[Federal Register Volume 77, Number 102 (Friday, May 25, 2012)]
[Proposed Rules]
[Pages 31262-31265]
[FR Doc No: 2012-12799]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2012-0336; FRL-3675-6 ]

Approval and Promulgation of Implementation Plans; Kentucky;
Louisville; Fine Particulate Matter 2002 Base Year Emissions Inventory

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve the fine particulate matter
(PM2.5) 2002 base year emissions inventory, portion of the
State Implementation Plan (SIP) revision submitted by the Commonwealth
of Kentucky on December 3, 2008. The emissions inventory is part of the
Kentucky's December 3, 2008, SIP revision that was submitted to meet
the nonattainment requirements related to the Commonwealth's portion of
the bi-state Louisville, KY-IN nonattainment area for the 1997 annual
PM2.5 national ambient air quality standards (NAAQS). The
bi-state Louisville, KY-IN nonattainment area is comprised of Clark and
Floyd Counties in Indiana, in their entireties; the Madison Township
portion of Jefferson County, Indiana; and Bullitt and Jefferson
Counties in Kentucky, in their entireties. This proposed action only
relates to the Kentucky portion (i.e., Bullitt and Jefferson Counties)
of this Area. EPA will consider action on the emissions inventory for
the Indiana portion of this Area in a separate action. This action is
being taken pursuant to section 110 of the Clean Air Act.

DATES: Comments must be received on or before June 25, 2012.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2012-0336, by one of the following methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``EPA-R04-OAR-2012-0336,'' Regulatory Development Section,
Air Planning Branch, Air, Pesticides and Toxics Management Division,
U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303-8960.
    5. Hand Delivery or Courier: Lynorae Benjamin, Chief, Regulatory
Development Section, Air Planning Branch, Air, Pesticides and Toxics
Management Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street SW., Atlanta, Georgia 30303-8960. Such deliveries are
only accepted during the Regional Office's normal hours of operation.
The Regional Office's official hours of business are Monday through
Friday, 8:30 to 4:30, excluding federal holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R04-OAR-
2012-0336. EPA's policy is that all comments received will be included
in the public docket without change and may be

made available online at www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit through
www.regulations.gov or email, information that you consider to be CBI
or otherwise protected. The 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 email comment directly to EPA without
going through www.regulations.gov, your email address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, 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. For additional information about EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the electronic docket are listed in the
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 www.regulations.gov or
in hard copy at the Regulatory Development Section, Air Planning
Branch, Air, Pesticides and Toxics Management Division, U.S.
Environmental Protection Agency, Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday, 8:30 to 4:30, excluding
federal holidays.

FOR FURTHER INFORMATION CONTACT: Richard Wong, Regulatory Development
Section, Air Planning Branch, Air, Pesticides and Toxics Management
Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth
Street SW., Atlanta, Georgia 30303-8960. The telephone number is (404)
562-8726. Mr. Wong can be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background
II. Analysis of the Commonwealth's Submittal
III. Proposed Action
IV. Statutory and Executive Order Reviews

I. Background

    On July 18, 1997 (62 FR 36852), EPA established an annual
PM2.5 NAAQS at 15.0 micrograms per cubic meter based on a 3-
year average of annual mean PM2.5 concentrations. On January
5, 2005 (70 FR 944), EPA published its air quality designations and
classifications for the 1997 annual PM2.5 NAAQS based upon
air quality monitoring data for calendar years 2001-2003. These
designations became effective on April 5, 2005. The bi-state Louisville
Area (which is comprised of Clark and Floyd Counties in Indiana, in
their entireties; the Madison Township portion of Jefferson County,
Indiana; and Bullitt and Jefferson Counties in Kentucky in their
entireties) was designated nonattainment for the 1997 annual
PM2.5 NAAQS. See 40 CFR 81.318 for Kentucky and 40 CFR
81.315 for Indiana.
    Designation of an area as nonattainment starts the process for a
state to develop and submit to EPA a SIP under title I, part D of the
Clean Air Act (CAA or Act). This SIP must include, among other
elements, a demonstration of how the NAAQS will be attained in the
nonattainment area as expeditiously as practicable, but no later than
the date required by the CAA. Under CAA section 172(b), a state has up
to three years after an area's designation as nonattainment to submit
its SIP to EPA. For the 1997 PM2.5 NAAQS, these SIPs were
due April 5, 2008. See 40 CFR 51.1002(a).
    On December 3, 2008, Kentucky submitted an attainment demonstration
and associated reasonably available control measures (RACM), a
reasonable further progress (RFP) plan, contingency measures, a 2002
base year emissions inventory and other planning SIP revisions related
to attainment of the 1997 annual PM2.5 NAAQS in the
Commonwealth's portion of the bi-state Louisville Area. Subsequently,
on March 9, 2011 (76 FR 12860), EPA determined that the bi-state
Louisville Area attained the 1997 annual average PM2.5
NAAQS. The determination of attainment was based upon complete,
quality-assured and certified ambient air monitoring data for the 2007-
2009 period, showing that the Area had monitored attainment of the 1997
annual PM2.5 NAAQS. The requirements for the Area to submit
an attainment demonstration and associated RACM, RFP plan, contingency
measures, and other planning SIP revisions related to attainment of the
standard were suspended as a result of the determination of attainment,
so long as the Area continues to attain the 1997 annual
PM2.5 NAAQS. See 40 CFR 51.1004(c).
    On September 30, 2011, Kentucky withdrew the nonattainment
submissions (everything with the exception of the 2002 base year
emissions inventory) for its portion of the bi-state Louisville Area as
allowed by 40 CFR 51.1004(c). EPA notes that the determination of
attainment did not suspend the emissions inventory requirement found in
CAA section 172(c)(3), and as such, Kentucky did not withdraw this
portion of its December 3, 2008, SIP revision. Section 172(c)(3) of the
CAA requires submission and approval of a comprehensive, accurate, and
current inventory of actual emissions. EPA is now proposing to approve
the emissions inventory portion of the SIP revision submitted by the
Commonwealth of Kentucky on December 3, 2008, as required by section
172(c)(3).

II. Analysis of the Commonwealth's Submittal

    As discussed above, section 172(c)(3) of the CAA requires areas to
submit a comprehensive, accurate and current inventory of actual
emissions from all sources of the relevant pollutant or pollutants in
such area. Kentucky selected 2002 as base year for the emissions
inventory per 40 CFR 51.1008(b). Emissions contained in Kentucky's
December 3, 2008, SIP revision cover the general source categories of
point sources, non-road mobile sources, area sources, on-road mobile
sources, and biogenic sources. A detailed discussion of the emissions
inventory development can be found in Appendix H of the Kentucky
submittal; a summary is provided below.
    The table below provides a summary of the annual 2002 emissions of
nitrogen oxides (NOX), sulfur dioxide (SO2) and
PM2.5 included in the Kentucky submittal.

