[Federal Register Volume 86, Number 78 (Monday, April 26, 2021)]
[Notices]
[Pages 22102-22103]
[FR Doc No: 2021-08733]

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UNIFIED CARRIER REGISTRATION PLAN

Sunshine Act Meetings; Unified Carrier Registration Plan Board
Subcommittee Meeting

TIME AND DATE: April 29, 2021, from Noon to 2:00 p.m., Eastern time.

PLACE: This meeting will be accessible via conference call and via Zoom
Meeting and Screenshare. Any interested person may call (i) 1-929-205-
6099 (US Toll) or 1-669-900-6833 (US Toll) or (ii) 1-877-853-5247 (US
Toll Free) or 1-888-788-0099 (US Toll Free), Meeting ID: 976 6979 8627,
to listen and participate in this meeting. The website to participate
via Zoom Meeting and Screenshare is https://kellen.zoom.us/j/97669798627.

STATUS: This meeting will be open to the public.

MATTERS TO BE CONSIDERED: The Unified Carrier Registration Plan
Education and Training Subcommittee (the ``Subcommittee'') will
continue its work in developing and implementing the Unified Carrier
Registration Plan and Agreement. The subject matter of this meeting
will include:

Proposed Agenda

I. Call to Order--Subcommittee Chair

    The Subcommittee Chair will welcome attendees, call the meeting to
order, call roll for the Subcommittee, confirm whether a quorum is
present, and facilitate self-introductions.

II. Verification of Publication of Meeting Notice--UCR Executive
Director

    The UCR Executive Director will verify the publication of the
meeting notice on the UCR website and distribution to the UCR contact
list via email followed by the subsequent publication of the notice in
the Federal Register.

III. Review and Approval of Subcommittee Agenda and Setting of Ground
Rules--Subcommittee Chair

For Discussion and Possible Subcommittee Action

    The Subcommittee Agenda will be reviewed, and the Subcommittee will
consider adoption.
Ground Rules
    [rtarr8] Subcommittee action only to be taken in designated areas
on agenda.

IV. Review and Approval of Minutes From the March 18, 2021 Meeting--
Subcommittee Chair

For Discussion and Possible Subcommittee Action

    Draft minutes from the March 18, 2021 Subcommittee meeting via
teleconference will be reviewed. The Subcommittee will consider action
to approve.

V. Audit Module Development Discussion With the Education and Training
Subcommittee--UCR Operations Director

    The Subcommittee will discuss and provide updates on development of
the Audit Module.

VI. Other Items--Subcommittee Chair

    The Subcommittee Chair will call for any other items Subcommittee
members would like to discuss.

VII. Adjournment--Subcommittee Chair

    The Subcommittee Chair will adjourn the meeting.
    The agenda will be available no later than 5:00 p.m. Eastern time,
April 22, 2021 at: https://plan.ucr.gov.

CONTACT PERSON FOR MORE INFORMATION: Elizabeth Leaman, Chair, Unified
Carrier Registration Plan Board of Directors,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
Alex B. Leath,
Chief Legal Officer, Unified Carrier Registration Plan.
[FR Doc. 2021-08733 Filed 4-22-21; 11:15 am]
BILLING CODE 4910-YL-P


[Federal Register Volume 78, Number 58 (Tuesday, March 26, 2013)]
[Notices]
[Pages 18382-18384]
[FR Doc No: 2013-06878]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-69188; File No. SR-OCC-2013-03]

Self-Regulatory Organizations; The Options Clearing Corporation;
Notice of Filing of Proposed Rule Change To Add Provisions to the By-
Laws To Facilitate the Use of the Stock Loan/Hedge Program by Canadian
Clearing Members

March 20, 2013.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder \2\ notice is hereby given that
on March 8, 2013, The Options Clearing Corporation (``OCC'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I, II and III below, which Items have
been prepared primarily by OCC. 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

    OCC proposes to add provisions to the By-Laws to facilitate the use
of the Stock Loan/Hedge Program by Canadian Clearing Members.

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

    In its filing with the Commission, OCC 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. OCC has prepared summaries, set forth in sections (A),
(B), and (C) below, of the most significant aspects of such
statements.\3\
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    \3\ The Commission has modified the text of the summaries
prepared by OCC.
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(A) Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    The purpose of the proposed rule change is to add provisions to the
By-Laws governing the OCC's Stock Loan/Hedge Program to facilitate the
use of the Stock Loan/Hedge Program by Canadian Clearing Members.

Background
    OCC's Stock Loan/Hedge Program is provided for in Article XXI of
the By-Laws and Chapter XXII of the Rules, and provides a means for OCC
clearing members to submit broker-to-broker stock loan transactions to
OCC for clearance. Broker-to-broker transactions are independently-
executed stock loan transactions that are negotiated directly between
two OCC clearing members.
    Where a stock loan transaction is submitted to, and accepted by,
OCC for clearance, OCC substitutes itself as the lender to the borrower
and the borrower to the lender, thus serving a function for the stock
loan market similar to the one it serves within the listed options
market. OCC thereby guarantees the future daily mark-to-market payments
between the lending clearing member and borrowing clearing member,
which are effected through OCC's cash settlement system, and the return
of the loaned stock to the lending clearing member and the collateral
to the borrowing clearing member, upon close-out of the stock loan
transaction. OCC leverages the infrastructure of the Depository Trust
Company (``DTC'') to transfer loaned stock and collateral between OCC
clearing members.
Description of Proposed Rule Change
    Currently, for OCC clearing members to participate in OCC's Stock
Loan/Hedge Program, they must be members of DTC and maintain accounts
to facilitate Delivery Orders (``DOs'') to approved counterparties for
stock loan transactions. Canadian Clearing Members \4\ (who are
otherwise eligible to participate in the Stock Loan/Hedge Program) are
not participants of DTC. For purposes of settling transactions in U.S.
equity securities, Canadian Clearing Members ordinarily rely on the
services of CDS Clearing and Depository Services Inc. (``CDS''),\5\
which provides a cross-border service to clear and settle trades with
U.S. counterparties.\6\ CDS is Canada's national securities depository,
processing over 413 million trades annually. One of CDS's services
enable its Canadian participants to clear and settle trades (which
would include stock loan and borrow transactions) with U.S.
counterparties through affiliations with DTC and the National
Securities Clearing Corporation (``NSCC'').
---------------------------------------------------------------------------

    \4\ OCC By-Laws define a Canadian Clearing Member as a Non-U.S.
Clearing Member formed and operating under the laws of Canada or a
province thereof with its principal place of business in Canada.
    \5\ CDS is Canada's national securities depository, processing
over 413 million trades annually. One of CDS's services enables its
Canadian participants to clear and settle trades (including stock
loan and borrow transactions) with U.S. counterparties through
affiliations with DTC and the National Securities Clearing
Corporation (``NSCC'').
    \6\ OCC is not a party to such cross-border service
arrangements.
---------------------------------------------------------------------------

