[Federal Register: September 29, 2010 (Volume 75, Number 188)]
[Rules and Regulations]
[Page 59975-59983]
[DOCID:fr29se10-8]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 300

[EPA-HQ-SFUND-2009-0067, EPA-HQ-SFUND-2010-0068, EPA-HQ-SFUND-2010-
0069, EPA-HQ-SFUND-2010-0070, EPA-HQ-SFUND-2010-0074, EPA-HQ-SFUND-
2010-0076; FRL-9207-3]
RIN 2050-AD75

National Priorities List, Final Rule No. 50

AGENCY: Environmental Protection Agency.

ACTION: Final rule.

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SUMMARY: The Comprehensive Environmental Response, Compensation, and
Liability Act of 1980 (``CERCLA'' or ``the Act''), as amended, requires
that the National Oil and Hazardous Substances Pollution Contingency
Plan (``NCP'') include a list of national priorities among the known
releases or threatened releases of hazardous substances, pollutants, or
contaminants throughout the United States. The National Priorities List
(``NPL'') constitutes this list. The NPL is intended primarily to guide
the Environmental Protection Agency (``EPA'' or ``the Agency'') in
determining which sites warrant further investigation. These further
investigations will allow EPA to assess the nature and extent of public
health and environmental risks associated with the site and to
determine what CERCLA-financed remedial action(s), if any, may be
appropriate. This rule adds six sites to the NPL, all to the General
Superfund Section.

DATES: Effective Date: The effective date for this amendment to the NCP
is October 29, 2010.

ADDRESSES: For addresses for the Headquarters and Regional dockets, as
well as further details on what these dockets contain, see section II,
``Availability of Information to the Public'' in the SUPPLEMENTARY
INFORMATION portion of this preamble.

FOR FURTHER INFORMATION CONTACT: Terry Jeng, phone:<PHONE_NUMBER>, e-
mail<EMAIL_ADDRESS>Site Assessment and Remedy Decisions Branch;
Assessment and Remediation Division; Office of Superfund Remediation
and Technology Innovation (mail code 5204P); U.S. Environmental
Protection Agency; 1200 Pennsylvania Avenue, NW; Washington, DC 20460;
or the Superfund Hotline, phone<PHONE_NUMBER> or<PHONE_NUMBER> in the
Washington, DC, metropolitan area.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
    A. What are CERCLA and SARA?
    B. What is the NCP?
    C. What is the National Priorities List (NPL)?
    D. How are sites listed on the NPL?
    E. What happens to sites on the NPL?
    F. Does the NPL define the boundaries of sites?
    G. How are sites removed from the NPL?
    H. May EPA delete portions of sites from the NPL as they are
cleaned up?
    I. What is the Construction Completion List (CCL)?
    J. What is the Sitewide Ready for Anticipated Use Measure?
II. Availability of Information to the Public
    A. May I review the documents relevant to this final rule?
    B. What documents are available for review at the Headquarters
Docket?
    C. What documents are available for review at the regional
dockets?
    D. How do I access the documents?

    E. How may I obtain a current list of NPL sites?
III. Contents of This Final Rule
    A. Additions to the NPL
    B. Site Name Change
    C. What did EPA do with the public comments it received?
IV. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review
    1. What is Executive Order 12866?
    2. Is this final rule subject to Executive Order 12866 review?
    B. Paperwork Reduction Act
    1. What is the Paperwork Reduction Act?
    2. Does the Paperwork Reduction Act apply to this final rule?
    C. Regulatory Flexibility Act
    1. What is the Regulatory Flexibility Act?
    2. How has EPA complied with the Regulatory Flexibility Act?
    D. Unfunded Mandates Reform Act
    1. What is the Unfunded Mandates Reform Act (UMRA)?
    2. Does UMRA apply to this final rule?
    E. Executive Order 13132: Federalism
    1. What is Executive Order 13132?
    2. Does Executive Order 13132 apply to this final rule?
    F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    1. What is Executive Order 13175?
    2. Does Executive Order 13175 apply to this final rule?
    G. Executive Order 13045: Protection of Children From
Environmental Health and Safety Risks
    1. What is Executive Order 13045?
    2. Does Executive Order 13045 apply to this final rule?
    H. Executive Order 13211: Actions that Significantly Affect
Energy Supply, Distribution, or Usage
    1. What is Executive Order 13211?
    2. Does Executive Order 13211 apply to this final rule?
    I. National Technology Transfer and Advancement Act
    1. What Is the National Technology Transfer and Advancement Act?
    2. Does the National Technology Transfer and Advancement Act
apply to this final rule?
    J. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations
    1. What is Executive Order 12898?
    2. Does Executive Order 12898 apply to this final rule?
    K. Congressional Review Act
    1. Has EPA submitted this rule to Congress and the Government
Accountability Office?
    2. Could the effective date of this final rule change?
    3. What could cause a change in the effective date of this rule?

I. Background

A. What are CERCLA and SARA?

    In 1980, Congress enacted the Comprehensive Environmental Response,
Compensation, and Liability Act, 42 U.S.C. 9601-9675 (``CERCLA'' or
``the Act''), in response to the dangers of uncontrolled releases or
threatened releases of hazardous substances, and releases or
substantial threats of releases into the environment of any pollutant
or contaminant that may present an imminent or substantial danger to
the public health or welfare. CERCLA was amended on October 17, 1986,
by the Superfund Amendments and Reauthorization Act (``SARA''), Public
Law 99-499, 100 Stat. 1613 et seq.

B. What is the NCP?

    To implement CERCLA, EPA promulgated the revised National Oil and
Hazardous Substances Pollution Contingency Plan (``NCP''), 40 CFR part
300, on July 16, 1982 (47 FR 31180), pursuant to CERCLA section 105 and
Executive Order 12316 (46 FR 42237, August 20, 1981). The NCP sets
guidelines and procedures for responding to releases and threatened
releases of hazardous substances, or releases or substantial threats of
releases into the environment of any pollutant or contaminant that may
present an imminent or substantial danger to the public health or
welfare. EPA has revised the NCP on several occasions. The most recent
comprehensive revision was on March 8, 1990 (55 FR 8666).
    As required under section 105(a)(8)(A) of CERCLA, the NCP also
includes ``criteria for determining priorities among releases or
threatened releases throughout the United States for the purpose of
taking remedial action and, to the extent practicable taking into
account the potential urgency of such action, for the purpose of taking
removal action.'' ``Removal'' actions are defined broadly and include a
wide range of actions taken to study, clean up, prevent or otherwise
address releases and threatened releases of hazardous substances,
pollutants or contaminants (42 U.S.C. 9601(23)).

C. What is the National Priorities List (NPL)?

    The NPL is a list of national priorities among the known or
threatened releases of hazardous substances, pollutants, or
contaminants throughout the United States. The list, which is appendix
B of the NCP (40 CFR part 300), was required under section 105(a)(8)(B)
of CERCLA, as amended. Section 105(a)(8)(B) defines the NPL as a list
of ``releases'' and the highest priority ``facilities'' and requires
that the NPL be revised at least annually. The NPL is intended
primarily to guide EPA in determining which sites warrant further
investigation to assess the nature and extent of public health and
environmental risks associated with a release of hazardous substances,
pollutants or contaminants. The NPL is only of limited significance,
however, as it does not assign liability to any party or to the owner
of any specific property. Also, placing a site on the NPL does not mean
that any remedial or removal action necessarily need be taken.
    For purposes of listing, the NPL includes two sections, one of
sites that are generally evaluated and cleaned up by EPA (the ``General
Superfund Section''), and one of sites that are owned or operated by
other Federal agencies (the ``Federal Facilities Section''). With
respect to sites in the Federal Facilities Section, these sites are
generally being addressed by other Federal agencies. Under Executive
Order 12580 (52 FR 2923, January 29, 1987) and CERCLA section 120, each
Federal agency is responsible for carrying out most response actions at
facilities under its own jurisdiction, custody, or control, although
EPA is responsible for preparing a Hazard Ranking System (``HRS'')
score and determining whether the facility is placed on the NPL.