         Table 1--2002 Annual Emissions for the Louisville Area
                             [Tons per year]
------------------------------------------------------------------------

------------------------------------------------------------------------
                 County                           Point sources
                                        --------------------------------
                                               NOX        SO2      PM2.5
------------------------------------------------------------------------
Bullitt................................        221        391         56
------------------------------------------------------------------------
Jefferson..............................     25,915     41,483        830
------------------------------------------------------------------------
                 County                          Non-road sources
                                        --------------------------------
                                               NOX        SO2      PM2.5
------------------------------------------------------------------------
Bullitt................................        578         50         44
------------------------------------------------------------------------
Jefferson..............................     10,989      1,429        720
------------------------------------------------------------------------
                 County                            Area sources
                                        --------------------------------
                                               NOX        SO2      PM2.5
------------------------------------------------------------------------
Bullitt................................         51         93        804
------------------------------------------------------------------------
Jefferson..............................        234          0      1,083
------------------------------------------------------------------------
                 County                           Mobile sources
                                        --------------------------------
                                               NOX        SO2      PM2.5
------------------------------------------------------------------------
Bullitt................................      2,979         89         43
------------------------------------------------------------------------
Jefferson..............................     25,864        917        369
------------------------------------------------------------------------

    The 172(c)(3) emissions inventory is developed by the incorporation
of data from multiple sources. States were required to develop and
submit to EPA a triennial emissions inventory according to the
Consolidated Emissions Reporting Rule for all source categories (i.e.,
point, area, nonroad mobile and on-road mobile). This inventory often
forms the basis of data that are updated with more recent information
and data that also is used in their attainment demonstration modeling
inventory. Such was the case in the development of the 2002 emissions
inventory that was submitted in the Commonwealth's attainment SIP for
its portion of the bi-state Louisville Area. The 2002 emissions
inventory was based on data developed with the Visibility Improvement
State and Tribal Association of the Southeast (VISTAS) contractors and
submitted by the states to the 2002 National Emissions Inventory.
Several iterations of the 2002 inventories were developed for the
different emissions source categories resulting from revisions and
updates to the data. This resulted in the use of version G2 of the
updated data to represent the point sources' emissions. Data from many
databases, studies and models (e.g., Vehicle Miles Traveled, fuel
programs, the NONROAD 2002 model data for commercial marine vessels,
locomotives and Clean Air Market Division, etc.) resulted in the
inventory submitted in this SIP. The data were developed according to
current EPA emissions inventory guidance ``Emissions Inventory Guidance
for Implementation of Ozone and Particulate Matter National Ambient Air
Quality Standards (NAAQS) and Regional Haze Regulations'' (August 2005)
and a quality assurance project plan that was developed through VISTAS
and approved by EPA. EPA preliminarily agrees that the process used to
develop this inventory was adequate to meet the requirements of CAA
section 172(c)(3) and the implementing regulations.
    EPA has reviewed Kentucky's emissions inventory and has
preliminarily determined that it is adequate for the purposes of
meeting section 172(c)(3) emissions inventory requirement. Further, EPA
has made the preliminary determination that the emissions were
developed consistent with the CAA, implementing regulations and EPA
guidance for emission inventories.

III. Proposed Action

    EPA is proposing to approve the 2002 base year emissions inventory
portion of the SIP revision submitted by the Commonwealth of Kentucky
on December 3, 2008. EPA has made the preliminary determination that
this action is consistent with section 110 of the CAA.

IV. Statutory and Executive Order Reviews

    Under the CAA, 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 CAA. Accordingly, this
proposed 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 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 F43255, 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 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 Commonwealth, 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

    Air pollution control, Environmental protection, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Particulate
matter, Reporting and recordkeeping requirements and Sulfur oxides.

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

    Dated: May 11, 2012.
A. Stanley Meiburg,
Acting Regional Administrator, Region 4.
[FR Doc. 2012-12799 Filed 5-24-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 7 (Friday, January 10, 2020)]
[Rules and Regulations]
[Pages 1277-1282]
[FR Doc No: 2019-27844]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 282

[EPA-R10-UST-2019-0363; FRL-10003-28-Region 10]

Idaho: Final Approval of State Underground Storage Tank Program
Revisions, Codification and Incorporation by Reference

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: Pursuant to the Resource Conservation and Recovery Act (RCRA
or Act), the Environmental Protection Agency (EPA) is taking direct
final action to approve revisions to the State of Idaho's Underground
Storage Tank (UST) program submitted by the State. The EPA has
determined that these revisions satisfy all requirements needed for
program approval. This action also codifies the EPA's approval of
Idaho's state program and incorporates by reference those provisions of
the State's regulations that we have determined meet the requirements
for approval. The State's federally-authorized and codified UST
program, as revised pursuant to this action, will remain subject to the
EPA's inspection and enforcement authorities under sections 9005 and
9006 of RCRA subtitle I and other applicable statutory and regulatory
provisions.

DATES: This rule is effective March 10, 2020, unless the EPA receives
adverse comment by February 10, 2020. If EPA receives adverse comment,
it will publish a timely withdrawal in the Federal Register informing
the public that the rule will not take effect. The incorporation by
reference of certain publications listed in the regulations is approved
by the Director of the Federal Register, as of March 10, 2020, in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51.

ADDRESSES: Submit your comments by one of the following methods:
    1. Federal eRulemaking Portal: https://www.regulations.gov. Follow
the online instructions for submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Mail: Scott Wilder, Region 10, Enforcement and Compliance
Assurance Division (ECAD 20-CO4), EPA Region 10, 1200 6th Avenue, Suite
155, Seattle, Washington 98101-3123.
    4. Hand Delivery or Courier: Deliver your comments to Scott Wilder,
Region 10, Office of Complince and Enforcement (OCE), EPA Region 10,

1200 6th Avenue, Suite 155, Seattle, Washington 98101-3123.
    Instructions: Submit your comments, identified by Docket ID No.
EPA-R10-UST-2019-0363, at https://www.regulations.gov. Follow the
online instructions for submitting comments. Once submitted, comments
cannot be edited or removed from Regulations.gov. The EPA may publish
any comment received to its public docket. Do not submit electronically
any information you consider to be Confidential Business Information
(CBI) or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e. on the web, cloud, or other
file sharing system). For additional submission methods, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit https://www2.epa.gov/dockets/commenting-epa-dockets.
    You can view and copy the documents that form the basis for this
action and associated publicly available materials from 8:30 a.m. to
4:00 p.m. Monday through Friday at the following location: EPA Region
10, 1200 6th Avenue, Suite 155, Seattle, Washington 98101-3123, phone
number<PHONE_NUMBER>. Interested persons wanting to examine these
documents should make an appointment with the office at least 2 days in
advance.

FOR FURTHER INFORMATION CONTACT: Scott Wilder,<PHONE_NUMBER>,
<EMAIL_ADDRESS>To inspect the hard copy materials, please
schedule an appointment with Scott Wilder at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Approval of Revisions to Idaho's Underground Storage Tank Program

A. Why are revisions to state programs necessary?

    States which have received final approval from the EPA under RCRA
section 9004(b) of RCRA, 42 U.S.C. 6991c(b), must maintain an
underground storage tank program that is equivalent to, consistent
with, and no less stringent than the Federal underground storage tank
program. When the EPA makes revisions to the regulations that govern
the UST program, states must revise their programs to comply with the
updated regulations and submit these revisions to the EPA for approval.
Most commonly, states must change their programs because of changes to
the EPA's regulations in 40 Code of Federal Regulations (CFR) part 280.
States can also initiate changes on their own to their underground
storage tank program and these changes must then be approved by the
EPA.

B. What decisions has the EPA made in this rule?

    On September 19, 2018, in accordance with 40 CFR 281.51(a), Idaho
submitted a complete program revision application seeking the EPA
approval for its UST program revisions (State Application). Idaho's
revisions correspond to the EPA final rule published on July 15, 2015
(80 FR 41566), which revised the 1988 UST regulations and the 1988
state program approval (SPA) regulations (2015 Federal Revisions). As
required by 40 CFR 281.20, the State Application contains the
following: A transmittal letter from the Governor requesting program
approval, a description of the program and operating procedures, a
demonstration of the State's procedures to ensure adequate enforcement,
a Memorandum of Agreement outlining the roles and responsibilities of
the EPA and the implementing agency, a statement of certification from
the Attorney General, and copies of all applicable state statutes and
regulations. We have reviewed the State Application and determined that
the revisions to Idaho's UST program are equivalent to, consistent
with, and no less stringent than the corresponding Federal requirements
in subpart C of 40 CFR part 281, and that the Idaho program provides
for adequate enforcement of compliance (40 CFR 281.11(b)). Therefore,
the EPA grants Idaho final approval to operate its UST program with the
changes described in the program revision application, and as outlined
below in Section I.G of this document.

