[Federal Register: March 9, 2006 (Volume 71, Number 46)]
[Notices]
[Page 12224-12226]
[DOCID:fr09mr06-107]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53405; File No. SR-FICC-2005-22]

Self-Regulatory Organizations; Fixed Income Clearing Corporation;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
to Provide for the Payment of Interest on Cash Clearing Fund Collateral
Posted by Members of the Government Securities Division and to Provide
for the Payment of Interest on the Basic Deposit Portion of the
Participants' Fund Posted by Members of the Mortgage-Backed Securities
Division

 March 3, 2006.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ notice is hereby given that on December 23, 2005, the
Fixed Income Clearing Corporation (``FICC'') filed with the Securities
and Exchange Commission (``Commission'') and on February 17, 2006, and
February 27, 2006, amended \2\ the proposed rule change described in
Items I, II, and III below, which items have been prepared primarily by
FICC. FICC filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \3\ and Rule 19b-4(f)(4) thereunder \4\
whereby the proposal became effective upon filing with the Commission.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested parties.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ The amendments clarified the type of securities in which
cash contained in the participants' fund may be invested.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(4).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    FICC is amending (i) the rules of its Government Securities
Division (``GSD'') to provide for payment of interest on cash clearing
fund collateral posted by members and (ii) the rules of its Mortgage-
Backed Securities Division (``MBSD'') to provide for the payment of
interest on the Basic Deposit component of participants' fund
collateral posted by members. FICC is also proposing technical changes
to the provisions in the GSD's and MBSD's rules regarding the payment
of interest on members' cash deposits.

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

    In its filing with the Commission, FICC 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. FICC has prepared summaries, set forth in Sections (A),
(B), and (C) below, of the most significant aspects of these
statements.\5\
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    \5\ The Commission has modified the text of the summaries
prepared by FICC.
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(A) Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    The proposed rule change provides for the payment of interest on
cash clearing fund collateral posted by GSD members and payment of
interest on the Basic Deposit component of participants' fund
collateral posted by MBSD members.
    The GSD requires that all netting members maintain a portion of
their clearing fund deposit in cash.\6\ FICC

currently retains the interest earned on those balances and effectively
pays the interest income to GSD members through its rebate process.\7\
Among all the subsidiary clearing agencies of The Depository Trust and
Clearing Corporation (DTCC), only FICC's GSD does not pay the interest
earned on clearing fund cash balances directly to its members.\8\
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    \6\ See GSD Rule 4, Section 4.
    \7\ The GSD's rebate policy is detailed in the GSD Fee Schedule,
Section XII (``Capital Base, Pricing, and Rebate Policy''). It
reads, in pertinent part, that FICC ``will rebate excess net income
to members, pro rata, at periodic intervals deemed appropriate by,
and at the discretion of, the Corporation based upon their gross
fees paid to the Corporation within the applicable rebate period.''
    \8\ While FICC's MBSD pays interest on participants' fund cash
to its participants, it currently retains interest on a small
portion of the participants' fund. This is discussed further below.
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    In order to more fairly distribute interest earned on the GSD cash
portion of the clearing fund and to implement a uniform policy across
DTCC, FICC is proposing to begin crediting interest earned on clearing
fund cash balances to GSD members on a periodic basis. FICC will begin
accruing the interest in this regard on January 1, 2006.\9\
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    \9\ FICC will announce by Important Notice the date of the first
payment of interest to members and the frequency of the payments of
interest going forward.
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    While the MBSD currently pays interest on participants' fund cash
directly to its participants, it retains the interest on a small
portion of the participants' fund called the Basic Deposit.\10\ FICC
believes that to be consistent with the GSD rule change and the
practice observed for all other cash deposits, the MBSD rule should be
amended to also provide for the payment of interest earned on the Basic
Deposits to be paid to participants. FICC is proposing to begin
accruing the interest in this regard on January 1, 2006.\11\
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    \10\ The Basic Deposit is a relatively small amount that is
required to be paid in cash by each clearing participant and is
meant to protect FICC against a participant's failure to pay its
MBSD fees.
    \11\ FICC will announce by Important Notice the date of the
first payment of interest to members and the frequency of the
payments of interest going forward.
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    FICC is also proposing technical changes to the provision in the
MBSD's rules regarding the investment of participants' fund cash and to
the provision in the GSD's rules regarding the investment of clearing
fund cash to make the rules on investing cash deposits uniform with
that of its affiliate, The Depository Trust Company. Specifically, FICC
is clarifying that cash contained in the clearing fund or participants'
fund may be partially or wholly invested by FICC for its account in
securities issued or guaranteed as to principal and interest by the
United States or agencies or instrumentalities of the United States or
repurchase agreements relating to securities issued or guaranteed as to
principal and interest by the United States or agencies and
instrumentalities of the United States.
    FICC believes the proposed rule change is consistent with the
requirements of Section 17A of the Act \12\ and the rules and
regulations thereunder applicable to FICC because it will enable FICC
to more fairly distribute the payment of interest on cash collateral to
its members. As such, the proposed rule change effects a change in an
existing service that does not adversely affect the safeguarding of
securities or funds in the custody or control of FICC and does not
significantly affect the respective rights or obligations of FICC or
persons using its service.
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    \12\ 15 U.S.C. 78q-1.
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(B) Self-Regulatory Organization's Statement on Burden on Competition

    FICC does not believe that the proposed rule change will have an
impact or impose any burden on competition.

