processing, labeling, or repacking of the
device for 2 years after the shipment or delivery of the device.
Section 801.150(a)(2) also requires that the subject respondents make
copies of this agreement available for inspection at any reasonable
hour to any officer or employee of the Department of Health and Human
Services (HHS) who requests them.

    Section 801.410(e) requires copies of invoices, shipping documents,
and records of sale or distribution of all impact resistant lenses,
including finished eyeglasses and sunglasses, be maintained for 3 years
by the retailer and made available upon request by any officer or
employee of FDA or by any other officer or employee acting on behalf of
the Secretary of HHS.
    Section 801.410(f) requires that the results of impact tests and
description of the test method and apparatus be retained for a period
of 3 years.
    Section 801.421(d) establishes requirements for hearing aid
dispensers to retain copies of all physician statements or any waivers
of medical evaluation for 3 years after dispensing the hearing aid.
    Section 801.430(f) requires manufacturers of menstrual tampons to
devise and follow an ongoing sampling plan for measuring the absorbency
of menstrual tampons. In addition, manufacturers must use the method
and testing parameters described in Sec.  801.430(f).
    Section 801.435(g) requires latex condom manufacturers to document
and provide, upon request, an appropriate justification for the
application of the testing data from one product on any variation of
that product to support expiration dating in the user labeling.

Third-Party Disclosure Burden

    Sections 800.10(a)(3) and 800.12(c) require that the label for
contact lens cleaning solutions bear a prominent statement alerting
consumers of the tamper-resistant feature. Further, Sec.  800.12
requires that packaged contact lens cleaning solutions contain a
tamper-resistant feature, to prevent malicious adulteration.
    Section 800.10(b)(2) requires that the labeling for liquid
ophthalmic preparations packed in multiple-dose containers provide
information on the duration of use and the necessary warning
information to afford adequate protection from contamination during
use.
    Section 801.1 requires that the label for a device in package form,
contain the name and place of business of the manufacturer, packer, or
distributor.
    Section 801.5 requires that labeling for a device include
information on intended use as defined under Sec.  801.4 and provide
adequate directions to assure safe use by the lay consumers.
    Section 801.61 requires that the principal display panel of an
over-the-counter (OTC) device in package form must bear a statement of
the identity of the device. The statement of identity of the device
must include the common name of the device followed by an accurate
statement of the principal intended actions of the device.
    Section 801.62 requires that the label for an OTC device in package
form must bear a statement of declaration of the net quantity of
contents. The label must express the net quantity in terms of weight,
measure, numerical count, or a combination of numerical count and
weight, measure, or size.
    Section 801.109 establishes labeling requirements for prescription
devices, in which the label for the device must describe the
application or use of the device, and contain a cautionary statement
restricting the device for sale by, or on the order of an appropriate
professional.
    For prescription by a licensed practitioner, Sec.  801.110
establishes labeling requirements for a prescription device delivered
to the ultimate purchaser or user. The device must be accompanied by
labeling bearing the name and address of the licensed practitioner,
directions for use, and cautionary statements if any, provided by the
order.
    Section 801.150(e) requires a written agreement between firms
involved when a nonsterile device is assembled or packaged with
labeling that identifies the final finished device as sterile, for
which the device is ultimately introduced into interstate commerce to
an establishment or contract manufacturer to be sterilized. When a
written agreement complies with the requirements under Sec.
801.150(e), FDA takes no regulatory action against the device as being
misbranded or adulterated. In addition, Sec.  801.150(e) requires that
each pallet, carton, or other designated unit, be conspicuously marked
to show its nonsterile nature when introduced into interstate commerce,
and while being held prior to sterilization.
    Section 801.405(b)(1) provides for labeling requirements for
articles, including repair kits, re-liners, pads, and cushions,
intended for use in temporary repairs and refitting of dentures for lay
persons. Section 801.405(b)(1) also requires that the labeling contain
the word ``emergency'' preceding and modifying each indication-for-use
statement for denture repair kits and the word ``temporary'' preceding
and modifying each indication-for-use statement for re-liners, pads,
and cushions.
    Section 801.405(c) provides for labeling requirements that contain
essentially the same information described under Sec.  801.405(b)(1).
The information is intended to enable a lay person to understand the
limitations of using OTC denture repair kits, and denture re-liners,
pads, and cushions.
    Section 801.420(c)(1) requires that manufacturers or distributors
of hearing aids develop a user instructional brochure to be provided by
the dispenser of the hearing aid to prospective users. The brochure
must contain detailed information on the use and maintenance of the
hearing aid.
    Section 801.420(c)(4) establishes requirements that the user
instructional brochure or separate labeling, provide for technical data
elements useful for selecting, fitting, and checking the performance of
a hearing aid. In addition, Sec.  801.420(c)(4) provides for testing
requirements to determine that the required data elements must be
conducted in accordance with the American National Standards
Institute's (ANSI) ``Specification of Hearing Aid Characteristics,''
ANSI S3.22-1996 (ASA 70-1996); (Revision of ANSI S3.22-1987), which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51.
    Section 801.421(b) establishes requirements for the hearing aid
dispenser to provide prospective users with a copy of the user
instructional brochure along with an opportunity to review comments,
either orally or by the predominant method of communication used during
the sale.
    Section 801.421(c) establishes requirements for the hearing aid
dispenser to provide a copy of the user instructional brochure to the
prospective purchaser of any hearing aid upon request or, if the
brochure is unavailable, provide the name and address of the
manufacturer or distributor from which it may be obtained.
    Section 801.430(d) establishes labeling requirements for menstrual
tampons to provide information on signs, risk factors, and ways to
reduce the risk of Toxic Shock Syndrome (TSS).
    Section 801.430(e)(2) requires menstrual tampon package labels to
provide information on the absorbency term based on testing required
under Sec.  801.430(f) and an explanation of selecting absorbencies
that reduce the risk of contracting TSS.
    Section 801.435(b), (c), and (h) establishes requirements for
condom labeling to bear an expiration date that is supported by testing
that demonstrates the integrity of three random lots of the product.
    Section 809.10(a) and (b) establishes requirements that a label for
an in vitro diagnostic (IVD) device and the accompanying labeling
(package insert), must contain information identifying its