C. What is the effect of this action on the regulated community?

    This action does not impose additional requirements on the
regulated community because the regulations being approved by this rule
are already in effect in the State of Idaho, and are not changed by
this action. This action merely approves the existing state regulations
as meeting the Federal requirements and renders them federally
enforceable.

D. Why is EPA using a direct final rule?

    The EPA is publishing this direct final rule without a prior
proposed rule because we view this as a noncontroversial action and we
anticipate no adverse comment. Idaho did not receive substantial
comments during its comment period when the rules and regulations being
considered in this direct final rule were proposed at the state level.

E. What happens if the EPA receives comments that oppose this action?

    Along with this direct final rule, the EPA is publishing a separate
document in the ``Proposed Rules'' section of this Federal Register
that serves as the proposal to approve the State's UST program
revisions, and provides an opportunity for public comment. If the EPA
receives comments that oppose this approval, the EPA will withdraw this
direct final rule by publishing a document in the Federal Register
before it becomes effective. The EPA will make any further decision on
approval of the State Application after considering all comments
received during the comment period. The EPA will then address all
public comments in a later final rule. You may not have another
opportunity to comment. If you want to comment on this approval, you
must do so at this time.

F. For what has Idaho previously been approved?

    On February 28, 2012, the EPA finalized a rule approving the UST
program that Idaho proposed to administer in lieu of the Federal UST
program.

G. What changes are we approving with this action and what standards do
we use for review?

    In order to be approved, each state program application must meet
the general requirements in 40 CFR 281.11, and specific requirements in
40 CFR part 281, subpart B (Components of a Program Application);
subpart C (Criteria for No Less Stringent); and subpart D (Adequate
Enforcement of Compliance). This also is true for proposed revisions to
approved state programs.
    As more fully described below, the State has made the changes to
its approved UST program to reflect the 2015 Federal Revisions. The EPA
is approving the State's changes because they are equivalent to,
consistent with, and no less stringent than the Federal UST program and
because the EPA has confirmed that the Idaho UST program will continue
to provide for adequate enforcement of compliance as described

in 40 CFR 281.11(b) and part 281, subpart D, after this approval.
    The Idaho Department of Environmental Quality (DEQ) is the lead
implementing agency for the UST program in Idaho, except in Indian
country.
    The DEQ continues to have broad statutory authority to regulate the
installation, operation, maintenance, and closure of USTs, as well as
UST releases under Idaho Code, Title 39, Chapter 88, Idaho Underground
Storage Tank Act, Sections 39-8801 through 39-8813. The Idaho UST
Program gets its enforcement authority from the powers and duties of
the DEQ Director (Director) found in Title 39, Chapter 1, Section 39-
108. Under Title 39, Chapter 1, Sections 39-108 and Chapter 88, Section
39-8805, the Director is authorized to require an owner to furnish
records, conduct monitoring or testing, and provide access to tanks.
Penalties for non-compliance with Idaho's Underground Storage Tank Act
may be assessed under Title 39, Chapter 1, Sections 39-108(5) and 39-
8811. Under Idaho Administrative Code (IDAPA) <IP_ADDRESS>0, a delivery
prohibition tag may be placed on a tank for failure to install required
spill prevention, overfill protection, leak detection, or corrosion
protection equipment.
    Specific authorities to regulate the installation, operation,
maintenance, and closure of USTs, as well as UST releases are found in
IDAPA 58.01.07, Rules Regulating Underground Storage Tank Systems, as
amended effective March 24, 2017, and Rules of Administrative Procedure
Before the Board of Environmental Quality are found under IDAPA
58.01.23. Compliance monitoring authorities are found under IDAPA
<IP_ADDRESS>0, as amended March 24, 2017. The aforementioned statutory
sections and regulations satisfy the requirements of 40 CFR 281.40 and
281.41. Idaho has met the public participation requirements found in 40
CFR 281.42 by allowing intervention in the state enforcement process as
provided in the Idaho Rules of Civil Procedure Rule 24(a).
    To qualify for final approval, revisions to a state's program must
be ``equivalent to, consistent with, and no less stringent'' than the
2015 Federal Revisions. In the 2015 Federal Revisions the EPA addressed
UST systems deferred in the 1988 UST regulations, and added, among
other things, new operation and maintenance requirements; secondary
containment requirements for new and replaced tanks and piping;
operator training requirements; and a requirement to ensure UST system
compatibility before storing certain biofuel blends. In addition, the
EPA removed past deferrals for emergency generator tanks, field
constructed tanks, and airport hydrant systems. The EPA analyzes
revisions to approved state programs pursuant to the criteria found in
40 CFR 281.30 through 281.39.
    The DEQ has revised its regulations to help ensure that the State's
UST program revisions are equivalent to, consistent with, and no less
stringent than the 2015 Federal Revisions. IDAPA <IP_ADDRESS>
incorporates by reference the requirements of 40 CFR part 280,
including the requirements added by the 2015 Federal Revisions,
excepting 40 CFR part 280, subpart J (Operator Training), and
provisions such as the definitions of ``Replaced'' and ``Under-
dispenser containment,'' recordkeeping requirements for operator
training, and certain limiting date ranges. The State, therefore, has
ensured that the criteria found in 40 CFR 281.30 through 281.38 are
met.
    Title 40 CFR 281.39 describes the state operator training
requirements that must be met in order to be considered no less
stringent than Federal requirements. Idaho did not incorporate by
reference Federal requirements for operator training, and has
promulgated and is implementing its own operator training provisions
under IDAPA <IP_ADDRESS>0. After a thorough review, the EPA has
determined that Idaho's operator training requirements are equivalent
to, consistent with, and no less stringent than Federal requirements.
    As part of the State Application the Idaho Attorney General
certified that the State revisions meet the ``no less stringent''
criteria in 40 CFR 281.30 through 281.39. The EPA is relying on this
certification in addition to the analysis submitted by the State in
making its determination.

H. Where are the revised rules different from the Federal rules?

Broader in Scope Provisions
    Where an approved state program has a greater scope of coverage
than required by Federal law, the additional coverage is not part of
the federally-approved program and is not federally enforceable (40 CFR
281.12(a)(3)(ii)). The following statutory and regulatory requirements
are considered broader in coverage than the Federal program as these
state-only regulations are not required by Federal regulation and are
implemented by the State in addition to the federally-approved program:
IDAPA <IP_ADDRESS> requires secondary containment and monitoring of any
UST system, including tanks, pipes, and dispensers, installed or
replaced after February 23, 2007, that is within 1,000 feet of a
potable drinking water source. IDAPA <IP_ADDRESS>.16 requires secondary
containment and monitoring of replaced piping if 100% of the piping,
excluding connectors, connected to a single UST is replaced in
accordance with section 9003(i)(1) of the Solid Waste Disposal. IDAPA
<IP_ADDRESS> requires owners and/or operators to provide written notice
to the DEQ 30 days prior to installing a new piping system or a new or
replacement UST and provide 24-hour notice to the DEQ prior to
installing a replacement piping system. IDAPA <IP_ADDRESS>0 requires the
DEQ to maintain a public database providing details on the status of
all USTs subject to regulation in Idaho. IDAPA <IP_ADDRESS>1 requires
all regulated USTs to pay annual fees. IDAPA <IP_ADDRESS> requires
owners or operators to report the source and cause of a release to the
DEQ.
More Stringent Provisions
    Where an approved state program includes requirements that are
considered more stringent than required by Federal law, the more
stringent requirements become part of the federally-approved program
(40 CFR 281.12(a)(3)). IDAPA <IP_ADDRESS>.04 specifies that the State's
rules ``shall be no more stringent than federal law or regulations
governing underground storage tank systems.''

