[Federal Register Volume 87, Number 119 (Wednesday, June 22, 2022)]
[Proposed Rules]
[Pages 37252-37253]
[FR Doc No: 2022-13226]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2022-0766 Airspace Docket No. 22-AGL-25]
RIN 2120-AA66

Proposed Revocation of Class E Airspace; Watersmeet, MI

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to remove the Class E airspace at
Watersmeet, MI. The FAA is proposing this action as the result of an
airspace review due to the decommissioning of the Watersmeet non-
directional beacon (NDB).

DATES: Comments must be received on or before August 8, 2022.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590; telephone
(202) 366-9826, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2022-0766/Airspace Docket No. 22-AGL-25, at the beginning of your
comments. You may also submit comments through the internet at https://www.regulations.gov. You may review the public docket containing the
proposal, any comments received, and any final disposition in person in
the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through
Friday, except federal holidays.
    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
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: Rebecca Shelby, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

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 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 remove the Class E airspace extending upward from 700 feet above
the surface at Northwoods Airport, Watersmeets, MI, due to the
cancellation of the instrument procedures at this airport, and the
airspace is no longer being required.

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 and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2022-0766/
Airspace Docket No. 22-AGL-25.'' The postcard will be date/time stamped
and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    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 the ADDRESSES section for the 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 Federal Aviation Administration, Air Traffic
Organization, Central Service Center, Operations Support Group, 10101
Hillwood Parkway, Fort Worth, TX 76177.

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.

The Proposal

    The FAA is proposing an amendment to 14 CFR part 71 by
decommissioning the Watersmeet NDB and all associated extensions; and
removing the Class E airspace extending upward from 700 feet above the
surface at Northwoods Airport, Watersmeet, MI, due to the cancellation
and removal of instrument procedures and the airspace is no longer
required.
    This action is the result of an airspace review due to the
decommissioning of the Watersmeet NDB which provided guidance to
instrument procedures at this airport.
    Class E airspace designations are published in paragraph 6005 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 Class
E airspace designations listed in this document will be published
subsequently in FAA Order JO 7400.11.
    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 regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (1) is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
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 rule, when promulgated, would 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 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, 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

0
1. The authority citation for 14 CFR 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]

0
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 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

AGL MI E5 Watersmeet, MI (Removed)

    Issued in Fort Worth, Texas, on June 15, 2022.
Martin A. Skinner,
Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2022-13226 Filed 6-21-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 72 (Monday, April 15, 2019)]
[Rules and Regulations]
[Pages 15096-15098]
[FR Doc No: 2019-07463]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 868

[Docket No. FDA-2019-N-0647]

Medical Devices; Anesthesiology Devices; Classification of the
Ventilatory Electrical Impedance Tomograph

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the ventilatory electrical impedance tomograph into class II (special
controls). The special controls that apply to the device type are
identified in this order and will be part of the codified language for
the ventilatory electrical impedance tomograph's classification. We are
taking this action because we have determined that classifying the
device into class II (special controls) will provide a reasonable
assurance of safety and effectiveness of the device. We believe this
action will also enhance patients' access to beneficial innovative
devices, in part by reducing regulatory burdens.

DATES: This order is effective April 15, 2019. The classification was
applicable on December 20, 2018.

FOR FURTHER INFORMATION CONTACT: Deepika Arora Lakhani, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 2560, Silver Spring, MD 20993-0002,
301-796-4042, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the ventilatory electrical
impedance tomograph as class II (special controls), which we have
determined will provide a reasonable assurance of safety and
effectiveness. In addition, we believe this action will enhance
patients' access to beneficial innovation, in part by reducing
regulatory burdens by placing the device into a lower device class than
the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate by means of the procedures
for premarket notification under section 510(k) of the FD&C Act and
part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 (Pub. L. 105-115) established the first procedure for De
Novo classification. Section 607 of the Food and Drug Administration
Safety and Innovation Act (Pub. L. 112-144) modified the De Novo
application process by adding a second procedure. A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person

then requests a classification under section 513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval application in order to market a substantially
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial
equivalence''). Instead, sponsors can use the 510(k) process, when
necessary, to market their device.