intended use, instructions for use and lot or control number, and
source.
    Section 809.10(d)(1) provides that the labeling requirements for
general purpose laboratory reagents may be exempt from the requirements
of Sec.  809.10(a) and (b), if the labeling contains information
identifying its intended use, instructions for use, lot or control
number, and source.
    Section 809.10(e) provides that the labeling for ``Analytic
Specific Reagents'' (ASRs) must provide information identifying the
quantity or proportion of each reagent ingredient, instructions for
use, lot or control number, and source.
    Section 809.10(f) provides that the labeling for OTC test sample
collection systems for drugs of abuse must include information on the
intended use, specimen collection instructions, identification system,
and information about use of the test results. In addition, Sec.
809.10(f) requires that this information be in language appropriate for
the intended users.
    Section 809.30(d) requires that advertising and promotional
materials for ASRs include the identity and purity of the ASR and the
identity of the analyte.
    Section 1040.20(d) (21 CFR 1040.20) provides that manufacturers of
sunlamp products and ultraviolet lamps are subject to the labeling
regulations under part 801.
    The burden estimates are based on FDA's current registration and
listing data and shipment information.
    FDA estimates the burden of this collection of information as
follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                     Number of                    Average burden
     Activity/21 CFR section         Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
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Processing, labeling, or                   4,870             739       3,598,930            0.50       1,799,465
 repacking agreement--
 801.150(a)(2)..................
Impact resistant lenses;                   1,136         924,100      27,723,000          0.0008          22,178
 invoices, shipping documents,
 and records of sale or
 distribution--801.410(e) and
 (f)............................
Hearing aid records--801.421(d).          10,000             160       1,600,000            0.25         400,000
Menstrual tampons, sampling plan              22               8             176              80          14,080
 for measuring absorbency--
 801.430(f).....................
Latex condoms; justification for              63               6             378               1             378
 the application of testing data
 to the variation of the tested
 product--801.435(g)............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............       2,236,101
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                           Table 2--Estimated Annual Third-Party Disclosure Burden \1\
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                                                     Number of
     Activity/21 CFR section         Number of      disclosures    Total annual   Average burden    Total hours
                                    respondents   per respondent    disclosures   per disclosure
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Contact lens cleaning solution                17               8             136               1             136
 labeling--800.10(a)(3) and
 800.12(c)......................
Liquid ophthalmic preparation                 17               8             136               1             136
 labeling--800.10(b)(2).........
Manufacturer, packer, or                  13,780               7          96,460               1          96,460
 distributor information--801.1.
Adequate directions for use--              6,657               6          39,942           22.35         892,704
 801.5..........................
Statement of identity--801.61...           6,657               6          39,942               1          39,942
Declaration of net quantity of             6,657               6          39,942               1          39,942
 contents--801.62...............
Prescription device labeling--             7,558               6          45,348           17.77         805,834
 801.109........................
Retail exemption for                      30,000             667      20,010,000            0.25       5,002,500
 prescription devices--801.110..
Processing, labeling, or                     377              34          12,818               4          51,272
 repacking; non-sterile devices--
 801.150(e).....................
Labeling of articles intended                 31               1              31               4             124
 for lay use in the repairing
 and/or refitting of dentures--
 801.405(b)(1)..................
Dentures; information regarding               31               1              31               4             124
 temporary and emergency use--
 801.405(c).....................
Labeling requirements for                     86              12           1,032              40          41,280
 hearing aids--801.420(c)(1)....
Technical data for hearing aids--             86              12           1,032              80          82,560
 801.420(c)(4)..................
Hearing aids, opportunity to              10,000             160       1,600,000            0.30         480,000
 review user instructional
 brochure--801.421(b)...........
Hearing aids, availability of             10,000               5          50,000            0.17           8,500
 user instructional brochure--
 801.421(c).....................
User labeling for menstrual                   22               8             176               2             352
 tampons--801.430(d)............
Menstrual tampons, ranges of                  22               8             176               2             352
 absorbency--801.430(e)(2)......
User labeling for latex condoms--             63               6             378             100          37,800
 801.435(b), (c), and (h).......
Labeling for IVDs--809.10(a) and           1,700               6          10,200              80         816,000
 (b)............................
Labeling for general purpose                 300               2             600              40          24,000
 laboratory reagents--
 809.10(d)(1)...................
Labeling for analyte specific                300              25           7,500               1           7,500
 reagents--809.10(e)............
Labeling for OTC test sample                  20               1              20             100           2,000
 collection systems for drugs of
 abuse testing--809.10(f).......
Advertising and promotional                  300              25           7,500               1           7,500
 materials for ASRs--809.30(d)..

Labeling of sunlamp products--                30               1              30              10             300
 1040.20(d).....................
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    Total.......................  ..............  ..............  ..............  ..............       8,437,318
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: July 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-18197 Filed 7-31-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 51 (Friday, March 17, 2017)]
[Notices]
[Pages 14265-14269]
[FR Doc No: 2017-05403]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-80236; File No. SR-FICC-2017-003]

Self-Regulatory Organizations; Fixed Income Clearing Corporation;
Notice of Filing of Proposed Rule Change, as Modified by Amendment No.
1 Thereto, To Expand the Types of Entities That Are Eligible To
Participate in Fixed Income Clearing Corporation as Sponsored Members
and Make Other Changes

March 14, 2017.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on March 1, 2017, Fixed Income Clearing Corporation (``FICC'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change. On March 13, 2017, FICC filed Amendment No. 1 to
the proposed rule change, which amended and replaced the original
filing in its entirety. The proposed rule change, as modified by
Amendment No. 1, is described in Items I, II and III below, which Items
have been prepared by the clearing agency.\3\ The Commission is
publishing this notice to solicit comments on the proposed rule change,
as modified by Amendment No. 1 thereto, from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ FICC previously filed SR-FICC-2017-003 on March 1, 2017,
which is being amended and replaced in its entirety by this proposed
rule change.
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I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    The proposed rule change consists of amendments to the Government
Securities Division (``GSD'') Rulebook (``Rules'') \4\ that would (i)
expand the types of entities that are eligible to participate in FICC
as Sponsored Members under Rule 3A (Sponsoring Members and Sponsored
Members) and (ii) make the following other amendments and
clarifications to the Rules:
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    \4\ Capitalized terms not defined herein are defined in the
Rules, available at http://www.dtcc.com/legal/rules-and-procedures.
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     Clarify that the ``Sponsoring Member Omnibus Account''
definition in Rule 1 (Definitions) refers to an ``Account'' as defined
in Rule 1;
     Amend Section 7 of Rule 3A to reference the application of
fails charges to a Sponsoring Member Omnibus Account and to correct
certain typographical errors;
     Amend Section 9 of Rule 3A to correct an out-of-date
cross-reference to Rule 13 (Funds-Only Settlement);
     Amend Section 10 of Rule 3A to reflect the current
Clearing Fund calculation procedures applicable to a Sponsoring Member
Omnibus Account and to correct certain out-of-date cross-references to
Rule 4 (Clearing Fund and Loss Allocation);
     Amend Section 12 of Rule 3A to reflect the current loss
allocation process applicable to Sponsored Member Trades in the event
that the Sponsoring Member is insolvent or otherwise in default to FICC
and to correct certain out-of-date cross-references to Rule 4 and
certain typographical errors;
     Amend Sections 13 and 14 of Rule 3A to correct certain
out-of-date cross-references to Rule 21 (Restrictions on Access to
Services); and
     Amend Section 15 of Rule 3A to specify the standard with
respect to which a Sponsoring Member is deemed by FICC to have
knowledge that one of its Sponsored Members is insolvent or is
otherwise unable to perform on any of its material contracts,
obligations or agreements for purposes of the Sponsoring Member's
obligation to inform FICC of such matter.

