[Federal Register: February 8, 2010 (Volume 75, Number 25)]
[Rules and Regulations]
[Page 6120-6123]
[DOCID:fr08fe10-13]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 64

[Docket ID FEMA-2010-0003; Internal Agency Docket No. FEMA-8119]

Suspension of Community Eligibility

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule.

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SUMMARY: This rule identifies communities, where the sale of flood
insurance has been authorized under the National Flood Insurance
Program (NFIP), that are scheduled for suspension on the effective
dates listed within this rule because of noncompliance with the
floodplain management requirements of the program. If the Federal
Emergency Management Agency (FEMA) receives documentation that the
community has adopted the required floodplain management measures prior
to the effective suspension date given in this rule, the suspension
will not occur and a notice of this will be provided by publication in
the Federal Register on a subsequent date.

DATES: Effective Dates: The effective date of each community's
scheduled suspension is the third date (``Susp.'') listed in the third
column of the following tables.

FOR FURTHER INFORMATION CONTACT: If you want to determine whether a
particular community was suspended on the suspension date or for
further information, contact David Stearrett, Mitigation Directorate,
Federal Emergency Management Agency, 500 C Street, SW., Washington, DC
20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The NFIP enables property owners to purchase
flood insurance which is generally not otherwise available. In return,
communities agree to adopt and administer local floodplain management
aimed at protecting lives and new construction from future flooding.
Section 1315 of the National Flood Insurance Act of 1968, as amended,
42 U.S.C. 4022, prohibits flood insurance coverage as authorized under
the NFIP, 42 U.S.C. 4001 et seq.; unless an appropriate public body
adopts adequate floodplain management measures with effective
enforcement measures. The communities listed in this document no longer
meet that statutory requirement for compliance with program
regulations, 44 CFR part 59. Accordingly, the communities will be
suspended on the effective date in the third column. As of that date,
flood insurance will no longer be available in the community. However,
some of these communities may adopt and submit the required
documentation of legally enforceable floodplain management measures
after this rule is published but prior to the actual suspension date.
These communities will not be suspended and will continue their
eligibility for the sale of insurance. A notice withdrawing the
suspension of the communities will be published in the Federal
Register.
    In addition, FEMA has identified the Special Flood Hazard Areas
(SFHAs) in these communities by publishing a Flood Insurance Rate Map
(FIRM). The date of the FIRM, if one has been published, is indicated
in the fourth column of the table. No direct Federal financial
assistance (except assistance pursuant to the Robert T. Stafford
Disaster Relief and Emergency Assistance Act not in connection with a
flood) may legally be provided for construction or acquisition of
buildings in identified SFHAs for communities not participating in the
NFIP and identified for more than a year, on FEMA's initial flood
insurance map of the community as having flood-prone areas (section
202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a),
as amended). This prohibition against certain types of Federal
assistance becomes effective for the communities listed on the date
shown in the last column. The Administrator finds that notice and
public comment under 5 U.S.C. 553(b) are impracticable and unnecessary
because communities listed in this final rule have been adequately
notified.
    Each community receives 6-month, 90-day, and 30-day notification
letters addressed to the Chief Executive Officer stating that the
community will be suspended unless the required floodplain management
measures are met prior to the effective suspension date. Since these
notifications were made, this final rule may take effect within less
than 30 days.

    National Environmental Policy Act. This rule is categorically
excluded from the requirements of 44 CFR part 10, Environmental
Considerations. No environmental impact assessment has been prepared.
    Regulatory Flexibility Act. The Administrator has determined that
this rule is exempt from the requirements of the Regulatory Flexibility
Act because the National Flood Insurance Act of 1968, as amended, 42
U.S.C. 4022, prohibits flood insurance coverage unless an appropriate
public body adopts adequate floodplain management measures with
effective enforcement measures. The communities listed no longer comply
with the statutory requirements, and after the effective date, flood
insurance will no longer be available in the communities unless
remedial action takes place.
    Regulatory Classification. This final rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
    Executive Order 13132, Federalism. This rule involves no policies
that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This rule meets the
applicable standards of Executive Order 12988.
    Paperwork Reduction Act. This rule does not involve any collection
of information for purposes of the Paperwork Reduction Act, 44 U.S.C.
3501 et seq.

