[Federal Register Volume 76, Number 99 (Monday, May 23, 2011)]
[Proposed Rules]
[Pages 29686-29688]
[FR Doc No: 2011-12515]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2010-0856; FRL-9308-2]

Approval and Promulgation of Air Quality Implementation Plans;
Virginia; Permits for Major Stationary Sources and Major Modifications
Locating in Prevention of Significant Deterioration (PSD) Areas

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve a State Implementation Plan (SIP)
revision submitted by the Virginia Department of Environmental Quality
(VADEQ). This revision pertains to EPA's proposal to approve the
addition of nitrogen oxides (NOX) as a precursor to ozone in
the Virginia SIP that governs permits for constructing or significantly
modifying facilities located in areas attaining the national ambient
air quality standards (NAAQS). This action is being taken under the
Clean Air Act (CAA).

DATES: Written comments must be received on or before June 22, 2011.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2010-0856 by one of the following methods:
    A. http://www.regulations.gov. Follow the on-line instructions for
submitting comments.
    B. E-mail<EMAIL_ADDRESS>    C. Mail: EPA-R03-OAR-2010-0856, Kathleen Cox, Associate Director,
Office of Permits and Air Toxics, Mailcode 3AP10, U.S. Environmental
Protection Agency, Region III, 1650 Arch Street, Philadelphia,
Pennsylvania 19103.
    D. Hand Delivery: At the previously-listed EPA Region III address.
Such 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-R03-OAR-
2010-0856. EPA's policy is that all comments received will be included
in the public docket without change, and may be made available online
at http://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 http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail 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, 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 EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, 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.
    Docket: All documents in the electronic docket are listed in the
http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in http://www.regulations.gov or in hard copy during normal business hours at the
Air Protection Division, U.S. Environmental Protection Agency, Region
III, 1650 Arch Street, Philadelphia, Pennsylvania 19103. Copies of the
Virginia submittal are available at the VADEQ Office, 629 East Main
Street, Richmond, Virginia 23219.

FOR FURTHER INFORMATION CONTACT: Sharon McCauley,<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. On June 7, 2010, the VADEQ
submitted a revision to the Virginia SIP for including NOX
as a precursor to ozone for permits of major stationary

sources or major modifications locating in areas in Virginia that are
attaining the NAAQS, also known as Prevention of Significant
Deterioration (PSD) areas.

I. Background

    We are proposing approval of Virginia's SIP submission dated June
7, 2010 which addresses regulatory changes needed to be equivalent to
the CAA's part C PSD permit program. This SIP submission also corrects
deficiencies identified by EPA in the March 27, 2008 Federal Register
action entitled, ``Completeness Findings for Section 110(a) State
implementation Plans for the 8-hour ozone National Ambient Air Quality
Standards (1997 Ozone NAAQS)'' (73 FR 16205). EPA's proposed approval
of this SIP submission addresses Virginia's compliance with the portion
of CAA Section 110(a)(2)(C) & (J) relating to the CAA's part C PSD
permit program for the 1997 Ozone NAAQS, because this proposed approval
would approve regulating NOX as a precursor to ozone in
Virginia's SIP in accordance with the Federal Register action dated
November 29, 2005 (70 FR 71612) that finalized NOX as a
precursor for ozone regulations set forth at 40 CFR 51.166 and in 40
CFR 52.21.

II. Summary of SIP Revision

    VADEQ's regulations adding NOX as a precursor to ozone
establish a construction permit program consistent with the Federal
CAA's Title I program and implementing regulations at 40 CFR 51.166,
``Prevention of Significant Deterioration of Air Quality.'' VADEQ's
regulation 9VAC5 Chapter 80, Article 8 is part of the SIP and sets
forth the criteria and procedures for major stationary sources to
obtain a permit to construct, operate and/or modify a major stationary
source.
    We are proposing to fully approve the regulatory citation changes
which became effective in Virginia on December 31, 2008, as referenced
here in this document and in the Virginia Code of Regulations 9VAC5
Chapter 80, Article 8, sections 5-80-1615 and 5-80-1695 which establish
NOX as a precursor to ozone, into the Virginia SIP. These
proposed changes will add NOX as a precursor to ozone, in
addition to volatile organic compounds (VOC), in the definitions of
``major modification'', ``major stationary source'', ``regulated New
Source Review (NSR) pollutant'' and ``significant'' and to the list of
exempted facilities.
    Previously, EPA had issued an ``limited approval'' of Virginia's
PSD regulations (9VAC5 Chapter 80, Article 8) for reasons that will not
deny this action as being fully approved. The ``limited approval''
issues can be found in the Technical Support Document contained in this
Docket or in the Federal Register action dated October 22, 2008 (73 FR
62897).