I. How does this action affect Indian country (18 U.S.C. 1151) in
Idaho?

    The EPA's approval of Idaho's Program does not extend to Indian
country as defined in 18 U.S.C. 1151. Indian country generally includes
lands within the exterior boundaries of the following Indian
reservations located within Idaho: Coeur D'Alene Tribe, Kootenai Tribe
of Idaho, Nez Perce Tribe, Shoshone-Bannock Tribes of the Fort Hall
Reservation; any land held in trust by the United States for an Indian
tribe; and any other areas that are ``Indian country'' within the
meaning of 18 U.S.C. 1151. Any lands removed from an Indian reservation
status by Federal court action are not considered reservation lands
even if located within the exterior boundaries of an Indian
reservation. The EPA will retain responsibilities under RCRA for
underground storage tanks in Indian country. Therefore, this action has
no effect in Indian country. 40 CFR 281.12(a)(2).

II. Codification

A. What is codification?

    Codification is the process of placing a state's statutes and
regulations that comprise the state's approved UST program into the
CFR. Section 9004(b) of RCRA, as amended, allows the EPA to approve
State UST programs to operate in lieu of the Federal program. The EPA
codifies its authorization of state programs in 40 CFR part 282 and
incorporates by reference state regulations that the EPA will enforce
under sections 9005 and 9006 of RCRA and any other applicable statutory
provisions. The incorporation by reference of state authorized programs
in the CFR should substantially enhance the public's ability to discern
the current status of the approved state program and state requirements
that can be federally enforced. This effort provides clear notice to
the public of the scope of the approved program in each state.

B. What codification decisions have we made in this rule?

    In this rule, we are finalizing the Federal regulatory text that
incorporates by reference the federally-authorized Idaho UST Program.
In accordance with the requirements of 1 CFR 51.5, we are finalizing
the incorporation by reference of the Idaho rules described in the
amendments to 40 CFR part 282 set forth below. The EPA has made, and
will continue to make, these documents generally available through
https://www.regulations.gov and at the EPA Region 10 office (see the
ADDRESSES section of this preamble for more information).
    One purpose of this Federal Register document is to codify Idaho's
approved UST program. The codification reflects the State program that
would be in effect at the time the EPA's approved revisions to the
Idaho UST program addressed in this direct final rule become final. If,
however, the EPA receives substantive comment on the proposed rule then
this codification will not take effect, and the State rules that are
approved after the EPA considers public comment will be codified
instead. By codifying the approved Idaho program and by amending the
Code of Federal Regulations (CFR), the public will more easily be able
to discern the status of the federally-approved requirements of the
Idaho program.
    The EPA is incorporating by reference the Idaho approved UST
program in 40 CFR 282.62. Section 282.62(d)(1)(ii)(B) incorporates by
reference for enforcement purposes the State's relevant statutes and
regulations. Section 282.62 also references the Attorney General's
Statement, Demonstration of Adequate Enforcement Procedures, the
Program Description, and the Memorandum of Agreement, which are
approved as part of the UST program under subtitle I of RCRA.

C. What is the effect of EPA's codification of the federally-authorized
State UST Program on enforcement?

    The EPA retains the authority under sections 9003(h), 9005 and 9006
of subtitle I of RCRA, 42 U.S.C. 6991b(h), 6991d and 6991e, and other
applicable statutory and regulatory provisions to undertake corrective
action, inspections, and enforcement actions, and to issue orders in
approved States. If the EPA determines it will take such actions in
Idaho, the EPA will rely on Federal sanctions, Federal inspection
authorities, and other Federal procedures rather than the State
analogs. Therefore, though the EPA has approved the State procedures
listed in 40 CFR 282.62(d)(1)(ii), the EPA is not incorporating by
reference Idaho's procedural and enforcement authorities.

D. What State provisions are not part of the codification?

    The public also needs to be aware that some provisions of the
State's UST program are not part of the federally-approved State
program. Such provisions are not part of the RCRA subtitle I program
because they are ``broader in coverage'' than subtitle I of RCRA. Title
40 CFR 281.12(a)(3)(ii) states that where a state operates an approved
program with a greater scope of coverage than the Federal program,
those provisions creating greater coverage are not a part of the
federally-approved program. As a result, State provisions which are
``broader in coverage'' than the Federal program are not incorporated
by reference for purposes of enforcement in part 282. Title 40 CFR
282.62(d)(1)(iii) lists for reference and clarity the Idaho statutory
and regulatory provisions which are ``broader in coverage'' than the
Federal program and which are not, therefore, part of the approved
program being codified in this rule. Provisions that are ``broader in
coverage'' cannot be enforced by EPA; the State, however, will continue
to implement and enforce such provisions under State law.

III. Statutory and Executive Order (E.O.) Reviews

    This action only applies to Idaho's UST Program requirements
pursuant to RCRA Section 9004 and imposes no requirements other than
those imposed by State law. It complies with applicable EOs and
statutory provisions as follows:

A. Executive Order 12866 Regulatory Planning and Review, Executive
Order 13563: Improving Regulation and Regulatory Review

    The Office of Management and Budget (OMB) has exempted this action
from the requirements of Executive Order 12866 (58 FR 51735, Oct. 4,
1993) and 13563 (76 FR 3821, Jan. 21, 2011). This action approves and
codifies state requirements for the purpose of RCRA section 9004 and
imposes no additional requirements beyond those imposed by state law.
Therefore, this action is not subject to review by OMB.

B. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs

    This action is not an Executive Order 13771 (82 FR 9339, February
3, 2017) regulatory action because actions such as this final approval
of Idaho's revised underground storage tank program under RCRA are
exempted under Executive Order 12866. Accordingly, I certify that this
action will not have a significant economic impact on a substantial
number of small entities under the Regulatory Flexibility Act (5 U.S.C.
601 et seq.).

C. Unfunded Mandates Reform Act and Executive Order 13175: Consultation
and Coordination With Indian Tribal Governments

    Because this action approves and codifies pre-existing requirements
under state law and does not impose any additional enforceable duty
beyond that required by state law, it does not contain any unfunded
mandate or significantly or uniquely affect small governments, as
described in the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-
1538). For the same reason, this action also does not significantly or
uniquely affect the communities of tribal governments, as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000).

D. Executive Order 13132: Federalism

    This action will not 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, as specified in Executive Order 13132 (64 FR
43255, Aug. 10, 1999), because it merely approves and codifies state
requirements as part of the State RCRA

Underground Storage Tank Program without altering the relationship or
the distribution of power and responsibilities established by RCRA.

E. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    This action also is not subject to Executive Order 13045 (62 FR
19885, Apr. 23, 1997), because it is not economically significant, as
defined in Executive Order 12866, and because the EPA does not believe
the environmental health or safety risks addressed by this action
present a disproportionate risk to children.

F. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This rule is not subject to Executive Order 13211 (66 FR 28355, May
22, 2001) because it is not a ``significant regulatory action'' as
defined under Executive Order 12866.

G. National Technology Transfer and Advancement Act

    Under RCRA section 9004(b), the EPA grants a state's application
for approval as long as the state meets the criteria required by RCRA.
It would thus be inconsistent with applicable law for the EPA, when it
reviews a state approval application, to require the use of any
particular voluntary consensus standard in place of another standard
that otherwise satisfies the requirements of RCRA. Thus, the
requirements of section 12(d) of the National Technology Transfer and
Advancement Act of 1995 (15 U.S.C. 272 note) do not apply.

