[Federal Register Volume 76, Number 79 (Monday, April 25, 2011)]
[Rules and Regulations]
[Pages 22805-22807]
[FR Doc No: 2011-9899]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2006-N-0045] (Formerly Docket No. 2006N-0109)

Medical Devices; Reclassification of the Topical Oxygen Chamber
for Extremities

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is reclassifying the
topical oxygen chamber for extremities (TOCE) from class III to class
II. This device is intended to surround a patient's limb and apply
humidified oxygen topically at a pressure slightly greater than
atmospheric pressure to aid healing of chronic skin ulcers, such as
bedsores. This reclassification is on the Secretary of Health and Human
Services's own initiative based on new information. This action is
being taken under the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) as amended by the Medical Device Amendments of 1976 (the 1976
Amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the
Food and Drug Administration Modernization Act of 1997 (FDAMA).
Elsewhere in this issue of the Federal Register, FDA is announcing the
availability of the guidance document entitled ``Class II Special
Controls Guidance Document: Topical Oxygen Chamber for Extremities,''
which will serve as the special control for this device.

DATES: This rule is effective May 25, 2011.

FOR FURTHER INFORMATION CONTACT: Charles N. Durfor, Center for Devices
and Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The FD&C Act (21 U.S.C. 301 et seq.), as amended by the 1976
Amendments (Pub. L. 94-295), the SMDA (Pub. L. 101-629), and the FDAMA
(Pub. L. 105-115), established a comprehensive system for the
regulation of medical devices intended for human use. Section 513 of
the FD&C Act (21 U.S.C. 360c) established three categories (classes) of
devices, depending on the regulatory controls needed to provide
reasonable assurance of their safety and

effectiveness. The three categories of devices are class I (general
controls), class II (special controls), and class III (premarket
approval).
    Under section 513 of the FD&C Act, devices that were in commercial
distribution before May 28, 1976 (the date of enactment of the 1976
Amendments), generally referred to as preamendments devices, are
classified after FDA has: (1) Received a recommendation from a device
classification panel (an FDA advisory committee); (2) published the
panel's recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
    Devices that were not in commercial distribution prior to May 28,
1976, generally referred to as postamendments devices, are classified
automatically by statute (section 513(f) of the FD&C Act (21 U.S.C.
360c(f)) into class III without any FDA rulemaking process.
Postamendment devices remain in class III and require premarket
approval, unless the device is reclassified into class I or II, or FDA
issues an order finding the device to be substantially equivalent, in
accordance with section 513(i) of the FD&C Act (21 U.S.C. 360c(i)), to
a predicate device that does not require premarket approval. The agency
determines whether new devices are substantially equivalent to
predicate devices by means of premarket notification procedures in
section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 of the
regulations (21 CFR part 807).
    A preamendments device that has been classified into class III may
be marketed, by means of premarket notification procedures, without
submission of a premarket approval application (PMA) until FDA issues a
final regulation under section 515(b) of the FD&C Act (21 U.S.C.
360e(b)) requiring premarket approval.
    Section 513(e) of the FD&C Act (21 U.S.C. 360c(e)) governs
reclassification of classified preamendments devices. This section
provides that FDA may, by rulemaking, reclassify a device based upon
``new information.'' FDA can initiate a reclassification under section
513(e) of the FD&C Act or an interested person may petition FDA to
reclassify a preamendments device. The term ``new information,'' as
used in section 513(e) of the FD&C Act, includes information developed
as a result of a reevaluation of the data before the agency when the
device was originally classified, as well as information not presented,
not available, or not developed at that time. (See, e.g., Holland
Rantos v. United States Department of Health, Education, and Welfare,
587 F.2d 1173, 1174 n.1 (DC Cir. 1978); Upjohn v. Finch, 422 F.2d 944
(6th Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966)).
    Reevaluation of the data previously before the agency is an
appropriate basis for subsequent regulatory action where the
reevaluation is made in light of newly available regulatory authority
(see Bell v. Goddard, supra, 366 F.2d at 181; Ethicon, Inc. v. FDA, 762
F. Supp. 382, 389-91 (D.D.C. 1991)), or in light of changes in
``medical science.'' (See Upjohn v. Finch, supra, 422 F.2d at 951).
Regardless of whether data before the agency are past or new data, the
``new information'' to support reclassification under section 513(e)(1)
of the FD&C Act must be ``valid scientific evidence,'' as defined in
section 513(a)(3) of the FD&C Act (21 U.S.C. 360c(a)(3)) and 21 CFR
860.7(c)(2). (See, e.g., General Medical Co. v. FDA, 770 F.2d 214 (DC
Cir. 1985); Contact Lens Assoc. v. FDA, 766 F.2d 592 (DC Cir.), cert.
denied, 474 U.S. 1062 (1985)). FDA relies upon ``valid scientific
evidence'' in the classification process to determine the level of
regulation for devices. For the purpose of reclassification, the valid
scientific evidence upon which the agency relies must be publicly
available. Publicly available information excludes trade secret and/or
confidential commercial information, e.g., the contents of a pending
PMA. (See section 520(c) of the FD&C Act (21 U.S.C. 360j(c)).
    In accordance with section 513(e) of the FD&C Act and 21 CFR
860.130(b)(1), based on new information with respect to the device,
FDA, on its own initiative, is reclassifying this device from class III
to class II.

II. Regulatory History of the Device

    As discussed in the proposed rule, the agency issued a final rule
classifying this device into class III (53 FR 23856, June 24, 1988). In
August 1997, in response to FDA's order for the submission of
information on the TOCE, two manufacturers submitted 515(i) summaries
of safety and effectiveness information to the agency for the TOCE. FDA
referred the 515(i) submissions to the General and Plastic Surgery
Devices Panel (GPS Panel) for their recommendation on the requested
reclassification. At a public meeting on November 17, 1998, the GPS
Panel recommended that the device be retained in class III.
    Since the 1998 GPS Panel meeting, three studies (two prospective
and one retrospective) reported safe use and adequate healing of wounds
using the TOCE. In addition, FDA has evaluated more than 20 years of
clinical experience with the device and the agency's Medical Device
Reports, and has found sufficient information to determine the risks to
health associated with the use of this device and develop appropriate
special controls.
    As a result, in the Federal Register of April 6, 2006 (71 FR
17390), FDA proposed to reclassify the TOCE device from class III to
class II. The device is intended to surround a patient's limb and apply
humidified oxygen topically at a pressure slightly greater than
atmospheric pressure to aid healing of chronic skin ulcers such as
bedsores. Elsewhere in the Federal Register of April 6, 2006 (71 FR
17476), FDA announced the availability of the draft guidance document
entitled ``Class II Special Controls Draft Guidance Document: Topical
Oxygen Chamber for Extremities,'' which FDA intended to serve as the
special control for this device type following the effective date of
the final reclassification rule.
    Interested persons were invited to comment until July 5, 2006, on
the proposed regulation and special controls draft guidance document.

III. Analysis of Comments and FDA's Response

    FDA received 11 comments on the proposed rule. The comments
received discussed academic literature, clinical experiences, and
patient outcomes that support the proposed reclassification's
determinations of the safety and effectiveness of the TOCE device. The
comments did not recommend any changes to the proposed regulation.