III. General Information Pertaining to SIP Submittals From the
Commonwealth of Virginia

    In 1995, Virginia adopted legislation that provides, subject to
certain conditions, for an environmental assessment (audit)
``privilege'' for voluntary compliance evaluations performed by a
regulated entity. The legislation further addresses the relative burden
of proof for parties either asserting the privilege or seeking
disclosure of documents for which the privilege is claimed. Virginia's
legislation also provides, subject to certain conditions, for a penalty
waiver for violations of environmental laws when a regulated entity
discovers such violations pursuant to a voluntary compliance evaluation
and voluntarily discloses such violations to the Commonwealth and takes
prompt and appropriate measures to remedy the violations. Virginia's
Voluntary Environmental Assessment Privilege Law, Va. Code Sec. 10.1-
1198, provides a privilege that protects from disclosure documents and
information about the content of those documents that are the product
of a voluntary environmental assessment. The Privilege Law does not
extend to documents or information (1) That are generated or developed
before the commencement of a voluntary environmental assessment; (2)
that are prepared independently of the assessment process; (3) that
demonstrate a clear, imminent and substantial danger to the public
health or environment; or (4) that are required by law.
    On January 12, 1998, the Commonwealth of Virginia Office of the
Attorney General provided a legal opinion that states that the
Privilege law, Va. Code Sec. 10.1-1198, precludes granting a privilege
to documents and information ``required by law,'' including documents
and information required by Federal law to maintain program delegation,
authorization or approval, ``since Virginia must enforce Federally
authorized environmental programs in a manner that is no less stringent
than their Federal counterparts * * *.'' The opinion concludes that
``regarding 10.1-1198, therefore, documents or other information needed
for civil or criminal enforcement under one of these programs could not
be privileged because such documents and information are essential to
pursuing enforcement in a manner required by Federal law to maintain
program delegation, authorization or approval.''
    Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that to
the extent consistent with requirements imposed by Federal law, any
person making a voluntary disclosure of information to a state agency
regarding a violation of an environmental statute, regulation, permit,
or administrative order is granted immunity from administrative or
civil penalty. The Attorney General's January 12, 1998 opinion states
that the quoted language renders this statute inapplicable to
enforcement of any Federally authorized programs, since no immunity
could be afforded from administrative, civil, or criminal penalties
because granting such immunity would not be consistent with Federal
law, which is one of the criteria for immunity.
    Therefore, EPA has determined that Virginia's Privilege and
Immunity statutes will not preclude the Commonwealth from enforcing its
PSD program consistent with the Federal requirements. In any event,
because EPA has also determined that a state audit privilege and
immunity law can affect only state enforcement and cannot have any
impact on Federal enforcement authorities, EPA may at any time invoke
its authority under the CAA, including, for example, sections 113, 167,
205, 211 or 213, to enforce the requirements or prohibitions of the
state plan, independently of any state enforcement effort. In addition,
citizen enforcement under section 304 of the CAA is likewise unaffected
by this, or any, state audit privilege or immunity law.

IV. Proposed Action

    Our review of Virginia's SIP revision request indicates that our
proposed approval of this SIP revision is warranted. As previously
noted, these changes to the Virginia program are found in the Virginia
Code at 9VAC5 Chapter 80, Article 8, Permits for Major Stationary
Sources and Major Modifications Locating in Prevention of Significant
Deterioration Areas.
    This proposed SIP approval for sections 5-80-1615 and 5-80-1695
which addresses regulatory changes needed to be equivalent to the CAA's
part C PSD permit program. It will also correct deficiencies identified
by EPA in the March 27, 2008 Federal Register action entitled,
``Completeness Findings for Section 110(a) State implementation Plans
for the 8-hour Ozone National Ambient Air Quality Standards (1997 Ozone
NAAQS)'' (73 FR 16205). EPA's proposed approval of this SIP

submission addresses Virginia's compliance with the portion of CAA
Section 110(a)(2)(C) & (J) relating to the CAA's part C PSD permit
program for the 1997 Ozone NAAQS, because this proposed approval would
approve regulating NOX as a precursor to ozone in Virginia's
SIP in accordance with the Federal Register action dated November 29,
2005 (70 FR 71612) that finalized NOX as a precursor for
ozone regulations set forth at 40 CFR 51.166 and in 40 CFR 52.21.
    We are proposing to fully approve the Virginia SIP revision request
for these changes only. Prior ``limited approval'' of certain aspects
of Virginia's PSD program elements remain valid. A description of these
items for ``limited approval'' can be found in the Technical Support
Document contained in this Docket or in the Federal Register action
dated October 22, 2008 (73 FR 62897). EPA is soliciting public comments
on the issues discussed for this proposed approval document only. These
comments will be considered before taking final action.

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely proposes to approve state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed rule to include NOX as a
precursor to ozone in Virginia does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Intergovernmental
relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping
requirements.

    Authority: 42 U.S.C. 7401 et seq.

    Dated: April 25, 2011.
James W. Newson,
Acting Regional Administrator, Region III.
[FR Doc. 2011-12515 Filed 5-20-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 242 (Wednesday, December 16, 2020)]
[Proposed Rules]
[Pages 81433-81436]
[FR Doc No: 2020-27632]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2020-1100; Airspace Docket No. 20-AGL-1]
RIN 2120-AA66

Proposed Amendment of V-9, V-63, V-100, V-158, V-171, and T-325;
and Revocation of V-127 in the Vicinity of Rockford, IL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend VHF Omnidirectional Range (VOR)
Federal airways V-9, V-63, V-100, V-158, and V-171; amend Area
Navigation (RNAV) route T-325; and remove VOR Federal airway V-127 in
the vicinity of Rockford, IL. The air traffic service (ATS) route
modifications are necessary due to the planned decommissioning of the
VOR portion of the Rockford, IL, VOR/Distance Measuring Equipment (VOR/
DME) navigation aid (NAVAID). Except for RNAV route T-325, the Rockford
VOR/DME NAVAID provides navigation guidance for portions of the
affected routes listed above. The Rockford VOR is being decommissioned
as part of the FAA's VOR Minimum Operational Network (MON) program.