H. Executive Order 12988: Civil Justice Reform

    As required by section 3 of Executive Order 12988 (61 FR 4729,
February 7, 1996), in issuing this rule, the EPA has taken the
necessary steps to eliminate drafting errors and ambiguity, minimize
potential litigation, and provide a clear legal standard for affected
conduct.

I. Executive Order 12630: Governmental Actions and Interference With
Constitutionally Protected Property Rights

    The EPA has complied with Executive Order 12630 (53 FR 8859, Mar.
15, 1988) by examining the takings implications of the rule in
accordance with the ``Attorney General's Supplemental Guidelines for
the Evaluation of Risk and Avoidance of Unanticipated Takings'' issued
under the executive order.

J. Paperwork Reduction Act

    This rule does not impose an information collection burden under
the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
et seq.). ``Burden'' is defined at 5 CFR 1320.3(b).

K. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low Income Populations

    Executive Order 12898 (59 FR 7629, Feb. 16, 1994) establishes
Federal executive policy on environmental justice. Its main provision
directs Federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States. Because this rule approves pre-
existing state rules which are at least equivalent to, consistent with,
and no less stringent than existing Federal requirements, and imposes
no additional requirements beyond those imposed by state law, and there
are no anticipated significant adverse human health or environmental
effects, the rule is not subject to Executive Order 12898.

L. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801-808, 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. The EPA will submit a report containing this document 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 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). However,
this action will be effective March 10, 2020 because it is a direct
final rule.

    Authority: This rule is issued under the authority of Sections
2002(a), 7004(b), and 9004, 9005 and 9006 of the Solid Waste
Disposal Act, as amended, 42 U.S.C. 6912(a), 6974(b), and 6991c,
6991d, and 6991e.

List of Subjects in 40 CFR Part 282

    Environmental protection, Administrative practice and procedure,
Hazardous substances, Incorporation by reference, State program
approval, Underground storage tanks.

    Dated: November 27, 2019.
Chris Hladick,
Regional Administrator, EPA Region 10.

    For the reasons set forth in the preamble, EPA is amending 40 CFR
part 282 as follows:

PART 282--APPROVED UNDERGROUND STORAGE TANK PROGRAMS

0
1. The authority citation for part 282 continues to read as follows:

    Authority: 42 U.S.C. 6912, 6991c, 6991d, and 6991e.

0
2. Add Sec.  282.62 to read as follows:

Sec.  282.62  Idaho State-Administered Program.

    (a) History of the approval of Idaho's Program. The State of Idaho
is approved to administer and enforce an underground storage tank
program in lieu of the Federal program under subtitle I of the Resource
Conservation and Recovery Act of 1976 (RCRA), as amended, 42 U.S.C.
6991 et seq. The State's program, as administered by the Idaho
Department of Environmental Quality (DEQ), was approved by EPA pursuant
to 42 U.S.C. 6991c and part 281 of this chapter. The EPA published the
notice of final determination approving the Idaho underground storage
tank base program effective on February 28, 2012. A subsequent program
revision application was approved by EPA and became effective on March
10, 2020.
    (b) Enforcement authority. Idaho has primary responsibility for
administering and enforcing its federally-approved underground storage
tank program. However, the EPA retains the authority to exercise its
corrective action, inspection, and enforcement authorities under
sections 9003(h), 9005, and 9006 of subtitle I of RCRA, 42 U.S.C.
6991b(h), 6991d and 6991e, as well as under any other applicable
statutory and regulatory provisions.
    (c) Retention of program approval. To retain program approval,
Idaho must revise its approved program to adopt new changes to the
Federal subtitle I program which make it more stringent, in accordance
with section 9004 of RCRA, 42 U.S.C. 6991c, and 40 CFR part 281,
subpart E. If Idaho obtains approval for the revised requirements
pursuant to section 9004 of RCRA, 42 U.S.C. 6991c, the newly approved
statutory and regulatory provisions will be added to this subpart and
notice of any change will be published in the Federal Register.

    (d) Final approval. Idaho has final approval for the following
elements of its program application originally submitted to EPA and
approved, effective February 28, 2012, and the program revision
application approved by EPA effective on March 10, 2020:
    (1) State statutes and regulations--(i) Incorporation by reference.
The materials cited in this paragraph (d)(1) are incorporated by
reference as part of the underground storage tank program under
subtitle I of RCRA, 42 U.S.C. 6991 et seq. The Director of the Federal
Register approves this incorporation by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. You may obtain copies of the Idaho
provisions that are incorporated by reference in this paragraph
(d)(1)(i) from Idaho's Office of Administrative Rules Coordinator, P.O.
Box 83720, Boise, Idaho 83720; Phone number:<PHONE_NUMBER>; website:
https://adminrules.idaho.gov/. You may inspect all approved material at
the EPA Region 10 office, 1200 Sixth Avenue, Seattle, Washington 98101,
phone number<PHONE_NUMBER>, or the National Archives and Records
Administration (NARA). For information on the availability of the
material at NARA, email<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.
    (A) Idaho Statutory Requirements Applicable to the Underground
Storage Tank Program, September 2018.
    (B) Idaho Regulatory Requirements Applicable to the Underground
Storage Tank Program, September 2018.
    (ii) Legal basis. The EPA evaluated the following statutes and
regulations which provide the legal basis for the State's
implementation of the underground storage tank program, but they are
not being incorporated by reference and do not replace Federal
authorities:
    (A) The statutory provisions include:
    (1) Idaho Code, Title 39, ``Health and Safety,'' Chapter 1,
``Environmental Quality--Health,'' Sections 39-108 and -109.
    (2) Idaho Code, Title 39, ``Healthy and Safety,'' Chapter 88,
``Idaho Underground Storage Tank Act.'' The following Sections are part
of the approved State program, although not incorporated by reference
in this part for enforcement purposes: Sections 39-8805, -8808, -8810,
and -8811.
    (B) The regulatory provisions include:
    (1) Idaho Administrative Code 58 (April 1, 2018), Title 01, Chapter
02, ``Water Quality Standards,'' Sections 851 and 852.
    (2) Idaho Administrative Code 58 (April 1, 2018), Title 01, Chapter
07, ``Rules Regulating Underground Storage Tank Systems.'' The
following Sections are part of the approved State program, although not
incorporated by reference in this part for enforcement purposes:
Sections 004.01, 400.01 and .03, 500, and 600.
    (3) Idaho Rules of Civil Procedure, Rule 24(a).
    (iii) Provisions not incorporated by reference. The following
specifically identified sections and rules applicable to the Idaho
underground storage tank program that are broader in coverage than the
Federal program, are not part of the approved program, and are not
incorporated by reference in this part for enforcement purposes:
    (A) Idaho Administrative Code 58 (April 1, 2018), Title 01, Chapter
07, ``Rules Regulating Underground Storage Tank Systems,'' Sections
010.16, 100.01 and .03, 200, 600, and 601.
    (B) [Reserved]
    (2) Statement of legal authority. The Attorney General's Statement,
signed by the Deputy Attorney General of the State of Idaho on August
23, 2018, though not incorporated by reference, is referenced as part
of the approved underground storage tank program under subtitle I of
RCRA, 42 U.S.C. 6991 et seq.
    (3) Demonstration of procedures for adequate enforcement. The
``Demonstration of Procedures for Adequate Enforcement'' submitted as
part of the program revision application for approval on September 19,
2018, though not incorporated by reference, is referenced as part of
the approved underground storage tank program under subtitle I of RCRA,
42 U.S.C. 6991 et seq.
    (4) Program description. The program description and any other
material submitted as part of the program revision application for
approval on September 19, 2018, though not incorporated by reference,
are referenced as part of the approved underground storage tank program
under subtitle I of RCRA, 42 U.S.C. 6991 et seq.
    (5) Memorandum of Agreement. The Memorandum of Agreement between
EPA Region 10 and the Idaho Department of Environmental Quality, signed
by the EPA Regional Administrator on March 19, 2019, though not
incorporated by reference, is referenced as part of the approved
underground storage tank program under subtitle I of RCRA, 42 U.S.C.
6991 et seq.