II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

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

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

1. Purpose
    This filing constitutes Amendment No. 1 (``Amendment'') to Rule
Filing SR-FICC-2017-003 (``Rule Filing'') previously filed by FICC on
March 1, 2017. This Amendment amends and replaces the Rule Filing in
its entirety. FICC submits this Amendment in order to clarify the
Sponsored Member eligibility requirement as proposed herein.
    The proposed rule change would expand the types of entities that
are

eligible to participate in FICC as Sponsored Members under Rule 3A
(Sponsoring Members and Sponsored Members).
    This filing also contains proposed rule changes that are not
related to the proposed expansion of entity types eligible to be
Sponsored Members but would provide specificity, clarity and additional
transparency to the Rules.
(i) Background on the Proposed Expansion of Sponsored Member
Eligibility
    In 2005, the Commission approved FICC rule filing SR-FICC-2004-
22,\5\ which established a Sponsoring Member-Sponsored Member
relationship in the Rules. Under Rule 3A (Sponsoring Members and
Sponsored Members), Bank Netting Members that are well-capitalized (as
defined under applicable regulations) and have at least $5 billion in
equity capital are permitted to sponsor certain institutional firms
(Sponsored Members) into GSD membership.
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    \5\ Securities Exchange Act Release No. 51896 (June 21, 2005),
70 FR 36981 (June 27, 2005) (SR-FICC-2004-22).
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    Under Rule 3A, a Sponsoring Member is permitted to submit to FICC
for comparison, novation and netting certain types of eligible
transactions between itself and its Sponsored Members (Sponsored Member
Trades).\6\ The Sponsoring Member is required to establish an omnibus
account at FICC for all of its Sponsored Members' FICC-cleared activity
(Sponsoring Member Omnibus Account),\7\ which is separate from the
Sponsoring Member's regular netting account. For operational and
administrative purposes, FICC interacts solely with the Sponsoring
Member as agent for purposes of the day-to-day satisfaction of its
Sponsored Members' obligations to FICC, including their securities and
funds-only settlement obligations.\8\
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    \6\ See Rule 1, definition of ``Sponsored Member Trades.''
Rules, supra note 4.
    \7\ See Rule 1, definition of ``Sponsoring Member Omnibus
Account.'' Id.
    \8\ See Rule 3A, Sections 5, 6, 7, 8 and 9. Id.
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    Novation of eligible trading activity to FICC provides Sponsoring
Members and their Sponsored Members the benefits of FICC's independent
risk management and guaranty of completion of settlement of such
trading activity. In addition, Sponsoring Members also may be able to
offset on their balance sheets their obligations to FICC on Sponsored
Member Trades against their obligations to FICC on other eligible FICC-
cleared activity, as well as take lesser capital charges than would be
required to the extent they engaged in the same trading activity with
their Sponsored Members outside of a central counterparty.\9\ By
potentially alleviating balance sheet and capital constraints on their
Sponsoring Members, participation in FICC as Sponsored Members may
afford eligible institutional firms increased lending capacity and
income.
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    \9\ Sponsoring Members interested in such relief should discuss
this matter with their accounting and regulatory capital experts.
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    Currently, eligibility to become a Sponsored Member is limited to
an entity that is a registered Investment Company under the Investment
Company Act of 1940,\10\ is a ``qualified institutional buyer'' as
defined in Rule 144A \11\ under the Securities Act of 1933,\12\ and has
at least one Sponsoring Member willing to sponsor the entity into GSD
membership.\13\
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    \10\ 15 U.S.C. 80a-1 et seq. The Sponsoring Member-Sponsored
Member relationship has historically been based on a custodial
banking arrangement in which the Sponsored Member Trades novated to
FICC reflect investments by the Sponsoring Member of a registered
Investment Company Sponsored Member's cash through Repo
Transactions. However, a custodial banking relationship between a
Sponsored Member and its Sponsoring Member(s) is not required under
the Rules.
    \11\ See 17 CFR 230.144A.
    \12\ 15 U.S.C. 77a et seq.
    \13\ Currently, GSD has one Sponsoring Member and 1422 Sponsored
Members.
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    The proposed rule change would eliminate the requirement that a
Sponsored Member be a registered Investment Company under the
Investment Company Act of 1940. Nevertheless, in order to ensure that
Sponsored Members are financially sophisticated, FICC would retain the
current requirement that a Sponsored Member be a ``qualified
institutional buyer'' to the extent that its legal entity type falls
under one of the enumerated categories of Rule 144A's definition of a
``qualified institutional buyer.'' For institutional firms whose entity
types do not clearly fall into one of the enumerated categories in Rule
144A's definition of ``qualified institutional buyer,'' FICC would
instead require such Sponsored Members to satisfy the financial
requirements that an entity specifically listed in paragraph (a)(1)(i)
of Rule 144A must satisfy in order to be a ``qualified institutional
buyer'' as specified in that paragraph. Under this alternative
requirement, institutional firms whose entity types are not expressly
included within the definition of ``qualified institutional buyer'' in
Rule 144A (such as non-U.S. sovereign wealth funds) would be eligible
to be Sponsored Members, provided they satisfy the financial
requirements that an entity specifically listed in paragraph (a)(1)(i)
of Rule 144A must satisfy in order to be a ``qualified institutional
buyer'' as specified in that paragraph. Because conceptions of
financial sophistication may change with time, FICC believes it is
appropriate to tie this requirement to the definition of ``qualified
institutional buyer'' in Rule 144A, as such definition may be amended
from time to time.
    FICC believes that expanding eligibility to become a Sponsored
Member beyond registered Investment Companies under the Investment
Company Act of 1940 is appropriate because FICC's risk management of
the Sponsoring Member-Sponsored Member relationship occurs primarily at
the Sponsoring Member level,\14\ and the proposed expansion of the
entity types eligible to participate in FICC as Sponsored Members (and
the commensurate potential volume increase in novated activity) would
not require any changes to FICC's risk management practices applicable
to Sponsoring Members or to FICC's operational practices applicable to
the comparison, novation, netting and settlement of Sponsored Member
Trades.
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    \14\ For example, a Sponsoring Member is responsible under
Section 10 of Rule 3A for posting to FICC the Required Fund Deposit
for its Sponsoring Member Omnibus Account, which includes the sum of
the stand-alone VaR Charges for each of its Sponsored Members'
novated activity calculated separately. In addition, while Sponsored
Members are principally liable to FICC for their settlement
obligations, a Sponsoring Member is also required under Section 2 of
Rule 3A to provide a guaranty to FICC for such obligations. This
means that in the event one or more Sponsored Members does not
satisfy its settlement obligations, FICC is able to invoke the
guaranty provided by the Sponsoring Member.
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    FICC also believes that the proposed expansion of entity types
eligible to participate in FICC as Sponsored Members would help to
safeguard the U.S. financial market by lowering the risk of liquidity
drain, protecting against fire sale risk,\15\ and decreasing settlement
and operational risk.
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    \15\ Fire sale risk is the risk of rapid asset sales of
securities held by cash lenders when a dealer defaults. This rapid
sale has the potential to create a market crisis because cash
lenders are likely to sell large amounts of securities in a short
period of time, which could dramatically reduce the price of such
securities that such lenders are looking to sell.
---------------------------------------------------------------------------