D. How are sites listed on the NPL?

    There are three mechanisms for placing sites on the NPL for
possible remedial action (see 40 CFR 300.425(c) of the NCP): (1) A site
may be included on the NPL if it scores sufficiently high on the HRS,
which EPA promulgated as appendix A of the NCP (40 CFR part 300). The
HRS serves as a screening tool to evaluate the relative potential of
uncontrolled hazardous substances, pollutants or contaminants to pose a
threat to human health or the environment. On December 14, 1990 (55 FR
51532), EPA promulgated revisions to the HRS partly in response to
CERCLA section 105(c), added by SARA. The revised HRS evaluates four
pathways: Ground water, surface water, soil exposure, and air. As a
matter of Agency policy, those sites that score 28.50 or greater on the
HRS are eligible for the NPL. (2) Pursuant to 42 U.S.C. 9605(a)(8)(B),
each State may designate a single site as its top priority to be listed
on the NPL, without any HRS score. This provision of CERCLA requires
that, to the extent practicable, the NPL include one facility
designated by each State as the greatest danger to public health,
welfare, or the environment among known facilities in the State. This
mechanism for listing is set out in the NCP at 40 CFR 300.425(c)(2).
(3) The third mechanism for listing, included in the NCP at 40 CFR
300.425(c)(3), allows certain sites

to be listed without any HRS score, if all of the following conditions
are met:
     The Agency for Toxic Substances and Disease Registry
(ATSDR) of the U.S. Public Health Service has issued a health advisory
that recommends dissociation of individuals from the release.
     EPA determines that the release poses a significant threat
to public health.
     EPA anticipates that it will be more cost-effective to use
its remedial authority than to use its removal authority to respond to
the release.
    EPA promulgated an original NPL of 406 sites on September 8, 1983
(48 FR 40658) and generally has updated it at least annually.

E. What happens to sites on the NPL?

    A site may undergo remedial action financed by the Trust Fund
established under CERCLA (commonly referred to as the ``Superfund'')
only after it is placed on the NPL, as provided in the NCP at 40 CFR
300.425(b)(1). (``Remedial actions'' are those ``consistent with
permanent remedy, taken instead of or in addition to removal actions *
* *.'' 42 U.S.C. 9601(24).) However, under 40 CFR 300.425(b)(2),
placing a site on the NPL ``does not imply that monies will be
expended.'' EPA may pursue other appropriate authorities to respond to
the releases, including enforcement action under CERCLA and other laws.

F. Does the NPL define the boundaries of sites?

    The NPL does not describe releases in precise geographical terms;
it would be neither feasible nor consistent with the limited purpose of
the NPL (to identify releases that are priorities for further
evaluation), for it to do so. Indeed, the precise nature and extent of
the site are typically not known at the time of listing.
    Although a CERCLA ``facility'' is broadly defined to include any
area where a hazardous substance has ``come to be located'' (CERCLA
section 101(9)), the listing process itself is not intended to define
or reflect the boundaries of such facilities or releases. Of course,
HRS data (if the HRS is used to list a site) upon which the NPL
placement was based will, to some extent, describe the release(s) at
issue. That is, the NPL site would include all releases evaluated as
part of that HRS analysis.
    When a site is listed, the approach generally used to describe the
relevant release(s) is to delineate a geographical area (usually the
area within an installation or plant boundaries) and identify the site
by reference to that area. However, the NPL site is not necessarily
coextensive with the boundaries of the installation or plant, and the
boundaries of the installation or plant are not necessarily the
``boundaries'' of the site. Rather, the site consists of all
contaminated areas within the area used to identify the site, as well
as any other location where that contamination has come to be located,
or from where that contamination came.
    In other words, while geographic terms are often used to designate
the site (e.g., the ``Jones Co. plant site'') in terms of the property
owned by a particular party, the site, properly understood, is not
limited to that property (e.g., it may extend beyond the property due
to contaminant migration), and conversely may not occupy the full
extent of the property (e.g., where there are uncontaminated parts of
the identified property, they may not be, strictly speaking, part of
the ``site''). The ``site'' is thus neither equal to, nor confined by,
the boundaries of any specific property that may give the site its
name, and the name itself should not be read to imply that this site is
coextensive with the entire area within the property boundary of the
installation or plant. In addition, the site name is merely used to
help identify the geographic location of the contamination, and is not
meant to constitute any determination of liability at a site. For
example, the name ``Jones Co. plant site,'' does not imply that the
Jones company is responsible for the contamination located on the plant
site.
    EPA regulations provide that the Remedial Investigation (``RI'')
``is a process undertaken * * * to determine the nature and extent of
the problem presented by the release'' as more information is developed
on site contamination, and which is generally performed in an
interactive fashion with the Feasibility Study (``FS'') (40 CFR 300.5).
During the RI/FS process, the release may be found to be larger or
smaller than was originally thought, as more is learned about the
source(s) and the migration of the contamination. However, the HRS
inquiry focuses on an evaluation of the threat posed and therefore the
boundaries of the release need not be exactly defined. Moreover, it
generally is impossible to discover the full extent of where the
contamination ``has come to be located'' before all necessary studies
and remedial work are completed at a site. Indeed, the known boundaries
of the contamination can be expected to change over time. Thus, in most
cases, it may be impossible to describe the boundaries of a release
with absolute certainty.
    Further, as noted above, NPL listing does not assign liability to
any party or to the owner of any specific property. Thus, if a party
does not believe it is liable for releases on discrete parcels of
property, it can submit supporting information to the Agency at any
time after it receives notice it is a potentially responsible party.
    For these reasons, the NPL need not be amended as further research
reveals more information about the location of the contamination or
release.

G. How are sites removed from the NPL?

    EPA may delete sites from the NPL where no further response is
appropriate under Superfund, as explained in the NCP at 40 CFR
300.425(e). This section also provides that EPA shall consult with
states on proposed deletions and shall consider whether any of the
following criteria have been met:
    (i) Responsible parties or other persons have implemented all
appropriate response actions required;
    (ii) All appropriate Superfund-financed response has been
implemented and no further response action is required; or
    (iii) The remedial investigation has shown the release poses no
significant threat to public health or the environment, and taking of
remedial measures is not appropriate.

H. May EPA delete portions of sites from the NPL as they are cleaned
up?

    In November 1995, EPA initiated a new policy to delete portions of
NPL sites where cleanup is complete (60 FR 55465, November 1, 1995).
Total site cleanup may take many years, while portions of the site may
have been cleaned up and made available for productive use.

I. What is the Construction Completion List (CCL)?

    EPA also has developed an NPL construction completion list
(``CCL'') to simplify its system of categorizing sites and to better
communicate the successful completion of cleanup activities (58 FR
12142, March 2, 1993). Inclusion of a site on the CCL has no legal
significance.
    Sites qualify for the CCL when: (1) Any necessary physical
construction is complete, whether or not final cleanup levels or other
requirements have been achieved; (2) EPA has determined that the
response action should be limited to measures that do not involve
construction (e.g., institutional controls); or (3) the site qualifies
for deletion from the NPL. For the most up-to-date information on the
CCL, see

EPA's Internet site at http://www.epa.gov/superfund/cleanup/ccl.htm.

J. What is the Sitewide Ready for Anticipated Use Measure?

    The Sitewide Ready for Anticipated Use measure (formerly called
Sitewide Ready-for-Reuse) represents important Superfund
accomplishments and the measure reflects the high priority EPA places
on considering anticipated future land use as part of our remedy
selection process. See Guidance for Implementing the Sitewide Ready-
for-Reuse Measure, May 24, 2006, OSWER 9365.0-36. This measure applies
to final and deleted sites where construction is complete, all cleanup
goals have been achieved, and all institutional or other controls are
in place. EPA has been successful on many occasions in carrying out
remedial actions that ensure protectiveness of human health and the
environment, including current and future land users, in a manner that
allows contaminated properties to be restored to environmental and
economic vitality. For further information, please go to http://
www.epa.gov/superfund/programs/recycle/tools/index.html.