DATES: Comments must be received on or before February 1, 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:
(800) 647-5527, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2020-1100; Airspace Docket No. 20-AGL-1 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
Rules and Regulations 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: Colby Abbott, Rules and Regulations
Group, Office of Policy, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

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

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2020-1100; Airspace Docket No. 20-AGL-1) and be submitted in
triplicate to the Docket Management Facility (see ADDRESSES section for
address and phone number). You may also submit comments through the
internet at https://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to FAA Docket No. FAA-2020-1100; Airspace Docket No. 20-AGL-1.'' The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified comment
closing date will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the

comment closing date. A report summarizing each substantive public
contact with FAA personnel concerned with this rulemaking will be filed
in the docket.

Availability of 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 ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the office of the Operations Support Group, Central
Service Center, Federal Aviation Administration, 10101 Hillwood
Parkway, Fort Worth, TX, 76177.

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.

Background

    The FAA is planning decommissioning activities for the VOR portion
of the Rockford, IL, VOR/DME in October 2021. The Rockford, IL, VOR is
a candidate VOR identified for discontinuance by the FAA's VOR MON
program and listed in the final policy statement notice, ``Provision of
Navigation Services for the Next Generation Air Transportation System
(NextGen) Transition to Performance-Based Navigation (PBN) (Plan for
Establishing a VOR Minimum Operational Network),'' published in the
Federal Register of July 26, 2016 (81 FR 48694), Docket No. FAA-2011-
1082.
    Although the VOR portion of the Rockford VOR/DME is planned for
decommissioning, the co-located DME portion of the NAVAID is being
retained.
    The existing ATS route dependencies to the Rockford, IL, VOR/DME
NAVAID are VOR Federal airways V-9, V-63, V-100, V-127, V-158, and V-
171. With the planned decommissioning of the VOR portion of the
Rockford VOR/DME, the remaining ground-based NAVAID coverage in the
area is insufficient to enable the continuity of the affected airways.
As such, proposed modifications to the affected airways would result in
creating a gap in three of the airways (V-9, V-63, and V-100),
expanding an existing gap in one of the airways (V-171), redefining an
airway point to retain one of the airways as charted (V-158); and
removing the remaining airway completely (V-127).
    To overcome the gaps created or expanded in four of the airways,
and the loss of another airway, instrument flight rules (IFR) traffic
could use adjacent ATS routes, including VOR Federal airways V-6, V-24,
V-158, V-172, and V-216, or request air traffic control (ATC) radar
vectors to fly through or circumnavigate the affected area.
Additionally, IFR pilots equipped with RNAV PBN capabilities could also
navigate point to point using the existing fixes that will remain in
place to support continued operations though the affected area. Visual
flight rules (VFR) pilots who elect to navigate via the airways through
the affected area could also take advantage of the adjacent VOR Federal
airways or ATC services listed previously.
    To retain V-158 as charted, the FAA is proposing to redefine the
airway point defined by the intersection of the Polo, IL, VOR/DME
122[deg] and Rockford, IL, VOR/DME 169[deg] radials (SHOOF fix) by
using the existing Polo, IL, VOR/DME 122[deg] radial and replacing the
Rockford, IL, VOR/DME radial with a new Davenport, IA, VOR/Tactical Air
Navigation (VORTAC) 087[deg](T)/083[deg](M) radial. As a result, the V-
158 airway would remain unchanged and as currently charted.
    The FAA is also proposing to extend RNAV route T-325 from the Terre
Haute, IN, area to the Oshkosh, WI, area to, in part, mitigate arrival/
departure route issues associated with the proposed loss of the V-9 and
V-63 airway segments north of the Rockford VOR/DME. For approximately
two weeks each summer, more than 10,000 aircraft converge on Oshkosh,
WI, for the Experimental Aircraft Association (EAA) Air Venture Fly-In
held at the Aviation Museum located at the Wittman Regional Airport.
Extending T-325 to the Oshkosh, WI, area would mitigate the Air Venture
Fly-In arrival/departure route issues caused by the proposed V-9 and V-
63 modifications, provide airspace users with continued enroute ATS
route structure north of the Rockford, IL, area, and support ongoing
FAA NextGen efforts to modernize the NAS to performance-based
navigation.
    Prior to this NPRM, the FAA published a rule for Docket No. FAA-
2020-0505 in the Federal Register (85 FR 67648; October 26, 2020),
amending VOR Federal airway V-63 by removing the airway segment between
the Bowie, TX, VORTAC and the Texoma, OK, VOR/DME. That airway
amendment, effective December 31, 2020, is included in this NPRM.
    Also prior to this NPRM, the FAA published a rule for Docket No.
FAA-2020-0667 in the Federal Register (85 FR 79422; December 10, 2020),
amending VOR Federal airway V-100 by removing the airway segment
overlying the Sioux City, IA, VORTAC between the O'Neill, NE, VORTAC
and the Fort Dodge, IA, VORTAC. That airway amendment, effective
February 25, 2021, is included in this NPRM, as well.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 by modifying VOR Federal airways V-9, V-
63, V-100, V-158, and V-171; modifying RNAV route T-325; and removing
VOR Federal airway V-127. The planned decommissioning of the VOR
portion of the Rockford, IL, VOR/DME has made this action necessary.
    The proposed VOR Federal airway changes are outlined below.
    V-9: V-9 currently extends between the Leeville, LA, VORTAC and the
Houghton, MI, VOR/DME. The FAA proposes to remove the airway segment
overlying the Rockford, IL, VOR/DME between the Pontiac, IL, VOR/DME
and the Janesville, WI, VOR/DME. The unaffected portions of the
existing airway would remain as charted.
    V-63: V-63 currently extends between the Razorback, AR, VORTAC and
the Oshkosh, WI, VORTAC; and between the Wausau, WI, VOR/DME and the
Houghton, MI, VOR/DME. That airspace at and above 10,000 feet MSL from
5 NM north to 46 NM north of Quincy, IL, when the Howard West MOA is
active is excluded. The FAA proposes to remove the airway segment
overlying the Rockford, IL, VOR/DME between the Davenport, IA, VORTAC
and the Janesville, WI, VOR/DME. The unaffected portions of the
existing airway would remain as charted and the exclusion language
would remain unchanged.
    V-100: V-100 currently extends between the Medicine Bow, WY, VOR/
DME and the O'Neill, NE, VORTAC; and between the Fort Dodge, IA, VORTAC