    Expanding the types of institutional firms that are eligible to
participate in FICC as Sponsored Members and thereby benefit from
FICC's guaranty of completion of settlement of their eligible
transactions would mitigate the risk of a large scale exit by such
firms from the U.S. financial market in a stress scenario and therefore
lower the risk of a liquidity drain in such a scenario. Specifically,
to the extent institutional firms would otherwise be

engaging in the same type of eligible trading activity (e.g.,
repurchase agreement transactions) outside of a central counterparty,
having such activity novated to FICC and subject to FICC's guaranty of
completion of settlement would reduce the risk that such institutional
firms discontinue such trading activity in a Netting Member default
situation.
    Similarly, broadening the pool of entities eligible for central
clearing at FICC as Sponsored Members would also reduce the potential
for market disruption from fire sales. Specifically, in a Netting
Member default situation, the more institutional firms participate in
FICC as Sponsored Members, the more trading activity with the defaulted
Netting Member could be centrally liquidated in an orderly manner by
FICC rather than by individual counterparties in potential fire sale
conditions.
    Moreover, to the extent institutional firms would otherwise be
engaging in eligible trading activity (e.g., repurchase agreement
transactions) outside of a central counterparty, expanding the pool of
entities eligible to participate in FICC as Sponsored Members would
also decrease settlement and operational risk in the U.S. financial
market in that such trading activity would now be eligible to be netted
and subject to guaranteed settlement, novation and independent risk
management through FICC.
(ii) Detailed Description of the Proposed Rule Changes Related to the
Expansion of Sponsored Member Eligibility
A. Proposed Changes to Rule 3A, Sections 2(d) and 3(a)
    Sections 2(d) and 3(a) of Rule 3A currently require that a
Sponsored Member be a registered Investment Company under the
Investment Company Act of 1940 and also be a ``qualified institutional
buyer'' as defined in Rule 144A under the Securities Act of 1933.
    FICC is proposing to amend Sections 2(d) and 3(a) of Rule 3A to
eliminate the requirement that a Sponsored Member be a registered
Investment Company under the Investment Company Act of 1940.
    FICC is also proposing to amend Sections 2(d) and 3(a) of Rule 3A
to permit institutional firms whose entity types are not expressly
included within Rule 144A to be Sponsored Members, provided they
satisfy the financial requirements that an entity specifically listed
in paragraph (a)(1)(i) of Rule 144A must satisfy in order to be a
``qualified institutional buyer'' as specified in that paragraph.
    It should be noted that it is currently and, in connection with the
proposed expansion of entity types eligible to participate in FICC as
Sponsored Members, would continue to be the responsibility of each
Sponsored Member and its Sponsoring Member(s) to evaluate whether
entering into a given Sponsored Member Trade is consistent with a
Sponsored Member's legal and regulatory requirements, and that FICC has
no responsibility or liability in the event that a Sponsoring Member
submits data to FICC for a Sponsored Member Trade that is inconsistent
with those requirements.
B. Proposed Changes to Rule 3A, Sections 3(c) and 4
    To account for the fact that, as proposed, non-U.S. entities that
meet the proposed requirements would be permitted to be Sponsored
Members, FICC is proposing to amend Section 3(c) of Rule 3A to provide
that Sponsored Members that are FFI Members \16\ would be required to
be FATCA Compliant and to amend Section 4 of Rule 3A to provide that
Sponsored Members and their Sponsoring Members would be required to
comply with global sanctions laws.\17\
---------------------------------------------------------------------------

    \16\ Pursuant to Rule 1, the term ``FFI Member'' means ``any
Person that is treated as a non-U.S. entity for U.S. federal income
tax purposes.'' For the avoidance of doubt, the term FFI Member also
includes ``any Member that is a U.S. branch of an entity that is
treated as a non-U.S. entity for U.S. federal income tax purposes.''
Rules, supra note 4.
    \17\ Although GSD has Members, including certain Bank Netting
Members, which are non-U.S. entities, currently, there are no
Sponsoring Members that are non-U.S. entities.
    Any future Sponsoring Member or Sponsored Member that is an FFI
Member will be subject to the same FATCA Compliance screening and
global sanctions screening as any other Member that is a non-U.S.
entity.
---------------------------------------------------------------------------

(iii) Other Proposed Rule Changes
    This filing also contains proposed rule changes that are unrelated
to the proposed expansion of entity types eligible to be Sponsored
Members. These proposed rule changes would provide specificity, clarity
and additional transparency to the Rules as described below.
A. Proposed Changes to Rule 1 (Definitions)
    FICC is proposing to clarify that the ``Sponsoring Member Omnibus
Account'' definition in Rule 1 (Definitions) refers to an ``Account''
as defined in Rule 1.
B. Proposed Changes to Rule 3A, Section 7
    FICC is proposing to amend Section 7 of Rule 3A to reference the
application of fails charges \18\ to a Sponsoring Member Omnibus
Account in the same manner as such charges are applied to Netting
Members pursuant to Rule 11 (Netting System) and to correct certain
typographical errors.
---------------------------------------------------------------------------

    \18\ The term ``fails charge'' refers to the charge imposed by
FICC on Netting Members for a delivery failure in Treasury
Securities or debentures issued by Fannie Mae, Freddie Mac or the
Federal Home Loan Banks, pursuant to Section 14 of Rule 11. Rules,
supra note 4.
---------------------------------------------------------------------------