    Under current OCC Rules 901(a) and (g), Canadian Clearing Members
are able to effect settlement of deliver/receive obligations arising
from exercised or assigned stock options and matured stock futures by
appointing CDS to act as their agent through the arrangements with DTC
and NSCC described above.\7\ OCC is now proposing to amend
Interpretation .07 to Section 1 of Article V of the By-Laws to allow
participation by Canadian Clearing Members in the Stock Loan/Hedge
Program by permitting them to appoint CDS to act as their agent in
effecting DOs for stock loan transactions through DTC under
arrangements similar to those used for deliveries under options and
futures.\8\ Upon such an appointment, a sponsored sub-account would be
established on behalf of the Canadian Clearing Member in a CDS
participant account at DTC, through which the Canadian Clearing Member
could obtain access to similar DTC services used by U.S. clearing
members who maintain participant accounts at DTC in respect to stock
loan transactions. Through their identified sub-accounts within a CDS
participant account at DTC, Canadian Clearing Members would be able to
effect DOs for stock loan transactions to other DTC participants in the
same manner as U.S. clearing members. The cross-border service offered
by DTC and CDS would enable Canadian Clearing Members to transfer
securities between their accounts held at CDS and the identified sub-
accounts carried on their behalf in CDS participant accounts held at
DTC to effect DOs for stock loan transactions. DTC would continue to
play the same role in connection with such transactions as it does with
respect to stock loan transactions of all other clearing members,
except that DOs would be effected in the identifiable sub-account of
the Canadian Clearing Member maintained in a CDS participant account at
DTC.
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    \7\ In January 1994, OCC adopted Rule 913(h) whereby Canadian
Clearing Members that settle through the CDS were required to
execute a new agreement appointing CDS to act on its behalf, and for
which CDS and NSCC would acknowledge such appointment. See
Securities Exchange Act Release No. 33543 (January 28, 1994), 59 FR
5639 (February 7, 1994) (SR-OCC-1992-05). In March 2004, OCC
restructured Chapter IX of its rules applicable to physical
settlement of exercised stock options and matured stock futures, and
as part of this rule filing, re-designated Rule 913 as Rule 901. See
Securities Exchange Act Release No. 49420 (March 16, 2004), 69 FR
13345 (March 22, 2004) (SR-OCC-2003-08).
    \8\ Unlike settlement of deliver/receive obligations in respect
of stock options and stock futures, stock loan and borrow
transactions do not involve NSCC.
---------------------------------------------------------------------------

    Similar to appointments of CDS under Rules 901(a) and (g), under
the amended Interpretation .07 to Section 1 of Article V of the By-
Laws, a Canadian Clearing Member that appoints CDS to act for it in
connection with the Stock Loan/Hedge Program would be required to agree
with OCC that the clearing member remains responsible to OCC in respect
of its stock loan and borrow positions regardless of any non-
performance by CDS, that OCC may treat any failure of CDS to complete
delivery or payment required to close an open stock loan or borrow
position as a failure by such Canadian Clearing Member, thereby
triggering OCC's buy-in and sell-out procedures and such other
procedures and remedies as are provided under OCC's Rules, including
recourse to the collateral deposited by the clearing member.
Accordingly, OCC would have no credit exposure to CDS as the result of
a failure by CDS to perform. Also consistent with precedent under Rules
901(a) and (g), in amended Interpretation .07 to Section 1 of Article V
of the By-Laws, OCC would seek acknowledgement of CDS and DTC with
respect to these arrangements. If, for any reason, CDS ceased to act
for one or more Canadian Clearing Members,\9\ OCC would have authority
to require clearing members to close out open stock loan and borrow
positions through buy-in and sell-out procedures, or any other
procedures provided in the By-Laws or Rules, if necessary. A copy of
the proposed agreement through which a Canadian Clearing Member would
appoint CDS to act on the Canadian Clearing Member's behalf, and CDS
and DTC would acknowledge this appointment, is included as Exhibit
3A.\10\
---------------------------------------------------------------------------

    \9\ A Canadian Clearing Member would be obligated, under amended
Interpretation .07 to Section 1 of Article V of the By-Laws, to
promptly notify OCC in writing if it knew or reasonably expected CDS
to cease acting on its behalf, or if CDS had ceased acting on its
behalf, with respect to effecting DOs for stock loan and stock
borrow transactions.
    \10\ Both CDS and DTC have reviewed and signed off on this Form
of Appointment and Acknowledgement, which is included as Exhibit 3A.
---------------------------------------------------------------------------

    As part of the application process to become a clearing member of
OCC, any non-U.S. applicant must execute a copy of OCC's Non-U.S.
Clearing Member Agreement. In the agreement, the applicant makes
certain representations with respect to, among other things, the types
of transactions it will engage in as

a Non-U.S. Clearing Member.\11\ In order to accommodate the
participation by Canadian Clearing Members in the Stock Loan/Hedge
Program as provided in this proposed rule change, OCC proposes to make
certain conforming changes to its Non-U.S. Clearing Member Agreement.
OCC also proposes to make certain technical changes to its Non-U.S.
Clearing Member Agreement for clarity and consistency with its U.S.
Clearing Member Agreement.
---------------------------------------------------------------------------

    \11\ OCC's By-Laws define ``Non-U.S. Clearing Member'' as a Non-
U.S. Securities Firm that has been admitted to membership in OCC
pursuant to the provisions of OCC's By-Laws and Rules.
---------------------------------------------------------------------------

    Finally, for ease of reference throughout the proposed addition to
Interpretation .07 to Section 1 of Article V of the By-Laws, OCC
proposes to define a Canadian Clearing Member approved to participate
in the Stock Loan/Hedge Program as a ``Canadian Hedge Clearing Member''
for purposes of its By-Laws and Rules.
    OCC believes that the proposed changes to OCC By-Laws are
consistent with the purposes and requirements of Section 17A of the
Act,\12\ and the rules and regulations thereunder, because they are
designed to promote the prompt and accurate clearance and settlement of
stock loan and borrow transactions, foster cooperation and coordination
with persons engaged in the clearance and settlement of such
transactions, remove impediments to and perfect the mechanism of a
national system for the prompt and accurate clearance and settlement of
such transactions, and, in general, protect investors and the public
interest.\13\ OCC believes that the proposed changes to OCC By-Laws
achieve this by facilitating participation by Canadian Clearing Members
in OCC's Stock Loan/Hedge Program in a manner that protects the
clearing system against risk through the same or equivalent mechanisms
used with respect to domestic clearing members. OCC also believes that
the proposed rule change is not inconsistent with the existing OCC By-
Laws, including any By-Laws proposed to be amended.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78q-1.
    \13\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

(B) Self-Regulatory Organization's Statement on Burden on Competition

    OCC does not believe that the proposed rule change would impose any
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

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

    Written comments were not and are not intended to be solicited with
respect to the proposed rule change and none have been received.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove the proposed rule change or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.
    The proposed rule change shall not take effect until all regulatory
actions required with respect to the proposed rule change are
completed.