IV. Summary of Final Rule

    Based on the information discussed in the preamble to the proposed
rule, the comments on the proposed rule, a review of the Manufacturer
and User Facility Device Experience (MAUDE) database, and a review of
current scientific literature, FDA concludes that special controls, in
conjunction with general controls, will provide reasonable assurance of
the safety and effectiveness of TOCE. The agency is, therefore,
reclassifying TOCE from class III (premarket approval) into class II
(special controls) and issuing a final rule that revises 21 CFR
878.5650. Elsewhere in this issue of the Federal Register, FDA is
announcing the availability of the guidance document entitled ``Class
II Special Controls Guidance Document: Topical Oxygen Chamber for
Extremities,'' which will serve as the special control for this device.
Following the effective date of this final classification rule, any
firm

submitting a 510(k) premarket notification for a TOCE will need to
address the issues covered in the special controls guidance. However,
the firm need only show that its device meets the recommendations of
the guidance or in some other way provides equivalent assurances of
safety and effectiveness.
    Section 510(m) of the FD&C Act (21 U.S.C. 360(m)) provides that FDA
may exempt a class II device from the premarket notification
requirements under section 510(k) of the FD&C Act if FDA determines
that premarket notification is not necessary to provide reasonable
assurance of the safety and effectiveness of the device. FDA has
determined that premarket notification is necessary to provide
reasonable assurance of the safety and effectiveness of the TOCE and,
therefore, this device type is not exempt from premarket notification
requirements.

V. Environmental Impact

    The agency has determined under 21 CFR 25.34(b) that this
reclassification action is of a type that does not individually or
cumulatively have a significant effect on the human environment.
Therefore, neither an environmental assessment nor an environmental
impact statement is required.

VI. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this final rule is not a significant regulatory action under the
Executive order.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because the final rule reclassifying this device
from class III to class II will relieve all manufacturers of the device
of the cost of complying with the premarket approval requirements of
section 515 of the FD&C Act, it will impose no significant economic
impact on any small entities, and it may permit small potential
competitors to enter the marketplace by lowering their costs, and the
agency certifies that the final rule will not have a significant
economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $135 million, using the most current (2009) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.

VII. Federalism

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. Section 4(a) of the Executive order
requires agencies to ``construe * * * a Federal statute to preempt
State law only where the statute contains an express preemption
provision or there is some other clear evidence that the Congress
intended preemption of State law, or where the exercise of State law
conflicts with the exercise of Federal authority under the Federal
statute.'' Federal law includes an express preemption provision that
preempts certain State requirements ``different from or in addition
to'' certain Federal requirements applicable to devices. (See section
521 of the FD&C Act (21 U.S.C. 360k); Medtronic Inc., v. Lohr, 518 U.S.
470 (1996); Riegel v. Medtronic Inc., 128 S. Ct. 999 (2008)). The
special controls established by this final rule create ``requirements''
for specific medical devices under 21 U.S.C. 360k, even though product
sponsors have some flexibility in how they meet those requirements. See
Papike v. Tambrands, Inc., 107 F.3d 737, 740-742 (9th Cir. 1997).

VIII. Paperwork Reduction Act of 1995

    This final rule contains no collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520) is not
required. FDA concludes that the special controls guidance document
identified by this rule contains information collection provisions that
are subject to review and clearance by OMB under the PRA.
    Elsewhere in this issue of the Federal Register, FDA is publishing
a notice announcing the availability of the guidance document entitled,
``Class II Special Controls Guidance Document: Topical Oxygen Chamber
for Extremities.'' The notice contains an analysis of the paperwork
burden for the guidance.

List of Subjects in 21 CFR Part 878

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
878 is amended as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for 21 CFR part 878 continues to read as
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Section 878.5650 is revised to read as follows:

Sec.  878.5650  Topical oxygen chamber for extremities.

    (a) Identification. A topical oxygen chamber for extremities is a
device that is intended to surround a patient's limb and apply
humidified oxygen topically at a pressure slightly greater than
atmospheric pressure to aid healing of chronic skin ulcers such as
bedsores.
    (b) Classification. Class II (special controls). The special
control for this device is FDA's ``Class II Special Controls Guidance:
Topical Oxygen Chamber for Extremities.'' See Sec.  878.1(e) for the
availability of this guidance document.

    Dated: April 19, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-9899 Filed 4-22-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 85, Number 144 (Monday, July 27, 2020)]
[Notices]
[Pages 45276-45280]
[FR Doc No: 2020-16159]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-89363; File No. SR-FICC-2020-008]

Self-Regulatory Organizations; Fixed Income Clearing Corporation;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
to Revise the Clearing Agency Policy on Capital Requirements

July 21, 2020.
    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 July 15, 2020, Fixed Income Clearing Corporation (``FICC'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II and III below, which
Items have been prepared by the clearing agency. FICC filed the
proposed rule change pursuant to Section 19(b)(3)(A) of the Act \3\ and
Rule 19b-4(f)(3) thereunder.\4\ The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(3).
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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 Clearing
Agency Policy on Capital Requirements (``Capital Policy'' or
``Policy'') of FICC and its affiliates, National Securities Clearing
Corporation (``NSCC'') and The Depository Trust Company (``DTC,'' and
together with FICC and NSCC, the ``Clearing Agencies''). In particular,
the proposed revisions to the Capital Policy would (1) update the
frequency of the calculation of the Total Capital Requirement (as
defined below and in the Policy) to align with the Clearing Agencies'
quarterly financial statements; (2) replace the description of the
calculation of the Recovery/Wind-down Capital Requirement (as defined
below and in the Policy) with a reference to the Clearing Agencies'
Recovery & Wind-down Plans \5\ to eliminate redundancy between these
documents; (3) revise the description of the additional liquid net
assets (``LNA'') funded by equity, referred to as the ``Buffer'' to
provide the Clearing Agencies with flexibility in calculating this
discretionary amount; and (4) make other updates and revisions to the
Capital Policy in order to simplify the language and improve the
clarity of the Policy, as described in greater detail below.
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    \5\ See Securities Exchange Act Release Nos. 83972 (August 28,
2018), 83 FR 44964 (September 4, 2018) (SR-DTC-2017-021); 83953
(August 27, 2018), 83 FR 44381 (August 30, 2018) (SR-DTC-2017-803);
83973 (August 28, 2018), 83 FR 44942 (September 4, 2018) (SR-FICC-
2017-021); 83954 (August 27, 2018), 83 FR 44361 (August 30, 2018)
(SR-FICC-2017-805); 83974 (August 28, 2018), 83 FR 44988 (September
4, 2018) (SR-NSCC-2017-017); 83955 (August 27, 2018), 83 FR 44340
(August 30, 2018) (SR-NSCC-2017-805).
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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
    The Clearing Agencies are proposing to revise the Capital Policy,
which was adopted by the Clearing Agencies in July 2017 \6\ and is
maintained by the Clearing Agencies in compliance with Rule 17Ad-
22(e)(15) under the Act,\7\ in order to (1) update the frequency of the
calculation of the Total Capital Requirement to align with the Clearing
Agencies' quarterly financial statements; (2) replace the description
of the calculation of the Recovery/Wind-down Capital Requirement with a
reference to the Clearing Agencies' Recovery & Wind-down Plans to
eliminate redundancy between these documents; (3) revise the
description of the additional LNA funded by equity, referred to as the
``Buffer'' to provide the Clearing Agencies with flexibility in
calculating this discretionary amount; and (4) make other updates and
revisions to the Capital Policy in order to simplify the language and
improve the clarity of the Policy, as described in greater detail
below.
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    \6\ See Securities Exchange Act Release No. 81105 (July 7,
2017), 82 FR 32399 (July 13, 2017) (SR-DTC-2017-003, SR-FICC-2017-
007, SR-NSCC-2017-004).
    \7\ 17 CFR 240.17Ad-22(e)(15).
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Overview of the Capital Policy
    The Capital Policy sets forth the manner in which each Clearing
Agency identifies, monitors, and manages its general business risk with
respect to the requirement to hold sufficient LNA funded by equity to
cover potential general business losses so the Clearing Agency can
continue operations and services as a going concern if such losses
materialize.\8\ The amount of LNA funded by equity to be held by each
of the Clearing Agencies for this purpose is defined in the Policy as
the General Business Risk Capital Requirement. The