II. Availability of Information to the Public

A. May I review the documents relevant to this final rule?

    Yes, documents relating to the evaluation and scoring of the sites
in this final rule are contained in dockets located both at EPA
Headquarters and in the Regional offices.
    An electronic version of the public docket is available through
http://www.regulations.gov (see table below for Docket Identification
numbers). Although not all Docket materials may be available
electronically, you may still access any of the publicly available
Docket materials through the Docket facilities identified below in
section II D.

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              Site name                    City/county, state                      Docket ID No.
----------------------------------------------------------------------------------------------------------------
General Dynamics Longwood...........  Longwood, FL...............  EPA-HQ-SFUND-2009-0067
Sanford Dry Cleaners................  Sanford, FL................  EPA-HQ-SFUND-2010-0068
Ten-Mile Drain......................  St. Clair Shores, MI.......  EPA-HQ-SFUND-2010-0069
Vienna Wells........................  Vienna, MO.................  EPA-HQ-SFUND-2010-0070
Black River PCBs....................  Jefferson County, NY.......  EPA-HQ-SFUND-2010-0074
Smokey Mountain Smelters............  Knox County, TN............  EPA-HQ-SFUND-2010-0076
----------------------------------------------------------------------------------------------------------------

B. What documents are available for review at the Headquarters Docket?

    The Headquarters Docket for this rule contains, for each site, the
HRS score sheets, the Documentation Record describing the information
used to compute the score, pertinent information regarding statutory
requirements or EPA listing policies that affect the site, and a list
of documents referenced in the Documentation Record. For sites that
received comments during the comment period, the Headquarters Docket
also contains a Support Document that includes EPA's responses to
comments.

C. What documents are available for review at the Regional Dockets?

    The Regional Dockets contain all the information in the
Headquarters Docket, plus the actual reference documents containing the
data principally relied upon by EPA in calculating or evaluating the
HRS score for the sites located in their Region. These reference
documents are available only in the Regional Dockets. For sites that
received comments during the comment period, the Regional Docket also
contains a Support Document that includes EPA's responses to comments.

D. How do I access the documents?

    You may view the documents, by appointment only, after the
publication of this rule. The hours of operation for the Headquarters
Docket are from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding Federal holidays. Please contact the Regional Dockets for
hours.
    Following is the contact information for the EPA Headquarters:
Docket Coordinator, Headquarters; U.S. Environmental Protection Agency;
CERCLA Docket Office; 1301 Constitution Avenue, NW.; EPA West, Room
3334, Washington, DC 20004, 202/566-0276.
    The contact information for the Regional Dockets is as follows:

Joan Berggren, Region 1 (CT, ME, MA, NH, RI, VT), U.S. EPA, Superfund
Records and Information Center, Mailcode HSC, One Congress Street,
Suite 1100, Boston, MA 02114-2023; 617/918-1417.
Ildefonso Acosta, Region 2 (NJ, NY, PR, VI), U.S. EPA, 290 Broadway,
New York, NY 10007-1866; 212/637-4344.
Dawn Shellenberger (ASRC), Region 3 (DE, DC, MD, PA, VA, WV), U.S. EPA,
Library, 1650 Arch Street, Mailcode 3PM52, Philadelphia, PA 19103; 215/
814-5364.
Debbie Jourdan, Region 4 (AL, FL, GA, KY, MS, NC, SC, TN), U.S. EPA, 61
Forsyth Street, SW., Mailcode 9T25, Atlanta, GA 30303; 404/562-8862.
Janet Pfundheller, Region 5 (IL, IN, MI, MN, OH, WI), U.S. EPA, Records
Center, Superfund Division SMR-7J, Metcalfe Federal Building, 77 West
Jackson Boulevard, Chicago, IL 60604; 312/353-5821.
Brenda Cook, Region 6 (AR, LA, NM, OK, TX), U.S. EPA, 1445 Ross Avenue,
Suite 1200, Mailcode 6SFTS, Dallas, TX 75202-2733; 214/665-7436.
Michelle Quick, Region 7 (IA, KS, MO, NE), U.S. EPA, 901 North 5th
Street, Mailcode SUPRERNB, Kansas City, KS 66101; 913/551-7335.
Sabrina Forrest, Region 8 (CO, MT, ND, SD, UT, WY), U.S. EPA, 1595
Wynkoop Street, Mailcode 8EPR-B, Denver, CO 80202-1129; 303/312-6484.
Karen Jurist, Region 9 (AZ, CA, HI, NV, AS, GU, MP), U.S. EPA, 75
Hawthorne Street, Mailcode SFD-9-1, San Francisco, CA 94105; 415/972-
3219.
Ken Marcy, Region 10 (AK, ID, OR, WA), U.S. EPA, 1200 6th Avenue,
Mailcode ECL-112, Seattle, WA 98101; 206/463-1349.

E. How may I obtain a current list of NPL sites?

    You may obtain a current list of NPL sites via the Internet at
http://www.epa.gov/superfund/sites/npl/status.htm or by contacting the
Superfund Docket (see contact information above).

III. Contents of This Final Rule

A. Additions to the NPL

    This final rule adds the following six sites to the NPL, all to the
General Superfund Section. The sites are presented in the table below:

------------------------------------------------------------------------
          State                 Site name              City/county
------------------------------------------------------------------------
FL......................  General Dynamics      Longwood.
                           Longwood.
FL......................  Sanford Dry Cleaners  Sanford.
MI......................  Ten-Mile Drain......  St. Clair Shores.
MO......................  Vienna Wells........  Vienna.
NY......................  Black River PCBs....  Jefferson County.
TN......................  Smokey Mountain       Knox County.
                           Smelters.
------------------------------------------------------------------------

B. Site Name Change

    The Ten-Mile Drain site in St. Clair Shores, Michigan, was proposed
to the NPL under a different name. The former name was St. Clair Shores
Drain (see Proposed Rule at 75 FR 9843, March 4, 2010). EPA believes
the new name, Ten-Mile Drain, more accurately identifies the site.

C. What did EPA do with the public comments it received?

    EPA reviewed all comments received on the sites in this rule and
responded to all relevant comments. This rule adds six sites to the
NPL.
    Four sites received no comments: Black River PCBs in Jefferson
County, NY; Sanford Dry Cleaners in Sanford, FL; Smokey Mountain
Smelters in Knox County, TN; and Vienna Wells in Vienna, MO.
    One site being added to the NPL, General Dynamics Longwood in
Longwood, FL, received extensive comments related to its HRS score.
Responses to comments received on this site are contained in a publicly
available support document published concurrently with this final rule.
    One other site, Ten-Mile Drain (previously known as St. Clair
Shores Drain), located in St. Clair Shores, MI, is being added to the
NPL in this rule. Three comments were received but none related to the
HRS score. One comment, submitted on behalf of dozens of homeowners,
supported placing the Ten-Mile Drain site on the NPL and urged EPA to
conduct a complete and timely remediation. The Superfund remedial
process is designed to do just that. A second comment stated that the
site should not be listed because the city of St. Clair Shores is under
a court order to maintain the drain and should live up to its
responsibility. In response, liability is an issue separate from
listing and will be addressed later in the Superfund process. In the
meantime, listing and subsequent investigation to determine risk needs
to take place independent of any liability concerns.
    The third comment raised several points. It urged EPA to change the
name of the site from St. Clair Shores Drain to Ten-Mile Drain, which
is the legally established drain under the Michigan Drain Code. EPA
agrees with the commenter and has changed the name. Secondly, the
comment urged EPA to add the Lake Crest, Bayview, and Rio Vista Street
canals to the PCB-impacted areas in the HRS record. EPA did not include
these canals as sources because the data were unclear whether the
contamination found was the same or a separate release from
contamination found in the Ten-Mile Drain and surrounding soils. EPA
will consider this issue as the site investigation proceeds. The third
point raised in this comment was that it seems likely that the PCBs
were dumped on soil and migrated into the Ten-Mile Drain system rather
than the other way around, and that the HRS package language should be
changed to reflect this. In response, there is insufficient information
available to determine if the contamination went from the drain into
the surrounding soil or from the soils into the drainage system.
Regardless, this has no impact on the HRS score for the site, which is
based on contamination of both the drainage system and soil without
regard to which came first.
    All comments that were received by EPA are contained in the
Headquarters Docket and are also listed in EPA's electronic public
Docket and comment system at http://www.regulations.gov.