II. De Novo Classification

    On September 29, 2017, TIMPEL Inc. submitted a request for De Novo
classification of the ENLIGHT 1810. FDA reviewed the request in order
to classify the device under the criteria for classification set forth
in section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on December 20, 2018, FDA issued an order to the
requester classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 868.1505. We have named
the generic type of device ventilatory electrical impedance tomograph,
and it is identified as a prescription non-invasive, non-radiological
ventilatory device that provides an assessment of local impedance
variation within a cross-section of a patient's thorax.
    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

Table 1--Ventilatory Electrical Impedance Tomograph Risks and Mitigation
                                Measures
------------------------------------------------------------------------
            Identified risks                    Mitigation measure
------------------------------------------------------------------------
Adverse tissue reaction................  Biocompatibility evaluation.
Electromagnetic interference with other  Electromagnetic compatibility
 devices.                                 testing.
Infection..............................  Reprocessing validation and
                                          Labeling.
Inaccurate images due to either device   Software verification,
 hardware or software failure/            validation, and hazard
 malfunction.                             analysis; Non-clinical
                                          performance testing; and
                                          Labeling.
Electrical shock injury or thermal       Electrical, thermal, and
 injury.                                  mechanical safety testing;
                                          Software verification,
                                          validation, and hazard
                                          analysis; Non-clinical
                                          performance testing; and
                                          Labeling.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act.
    At the time of classification, ventilatory electrical impedance
tomographs are for prescription use only. Prescription devices are
exempt from the requirement for adequate directions for use for the
layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1))
and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met
(referring to 21 U.S.C. 352(f)(1)).

III. Analysis of Environmental Impact

    We have determined under 21 CFR 25.34(b) that this 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.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections
of information in the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' have been
approved under OMB control number 0910-0844; the collections of
information in 21 CFR part 820, regarding quality system regulation,
have been approved under OMB control number 0910-0073; the collections
of information in 21 CFR part 814, subparts A through E, regarding
premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding
premarket notification submissions, have been approved under OMB
control number 0910-0120; and the collections of information in 21 CFR
part 801, regarding labeling, have been approved under OMB control
number 0910-0485.

List of Subjects in 21 CFR Part 868

    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
868 is amended as follows:

PART 868--ANESTHESIOLOGY DEVICES

0
1. The authority citation for part 868 continues to read as follows:

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

0
2. Add Sec.  868.1505 to subpart B to read as follows:

Sec.  868.1505   Ventilatory electrical impedance tomograph.

    (a) Identification. A ventilatory electrical impedance tomograph is
a prescription non-invasive, non-radiological ventilatory device that
provides an assessment of local impedance variation within a cross-
section of a patient's thorax.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The patient-contacting components of the device must be
demonstrated to be biocompatible.
    (2) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use,
including the following:
    (i) Characterization of device parameters, including signal-to-
noise ratio, voltage accuracy, drift, reciprocity accuracy, amplitude
response, position error, and ringing;
    (ii) Real time evaluation of local impedance variation;
    (iii) Plethysmogram accuracy testing; and
    (iv) Use life testing of reusable components.
    (3) Performance data must validate reprocessing instructions for
any reusable components of the device.
    (4) Performance data must demonstrate the electrical, thermal, and
mechanical safety and the electromagnetic compatibility of the device.
    (5) Software verification, validation, and hazard analysis must be
performed.
    (6) Labeling must include the following:
    (i) Guidance for interpretation of the images generated;
    (ii) A warning that the device should be removed before use of a
defibrillator, or defibrillator interaction information based on
defibrillator performance testing with the device;
    (iii) A use life for any reusable components; and
    (iv) Instructions for reprocessing any reusable components.

    Dated: April 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-07463 Filed 4-12-19; 8:45 am]
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[Federal Register Volume 84, Number 193 (Friday, October 4, 2019)] [Rules and Regulations] [Pages 53052-53053] [FR Doc No: 2019-21414]

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OCCUPATIONAL SAFETY AND HEALTH REVIEW COMMISSION

29 CFR Part 2200

Rules of Procedure; Corrections

AGENCY: Occupational Safety and Health Review Commission.