List of Subjects in 44 CFR Part 64

    Flood insurance, Floodplains.

0
Accordingly, 44 CFR part 64 is amended as follows:

PART 64--[AMENDED]

0
1. The authority citation for part 64 continues to read as follows:

    Authority:  42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp.; p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp.; p. 376.

Sec.  64.6  [Amended]

0
2. The tables published under the authority of Sec.  64.6 are amended
as follows:

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                                                Effective date
                                                authorization/
                                  Community     cancellation of    Current effective map   Date certain Federal
      State and location             No.         sale of flood             date            assistance no longer
                                                 insurance in                               available in SFHAs
                                                   community
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           Region II

New York:
    Cincinnatus, Town of,             360177  July 7, 1975,       March 2, 2010.........  March 2, 2010
     Cortland County.                          Emerg; May 15,
                                               1985, Reg; March
                                               2, 2010, Susp.
    Cortland, City of,                360178  February 3, 1975,   ......do*.............   Do.
     Cortland County.                          Emerg; August 15,
                                               1983, Reg; March
                                               2, 2010, Susp.
    Cortlandville, Town of,           360179  June 24, 1975,      ......do*.............   Do.
     Cortland County.                          Emerg; August 15,
                                               1983, Reg; March
                                               2, 2010, Susp.
    Cuyler, Town of, Cortland         361386  June 6, 1977,       ......do*.............   Do.
     County.                                   Emerg; May 15,
                                               1985, Reg; March
                                               2, 2010, Susp.
    Freetown, Town of,                361325  June 19, 2007,      ......do*.............   Do.
     Cortland County.                          Emerg; N/A, Reg;
                                               March 2, 2010,
                                               Susp.
    Harford, Town of, Cortland        360180  June 26, 1975,      ......do*.............   Do.
     County.                                   Emerg; May 15,
                                               1985, Reg; March
                                               2, 2010, Susp.
    Homer, Town of, Cortland          360181  January 15, 1975,   ......do*.............   Do.
     County.                                   Emerg; August 15,
                                               1983, Reg; March
                                               2, 2010, Susp.
    Homer, Village of,                360182  October 10, 1974,   ......do*.............   Do.
     Cortland County.                          Emerg; August 15,
                                               1983, Reg; March
                                               2, 2010, Susp.
    Lapeer, Town of, Cortland         361326  November 4, 1976,   ......do*.............   Do.
     County.                                   Emerg; July 20,
                                               1984, Reg; March
                                               2, 2010, Susp.
    Marathon, Village of,             360183  November 21, 1974,  ......do*.............   Do.
     Cortland County.                          Emerg; October
                                               15, 1982, Reg;
                                               March 2, 2010,
                                               Susp.
    McGraw, Village of,               360184  March 12, 1975,     ......do*.............   Do.
     Cortland County.                          Emerg; December
                                               1, 1982, Reg;
                                               March 2, 2010,
                                               Susp.
    Preble, Town of, Cortland         360185  June 19, 1975,      ......do*.............   Do.
     County.                                   Emerg; May 15,
                                               1985, Reg; March
                                               2, 2010, Susp.
    Scott, Town of, Cortland          361328  December 17, 1975,  ......do*.............   Do.
     County.                                   Emerg; May 15,
                                               1985, Reg; March
                                               2, 2010, Susp.
    Solon, Town of, Cortland          361329  February 2, 1976,   ......do*.............   Do.
     County.                                   Emerg; May 15,
                                               1985, Reg; March
                                               2, 2010, Susp.
    Taylor, Town of, Cortland         361330  May 19, 1977,       ......do*.............   Do.
     County.                                   Emerg; May 15,
                                               1985, Reg; March
                                               2, 2010, Susp.
    Truxton, Town of, Cortland        360186  September 12,       ......do*.............   Do.
     County.                                   1975, Emerg; May
                                               15, 1985, Reg;
                                               March 2, 2010,
                                               Susp.
    Virgil, Town of, Cortland         360187  March 31, 1975,     ......do*.............   Do.
     County.                                   Emerg; May 15,
                                               1985, Reg; March
                                               2, 2010, Susp.
    Willet, Town of, Cortland         361331  January 21, 1977,   ......do*.............   Do.
     County.                                   Emerg; July 20,
                                               1984, Reg; March
                                               2, 2010, Susp.