IV. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

1. What Is Executive Order 12866?
    Under Executive Order 12866, (58 FR 51735 (October 4, 1993)) the
Agency must determine whether a regulatory action is ``significant''
and therefore subject to Office of Management and Budget (OMB) review
and the requirements of the Executive Order. The Order defines
``significant regulatory action'' as one that is likely to result in a
rule that may: (1) Have an annual effect on the economy of $100 million
or more or adversely affect in a material way the economy, a sector of
the economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
communities; (2) create a serious inconsistency or otherwise interfere
with an action taken or planned by another agency; (3) materially alter
the budgetary impact of entitlements, grants, user fees, or loan
programs or the rights and obligations of recipients thereof; or (4)
raise novel legal or policy issues arising out of legal mandates, the
President's priorities, or the principles set forth in the Executive
Order.
2. Is this final rule subject to Executive Order 12866 review?
    No. The listing of sites on the NPL does not impose any obligations
on any entities. The listing does not set standards or a regulatory
regime and imposes no liability or costs. Any liability under CERCLA
exists irrespective of whether a site is listed. It has been determined
that this action is not a ``significant regulatory action'' under the
terms of Executive Order 12866 and is therefore not subject to OMB
review.

B. Paperwork Reduction Act

1. What is the Paperwork Reduction Act?
    According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., an agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information that requires OMB
approval under the PRA, unless it has been approved by OMB and displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations, after initial display in the preamble of the final rules,
are listed in 40 CFR part 9.
2. Does the Paperwork Reduction Act apply to this final rule?
    This action does not impose an information collection burden under
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
EPA has determined that the PRA does not apply because this rule does
not contain any information collection requirements that require
approval of the OMB.
    Burden means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. This includes the time
needed to review instructions; develop, acquire, install, and utilize
technology

and systems for the purposes of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and
providing information; adjust the existing ways to comply with any
previously applicable instructions and requirements; train personnel to
be able to respond to a collection of information; search data sources;
complete and review the collection of information; and transmit or
otherwise disclose the information.
    An agency may not conduct or sponsor, and a person is not required
to respond to a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in 40 CFR are listed in 40 CFR part 9.

C. Regulatory Flexibility Act

1. What is the Regulatory Flexibility Act?
    Pursuant to the Regulatory Flexibility Act (5 U.S.C. 601 et seq.,
as amended by the Small Business Regulatory Enforcement Fairness Act
(SBREFA) of 1996) whenever an agency is required to publish a notice of
rulemaking for any proposed or final rule, it must prepare and make
available for public comment a regulatory flexibility analysis that
describes the effect of the rule on small entities (i.e., small
businesses, small organizations, and small governmental jurisdictions).
However, no regulatory flexibility analysis is required if the head of
an agency certifies the rule will not have a significant economic
impact on a substantial number of small entities. SBREFA amended the
Regulatory Flexibility Act to require Federal agencies to provide a
statement of the factual basis for certifying that a rule will not have
a significant economic impact on a substantial number of small
entities.
2. How has EPA complied with the Regulatory Flexibility Act?
    This rule listing sites on the NPL does not impose any obligations
on any group, including small entities. This rule also does not
establish standards or requirements that any small entity must meet,
and imposes no direct costs on any small entity. Whether an entity,
small or otherwise, is liable for response costs for a release of
hazardous substances depends on whether that entity is liable under
CERCLA 107(a). Any such liability exists regardless of whether the site
is listed on the NPL through this rulemaking. Thus, this rule does not
impose any requirements on any small entities. For the foregoing
reasons, I certify that this rule will not have a significant economic
impact on a substantial number of small entities.

D. Unfunded Mandates Reform Act

1. What is the Unfunded Mandates Reform Act (UMRA)?
    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and tribal
governments and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``Federal mandates'' that
may result in expenditures by State, local, and tribal governments, in
the aggregate, or by the private sector, of $100 million or more in any
one year. Before EPA promulgates a rule where a written statement is
needed, section 205 of the UMRA generally requires EPA to identify and
consider a reasonable number of regulatory alternatives and adopt the
least costly, most cost-effective, or least burdensome alternative that
achieves the objectives of the rule. The provisions of section 205 do
not apply when they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other than the least
costly, most cost-effective, or least burdensome alternative if the
Administrator publishes with the final rule an explanation why that
alternative was not adopted. Before EPA establishes any regulatory
requirements that may significantly or uniquely affect small
governments, including tribal governments, it must have developed under
section 203 of the UMRA a small government agency plan. The plan must
provide for notifying potentially affected small governments, enabling
officials of affected small governments to have meaningful and timely
input in the development of EPA regulatory proposals with significant
Federal intergovernmental mandates, and informing, educating, and
advising small governments on compliance with the regulatory
requirements.
2. Does UMRA apply to this final rule?
    This final rule does not contain a Federal mandate that may result
in expenditures of $100 million or more for State, local, and tribal
governments, in the aggregate, or the private sector in any one year.
Listing a site on the NPL does not itself impose any costs. Listing
does not mean that EPA necessarily will undertake remedial action. Nor
does listing require any action by a private party or determine
liability for response costs. Costs that arise out of site responses
result from site-specific decisions regarding what actions to take, not
directly from the act of placing a site on the NPL. Thus, this rule is
not subject to the requirements of section 202 and 205 of UMRA.
    This rule is also not subject to the requirements of section 203 of
UMRA because it contains no regulatory requirements that might
significantly or uniquely affect small governments. As is mentioned
above, site listing does not impose any costs and would not require any
action of a small government.

E. Executive Order 13132: Federalism

1. What is Executive Order 13132?
    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.''
2. Does Executive Order 13132 apply to this final rule?
    This final rule does not have federalism implications. It 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, because it does not contain any
requirements applicable to States or other levels of government. Thus,
the requirements of the Executive Order do not apply to this final
rule.
    EPA believes, however, that this final rule may be of significant
interest to State governments. In the spirit of Executive Order 13132,
and consistent with EPA policy to promote communications between EPA
and State and local governments, EPA therefore consulted with State
officials and/or representatives of State governments early in the
process of developing the rule to permit them to have meaningful and
timely input into its development. All sites included in this final
rule were referred to EPA by States for listing. For all sites in this
rule, EPA received letters of support either from the Governor or a
State official who was delegated the authority by the Governor to speak
on

their behalf regarding NPL listing decisions.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

1. What is Executive Order 13175?
    Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 6, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal government and Indian tribes.''
2. Does Executive Order 13175 apply to this final rule?
    This final rule does not have tribal implications, as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). Listing a site
on the NPL does not impose any costs on a tribe or require a tribe to
take remedial action. Thus, Executive Order 13175 does not apply to
this final rule.

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

1. What is Executive Order 13045?
    Executive Order 13045: ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997) applies
to any rule that: (1) Is determined to be ``economically significant''
as defined under Executive Order 12866, and (2) concerns an
environmental health or safety risk that EPA has reason to believe may
have a disproportionate effect on children. If the regulatory action
meets both criteria, the Agency must evaluate the environmental health
or safety effects of the planned rule on children, and explain why the
planned regulation is preferable to other potentially effective and
reasonably feasible alternatives considered by the Agency.
2. Does Executive Order 13045 apply to this final rule?
    This rule is not subject to Executive Order 13045 because it is not
an economically significant rule as defined by Executive Order 12866,
and because the Agency does not have reason to believe the
environmental health or safety risks addressed by this section present
a disproportionate risk to children.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Usage

1. What is Executive Order 13211?
    Executive Order 13211, ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use,'' (66 FR
28355 (May 22, 2001)) requires federal agencies to prepare a
``Statement of Energy Effects'' when undertaking certain regulatory
actions. A Statement of Energy Effects describes the adverse effects of
a ``significant energy action'' on energy supply, distribution and use,
reasonable alternatives to the action, and the expected effects of the
alternatives on energy supply, distribution and use.
2. Does Executive Order 13211 apply to this final rule?
    This action is not a ``significant energy action'' as defined in
Executive Order 13211, because it is not likely to have a significant
adverse effect on the supply, distribution, or use of energy. Further,
we have concluded that this final rule is not likely to have any
adverse energy impacts because adding a site to the NPL does not
require an entity to conduct any action that would require energy use,
let alone that which would significantly affect energy supply,
distribution, or usage. Thus, Executive Order 13175 does not apply to
this action.