Policy provides that the General Business Risk Requirement is
calculated for each Clearing Agency as the greatest of three separate
calculations--(1) an amount based on that Clearing Agency's general
business risk profile (``Risk-Based Capital Requirement''), (2) an
amount based on the time estimated to execute a recovery or orderly
wind-down of the critical operations of that Clearing Agency
(``Recovery/Wind-down Capital Requirement''), and (3) an amount based
on an analysis of that Clearing Agency's estimated operating expenses
for a six month period (``Operating Expense Capital Requirement''). The
General Business Risk Capital Requirement for each Clearing Agency is
determined as the greatest of these calculations.
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    \8\ Supra note 6.
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    The Capital Policy also addresses how each Clearing Agency
maintains an amount of LNA funded by equity as a part of its management
of credit risk \9\ pursuant to its respective rules,\10\ referred to as
the ``Corporate Contribution.'' These resources are maintained to
address losses due to a participant default and are held in addition to
the Clearing Agencies' General Business Risk Capital Requirement. The
Capital Policy describes how each Clearing Agency's General Business
Risk Capital Requirement and Corporate Contribution fit within the
Clearing Agencies' Capital Framework, where the ``Total Capital
Requirement'' of each Clearing Agency is calculated as the sum of its
General Business Risk Capital Requirement and Corporate Contribution.
Finally, the Policy provides a plan for the replenishment of capital
through the Clearing Agency Capital Replenishment Plan.
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    \9\ LNA funded by equity held as the Clearing Agencies'
Corporate Contribution is held in addition to resources held by the
Clearing Agencies for credit risk in compliance with Rule 17Ad-
22(e)(4) under the Act, and in addition to resources held by the
Clearing Agencies for liquidity risk in compliance with Rule 17Ad-
22(e)(7). 17 CFR 240.17Ad-22(e)(4), (7).
    \10\ See Rule 4 of the Rules, By-laws and Organizational
Certificate of DTC (``DTC Rules''), Rule 4 of the Rulebook of the
Government Securities Division of FICC (``GSD Rules''), Rule 4 of
the Clearing Rules of the Mortgage-Backed Securities Division of
FICC (``MBSD Rules''), and Rule 4 of the Rules & Procedures of NSCC
(``NSCC Rules,'' and together with the DTC Rules, GSD Rules and MBSD
Rules, the ``Clearing Agencies' Rules'' or ``Rules''), available at
http://dtcc.com/legal/rules-and-procedures.
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Proposed Revisions to the Capital Policy
    The Capital Policy is reviewed and approved by the Boards annually.
In connection with the most recent annual review of the Policy, the
Clearing Agencies are proposing revisions and updates, described in
greater detail below. These proposed changes are designed to update the
Capital Policy and enhance the clarity of the Policy to ensure that it
continues to operate as intended.
1. Update Frequency of Calculation of Total Capital Requirement
    The Clearing Agencies are proposing to update the Capital Policy to
change the frequency of the calculation of the Total Capital
Requirement to occur quarterly, and clarify that the calculation of the
Total Capital Requirement would use the most recently completed
calculations of the General Business Risk Capital Requirement and the
Corporate Contribution. In connection with this proposed change, the
Capital Policy would also be amended to remove references to the timing
of the other calculations.
    As described above, the Total Capital Requirement is the sum of the
General Business Risk Capital Requirement and the Corporate
Contribution; and the General Business Risk Capital Requirement is the
greatest of the Risk-Based Capital Requirement, Recovery/Wind-down
Capital Requirement and the Operating Expense Capital Requirement.
Currently the Capital Policy states that the Total Capital Requirement
is calculated monthly. The Capital Policy also describes the frequency
of each of the other calculations that are used in calculating the
Total Capital Requirement, which occur at different intervals
throughout the year.
    The Clearing Agencies are proposing to update the Capital Policy to
state that the Total Capital Requirement will be calculated quarterly,
using the most recently calculated components. This proposed change
would align the timing of this calculation with the timing of each of
the Clearing Agencies' quarterly financial statements, where the
results of this calculation is reported. While the calculation would
occur less frequently than it is currently conducted, the Total Capital
Requirement amount does not change materially from month to month.\11\
Therefore, the Clearing Agencies believe the calculation would still be
completed on an appropriate frequency.
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    \11\ The Total Capital Requirement amount has been reported in
footnote 9 to the Clearing Agencies' financial statements since the
third quarter of 2018, available at https://www.dtcc.com/legal/financial-statements.
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    The proposed change would also simplify the Capital Policy by
removing the reference to the frequency of each of the other
calculations. Each of the other calculations that determine the Total
Capital Requirement are completed at different frequencies throughout
the year, as currently described in the Capital Policy, and all occur
at least annually. The proposed change would state that the most recent
results of these calculations would be used in the quarterly
calculation of the Total Capital Requirement. These calculations have
different purposes and provide the Clearing Agencies with different
measures. Therefore, these calculations are completed at different
frequencies during the year, generally timed to occur when updated
information is available. By removing the frequency of these
calculations from the Capital Policy, and only specifying the frequency
of the Total Capital Requirement calculation, which would use the most
recent results of these underlying calculations, the proposed change
would simplify the Policy and would provide the Clearing Agencies with
flexibility to adjust the timing of these calculations as necessary.
    In order to reflect this change, the Clearing Agencies are
proposing to update Section 4 of the Capital Policy to state that the
Total Capital Requirement would be calculated quarterly, using the most
recent calculations of the General Business Risk Capital Requirement
and Corporate Contribution. The proposed changes would also remove
statements in Sections 5, 6, 6.1.2 and 6.3 regarding the timing of the
underlying calculations.
2. Update Description of Recovery/Wind-Down Capital Requirement To
Refer to the Recovery & Wind-Down Plans of the Clearing Agencies
    The Clearing Agencies are proposing to amend the Capital Policy
with respect to the Recovery/Wind-down Capital Requirement to update
references to the Recovery & Wind-down Plans of the Clearing Agencies.
In connection with this change, the Capital Policy would also be
updated to clarify the role of management in advising the Boards in
connection with their annual determination of the Recovery/Wind-down
Capital Requirement.
    First, the proposed changes would replace descriptions of the
calculation of the Recovery/Wind-down Capital Requirement with
references to the Clearing Agencies' Recovery & Wind-down Plans, which
have been adopted by the Clearing Agencies and include detailed
descriptions of the calculation of this amount.\12\ The Recovery/Wind-
down Capital Requirement is an amount based on the time estimated to
execute