           Region II

West Virginia: Franklin, Town         540154  July 2, 1975,       ......do*.............   Do.
 of, Pendleton County.                         Emerg; September
                                               1, 1987, Reg;
                                               March 2, 2010,
                                               Susp.

           Region IV

Mississippi:
    Forrest County,                   280052  March 6, 1975,      ......do*.............   Do.
     Unincorporated Areas.                     Emerg; April 2,
                                               1990, Reg; March
                                               2, 2010, Susp.

    Hattiesburg, City of,             280053  April 3, 1970,      ......do*.............   Do.
     Forrest and Lamar                         Emerg; April 3,
     Counties.                                 1970, Reg; March
                                               2, 2010, Susp.
    Lamar County,                     280304  April 16, 1979,     ......do*.............   Do.
     Unincorporated Areas.                     Emerg; April 2,
                                               1990, Reg; March
                                               2, 2010, Susp.
    Lumberton, City of, Lamar         280337  N/A, Emerg;         ......do*.............   Do.
     and Pearl River Counties.                 February 26,
                                               2009, Reg; March
                                               2, 2010, Susp.
    Petal, City of, Forrest           280260  September 27,       ......do*.............   Do.
     County.                                   1974, Emerg;
                                               April 15, 1980,
                                               Reg; March 2,
                                               2010, Susp.
    Purvis, Town of, Lamar            280318  May 14, 1980,       ......do*.............   Do.
     County.                                   Emerg; March 1,
                                               1987, Reg; March
                                               2, 2010, Susp.
    Sumrall, Town of, Lamar           280326  April 22, 1983,     ......do*.............   Do.
     County.                                   Emerg; August 19,
                                               1985, Reg; March
                                               2, 2010, Susp.
Tennessee: Fentress County,           470343  November 30, 2006,  ......do*.............   Do.
 Unincorporated Areas.                         Emerg; April 1,
                                               2007, Reg; March
                                               2, 2010, Susp.