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

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

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

    The foregoing proposed rule change has become effective upon filing
pursuant to Section 19(b)(3)(A)(iii) of the Act \13\ and Rule 19b-
4(f)(4) \14\ thereunder because the rule effects a change in an
existing service that: (i) Does not adversely affect the safeguarding
of securities or funds in the custody or control of the clearing agency
or for which it is responsible; and (ii) does not significantly affect
the respective rights or obligations of the clearing agency or persons
using the service. At any time within sixty days of the filing of the
proposed rule change,\15\ the Commission may summarily abrogate 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.
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    \13\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \14\ 17 CFR 240.19b-4(f)(4).
    \15\ For purposes of calculating the sixty day period within
which the Commission may summarily abrogate the proposed rule change
under Section 19(b)(3)(C) of the Act, the Commission considers the
period to commence on the date on which the last amendment to the
proposed rule change was filed with the Commission. 15 U.S.C.
78s(b)(3)(C).
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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 e-mail to<EMAIL_ADDRESS>Please include

File Number SR-FICC-2005-22 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-9303.
    All submissions should refer to File Number SR-FICC-2005-22. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments,

all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Section, 100 F Street,
NE., Washington, DC 20549. Copies of such filings also will be
available for inspection and copying at the principal office of FICC
and on FICC's Web site at http://www.ficc.com. All comments received

will be posted without change; the Commission does not edit personal
identifying information from submissions. You should submit only
information that you wish to make available publicly. All submissions

should refer to File Number SR-FICC-2005-22 and should be submitted on
or before March 30, 2006.

    For the Commission by the Division of Market Regulation,
pursuant to delegated authority.\16\
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    \16\ 17 CFR 200.30-3(a)(12).
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Jill M. Peterson,
Assistant Secretary.
[FR Doc. E6-3327 Filed 3-8-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 88, Number 72 (Friday, April 14, 2023)]
[Notices]
[Pages 23089-23091]
[FR Doc No: 2023-07896]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-5422]

Peripheral Percutaneous Transluminal Angioplasty and Specialty
Catheters--Premarket Notification (510(k)) Submissions; Guidance for
Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Peripheral Percutaneous
Transluminal Angioplasty (PTA) and Specialty Catheters--Premarket
Notification (510(k)) Submissions.'' FDA is issuing this final guidance
document to provide recommendations for 510(k) submissions for
peripheral percutaneous transluminal angioplasty (PTA) balloons and
specialty catheters (e.g., infusion catheters, PTA balloon catheters
for in-stent restenosis (ISR), scoring/cutting balloons).

DATES: The announcement of the guidance is published in the Federal
Register on April 14, 2023.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact

information, or other information that identifies you in the body of
your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-5422 for ``Peripheral Percutaneous Transluminal Angioplasty
and Specialty Catheters--Premarket Notification (510(k)) Submissions.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)). An electronic copy of the guidance document is available
for download from the internet. See the SUPPLEMENTARY INFORMATION
section for information on electronic access to the guidance. Submit
written requests for a single hard copy of the guidance document
entitled ``Peripheral Percutaneous Transluminal Angioplasty (PTA) and
Specialty Catheters--Premarket Notification (510(k)) Submissions'' to
the Office of Policy, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Eleni Whatley, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2267, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is issuing this guidance to clarify FDA's recommendations for
testing and information to include in 510(k) submissions for PTA
catheters and specialty catheters to promote consistency across
submissions. These devices are catheter-based devices intended to treat
lesions in the peripheral vasculature. This guidance expands on FDA's
current thinking for testing of PTA balloon catheters and specialty
catheters (e.g., infusion catheters, PTA balloon catheters for ISR,
scoring/cutting balloons), and provides specific recommendations
regarding performance testing and anatomy-specific assessments. This
document supplements other FDA documents regarding the specific content
requirements of premarket submissions.
    A notice of availability of the draft guidance appeared in the
Federal Register of January 13, 2020 (85 FR 1812). FDA considered
comments received and revised the guidance as appropriate in response
to the comments, including addition of details and clarification for
non-clinical test recommendations, and minor revisions to ensure
consistency with FDA-recognized consensus standards and other FDA
guidances.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Peripheral Percutaneous Transluminal
Angioplasty (PTA) and Specialty Catheters--Premarket Notification
(510(k)) Submissions.'' It does not establish any rights for any person
and is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov and https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to
download an electronic copy of ``Peripheral Percutaneous Transluminal
Angioplasty (PTA) and Specialty Catheters--Premarket Notification
(510(k)) Submissions'' may send an email request to [email protected] to receive an electronic copy of the document.
Please use the document number GUI00016018 and complete title to
identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it
does refer to previously approved FDA 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. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by

OMB under the PRA. The collections of information in the following FDA
regulations, guidance, and forms have been approved by OMB as listed in
the following table:

------------------------------------------------------------------------
                                                            OMB control
    21 CFR part or guidance               Topic                 No.
------------------------------------------------------------------------
807, subpart E.................  Premarket notification.       0910-0120
812............................  Investigational Device        0910-0078
                                  Exemption.
``Requests for Feedback and      Q-submissions..........       0910-0756
 Meetings for Medical Device
 Submissions: The Q-Submission
 Program''.
800, 801, and 809..............  Medical Device Labeling       0910-0485
                                  Regulations.
50, 56.........................  Protection of Human           0910-0130
                                  Subjects and
                                  Institutional Review
                                  Boards.
58.............................  Good Laboratory               0910-0119
                                  Practice (GLP)
                                  Regulations for
                                  Nonclinical Laboratory
                                  Studies.
------------------------------------------------------------------------

    Dated: April 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-07896 Filed 4-13-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 169 (Tuesday, September 2, 2014)]
[Notices]
[Pages 52102-52103]
[FR Doc No: 2014-20819]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Second Meeting: RTCA Special Committee 231, Special Committee
231, TAWS-GPWS

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Meeting Notice of RTCA Special Committee 231, TAWS-GPWS.

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SUMMARY: The FAA is issuing this notice to advise the public of the
second meeting of the RTCA Special Committee 231, TAWS-GPWS.

DATES: The meeting will be held September 30-October 2, 2014 from 9:00
a.m.-5:00 p.m.

ADDRESSES: The meeting will be held at RTCA Headquarters, RTCA, Inc.,
1150 18th Street NW., Suite 910, Washington, DC 20036.