I. National Technology Transfer and Advancement Act

1. What is the National Technology Transfer and Advancement Act?
    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note), directs EPA to use voluntary consensus standards in its
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical. Voluntary consensus standards
are technical standards (e.g., materials specifications, test methods,
sampling procedures, and business practices) that are developed or
adopted by voluntary consensus standards bodies. The NTTAA directs EPA
to provide Congress, through OMB, explanations when the Agency decides
not to use available and applicable voluntary consensus standards.
2. Does the National Technology Transfer and Advancement Act apply to
this final rule?
    No. This rulemaking does not involve technical standards.
Therefore, EPA did not consider the use of any voluntary consensus
standards.

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

1. What is Executive Order 12898?
    Executive Order (EO) 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.
2. Does Executive Order 12898 apply to this rule?
    EPA has determined that this final rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it does not
affect the level of protection provided to human health or the
environment. As this rule does not impose any enforceable duty upon
State, tribal or local governments, this rule will neither increase nor
decrease environmental protection.

K. Congressional Review Act

1. Has EPA submitted this rule to Congress and the Government
Accountability Office?
    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, that includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA has submitted a report containing this rule 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 rule is not a ``major rule'' as defined by 5 U.S.C.
804(2).

2. Could the effective date of this final rule change?
    Provisions of the Congressional Review Act (CRA) or section 305 of
CERCLA may alter the effective date of this regulation.
    Under the CRA, 5 U.S.C. 801(a), before a rule can take effect the
federal agency promulgating the rule must submit a report to each House
of the Congress and to the Comptroller General. This report must
contain a copy of the rule, a concise general statement relating to the
rule (including whether it is a major rule), a copy of the cost-benefit
analysis of the rule (if any), the agency's actions relevant to
provisions of the Regulatory Flexibility Act (affecting small
businesses) and the Unfunded Mandates Reform Act of 1995 (describing
unfunded federal requirements imposed on state and local governments
and the private sector), and any other relevant information or
requirements and any relevant Executive Orders.
    EPA has submitted a report under the CRA for this rule. The rule
will take effect, as provided by law, within 30 days of publication of
this document, since it is not a major rule. Section 804(2) defines a
major rule as any rule that the Administrator of the Office of
Information and Regulatory Affairs (OIRA) of the Office of Management
and Budget (OMB) finds has resulted in or is likely to result in: An
annual effect on the economy of $100,000,000 or more; a major increase
in costs or prices for consumers, individual industries, Federal,
State, or local government agencies, or geographic regions; or
significant adverse effects on competition, employment, investment,
productivity, innovation, or on the ability of United States-based
enterprises to compete with foreign-based enterprises in domestic and
export markets. NPL listing is not a major rule because, as explained
above, the listing, itself, imposes no monetary costs on any person. It
establishes no enforceable duties, does not establish that EPA
necessarily will undertake remedial action, nor does it require any
action by any party or determine its liability for site response costs.
Costs that arise out of site responses result from site-by-site
decisions about what actions to take, not directly from the act of
listing itself. Section 801(a)(3) provides for a delay in the effective
date of major rules after this report is submitted.
3. What could cause a change in the effective date of this rule?
    Under 5 U.S.C. 801(b)(1) a rule shall not take effect, or continue
in effect, if Congress enacts (and the President signs) a joint
resolution of disapproval, described under section 802.
    Another statutory provision that may affect this rule is CERCLA
section 305, which provides for a legislative veto of regulations
promulgated under CERCLA. Although INS v. Chadha, 462 U.S. 919,103 S.
Ct. 2764 (1983), and Bd. of Regents of the University of Washington v.
EPA, 86 F.3d 1214,1222 (D.C. Cir. 1996), cast the validity of the
legislative veto into question, EPA has transmitted a copy of this
regulation to the Secretary of the Senate and the Clerk of the House of
Representatives.
    If action by Congress under either the CRA or CERCLA section 305
calls the effective date of this regulation into question, EPA will
publish a document of clarification in the Federal Register.

List of Subjects in 40 CFR Part 300

    Environmental protection, Air pollution control, Chemicals,
Hazardous substances, Hazardous waste, Intergovernmental relations,
Natural resources, Oil pollution, Penalties, Reporting and
recordkeeping requirements, Superfund, Water pollution control, Water
supply.

    Dated: September 22, 2010.
Mathy Stanislaus,
Assistant Administrator, Office of Solid Waste and Emergency Response.

0
40 CFR part 300 is amended as follows:

PART 300--[AMENDED]

0
1. The authority citation for part 300 continues to read as follows:

    Authority: 33 U.S.C. 1321(c)(2); 42 U.S.C. 9601-9657; E.O.
12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR
2923, 3 CFR, 1987 Comp., p. 193.

0
2. Table 1 of Appendix B to part 300 is amended by adding the following
sites in alphabetical order to read as follows:

Appendix B to Part 300--National Priorities List

                                       TABLE 1--General Superfund Section
----------------------------------------------------------------------------------------------------------------
              State                         Site name                 City/county                Notes a
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
FL..............................  General Dynamics Longwood...  Longwood.

                                                  * * * * * * *
FL..............................  Sanford Dry Cleaners........  Sanford.

                                                  * * * * * * *
MI..............................  Ten-Mile Drain..............  St. Clair Shores.

                                                  * * * * * * *
MO..............................  Vienna Wells................  Vienna.

                                                  * * * * * * *
NY..............................  Black River PCBs............  Jefferson County.

                                                  * * * * * * *
TN..............................  Smokey Mountain Smelters....  Knox County.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
a A = Based on issuance of health advisory by Agency for Toxic Substance and Disease Registry (HRS score need
  not be <=28.50).
C = Sites on Construction Completion list.
S = State top priority (HRS score need not be <=28.50)
P = Sites with partial deletion(s).

[FR Doc. 2010-24311 Filed 9-28-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 181 (Monday, September 19, 2016)]
[Notices]
[Pages 64175-64177]
[FR Doc No: 2016-22441]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2673]

Progress Toward Implementing the Product Identification
Requirements of the Drug Supply Chain Security Act; Public Meeting;
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting entitled ``Progress Toward Implementing the Product
Identification Requirements of the Drug Supply Chain Security Act.''
This public meeting is intended to provide members of the
pharmaceutical distribution supply chain and other interested
stakeholders an opportunity to share information with FDA about the
efforts underway to implement the Drug Supply Chain Security Act's
(DSCSA's) product identification requirements, including the use of
product identifiers to enhance tracing at the product level.

DATES: The public meeting will be held on October 14, 2016, from 9 a.m.
to 4 p.m. To permit the widest possible opportunity to obtain public
comment, FDA is soliciting either electronic or written comments on all
aspects of the public meeting topics. The deadline for submitting
comments related to this public meeting is November 14, 2016.