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 Commissions Internet comment form (http://www.sec.gov/rules/sro.shtml) or Send an email to<EMAIL_ADDRESS>
Please include File Number SR-OCC-2013-03 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-OCC-2013-03. 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 Section, 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 such filings will also be
available for inspection and copying at the principal office of OCC and
on OCC's Web site at http://www.theocc.com/components/docs/legal/rules_and_bylaws/sr_occ_13_03.pdf.

    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-OCC-2013-03
and should be submitted on or before April 16, 2013.

For the Commission by the Division of Trading and Markets, pursuant
to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-06878 Filed 3-25-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 201 (Wednesday, October 17, 2018)]
[Notices]
[Pages 52437-52438]
[FR Doc No: 2018-22608]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP18-102-000 and CP18-103-000]

Cheyenne Connector, LLC and Rockies Express Pipeline LLC; Notice
of Schedule for Environmental Review of the Cheyenne Connector Pipeline
and Cheyenne Hub Enhancement Projects

    On March 5, 2018, Cheyenne Connector, LLC and Rockies Express
Pipeline LLC (``applicants'') filed an application in Docket Nos. CP18-
102-000 and CP18-103-000 requesting a Certificate of Public Convenience
and Necessity pursuant to Section 7(c) of the Natural Gas Act to
construct and operate certain natural gas pipeline facilities. The
proposed projects are known as the Cheyenne Connector Pipeline and
Cheyenne Hub Enhancement Projects (Projects), and would include new
natural gas pipeline, metering, and compression facilities to transport
about 600 million cubic feet per day.
    On March 19, 2018, the Federal Energy Regulatory Commission
(Commission or FERC) issued its Notice of Application for the Projects.
Among other things, that notice alerted agencies issuing federal
authorizations of the requirement to complete all necessary reviews and
to reach a final decision on a request for a federal authorization
within 90 days of the date of issuance of the Commission staff's
Environmental Assessment (EA) for the Project. This instant notice
identifies the FERC staff's planned schedule for the completion of the
EA for the Project.

Schedule for Environmental Review

Issuance of EA December 18, 2018
90-day Federal Authorization Decision Deadline March 18, 2019

    If a schedule change becomes necessary, additional notice will be
provided so that the relevant agencies are kept informed of the
Projects' progress.

Project Description

    The Projects include approximately 70 miles of 36-inch-diameter
pipeline, three associated mainline valves, and other ancillary
facilities; five meter and regulating stations; one new approximately
32,100 horsepower Cheyenne Hub Booster Compressor Station; and
enhancements to modify the existing Cheyenne Hub interconnect
facilities in Weld County, Colorado.

Background

    On May 3, 2018, the Commission issued a Notice of Intent to Prepare
an Environmental Assessment for the Proposed Cheyenne Connector
Pipeline and Cheyenne Hub Enhancement Projects and Request for Comments
on Environmental Issues (NOI). The NOI was sent to affected landowners;
federal, state, and local government agencies; elected officials;
environmental and public interest groups; Native American tribes; other
interested parties; and local libraries and newspapers. In response to
the NOI, the Commission received comments from: DCP Midstream, LP,
Teamsters National Pipeline LMCP, Colorado Interstate Pipeline, L.L.C.,
Anadarko Energy Services Company, Cheyenne Connector, LLC, HLT Farms,
LLLP, the Town of Kersey, two Native American tribes, and four
individuals. The primary issues raised by the commentors are
alternatives, Project construction affecting the Irons Lateral Ditch,
cultural resources, public health and safety, land values,
industrialization of agricultural land, and environmental justice. All
substantive comments will be addressed in the EA.

Additional Information

    In order to receive notification of the issuance of the EA and to
keep track of all formal issuances and submittals in specific dockets,
the Commission offers a free service called eSubscription. This can
reduce the amount of time you spend researching proceedings by
automatically providing you with notification of these filings,
document summaries, and direct links to the documents. Go to
www.ferc.gov/docs-filing/esubscription.asp.
    Additional information about the Projects is available from the
Commission's Office of External Affairs at (866) 208-FERC or on the
FERC website (www.ferc.gov). Using the eLibrary link, select General
Search from the eLibrary menu, enter the selected date range and Docket
Number excluding the last three digits (i.e., CP18-102 or CP18-103),
and follow the instructions. For assistance with access to eLibrary,
the helpline can be reached at<PHONE_NUMBER>, TTY<PHONE_NUMBER>, or
at [email protected]. The eLibrary link on the FERC website
also provides access to the texts of formal documents issued by the
Commission, such as orders, notices, and rule makings.

    Dated: October 11, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-22608 Filed 10-16-18; 8:45 am]
 BILLING CODE 6717-01-P


Technical Appendices

For

Redesignation Request,

Maintenance Plan

and 2002 Base Year Inventory

Greene County

 Ozone Nonattainment Area

January 2007

Commonwealth of Pennsylvania

Department of Environmental Protection

Bureau of Air Quality

TABLE OF CONTENTS

Appendix A:  	Stationary Point Sources

A-1  	Methodology – Preparation of Pennsylvania Point Source Inventories and Instructions for Completing the Annual Emissions Reporting Forms

A-2  	Facility Annual Emissions by SCC

A-3	Facility Daily Emissions by SCC

A-4	Banked Emission Reduction Credits

	Appendix B:  	Stationary Area Sources

B-1    	Pennsylvania 2002 Area Source Criteria Air Pollutant Emission Estimation Methods (EH Pechan, Feb. 2004)

B-2	Area Source Annual Emissions by SCC

B-3	Area Source Daily Emissions by SCC

	Appendix C:  	Highway Vehicles  (includes Executive Summary)

C-1   	Mobile Source Highway Emissions Inventory – An Explanation of Methodology

C-2	Greene County Highway Emissions Estimates

2002 Annual and Daily CO, NOx, VOC & VMT by SCC; Daily NOx, VOC and VMT by Facility and Vehicle Type.

2004, 2009, 2018 Daily VOC, NOx and VMT by Facility Type, Vehicle Type and SCC; Daily CO by SCC

C-3   	MOBILE6.2 Input Parameter Summary

C-4	MOBILE6.2 Sample Input File

C-5	Traffic Growth Forecasting System Report

	Appendix D:  	Nonroad Sources

D-1	Emissions Estimation Methodology

D-2	Nonroad Source Emissions by Category and SCC

	Appendix E:	Source Emissions Projection Methodology


[Federal Register Volume 85, Number 249 (Tuesday, December 29, 2020)]
[Proposed Rules]
[Pages 85564-85565]
[FR Doc No: 2020-28643]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2020-1098; Airspace Docket No. 20-ANM-25]
RIN 2120-AA66

Proposed Amendment of Class E Airspace; Meeker, CO

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to modify the Class E airspace extending
upward from 700 feet above the surface at Meeker Coulter Field Airport.
The airspace area is larger than required and should be reduced to
properly contain instrument flight rules (IFR) aircraft departing and
arriving at the airport. Additionally, this action proposes an
administrative update to the airport's name. This action would ensure
the safety and management of IFR operations at the airport.