and the Litchfield, MI, VOR/DME. The FAA proposes to remove the airway
segment overlying the Rockford, IL, VOR/DME between the Dubuque, IA,
VORTAC and the Northbrook, IL, VOR/DME. The unaffected portions of the
existing airway would remain as charted.
    V-127: V-127 currently extends between the Bradford, IL, VORTAC and
the Rockford, IL, VOR/DME. The FAA proposes to remove the airway in its
entirety.
    V-158: V-158 currently extends between the Mason City, IA, VORTAC
and the intersection of the Polo, IL, VOR/DME 122[deg] and the
Rockford, IL, VOR/DME 169[deg] radials (SHOOF fix). The airspace within
R-3302 is excluded. The FAA proposes to retain the airway and redefine
the SHOOF fix as the intersection of the existing Polo, IL, VOR/DME
122[deg] radial and the new Davenport, IA, VORTAC, 087[deg](T)/
083[deg](M) radial. The existing airway would remain as charted and the
exclusion language would remain unchanged.
    V-171: V-171 currently extends between the Lexington, KY, VOR/DME
and the Rockford, IL, VOR/DME; and between the Nodine, MN, VORTAC and
the Roseau, MN, VOR/DME. The FAA proposes to remove the airway segment
between the Joliet, IL, VOR/DME and the Rockford, IL, VOR/DME. The
unaffected portions of the existing airway would remain as charted.
    The proposed RNAV T-route changes are outlined below.
    T-325: T-325 currently extends between the Bowling Green, KY, DME
navigation aid and the Terre Haute, IN, VORTAC. The proposed change
would remove the Terre Haute VORTAC and replace it with the JIBKA, IN,
waypoint (WP) located near the Terre Haute VORTAC, and extend the route
northward from the JIBKA, IN, WP to the Oshkosh, WI, VORTAC. The
following points would be added between the JIBKA WP and the Oshkosh
VORTAC: CAPPY, IL, WP; SMARS, IL, WP; TRENM, IL, WP; START, IL, WP;
GRIFT, IL, WP; DEBOW, WI, WP; LUNGS, WI, WP; and the HOMNY, WI, WP. The
unaffected segments of the existing route would remain as charted.
    All radials in the VOR Federal airway descriptions below that do
not reflect True (T)/Magnetic (M) degree radial information are
unchanged and stated in True degrees.
    VOR Federal airways are published in paragraph 6010(a) and United
States RNAV T-routes are published in paragraph 6011 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 ATS routes listed in
this document would be subsequently published 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 proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under
Department of Transportation (DOT) Regulatory Policies and Procedures
(44 FR 11034; February 26, 1979); and (3) does not warrant preparation
of a regulatory evaluation as the anticipated impact is so minimal.
Since this is a routine matter that will only affect air traffic
procedures and air navigation, it is certified that this proposed rule,
when promulgated, will not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.

Environmental Review

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

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

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

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

0
1. The authority citation for part 71 continues to read as follows:

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

Sec.  71.1   [Amended]

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 6010(a) Domestic VOR Federal Airways.

* * * * *

V-9 [Amended]

    From Leeville, LA; McComb, MS; INT McComb 004[deg] and Magnolia,
MS, 194[deg] radials; Magnolia; Sidon, MS; Marvell, AR; Gilmore, AR;
Malden, MO; Farmington, MO; St. Louis, MO; Spinner, IL; to Pontiac,
IL. From Janesville, WI; Madison, WI; Oshkosh, WI; Green Bay, WI;
Iron Mountain, MI; to Houghton, MI.
* * * * *

V-63 [Amended]

    From Razorback, AR; Springfield, MO; Hallsville, MO; Quincy, IL;
Burlington, IA; Moline, IL; to Davenport, IA. From Janesville, WI;
Badger, WI; to Oshkosh, WI. From Wausau, WI; Rhinelander, WI; to
Houghton, MI. Excluding that airspace at and above 10,000 feet MSL
from 5 NM north to 46 NM north of Quincy, IL, when the Howard West
MOA is active.
* * * * *

V-100 [Amended]