ACTION: Correcting amendments.

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SUMMARY: This document makes technical amendments to the final rule  published by the Occupational Safety and Health Review Commission in  the Federal Register on April 10, 2019 and corrected on August 30,  2019. That rule revised the procedural rules governing practice before  the Occupational Safety and Health Review Commission.

DATES: Effective on October 4, 2019.

FOR FURTHER INFORMATION CONTACT: Ron Bailey, Attorney-Advisor, Office  of the General Counsel, by telephone at<PHONE_NUMBER>, by email at  <EMAIL_ADDRESS>or by mail at: 1120 20th Street NW, Ninth Floor,  Washington, DC 20036-3457.

SUPPLEMENTARY INFORMATION: OSHRC published revisions to its rules of  procedure in the Federal Register on April 10, 2019 (84 FR 14554) and  published corrections on August 30, 2019 (84 FR 45654). This document  makes further technical amendments to the final rule.

List of Subjects in 29 CFR Part 2200

    Administrative practice and procedure, Hearing and appeal  procedures.

    Accordingly, 29 CFR part 2200 is amended by making the following  correcting amendments:

PART 2200--RULES OF PROCEDURE

0 1. The authority citation for part 2200 continues to read as follows:

    Authority: 29 U.S.C. 661(g), unless otherwise noted.

    Section 2200.96 is also issued under 28 U.S.C. 2112(a).

0 2. Amend Sec.  2200.7 by revising paragraph (k)(1)(ii) to read as  follows:

Sec.  2200.7  Service, notice, and posting.

* * * * *     (k) * * *     (1) * * *

    (ii) A copy of the Secretary's statement of reasons, filed in  conformance with Sec.  2200.38(a). * * * * *

0 3. Amend Sec.  2200.37 by revising the last sentence of paragraph  (d)(4) to read as follows:

Sec.  2200.37  Petitions for modification of the abatement period.

* * * * *     (d) * * *     (4) * * * The requirements set forth in Sec.  2200.35(b) through  (c) shall apply. * * * * *

0 4. Amend Sec.  2200.64 by revising the last sentence of paragraph (b)  to read as follows:

Sec.  2200.64  Failure to appear.

* * * * *     (b) * * * See Sec.  2200.90(c). * * * * *

0 5. Amend Sec.  2200.73 by revising paragraph (g) to read as follows:

Sec.  2200.73  Interlocutory review.

* * * * *     (g) When filing effective. A petition for interlocutory review is  deemed to be filed only when received by the Commission, as specified  in Sec.  2200.8(d)(3)(ii).

0 6. Amend Sec.  2200.90 by revising paragraph (c) to read as follows:

Sec.  2200.90  Decisions and reports of Judges.

* * * * *     (c) Relief from default. Until the Judge's report has been docketed  by the Executive Secretary, the Judge may relieve a party of default or  grant reinstatement under Sec.  2200.101(b), Sec.  2200.52(f)(2), or  Sec.  2200.64(b). * * * * *

0 7. Amend Sec.  2200.91 by revising paragraph (e) to read as follows:

Sec.  2200.91  Discretionary review; petitions for discretionary  review; statements in opposition to petitions.

* * * * *     (e) When filing effective. A petition for discretionary review is  filed when received by the Commission, as specified in Sec.   2200.8(d)(3)(ii). * * * * *

0 8. Amend Sec.  2200.93 by revising the first sentence of paragraph (i)  to read as follows:

Sec.  2200.93  Briefs before the Commission.

* * * * *     (i) Brief of an amicus curiae. The Commission may allow a brief of  an amicus curiae pursuant to the criteria and time period set forth in  Sec.  2200.24. * * *

0 9. Amend Sec.  2200.211 by revising the first sentence to read as  follows:

Sec.  2200.211  Applicability of subparts A through G.