FOR FURTHER INFORMATION CONTACT: The RTCA Secretariat, 1150 18th Street
NW., Suite 910, Washington, DC 20036, or by telephone at (202) 330-
0652/(202) 833-9339, fax at<PHONE_NUMBER>, or Web site at http://www.rtca.org.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is
hereby given for a meeting of Special Committee 213. The agenda will
include the following:

September 30th--9:00 a.m.-5:00 p.m.

 Welcome/Introduction
 Administrative Remarks
 Agenda Review
 Review of Revised Terms of Reference
 Summary of Working Group activities
 Other Business
 Date and Place of Next Meeting

October 1st--9:00 a.m.-5:00 p.m.

 Continuation of Plenary or Working Group Session

October 2nd--9:00 a.m.-3:00 p.m.

 Continuation of Plenary or Working Group Session

    Attendance is open to the interested public but limited to space
availability. With the approval of the chairman, members of the public
may present oral

statements at the meeting. Persons wishing to present statements or
obtain information should contact the person listed in the FOR FURTHER
INFORMATION CONTACT section. Members of the public may present a
written statement to the committee at any time.

    Issued in Washington, DC, on August 26, 2014.
Mohannad Dawoud,
Management Analyst, NextGen, Business Operations Group, Federal
Aviation Administration.
[FR Doc. 2014-20819 Filed 8-29-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 160 (Friday, August 17, 2018)]
[Rules and Regulations]
[Pages 40968-40971]
[FR Doc No: 2018-17616]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 31207; Amdt. No. 3812]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This rule amends, suspends, or removes Standard Instrument
Approach Procedures (SIAPs) and associated Takeoff Minimums and
Obstacle Departure Procedures for operations at certain airports. These
regulatory actions are needed because of the adoption of new or revised
criteria, or because of changes occurring in the National Airspace
System, such as the commissioning of new navigational facilities,
adding new obstacles, or changing air traffic requirements. These
changes are designed to provide for the safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective August 17, 2018. The compliance date for
each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of August 17, 2018.

ADDRESSES: Availability of matter incorporated by reference in the
amendment is as follows:

For Examination

    1. U.S. Department of Transportation, Docket Ops-M30, 1200 New
Jersey

Avenue SE, West Bldg., Ground Floor, Washington, DC 20590-0001;
    2. The FAA Air Traffic Organization Service Area in which the
affected airport is located;
    3. The office of Aeronautical Navigation Products, 6500 South
MacArthur Blvd., Oklahoma City, OK 73169 or,
    4. The National Archives and Records Administration (NARA).
    For information on the availability of this material at NARA, call
202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

Availability

    All SIAPs and Takeoff Minimums and ODPs are available online free
of charge. Visit the National Flight Data Center online at nfdc.faa.gov
to register. Additionally, individual SIAP and Takeoff Minimums and ODP
copies may be obtained from the FAA Air Traffic Organization Service
Area in which the affected airport is located.

FOR FURTHER INFORMATION CONTACT: Thomas J. Nichols, Flight Procedure
Standards Branch (AFS-420) Flight Technologies and Procedures Division,
Flight Standards Service, Federal Aviation Administration, Mike
Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma
City, OK 73169 (Mail Address: P.O. Box 25082 Oklahoma City, OK. 73125)
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14, Code of Federal
Regulations, part 97 (14 CFR part 97) by amending the referenced SIAPs.
The complete regulatory description of each SIAP is listed on the
appropriate FAA Form 8260, as modified by the National Flight Data
Center (NFDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated
by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20.
The large number of SIAPs, their complex nature, and the need for a
special format make their verbatim publication in the Federal Register
expensive and impractical. Further, airmen do not use the regulatory
text of the SIAPs, but refer to their graphic depiction on charts
printed by publishers of aeronautical materials. Thus, the advantages
of incorporation by reference are realized and publication of the
complete description of each SIAP contained on FAA form documents is
unnecessary.
    This amendment provides the affected CFR sections, and specifies
the SIAPs and Takeoff Minimums and ODPs with their applicable effective
dates. This amendment also identifies the airport and its location, the
procedure and the amendment number.

Availability and Summary of Material Incorporated by Reference

    The material incorporated by reference is publicly available as
listed in the ADDRESSES section.
    The material incorporated by reference describes SIAPs, Takeoff
Minimums and ODPs as identified in the amendatory language for part 97
of this final rule.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP and Takeoff Minimums and ODP as amended in the
transmittal. For safety and timeliness of change considerations, this
amendment incorporates only specific changes contained for each SIAP
and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.
    The SIAPs and Takeoff Minimums and ODPs, as modified by FDC
permanent NOTAM, and contained in this amendment are based on the
criteria contained in the U.S. Standard for Terminal Instrument
Procedures (TERPS). In developing these changes to SIAPs and Takeoff
Minimums and ODPs, the TERPS criteria were applied only to specific
conditions existing at the affected airports. All SIAP amendments in
this rule have been previously issued by the FAA in a FDC NOTAM as an
emergency action of immediate flight safety relating directly to
published aeronautical charts.
    The circumstances that created the need for these SIAP and Takeoff
Minimums and ODP amendments require making them effective in less than
30 days.
    Because of the close and immediate relationship between these
SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find
that notice and public procedure under 5 U.S.C. 553(b) are
impracticable and contrary to the public interest and, where
applicable, under 5 U.S.C. 553(d), good cause exists for making these
SIAPs effective in less than 30 days.
    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.
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. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

    Air Traffic Control, Airports, Incorporation by reference,
Navigation (air).