    From Medicine Bow, WY; Scottsbluff, NE; Alliance, NE; Ainsworth,
NE; to O'Neill, NE. From Fort Dodge, IA; Waterloo, IA; to Dubuque,
IA. From Northbrook, IL; INT Northbrook 095[deg] and Keeler, MI,
271[deg] radials; Keeler; to Litchfield, MI.
* * * * *

V-127 [Removed]

* * * * *

V-158 [Amended]

    From Mason City, IA; INT Mason City 106[deg] and Dubuque, IA,
293[deg] radials; Dubuque; Polo, IL; to INT Polo 122[deg] and
Davenport, IA, 087[deg](T)/083[deg](M) radials. The airspace within
R-3302 is excluded.
* * * * *

V-171 [Amended]

    From Lexington, KY; INT Lexington 251[deg] and Louisville, KY,
114[deg] radials; Louisville; Terre Haute, IN; Danville, IL;
Peotone, IL; INT Peotone 281[deg] and Joliet, IL, 173[deg] radials;
to Joliet. From Nodine, MN; INT Nodine 298[deg] and Farmington, MN,
124[deg] radials; Farmington; Darwin, MN; Alexandria, MN; INT
Alexandria 321[deg] and Grand Forks, ND, 152[deg] radials; Grand
Forks; to Roseau, MN.
* * * * *

Paragraph 6011 United States Area Navigation Routes.

* * * * *

T-325 Bowling Green, KY (BWG) to Oshkosh, WI (OSH) [Amended]
Bowling Green, KY (BWG)          DME                (Lat. 36[deg]55'43.47'' N, long. 086[deg]26'36.36'' W).

RENRO, KY                        FIX                (Lat. 37[deg]28'50.53'' N, long. 086[deg]39'19.25'' W).
LOONE, KY                        WP                 (Lat. 37[deg]44'14.43'' N, long. 086[deg]45'18.02'' W).
APALO, IN                        FIX                (Lat. 38[deg]00'20.59'' N, long. 086[deg]51'35.27'' W).
BUNKA, IN                        FIX                (Lat. 39[deg]04'57.32'' N, long. 087[deg]09'06.58'' W).
JIBKA, IN                        WP                 (Lat. 39[deg]30'08.93'' N, long. 087[deg]16'26.74'' W).
CAPPY, IL                        WP                 (Lat. 40[deg]00'06.00'' N, long. 087[deg]44'31.22'' W).
SMARS, IL                        WP                 (Lat. 41[deg]07'38.18'' N, long. 088[deg]51'38.22'' W).
TRENM, IL                        WP                 (Lat. 41[deg]17'24.93'' N, long. 089[deg]00'27.53'' W).
START, IL                        WP                 (Lat. 41[deg]45'24.83'' N, long. 089[deg]00'21.81'' W).
GRIFT, IL                        WP                 (Lat. 42[deg]17'28.14'' N, long. 088[deg]53'41.42'' W).
DEBOW, WI                        WP                 (Lat. 42[deg]44'08.30'' N, long. 088[deg]50'48.92'' W).
LUNGS, WI                        WP                 (Lat. 43[deg]02'43.66'' N, long. 088[deg]56'54.86'' W).
HOMNY, WI                        WP                 (Lat. 43[deg]31'02.22'' N, long. 088[deg]39'40.15'' W).
Oshkosh, WI (OSH)                VORTAC             (Lat. 43[deg]59'25.56'' N, long. 088[deg]33'21.36'' W).

* * * * *

    Issued in Washington, DC, on December 11, 2020.
George Gonzalez,
Acting Manager, Rules and Regulations Group.
[FR Doc. 2020-27632 Filed 12-15-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 74, Number 85 (Tuesday, May 5, 2009)]
[Rules and Regulations]
[Pages 20599-20601]
[FR Doc No: E9-10335]

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

40 CFR Part 52

[EPA-R05-OAR-2008-0031; FRL-8899-3]

Approval and Promulgation of Air Quality Implementation Plans;
Indiana; Extended Permit Terms for Renewal of Federally Enforceable
State Operating Permits

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is approving Indiana's rule revision to extend permit
terms for the renewal of Federally Enforceable State Operating Permits
(FESOPs) from five years to ten years. Indiana submitted this rule
revision for approval on December 19, 2007. FESOPs apply to non-major
sources that obtain enforceable limits to avoid being subject to
certain Clean Air Act (Act) requirements, including the Title V
operating permit program. Neither the Act nor its implementing
regulations specify a permit-term requirement for FESOPs. This rule
revision will provide relief to Indiana's resource burden of processing
permit renewals. It will also allow the Indiana Department of
Environmental Management (IDEM) to devote more resources to major
source Title V permitting actions and permit modifications for both
Title V and FESOP sources.

DATES: This direct final rule will be effective July 6, 2009, unless
EPA receives adverse comments by June 4, 2009. If adverse comments are
received, EPA will publish a timely withdrawal of the direct final rule
in the Federal Register informing the public that the rule will not
take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2008-0031, by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: Pamela Blakley, Chief, Air Permits Section, Air Programs
Branch (AR-18J), U.S. Environmental Protection Agency, 77 West Jackson
Boulevard, Chicago, Illinois 60604.
    5. Hand Delivery: Pamela Blakley, Chief, Air Permits Section, Air
Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West
Jackson Boulevard, Chicago, Illinois 60604. Such deliveries are only
accepted during the Regional Office normal hours of operation, and
special arrangements should be made for deliveries of boxed
information. The Regional Office official hours of business are Monday
through Friday, 8:30 a.m. to 4:30 p.m. excluding Federal holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R05-OAR-
2008-0031. 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.govv, 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.govv or e-mail.
The www.regulations.govv Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through www.regulations.govv
your e-mail 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, 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 EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, 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.
    Docket: All documents in the docket are listed in the
www.regulations.govv 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.govv or in hard copy at the Environmental Protection
Agency, Region 5, Air and Radiation Division, 77 West Jackson
Boulevard, Chicago, Illinois 60604. This Facility is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. We
recommend that you telephone Sam Portanova, Environmental Engineer, at
(312) 886-3189 before visiting the Region 5 office.