0
3. Appendix A to part 282 is amended by adding an entry for ``Idaho''
in alphabetical order by State to read as follows:

Appendix A to Part 282--State Requirements Incorporated by Reference in
Part 282 of the Code of Federal Regulations

* * * * *

Idaho

    (a) The statutory provisions include:
    (1) Idaho Code, Title 39, ``Health and Safety,'' Chapter 1,
``Environmental Quality--Health'': Section 39-103, ``Definitions,''
39-103(3), (6), (7), (11), (12), (15)-(18); Section 39-107,
``Board--Composition--Officers--Compensation--Powers--Subpoena--
Depositions--Review--Rules,'' 39-107(7).
    (2) Idaho Code, Title 39, ``Health and Safety,'' Chapter 88,
``Idaho Underground Storage Tank Act'': Sections 39-8803,
``Definitions,'' -8804, ``Program Scope,'' -8805, ``Rules Governing
Underground Storage Tank Systems,'' -8805A, ``Compliance Dates for
Certain Rules,'' -8806, ``Additional Measures to Protect Ground
Water,'' -8807, ``Operator Training,'' -8808, ``Inspections,'' -
8809, ``Delivery Prohibition,'' and -8810, ``Underground Storage
Tank Database.''
    (b) The regulatory provisions include:
    (1) Idaho Administrative Code 58, Title 01, Chapter 07:
    Section 004 Incorporation by Reference;
    Section 010 Definitions (except 010.16, defining ``Replace'');
    Section 100 Additional Measures to Protect Ground Water from
Contamination (except 100.01-.03);
    Section 101 Alternative Periodic Testing of Containment Sumps
Used for Interstitial Monitoring of Piping;
    Section 300 Training Requirements.
    (2) Idaho Administrative Code 58, Title 01, Chapter 24.
    (c) Copies of the Idaho provisions that are incorporated by
reference are available from Idaho's Office of Administrative Rules
Coordinator, P.O. Box 83720, Boise, ID 83720; Phone number: 208-332-
1820; website: https://adminrules.idaho.gov/.
* * * * *
[FR Doc. 2019-27844 Filed 1-9-20; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 141 (Monday, July 25, 2022)]
[Notices]
[Page 44134]
[FR Doc No: 2022-15875]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4652-DR; Docket ID FEMA-2022-0001]

New Mexico; Amendment No. 3 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of New Mexico (FEMA-4652-DR), dated May 4, 2022, and
related determinations.

DATES: This amendment was issued June 8, 2022.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of New Mexico is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of May 4, 2022.

    Colfax, Mora, and San Miguel Counties for permanent work
[Categories C-G] (already designated for Individual Assistance and
assistance for debris removal and emergency protective measures
[Categories A and B], including direct federal assistance, under the
Public Assistance program).

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2022-15875 Filed 7-22-22; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: July 31, 2009 (Volume 74, Number 146)]
[Notices]
[Page 38261-38262]
[DOCID:fr31jy09-127]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2009-0113; Notice 1]

Auto Temp, Inc., Receipt of Petition for Decision of
Inconsequential Noncompliance

    Auto Temp, Inc. (Auto Temp) has determined that certain replacement
backlights (part number FB22692 GTY ATI), manufactured for 2006-09
Honda Civic 2-Door Coupe passenger cars, do not fully comply with
paragraph S5.2 of 49 CFR 571.205, Federal Motor Vehicle Safety Standard
(FMVSS) No. 205 Glazing Materials. Auto Temp has filed an appropriate
report pursuant to 49 CFR part 573, Defect and Noncompliance
Responsibility and Reports.
    Pursuant to 49 U.S.C. 30118(d) and 30120(h) (see implementing rule
at 49 CFR part 556), Auto Temp has petitioned for an exemption from the
notification and remedy requirements of 49 U.S.C. Chapter 301 on the
basis that this noncompliance is inconsequential to motor vehicle
safety.
    This notice of receipt of Auto Temp's petition is published under
49 U.S.C. 30118 and 30120 and does not represent any agency decision or
other exercise of judgment concerning the merits of the petition.
    Auto Temp estimated that 68 replacement backlights manufactured on
July 14, 2008, intended for 2006-09 Honda Civic 2-Door coupe passenger
cars, are involved and that 80% of those backlights may be
noncompliant.
    Paragraphs S5.2 of FMVSS No. 108 require in pertinent part:

    S5.2 Each of the test specimens described in ANSI/SAE Z26.1-1996
Section 5.7 (fracture test) must meet the fracture test requirements
of that section when tested in accordance with the test procedure
set forth in that section.
    5.7.4 Interpretation of Results. NO individual fragment free
from cracks and obtained within 3 minutes subsequent to test shall
weight more than 4.25g (0.15oz).

    Auto Temp explained that the noncompliance is that the subject
backlights do not meet the fracture test requirements of FMVSS No. 205
Section 5.7 Fracture Test 7 ANSI/SAE Z26.1-1996, because several tests
revealed that out of 8 tested backlights, 6 contained fragments that
exceeded the 4.25g (0.15oz) threshold specified by the above standard.
    Auto Temp states that it believes that this noncompliance is
inconsequential to motor vehicle safety for the following reasons. Out
of several thousand total fragments no more than 2 noncompliant
fragments were found from a single backlight. Each of the noncompliant
fragments exhibited all of the characteristics of tempered safety
glass. The position of the noncompliant fragments in the backlight,
coupled with the package tray location of the Honda Civic 2-Door Coupe,
minimizes the potential for any contact between glass fragments and
vehicle occupants. The extremely low percentage of noncompliant
fragments, together with the small number of total affected backlights,
results in a minimal impact on issue of motor vehicle safety.
    Auto Temp also has informed NHTSA that since it has petitioned for
an exemption from the notification and remedy requirements of 49 U.S.C.
Chapter 301 on the basis that this noncompliance is inconsequential to
motor vehicle safety it has not yet formulated a remedy for the
noncompliance. However, Auto Temp has agreed to reimburse its customers
for all returned parts (FB22692 GTY ATI backlights produces on July 14,
2008) regardless of the filing of an inconsequential petition.
    Auto Temp also informed NHTSA that it has corrected the problem
that caused this noncompliance.
    In summation, Auto Temp states that it believes that the
noncompliances are inconsequential to motor vehicle safety and that no
corrective action is warranted.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance.
    Interested persons are invited to submit written data, views, and
arguments on this petition. Comments must refer to the docket and
notice number cited at the beginning of this notice and be submitted by
any of the following methods:
    a. By mail addressed to: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
    b. By hand delivery to U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590. The Docket Section is open on
weekdays from 10 a.m. to 5 p.m. except Federal Holidays.
    c. Electronically: by logging onto the Federal Docket Management
System (FDMS) Web site at http://www.regulations.gov/. Follow the
online instructions for submitting comments. Comments may also be faxed
to 1-202-493-2251.
    Comments must be written in the English language, and be no greater
than 15 pages in length, although there is no limit to the length of
necessary attachments to the comments. If comments are submitted in
hard copy form, please ensure that two copies are provided. If you wish
to receive confirmation that your comments were received, please
enclose a stamped, self-addressed postcard with the comments. Note that
all comments received will be posted without change to http://
www.regulations.gov, including any personal information provided.
    Anyone is able to search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). DOT's complete Privacy
Act Statement in the Federal Register published on April 11, 2000 (65
FR 19477-78).
    You may view documents submitted to a docket at the address and
times given above. You may also view the documents on the Internet at
http://www.regulations.gov by following the online instructions for
accessing the dockets available at that Web site.
    The petition, supporting materials, and all comments received
before the close of business on the closing date indicated below will
be filed and will be considered. All comments and supporting materials
received after the closing date will also be filed and will be
considered to the extent possible. When the petition is granted or
denied, notice of the decision will be published in the Federal
Register pursuant to the authority indicated below.