    Issued in Washington, DC, on July 27, 2018.
Rick Domingo,
Executive Director, Flight Standards Service.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14,
Code of Federal regulations, part 97, (14 CFR part 97), is amended by
amending Standard Instrument Approach Procedures and Takeoff Minimums
and ODPs, effective at 0901 UTC on the dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g), 40103, 40106, 40113,
40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:
    By amending: Sec.  97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or
TACAN; Sec.  97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; Sec.
97.27 NDB, NDB/DME; Sec.  97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV;
Sec.  97.31 RADAR SIAPs; Sec.  97.33 RNAV SIAPs; and Sec.  97.35 COPTER
SIAPs, Identified as follows:

* * * Effective Upon Publication

--------------------------------------------------------------------------------------------------------------------------------------------------------
       AIRAC date            State              City               Airport          FDC No.      FDC date                      Subject
--------------------------------------------------------------------------------------------------------------------------------------------------------
13-Sep-18..............  ID             Coeur D'Alene......  Coeur D'Alene--           8/0531      7/23/18  ILS OR LOC/DME RWY 6, Amdt 5D.
                                                              Pappy Boyington
                                                              Field.
13-Sep-18..............  AK             Homer..............  Homer..............       8/1026      7/23/18  LOC RWY 4, Amdt 11A.
13-Sep-18..............  CA             Palm Springs.......  Bermuda Dunes......       8/1171      7/10/18  RNAV (GPS) RWY 28, Orig.