    The provisions of subpart D (Sec. Sec.  2200.50-2200.57) and  Sec. Sec.  2200.34, 2200.37(d), 2200.38, 2200.71, and 2200.73 will not  apply to Simplified Proceedings. * * *

    Dated: September 25, 2019. James J. Sullivan, Jr., Chairman. [FR Doc. 2019-21414 Filed 10-3-19; 8:45 am]  BILLING CODE 7600-01-P


[Federal Register Volume 85, Number 217 (Monday, November 9, 2020)]
[Notices]
[Pages 71352-71353]
[FR Doc No: 2020-24847]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2007-0008]

National Advisory Council; Meeting

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Committee Management; notice of open Federal Advisory Committee
meeting.

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SUMMARY: The Federal Emergency Management Agency's National Advisory
Council (NAC) will meet December 1-2, 2020. The meeting will be open to
the public through virtual means.

DATES: The NAC will meet by virtual means Tuesday, December 1 and
Wednesday, December 2, 2020, between 12:30 p.m. to 5 p.m. Eastern Time
(ET). Please note that the meeting may close early if the NAC has
completed its business.

ADDRESSES: All membership, FEMA, invited guest and public participation
is by virtual means only. Anyone who wishes to participate must
register with FEMA prior to the meeting by providing their name,
telephone number, email address, title, and organization to the person
listed in the FOR FURTHER INFORMATION CONTACT caption by 5 p.m. ET
Friday, November 27, 2020.
    To facilitate public participation, members of the public are
invited to provide written comments on the issues to be considered by
the NAC. The topic areas are indicated in the SUPPLEMENTARY INFORMATION
caption. The full agenda and any related documents for this meeting
will be available by Friday, November 27, 2020, by contacting the
person listed in the FOR FURTHER INFORMATION CONTACT caption. Written
comments must be submitted and received by 5 p.m. ET on November 27,
2020, identified by Docket ID FEMA-2007-0008, and submitted by the
following method: Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.
    Instructions: All submissions must include the words ``Federal
Emergency Management Agency'' and the docket ID for this action.
Comments received, including any personal information provided, will be
posted without alteration at http://www.regulations.gov. You may wish
to read the ``Privacy & Security Notice'' found via a link on the
homepage of www.regulations.gov.
    Docket: For access to the docket to read comments received by the
NAC, go to http://www.regulations.gov, and search for Docket ID FEMA-
2007-0008.
    Public comment periods will be held on Tuesday, December 1, 2020,
from 1:30 p.m. to 1:40 p.m. ET and on Wednesday, December 2, 2020, from
1:30 p.m. to 1:40 p.m. ET. All speakers must limit their comments to 3
minutes. Comments should be addressed to the NAC. Any comments not
related to the agenda topics will not be considered by the NAC. To
register to make remarks during the public comment period, contact the
person listed in the FOR FURTHER INFORMATION CONTACT caption by 5 p.m.
ET Friday, November 27, 2020. Please note that the public comment
period may end before the time indicated, following the last call for
comments.
    Reasonable accommodations are available for people with
disabilities. To request a reasonable accommodation, contact the person
listed in the FOR FURTHER INFORMATION CONTACT caption as soon as
possible. Last minute requests will be accepted but may not be possible
to fulfill.

FOR FURTHER INFORMATION CONTACT: Jasper Cooke, Designated Federal
Officer, Office of the National Advisory Council, Federal Emergency
Management Agency, 500 C Street SW, Washington, DC 20472-3184,
telephone<PHONE_NUMBER>, and email<EMAIL_ADDRESS>The NAC
website is http://www.fema.gov/national-advisory-council.

SUPPLEMENTARY INFORMATION: Notice of this meeting is given under the
Federal Advisory Committee Act, 5 U.S.C. Appendix.
    The NAC advises the FEMA Administrator on all aspects of emergency
management. The NAC incorporates input from State, local, territorial,
and Tribal governments and the private sector in making recommendations
to the FEMA Administrator to be considered and potentially incorporated
into FEMA plans and strategies. The NAC includes a cross-section of
officials, emergency managers, and emergency response providers from
State, local, territorial, and Tribal governments, the private sector,
and nongovernmental organizations.
    Agenda: On Tuesday, December 1, 2020, the NAC will hear from
participants and discuss expediting disaster assistance.
    On Wednesday, December 2, 2020, the NAC will hear from participants
and discuss creating an equity standard.
    The full agenda and any related documents for this meeting will be
available by Friday, November 27, 2020, by contacting the person listed
in FOR FURTHER INFORMATION CONTACT.