    Comment closing date: August 31, 2009.

    Authority: (49 U.S.C. 30118, 30120: delegations of authority at
CFR 1.50 and 501.8).

    Issued on: July 27, 2009.
Claude H. Harris,
Director, Office of Vehicle Safety Compliance.
[FR Doc. E9-18253 Filed 7-30-09; 8:45 am]

BILLING CODE 4910-59-P


[Federal Register Volume 75, Number 227 (Friday, November 26, 2010)]
[Notices]
[Pages 72820-72821]
[FR Doc No: 2010-29707]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice Of Filings No. 1

November 17, 2010.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP11-1531-000.
    Applicants: Eastern Shore Natural Gas Company.
    Description: Eastern Shore Natural Gas Company submits tariff
filing per 154.403: Storage Tracker 11-2010 to be effective 11/1/2010.
    Filed Date: 11/16/2010.
    Accession Number: 20101116-5091.
    Comment Date: 5 p.m. Eastern Time on Monday, November 29, 2010.

    Docket Numbers: RP11-1532-000.
    Applicants: Venice Gathering System, L.L.C.
    Description: Venice Gathering System, L.L.C. submits tariff filing
per 154.203: Compliance Filing and Housekeeping Changes to Sheet No.
161, NAESB 1.9 Filing to be effective 11/1/2010.
    Filed Date: 11/17/2010.
    Accession Number: 20101117-5032.
    Comment Date: 5 p.m. Eastern Time on Monday, November 29, 2010.

    Docket Numbers: CP11-13-000.
    Applicants: Columbia Gulf Transmission Company.
    Description: Columbia Gulf Transmission Company's Application for a
Pipeline Certificate to Abandon Service Only on Various Offshore
Facilities Located in the Gulf of Mexico.
    Filed Date: 10/21/2010.
    Accession Number: 20101021-5076.
    Comment Date: 5 p.m. Eastern Time on Monday, November 22, 2010.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St. NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance

with any FERC Online service, please e-mail<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-29707 Filed 11-24-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 225 (Tuesday, November 22, 2016)]
[Rules and Regulations]
[Pages 83665-83667]
[FR Doc No: 2016-26614]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-6672; Directorate Identifier 2016-NM-022-AD;
Amendment 39-18706; AD 2016-22-17]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
The Boeing Company Model 787-8 airplanes. This AD was prompted by a
report that the grounding jumpers between the environmental control
system (ECS) bracket and the current return network (CRN) straps near
certain passenger entry doors were not bonded correctly during
manufacturing. This AD requires changing the configuration of the
grounding jumpers connecting the ECS brackets and CRN straps; measuring
the bond resistance; and doing related investigative and corrective
actions if necessary. We are issuing this AD to address the unsafe
condition on these products.

DATES: This AD is effective December 27, 2016.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of December 27,
2016.

ADDRESSES: For service information identified in this final rule,
contact Boeing Commercial Airplanes, Attention: Data & Services
Management, P. O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone
206-544-5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may view this referenced service information
at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW.,
Renton, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
6672.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
6672; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday,

except Federal holidays. The AD docket contains this AD, the regulatory
evaluation, any comments received, and other information. The address
for the Docket Office (phone:<PHONE_NUMBER>) is Document Management
Facility, U.S. Department of Transportation, Docket Operations, M-30,
West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Brendan Shanley, Aerospace Engineer,
Systems and Equipment Branch, ANM-130S, FAA, Seattle Aircraft
Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-
3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain The Boeing Company
Model 787-8 airplanes. The NPRM published in the Federal Register on
June 3, 2016 (81 FR 35655) (``the NPRM''). The NPRM was prompted by a
report that the grounding jumpers between the ECS bracket and the CRN
straps near passenger 1 left and 1 right entry doors were not bonded
correctly during manufacturing. The NPRM proposed to require changing
the configuration of the grounding jumpers connecting the ECS brackets
and CRN straps; measuring the bond resistance; and doing related
investigative and corrective actions if necessary. We are issuing this
AD to prevent an incorrectly bonded jumper between the ECS bracket and
the CRN strap, which does not provide proper grounding to the door
frames at doors 1 left and 1 right. If a fault occurs, an electrical
shock hazard can exist and could result in serious or fatal injury to
passengers and flight crew.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the NPRM and
the FAA's response to each comment.

Support for the NPRM

    Boeing stated that it concurs with the content of the NPRM. United
Airlines (UAL) stated that the 12-month compliance time is a safe and
reasonable timeframe.

Requests To Reference New Service Information and Add Credit

    All Nippon Airways and UAL requested that we revise the NPRM to
reference Boeing Service Bulletin B787-81205-SB530025-00, Issue 002,
dated June 2, 2016 (``B787-81205-SB530025-00 Issue 002''), and give
credit for actions accomplished using Boeing Service Bulletin B787-
81205-SB530025-00, Issue 001, dated July 17, 2014 (``B787-81205-
SB530025-00 Issue 001'').
    We agree with the commenters' requests. B787-81205-SB530025-00
Issue 002 clarifies instructions and specifies the category of fay seal
application. No additional work is required by B787-81205-SB530025-00
Issue 002. B787-81205-SB530025-00 Issue 002 has steps that are labeled
as Required for Compliance (RC).
    We have revised paragraphs (c) and (g) of this AD to reference
B787-81205-SB530025-00 Issue 002, and added new paragraph (h) of this
AD to provide credit for actions accomplished prior to the effective
date of this AD using B787-81205-SB530025-00 Issue 001. We have
redesignated subsequent paragraphs accordingly. We have added new
paragraph (i)(4) of this AD to address the steps marked RC in B787-
81205-SB530025-00 Issue 002.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this AD with the changes described previously and minor editorial
changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of this AD.

Related Service Information Under 1 CFR Part 51

    We reviewed B787-81205-SB530025-00 Issue 002. The service
information describes procedures for changing the configuration of the
grounding jumpers connecting the ECS brackets and CRN straps; measuring
the bond resistance; and related investigative and corrective actions
if necessary. This service information is reasonably available because
the interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 6 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
               Action                        Labor cost           Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
Installation........................  6 work-hours x $85 per             $100             $610           $3,660
                                       hour = $510.
----------------------------------------------------------------------------------------------------------------

    We have received no definitive data that would enable us to provide
cost estimates for the on-condition actions specified in this AD.
    According to the manufacturer, some of the costs of this AD may be
covered under warranty, thereby reducing the cost impact on affected
individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. 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.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect 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.
    For the reasons discussed above, I certify that this AD:
    (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),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2016-22-17 The Boeing Company: Amendment 39-18706; Docket No. FAA-
2016-6672; Directorate Identifier 2016-NM-022-AD.