13-Sep-18..............  CA             Palm Springs.......  Bermuda Dunes......       8/1175      7/10/18  VOR-C, Orig-A.
13-Sep-18..............  MO             Salem..............  Salem Memorial.....       8/1892      7/25/18  RNAV (GPS) RWY 17, Orig.
13-Sep-18..............  MO             Salem..............  Salem Memorial.....       8/1893      7/25/18  RNAV (GPS) RWY 35, Orig.
13-Sep-18..............  TX             Graham.............  Graham Muni........       8/1894      7/25/18  RNAV (GPS) RWY 3, Orig.
13-Sep-18..............  TX             Graham.............  Graham Muni........       8/1899      7/25/18  RNAV (GPS) RWY 21, Orig.
13-Sep-18..............  NC             Elizabethtown......  Curtis L Brown Jr         8/1954      7/10/18  RNAV (GPS) RWY 33, Orig.
                                                              Field.
13-Sep-18..............  MD             Churchville........  Harford County.....       8/2250      7/23/18  RNAV (GPS)-B, Orig.
13-Sep-18..............  MO             St Louis...........  Creve Coeur........       8/2299      7/23/18  RNAV (GPS) RWY 34, Amdt 1.
13-Sep-18..............  MO             St Louis...........  Creve Coeur........       8/2302      7/23/18  VOR-A, Amdt 5.
13-Sep-18..............  MO             St Louis...........  Creve Coeur........       8/2309      7/23/18  RNAV (GPS) RWY 16, Amdt 1A.
13-Sep-18..............  AL             Troy...............  Troy Muni At N            8/2470      7/23/18  RNAV (GPS) RWY 25, Amdt 3.
                                                              Kenneth Campbell
                                                              Field.
13-Sep-18..............  MD             Ocean City.........  Ocean City Muni....       8/2476      7/25/18  VOR-A, Amdt 3A.
13-Sep-18..............  MD             Ocean City.........  Ocean City Muni....       8/2477      7/25/18  RNAV (GPS) RWY 2, Orig-B.
13-Sep-18..............  MD             Ocean City.........  Ocean City Muni....       8/2478      7/25/18  RNAV (GPS) RWY 32, Orig-B.
13-Sep-18..............  MD             Ocean City.........  Ocean City Muni....       8/2479      7/25/18  RNAV (GPS) RWY 14, Orig-F.
13-Sep-18..............  MD             Ocean City.........  Ocean City Muni....       8/2480      7/25/18  LOC RWY 14, Amdt 2A.
13-Sep-18..............  IN             Indianapolis.......  Indy South                8/2629      7/25/18  RNAV (GPS) RWY 19, Amdt 1B.
                                                              Greenwood.
13-Sep-18..............  WI             Neillsville........  Neillsville Muni...       8/2675      7/25/18  RNAV (GPS) RWY 28, Orig.
13-Sep-18..............  WI             Rhinelander........  Rhinelander--Oneida       8/3121      7/25/18  Takeoff Minimums and Obstacle DP, Amdt 4.
                                                              County.
13-Sep-18..............  GA             Griffin............  Griffin--Spalding         8/3323      7/23/18  RNAV (GPS) RWY 14, Orig-D.
                                                              County.
13-Sep-18..............  AL             Birmingham.........  Birmingham--Shuttle       8/3333      7/23/18  RNAV (GPS) Y RWY 6, Amdt 1B.
                                                              sworth Intl.
13-Sep-18..............  TX             Austin.............  Austin--Bergstrom         8/3410      7/25/18  ILS OR LOC RWY 35L, Amdt 6.
                                                              Intl.
13-Sep-18..............  TX             Crosbyton..........  Crosbyton Muni.....       8/3666      7/23/18  RNAV (GPS) RWY 35, Orig-A.
13-Sep-18..............  CA             Napa...............  Napa County........       8/3668      7/23/18  ILS OR LOC RWY 36L, Orig-B.
13-Sep-18..............  CA             Napa...............  Napa County........       8/3669      7/23/18  RNAV (GPS) Y RWY 36L, Amdt 2B.
13-Sep-18..............  NE             Fairbury...........  Fairbury Muni......       8/3783      7/23/18  NDB-A, Amdt 3B.
13-Sep-18..............  NE             Fairbury...........  Fairbury Muni......       8/3785      7/23/18  RNAV (GPS) RWY 35, Orig-A.
13-Sep-18..............  MD             Annapolis..........  Lee................       8/3830      7/23/18  RNAV (GPS)-A, Orig.
13-Sep-18..............  WI             Medford............  Taylor County......       8/4100      7/23/18  RNAV (GPS) RWY 9, Orig-A.
13-Sep-18..............  WI             Medford............  Taylor County......       8/4102      7/23/18  RNAV (GPS) RWY 16, Orig-A.
13-Sep-18..............  WI             Medford............  Taylor County......       8/4103      7/23/18  RNAV (GPS) RWY 34, Orig-A.
13-Sep-18..............  AK             Kenai..............  Kenai Muni.........       8/4752      7/10/18  RNAV (GPS) RWY 2L, Amdt 3.
13-Sep-18..............  AK             Kenai..............  Kenai Muni.........       8/4753      7/10/18  RNAV (GPS) RWY 20R, Amdt 4.
13-Sep-18..............  AK             Kenai..............  Kenai Muni.........       8/4754      7/10/18  VOR RWY 2L, Amdt 10.
13-Sep-18..............  AK             Kenai..............  Kenai Muni.........       8/4755      7/10/18  VOR RWY 20R, Amdt 21.
13-Sep-18..............  AK             Kenai..............  Kenai Muni.........       8/4756      7/10/18  Takeoff Minimums and Obstacle DP, Amdt 2.
13-Sep-18..............  ND             Harvey.............  Harvey Muni........       8/4762      7/10/18  RNAV (GPS) RWY 11, Orig.
13-Sep-18..............  ND             Harvey.............  Harvey Muni........       8/4763      7/10/18  RNAV (GPS) RWY 29, Orig-B.
13-Sep-18..............  TX             Angleton/Lake        Texas Gulf Coast          8/5556      7/23/18  RNAV (GPS) RWY 35, Amdt 2.
                                         Jackson.             Rgnl.
13-Sep-18..............  TX             Angleton/Lake        Texas Gulf Coast          8/5557      7/23/18  RNAV (GPS) RWY 17, Amdt 2.
                                         Jackson.             Rgnl.
13-Sep-18..............  NY             Le Roy.............  Le Roy.............       8/5610      7/25/18  VOR-A, Amdt 1B.
13-Sep-18..............  NY             Le Roy.............  Le Roy.............       8/5616      7/25/18  RNAV (GPS) RWY 28, Orig-C.
13-Sep-18..............  NY             Le Roy.............  Le Roy.............       8/5617      7/25/18  RNAV (GPS) RWY 10, Orig-B.
13-Sep-18..............  MA             Worcester..........  Worcester Rgnl.....       8/5622      7/25/18  RNAV (GPS) RWY 33, Orig-A.
13-Sep-18..............  IL             Mount Sterling.....  Mount Sterling Muni       8/5665      7/23/18  RNAV (GPS) RWY 36, Orig.
13-Sep-18..............  IL             Mount Sterling.....  Mount Sterling Muni       8/5667      7/23/18  RNAV (GPS) RWY 18, Orig.
13-Sep-18..............  IA             Mapleton...........  James G Whiting           8/5671      7/23/18  RNAV (GPS) RWY 2, Orig.
                                                              Memorial Field.
13-Sep-18..............  IA             Mapleton...........  James G Whiting           8/5673      7/23/18  RNAV (GPS) RWY 20, Orig.
                                                              Memorial Field.
13-Sep-18..............  WV             Summersville.......  Summersville.......       8/6177      7/25/18  Takeoff Minimums and Obstacle DP, Amdt 3A.
13-Sep-18..............  PA             Grove City.........  Grove City.........       8/6588      7/23/18  RNAV (GPS) RWY 28, Amdt 1A.
13-Sep-18..............  PA             Grove City.........  Grove City.........       8/6590      7/23/18  RNAV (GPS) RWY 10, Amdt 1A.
13-Sep-18..............  KS             Topeka.............  Topeka Rgnl........       8/6797      7/23/18  RNAV (GPS) RWY 13, Orig-B.
13-Sep-18..............  IL             Litchfield.........  Litchfield Muni....       8/6815      7/23/18  RNAV (GPS) RWY 9, Orig.
13-Sep-18..............  AR             Magnolia...........  Ralph C Weiser            8/6897      7/23/18  RNAV (GPS) RWY 36, Amdt 1A.
                                                              Field.
13-Sep-18..............  TX             Houston............  George Bush               8/7516      7/23/18  RNAV (RNP) Y RWY 27, Amdt 2.
                                                              Intercontinental/
                                                              Houston.
13-Sep-18..............  TX             Houston............  George Bush               8/7530      7/23/18  RNAV (RNP) Y RWY 8L, Orig-A.
                                                              Intercontinental/
                                                              Houston.
13-Sep-18..............  TX             Houston............  George Bush               8/7531      7/23/18  RNAV (RNP) Y RWY 9, Orig-A.
                                                              Intercontinental/
                                                              Houston.
13-Sep-18..............  OH             Shelby.............  Shelby Community...       8/7532      7/23/18  VOR-A, Amdt 5.
13-Sep-18..............  TX             Houston............  George Bush               8/7533      7/23/18  RNAV (RNP) Y RWY 26R, Orig-C.
                                                              Intercontinental/
                                                              Houston.
13-Sep-18..............  CA             Van Nuys...........  Van Nuys...........       8/7957      7/10/18  LDA-C, Amdt 3.