           Region V

Ohio:
    Camden, Village of, Preble        390461  June 28, 1984,      ......do*.............   Do.
     County.                                   Emerg; June 28,
                                               1984, Reg; March
                                               2, 2010, Susp.
    Coshocton, City of,               390089  July 24, 1975,      ......do*.............   Do.
     Coshocton County.                         Emerg; December
                                               18, 1986, Reg;
                                               March 2, 2010,
                                               Susp.
    Coshocton County,                 390765  February 28, 1977,  ......do*.............   Do.
     Unincorporated Areas.                     Emerg; February
                                               4, 1987, Reg;
                                               March 2, 2010,
                                               Susp.
    Eaton, City of, Preble            390462  February 14, 1975,  ......do*.............   Do.
     County.                                   Emerg; April 15,
                                               1981, Reg; March
                                               2, 2010, Susp.
    New Paris, Village of,            390463  March 3, 1975,      ......do*.............   Do.
     Preble County.                            Emerg; April 15,
                                               1981, Reg; March
                                               2, 2010, Susp.
    Preble County,                    390460  February 12, 1982,  ......do*.............   Do.
     Unincorporated Areas.                     Emerg; February
                                               12, 1982, Reg;
                                               March 2, 2010,
                                               Susp.
    Warsaw, Village of,               390733  August 26, 1977,    ......do*.............   Do.
     Coshocton County.                         Emerg; September
                                               1, 1987, Reg;
                                               March 2, 2010,
                                               Susp.
    West Alexandria, Village          390905  N/A, Emerg; May     ......do*.............   Do.
     of, Preble County.                        21, 2001, Reg;
                                               March 2, 2010,
                                               Susp.
    West Lafayette, Village           390814  August 26, 1977,    ......do*.............   Do.
     of, Coshocton County.                     Emerg; March 22,
                                               1982, Reg; March
                                               2, 2010, Susp.
Wisconsin:
    Bloomer, City of, Chippewa        550042  March 20, 1975,     ......do*.............   Do.
     County.                                   Emerg; August 19,
                                               1991, Reg; March
                                               2, 2010, Susp.
    Cadott, Village of,               550043  January 23, 1975,   ......do*.............   Do.
     Chippewa County.                          Emerg; March 5,
                                               1996, Reg; March
                                               2, 2010, Susp.
    Chippewa County,                  555549  March 26, 1971,     ......do*.............   Do.
     Unincorporated Areas.                     Emerg; June 22,
                                               1973, Reg; March
                                               2, 2010, Susp.
    Chippewa Falls, City of,          550044  April 16, 1971,     ......do*.............   Do.
     Chippewa County.                          Emerg; September
                                               1, 1977, Reg;
                                               March 2, 2010,
                                               Susp.
    Cornell, City of, Chippewa        550045  September 25,       ......do*.............   Do.
     County.                                   1974, Emerg;
                                               September 28,
                                               1990, Reg; March
                                               2, 2010, Susp.
    Eau Claire, City of,              550128  March 19, 1971,     ......do*.............   Do.
     Chippewa and Eau Claire                   Emerg; June 1,
     Counties.                                 1977, Reg; March
                                               2, 2010, Susp.
    Stanley, City of, Chippewa        550047  April 1, 1975,      ......do*.............   Do.
     and Clark Counties.                       Emerg; September
                                               18, 1985, Reg;
                                               March 2, 2010,
                                               Susp.

           Region VI

Arkansas:
    Atkins, City of, Pope             050304  August 7, 1975,     ......do*.............   Do.
     County.                                   Emerg; July 6,
                                               1982, Reg; March
                                               2, 2010, Susp.
    Dover, City of, Pope              050321  May 24, 1976,       ......do*.............   Do.
     County.                                   Emerg; March 15,
                                               1983, Reg; March
                                               2, 2010, Susp.
    London, Town of, Pope             050340  September 17,       ......do*.............   Do.
     County.                                   1975, Emerg; July
                                               13, 1982, Reg;
                                               March 2, 2010,
                                               Susp.
    Pope County,                      050458  April 8, 2005,      ......do*.............   Do.
     Unincorporated Areas.                     Emerg; July 1,
                                               2009, Reg; March
                                               2, 2010, Susp.
    Pottsville, Town of, Pope         050277  August 26, 1976,    ......do*.............   Do.
     County.                                   Emerg; April 15,
                                               1982, Reg; March
                                               2, 2010, Susp.
    Russellville, City of,            050178  July 17, 1970,      ......do*.............   Do.
     Pope County.                              Emerg; July 18,
                                               1970, Reg; March
                                               2, 2010, Susp.
Louisiana:
     Cotton Valley, Town of,          220322  December 21, 1978,  ......do*.............   Do.
     Webster Parish.                           Emerg; October
                                               15, 1985, Reg;
                                               March 2, 2010,
                                               Susp.
    Cullen, Town of, Webster          220235  April 30, 1975,     ......do*.............   Do.
     Parish.                                   Emerg; February
                                               12, 1979, Reg;
                                               March 2, 2010,
                                               Susp.