FOR FURTHER INFORMATION CONTACT: Sam Portanova, Environmental Engineer,
Air Permits Section, Air Programs Branch (AR-18J), Environmental
Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago,
Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This supplementary information
section is arranged as follows:

I. What Is Being Addressed in This Document?
II. What Are the Changes That EPA Is Approving?
III. What Action Is EPA Taking?
IV. Statutory and Executive Order Reviews

I. What Is Being Addressed in This Document?

    We are approving revisions to the State of Indiana's FESOP
regulations. EPA approved the Indiana FESOP program into the state
implementation plan (SIP) on August 18, 1995 (60 FR 43008). On December
19, 2007, IDEM submitted revisions to the FESOP regulations requesting
EPA approval as a revision to the SIP. This submittal includes
revisions to 326 IAC 2-1.1-9.5 and 326 IAC 2-8-4 to extend FESOP permit
renewal terms for up to ten years. We have determined that this
submittal is approvable.

II. What Are the Changes That EPA Is Approving?

    326 IAC 2-1.1-9.5 is a general provision in the Indiana permitting
rules that cites the term of a permit. This section has been modified
to add a provision (326 IAC 2-1.1-9.5(b)) stating that a FESOP permit
renewal is effective for a permit term not to exceed ten years. The
rule modification also states that a minor source operating permit
(MSOP) renewal is effective for a permit term not to exceed ten years.
However, MSOPs are not part of the Indiana SIP and MSOP rules are
specifically excluded from Indiana's December 19, 2007, request.
    Indiana has modified 326 IAC 2-8-4(2)(B) to increase the permit
term for FESOP renewals from five years to ten years. In addition,
Indiana has made some minor grammatical changes to 326 IAC 2-8-4. The
change in permit term only applies to FESOP renewals and not to a
source's first-time FESOP permit, which will continue to have a permit
term of five years pursuant to 326 IAC 2-8-4(2)(A). This provision does
not apply to Title V permits issued by IDEM under 326 IAC 2-7.
    EPA's requirements for FESOPs are contained in a June 28, 1989,
rule addressing federal enforceability (54 FR 27274). In its August 18,
1995, approval of FESOP rule 326 IAC 2-8, EPA determined that Indiana's
regulation was consistent with those requirements. EPA's June 28, 1989,
rule does not require a specific permit term for FESOPs. As such, EPA
finds the modifications to 326 IAC 2-1.1-9.5 and 326 IAC 2-8-4
acceptable.

III. What Action Is EPA Taking?

    EPA is approving the revisions to 326 IAC 2-1.1-9.5 and 326 IAC 2-
8-4 regarding the permit terms for FESOP renewals. We are publishing
this action without prior proposal because we view this as a
noncontroversial amendment and anticipate no adverse comments. However,
in the proposed rules section of this Federal Register publication, we
are publishing a separate document that will serve as the proposal to
approve the state plan if relevant adverse written comments are filed.
This rule will be effective July 6, 2009 without further notice unless
we receive relevant adverse written comments by June 4, 2009. If we
receive such comments, we will withdraw this action before the
effective date by publishing a subsequent document that will withdraw
the final action. All public comments received will then be addressed
in a subsequent final rule based on the proposed action. The EPA will
not institute a second comment period. Any parties interested in
commenting on this action should do so at this time. If we do not
receive any comments, this action will be effective July 6, 2009.

IV. Statutory and Executive Order Reviews

    Under the Act, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the Act. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by July 6, 2009. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. Parties with objections to this direct final
rule are encouraged to file a comment in response to the parallel
notice of proposed rulemaking for this action published in the proposed
rules section of today's Federal Register, rather than file an
immediate petition for judicial review of this direct final rule, so
that EPA can withdraw this direct final rule and address the comment in
the

proposed rulemaking. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: April 20, 2009.
Walter W. Kovalick, Jr.,
Acting Regional Administrator, Region 5.

0
For the reasons stated in the preamble, part 52, chapter I, of title 40
of the Code of Federal Regulations is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart P--Indiana

0
2. Section 52.770 is amended by adding and reserving paragraph (c)(189)
and adding paragraph (c)(190) to read as follows:

Sec.  52.770  Identification of plan.

* * * * *
    (c) * * *
    (189) [Reserved]
    (190) On December 19, 2007, Indiana submitted modifications to its
Federally Enforceable State Operating Permits rules as a revision to
the state implementation plan. The revision extends the maximum permit
term for renewals of Federally Enforceable State Operating Permits from
five years to ten years. EPA has determined that this revision is
approvable under the Clean Air Act.
    (i) Incorporation by reference.
    (A) Indiana Administrative Code Title 326, Article 2: Permit Review
Rules, sections 2-1.1-9.5, ``General provisions; term of permit'', and
2-8-4, ``Permit content'', are incorporated by reference. Filed with
the Publisher of the Indiana Register on November 16, 2007, and became
effective on December 16, 2007. Published in the Indiana Register on
December 13, 2007 (20071212-IR-326060487FRA).