    With respect to the application of fails charges, in 2009, FICC
received Commission approval of a rule filing to impose fails charges
on Netting Members, which was an action that had been requested of GSD
by the Treasury Markets Practices Group (``TMPG'') \19\ in order to
encourage market participants to resolve fails promptly.\20\ The
approved rule changes were included in Section 14 of Rule 11 (Netting
System) and were stated to apply to Netting Members. As an account of a
Netting Member (acting as a Sponsoring Member), FICC has imposed fails
charges, if applicable, on Sponsoring Members for their Sponsoring
Member Omnibus Accounts since the implementation of the charges in
2009. In reviewing the Rules in connection with this present filing,
FICC believes that the application of the fails charges to a Sponsoring
Member's Sponsoring Member Omnibus Account should be made clear in Rule
3A for transparency.
---------------------------------------------------------------------------

    \19\ The TMPG is a group of market participants that is active
in the Treasury securities market and is sponsored by The Federal
Reserve Bank of New York.
    \20\ Securities Exchange Act Release No. 59802 (April 20, 2009),
74 FR 19248 (April 28, 2009) (SR-FICC-2009-03).
---------------------------------------------------------------------------

C. Proposed Changes to Rule 3A, Section 9
    FICC is proposing to amend Section 9 of Rule 3A to correct an out-
of-date cross-reference to Rule 13 (Funds-Only Settlement).
D. Proposed Changes to Rule 3A, Section 10
    FICC is proposing to amend Section 10 of Rule 3A to reflect the
current Clearing Fund calculation procedures applicable to a Sponsoring
Member's Sponsoring Member Omnibus Account. Specifically, FICC is
proposing to amend Section 10 of Rule 3A to specify that a Sponsoring
Member's Sponsoring Member Omnibus Account Required Fund Deposit would
be equal to the sum of the following: (I) The sum of the VaR Charges
for all of the Sponsored Members whose activity is represented in the
Sponsoring Member Omnibus Account as derived pursuant to Section
1b(a)(i) of Rule 4 (Clearing Fund and Loss Allocation), and (II) all
amounts derived pursuant to the provisions of Rule 4 other than
pursuant to Section

1b(a)(i) of Rule 4 computed at the level of the Sponsoring Member
Omnibus Account. The proposed rule changes maintain the substance of
the calculation of the Required Fund Deposit for a Sponsoring Member's
Sponsoring Member Omnibus Account (i.e., the main charges applicable to
the individual Sponsored Members in the account are summed and then
certain components are applied at the level of the Sponsoring Member
Omnibus Account) but update the rules provisions to reflect the current
Clearing Fund calculation terminology and delete references to terms
that are no longer used in the Rules (such as ``Clearing Fund
components related to Fail Net Settlement Positions and Funds-Only
Settlement amounts'').
    FICC is also proposing to amend Section 10 of Rule 3A to specify
that for purposes of calculating the Unadjusted GSD Margin Portfolio
Amount applicable to a Sponsoring Member Omnibus Account, FICC would
apply the higher of the Required Fund Deposit calculation as of the
beginning of the current Business Day and intraday on the current
Business Day.
    In 2011, FICC received Commission approval to re-calculate each
Business Day, at times established by FICC for this purpose, the amount
of the VaR Charge applicable to each Margin Portfolio of a Member,
based upon the open, intraday positions of such Margin Portfolio, for
purposes of establishing whether a Member would be required to make
payment of an additional amount (the Member's ``Intraday Supplemental
Fund Deposit'') to its Required Fund Deposit.\21\ The approved rule
changes were included in Section 2a of Rule 4 (Clearing Fund and Loss
Allocation). Prior to this approval, Clearing Fund requirements
(including with respect to a Sponsoring Member's Sponsoring Member
Omnibus Account) were calculated once each Business Day. Since the
approval of these rule changes in 2011, FICC has calculated the
Unadjusted GSD Margin Portfolio Amount applicable to a Sponsoring
Member Omnibus Account based on the higher of the Required Fund Deposit
calculation as of the beginning of the current Business Day and
intraday on the current Business Day. In reviewing the Rules in
connection with this present filing, FICC believes that this
calculation procedure for the Unadjusted GSD Margin Portfolio Amount
applicable to a Sponsoring Member Omnibus Account should be made clear
in Rule 3A for transparency.
---------------------------------------------------------------------------

    \21\ Securities Exchange Act Release No. 63986 (February 28,
2011), 76 FR 12144 (March 4, 2011) (SR-FICC-2010-09).
---------------------------------------------------------------------------

    FICC is also proposing to amend Section 10 of Rule 3A to correct
certain out-of-date cross-references to Rule 4 (Clearing Fund and Loss
Allocation).
E. Proposed Changes to Rule 3A, Section 12
    FICC is proposing to amend Section 12 of Rule 3A to reflect the
current loss allocation process applicable to Sponsored Member Trades
in the event that the Sponsoring Member is insolvent or otherwise in
default to FICC. Specifically, FICC is proposing to amend Section 12 of
Rule 3A to specify that any Remaining Loss incurred by FICC would be
allocated to the Tier One Netting Members in accordance with the
principles set forth in Section 7(d) of Rule 4 (Clearing Fund and Loss
Allocation).
    In 2011, FICC received Commission approval for its current loss
allocation process set forth in Rule 4, which provides for loss
mutualization of any Remaining Loss among all Tier One Netting
Members.\22\ FICC proposes to update references in Section 12 of Rule
3A to reference the current loss allocation process for Tier One
Netting Members.
---------------------------------------------------------------------------

    \22\ Id.
---------------------------------------------------------------------------

    FICC also proposes to amend Section 12 of Rule 3A to correct
certain out-of-date cross-references to Rule 4 (Clearing Fund and Loss
Allocation) and to correct certain typographical errors.
F. Proposed Changes to Rule 3A, Sections 13 and 14
    FICC is proposing to amend Sections 13 and 14 of Rule 3A to correct
certain out-of-date cross-references to Rule 21 (Restrictions on Access
to Services).
G. Proposed Changes to Rule 3A, Section 15
    FICC is proposing to amend Section 15 of Rule 3A to specify the
standard with respect to which a Sponsoring Member is deemed by FICC to
have knowledge that one of its Sponsored Members is insolvent or is
otherwise unable to perform on any of its material contracts,
obligations or agreements for purposes of the Sponsoring Member's
obligation to inform FICC of such matter. Specifically, FICC is
proposing to specify that if one or more duly authorized
representatives of a Sponsoring Member, in its capacity as such, has
knowledge that one of its Sponsored Members is insolvent or otherwise
unable to perform on any of its material contracts, obligations or
agreements, that such knowledge triggers the Sponsoring Member's
obligation to inform FICC of such matter.
2. Statutory Basis
    Section 17A(b)(3)(F) of the Act requires, in part, that the Rules
be designed to (i) ``promote the prompt and accurate clearance and
settlement of securities transactions,'' \23\ and (ii) ``remove
impediments to and perfect the mechanism of a national system for the
prompt and accurate clearance and settlement of securities
transactions, and, in general, to protect investors and the public
interest.'' \24\
---------------------------------------------------------------------------