    Doyline, Village of,              220236  July 21, 1978,      ......do*.............   Do.
     Webster Parish.                           Emerg; September
                                               18, 1979, Reg;
                                               March 2, 2010,
                                               Susp.
    Minden, City of, Webster          220237  December 17, 1974,  ......do*.............   Do.
     Parish.                                   Emerg; July 18,
                                               1985, Reg; March
                                               2, 2010, Susp.
    Sibley, Village of,               220258  May 16, 1980,       ......do*.............   Do.
     Webster Parish.                           Emerg; July 18,
                                               1985, Reg; March
                                               2, 2010, Susp.
    Springhill, City of,              220238  March 12, 1975,     ......do*.............   Do.
     Webster Parish.                           Emerg; June 15,
                                               1981, Reg; March
                                               2, 2010, Susp.

           Region X

Oregon:
    Amity, City of, Yamhill           410250  May 20, 1975,       ......do*.............   Do.
     County.                                   Emerg; December
                                               1, 1981, Reg;
                                               March 2, 2010,
                                               Susp.
    Carlton, City of, Yamhill         410251  May 6, 1975,        ......do*.............   Do.
     County.                                   Emerg; June 30,
                                               1976, Reg; March
                                               2, 2010, Susp.
    Dayton, City of, Yamhill          410252  June 4, 1975,       ......do*.............   Do.
     County.                                   Emerg; June 1,
                                               1982, Reg; March
                                               2, 2010, Susp.
    Dundee, City of, Yamhill          410253  April 23, 1975,     ......do*.............   Do.
     County.                                   Emerg; March 1,
                                               1982, Reg; March
                                               2, 2010, Susp.
    Lafayette, City of,               410254  May 20, 1975,       ......do*.............   Do.
     Yamhill County.                           Emerg; June 15,
                                               1982, Reg; March
                                               2, 2010, Susp.
    McMinnville, City of,             410255  July 22, 1975,      ......do*.............   Do.
     Yamhill County.                           Emerg; December
                                               1, 1982, Reg;
                                               March 2, 2010,
                                               Susp.
    Newberg, City of, Yamhill         410256  August 5, 1974,     ......do*.............   Do.
     County.                                   Emerg; March 1,
                                               1982, Reg; March
                                               2, 2010, Susp.
    Sheridan, City of, Yamhill        410257  January 21, 1975,   ......do*.............   Do.
     County.                                   Emerg; August 1,
                                               1980, Reg; March
                                               2, 2010, Susp.
    Willamina, City of,               410258  January 21, 1975,   ......do*.............   Do.
     Yamhill County.                           Emerg; March 15,
                                               1982, Reg; March
                                               2, 2010, Susp.
    Yamhill, City of, Yamhill         410259  June 30, 1975,      ......do*.............   Do.
     County.                                   Emerg; March 1,
                                               1982, Reg; March
                                               2, 2010, Susp.
    Yamhill County,                   410249  May 28, 1974,       ......do*.............   Do.
     Unincorporated Areas.                     Emerg; September
                                               30, 1983, Reg;
                                               March 2, 2010,
                                               Susp.
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* do=Ditto.
Code for reading third column: Emerg.--Emergency; Reg.--Regular; Susp.--Suspension.

    Dated: February 2, 2010.
Sandra K. Knight,
Deputy Assistant Administrator for Mitigation, Department of Homeland
Security, Federal Emergency Management Agency.
[FR Doc. 2010-2615 Filed 2-5-10; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 86, Number 124 (Thursday, July 1, 2021)]
[Notices]
[Pages 35113-35116]
[FR Doc No: 2021-14114]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2021-0002; Internal Agency Docket No. FEMA-B-2147]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security.

ACTION: Notice.