ADDRESSES: The public meeting will be held at FDA's White Oak Campus,

10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(rm. 1503A), Silver Spring, MD 20993. Entrance for the public meeting
participants (non-FDA employees) is through Building 1 where routine
security check procedures will be performed. For parking and security
information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-N-2673 for ``Progress Toward Implementing the Product
Identification Requirements of the Drug Supply Chain Security Act.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Daniel Bellingham, Office of
Compliance, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4285, Silver
Spring, MD 20993,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On November 27, 2013, the DSCSA (Title II, Pub. L. 113-54) was
signed into law. The DSCSA outlines critical steps to build an
electronic, interoperable system by 2023 to identify and trace certain
prescription drugs as they are distributed within the United States.
This system will enhance FDA's ability to protect U.S. consumers from
exposure to drugs that may be counterfeit, stolen, contaminated, or
otherwise harmful by improving the detection and removal of potentially
dangerous drugs from the drug supply chain.
    Section 582(i) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360eee-1), which was added by the DSCSA, directs
FDA to hold at least five public meetings to enhance the safety and
security of the pharmaceutical distribution supply chain and provide
opportunities for comment from stakeholders. In carrying out these
public meetings, FDA is required to prioritize topics necessary to
inform the guidances described in section 582(h)(3) and (h)(4) related
to unit-level tracing and standards for the interoperable data
exchanges, respectively, and to take all reasonable and practicable
measures to ensure the protection of confidential commercial
information and trade secrets. FDA is also required to address each of
the eight topics enumerated in section 582(i)(2) in at least one of the
five required public meetings.
    FDA will hold a public meeting on October 14, 2016, to provide
members of the pharmaceutical distribution supply chain and other
interested stakeholders an opportunity to share information about
current practices and industry efforts to implement the DSCSA's product
identification requirements, including the use of product identifiers.
The format of the meeting involves presentations from the public and
followup questions from an FDA panel. FDA will not be inviting specific
presenters; rather, with this notice, FDA is soliciting presentations
from interested stakeholders.

II. Topics for This Public Meeting

    The main topic FDA is interested in discussing at the public
meeting is the supply chain's progress toward implementing the DSCSA's
product identification requirements, including best practices in each
sector of the pharmaceutical distribution supply chain to conduct
product tracing, verification, and product identification. This may
include the processes needed to utilize the product identifiers to

enhance tracing of product at the package level, including allowing for
verification, aggregation, and inference, as necessary. (The product
identifier is a standardized graphic that includes, in both human- and
machine-readable forms, the National Drug Code, serial number, lot
number, and expiration date of the product.) Under section 582(b)(2)
and (e)(2) of the FD&C Act, manufacturers and repackagers must affix or
imprint a product identifier to each package and homogenous case of a
product intended to be introduced in a transaction into commerce, by
November 2017 and November 2018, respectively.
    Other topics of interest to FDA that may be presented at the public
meeting include, but are not limited to:
     An assessment of the steps taken by supply chain members
to build capacity for a unit-level system for electronic product
tracing, including the impact on (1) the ability of the health care
system to maintain patient access to medicines; (2) the scalability of
such requirements, including as it relates to product lines; and (3)
the capability of different sectors and subsectors, including both
large and small businesses, to affix and utilize the product
identifier; and
     information related to the secure, interoperable
electronic data exchange among sectors within the pharmaceutical
distribution supply chain.
    FDA will post the agenda of the meeting at http://www.fda.gov/Drugs/NewsEvents/ucm519587.htm.

III. Registration

    Registration to attend is free and will be on a first-come, first-
served basis. To register for the meeting either: (1) Email your
registration information to<EMAIL_ADDRESS>or (2)
mail your registration information to the contact person (see FOR
FURTHER INFORMATION CONTACT). Registration information should include:
     ``Registration for October 14, 2016, DSCSA meeting'' in
the subject line, and
     Registrant name, company or organization, address, phone
number, and email address in the body of your email or mailing.
    Registration requests should be received by October 6, 2016. Onsite
registration on the day of the meeting, starting at 8 a.m., will be
based on space availability. Seating will be limited; therefore, if
registration meets the maximum capacity, FDA will post a notice closing
meeting registration for the meeting on FDA's Web site at: http://www.fda.gov/Drugs/NewsEvents/ucm519587.htm.
    If you need special accommodations due to a disability, please
contact Daniel Bellingham (see FOR FURTHER INFORMATION CONTACT) at
least 7 days in advance of the public meeting.

IV. Requests for Oral Presentations

    Any person interested in presenting at the public meeting should
include a request to present in a single email with a registration
request (see section III. Registration). The request should specify the
topic(s) that will be addressed in the presentation. FDA will do its
best to accommodate requests for oral presentations. Individuals and
organizations with common interests are encouraged to consolidate or
coordinate their presentations and can submit a single request to
present.
    All requests to make oral presentations must be received by October
5, 2016. Time allotted for each presentation may be limited. If the
number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled public comment session,
FDA may conduct a lottery to determine the speakers for the public
comment session. The contact person will notify interested persons
regarding their request to speak by October 7, 2016. Presenters must
email their presentation materials, if any, to
<EMAIL_ADDRESS>no later than October 12, 2016.
This meeting is not intended to be a venue for circulation of product-
specific promotional material, but rather an opportunity to gather
information related to stakeholder progress towards implementing the
product identification requirements of the DSCSA.

V. Webcasting of the Public Meeting

    Portions of this public meeting will be recorded and Webcast on the
day of the meeting. Information for how to access the Webcast will be
available at http://www.fda.gov/Drugs/NewsEvents/ucm519587.htm by
October 14, 2016. The Webcast will be conducted in listening mode only.

    Dated: September 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22441 Filed 9-16-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: March 19, 2010 (Volume 75, Number 53)]
[Notices]
[Page 13270-13271]
[DOCID:fr19mr10-59]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12841-001]

Ute Water Conservancy District; Notice of Application Accepted
for Filing and Soliciting Comments, Motions To Intervene, Protests,
Recommendations, and Terms and Conditions

March 12, 2010.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Conduit Exemption.
    b. Project No.: P-12841-001.
    c. Date filed: February 23, 2010.
    d. Applicant: Ute Water Conservancy District.
    e. Name of Project: Plateau Creek Hydroelectric Project.
    f. Location: The Plateau Creek Hydroelectric Project would be
located on the Plateau Creek Pipeline at the Rapid Creek Water
Treatment Plant, in Mesa County, Colorado. The land in which all the
project structures are located is owned by the applicant.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791a-825r.
    h. Applicant Contact: Mr. Larry Clever, General Manager, Ute Water
Conservancy District, 560 25 Road, P.O. Box 460, Grand Junction, CO
81502<EMAIL_ADDRESS>    i. FERC Contact: Kelly Houff,<PHONE_NUMBER><EMAIL_ADDRESS>    j. Status of Environmental Analysis: This application is ready for
environmental analysis at this time, and the Commission is requesting
comments, reply comments, recommendations, terms and conditions, and
prescriptions.
    k. Deadline for filing responsive documents: Due to the small size
and location of the proposed project in a closed system, as well as the
resource agency consultation letters filed with the application, the
60-day timeframe specified in 18 CFR 4.43(b) for filing all comments,
motions to intervene, protests, recommendations, terms and conditions,
and prescriptions is shortened to 30 days from the issuance date of
this notice. All reply comments filed in response to comments submitted
by any resource agency, Indian tribe, or person, must be filed with the
Commission within 45 days from the issuance date of this notice.
    Comments, protests, and interventions may be filed electronically
via the Internet in lieu of paper; see 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site under the ``e-Filing''
link. The Commission strongly encourages electronic filings.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person in the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    l. Description of Project: The proposed Plateau Creek Hydroelectric
Project consists of: (1) A proposed turbine generating unit having an
installed capacity of 610 kilowatts at the