[FR Doc. E9-10335 Filed 5-4-09; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 40 (Thursday, February 28, 2013)]
[Notices]
[Pages 13681-13684]
[FR Doc No: 2013-04677]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0134]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Mammography Quality Standards Act Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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

the estimated reporting, recordkeeping, and third-party disclosure
burden associated with the Mammography Quality Standards Act
requirements.

DATES: Submit either electronic or written comments on the collection
of information by April 29, 2013.

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

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Mammography Quality Standards Act Requirements--21 CFR Part 900 (OMB
Control Number 0910-0309)--Extension

    The Mammography Quality Standards Act requires the establishment of
a Federal certification and inspection program for mammography
facilities; regulations and standards for accreditation and
certification bodies for mammography facilities; and standards for
mammography equipment, personnel, and practices, including quality
assurance. The intent of these regulations is to assure safe, reliable,
and accurate mammography on a nationwide level. Under the regulations,
as a first step in becoming certified, mammography facilities must
become accredited by an FDA-approved accreditation body (AB). This
requires undergoing a review of their clinical images and providing the
AB with information showing that they meet the equipment, personnel,
quality assurance and quality control standards, and have a medical
reporting and recordkeeping program, a medical outcomes audit program,
and a consumer complaint mechanism. On the basis of this accreditation,
facilities are then certified by FDA or an FDA-approved State
certification agency and must prominently display their certificate.
These actions are taken to ensure safe, accurate, and reliable
mammography on a nationwide basis.
    The following sections of Title 21 of the Code of Federal
Regulations (CFR) are not included in the burden tables because they
are considered usual and customary practice and were part of the
standard of care prior to the implementation of the regulations.
Therefore, they resulted in no additional burden: 21 CFR 900.12(c)(1)
and (c)(3) and 21 CFR 900.3(f)(1). Section 900.24(c) was also not
included in the burden tables because if a certifying State had its
approval withdrawn, FDA would take over certifying authority for the
affected facilities. Because FDA already has all the certifying State's
electronic records, there wouldn't be an additional reporting burden.
    We have rounded numbers in the ``Total Hours'' column in all three
burden tables. (Where the number was a portion of one hour, it has been
rounded to 1 hour. All other ``Total Hours'' have been rounded to the
nearest whole number.)
    We do not expect any respondents for Sec.  900.3(c) because all
four ABs are approved until April 2020.
    FDA estimates the burden of this collection of information as
follows:

                                                       Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Number of                                                          Total
                                                                Number of    responses      Total       Average    Total hours     Total     operating &
            Activity/21 CFR Section/FDA Form No.               respondents      per         annual     burden per      \1\        capital    maintenance
                                                                             respondent   responses     response                   costs        costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification of intent to become an AB--900.3(b)(1).........          0.33            1         0.33        1                1  ...........  ...........
Application for approval as an AB; full \2\--900.3(b)(3)....          0.33            1         0.33      320              106      $10,000  ...........
Application for approval as an AB; limited \3\--900.3(b)(3).          5               1         5          30              150  ...........  ...........
AB renewal of approval--900.3(c)............................          0               1         0          15                1  ...........  ...........
AB application deficiencies--900.3(d)(2)....................          0.1             1         0.1        30                3  ...........  ...........
AB resubmission of denied applications--900.3(d)(5).........          0.1             1         0.1        30                3  ...........  ...........
Letter of intent to relinquish accreditation authority--              0.1             1         0.1         1                1  ...........  ...........
 900.3(e)...................................................
Summary report describing all facility assessments--900.4(f)        330               1       330           7            2,310  ...........      $77,600
AB reporting to FDA; facility \4\--900.4(h).................      8,654               1     8,654           1            8,654  ...........        4,327
AB reporting to FDA; AB \5\--900.4(h).......................          5               1         5          10               50  ...........  ...........
AB financial records--900.4(i)(2)...........................          1               1         1          16               16  ...........  ...........

Former AB new application--900.6(c)(1)......................          0.1             1         0.1        60                6  ...........  ...........
Reconsideration of accreditation following appeal--                   1               1         1           2                2  ...........  ...........
 900.15(d)(3)(ii)...........................................
Application for alternative standard--900.18(c).............          2               1         2           2                4  ...........  ...........
Alternative standard amendment--900.18(e)...................         10               1        10           1               10  ...........  ...........
Certification agency application--900.21(b).................          0.33            1         0.33      320              106  ...........         $208
Certification agency application deficiencies--900.21(c)(2).          0.1             1         0.1        30                3  ...........  ...........
Certification electronic data transmission--900.22(h).......          5             200      1000           0.083           83      $30,000  ...........
Changes to standards--900.22(i).............................          2               1         2          30               60  ...........          $20
Certification agency minor deficiencies--900.24(b)..........          1               1         1          30               30  ...........  ...........
Appeal of adverse action taken by FDA--900.25(a)............          0.2             1         0.2        16                3  ...........  ...........
Inspection fee exemption--FDA Form 3422.....................        700               1       700           0.25           175  ...........  ...........
                                                             -------------------------------------------------------------------------------------------
    Total...................................................  ............  ...........  ...........  ...........       11,777       40,000       82,155
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Total hours have been rounded.
\2\ One time burden.
\3\ Refers to accreditation bodies applying to accredit specific full-field digital mammography units.
\4\ Refers to the facility component of the burden for this requirement.
\5\ Refers to the AB component of the burden for this requirement.