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SUMMARY: This notice lists communities where the addition or
modification of Base Flood Elevations (BFEs), base flood depths,
Special Flood Hazard Area (SFHA) boundaries or zone designations, or
the regulatory floodway (hereinafter referred to as flood hazard
determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and
where applicable, in the supporting Flood Insurance Study (FIS)
reports, prepared by the Federal Emergency

Management Agency (FEMA) for each community, is appropriate because of
new scientific or technical data. The FIRM, and where applicable,
portions of the FIS report, have been revised to reflect these flood
hazard determinations through issuance of a Letter of Map Revision
(LOMR), in accordance with Federal Regulations. The LOMR will be used
by insurance agents and others to calculate appropriate flood insurance
premium rates for new buildings and the contents of those buildings.
For rating purposes, the currently effective community number is shown
in the table below and must be used for all new policies and renewals.

DATES: These flood hazard determinations will be finalized on the dates
listed in the table below and revise the FIRM panels and FIS report in
effect prior to this determination for the listed communities.
    From the date of the second publication of notification of these
changes in a newspaper of local circulation, any person has 90 days in
which to request through the community that the Deputy Associate
Administrator for Insurance and Mitigation reconsider the changes. The
flood hazard determination information may be changed during the 90-day
period.

ADDRESSES: The affected communities are listed in the table below.
Revised flood hazard information for each community is 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 https://msc.fema.gov for
comparison.
    Submit comments and/or appeals to the Chief Executive Officer of
the community as listed in the table below.

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
<EMAIL_ADDRESS>or visit the FEMA Mapping and Insurance
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The specific flood hazard determinations are
not described for each community in this notice. However, the online
location and local community map repository address where the flood
hazard determination information is available for inspection is
provided.
    Any request for reconsideration of flood hazard determinations must
be submitted to the Chief Executive Officer of the community as listed
in the table below.
    The modifications are made pursuant to section 201 of the Flood
Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance
with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq.,
and with 44 CFR part 65.
    The FIRM and FIS report are the basis of the floodplain management
measures that the community is required either to adopt or to show
evidence of having in effect in order to qualify or remain qualified
for participation in the National Flood Insurance Program (NFIP).
    These 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. The flood hazard
determinations are in accordance with 44 CFR 65.4.
    The affected communities are listed in the following table. Flood
hazard determination information for each community is 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 https://msc.fema.gov for
comparison.

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

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.

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                                                            Chief executive officer of                                    Online location of letter of map                            Community
         State and county          Location and case No.             community              Community map  repository                 revision                Date of  modification      No.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Arizona:
    Maricopa.....................  City of Buckeye (20-   The Honorable Eric Orsborn,     Engineering Department, 530    https://msc.fema.gov/portal/        Sep. 24, 2021.........       040039
                                    09-0491P).             Mayor, City of Buckeye, 530     East Monroe Avenue, Buckeye,   advanceSearch.
                                                           East Monroe Avenue, Buckeye,    AZ 85326.
                                                           AZ 85326.
    Maricopa.....................  City of Buckeye (21-   The Honorable Eric Orsborn,     Engineering Department, 530    https://msc.fema.gov/portal/        Sep. 10, 2021.........       040039
                                    09-0258P).             Mayor, City of Buckeye, 530     East Monroe Avenue, Buckeye,   advanceSearch.
                                                           East Monroe Avenue, Buckeye,    AZ 85326.
                                                           AZ 85326.
    Maricopa.....................  City of Goodyear (20-  The Honorable Georgia Lord,     Engineering and Development    https://msc.fema.gov/portal/        Sep. 24, 2021.........       040046
                                    09-1436P).             Mayor, City of Goodyear, 190    Services, 14455 West Van       advanceSearch.
                                                           North Litchfield Road,          Buren Street, Suite D101,
                                                           Goodyear, AZ 85338.             Goodyear, AZ 85338.
    Maricopa.....................  Unincorporated Areas   The Honorable Jack Sellers,     Flood Control District of      https://msc.fema.gov/portal/        Sep. 24, 2021.........       040037
                                    of Maricopa County     Chairman, Board of              Maricopa County, 2801 West     advanceSearch.
                                    (20-09-0491P).         Supervisors, Maricopa County,   Durango Street, Phoenix, AZ
                                                           301 West Jefferson Street,      85009.
                                                           10th Floor, Phoenix, AZ
                                                           85003.
California:
    San Luis Obispo..............  City of San Luis       The Honorable Heidi Harmon,     City Hall, 990 Palm Street,    https://msc.fema.gov/portal/        Oct. 4, 2021..........       060310
                                    Obispo (21-09-         Mayor, City of San Luis         San Luis Obispo, CA 93401.     advanceSearch.
                                    0591P).                Obispo, 990 Palm Street, San
                                                           Luis Obispo, CA 93401.