a recovery or orderly wind-down of the critical operations of that
Clearing Agency and is used by the Clearing Agencies to determine their
General Business Risk Capital Requirement, as described above. Each of
the Clearing Agencies have adopted a Recovery & Wind-down Plan, which
provides plans for the recovery and orderly wind-down of each of the
Clearing Agencies necessitated by credit losses, liquidity shortfalls,
losses from general business risk, or any other losses.\13\ Section 8.7
of each of the Recovery & Wind-down Plans includes an analysis of the
calculation of the Recovery/Wind-down Capital Requirement.
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    \12\ Supra note 5.
    \13\ Id.
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    The Clearing Agencies believe their respective Recovery & Wind-down
Plans are the appropriate documents for the description of the
calculation of the Recovery/Wind-down Capital Requirement. The proposed
change would remove redundancy between these documents and minimize the
risk of inconsistency in this description.
    In order to implement this change, the Clearing Agencies are
proposing to (1) revise the definition of Recovery/Wind-down Capital
Requirement in Section 2 of the Capital Policy to refer to the
description of this amount in the Recovery & Wind-down Plan of each
Clearing Agency; and (2) revise Section 6.2 of the Capital Policy to
remove the description of the calculation of the Recovery/Wind-down
Capital Requirement and replace it with a reference to this description
in the Recovery & Wind-down Plan of each of the Clearing Agencies.
    Second, the proposed changes would clarify the role of management
with respect to the Boards' annual determination of the Recovery/Wind-
down Capital Requirement. Pursuant to the Clearing Agencies' Recovery &
Wind-down Plans, and in compliance with the requirements of Rule 17Ad-
22(e)(15)(ii) under the Act,\14\ the Boards are responsible for
determining the Recovery/Wind-down Capital Requirement for each
Clearing Agency on an annual basis.
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    \14\ 17 CFR 240.17Ad-22(e)(15)(ii).
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    The Treasury group of The Depository Trust & Clearing Corporation
(``DTCC Treasury group'') and members of management in other relevant
groups may provide the Boards with analyses and relevant data to
facilitate this determination. Therefore, the Clearing Agencies are
proposing to amend Section 6.2 of the Capital Policy to state that the
DTCC Treasury group and members of management in other relevant groups
may provide such information to the Boards.
3. Revise Description of Buffer Amount
    The Clearing Agencies are proposing to amend the Capital Policy to
revise the description of the additional, discretionary amount of LNA
funded by equity held by the Clearing Agencies in addition to the Total
Capital Requirement, which is referred to as a ``Buffer.'' Currently,
the Capital Policy states that the amount of LNA funded by equity held
as Buffer would be periodically assessed by the DTCC Treasury group and
would generally equal approximately four to six (4-6) months of
operating expenses for the respective Clearing Agency. The Clearing
Agencies are proposing to make two changes to the description of the
Buffer in the Capital Policy, described below.
    First, the Clearing Agencies are proposing to remove the
specificity regarding how the Buffer amount held by the Clearing
Agencies is measured. This proposed change would provide the Clearing
Agencies with flexibility to manage capital when determining the
appropriate amount of LNA funded by equity that they would each hold in
addition to the Total Capital Requirement. The Clearing Agencies would
implement this proposed change by amending the description of Buffer in
Section 4 of the Capital Policy to remove the reference to four to six
(4-6) months of operating expenses, and state simply that this amount
is determined based on various factors, including historical
fluctuations of LNA and estimates of potential losses from general
business risk.
    Second, the Clearing Agencies are proposing to amend Section 4 of
the Capital Policy to clarify that the Buffer will be calculated at
least annually. Currently the Capital Policy states that the Buffer
will be calculated periodically. This proposed change would provide
more specificity regarding the frequency of this calculation.
4. Technical Revisions and Clarifications
    In addition to the proposed changes described above, the Clearing
Agencies are also proposing the following technical revisions to the
Capital Policy.
    First, the proposed changes would update the description of the
Corporate Contribution in Figure 1 of Section 4 of the Capital Policy.
The proposed change would replace the current description of this
amount with a reference to the Clearing Agencies' Rules, where this
amount is defined. The proposed change would align the description in
Figure 1 of Section 4 with the description of the Corporate
Contribution in Section 5 of the Capital Policy, which also describes
the Corporate Contribution by referring to the Clearing Agencies'
Rules.
    Second, the proposed changes would revise Section 6.3 of the
Capital Policy to use the defined term for Operating Expense Capital
Requirement, which is defined in the Glossary of Key Terms in Section 2
of the Capital Policy.
    Third, the proposed changes would also revise Section 6.3 to
clarify that the data used to estimate prospective Clearing Agency
expenses in calculating the Operating Expense Capital Requirement comes
from a budget developed by the Financial Planning & Analysis department
for the respective Clearing Agencies.
    Finally, the proposed changes would update Section 7.2 of the
Capital Policy, which describes where the Clearing Agencies report
their assessment of LNA funded by equity against the Total Capital
Requirement. The proposed change would state that, in addition to
internal reporting, this assessment is also reported publicly in the
Clearing Agencies' financial statements.
    Each of these proposed changes would make technical drafting
corrections or clarifications to the existing descriptions in the
Capital Policy. While these proposed changes would not substantively
alter the descriptions in the Capital Policy, they would improve the
clarity of the Policy.
2. Statutory Basis
    The Clearing Agencies believe that the proposed rule changes to the
Capital Policy are consistent with the requirements of the Act, and the
rules and regulations thereunder applicable to a registered clearing
agency. In particular, the Clearing Agencies believe that the proposed
changes are consistent with Section 17A(b)(3)(F) of the Act \15\ and
Rule 17Ad-22(e)(15) under the Act,\16\ for the reasons described below.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78q-1(b)(3)(F).
    \16\ 17 CFR 240.17Ad-22(e)(15).
---------------------------------------------------------------------------

    Section 17A(b)(3)(F) of the Act requires, in part, that the rules
of the Clearing Agencies be designed to promote the prompt and accurate
clearance and settlement of securities transactions, and to assure the
safeguarding of securities and funds which are in the custody or
control of the Clearing Agencies or for which they are responsible.\17\
The Capital Policy is designed to ensure that each of the Clearing
Agencies hold sufficient LNA

funded by equity to cover potential general business losses so that
they can continue the prompt and accurate clearance and settlement of
securities transactions, and can continue to assure the safeguarding of
securities and funds which are in their custody or control or for which
they are responsible if those losses materialize.
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    The proposed changes described above would not materially alter how
the Capital Policy accomplishes this goal. The proposed changes would
update the frequency of the calculation of the amount of LNA funded by
equity held by the Clearing Agencies. Changing this frequency would not
alter the Clearing Agencies' ability to hold an amount needed to cover
potential general business losses, as the result of these calculations
do not currently change materially on a month to month basis. The
proposed change to refer to the Clearing Agencies' Recovery & Wind-down
Plans for the description of the Recovery/Wind-down Capital Requirement
would reduce the redundancy between the Policy and these plans, and
would not alter the calculation of this amount. The proposed change to
the description of the Buffer would provide the Clearing Agencies with
additional flexibility in calculating this amount, which is held in
addition to the amounts needed to meet compliance with their regulatory
requirements. Finally, the proposed technical revisions would simplify
and clarify the descriptions in the Policy, and would not alter the way
the Policy operates.
    The proposed revisions would not materially change how the Policy
ensures that each of the Clearing Agencies hold sufficient LNA funded
by equity to cover potential general business losses but would allow
the Clearing Agencies to maintain this document to operate in the way
it was intended. Therefore, such proposed revisions would be consistent
with the requirements of Section 17A(b)(3)(F) of the Act.\18\
---------------------------------------------------------------------------

    \18\ Id.
---------------------------------------------------------------------------

    Rule 17Ad-22(e)(15) under the Act requires the Clearing Agencies to
establish, implement, maintain and enforce written policies and
procedures reasonably designed to identify, monitor, and manage their
respective general business risk and hold sufficient liquid net assets
funded by equity to cover potential general business losses so that the
Clearing Agencies can continue operations and services as a going
concern if those losses materialize.\19\ As originally implemented, the
Capital Policy was designed to meet the requirements of Rule 17Ad-
22(e)(15). For the reasons described above, the proposed revisions
would not materially alter how the Clearing Agencies comply with their
requirements under this rule. Therefore, the proposed changes would
allow the Clearing Agencies to maintain the Capital Policy in a way
that continues to be consistent with the requirements of Rule 17Ad-
22(e)(15) under the Act.\20\
---------------------------------------------------------------------------

    \19\ 17 CFR 240.17Ad-22(e)(15).
    \20\ Id.
---------------------------------------------------------------------------

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

    Each of the Clearing Agencies believes that none of the proposed
revisions to the Capital Policy would have any impact, or impose any
burden, on competition. The Policy is maintained by the Clearing
Agencies in order to satisfy their regulatory requirements and
generally reflect internal tools and procedures. Tools and procedures
that have a direct impact on the rights, responsibilities or
obligations of members or participants of the Clearing Agencies are
reflected in the Clearing Agencies' Rules. Accordingly, the Capital
Policy enhances the Clearing Agencies' regulatory compliance and
internal management and does not have any impact, or impose any burden,
on competition.
    The proposed revisions would not effect any changes to the
fundamental purpose or materially impact the operation of the Capital
Policy. As such, the proposed changes also would not have any impact,
or impose any burden, on competition.