Pete Gaynor,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2020-24847 Filed 11-6-20; 8:45 am]
BILLING CODE 9111-48-P


Heritage Conference Call Thursday, October 30, 2003 2: 30 PM Conference call with Dr. Ralph Roper: Attendees: Juan Parra Hugh Davis Q1: How does pH affects the solubility in raw Guardian EP dust Data: shows that minimum solubility is maintained at pH 11.5 The calcium content of the EPA dust ranges from 22 to 33% due to lime added as a treatment reagent in the EP gas cleaning process at Guardian. The solubility data is the above chart is most likely governed by the solubility of calcium selenate and/ or calcium selenite.

Chemistry: Selenium is an oxyanion forming element. Selenium is found in high concentration in leachate in alkaline media. Under oxidizing conditions, the oxyanionic species selenite ( Se O32) and selenate SE042 are the predominant forms of Se. The Se species HSe and H2Se are only stable under strong reducing conditions. Cement additives such as blast furnace slag may generate reducing conditions. Selenite is considered to be the less mobile species. It forms inner sphere complexes with surface functional groups under neutral and acidic conditions. . In cement pore water, CA occurs in millimolar concentrations, CA Se03 limits the solubility of selenite. Selenate sorbs via weakly bonded outer sphere complexes and has lower affinity with for oxide surfaces.

Q2: Why use Portland cement as a reagent for stabilization of Selenium?

The mayor hydration products in cement, calcium silicate hydrate ( CSH) and calcium ( sulfo) aluminate hydrate is important for sorption and substitution for contaminants.

High pH: At high pH ( low [ h+]), cation (+) adsorption is favorable and anion adsorption is limited on the negatively charged surface oxide sites. Substitution for SO42 in etringite and monosulfate is suggested to be the most efficient sorption reaction for several oxyanions, including SeO42 and H2O located in the interchannels, while monosulfate in the intralayers. Sulfate substitution in ettringite and monosulfate have been reported for selenate.

The selenite sorbtion by ettringite was around 25% uptake from solution, five times higher than the sorbtion of selenate. Selenate had up to 80% uptake from solution by sorption on monosulfate, twice as well as selenite.

Q3: What alternative management methods for the Guardian waste were evaluated?

From January   March 2003, Heritage explored several approaches for managing the selenium bearing waste generated by Guardian. Heritage has performed nearly 200 TCLP tests on this particular wastestream using a wide variety of stabilization concepts but none appeared capable of achieving the 5.7 mg/ L TCLP criterion reliably. Although Heritage continues to explore and test alternative stabilization techniques for this wastestream, a workable method is not available at the current time.

Selenium recovery by hydrometallurgical recovery was a treatment option that has been evaluated by Heritage in their variance petition. Several other methods for extracting selenium out of waste were evaluated and various methods for converting the extracted selenium to a useful product were also tested. Previous attempts to recover materials from relatively low volume wastes suggest that financial viability was a concern."


[Federal Register Volume 82, Number 37 (Monday, February 27, 2017)]
[Notices]
[Pages 11971-11973]
[FR Doc No: 2017-03799]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-80080; File No. SR-ISE-2017-10]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change To Amend the Schedule of Fees