DATES: Comments must be received on or before February 12, 2021.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590; telephone:
1-800-647-5527, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2020-1098; Airspace Docket No. 20-ANM-25, at the beginning of your
comments. You may also submit comments through the internet at https://www.regulations.gov.
    FAA Order 7400.11E, 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. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11E at NARA, email<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Matthew Van Der Wal, Federal Aviation
Administration, Western Service Center, Operations Support Group, 2200
S 216th Street, Des Moines, WA 98198; 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 amend the Class E airspace at Meeker Coulter Field Airport,
Meeker, CO, to support IFR operations at the airport.

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. Persons 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-2020-1098;
Airspace Docket No. 20-ANM-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 Northwest Mountain Regional Office of the Federal
Aviation Administration, Air Traffic Organization, Western Service
Center, Operations Support Group, 2200 S 216th Street, Des Moines, WA
98198.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11E, Airspace
Designations and Reporting Points, dated July 21, 2020, and effective
September 15, 2020. FAA Order 7400.11E is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11E 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 Title 14 Code of Federal
Regulations Part 71 by modifying the Class E airspace extending upward
from 700 feet above the surface at Meeker Coulter Field Airport,
Meeker, CO. This airspace is designed to contain IFR departures to
1,200 feet above the surface and IFR arrivals descending below 1,500
feet above the surface. The airspace area is larger than required to
properly contain IFR aircraft departing and arriving at the airport. To
properly contain IFR aircraft, a 3.5-mile radius of the airport should
be established to contain aircraft performing a circling maneuver. An
area should be added southeast of the airport to contain IFR aircraft
arriving via the RNAV (GPS) Runway 3 approach. An area west of the
airport should also be added to contain IFR aircraft performing the
procedure turn maneuver for the VOR-A approach. The airspace area

would be described as follows: That airspace extending upward from 700
feet above the surface within a 3.5-mile radius of the airport, and
within 1 mile each side of the 220[deg] bearing from the airport,
extending from the 3.5-mile radius to 9 mile southwest of the airport,
and within 4 miles north and 8 miles south of the 292[deg] bearing from
the airport, extending from the 3.5-mile radius of the airport and
extending from 2.1 miles west of the airport to 18.1 miles west of
Meeker Coulter Field Airport.
    Additionally, this action proposes an administrative update to the
airport's name. To match the FAA database, the airport name should be
updated to Meeker Coulter Field Airport.
    Class E5 airspace designations are published in paragraph 6005 of
FAA Order 7400.11E, dated July 21, 2020, and effective September 15,
2020, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in the Order.
    FAA Order 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 Part 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 7400.11E,
Airspace Designations and Reporting Points, dated July 21, 2020, and
effective September 15, 2020, is amended as follows:

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

* * * * *

ANM CO E5 Meeker, CO [Amended]

Meeker Coulter Field Airport, CO
    (Lat. 40[deg]02'56'' N, long. 107[deg]53'09'' W)

    That airspace extending upward from 700 feet above the surface
within a 3.5-mile radius of the airport, and within 1 mile each side
of the 220[deg] bearing from the airport, extending from the 3.5-
mile radius to 9 mile southwest of the airport, and within 4 miles
north and 8 miles south of the 292[deg] bearing from the airport,
extending from the 3.5-mile radius of the airport and extending from
2.1 miles west of the airport to 18.1 miles west of Meeker Coulter
Field Airport.

    Issued in Seattle, Washington, on December 21, 2020.
Brian D. Ochs,
Acting Group Manager, Operations Support Group, Western Service Center.
[FR Doc. 2020-28643 Filed 12-28-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 152 (Thursday, August 6, 2020)]
[Rules and Regulations]
[Pages 47643-47645]
[FR Doc No: 2020-17203]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 31323 Amdt. No. 3915]

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

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This rule establishes, amends, suspends, or removes Standard
Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums
and Obstacle Departure Procedures (ODPs) 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 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 6, 2020. 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 6, 2020.

ADDRESSES: Availability of matters 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, email
<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

Availability

    All SIAPs and Takeoff Minimums and ODPs are available online free
of charge. Visit the National Flight Data Center 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 Procedures
and Airspace Group, Flight Technologies and Procedures Division, Flight
Standards Service, Federal Aviation Administration. Mailing Address:
FAA Mike Monroney Aeronautical Center, Flight Procedures and Airspace
Group, 6500 South MacArthur Blvd., Registry Bldg. 29, Room 104,
Oklahoma City, OK 73169. Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14 of the Code of
Federal Regulations, Part 97 (14 CFR part 97), by establishing,
amending, suspending, or removes SIAPS, Takeoff Minimums and/or ODPS.
The complete regulatory description of each SIAP and its associated
Takeoff Minimums or ODP for an identified airport is listed on FAA form
documents which are incorporated by reference in this amendment under 5
U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA
forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when
required by an entry on 8260-15A.
    The large number of SIAPs, Takeoff Minimums and ODPs, their complex
nature, and the need for a special format make publication in the
Federal Register expensive and impractical. Further, airmen do not use
the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead
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, Takeoff Minimums and ODP listed on FAA form documents is
unnecessary. This amendment provides the affected CFR sections and
specifies the types of SIAPs, 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/or 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, Takeoff Minimums and ODP as Amended in the
transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments
may have been issued previously by the FAA in a Flight Data Center
(FDC) Notice to Airmen (NOTAM) as an emergency action of immediate
flight safety relating directly to published aeronautical charts.
    The circumstances that created the need for some SIAP and Takeoff
Minimums and ODP amendments may require making them effective in less
than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an
effective date at least 30 days after publication is provided.
    Further, the SIAPs and Takeoff Minimums and ODPs contained in this
amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these SIAPs and
Takeoff Minimums and ODPs, the TERPS criteria were applied to the
conditions existing or anticipated at the affected airports. 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 some 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 24, 2020.
Wade E.K. Terrell,
Manager, Flight Procedures & Airspace Group.