    \23\ 15 U.S.C. 78q-1(b)(3)(F).
    \24\ Id.
---------------------------------------------------------------------------

    By expanding the types of entities that may participate in FICC as
Sponsored Members, FICC believes that the proposed rule change would
help to safeguard the U.S. financial market by lowering the risk of
liquidity drain (through FICC's guaranty of completion of settlement
for a greater number of eligible transactions), protecting against fire
sale risk (through FICC's ability to centralize and control the
liquidation of a greater portion of a failed counterparty's portfolio)
and decreasing settlement and operational risk (by making a greater
number of transactions eligible to be netted and subject to guaranteed
settlement, novation and independent risk management through FICC). By
lowering the risk of liquidity drain in the U.S. financial market and
protecting against fire sale risk, FICC believes the proposed rule
change would ``protect investors and the public interest'' consistent
with the requirements of the Act, cited above. By decreasing settlement
and operational risk, FICC believes the proposed rule change would also
``promote the prompt and accurate clearance and settlement of
securities transactions'' and ``remove impediments to and perfect the
mechanism of a national system for the prompt and accurate clearance
and settlement of securities transactions'' consistent with the
requirements of the Act, cited above.
    By providing specificity, clarity, and additional transparency to
the Rules, the proposed rule changes to Rule 1 (Definitions) and Rule
3A (Sponsoring Members and Sponsored Members) that are unrelated to the
proposed expansion of entity types eligible to be Sponsored Members
would provide Members with a better understanding of the Rules, making
errors in the performance of their responsibilities to FICC less likely
to occur and thereby ensuring that FICC's clearing and settlement
system works efficiently. Therefore, FICC

believes the proposed rule change would ``promote the prompt and
accurate clearance and settlement of securities transactions'' by FICC
and also ``remove impediments to and perfect the mechanism of a
national system for the prompt and accurate clearance and settlement of
securities transactions'' consistent with the requirements of the Act,
cited above.

(B) Clearing Agency's Statement on Burden on Competition

    FICC believes that the proposed rule changes associated with the
expansion of entity types eligible to be Sponsored Members would
promote competition by increasing the types of entities that may
participate in FICC as Sponsored Members and therefore permit more
market participants to utilize FICC's services.
    At the same time, participation in FICC as a Sponsored Member would
continue to be limited to legal entities that are either ``qualified
institutional buyers'' as defined in Rule 144A under the Securities Act
of 1933, or that otherwise satisfy the financial requirements that an
entity specifically listed in paragraph (a)(1)(i) of Rule 144A must
satisfy in order to be a ``qualified institutional buyer'' as specified
in that paragraph, and that have at least one Sponsoring Member willing
to sponsor them into GSD membership. These limitations may impact
institutional firms that are unable to satisfy such eligibility
requirements by excluding them from being able to novate their eligible
activity to FICC (and avail themselves of the commensurate benefits
described in Section 3(a)(i)--Background on the Proposed Expansion of
Sponsored Member Eligibility above). Nevertheless, FICC believes that
any resulting burden on competition would be necessary and appropriate
in furtherance of the Act, as permitted by Section 17A(b)(3)(I) of the
Act,\25\ in light of the fact that such eligibility requirements are
designed to allow FICC to ensure the financial sophistication of
Sponsored Members and to prudently manage the risk associated with
Sponsored Members' participation in FICC. Moreover, FICC would not
restrict the ability of institutional firms to enter into eligible
transactions with Netting Members (including Sponsoring Members)
outside of GSD.
---------------------------------------------------------------------------

    \25\ 15 U.S.C. 78q-1(b)(3)(I).
---------------------------------------------------------------------------

    FICC believes that the proposed changes to Rule 1 (Definitions) and
Rule 3A (Sponsoring Members and Sponsored Members) that are unrelated
to the proposed expansion of entity types eligible to be Sponsored
Members would not have an impact, nor impose any burden, on competition
because each of such proposed changes would simply provide specificity,
clarity and additional transparency within the Rules.

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants, or Others

    Written comments relating to the proposed rule change have not been
solicited or received. FICC will notify the Commission of any written
comments received by FICC.

III. Date of Effectiveness of the Proposed Rule Change, and Timing for
Commission Action

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self- regulatory organization consents, the Commission will:
    (A) By order approve or disapprove such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change, as modified by Amendment No. 1, is consistent with the Act.
Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-FICC-2017-003 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-FICC-2017-003. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of FICC and on
DTCC's Web site (http://dtcc.com/legal/sec-rule-filings.aspx). All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-FICC-2017-003 and should be
submitted on or before April 7, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\26\
---------------------------------------------------------------------------

    \26\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2017-05403 Filed 3-16-17; 8:45 am]
BILLING CODE 8011-01-P


Ambient Air Quality Standards Regulation ( Not for Inclusion into the Federal SIP)

Ozone AREA CLASSIFICATION BOUNDARY Denver 1 Hour Ozone Area ( effective 10/ 11/ 01) Attainment/ Maintenance All of Denver, Jefferson, and Douglas Counties; Boulder County ( excluding Rocky Mountain National Park) and the Automobile Inspection and Readjustment Program portions of Adams and Arapahoe Counties. See attached map.

8 Hour Ozone Control Area Designation Deferred All of the Counties of Adams, Arapahoe, Boulder, Douglas, Elbert, Jefferson, Larimer, Morgan, and Weld, and all of the Cities and Counties of Denver and Broomfield. See attached map. III. M. 8 Hour Ozone Control Area VIII. S Denver 8 Hour Ozone Adopted: March 12, 2004 The purpose of this rule change is to define the geographic scope of the Denver 8 hour Ozone Nonattainment Area for purposes of State law and Commission regulations. This definition is not to be included in the state implementation plan.

The Commission adopted this definition in conjunction with the Ozone Action Plan and certain revisions to of Regulation No. 7 to reduce emissions of volatile organic compounds from oil and gas operations and from stationary and portable reciprocal internal combustion engines. Such control measures in sections XVI, XVI, and XVII VI of Regulation No. 7 apply in the Denver 8 hour Ozone Nonattainment Area, as defined in the Ambient Air Quality Standards Regulation.