existing flow control vault of the Rapid Creek Water Treatment Plant;
and (2) appurtenant facilities. The project would have an estimated
annual generation of 2,400 megawatt-hours that would be used on-site
with any excess being sold to a local utility.
    m. This filing is available for review and reproduction at the
Commission in the Public Reference Room, Room 2A, 888 First Street,
NE., Washington, DC 20426. The filing may also be viewed on the Web at
http://www.ferc.gov using the ``eLibrary'' link. Enter the docket
number, here P-12841-001, in the docket number field to access the
document. For assistance, call toll-free 1-866-208-3676 or e-mail
<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>. A copy is
also available for review and reproduction at the address in item h
above.
    n. Development Application--Any qualified applicant desiring to
file a competing application must submit to the Commission, on or
before the specified deadline date for the particular application, a
competing development application, or a notice of intent to file such
an application. Submission of a timely notice of intent allows an
interested person to file the competing development application no
later than 120 days after the specified deadline date for the
particular application. Applications for preliminary permits will not
be accepted in response to this notice.
    o. Notice of Intent--A notice of intent must specify the exact
name, business address, and telephone number of the prospective
applicant, and must include an unequivocal statement of intent to
submit a competing development application. A notice of intent must be
served on the applicant(s) named in this public notice.
    p. Protests or Motions to Intervene--Anyone may submit a protest or
a motion to intervene in accordance with the requirements of Rules of
Practice and Procedure, 18 CFR 385.210, 385.211, and 385.214. In
determining the appropriate action to take, the Commission will
consider all protests filed, but only those who file a motion to
intervene in accordance with the Commission's Rules may become a party
to the proceeding. Any protests or motions to intervene must be
received on or before the specified deadline date for the particular
application.
    p. All filings must (1) bear in all capital letters the title
``PROTEST'', ``MOTION TO INTERVENE'', ``NOTICE OF INTENT TO FILE
COMPETING APPLICATION'', ``COMPETING APPLICATION'', ``COMMENTS'',
``REPLY COMMENTS,'' ``RECOMMENDATIONS,'' ``TERMS AND CONDITIONS,'' or
``PRESCRIPTIONS;'' (2) set forth in the heading the name of the
applicant and the project number of the application to which the filing
responds; (3) furnish the name, address, and telephone number of the
person protesting or intervening; and (4) otherwise comply with the
requirements of 18 CFR 385.2001 through 385.2005. All comments,
recommendations, terms and conditions or prescriptions must set forth
their evidentiary basis and otherwise comply with the requirements of
18 CFR 4.34(b). Agencies may obtain copies of the application directly
from the applicant. Any of these documents must be filed by providing
the original and eight copies to: The Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426. An
additional copy must be sent to Director, Division of Hydropower
Administration and Compliance, Office of Energy Projects, Federal
Energy Regulatory Commission, at the above address. A copy of any
protest or motion to intervene must be served upon each representative
of the applicant specified in the particular application. A copy of all
other filings in reference to this application must be accompanied by
proof of service on all persons listed in the service list prepared by
the Commission in this proceeding, in accordance with 18 CFR 4.34(b)
and 385.2010.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-6012 Filed 3-18-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 46 (Friday, March 10, 2017)]
[Notices]
[Page 13337]
[FR Doc No: 2017-04759]

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

[9931-93-OEI]

Cross-Media Electronic Reporting: Authorized Program Revision
Approval, State of North Carolina

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces EPA's approval of the State of North
Carolina's request to revise its EPA Administered Permit Programs: The
National Pollutant Discharge Elimination System and General
Pretreatment Regulations for Existing and New Sources of Pollution EPA-
authorized program to allow electronic reporting.

DATES: EPA's approval is effective March 10, 2017.

FOR FURTHER INFORMATION CONTACT: Karen Seeh, U.S. Environmental
Protection Agency, Office of Environmental Information, Mail Stop
2823T, 1200 Pennsylvania Avenue NW., Washington, DC 20460, (202) 566-
1175<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On October 13, 2005, the final Cross-Media
Electronic Reporting Rule (CROMERR) was published in the Federal
Register (70 FR 59848) and codified as part 3 of title 40 of the CFR.
CROMERR establishes electronic reporting as an acceptable regulatory
alternative to paper reporting and establishes requirements to assure
that electronic documents are as legally dependable as their paper
counterparts. Subpart D of CROMERR requires that state, tribal or local
government agencies that receive, or wish to begin receiving,
electronic reports under their EPA-authorized programs must apply to
EPA for a revision or modification of those programs and obtain EPA
approval. Subpart D provides standards for such approvals based on
consideration of the electronic document receiving systems that the
state, tribe, or local government will use to implement the electronic
reporting. Additionally, Sec.  3.1000(b) through (e) of 40 CFR part 3,
subpart D provides special procedures for program revisions and
modifications to allow electronic reporting, to be used at the option
of the state, tribe or local government in place of procedures
available under existing program-specific authorization regulations. An
application submitted under the subpart D procedures must show that the
state, tribe or local government has sufficient legal authority to
implement the electronic reporting components of the programs covered
by the application and will use electronic document receiving systems
that meet the applicable subpart D requirements.
    On November 3rd 2016, the North Carolina Department of Environment
and Natural Resources (NC DENR) submitted an application titled
Electronic Discharge Monitoring Report System for revision/modification
to its EPA-approved program under title 40 CFR to allow new electronic
reporting. EPA reviewed NC DENR's request to revise its EPA-authorized
Part 123--EPA Administered Permit Programs: The National Pollutant
Discharge Elimination System and General Pretreatment Regulations for
Existing and New Sources of Pollution program and, based on this
review, EPA determined that the application met the standards for
approval of authorized program revision/modification set out in 40 CFR
part 3, subpart D. In accordance with 40 CFR 3.1000(d), this notice of
EPA's decision to approve North Carolina's request to revise its Part
123--EPA Administered Permit Programs: The National Pollutant Discharge
Elimination System and General Pretreatment Regulations for Existing
and New Sources of Pollution program to allow electronic reporting
under 40 CFR part 122 is being published in the Federal Register.
    NC DENR was notified of EPA's determination to approve its
application with respect to the authorized program listed above.

Matthew Leopard,
Director, Office of Information Management.
[FR Doc. 2017-04759 Filed 3-9-17; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: December 9, 2008 (Volume 73, Number 237)]
[Proposed Rules]
[Page 74661-74663]
[DOCID:fr09de08-16]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-28077; Directorate Identifier 2007-NE-20-AD]
RIN 2120-AA64

Airworthiness Directives; Turbomeca S.A. Arriel 2B, 2B1, and 2B1A
Turboshaft Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above. This proposed AD results from mandatory
continuing airworthiness information (MCAI) provided by the aviation
authority of France to identify and correct an unsafe condition on an
aviation product. The MCAI states the following:

    Several cases of Gas Generator Turbine (HP Turbine) blade
rearward displacement have been detected during borescope inspection
or in repair centre following engine disassembly. Two of them
resulted in blade rubs between the rear face of the fir-tree roots
and the rear bearing support cover. High HP blade rearward
displacement can potentially result in blade release due to fatigue
of the blade, which would cause an uncommanded in-flight engine
shutdown.

We are proposing this AD to prevent an uncommanded in-flight engine
shutdown which could result in an emergency autorotation landing or, at
worst, an accident.

DATES: We must receive comments on this proposed AD by January 8, 2009.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
the same as the Mail address provided in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Christopher Spinney, Aerospace
Engineer, Engine Certification Office, FAA, Engine & Propeller
Directorate, 12 New England Executive Park, Burlington, MA 01803; e-
mail<EMAIL_ADDRESS>telephone<PHONE_NUMBER>; fax (781)
238-7199.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2007-
28077; Directorate Identifier 2007-NE-27-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact
with FAA personnel concerning this proposed AD. Using the search
function of the Web site, anyone can find and read the comments in any
of our dockets, including, if provided, the name of the individual who
sent the comment (or signed the comment on behalf of an association,
business, labor union, etc.). You may review the DOT's complete Privacy
Act Statement in the Federal Register published on April 11, 2000 (65
FR 19477-78).

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2007-0109, dated April 19, 2007 (referred to
after this as ``the MCAI''), to correct an unsafe condition for the
specified products. The EASA AD states:

    Several cases of Gas Generator Turbine (HP Turbine) blade
rearward displacement have been detected during borescope inspection
or in repair centre following engine disassembly. Two of them
resulted in blade rubs between the rear face of the fir-tree roots
and the rear bearing support cover.
    High HP blade rearward displacement can potentially result in
blade release due to fatigue of the blade, which would cause an
uncommanded in-flight engine shutdown.
    The evaluation of this condition has prompted to require a
periodic borescope inspection in order to detect HP blade rearward
displacement. Additionally, in case displacement is found above the
specified limit, removal of Module 03 is required.

You may obtain further information by examining the EASA AD in the AD
docket.

Relevant Service Information

    Turbomeca S.A. has issued Mandatory Service Bulletin No. 292 72

2825, Original Issue, dated April 5, 2007. The actions described in
this service information are intended to correct the unsafe condition
identified in the EASA AD.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of France,
and is approved for operation in the United States. Pursuant to our
bilateral agreement with France, they have notified us of the unsafe
condition described in the EASA AD and service information referenced
above. We are proposing this AD because we evaluated all information
provided by EASA, and determined the unsafe condition exists and is
likely to exist or develop on other products of the same type design.
This proposed AD would require inspecting for HP blade rearward
displacement.