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
establishing, amending, suspending, or removing Standard Instrument
Approach Procedures and/or Takeoff Minimums and Obstacle Departure
Procedures 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:

Effective 10 September 2020

Aniak, AK, Aniak, ILS OR LOC RWY 11, Amdt 1
Aniak, AK, Aniak, RNAV (GPS) RWY 11, Amdt 2
Point Hope, AK, Point Hope, NDB RWY 1, Amdt 2C, CANCELLED
Point Hope, AK, Point Hope, NDB RWY 19, Amdt 2C, CANCELLED
Haleyville, AL, Posey Field, VOR/DME RWY 18, Amdt 5C, CANCELLED
Prattville, AL, Prattville--Grouby Field, VOR/DME-A, Amdt 3C,
CANCELLED
Tuskegee, AL, Moton Field Muni, VOR-A, Amdt 4B, CANCELLED
Wetumpka, AL, Wetumpka Muni, VOR-A, Amdt 2A, CANCELLED
Dumas, AR, Billy Free Muni, VOR/DME RWY 36, Amdt 3B, CANCELLED
Mena, AR, Mena Intermountain Muni, NDB RWY 27. Amdt 1B, CANCELLED
Chandler, AZ, Stellar Airpark, VOR-A, Amdt 1C
Grand Canyon, AZ, Valle, VOR/DME RWY 19, Orig-A, CANCELLED
Long Beach, CA, Long Beach/Daugherty Field, Takeoff Minimums and
Obstacle DP, Amdt 6B
Modesto, CA, Modesto City-Co-Harry Sham FLD, VOR RWY 28R, Amdt 1,
CANCELLED
Paso Robles, CA, Paso Robles Muni, RNAV (GPS) RWY 19, Amdt 2
Paso Robles, CA, Paso Robles Muni, RNAV (GPS) RWY 31, Amdt 1
Sacramento, CA Sacramento Mather, VOR RWY 4R, Orig-F, CANCELLED
Santa Rosa, CA, Charles M. Schulz--Sonoma County, VOR/DME RWY 14,
Amdt 3B, CANCELLED
Pensacola, FL, Pensacola Intl, NDB RWY 35, Orig-A, CANCELLED
Cedartown, GA, Polk County Airport--Cornelius Moore Field, VOR-A,
Amdt 13, CANCELLED
Dawson, GA, Dawson Muni, VOR RWY 32, Orig-D, CANCELLED
Lawrenceville, GA, Gwinnett County--Briscoe Field, VOR RWY 7, Amdt
2B, CANCELLED
Albia, IA, Albia Muni, VOR-A, Amdt 4A, CANCELLED
Winterset, IA, Winterset Muni, VOR/DME-A, Amdt 3, CANCELLED
Lewiston, ID, Lewiston-Nez Perce County, VOR RWY 8, Amdt 6,
CANCELLED
Chicago, IL, Chicago O'Hare Intl, RNAV (GPS) RWY 4L, Amdt 2A,
CANCELLED
Effingham, IL, Effingham County Memorial, VOR RWY 1, Amdt 10D,
CANCELLED
Lake In The Hills, IL, Lake In The Hills, VOR-A, Orig, CANCELLED
Marion, IL, Veterans Airport Of Southern Illinois, NDB RWY 20, Amdt
10D, CANCELLED
Marion, IL, Veterans Airport Of Southern Illinois, VOR RWY 20, Amdt
17D, CANCELLED
Peoria, IL, Mount Hawley Auxiliary, VOR-A, Orig-B, CANCELLED
Michigan City, IN, Michigan City Muni-Phillips Field, VOR-A, Amdt 6,
CANCELLED
Terre Haute, IN, Sky King, VOR-A, Amdt 7, CANCELLED
Atwood, KS, Atwood-Rawlins County City-County, RNAV (GPS) RWY 17,
Amdt 1
Atwood, KS, Atwood-Rawlins County City-County, Takeoff Minimums and
Obstacle DP, Orig-A
Burlington, KS, Coffey County, NDB RWY 36, Amdt 2A, CANCELLED
Junction City, KS, Freeman Field, NDB-B, Amdt 5B, CANCELLED
Wichita, KS, Colonel James Jabara, VOR-A, Amdt 4A, CANCELLED
Eunice, LA, Eunice, NDB RWY 16, Amdt 1A, CANCELLED
Eunice, LA, Eunice, VOR/DME-A, Amdt 3A, CANCELLED
Augusta, ME, Augusta State, VOR/DME-A, Amdt 12, CANCELLED
Adrian, MI, Lenawee County, NDB RWY 5, Orig-A, CANCELLED
Clare, MI, Clare Muni, VOR-A, Amdt 2A, CANCELLED
Greenville, MI, Greenville Muni, VOR-A, Amdt 3, CANCELLED
Cloquet, MN, Cloquet Carlton County, NDB RWY 18, Amdt 4B
Cloquet, MN, Cloquet Carlton County, NDB RWY 36, Amdt 5B
Cloquet, MN, Cloquet Carlton County, RNAV (GPS) RWY 18, Orig-B
Cloquet, MN, Cloquet Carlton County, RNAV (GPS) RWY 36, Amdt 1B
Cloquet, MN, Cloquet Carlton County, Takeoff Minimums and Obstacle
DP, Amdt 3
Waseca, MN, Waseca Muni, VOR-A, Amdt 5, CANCELLED
Excelsior Springs, MO, Excelsior Springs Memorial, VOR-A, Orig,
CANCELLED
Malden, MO, Malden Rgnl, VOR RWY 32, Amdt 9, CANCELLED
St Louis, MO, St Louis Lambert Intl, RNAV (RNP) Z RWY 30L, Amdt 1A