The U. S. EPA will also define the geographic scope of the Denver 8 hour Ozone Nonattainment Area. The Commission intends for its State definition of such area to be identical to the federal definition. The Commission would ordinarily incorporate the federal definition by reference but the Commission cannot do that in this case because EPA has not yet adopted a final rule defining the Denver 8 hour Ozone Nonattainment Area and will not do so until April 15, 2004 at the earliest. Section 24 4 103( 12.5), C. R. S. prohibits the Commission from adopting a later edition of the federal rule. In the event the area defined by the federal rule is smaller than the area defined by this rule, the Commission will promptly revise this rule to conform to the federal rule.

The statutory authority to define the nonattainment area is set out in sections 25 7 105( 1)( a) and ( 1)( b); 25 7 106( 1)( b)( VIII), ( 1)( c) and ( 5); and 25 7 109( 1)( a) and ( 2), C. R. S.


[Federal Register Volume 86, Number 38 (Monday, March 1, 2021)]
[Notices]
[Page 11994]
[FR Doc No: 2021-04153]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13755-006]

FFP Missouri 12, LLC; Notice of Application for Amendment of
License, Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Proceeding: Application for non-capacity amendment of
license.
    b. Project No.: 13755-006.
    c. Date Filed: January 19, 2021.
    d. Licensee: FFP Missouri 12, LLC.
    e. Name of Project: Allegheny Lock and Dam 2 Hydroelectric Project.
    f. Location: The project is located on the Allegheny River in the
City of Sharpsburg in Allegheny County, Pennsylvania.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Licensee Contact: Paul Jacob, FFP Missouri 12, LLC, c/o Rye
Development, 745 Atlantic Ave, 8th Floor, Boston, MA 02111, (617) 7010-
3288<EMAIL_ADDRESS>    i. FERC Contact: Rebecca Martin,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    j. Deadline for filing comments, interventions, and protests
Deadline for filing comments, motions to intervene, and protests: March
25, 2021.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, and protests using the Commission's
eFiling system at http://www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>(866) 208-3676 (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, you may
submit a paper copy. Submissions sent via the U.S. Postal Service must
be addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Submissions sent via any other carrier must be addressed to: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, Maryland 20852. The first page of any filing should
include docket number P-13755-006. Comments emailed to Commission staff
are not considered part of the Commission record.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervenor files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency.
    k. Description of Request: The Allegheny Lock and Dam Project has
not yet been constructed. The applicant is proposing to modify the
approved project works identified in Ordering Paragraph (B) of the
Order Issuing Original License, issued March 13, 2017, to: (1) Change
the design of the intake channel and intake structure to a combined
reinforced concrete ``U'' section 150-foot-long, 90-foot-wide, and 57-
foot-high; (2) delete the two 45-foot-wide, 40-foot-high spill gates
from the intake structure; (3) delete the 1,100-foot-long series of
2.5-foot-high adjustable crest gates on top of the dam; (4) change the
design of the powerhouse (the powerhouse will remain a concrete
structure supported on a mat foundation but will be decreased in size
from 180-foot long, 170-foot wide, and 70-foot high to a building 150-
foot long, 90-foot wide, and 70-foot high); (5) decrease the number of
generating units from three identical Kaplan turbine generators having
an installed capacity of 17 megawatts (MW) to two identical 5.0 MW
units for a combined installed capacity of 10.0 MW; and (6) change the
design of the tailrace to an excavated channel 150-foot-long and 90-
foot-wide. As a result of these modifications the approved 17 MW
generating capacity would be reduced to 10 MW and the size of the
project boundary would be decreased to accommodate the smaller
footprint of the project.
    l. Locations of the Application: This filing may be viewed on the
Commission's website at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. You may also register
online at http://www.ferc.gov/docs-filing/esubscription.asp to be
notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. Agencies may
obtain copies of the application directly from the applicant.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214, respectively. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Documents: Any filing must (1) bear in all
capital letters the title ``COMMENTS'', ``PROTEST'', or ``MOTION TO
INTERVENE'' as applicable; (2) set forth in the heading the name of the
applicant and the project number of the application to which the filing
responds; (3) furnish the name, address, and telephone number of the
person commenting, protesting or intervening; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis. Any filing made by an intervenor must be accompanied
by proof of service on all persons listed in the service list prepared
by the Commission in this proceeding, in accordance with 18 CFR
385.2010.

    Dated: February 23, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-04153 Filed 2-26-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 33 (Friday, February 16, 2018)]
[Rules and Regulations]
[Pages 6968-6970]
[FR Doc No: 2018-03252]

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

40 CFR Part 52

[EPA-R01-OAR-2017-0150; FRL-9973-18-Region 1]

Air Plan Approval; Connecticut; Nonattainment New Source Review
Permit Requirements for the 2008 8-Hour Ozone Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve the state implementation plan (SIP) revision
submitted on March 9, 2017 by the Connecticut Department of Energy and
Environmental Protection (CT DEEP) addressing the nonattainment new
source review (NNSR) requirements for the 2008 8-hour ozone National
Ambient Air Quality Standard (NAAQS). The SIP revision addresses both
of Connecticut's ozone nonattainment areas for the 2008 ozone NAAQS;
the Greater Connecticut area and the Connecticut portion of the New
York-N. New Jersey-Long Island, NY-NJ-CT area. The Connecticut portion
of the New York-N. New Jersey-Long Island, NY-NJ-CT ozone nonattainment
area consists of Fairfield, New Haven, and Middlesex counties. The
Greater Connecticut nonattainment area includes the rest of the State.
This action is being taken pursuant to the Clean Air Act (CAA or Act)
and its implementing regulations.

DATES: This rule is effective on March 19, 2018.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R01-OAR-2017-0150. 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
New England Regional Office, Office of Ecosystem Protection, Air
Quality Planning Unit, 5 Post Office Square--Suite 100, Boston, MA. The
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.

FOR FURTHER INFORMATION CONTACT: Donald Dahl, U.S. Environmental
Protection Agency, EPA New England Regional Office, Office of Ecosystem
Protection, Air Permits, Toxics, and Indoor Programs Unit, 5 Post
Office Square--Suite 100, (Mail code OEP05-2), Boston, MA 02109-3912.
Mr. Dahl's telephone number is<PHONE_NUMBER>; email address:
[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. Response to Comment
III. Final Action
IV. Statutory and Executive Order Reviews

I. Background and Purpose

    On August 14, 2017, EPA published a Notice of Proposed Rulemaking
(NPR) (82 FR 37829) and Direct Final Rulemaking (DFRN) (82 FR 37819)
proposing to approve and approving, respectively, Connecticut's
demonstration that its nonattainment new source review regulations
approved into the state implementation plan meet the requirements of
the 2008 8-hour ozone standard. The demonstration was submitted on
March 9, 2017 by the CT DEEP as a SIP revision. In the DFRN, EPA stated
that if an adverse comment were to be submitted to EPA by September 13,
2017, the action would be withdrawn and not take effect, and a final
rule would be issued based on the NPR. EPA received one adverse comment
prior to the close of the comment period. Therefore, EPA withdrew the
DFRN on October 13, 2017 (82 FR 47630). This action is a final rule
based on the NPR. A detailed discussion of Connecticut's March 9, 2017
SIP revision and EPA's rationale for approving the SIP revision was
provided in the DFRN and will not be restated here, except to the
extent it is relevant to our response to the public comment we
received.