13-Sep-18..............  FL             Fort Lauderdale....  Fort Lauderdale/          8/8174      7/10/18  ILS OR LOC RWY 10L, Amdt 24.
                                                              Hollywood Intl.
13-Sep-18..............  FL             Fort Lauderdale....  Fort Lauderdale/          8/8183      7/10/18  ILS OR LOC RWY 10R, Amdt 1.
                                                              Hollywood Intl.
13-Sep-18..............  FL             Fort Lauderdale....  Fort Lauderdale/          8/8189      7/10/18  ILS OR LOC RWY 28R, Amdt 11.
                                                              Hollywood Intl.
13-Sep-18..............  FL             Fort Lauderdale....  Fort Lauderdale/          8/8201      7/10/18  RNAV (GPS) RWY 10R, Amdt 1.
                                                              Hollywood Intl.
13-Sep-18..............  FL             Fort Lauderdale....  Fort Lauderdale/          8/8211      7/10/18  RNAV (GPS) RWY 28L, Amdt 1.
                                                              Hollywood Intl.
13-Sep-18..............  FL             Fort Lauderdale....  Fort Lauderdale/          8/8232      7/10/18  RNAV (RNP) Y RWY 10L, Amdt 1A.
                                                              Hollywood Intl.
13-Sep-18..............  FL             Fort Lauderdale....  Fort Lauderdale/          8/8240      7/10/18  RNAV (GPS) Y RWY 28R, Amdt 4.
                                                              Hollywood Intl.
13-Sep-18..............  FL             Fort Lauderdale....  Fort Lauderdale/          8/8244      7/10/18  RNAV (GPS) Z RWY 10L, Amdt 4.
                                                              Hollywood Intl.
13-Sep-18..............  GA             Calhoun............  Tom B David Fld....       8/8262      7/23/18  RNAV (GPS) RWY 35, Amdt 1B.
13-Sep-18..............  GA             Calhoun............  Tom B David Fld....       8/8265      7/23/18  RNAV (GPS) RWY 17, Amdt 1A.
13-Sep-18..............  AL             Mobile.............  Mobile Downtown....       8/8670      7/10/18  RNAV (GPS) RWY 14, Amdt 2.
13-Sep-18..............  NJ             Ocean City.........  Ocean City Muni....       8/8675      7/10/18  GPS RWY 6, Orig-B.
13-Sep-18..............  NJ             Ocean City.........  Ocean City Muni....       8/8676      7/10/18  VOR-A, Orig-B.
13-Sep-18..............  TX             Houston............  David Wayne Hooks         8/8861      7/25/18  RNAV (GPS) RWY 35L, Amdt 1C.
                                                              Memorial.
13-Sep-18..............  TX             Houston............  David Wayne Hooks         8/8862      7/25/18  RNAV (GPS) RWY 17R, Amdt 1D.
                                                              Memorial.
13-Sep-18..............  TX             Houston............  David Wayne Hooks         8/8863      7/25/18  LOC RWY 17R, Amdt 3D.
                                                              Memorial.
13-Sep-18..............  OK             Oklahoma City......  Will Rogers World..       8/9620      7/23/18  VOR RWY 17L, Amdt 2.
13-Sep-18..............  KS             Independence.......  Independence Muni..       8/9691      7/23/18  RNAV (GPS) RWY 17, Amdt 2.
13-Sep-18..............  MN             Moose Lake.........  Moose Lake Carlton        8/9703      7/25/18  NDB RWY 4, Amdt 1.
                                                              County.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2018-17616 Filed 8-16-18; 8:45 am]
 BILLING CODE 4910-13-P


A Summary of Human Studies for Consideration by the HSRB Louis Scarano, Ph. D.

Louis Scarano, Ph. D.

U. S. EPA U. S. EPA Office of Pesticide Programs Office of Pesticide Programs April 4, 2006 April 4, 2006 2 Topics Covered Topics Covered

General Information

The Studies:

 Effects Monitored  Study Design

How the Studies Will be Used in OPP Risk Assessments 3 General Information General Information

For all the studies to be discussed, you have received the following documents:

 The full original study  The OPP Data Evaluation Record ( DER) summarizing OPP s review of the study  The OPP Weight of Evidence ( WOE) analysis that describes how OPP proposes to use the study in a risk assessment

The next few slides provide some perspective on the types of studies you will be discussing over the next two days 4 General Information General Information

Eight pesticides will be discussed

Aldicarb, methomyl, oxamyl, azinphos methyl, DDVP, ethephon,

amitraz, hydrogen ( sodium) cyanide

Eleven studies will be presented in detail*

10 of 11 are oral studies ( one is a dermal study)

Six involve acute exposures, five involve repeated dose exposures

* In one case ( DDVP), numerous studies are mentioned in the WOE analysis but are not relied upon 5 General Information General Information

For six pesticides, one human study is presented

For the other two pesticides, two ( ethephon)

and three ( amitraz) studies are presented

Importantly, the animal and human data are considered on a case by case basis 6 Study Design: Effects Monitored Study Design: Effects Monitored

Cholinesterase inhibition ( RBC/ Plasma)

 N methyl carbamates ( aldicarb, methomyl,

oxamyl)

 Organophosphates ( azinphos methyl, DDVP)

Other ( measurable clinical signs and/ or symptoms)

 Ethephon, amitraz, hydrogen cyanide 7 Study Design: Year, No. of Subjects, Location Study Design: Year, No. of Subjects, Location Table 1. General Information on Human Exposure Studies Pesticide Study Year No. of Males1 No. of Females1 Laboratory Aldicarb 1992 38 9 Methomyl 1998 19 None Oxamyl 1999 40 None Azinphos methyl 1999 12 None Inveresk ( Scotland)

DDVP 1997 9 None Medeval, ( UK)

1 Includes control/ placebo group. 8 Study Design: Year, No. of Subjects, Location Study Design: Year, No. of Subjects, Location Table 1. General Information on Human Exposure Studies Pesticide Study Year No. of Males1 No. of Females1 Laboratory 1972 8 8 Ethephon 1977 16 14 Litton ( US)

19982 8 1992 6 Simbec ( UK)

Amitraz 1984 2 None FBC ( UK)

Hydrogen cyanide 1982 100 78 Cancer patients from four different cancer centers in US.