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

    The Clearing Agencies have not solicited or received any written
comments relating to this proposal. The Clearing Agencies will notify
the Commission of any written comments received by the Clearing
Agencies.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) \21\ of the Act and paragraph (f) \22\ of Rule 19b-4
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \21\ 15 U.S.C 78s(b)(3)(A).
    \22\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form(http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-FICC-2020-008 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-2020-008. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (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 website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 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 website
(http://dtcc.com/legal/sec-rule-filings.aspx). All comments received
will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-FICC-2020-008 and should be submitted on
or before August 17, 2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\23\
---------------------------------------------------------------------------

    \23\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-16159 Filed 7-24-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: June 30, 2008 (Volume 73, Number 126)]
[Notices]
[Page 36952]
[DOCID:fr30jn08-139]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Executive Committee of the Aviation Rulemaking Advisory
Committee; Meeting

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of meeting.

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

SUMMARY: The FAA is issuing this notice to advise the public of a
meeting of the Executive Committee of the Aviation Rulemaking Advisory
Committee.

DATES: The meeting will be on July 23, 2008, at 10 a.m.

ADDRESS: The meeting will take place at the General Aviation
Manufacturers Association (GAMA), 1400 K Street, NW., Suite 801,
Washington, DC 20005.

FOR FURTHER INFORMATION CONTACT: Gerri Robinson, Federal Aviation
Administration, 800 Independence Avenue, SW., Washington, DC 20591,
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under section 10(a)(2) of the Federal
Advisory Committee Act (5 U.S.C. App. 2), we are giving notice of a
meeting of the Executive Committee of the Aviation Rulemaking Advisory
Committee taking place on July 23, 2008, at the General Aviation
Manufacturers Association (GAMA), 1400 K Street, NW., Suite 801,
Washington, DC 20005. The agenda includes:
     Introduction of new Assistant Chair
     Continuous Improvement (Committee Process)
     Part 147 Working Group Report
     Fall Regulatory Agenda
     Rulemaking Harmonization
     Issue Area Status Reports from Assistant Chairs
     Remarks from other EXCOM members
Attendance is open to the interested public but limited to the space
available. The FAA will arrange teleconference service for individuals
wishing to join in by teleconference if we receive notice by July 16.
Arrangements to participate by teleconference can be made by contacting
the person listed in the FOR FURTHER INFORMATION CONTACT section.
Callers outside the Washington metropolitan area are responsible for
paying long-distance charges.
    The public must arrange by July 16 to present oral statements at
the meeting. The public may present written statements to the executive
committee by providing 25 copies to the Executive Director, or by
bringing the copies to the meeting.
    If you are in need of assistance or require a reasonable
accommodation for this meeting, please contact the person listed under
the heading FOR FURTHER INFORMATION CONTACT.

    Issued in Washington, DC, June 24, 2008.
Pamela Hamilton-Powell,
Executive Director, Aviation Rulemaking Advisory Committee.
[FR Doc. E8-14573 Filed 6-27-08; 8:45 am]

BILLING CODE 4910-13-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

     WASHINGTON, D.C. 20460

OFFICE OF PREVENTION,                                                                                PESTICIDES  AND  TOXIC

                                      SUBSTANCES

					FEB 23 2006

MEMORANDUM

SUBJECT:	Review of materials submitted by Syngenta in support of extension of Section G Experimental Use Permit (EUP No: 67979-EUP-4) for Event MIR604 corn, which contains the active ingredient mCry3A. Submission dated December 12, 2005 and revised January 20, 2006, February 9, 2006, and February 23, 2006.

TO:			Michael Mendelsohn

			Senior Regulatory Action Leader

			Microbial Pesticides Branch, Biopesticides and

Pollution Prevention Division (7511C)

FROM:		Tessa Milofsky, M.S. Agronomist				signed

			Microbial Pesticides Branch, Biopesticides and

Pollution Prevention Division (7511C)

Conclusion

The requested EUP program and corresponding acreage are ACCEPTABLE. It is recommended that the registrant’s full request of 6,894 EUP acres should be granted.

Comments

The participant/collaborator information is sufficient provided that collaborator names and contact information are submitted prior to experiment initiation.

Background

Syngenta has submitted materials in support of their request to extend the duration of their Event MIR604 Experimental Use Permit (67979-EUP-4) to cover the period mid-March 2006 through February 2007. Event MIR604 field corn, which contains the active ingredient mCry3A Bacillus thuringiensis delta endotoxin, is said to protect field corn against western corn rootworm (Diabrotica virgifera virgifera), northern corn rootworm (D. longicornis barveri), southern corn rootworm (D. undecimpunctata howardi), and Mexican corn rootworm (D. virgifera zea). Planting proposed under the EUP will take place in 29 states and Puerto Rico, and will not exceed 6,894 total acres.

Program Overview

Participant/Collaborator Information

The names, telephone numbers, and mailing addresses of participants who will supervise experimental work covered under this EUP are listed under each protocol. Information on cooperators was not included, yet the registrant states that this listing will be provided prior to planting or initiation of the research trials.

BPPD Review

Participant information provided in the submission is sufficient. Names and contact information of collaborators must be submitted prior to experiment initiation.

Field Trial Containment

In Syngenta’s revised February 9, 2006 EUP program submission, they state that corn produced in Breeding and Observation, Efficacy Evaluation, Inbred and Hybrid Production, and Regulatory trials will comply with USDA-APHIS Performance Standards for regulated corn trials.  However, if MIR604 corn is deregulated by USDA-APHIS during the EUP program, Syngenta has stated that for acreage covered under Agronomic Observation field trials, they may choose to terminate compliance with USDA’s containment requirements for regulated corn. In particular, Syngenta states that corn harvested from Agronomic Observation field trials may be sold or distributed for use as food or feed. Note: Under USDA-APHIS Performance Standards for regulated corn trials, corn may not be used for food or feed.

BPPD Review

Containment procedures described in the submission are adequate.

Acreage Calculation

Under this PIP EUP program submission, the registrant has requested a total of 6,898 EUP acres, of which 3,665 acres are transgenic. A breakdown of acreage by protocol and by PIP is provided below (Table 1). Detailed tables that show acreage breakdowns by state and location are provided in the Appendix.

Table 1. MIR604 and Bt11 EUP acreage requests by protocol for 2006-2007.