St Louis, MO, Creve Coeur, VOR-A, Amdt 5A, CANCELLED
Brookhaven, MS, Brookhaven-Lincoln County, VOR/DME-A, Amdt 9A,
CANCELLED
Atkinson, NE, Stuart-Atkinson Muni, VOR/DME RWY 29, Amdt 1A,
CANCELLED
David City, NE, David City Muni, VOR/DME RWY 32, Amdt 1A, CANCELLED
Minden, NE, Pioneer Village Field, VOR-A, Amdt 1, CANCELLED
Norfolk, NE, Norfolk Rgnl/Karl Stefan Memorial Fld, ILS OR LOC RWY
2, Amdt 6A
Norfolk, NE, Norfolk Rgnl/Karl Stefan Memorial Fld, RNAV (GPS) RWY
2, Amdt 2
Norfolk, NE, Norfolk Rgnl/Karl Stefan Memorial Fld, RNAV (GPS) RWY
14, Amdt 2
Norfolk, NE, Norfolk Rgnl/Karl Stefan Memorial Fld, RNAV (GPS) RWY
20, Amdt 2
Norfolk, NE, Norfolk Rgnl/Karl Stefan Memorial Fld, RNAV (GPS) RWY
32, Amdt 2
Norfolk, NE, Norfolk Rgnl/Karl Stefan Memorial Fld, Takeoff Minimums
and Obstacle DP, Amdt 1
Norfolk, NE, Norfolk Rgnl/Karl Stefan Memorial Fld, VOR RWY 14, Amdt
8
Norfolk, NE, Norfolk Rgnl/Karl Stefan Memorial Fld, VOR RWY 19, Amdt
8A, CANCELLED
Norfolk, NE, Norfolk Rgnl/Karl Stefan Memorial Fld, VOR RWY 32, Amdt
8
Nashua, NH, Boire Field, VOR RWY 32, Orig-A, CANCELLED
Nashua, NH, Boire Field, VOR-A, Amdt 12A, CANCELLED
Blairstown, NJ, Blairstown, VOR RWY 25, Amdt 2A, CANCELLED
Manville, NJ, Central Jersey Rgnl, VOR-A, Amdt 7B, CANCELLED
Ocean City, NJ, Ocean City Muni, VOR-A, Orig-C, CANCELLED
Gallup, NM, Gallup Muni, VOR RWY 6, Amdt 8B
Silver City, NM, Grant County, LOC RWY 26, Amdt 5D
Silver City, NM, Grant County, RNAV (GPS) RWY 26, Orig-C
Tucumcari, NM, Tucumcari Muni, VOR RWY 26, Amdt 6A, CANCELLED
Cortland, NY, Cortland County-Chase Field, RNAV (GPS) RWY 6, Amdt 1
Cortland, NY, Cortland County-Chase Field, RNAV (GPS) RWY 24, Amdt 2
Montauk, NY, Montauk, VOR RWY 6, Amdt 4, CANCELLED
Monticello, NY, Sullivan County Intl, VOR RWY 33, Amdt 4, CANCELLED
Ashland, OH, Ashland County, VOR-A, Amdt 9D, CANCELLED
Middlefield, OH, Geauga County, VOR-A, Amdt 6, CANCELLED
Ada, OK, Ada Rgnl, Takeoff Minimums and Obstacle DP, Amdt 4A
Bristow, OK, Jones Memorial, RNAV (GPS) RWY 18, Amdt 2
Bristow, OK, Jones Memorial, RNAV (GPS) RWY 36, Amdt 2
Bristow, OK, Jones Memorial, Takeoff Minimums and Obstacle DP, Amdt
5
Goldsby, OK, David Jay Perry, VOR RWY 31, Amdt 2A, CANCELLED
Madill, OK, Madill Muni, VOR/DME-A, Amdt 3A, CANCELLED
Lakeview, OR, Lake County, VOR/DME-A, Orig-A, CANCELLED
Redmond, OR, Roberts Field, RNAV (GPS) Y RWY 5, Amdt 3A
Sunriver, OR, Sunriver, VOR RWY 18, Amdt 1D, CANCELLED
Grove City, PA, Grove City, VOR-A, Amdt 7A, CANCELLED
Greenville, SC, Donaldson Center, NDB RWY 5, Amdt 6A, CANCELLED
Dayton, TN, Mark Anton, NDB RWY 3, Amdt 2A, CANCELLED
Nashville, TN, Nashville Intl, VOR RWY 13, Amdt 13E, CANCELLED
Alpine, TX, Alpine-Casparis Muni, NDB RWY 19, Amdt 5D, CANCELLED
El Paso, TX, El Paso Intl, ILS OR LOC RWY 22, Amdt 32E
El Paso, TX, El Paso Intl, RNAV (GPS) Y RWY 22, Orig-F
El Paso, TX, El Paso Intl, RNAV (RNP) Z RWY 22, Amdt 1B
Fort Stockton, TX, Fort Stockton-Pecos County, VOR/DME RWY 30, Orig-
B, CANCELLED
La Grange, TX, Fayette Regional Air Center, VOR/DME-A, Amdt 1B,
CANCELLED
Muleshoe, TX, Muleshoe Municipal, VOR/DME-A, Amdt 1A, CANCELLED
Brookneal, VA, Brookneal/Campbell County, VOR-A, Amdt 2A, CANCELLED
Norfolk, VA, Hampton Roads Executive, ILS OR LOC RWY 10, Orig-A
Deer Park, WA, Deer Park, NDB-A, Amdt 2C, CANCELLED
Ephrata, WA, Ephrata Muni, VOR/DME RWY 3, Amdt 4, CANCELLED
New Holstein, WI, New Holstein Muni, VOR/DME-A, Amdt 2, CANCELLED
Moundsville, WV, Marshall County, VOR/DME-A, Amdt 2C, CANCELLED

RESCINDED: On July 13, 2020 (85 FR 41912), the FAA published an
Amendment in Docket No. 31319 Amdt No. 3911, to Part 97 of the Federal
Aviation Regulations under sections 97.33. The following Entry for
Thief River Falls, MN, effective September 10, 2020, is hereby
rescinded in its entirety:

Thief River Falls, MN, Thief River Falls Rgnl, RNAV (GPS) RWY 4,
Orig-A

[FR Doc. 2020-17203 Filed 8-5-20; 8:45 am]
BILLING CODE 4910-13-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 EPA/ OSWER/ OSW 2. OMB control number a. 2050 0124 b. 9 None 3. Type of information collection ( check one)

9 a. New collection 9 b. Revision of a currently approved collection : c. Extension of a currently approved collection 9 d. Reinstatement, without change, of a previously approved collection for which approval has expired 9 e. Reinstatement, with change, of a previously approved collection for which approval has expired 9 f. Existing collection in use without an OMB control number For b f, note Item A2 of Supporting Statement instructions 4. Type of review requested ( check one)

: a. Regular 9 b. Emergency 9 c. Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities?

9 Yes : No 6. Requested Expiration Date : a. Three years from the approval date 9 b. Other 7. Title Used Oil Management Standards Recordkeeping and Reporting Requirements ( Renewal)

8. Agency form number( s) ( If applicable) ICR # 1286.07 9. Keywords used oil, recycling, reporting and recordkeeping requirements 10. Abstract This ICR provides a comprehensive description of the requirements applicable to used oil handlers at 40 CFR part 279.

11. Affected public ( Mark primary with " P" and all others with " X")

9 a. Individuals or households : d. Farms P b. 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")

9 a. Voluntary P b. Required to obtain or retain benefits : c. Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 1,640 b. Total annual responses 1,640 1. Percentage of these responses collected electronically 0 % c. Total annual hours requested 460,286 d. Current OMB inventory 460,286 e. Difference 0 f. Explanation of difference 1. Program Change 0 2. Adjustment 0 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars) a. Total annualized capital/ startup costs $ 0 b. Total annual costs ( O& M) $ 10,011 c. Total annualized cost requested $ 10,011 d. Current OMB inventory $ 10,011 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")

9 a. Application for benefits 9 e. Program planning or management 9 b. Program evaluation 9 f. Research 9 c. General purpose statistics P g. Regulatory or compliance 9 d. Audit 16. Frequency of recordkeeping or reporting ( check all that apply)

: a. Recordkeeping 9 b. Third party disclosure : c. Reporting:

9 1. On occasion Q 2. Weekly Q 3. Monthly Q 4. Quarterly Q 5. Semi annually Q 6. Annually : 7. Biennially Q 8. Other ( describe )

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

Q Yes : No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Mike Svizzero Phone: 703 308 0046 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 Office Official Bob Hall, Director Permits and State Programs Division Office of Solid Waste Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information ( OEI) 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 collected; "( 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."