February 22, 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 February 10, 2017, the International Securities Exchange, LLC
(``ISE'' or ``Exchange'') filed with the Securities and Exchange
Commission (``SEC'' or ``Commission'') the proposed rule change as
described in Items I and II, below, which Items have been prepared by
the Exchange. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the Exchange's Schedule of Fees, as
described in further detail below.
    The text of the proposed rule change is available on the Exchange's
Web site at www.ise.com, at the principal office of the Exchange, and
at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The purpose of the proposed rule change is to amend the Exchange's
Schedule of Fees to increase, for all symbols other than FX Option
Symbols,\3\ the fees applicable to Professional Customers \4\ for the
initiating or contra side of Qualified Contingent Cross (``QCC'')
orders or orders executed in the Solicited Order Mechanism
(``Solicitation'' orders). Accordingly, the proposed rule change will
also increase the rebates that the Exchange currently provides to
members using QCC and/or other solicited crossing orders, including
solicited orders executed in the Solicitation, Facilitation, and Price
Improvement Mechanisms (``solicited crossing orders''), in each case
between Professional Customers or between a Professional Customer and a
Priority Customer.\5\
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    \3\ ``FX Option Symbols'' are options overlying AUM, GBP, EUU
and NDO.
    \4\ A ``Professional Customer'' is a person or entity that is
not a broker/dealer and is not a Priority Customer.
    \5\ A ``Priority Customer'' is a person or entity that: (i) is
not a broker or dealer in securities; and (ii) does not place more
than 390 orders in listed options per day on average during a
calendar month for its own beneficial account(s), as defined in ISE
Rule 100(a)(37A).
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    Currently, the Exchange does not charge a fee to Professional
Customers for QCC and Solicitation orders.\6\ As such, Professional
Customer volume in QCC and Solicitation orders are rebated in
accordance with the standard ``Customer to Customer'' rebate tiers,
which are lower than the rebates provided for QCC and other solicited
crossing orders to all other market participants than Professional and
Priority Customers, as further described below.
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    \6\ See Securities Exchange Act Release No. 79811 (January 17,
2017), 82 FR 8244 (January 24, 2017) (SR-ISE-2017-01) (eliminating
the Professional Customer fee for the initiating or contra side of a
QCC or Solicitation order) (the ``January Fee Filing'').
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    The Exchange presently offers members rebates in QCC and other
solicited crossing orders. These rebates are provided for each
originating contract side of a crossing order, based on a member's
volume in the crossing mechanisms during a given month. The applicable
rebates will be applied on QCC and other solicited crossing order
traded contracts once the specified volume threshold is met. Members
receive the Non-``Customer to Customer'' Rebate for all QCC and/or
other solicited crossing orders except for QCC and other solicited
crossing orders between two Priority and/or Professional Customers. QCC
and other solicited crossing orders between two Priority and/or
Professional Customers receive the ``Customer to Customer'' Rebate or
``Customer to Customer''