Protocol Type	EUP Acreage*

	PIP Acreage

	Non-PIP Acreage	Total EUP Acreage

	MIR604	MIR604 x Bt11	Bt11

Breeding and observation	117	106	0	137	360

Efficacy evaluation	61	47	0	614	722

Agronomic observation	621	621	0	1,978	3,220

Inbred and hybrid production	1,456	146	670	0	2,272

Regulatory field trials (e.g. IRM and non-target insect field trials, etc.)	45	45	0	230	320

Total	2300	965	670	2,959	6,894

* EUP acreage is the sum of the acreage found within the perimeter of all associated experimental blocks. This includes PIP plants plants, non-PIP plants, and border rows included within the blocks.

BPPD Review

Syngenta’s approach to PIP EUP calculation appears to comply with EPA’s guidelines for PIP EUP acreage calculation (below) and is therefore acceptable.

Total PIP EUP acreage is equivalent to the sum of the acreage contained within each experiment covered under protocols listed in the EUP program submission. If a single experiment is divided among multiple locations, acreage at all locations must be summed to determine total acreage for the experiment. It is recommended that total EUP acreage should be broken down into PIP acres and non-PIP acres, since this delineation will assist the registrant in their efforts to justify the requested EUP acreage. For the purposes of PIP EUP acreage calculation, PIP plants are defined as plants containing a PIP and all non-PIP plants that are intentionally crossed with PIP plants. Non-PIP plants are defined as all non-PIP containing plants included within the experiment, such as border row (internal and perimeter) and control plants, that are not intentional recipients of pollen from PIP-containing plants. Buffer acreage (e.g. 660 feet for corn) is not included in PIP EUP acreage calculation.

Seed and Active Ingredient Quantities

MIR604 and Bt11 corn seed required for the proposed acreage was calculated (by the reviewer) to be approximately 50,420 lbs; the corresponding quantity of A.I. present in that seed was calculated to be 20.6 grams (based on 0.9 µg mCry3A/g fresh weight seed).

BPPD Review

MIR604 and Bt11 seed and A.I. calculations are acceptable.

Trial Protocols

Protocol descriptions provided in the Section G submission provide information on the test sites (acres per state), objective, experimental design, plot treatments, genotypes, estimated planting and harvest schedules for each trial, and containment procedures (shipping, pollen flow, and post-harvest). Protocol objectives are provided below.

Breeding and Observation

Objectives: 1) Introgress the mcry3A gene into elite parent inbred corn lines for the purposes of determining gene stability, inheritance pattern, and efficacy in different elite genetic backgrounds that may also include Event Bt11; and 2) Make up hybrid test-crosses for future evaluation.

Efficacy Evaluation

Objective: To assess the efficacy of up to 100 Event MIR604 and/or stacked MIR604 X Bt11 lines towards corn insect pests, including northern, western, southern and Mexican corn rootworms and/or insects specifically controlled by Bt11 corn.

Agronomic Observation

Objectives: 1) Assess Event MIR604 and/or stacked MIR604 X Bt11 lines and inbred lines in small plots (packet plots) for a variety of agronomic traits pertinent to corn production, including germinability, early-season vigor, days to pollen shed, and yield; and 2) Assess Event MIR604 hybrids in strip plots under a wide range of field conditions for numerous traits pertinent to corn production.

Inbred and Hybrid Production

Objectives: 1) Produce up to 60 hybrid crosses with Event MIR604, Bt11 and MIR604 X Bt11 and up to 20 inbred corn lines for future evaluations.  Assess parameters including stand, uniformity, plant population, frequency of off-types, overall growth rating, and flowering synchronicity; and 2) Increase seed of MIR604, Bt11 or stacked MIR604 X Bt11 inbreds for use in hybrid production, feeding and safety studies.

Regulatory Field Trials

Objective: Obtain regulatory-quality data for the development and support of the assessment of Event MIR604 corn and/or stacked MIR604 X Bt11 corn which will include but not be limited to insect resistance management field trials and large-scale, non-target insect field trials.

BPPD Review

Acreage requests for each protocol are acceptable.

Appendix

Table A1.  Proposed Experimental Use Program for MIR604 Field Corn Plantings from March 2006 through February 2007

ST	Tot.

	Breeding & Obs.	Efficacy Evaluation.	Agronomic Observation Inbred/Hybrid Prod.	Regulatory Studies	Max. No.

	MIR

604

Ac.	Tot.

Oth.

Ac.	Tot.

No.

Loc	MIR

604

Ac.	Oth.

Ac.	No.

Loc.	MIR

604

Ac.	Oth.

Ac.	No.

Loc.	MIR

604

Ac.	Oth.

Ac.	No.

Loc.	MIR

604

Ac.	Oth.

Ac.	No.

Loc.	MIR604

Ac.	Oth.

Ac.	No.

Loc.	MIR604

Plants

AR	0	0	0	 	 	 	0	0	0	0	0	0	 	 	 	 	 	 	0

CA	1	20	1	 	 	 	1	20	1	0	0	0	 	 	 	 	 	 	30,000

CO	11	35	6	0	0	0	2	10	2	9	25	4	 	 	 	 	 	 	330,000

FL	5	5	3	 	 	 	5	5	3	0	0	0	 	 	 	 	 	 	150,000

HI	176	12	62	36	12	12	0	0	0	0	0	0	140	0	50	 	 	 	5,280,000

IA	997	306	126	17	11	12	7	45	35	166	230	47	800	0	30	7	20	2	29,910,000

ID	0	0	0	 	 	 	0	0	0	0	0	0	 	 	 	 	 	 	0

IL	162	348	95	17	11	15	14	90	40	123	227	38	0	0	0	10	20	2	4,920,000

IN	42	74	30	0	0	0	2	10	17	40	64	13	0	0	0	 	 	 	1,260,000

KS	17	25	13	0	0	0	2	10	7	15	15	6	 	 	 	 	 	 	510,000

KY	2	10	1	0	0	0	0	0	0	2	10	1	 	 	 	 	 	 	60,000

LA	0	0	0	 	 	 	0	0	0	0	0	0	 	 	 	 	 	 	0

MD	10	20	2	 	 	 	0	0	0	0	0	0	 	 	 	10	20	2	300,000

MI	4	4	1	0	0	0	0	0	0	4	4	1	0	0	0	 	 	 	120,000

MN	132	246	60	17	11	8	7	45	21	98	170	29	0	0	0	10	20	2	3,960,000

MO	12	45	19	0	0	0	2	10	11	9	25	4	0	0	0	1	10	4	360,000

MS	3	17	4	 	 	 	3	17	4	0	0	0	 	 	 	 	 	 	90,000

NC	0	0	0	 	 	 	0	0	0	0	0	0	 	 	 	 	 	 	0

NM	7	15	6	 	 	 	2	10	3	0	0	0	 	 	 	5	5	3	210,000

NE	148	139	63	0	0	0	2	10	25	95	119	26	50	0	10	1	10	2	4,500,000

ND	0	0	0	 	 	 	0	0	0	0	0	0	 	 	 	 	 	 	0

NY	10	18	5	 	 	 	2	10	3	8	8	2	 	 	 	 	 	 	300,000

OH	12	28	17	0	0	0	2	10	14	10	18	3	0	0	0	 	 	 	360,000

PA	4	4	1	 	 	 	0	0	0	4	4	1	 	 	 	 	 	 	120,000

PR	150	18	24	30	18	12	0	0	0	0	0	0	120	0	12	 	 	 	1,230,000

SD	34	59	18	0	0	0	2	10	8	31	39	9	 	 	 	1	10	1	1,020,000

TN	0	0	0	 	 	 	0	0	0	0	0	0	 	 	 	 	 	 	0

TX	2	10	3	0	0	0	2	10	3	0	0	0	 	 	 	 	 	 	60,000

VA	2	10	3	 	 	 	2	10	3	0	0	0	 	 	 	 	 	 	60,000

WI	9	41	25	0	0	0	2	10	13	7	31	12	0	0	0	 	 	 	270,000

Tot.	1954	1509	588	117	63	59	61	342	213	621	989	196	1110	0	102	45	115	18 58,620,000

Table A2.  Proposed Experimental Use Program for Stacked MIR604 X Bt11 Field Corn Plantings from March 2006 through February 2007

	Total Acres

Breeding & Obs’n	Efficacy Evaluation	Agronomic Observ’n	Inbred & Hybrid Production	Regulatory Studies	Max. No.