(a) Effective Date

    This AD is effective December 27, 2016.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 787-8 airplanes,
certificated in any category, as identified in Boeing Service
Bulletin B787-81205-SB530025-00, Issue 002, dated June 2, 2016
(``B787-81205-SB530025-00 Issue 002'').

(d) Subject

    Air Transport Association (ATA) of America Code 53; Fuselage.

(e) Unsafe Condition

    This AD was prompted by a report that the grounding jumpers
between the environmental control system (ECS) bracket and the
current return network (CRN) straps near passenger 1 left and 1
right entry doors were not bonded correctly during manufacturing. We
are issuing this AD to prevent an incorrectly bonded jumper between
the ECS bracket and the CRN strap, which does not provide proper
grounding to the door frames at doors 1 left and 1 right. If a fault
occurs, an electrical shock hazard can exist and could result in
serious or fatal injury to passengers and flight crew.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Grounding Jumper Revision

    Within 12 months after the effective date of this AD: Change the
configuration of the grounding jumpers connecting the ECS brackets
and CRN straps, including measuring the bond resistance and doing
all applicable related investigative and corrective actions, in
accordance with the Accomplishment Instructions of B787-81205-
SB530025-00 Issue 002. Do all applicable related investigative and
corrective actions before further flight.

(h) Credit for Previous Actions

    This paragraph provides credit for the actions specified in
paragraph (g) of this AD, if those actions were performed before the
effective date of this AD using Boeing Service Bulletin B787-81205-
SB530025-00, Issue 001, dated July 17, 2014.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in paragraph (j) of this AD.
Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by the Boeing Commercial Airplanes Organization
Designation Authorization (ODA) that has been authorized by the
Manager, Seattle ACO, to make those findings. To be approved, the
repair method, modification deviation, or alteration deviation must
meet the certification basis of the airplane, and the approval must
specifically refer to this AD.
    (4) For service information that contains steps that are labeled
as Required for Compliance (RC), the provisions of paragraphs
(i)(4)(i) and (i)(4)(ii) of this AD apply.
    (i) The steps labeled as RC, including substeps under an RC step
and any figures identified in an RC step, must be done to comply
with the AD. If a step or substep is labeled ``RC Exempt,'' then the
RC requirement is removed from that step or substep. An AMOC is
required for any deviations to RC steps, including substeps and
identified figures.
    (ii) Steps not labeled as RC may be deviated from using accepted
methods in accordance with the operator's maintenance or inspection
program without obtaining approval of an AMOC, provided the RC
steps, including substeps and identified figures, can still be done
as specified, and the airplane can be put back in an airworthy
condition.

(j) Related Information

    For more information about this AD, contact Brendan Shanley,
Aerospace Engineer, Systems and Equipment Branch, ANM-130S, FAA,
Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW.,
Renton, WA 98057-3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Boeing Service Bulletin B787-81205-SB530025-00, Issue 002,
dated June 2, 2016.
    (ii) Reserved.
    (3) For Boeing service information identified in this AD,
contact Boeing Commercial Airplanes, Attention: Data & Services
Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207;
telephone<PHONE_NUMBER>, extension 1; fax<PHONE_NUMBER>; Internet
https://www.myboeingfleet.com.
    (4) You may view this service information at FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on October 25, 2016.
Dionne Palermo,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-26614 Filed 11-21-16; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 113 (Friday, June 12, 2015)]
[Notices]
[Pages 33524-33525]
[FR Doc No: 2015-14358]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0776]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Reclassification
Petitions for Medical Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by July
13, 2015.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0138.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Reclassification Petitions for Medical Devices (OMB Control Number
0910-0138)--Extension

    Under sections 513(e) and (f), 514(b), 515(b), and 520(l) of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(e)
and (f), 360d(b), 360e(b), and 360j(l)) and part 860 (21 CFR part 860),
subpart C, FDA has responsibility to collect data and information
contained in reclassification petitions. The reclassification
provisions of the FD&C Act allow any person to petition for
reclassification of a device from any of the three classes, i.e., I,
II, and III, to another class. The reclassification content regulation
(Sec.  860.123) requires the submission of valid scientific evidence
demonstrating that the proposed reclassification will provide a
reasonable assurance of safety and effectiveness of the device type for
its indications for use.
    The reclassification procedure regulation requires the submission
of specific data when a manufacturer is petitioning for
reclassification. This includes a ``Supplemental Data Sheet,'' Form FDA
3427, and a ``General Device Classification Questionnaire,'' Form FDA
3429. Both forms contain a series of questions concerning the safety
and effectiveness of the device type.
    In the Federal Register of March 25, 2014 (79 FR 16252), FDA issued
a proposed rule that would eliminate the need for Forms FDA 3427 and
FDA 3429. However, because the proposed rule has not been finalized, we
continue to include the forms in the burden estimate for this
information collection.
    The reclassification provisions of the FD&C Act serve primarily as
a vehicle for manufacturers to seek reclassification from a higher to a
lower class, thereby reducing the regulatory requirements applicable to
a particular device type, or to seek reclassification from a lower to a
higher class, thereby increasing the regulatory requirements applicable
to that device type. If approved, petitions requesting classification
from class III to class II or class I provide an alternative route to
market in lieu of premarket approval for class III devices. If
approved, petitions requesting reclassification from class I or II, to
a different class, may increase requirements.
    In the Federal Register of March 10, 2015 (80 FR 12642), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received.
    The comment refers to changes to the form FDA 3429 as proposed by
the commenter in a citizen petition (FDA-2014-P-0283-0001), which was
subsequently denied by FDA in a final response letter to the petitioner
(FDA-2014-P-0283-0003). Because the proposed changes have already been
denied through the citizen petition process, we have not made changes
to this information collection based on the comment.
    The Center for Devices and Radiological Health (CDRH) has
continually maintained contact with industry. Informal communications
concerning the importance and effect of reclassification are provided
primarily through trade organizations, and via CDRH's Web site. The
consensus from the Agency's most recent contact with these trade
organizations is that they are in favor of the program. The trade
organizations involved are AdvaMed, the Food and Drug Law Institute
(FDLI), and the National Electrical Manufacturers Association (NEMA):
    AdvaMed, Tara Federici, 1030 15th Street NW., suite 1100,
Washington, DC 20005,<PHONE_NUMBER>;
    Food and Drug Law Institute (FDLI), 1000 Vermont Ave. NW., suite
1200, Washington, DC 20005,<PHONE_NUMBER>; and National Electrical
Manufacturers Association (NEMA), 1300 North 17th Street, suite 1847,
Rosslyn, VA 22209,<PHONE_NUMBER>.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                        Average
                           Activity                               FDA Form      Number of     responses per   Total annual     burden per    Total hours
                                                                    Nos.       respondents     respondent       responses       response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Supporting data for reclassification petition.................  ...........               6               1               6             497        2,982
Supplemental Data Sheet.......................................         3427               6               1               6             1.5            9
General Device Classification Questionnaire...................         3429               6               1               6             1.5            9
Total.........................................................  ...........  ..............  ..............  ..............  ..............        3,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on reclassification petitions received in the last 3 years,
FDA anticipates that six petitions will be submitted each year. The
time required to prepare and submit a reclassification petition,
including the time needed to assemble supporting data, averages 500
hours per petition. This average is based upon estimates by FDA
administrative and technical staff who: (1) Are familiar with the
requirements for submission of a reclassification petition, (2) have
consulted and advised manufacturers on these requirements, and (3) have
reviewed the documentation submitted.
    This document refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 807, subpart E, have been
approved under OMB control number 0910-0120 and the collections of
information in 21 CFR part 814, subparts A through E, have been
approved under OMB control number 0910-0231.

    Dated: June 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14358 Filed 6-11-15; 8:45 am]
 BILLING CODE 4164-01-P