Rebate PLUS,\7\ respectively. Currently, for the Non-``Customer to
Customer'' Rebate, for members that execute 0 to 99,999 originating
contract sides (``Tier 1'') the rebate is $0.00 per contract, for
members that execute 100,000 to 199,999 originating contract sides
(``Tier 2'') the rebate is $0.05 per contract, for members that execute
200,000 to 499,999 originating contract sides (``Tier 3'') the rebate
is $0.07 per contract, for members that execute 500,000 to 699,999
originating contract sides (``Tier 4'') the rebate is $0.08 per
contract, for members that execute 700,000 to 999,999 originating
contract sides (``Tier 5'') the rebate is $0.09 per contract, and for
members that execute 1,000,000 originating contract sides or more
(``Tier 6'') the rebate is $0.11 per contract.\8\ Also, for the
``Customer to Customer'' Rebate, for Tier 1 the rebate is $0.00, for
Tiers 2 and 3 the rebate is $0.01, and for Tiers 4 through 6 the rebate
is $0.03. Lastly, for the ``Customer to Customer'' Rebate PLUS, for
Tier 1 the rebate is $0.00, and for Tiers 2 through 6 the rebate is
$0.05.
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    \7\ The PLUS rebates currently apply to ``Customer to Customer''
Orders (i.e. QCC and other solicited crossing orders between two
Priority and/or Professional Customers) executed by members with (1)
a specified volume of QCC and other solicited crossing orders in a
given month and (2) 175,000 or more unsolicited originating
Facilitation contract sides per month. The Exchange notes that
members may receive either the ``Customer to Customer'' Rebate or
the ``Customer to Customer'' Rebate PLUS--not both.
    \8\ The rebate is applied to the originating contract side of
QCC and other solicited crossing orders traded in a given month once
a member reaches the specified volume threshold/tier during that
month.
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    The Exchange now proposes to charge a fee of $0.10 per contract to
Professional Customers for QCC and Solicitation orders. Accordingly,
the Exchange also proposes that Professional Customer volume in QCC and
Solicitation orders, as well as other solicited crossing orders, be
rebated in the higher amounts set forth in the Non-``Customer to
Customer'' Rebate tiers as described above. As a result of the proposed
changes, members would receive the ``Customer to Customer'' Rebate and
the ``Customer to Customer'' Rebate PLUS for QCC and/or other solicited
crossing orders between two Priority Customers only.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\9\ in general, and furthers the objectives of Sections
6(b)(4) and 6(b)(5) of the Act,\10\ in particular, in that it provides
for the equitable allocation of reasonable dues, fees and other charges
among members and issuers and other persons using any facility, and is
not designed to permit unfair discrimination between customers,
issuers, brokers, or dealers.
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    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(4) and (5).
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    The Exchange believes that it is reasonable and equitable to
increase the fee for Professional Customer QCC and Solicitation orders
because the proposed fee is designed to be attractive to Professional
Customers that trade on ISE, and is generally lower than the fees
applicable to other market participants, except for Priority Customers.
Although the Exchange is increasing the Professional Customer fee for
QCC and Solicitation orders, it is also increasing the associated
rebates that the Exchange provides to members using such orders with
the intent to attract greater order flow to ISE, which would ultimately
benefit all market participants that trade on the Exchange.
    In addition, the Exchange believes that it is equitable and not
unfairly discriminatory to continue to provide lower fees for Priority
Customer orders. A Priority Customer is by definition not a broker or
dealer in securities, and does not place more than 390 orders in listed
options per day on average during a calendar month for its own
beneficial account(s). This limitation does not apply to participants
whose behavior is substantially similar to that of market
professionals, including Professional Customers, who will generally
submit a higher number of orders than Priority Customers. The Exchange
notes that a recent modification to its rules caused a number of its
Priority Customers to be re-classified as Professional Customers.\11\
Under the rule change, such market participants who were previously
classified as Priority Customers, and incurred no fees for executing
QCC and Solicitation orders, would have started incurring such fees
after being re-classified as Professional Customers. The Exchange
therefore decided to treat these market participants the same as
Priority Customers for purposes of the QCC and Solicitation orders as a
means of easing the transition process for such participants. Following
the one month period, the Exchange has determined that it is reasonable
to begin assessing fees for Professional Customer QCC and Solicitation
orders, which are still lower than the original amounts assessed prior
to the January Fee Filing.
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    \11\ See Securities Exchange Act Release No. 78788 (September 8,
2016), 81 FR 63252 (September 14, 2016) (SR-ISE-2016-19).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. In terms of inter-market
competition, the Exchange notes that it operates in a highly
competitive market in which market participants can readily favor
competing venues if they deem fee levels at a particular venue to be
excessive, or rebate opportunities available at other venues to be more
favorable. In such an environment, the Exchange must continually adjust
its fees to remain competitive with other exchanges and with
alternative trading systems that have been exempted from compliance
with the statutory standards applicable to exchanges. Because
competitors are free to modify their own fees in response, and because
market participants may readily adjust their order routing practices,
the degree to which fee changes in this market may impose any burden on
competition is extremely limited.

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

    No written comments were either solicited or received.

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)(ii) of the Act,\12\ and Rule 19b-4(f)(2) \13\ 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: (i) Necessary or
appropriate in the public interest; (ii) for the protection of
investors; or (iii) otherwise in furtherance of the purposes of the
Act. If the Commission takes such action, the Commission shall
institute proceedings to determine whether the proposed rule should be
approved or disapproved.
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    \12\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \13\ 17 CFR 240.19b-4(f)(2).
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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-ISE-2017-10 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2017-10. 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 the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number and should be submitted on or
before March 20, 2017.
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    \14\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-03799 Filed 2-24-17; 8:45 am]
 BILLING CODE 8011-01-P