ST	MIR

604+

Bt11	MIR

604	Bt

11

Oth.	Tot

Loc.	MIR

604+Bt11Ac.	Oth

Ac.	No.Loc	MIR

604+ Bt11

Ac.	Oth. Ac.	No Loc	MIR

604+Bt11Ac.	Oth. Ac.	No.Loc	604+Bt11

Ac.	MIR

604

Ac.

Bt11

Ac.	Oth. Ac.	No.Loc	604+Bt11

Ac.	Oth

Ac.	No.

Loc	MIR604 +/or,

Bt11

Plants

AR	0	0	0	0	0	 	 	 	0	0	0	0	0	0	 	 	 	 	 	 	 	 	0

CA	1	0	0	20	1	 	 	 	1	20	1	0	0	0	 	 	 	 	 	 	 	 	30,000

CO	9	0	0	25	4	0	0	0	0	0	0	9	25	4	 	 	 	 	 	 	 	 	270,000

FL	5	0	0	5	3	 	 	 	5	5	3	0	0	0	 	 	 	 	 	 	 	 	150,000

HI	163	10	10	15	52	33	15	12	0	0	0	0	0	0	130	10	10	0	40	 	 	  5,490,000

IA	195	300	600	308	126	15	13	12	7	45	35	166	230	47	0	300	600	0	30	7	20	2 32,850,000

ID	0	0	0	0	0	 	 	 	0	0	0	0	0	0	 	 	 	 	 	 	 	 	0

IL	162	0	0	350	95	15	13	15	14	90	40	123	227	38	0	 	 	0	0	10	20	2 4,860,000

IN	42	0	0	74	30	0	0	0	2	10	17	40	64	13	0	 	 	0	0	 	 	 	1,260,000

KS	15	0	0	15	6	0	0	0	0	0	0	15	15	6	 	 	 	 	 	 	 	 	450,000

KY	2	0	0	10	1	0	0	0	0	0	0	2	10	1	 	 	 	 	 	 	 	 	60,000

LA	0	0	0	0	0	 	 	 	0	0	0	0	0	0	 	 	 	 	 	 	 	 	0

MD	10	0	0	20	2	 	 	 	0	0	0	0	0	0	 	 	 	 	 	10	20	2	300,000

MI	4	0	0	4	1	0	0	0	0	0	0	4	4	1	0	 	 	0	0	 	 	 	120,000

MN	130	0	0	248	60	15	13	8	7	45	21	98	170	29	0	 	 	0	0	10	20	2 3,900,000

MO	12	0	0	45	19	0	0	0	2	10	11	9	25	4	0	 	 	0	0	1	10	4	360,000

MS	3	0	0	17	4	 	 	 	3	17	4	0	0	0	 	 	 	 	 	 	 	 	90,000

NC	0	0	0	0	0	 	 	 	0	0	0	0	0	0	 	 	 	 	 	 	 	 	0

NM	5	0	0	5	3	 	 	 	0	0	0	0	0	0	 	 	 	 	 	5	5	3	150,000

NE	98	20	20	139	63	0	0	0	2	10	25	95	119	26	0	20	20	0	10	1	10	2	4,140,000

ND	0	0	0	0	0	 	 	 	0	0	0	0	0	0	 	 	 	 	 	 	 	 	0

NY	10	0	0	18	5	 	 	 	2	10	3	8	8	2	 	 	 	 	 	 	 	 	300,000

OH	10	0	0	18	3	0	0	0	0	0	0	10	18	3	0	 	 	0	0	 	 	 	300,000

PA	4	0	0	4	1	 	 	 	0	0	0	4	4	1	 	 	 	 	 	 	 	 	120,000

PR	44	16	40	20	24	28	20	12	0	0	0	0	0	0	16	16	40	0	12	 	 	 	3,000,000

SD	32	0	0	49	10	0	0	0	0	0	0	31	39	9	 	 	 	 	 	1	10	1	960,000

TN	0	0	0	0	0	 	 	 	0	0	0	0	0	0	 	 	 	 	 	 	 	 	0

TX	0	0	0	0	0	0	0	0	0	0	0	0	0	0	 	 	 	 	 	 	 	 	0

VA	0	0	0	0	0	 	 	 	0	0	0	0	0	0	 	 	 	 	 	 	 	 	0

WI	9	0	0	41	25	0	0	0	2	10	13	7	31	12	0	 	 	0	0	 	 	 	270,000

 PAGE

Page   PAGE  1  of   NUMPAGES  6


[Federal Register Volume 83, Number 108 (Tuesday, June 5, 2018)]
[Rules and Regulations]
[Page 25936]
[FR Doc No: 2018-12013]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 60, 61, and 63

[EPA-R06-OAR-2016-0091; FRL-9978-89-Region 6]

New Source Performance Standards and National Emission Standards
for Hazardous Air Pollutants; Delegation of Authority to New Mexico

AGENCY: Environmental Protection Agency (EPA).

ACTION: Withdrawal of direct final rule.

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

SUMMARY: On April 13, 2018, the Environmental Protection Agency (EPA)
published a direct final rule approving the updated delegation of EPA
authority for implementation and enforcement of certain New Source
Performance Standards (NSPS) and National Emission Standards for
Hazardous Air Pollutants (NESHAPs) for all sources (both part 70 and
non-part 70 sources) to the New Mexico Environmental Department (NMED).
EPA stated in the direct final rule that if EPA received relevant
adverse comments by May 14, 2018, EPA would publish a timely withdrawal
in the Federal Register. EPA received an adverse comment on May 14,
2018, and accordingly is withdrawing the direct final rule.

DATES: The direct final rule published on April 13, 2018 (83 FR 15964),
is withdrawn effective June 5, 2018.

FOR FURTHER INFORMATION CONTACT: Mr. Rick Barrett,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: On April 13, 2018, EPA published a direct
final rule approving the updated delegation of authority for
implementation and enforcement of NSPS and NESHAPs for all sources
(both part 70 and non-part 70 sources) to the NMED. The direct final
rule was published without prior proposal because EPA anticipated no
relevant adverse comments. EPA stated in the direct final rule that if
relevant adverse comments were received by May 14, 2018, EPA would
publish a timely withdrawal in the Federal Register. EPA received an
adverse comment on May 14, 2018. Accordingly, EPA is withdrawing the
direct final rule. In a separate subsequent final action EPA will
address the comment received. The withdrawal is being taken pursuant to
sections 111 and112 of the CAA.

List of Subjects

40 CFR Part 60

    Environmental protection, Administrative practice and procedure,
Air pollution control, Intergovernmental relations, Reporting and
recordkeeping requirements.

40 CFR Part 61

    Environmental protection, Administrative practice and procedure,
Air pollution control, Arsenic, Benzene, Beryllium, Hazardous
substances, Intergovernmental relations, Mercury, Reporting and
recordkeeping requirements, Vinyl chloride.

40 CFR Part 63

    Environmental protection, Administrative practice and procedure,
Air pollution control, Hazardous substances, Intergovernmental
relations, Reporting and recordkeeping requirements.