1 Includes control/ placebo group.

2 Dermal study. 9 Study Design: Summary of No. of Subjects Study Design: Summary of No. of Subjects

Range of number of volunteers in the 11 studies: 2 ( amitraz) to 178 ( hydrogen cyanide)

 For the 9 studies between 2 and 178

( representing 7 pesticides)   the range is 6  47  Range of number of volunteers by pesticide ( 9

178)   thus the lowest " n" is 9 ( DDVP)

7 of 11 studies involved male volunteers only 10 Study Design: Doses, Exposure Details Study Design: Doses, Exposure Details Table 2. General Information on Human Exposure Studies Pesticide Number of Doses Exposure Method Study Design Aldicarb 5 plus placebo ( males) and 2 plus placebo ( females) In orange juice with breakfast Double blind Methomyl 3 plus placebo ( males only)

Oxamyl 6 plus placebo ( males only) Double blind, ascending dose schedule Azinphos methyl 1 plus placebo ( males only) Gelatin capsule five minutes after breakfast. Double blind DDVP 1 plus placebo ( males only) Capsule taken with water after overnight fast Single blind 11 Study Design: Doses, Exposure Details Study Design: Doses, Exposure Details Table 2. General Information on Human Exposure Studies Pesticide Number of Doses Exposure Method Study Design Ethephon 1 plus placebo ( males and females) Capsule   3X/ day; first two after a meal. Unclear whether investigators/ subjects were blinded to treatment 3 plus placebo ( males only) 1 Four equal exposures applied dermally every 2.5 hrs for 10 hrs for two days. Randomized crossover ( double blind, ascending dose schedule). Each person received all doses   exposures separated by 7 days.

2 plus placebo ( males only) Capsule taken 30 minutes after breakfast with water. Randomized crossover ( double blind, ascending dose schedule). Each person received all doses   exposures separated by 14 days.

Amitraz 1, no placebo ( males only) Capsule; possible light breakfast eaten two hrs prior to exposure. Metabolism study   radiolabelled material used.

Hydrogen cyanide 2, no placebo ( males and females) Oral exposure given either three or four times/ day Intravenous dosing for 21 days, followed by oral dosing for an unspecified period of time.

1 Dermal study. 12 Study Design: Summary of Exposure Details Study Design: Summary of Exposure Details

Range of doses used ( from 1 6)

 4 of 11 studies used only one dose

9 of 11 studies had placebo groups ( exceptions   hydrogen cyanide and amitraz metabolism study)

6 of 11 studies had either single or doubleblind study design 13 How are the studies to be used in OPP Risk How are the studies to be used in OPP Risk Assessments?

Assessments?

Single Chemical Assessments:

 Human data used directly as the point of departure ( PoD)

for five pesticides ( azinphos methyl, DDVP, ethephon,

amitraz, and hydrogen cyanide)

 For methomyl and oxamyl, the single chemical risk assessments were completed before the human data were submitted and/ or reviewed  For aldicarb, the human data were used to reduce the interspecies UF 14 How are the studies to be used in OPP Risk How are the studies to be used in OPP Risk Assessments?

Assessments?

Cumulative Assessments:

 Organophosphate:

  Azinphos methyl ( keep the interspecies UF of 10)

  DDVP ( keep the interspecies UF of 10)

 N methyl carbamate:

  Aldicarb and oxamyl ( reduce the interspecies UF of 10)

  Methomyl ( keep the interspecies UF of 10)


[Federal Register Volume 81, Number 218 (Thursday, November 10, 2016)]
[Notices]
[Pages 79009-79010]
[FR Doc No: 2016-27187]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2015-0365; FRL-9955-09-ORD]

Board of Scientific Counselors (BOSC) Air, Climate, and Energy
Subcommittee Meeting--December 2016

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of meeting.

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

SUMMARY: Pursuant to the Federal Advisory Committee Act, Public Law 92-
463, the U.S. Environmental Protection Agency (EPA), Office of Research
and Development (ORD), gives notice of a meeting (via conference call)
of the Board of Scientific Counselors (BOSC) Air, Climate, and Energy
Subcommittee.

DATES: The conference call will be held on Friday, December 2, 2016,
from 1:30 p.m. to 3:30 p.m., Eastern Time. These times are approximate;
the conference call may adjourn early if all business is finished or
may adjourn late if additional time is needed. Written comments and
requests for the draft agenda or for making oral presentations at the
meeting will be accepted through Thursday, December 1, 2016.

ADDRESSES: Participation in the conference call will be by
teleconference only; meeting rooms will not be used. Members of the
public may obtain the call-in number and access code for the call from
Tim Benner, the Designated Federal Officer, via any of the contact
methods listed in the FOR FURTHER INFORMATION CONTACT section below.
    Submitting Comments: Submit your comments, identified by Docket ID
No. EPA-HQ-ORD-2015-0365, by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Email: Send comments by electronic mail (email) to:
<EMAIL_ADDRESS>Attention Docket ID No. EPA-HQ-ORD-2015-0365.
     Fax: Fax comments to:<PHONE_NUMBER>, Attention Docket ID
No. EPA-HQ-ORD-2015-0365.
     Mail: Send comments by mail to: Board of Scientific
Counselors (BOSC) Air, Climate, and Energy Subcommittee Docket, Mail
Code: 2822T, 1301 Constitution Ave. NW., Washington, DC 20004,
Attention Docket ID No. EPA-HQ-ORD-2015-0365.
     Hand Delivery or Courier: Deliver comments to: EPA Docket
Center (EPA/DC), Room 3334, William Jefferson Clinton West Building,
1301 Constitution Ave. NW., Washington, DC, Attention Docket ID No.
EPA-HQ-ORD-2015-0365. Note: this is not a mailing address. Deliveries
are only accepted during the docket's normal hours of operation, and
special arrangements should be made for deliveries of boxed
information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2015-0365. The EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through www.regulations.gov
or email. The www.regulations.gov Web site is an ``anonymous access''
system, which means the EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an email comment directly to the EPA without going through
www.regulations.gov, your email address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, the EPA recommends that you include your name and other
contact information in the body of your comment and with any disk or
CD-ROM you submit. If the EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, the EPA may not
be able to consider your comment. Electronic files should avoid the use
of special characters, any form of encryption, and be free of any
defects or viruses. For additional information about the EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/dockets/.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the Board of Scientific
Counselors (BOSC) Air, Climate, and Energy Subcommittee Docket, EPA/DC,
William Jefferson Clinton West Building, Room

3334, 1301 Constitution Ave. NW., Washington, DC. The Public Reading
Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone number for the Public Reading
Room is<PHONE_NUMBER>, and the telephone number for the ORD Docket is
(202) 566-1752.