Costs of Compliance

    We estimate that this proposed AD would affect about 248 engines on
helicopters of U.S. registry. We also estimate that it would take about
2 work-hours per engine to perform the proposed actions and that the
average labor rate is $80 per work-hour. Based on these figures, we
estimate the total cost of the proposed AD to U.S. operators to be
$39,680. Our cost estimate is exclusive of possible warranty coverage.

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

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. 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.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

    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]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Turbomeca S.A.: Docket No. FAA-2007-28077; Directorate Identifier
2007-NE-20-AD.

Comments Due Date

    (a) We must receive comments by January 8, 2009.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Turbomeca S.A. Arriel 2B, 2B1, and 2B1A
turboshaft engines. These engines are installed on, but not limited
to, Eurocopter AS 350 B3 and EC 130 B4 helicopters.

Reason

    (d) Several cases of Gas Generator Turbine (HP Turbine) blade
rearward displacement have been detected during borescope inspection
or in repair centre following engine disassembly. Two of them
resulted in blade rubs between the rear face of the fir-tree roots
and the rear bearing support cover. High HP blade rearward
displacement can potentially result in blade release due to fatigue
of the blade, which would cause an uncommanded in-flight engine
shutdown.
    We are issuing this AD to prevent an uncommanded in-flight
engine shutdown which could result in an emergency autorotation
landing or, at worst, an accident.

Actions and Compliance

    (e) Unless already done, do the following actions:

Initial Inspection

    (1) Perform an initial HP turbine borescope inspection according
to Turbomeca S.A. Mandatory Service Bulletin (MSB) No. 292 72 2825,
dated April 5, 2007 as follows:
    (i) For engines with fewer than 500 hours and 450 cycles since
new or since the last HP turbine borescope inspection, inspect
before reaching 600 hours or 500 cycles whichever occurs first.
Replace HP turbine modules with rearward turbine blade displacement
greater than 0.5 mm.
    (ii) For the remaining engines, inspect within the next 100
hours. Replace HP turbine modules with rearward turbine blade
displacement greater than 0.5 mm.

Repetitive Inspections

    (2) Perform repetitive HP turbine borescope inspections
according to Turbomeca S.A. MSB No. 292 72 2825, dated April 5,
2007:
    (i) Within 600 hours or 500 cycles from the previous inspection,
whichever occurs first, if the rearward displacement of the turbine
blades was less than 0.2 mm. Replace HP turbine modules with
rearward turbine blade displacement greater than 0.5 mm.
    (ii) Within 100 hours of the previous inspection if the rearward
displacement of the turbine blades was between 0.2 mm and 0.5 mm.
Replace HP turbine modules with rearward turbine blade displacement
greater than 0.5 mm.
    (3) After each inspection, the compliance certificate must be
sent to Turbomeca S.A. within 7 days, according to Sec.  2.D(1)(c)
of Turbomeca S.A. MSB No. 292 72 2825, dated April 5, 2007.

FAA AD Differences

    (f) We modified the drawdown times to be more consistent with
the compliance times.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Engine Certification Office, FAA, has the authority to approve AMOCs
for this AD, if requested using the procedures found in 14 CFR
39.19.
    (2) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act, the
Office of Management and Budget (OMB) has approved the information
collection requirements and has assigned OMB Control Number 2120-
0056.

Related Information

    (h) Refer to EASA Airworthiness Directive 2007-0109, dated April
19, 2007, and Turbomeca S.A. MSB No. 292 72 2825, dated April 5,
2007, for related information.
    (i) Contact Christopher Spinney, Aerospace Engineer, Engine
Certification Office, FAA, Engine & Propeller Directorate, 12 New
England Executive Park, Burlington, MA

01803; e-mail<EMAIL_ADDRESS>telephone (781) 238-
7175; fax<PHONE_NUMBER>, for more information about this AD.

    Issued in Burlington, Massachusetts, on December 2, 2008.
Peter A. White,
Assistant Manager, Engine and Propeller Directorate, Aircraft
Certification Service.
[FR Doc. E8-29102 Filed 12-8-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 51 (Monday, March 17, 2014)]
[Notices]
[Pages 14724-14725]
[FR Doc No: 2014-05795]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket No. FEMA-2014-0002; Internal Agency Docket No. FEMA-B-1347]

Proposed Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency; DHS.

ACTION: Notice; correction.

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SUMMARY: On September 23, 2013, FEMA published in the Federal Register
a proposed flood hazard determination notice that contained an
erroneous table. This notice provides corrections to that table, to be
used in lieu of the information published at 78 FR 58338. The table
provided here represents the proposed flood hazard determinations and
communities affected for Navajo County, Arizona, and Incorporated
Areas.

DATES: Comments are to be submitted on or before June 16, 2014.

ADDRESSES: The Preliminary Flood Insurance Rate Map (FIRM), and where
applicable, the Flood Insurance Study (FIS) report for each community
are available for inspection at both the online location and the
respective Community Map Repository address listed in the table below.
Additionally, the current effective FIRM and FIS report for each
community are accessible online through the FEMA Map Service Center at
www.msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-1347, to
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance
and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC
20472,<PHONE_NUMBER>, or (email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
FEMA, 500 C Street SW., Washington, DC 20472,<PHONE_NUMBER> or (email)
<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard
determinations for each community listed in the table below, in
accordance with Section 110 of the Flood Disaster Protection Act of
1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
    These proposed flood hazard determinations, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own, or pursuant to policies
established by other Federal, State, or regional entities. These flood
hazard determinations are used to meet the floodplain management
requirements of the NFIP and are also used to calculate the appropriate
flood insurance premium

rates for new buildings built after the FIRM and FIS report become
effective.
    Use of a Scientific Resolution Panel (SRP) is available to
communities in support of the appeal resolution process. SRPs are
independent panels of experts in hydrology, hydraulics, and other
pertinent sciences established to review conflicting scientific and
technical data and provide recommendations for resolution. Use of the
SRP may only be exercised after FEMA and local communities have been
engaged in a collaborative consultation process for at least 60 days
without a mutually acceptable resolution of an appeal. Additional
information regarding the SRP process can be found online at http://floodsrp.org/pdfs/srp_fact_sheet.pdf.
    The communities affected by the flood hazard determinations are
provided in the table below. Any request for reconsideration of the
revised flood hazard determinations shown on the Preliminary FIRM and
FIS report that satisfies the data requirements outlined in 44 CFR
67.6(b) is considered an appeal. Comments unrelated to the flood hazard
determinations will also be considered before the FIRM and FIS report
are made final.

Correction

    In the proposed flood hazard determination notice published at 78
FR 58338 in the September 23, 2013, issue of the Federal Register, FEMA
published a table titled Navajo County, Arizona, and Incorporated
Areas. This table contained inaccurate information as to the community
map repository for the City of Show Low, the Town of Pinetop-Lakeside,
and the Unincorporated Areas of Navajo County featured in the table. In
this document, FEMA is publishing a table containing the accurate
information. The information provided below should be used in lieu of
that previously published.

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
             Navajo County, Arizona, and Incorporated Areas
------------------------------------------------------------------------
Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
------------------------------------------------------------------------
City of Holbrook.......................  465 1st Avenue, Holbrook, AZ
                                          86025.
City of Show Low.......................  180 North 9th Street, Show Low,
                                          AZ 85901.
Town of Pinetop-Lakeside...............  1360 North Niels Hansen Lane,
                                          Lakeside, AZ 85929.
Unincorporated Areas of Navajo County..  Navajo County Flood Control
                                          District, 100 East Code
                                          Talkers Drive, Holbrook, AZ
                                          86025.
------------------------------------------------------------------------

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: March 7, 2014.
Roy E. Wright,
Deputy Associate Administrator for Mitigation, Department of Homeland
Security, Federal Emergency Management Agency.
[FR Doc. 2014-05795 Filed 3-14-14; 8:45 am]
BILLING CODE 9110-12-P