    Dated: May 30, 2018.
Wren Stenger,
Director, Multimedia Division, Region 6.

0
Accordingly, the direct final rule published in the Federal Register on
April 13, 2018 (83 FR 15964), amending 40 CFR 60.4, 40 CFR 61.04, and
40 CFR 63.99, which was to become effective on June 12, 2018, is
withdrawn.
[FR Doc. 2018-12013 Filed 6-4-18; 8:45 am]
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[Federal Register Volume 86, Number 203 (Monday, October 25, 2021)]
[Proposed Rules]
[Pages 58817-58819]
[FR Doc No: 2021-22982]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2021-0857; Airspace Docket No. 19-AAL-51]
RIN 2120-AA66

Proposed Establishment of United States Area Navigation (RNAV)
Route T-382; Hooper Bay, AK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to establish United States Area
Navigation (RNAV) route T-382 in the vicinity of Hooper Bay, AK in
support of a large and comprehensive T-route modernization project for
the state of Alaska.

DATES: Comments must be received on or before December 9, 2021.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140,

Washington, DC 20590; telephone: 1(800) 647-5527, or<PHONE_NUMBER>.
You must identify FAA Docket No. FAA-2021-0857; Airspace Docket No. 19-
AAL-51 at the beginning of your comments. You may also submit comments
through the internet at https://www.regulations.gov.
    FAA Order JO 7400.11F, Airspace Designations and Reporting Points,
and subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Rules and Regulations Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC, 20591; telephone: (202) 267-
8783. FAA Order JO 7400.11F is also available for inspection at the
National Archives and Records Administration (NARA). For information on
the availability of FAA Order JO 7400.11F at NARA, email:
[email protected] or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Christopher McMullin, Rules and
Regulations Group, Office of Policy, Federal Aviation Administration,
800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it would expand the availability of RNAV in Alaska and
improve the efficient flow of air traffic within the National Airspace
System (NAS) by lessening the dependency on ground based navigation.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2021-0857; Airspace Docket No. 19-AAL-51) and be submitted in
triplicate to the Docket Management Facility (see ADDRESSES section for
address and phone number). You may also submit comments through the
internet at https://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to FAA Docket No. FAA-2021-0857; Airspace Docket No. 19-AAL-51.'' The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified comment
closing date will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the comment
closing date. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRM

    An electronic copy of this document may be downloaded through the
internet at https://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at https://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
holidays. An informal docket may also be examined during normal
business hours at the office of the Western Service Center, Operations
Support Group, Federal Aviation Administration, 2200 South 216th St.,
Des Moines, WA 98198.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order JO 7400.11F, Airspace
Designations and Reporting Points, dated August 10, 2021, and effective
September 15, 2021. FAA Order JO 7400.11F is publicly available as
listed in the ADDRESSES section of this document. FAA Order JO 7400.11F
lists Class A, B, C, D, and E airspace areas, air traffic service
routes, and reporting points.

Background

    In 2003, Congress enacted the Vision 100-Century of Aviation
Reauthorization Act (Pub. L. 108-176), which established a joint
planning and development office in the FAA to manage the work related
to the Next Generation Air Transportation System (NextGen). Today,
NextGen is an ongoing FAA-led modernization of the nation's air
transportation system to make flying safer, more efficient, and more
predictable.
    In support of NextGen, this proposal is part of a larger and
comprehensive T-route modernization project in the state of Alaska. The
project mission statement states: ``To modernize Alaska's Air Traffic
Service route structure using satellite based navigation Development of
new T-routes and optimization of existing T-routes will enhance safety,
increase efficiency and access, and will provide en route continuity
that is not subject to the restrictions associated with ground based
airway navigation.'' As part of this project, the FAA evaluated the
existing Colored Airway structure for: (a) Direct replacement (i.e.,
overlay) with a T-route that offers a similar or lower Minimum En route
Altitude (MEA) or Global Navigation Satellite System Minimum En route
Altitude (GNSS MEA); (b) the replacement of the colored airway with a
T-route in an optimized but similar geographic area, while retaining
similar or lower MEA; or (c) removal with no route structure (T-route)
restored in that area because the value was determined to be
insignificant.
    The aviation industry/users have indicated a desire for the FAA to
transition the Alaskan en route navigation structure away from
dependency on Non-Directional Beacons (NDB), and move to develop and
improve the RNAV route structure. The FAA proposes to establish RNAV
route T-382 to offer alternate routing while providing a lower MEA over
more favorable terrain for Colored Federal airway G-15 and Alaskan VHF
Omnidirectional Radar (VOR) Federal airways V-496 and V-510 from Hooper
Bay, AK, (HPB) VOR/Distance Measuring Equipment (VOR/DME) to McGrath,
AK, (MCG) VOR and Tactical Air Navigational System (VORTAC). The
proposed route would provide

instrument approach connectivity for Scammon Bay Airport (PACM) while
also including new RNAV waypoints JOPES over St Mary (SMA), AK and
WEREL over Anvik (ANV), AK, NDBs in anticipation of their pending
decommissioning.

The Proposal

    The FAA is proposing an amendment to 14 CFR part 71 to establish
RNAV route T-382 in the vicinity of Big Lake, AK in support of a large
and comprehensive T-route modernization project for the state of
Alaska. The proposed route is described below.
    T-381: The FAA proposes to establish T-382 from the Hooper Bay, AK,
(HPB) VOR/DME to the McGrath, AK, (MCG) VORTAC.
    United States Area Navigation Routes are published in paragraph
6011 of FAA Order JO 7400.11F dated August 10, 2021 and effective
September 15, 2021, which is incorporated by reference in 14 CFR 71.1.
The RNAV listed in this document would be published subsequently in FAA
Order JO 7400.11F.
    FAA Order JO 7400.11, Airspace Designations and Reporting Points,
is published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under
Department of Transportation (DOT) Regulatory Policies and Procedures
(44 FR 11034; February 26, 1979); and (3) does not warrant preparation
of a regulatory evaluation as the anticipated impact is so minimal.
Since this is a routine matter that will only affect air traffic
procedures and air navigation, it is certified that this proposed rule,
when promulgated, will not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

    1. The authority citation for part 71 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11F, Airspace Designations and Reporting Points, dated August 10,
2021, and effective September 15, 2021, is amended as follows:

Paragraph 6011 United States Area Navigation Routes.

* * * * *

T-381 Hooper Bay, AK to McGrath, AK [New]

HOOPER BAY, AK (HPB)          VOR/DME             (Lat. 61[deg]30'51.65'' N, long. 166[deg]08'04.13'' W)
JOPES, AK                     WP                  (Lat. 62[deg]03'33.80'' N, long. 163[deg]16'54.82'' W)
FELSA, AK                     WP                  (Lat. 62[deg]26'52.62'' N, long. 161[deg]35'12.99'' W)
WEREL, AK                     WP                  (Lat. 62[deg]38'29.25'' N, long. 160[deg]11'07.20'' W)
OTTAC, AK                     WP                  (Lat. 63[deg]02'12.19'' N, long. 158[deg]08'46.85'' W)
CHEFF, AK                     WP                  (Lat. 63[deg]04'15.06'' N, long. 157[deg]20'39.55'' W)
MC GRATH, AK (MCG)            VORTAC              (Lat. 62[deg]57'03.72'' N, long. 155[deg]36'40.97'' W)

* * * * *

    Issued in Washington, DC, on October 14, 2021.
Michael R. Beckles,
Acting Manager, Rules and Regulations Group.
[FR Doc. 2021-22982 Filed 10-22-21; 8:45 am]
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