10/ 95


[Federal Register: May 30, 2008 (Volume 73, Number 105)]
[Proposed Rules]
[Page 31040-31043]
[DOCID:fr30my08-12]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 892

[Docket No. FDA-2008-N-0273]

Medical Devices; Radiology Devices; Reclassification of Full
Field Digital Mammography System

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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

SUMMARY: The Food and Drug Administration (FDA) is proposing to
reclassify the full field digital mammography (FFDM) system from class
III (premarket approval) to class II (special controls). The device
type is intended to produce full field digital x-ray images of the
breast. Elsewhere in this issue of the Federal Register, FDA is
announcing the availability of the draft guidance document entitled
``Class II Special Controls Guidance Document: Full Field Digital
Mammography System'' that would serve as the special control for the
device, if FDA reclassifies this device type.

DATES: Submit written or electronic comments by August 28, 2008. See
section X of this document for the proposed effective date of a final
rule based on this proposed rule.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2008-
N-0273, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
    Submit written submissions in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal or the agency Web site, as described previously, in
the ADDRESSES portion of this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN
number has been assigned) for this rulemaking. All comments received
may be posted without change to http://www.regulations.gov, including
any personal information provided. For additional information on
submitting comments, see the ``Comments'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number(s), found in brackets in the heading of this document,
into the ``Search'' box and follow the prompts and/or go to the
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.

FOR FURTHER INFORMATION CONTACT: Robert A. Phillips, Center for Devices
and Radiological Health (HFZ-470), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301
et seq.), as amended by (among other amendments) the Medical Device
Amendments of 1976 (the 1976 amendments) (Public Law 94-295), the Safe
Medical Devices Act of 1990 (Public Law 101-629), and the Food and Drug
Administration Modernization Act of 1997 (Public Law 105-115),
established a comprehensive

system for the regulation of medical devices intended for human use.
Section 513 of the act (21 U.S.C. 360c) established three categories
(classes) of devices, depending on the regulatory controls needed to
provide reasonable assurance of their safety and effectiveness. The
three categories of devices are class I (general controls), class II
(special controls), and class III (premarket approval).
    Under section 513 of the act, FDA refers to devices that were in
commercial distribution before May 28, 1976 (the date of enactment of
the 1976 amendments) as ``preamendments'' devices. FDA classifies these
devices after the agency takes the following steps: (1) Receives a
recommendation from a device classification panel (an FDA advisory
committee); (2) publishes the panel's recommendation for comment, along
with a proposed regulation classifying the device; and (3) publishes a
final regulation classifying the device. FDA has classified most
preamendments devices under these procedures.
    Under section 513 of the act, FDA refers to devices that were not
in commercial distribution prior to May 28, 1976, as ``postamendments''
devices. Postamendments devices are classified automatically by statute
(section 513(f) of the act) into class III without any FDA rulemaking
process. These devices remain in class III and require premarket
approval, unless the device is reclassified into class I or II or FDA
issues an order finding the device to be substantially equivalent,
under section 513(i) of the act, to a predicate device that does not
require premarket approval. The agency determines whether new devices
are substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the act (21 U.S.C. 360(k))
and part 807 (21 CFR part 807) of the regulations.
    Reclassification of classified postamendments devices is governed
by section 513(f)(3) of the act. This section provides that FDA may
initiate the reclassification of a device classified into class III
under section 513(f)(1) of the act, or the manufacturer or importer of
a device may petition the Secretary of Health and Human Services (the
Secretary) for the issuance of an order classifying the device into
class I or class II. FDA's regulations in 21 CFR 860.134 set forth the
procedures for the filing and review of a petition for reclassification
of these class III devices. To change the classification of the device,
the proposed new class must have sufficient regulatory controls to
provide reasonable assurance of the safety and effectiveness of the
device for its intended use.
    Under section 513(f)(3)(B)(i) of the act, the Secretary may ask for
a recommendation from a device classification panel on a proposed
reclassification, whether initiated by FDA or a petitioner. The panel
will make a recommendation to FDA concerning the proposed
reclassification. The recommendation must contain the following
information: (1) A summary of the reasons for the recommendation, (2) a
summary of the data upon which the recommendation is based, and (3) an
identification of the risks to health (if any) presented by the device
that is the subject of the proposed reclassification.

II. Regulatory History of the Device

    An FFDM system is a postamendments device classified into class III
under section 513(f)(1) of the act. This generic type of device cannot
be placed in commercial distribution unless it is reclassified under
section 513(f)(3) or subject to an approval of a premarket approval
(PMA) application under section 515 of the act (21 U.S.C. 360e). In
accordance with section 513(f)(3) of the act and based on information
regarding the device, FDA, on its own initiative, is proposing to
reclassify this device type from class III to class II when intended to
produce full field digital x-ray images of the breast. Consistent with
the act and the regulation, FDA referred the proposed reclassification
to the Radiological Devices Panel (the Panel) for its recommendation on
the requested change in classification.

III. Device Description

    An FFDM system is a device intended to be used to produce full
field digital x-ray images of the breast. This generic type of device
may include one or more of the following: Digital mammography software,
full field digital image receptor, acquisition workstation, and signal
analysis programs. Mammographic x-ray producing equipment (x-ray
generator, x-ray control, x-ray tube, collimator, beam filter, and
breast compression system) and display accessories are regulated under
21 CFR 892.1710, 892.2040, and 892.2050 as class II devices (special
controls).

IV. Recommendations of the Panel

    At a public meeting on May 23, 2006, the Panel unanimously
recommended that the FFDM system be reclassified from class III to
class II (special controls). The Panel believed that class II with the
draft special controls guidance document, in addition to general
controls, would provide reasonable assurance of the safety and
effectiveness of the device (Ref. 1).

V. Risks to Health

    After considering the information in the Panel's recommendation,
published medical literature (Refs. 2 through 4), and device recalls
(Ref. 5), FDA determined that the potential risks to health associated
with use of the FFDM system are electrical hazards, corrupted or non-
diagnostic image, incorrect patient positioning, excessive x-ray
exposure, excessive breast compression, and infection and skin
irritation. FDA's draft special controls guidance document aids in
mitigating the potential risks by recommending electrical safety
characteristics, physical laboratory testing, clinical studies, and
labeling. (See table 1 in section VIII of this document.)

VI. Summary of Reasons for Recommendation

    After reviewing the data provided by FDA, and after considering the
open discussions during the Panel meeting and the Panel members'
personal knowledge of and clinical experience with the device, the
Panel recommended that FDA reclassify the FFDM system intended to
produce full field digital x-ray images of the breast from class III
into class II (special controls). The Panel believes that the special
controls discussed in section VIII of this document, in addition to
general controls, would provide reasonable assurance of the safety and
effectiveness of the device, and there is sufficient information to
establish special controls to provide this assurance (Ref. 1).