II. Response to Comment

    EPA received one adverse comment on its August 14, 2017 (82 FR
37829) Notice of Proposed Rulemaking.
    Comment: The commenter stated that EPA is required to evaluate
Connecticut's NNSR SIP as it relates to the ozone transport region
(OTR) requirements in section 184 of the CAA.
    Response: The Connecticut SIP's NNSR requirements are at least as
stringent, and in some instances more

stringent, than what is required by CAA section 184. That is the reason
why EPA's DFRN did not discuss the section 184 requirements. As stated
in the DFRN, Connecticut's SIP-approved NNSR regulation contains the
CAA's NNSR requirements applicable to serious and severe nonattainment
areas, even though the two nonattainment areas in the State are now
classified as moderate nonattainment under the 2008 8-hour ozone NAAQS.
Connecticut retained these requirements based on its designations and
classifications associated with the earlier, revoked 1-hour ozone
standard, effective November 15, 1990. For example, the Connecticut
SIP's major stationary source threshold for nitrogen oxides
(NOX) and volatile organic compounds (VOC) in the area of
the State defined in the SIP as a ``Severe nonattainment area for
ozone'' is 25 tons per year. The SIP defines ``Severe nonattainment
area for ozone'' as 24 specific towns, independently from how these
towns are currently classified under the ozone NAAQS. The SIP defines
the remaining towns in the State as ``Serious nonattainment area for
ozone.'' The Connecticut SIP's major stationary source threshold for
NOX and VOC in the area of the State defined in the SIP as a
``Serious nonattainment area for ozone'' is 50 tons per year. Section
184(b)(2) of the CAA provides that stationary sources that emit or have
the potential to emit at least 50 tons per year of VOCs shall be
considered a major stationary source and are subject to the
requirements that would be applicable to major stationary sources if
the area were classified as a moderate nonattainment area. For areas
within the OTR that are classified as marginal nonattainment, moderate
nonattainment, attainment, or unclassifiable, the major stationary
source threshold for sources of NOX is 100 tons per year.
See 40 CFR 51.165(a)(1)(iv)(A)(2). Thus, Connecticut's NNSR SIP
contains major stationary source thresholds that are at least as
stringent as, and in some instances more stringent than, the thresholds
required by CAA section 184 and EPA's implementing regulations.
    Connecticut's NNSR SIP also contains more stringent modification
thresholds for VOC and NOX, as precursors to ozone, in the
State's SIP definition of ``Major modification.'' The Connecticut SIP's
major modification thresholds for NOX and VOC are both 25
tons per year. Under the CAA's implementing regulations, for areas
within the OTR that are classified as marginal nonattainment, moderate
nonattainment, attainment, or unclassifiable, the major modification
thresholds for both ozone precursors is 40 tons per year. See 40 CFR
51.165(a)(1)(x). Thus, Connecticut's NNSR SIP contains major
modification thresholds that are more stringent than the thresholds
required by CAA section 184 and EPA's implementing regulations.
    Connecticut's NNSR SIP is at least as stringent in all respects as
compared to the OTR requirements contained in CAA section 184. By
demonstrating that Connecticut's NNSR SIP meets the requirements for
serious or severe nonattainment areas, the Connecticut SIP is shown to
be as stringent, or in some instances, more stringent, than the
requirements of section 184 of the CAA as it pertains to the NNSR
permit program.

III. Final Action

    EPA is approving Connecticut's March 9, 2017, SIP revision
addressing the NNSR requirements for the 2008 8-hour ozone NAAQS for
both nonattainment areas in the State. The approval encompasses both
the original designations under the 2008 8-hour ozone NAAQS of marginal
and the subsequent reclassification of both nonattainment areas to
moderate. The approval also includes the applicable NNSR provisions of
Connecticut's regulations that satisfy the CAA's anti-backsliding
requirements. That is, Connecticut's SIP retains the NNSR requirements
applicable to serious and severe nonattainment areas (associated with
the earlier, revoked 1-hour ozone standard), even though the two
nonattainment areas in the State are now classified as moderate
nonattainment areas for the 2008 ozone NAAQS. By demonstrating that
Connecticut's SIP meets the NNSR requirements for serious and severe
nonattainment areas, EPA has concluded that the State's submission
fulfills the requirements of 40 CFR 51.1114, and meets the requirements
of CAA sections 110, 182, and 184 as well as the minimum SIP
requirements of 40 CFR 51.165.

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 (Public Law 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 Second Circuit by April 17, 2018. 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, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Reporting and recordkeeping requirements, Volatile organic compounds.

    Dated: February 6, 2018.
Alexandra Dapolito Dunn,
Regional Administrator, EPA New England.

    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 52.377 is amended by adding paragraph (r) to read as
follows:

Sec.  52.377  Control strategy: Ozone.

* * * * *
    (r) Approval--Submittal from the Connecticut Department of Energy
and Environmental Protection dated March 9, 2017, to address the
nonattainment new source review requirements for the 2008 8-hour ozone
NAAQS for the Greater Connecticut and the New York-N. New Jersey-Long
Island, NY-NJ-CT ozone nonattainment areas, as it meets the
requirements for both the State's marginal and moderate
classifications.

[FR Doc. 2018-03252 Filed 2-15-18; 8:45 am]
BILLING CODE 6560-50-P


"Cline, John R."<EMAIL_ADDRESS> 04/02/2007 12:04 PM

To

Group A-AND-R-DOCKET@EPA

cc

Subject

Docket ID No. EPA-HQ-OAR-2001-0017

                                Docket ID No. EPA-HQ-OAR-2001-0017

                                Petition for Reconsideration

                                <<NMA.Part50AppJ.PetitionforReconsideration.033007.pdf>>

Dear Sir or Madam:

        On behalf of the National Mining Association, I request that the attached petition for reconsideration be added to

the above-referenced docket.  Should you have any questions, please do not hesitate to contact me.  Thank you.

John R. Cline

TROUTMAN SANDERS LLP

Troutman Sanders Building

1001 Haxall Point

Richmond, Virginia  23219

804-697-1265 (direct)

804-698-5134 (fax)

<EMAIL_ADDRESS>

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