FOR FURTHER INFORMATION CONTACT: The Designated Federal Officer via
mail at: Tim Benner, Mail Code 8104R, Office of Science Policy, Office
of Research and Development, U.S. Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460; via phone/voice mail at:
(202) 564-6769; via fax at:<PHONE_NUMBER>; or via email at:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    General Information: The conference call is open to the public. Any
member of the public interested in receiving a draft agenda, attending
the conference call, or making a presentation during the conference
call may contact Tim Benner, the Designated Federal Officer, via any of
the contact methods listed in the FOR FURTHER INFORMATION CONTACT
section above. In general, each individual making an oral presentation
will be limited to a total of three minutes. Proposed agenda items for
the meeting include, but are not limited to, the following:
Presentation and discussion of the subcommittee's draft responses to
the charge questions and approval of the final draft letter report
prior to its submission to the BOSC Executive Committee.
    Information on Services for Individuals with Disabilities: For
information on access or services for individuals with disabilities,
please contact Tim Benner at<PHONE_NUMBER> or<EMAIL_ADDRESS>To
request accommodation of a disability, please contact Tim Benner,
preferably at least ten days prior to the conference call, to give the
EPA as much time as possible to process your request.

    Dated: November 3, 2016.
Fred S. Hauchman,
Director, Office of Science Policy.
[FR Doc. 2016-27187 Filed 11-9-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 179 (Friday, September 16, 2022)]
[Notices]
[Pages 57010-57011]
[FR Doc No: 2022-20037]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-95739; File No. SR-MEMX-2022-17]

Self-Regulatory Organizations; MEMX LLC; Notice of Withdrawal of
a Proposed Rule Change To Amend Its Fee Schedule To Adopt Connectivity
Fees

September 12, 2022.
    On July 5, 2022, MEMX LLC (``MEMX'') filed with the Securities and
Exchange Commission (``Commission''), pursuant to Section 19(b)(1) of
the Securities Exchange Act of 1934 \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend its Fee Schedule to adopt Connectivity
Fees. The proposed rule change was immediately effective upon filing
with the Commission pursuant to Section 19(b)(3)(A) of the Act.\3\ The
proposed rule change was published for comment in the Federal

Register on July 21, 2022.\4\ On September 1, 2022, MEMX withdrew the
proposed rule change (SR-MEMX-2022-17).
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A). A proposed rule change may take
effect upon filing with the Commission if it is designated by the
exchange as ``establishing or changing a due, fee, or other charge
imposed by the self-regulatory organization on any person, whether
or not the person is a member of the self-regulatory organization.''
15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ See Securities Exchange Act Release No. 95299 (July 15,
2022), 87 FR 43563.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\5\
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    \5\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-20037 Filed 9-15-22; 8:45 am]
BILLING CODE 8011-01-P


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request U. S. Environmental Protection Agency 2. OMB control number b. G None a_ 2060 0178 __ __ __ __

3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. X Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b. G Other Specify: / /___

7. Title Regulation of Fuels and Fuel Additives: Gasoline Volatility ( 40 CFR 80.27) ( Renewal)

8. Agency form number( s) ( If applicable) EPA ICR # 1367.07 9. Keywords Gasoline, Ethanol 10. Abstract: Gasoline volatility, as measured by Reid Vapor Pressure ( RVP) in pounds per square inch ( psi), is controlled in the spring and summer in order to minimize evaporative hydrocarbon emissions from motor vehicles. RVP ranges generally from about 7 psi to 9 psi, depending on location. The addition of ethanol to gasoline increases the RVP by about 1 psi. Gasoline that contains at least 9 volume percent ethanol is subject to a standard that is 1 psi greater. As an aid to industry compliance and EPA enforcement, the product transfer document which accompanies a shipment of gasoline containing ethanol is required by regulation to contain a legible and conspicuous statement that the gasoline contains ethanol and the percentage concentration of ethanol. This is intended to deter the mixing within the distribution system, particularly in retail storage tanks, of gasoline which contains ethanol with gasoline which does not contain ethanol. Such mixing would likely result in a gasoline with an ethanol concentration of less than 9 volume percent but with an RVP above the standard. Parties wishing a testing exemption must submit certain information to EPA.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. P Business or other for profit e. Federal Government c. Not for profit institutions f. State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c. P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 1,500 b. Total annual responses 4,600,002 1. Percentage of these responses collected electronically 0 % c. Total hours requested 6,447 d. Current OMB inventory 4,178 e. Difference 2,269 f. Explanation of difference 1. Program Change 0 2. Adjustment 2,269 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs 0 b. Total annual costs ( O& M) 0 c. Total annualized cost requested 0 d. Current OMB inventory 0 e. Difference 0 f. Explanation of difference 1. Program change 0 _ 2. Adjustment 0__

15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. __ Application for benefits e. __ Program planning or management b. __ Program evaluation f. __ Research c. __ General purpose statistics g. P__ Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. Q Recordkeeping b. Q Third party disclosure c. X Reporting 1. X On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. Q Semi annually 6. Q Annually 7. Q Biannually 8. Q Other ( describe)

17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: James W. Caldwell Phone: 202 343 9303 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( I) Why the information is being collected' ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( I) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Official Margo Tsirigotis Oge, Director, Office of Transportation and Air Quality Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads " As part of the agency submission to OMB of a proposed collection of information, the agency ( through the head of the agency, the Senior Official or their designee) shall certify ( and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C § 601( 6)), the use of such techniques as:

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond;

"( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [ see below]

"( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public;

"( I) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of: "( I) the reasons the information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection ( together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit ( citing authority), or mandatory ( citing authority); "( v) the nature and extent of confidentiality to be provided, if any ( citing authority); and "( vi) the fact that any agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number."

OMB 83 I ( Instructions) 10/ 95