VII. Summary of Data Upon Which the Panel Recommendation Is Based

    After considering the Panel's recommendation, as well as the
medical literature and other information, FDA believes that the
potential risks to health associated with the FFDM system are addressed
in the draft special controls guidance document. FDA also believes that
the draft guidance would provide reasonable assurance of the safety and
effectiveness of the FFDM system regarding the identified risks to
health of this device.

VIII. Special Controls

    In addition to general controls, FDA believes that the draft
special controls guidance document is an adequate special control to
address the risks to health associated with the use of the device
described in section V of this

document. FDA believes that special controls, in addition to general
controls, would provide reasonable assurance of the safety and
effectiveness of the device.
    Elsewhere in this issue of the Federal Register, FDA is announcing
the availability of the draft guidance entitled ``Class II Special
Controls Guidance Document: Full Field Digital Mammography System''
that the agency intends to use as the special control for this device.
The draft guidance addresses the information FDA believes should be
included in a premarket notification submission (510(k)) for the FFDM
system. FDA has identified the risks to health associated with the use
of the device in the first column of table 1 of this document. The
recommended mitigation measures identified in the class II special
controls guidance document is in the second column of table 1 of this
document.

            Table 1.--Risks to Health and Mitigation Measures
------------------------------------------------------------------------
          Identified Risk              Recommended Mitigation  Measures
------------------------------------------------------------------------
Electrical hazards                   Electrical safety
------------------------------------------------------------------------
Corrupted or non-diagnostic image    Physical laboratory testing
                                     Clinical studies
------------------------------------------------------------------------
Incorrect patient positioning        Clinical studies
------------------------------------------------------------------------
Excessive x-ray exposure             Physical laboratory testing
------------------------------------------------------------------------
Excessive breast compression         Physical laboratory testing
------------------------------------------------------------------------
Infection, skin irritation           Labeling
------------------------------------------------------------------------

    Following the effective date of a final rule based on this
proposal, any firm submitting a 510(k) for an FFDM system will need to
address the issues covered in the special controls guidance. However,
the firm need only show that its device meets the recommendations of
the guidance or in some other way provides equivalent assurances of
safety and effectiveness.

IX. FDA's Tentative Findings

    FDA and the Panel believe that the FFDM system should be
reclassified into class II because special controls, in addition to
general controls, would provide reasonable assurance of the safety and
effectiveness of the device, and there is sufficient information to
establish special controls to provide this assurance. FDA, therefore,
is proposing to reclassify the device type from class III into class II
with the draft guidance as the special control for the device.
    Section 510(m) of the act provides that a class II device may be
exempted from the premarket notification requirements under section
510(k) of the act, if the agency determines that premarket notification
is not necessary to provide reasonable assurance of the safety and
effectiveness of the device. For this device, however, FDA believes
that premarket notification is necessary to provide reasonable
assurance of safety and effectiveness and, therefore, does not intend
to exempt the device from the premarket notification requirements.

X. Proposed Effective Date

    FDA proposes that any final rule that may issue based on this
proposal become effective 30 days after its date of publication in the
Federal Register.

XI. Environmental Impact

    The agency has 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.

XII. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this proposed rule is not a significant regulatory action as defined by
the Executive order.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because reclassification of this device from class
III to class II will relieve manufacturers of the device of the cost of
complying with the premarket approval requirements of section 515 of
the act and may permit small potential competitors to enter the market
place by lowering their costs, the agency certifies that the proposed
rule will not have a significant economic impact on a substantial
number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $127 million, using the most current (2006) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.

XIII. Federalism

    FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the proposed rule does not contain policies that have substantial
direct effects on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government. Accordingly,
the agency has tentatively concluded that the proposed rule does not
contain policies that have federalism implications as defined in the
Executive order and, consequently, a federalism summary impact
statement is not required.

XIV. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no
collections of information. Therefore, clearance by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(the PRA) (44 U.S.C. 3501-3520) is not required.
    FDA also tentatively concludes that the special controls guidance
document does not contain new information collection provisions that
are subject to review and clearance by OMB under the PRA. Elsewhere in
this issue of the Federal Register, FDA is announcing the availability
of the draft guidance document entitled ``Class II Special Controls
Guidance Document: Full Field Digital Mammography System;'' the
document addresses the paperwork burden for the draft guidance.

XV. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.

Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
    Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic comments and
submissions will be accepted by FDA only through FDMS at http://
www.regulations.gov.

XVI. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Radiological Devices Panel, Transcript, pp. 142-156,
available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/
cfAdvisory/details.cfm?mtg=659, May 23, 2006.
    2. Pisano, E., Gatsonis, C., Hendrick, E., et al., ``Digital
Mammographic Imaging Screening Trial (DMIST) Investigators Group,''
``Diagnostic Performance of Digital Versus Film Mammography for
Breast-Cancer Screening,'' New England Journal of Medicine, 353:
1773-1783, 2005.
    3. Yaffe, M., Bloomquist, A., Mawdsley, G., et al., ``Quality
Control for Digital Mammography: Part II Recommendations From the
ACRIN DMIST Trial,'' Medical Physics, 33(3): 737-752, 2006.
    4. Thomas, J., Chakrabarti, K., Kaczmarek, R., et al.,
``Contrast Detail Phantom Scoring Methodology,'' Medical Physics,
32(3), 807, 2005.
    5. Device recalls are described in FDA's briefing information,
slide number 12, available at http://www.fda.gov/ohrms/dockets/ac/
06/briefing/2006-4219b1_04_draft%20FDA%20presentation.pdf.

List of Subjects in 21 CFR Part 892

    Medical device, Radiation protection, X-rays.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 892 be amended as follows:

PART 892--RADIOLOGY DEVICES

    1. The authority citation for 21 CFR part 892 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    2. Section 892.1 is amended by adding paragraph (e) to read as
follows:

Sec.  892.1  Scope.

* * * * *
    (e) Guidance documents referenced in this part are available on the
Internet at http://www.fda.gov/cdrh/guidance.html.
    3. Section 892.1715 is added to subpart B to read as follows:

Sec.  892.1715  Full field digital mammography system.

    (a) Identification. A full field digital mammography system is a
device intended to produce full field digital x-ray images of the
breast. This generic type of device may include one or more of the
following: Digital mammography software, full field digital image
receptor, acquisition workstation, and signal analysis programs.
    (b) Classification. Class II (special controls). The special
control for the device is FDA's guidance document entitled ``Class II
Special Controls Guidance Document: Full Field Digital Mammography
System.'' See 892.1(e) for the availability of this guidance document.

    Dated: May 21, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E8-12120 Filed 5-29-08; 8:45 am]

BILLING CODE 4160-01-S