                                                     Table 2--Estimated Annual Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Total
                                                                             No. of        Total       Average                     Total      operating
                 Activity/21 CFR Section                       No. of      records per    annual      burden per   Total hours    capital        and
                                                           recordkeepers  recordkeeper    records   recordkeeping      \1\         costs     maintenance
                                                                                costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
AB transfer of facility records--900.3(f)(1).............            0.1             1         0.1         0                 1  ...........  ...........
Consumer complaints system; AB--900.4(g).................            5               1         5           1                 5  ...........  ...........
Documentation of interpreting physician initial                     87               1        87           8               696  ...........  ...........
 requirements--900.12(a)(1)(i)(B)(2).....................
Documentation of interpreting physician personnel                8,654               4    34,616           1            34,616  ...........  ...........
 requirements--900.12(a)(4)..............................
Permanent medical record--900.12(c)(4)...................        8,654               1     8,654           1             8,654      $28,000  ...........
Procedures for cleaning equipment--900.12(e)(13).........        8,654              52   450,008           0.083        37,351  ...........  ...........
Audit program--900.12(f).................................        8,654               1     8,654          16           138,464  ...........  ...........
Consumer complaints system; facility--900.12(h)(2).......        8,654               2    17,308           1            17,308  ...........  ...........
Certification agency conflict of interest--900.22(a).....            5               1         5           1                 5  ...........  ...........
Processes for suspension and revocation of certificates--            5               1         5           1                 5  ...........  ...........
 900.22(d)...............................................
Processes for appeals--900.22(e).........................            5               1         5           1                 5  ...........  ...........
Processes for additional mammography review--900.22(f)...            5               1         5           1                 5  ...........  ...........
Processes for patient notifications--900.22(g)...........            3               1         3           1                 3  ...........          $30
Evaluation of certification agency--900.23...............            5               1         5          20               100  ...........  ...........
Appeals--900.25(b).......................................            5               1         5           1                 5  ...........  ...........
                                                          ----------------------------------------------------------------------------------------------
    Total................................................  .............  ............  ..........  .............      237,223       28,000           30
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Total hours have been rounded.

                                                  Table 3--Estimated Annual Third-Party Disclosures \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                                                  Total
                                                                       Number of   disclosures   Total annual     Average    Total hours   operating and
                      Activity/21 CFR Section                         respondents      per        disclosures    burden per      \2\        maintenance
                                                                                respondent                   disclosure                    costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification of facilities that AB relinquishes its accreditation--          0.1             1            0.1       200               20             $50
 900.3(f)(2).......................................................
Clinical images; facility \2\--900.4(c), 900.11(b)(1), and               2,885               1        2,885           1.44         4,154  ..............
 900.11(b)(2)......................................................
Clinical images; AB \3\--900.4(c)..................................          5               1            5         416            2,080         230,773
Phantom images; facility \2\--900.4(d), 900.11(b)(1), and                2,885               1        2,885           0.72         2,077  ..............
 900.11(b)(2)......................................................
Phantom images; AB \3\--900.4(d)...................................          5               1            5         208            1,040  ..............
Annual equipment evaluation and survey; facility \2\--900.4(e),          8,654               1        8,654           1            8,654           8,654
 900.11(b)(1), and 900.11(b)(2)....................................
Annual equipment evaluation and survey; AB \3\--900.4(e)...........          5               1            5       1,730            8,650  ..............
Provisional mammography facility certificate extension application--         0               1            0           0.5              1  ..............
 900.11(b)(3)......................................................
Mammography facility certificate reinstatement application--               312               1          312           5            1,560      24,000,000
 900.11(c).........................................................
Lay summary of examination--900.12(c)(2)...........................      8,654           5,085   44,005,590           0.083    3,652,464  ..............
Lay summary of examination; patient refusal \4\--900.12(c)(2)......         87               1           87           0.5             44  ..............
Report of unresolved serious complaints--900.12(h)(4)..............         20               1           20           1               20  ..............
Information regarding compromised quality; facility \2\--                   20               1           20         200            4,000             300
 900.12(j)(1)......................................................
Information regarding compromised quality; AB \3\--900.12(j)(1)....         20               1           20         320            6,400             600
Patient notification of serious risk--900.12(j)(2).................          5               1            5         100              500          19,375
Reconsideration of accreditation--900.15(c)........................          5               1            5           2               10  ..............
Notification of requirement to correct major deficiencies--                  0.4             1            0.4       200               80              68
 900.24(a).........................................................
Notification of loss of approval; major deficiencies--900.24(a)(2).          0.15            1            0.15      100               15           25.50
Notification of probationary status--900.24(b)(1)..................          0.3             1            0.3       200               60              51
Notification of loss of approval; minor deficiencies--900.24(b)(3).          0.15            1            0.15      100               15           25.50
                                                                    ------------------------------------------------------------------------------------
    Total..........................................................  ............  ...........  ..............  ...........    3,691,842      24,259,921
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.
\2\ Total hours have been rounded.

    Dated: February 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04677 Filed 2-27-13; 8:45 am]
BILLING CODE 4160-01-P