    Santa Clara..................  Unincorporated Areas   The Honorable Mike Wasserman,   Santa Clara County,            https://msc.fema.gov/portal/        Sep. 16, 2021.........       060337
                                    of Santa Clara         President, Board of             Department of Planning and     advanceSearch.
                                    County (20-09-         Supervisors, Santa Clara        Development, 70 West Hedding
                                    1627P).                County, 70 West Hedding         Street, 7th Floor East Wing,
                                                           Street, 10th Floor, San Jose,   San Jose, CA 95110.
                                                           CA 95110.
Florida:
    Bay..........................  City of Panama City    The Honorable Mark Sheldon,     City Hall, 110 South Arnold    https://msc.fema.gov/portal/        Sep. 22, 2021.........       120013
                                    Beach (19-04-5458P).   Mayor, City of Panama City      Road, Panama City Beach, FL    advanceSearch.
                                                           Beach, 17007 Panama City        32413.
                                                           Beach Parkway, Panama City
                                                           Beach, FL 32413.
    Bay..........................  City of Panama City    The Honorable Mark Sheldon,     City Hall, 110 South Arnold    https://msc.fema.gov/portal/        Sep. 22, 2021.........       120013
                                    Beach (19-04-5699P).   Mayor, City of Panama City      Road, Panama City Beach, FL    advanceSearch.
                                                           Beach, 17007 Panama City        32413.
                                                           Beach Parkway, Panama City
                                                           Beach, FL 32413.
    Bay..........................  Unincorporated Areas   Mr. Robert Carroll, Chairman,   Bay County Planning and        https://msc.fema.gov/portal/        Sep. 22, 2021.........       120004
                                    of Bay County (19-04-  Commissioner District 2, Bay    Zoning, 707 Jenks Avenue,      advanceSearch.
                                    5458P).                County, 840 West 11th Street,   Suite B, Panama City, FL
                                                           Panama City, FL 32401.          32401.
    St. Johns....................  Unincorporated Areas   Mr. Jeremiah Ray Blocker,       St. Johns County               https://msc.fema.gov/portal/        Sep. 21, 2021.........       125147
                                    of St. Johns County    Chair, St. Johns County Board   Administration Building,       advanceSearch.
                                    (20-04-5766P).         of County Commissioners, 500    4020 Lewis Speedway, St.
                                                           San Sebastian View, St.         Augustine, FL 32095.
                                                           Augustine, FL 32084.
    St. Johns....................  Unincorporated Areas   Mr. Jeremiah Ray Blocker,       St. Johns County               https://msc.fema.gov/portal/        Sep. 24, 2021.........       125147
                                    of St. Johns County    Chair, St. Johns County Board   Administration Building,       advanceSearch.
                                    (20-04-5819P).         of County Commissioners, 500    4020 Lewis Speedway, St.
                                                           San Sebastian View, St.         Augustine, FL 32095.
                                                           Augustine, FL 32084.
    St. Johns....................  Unincorporated Areas   Mr. Jeremiah Ray Blocker,       St. Johns County               https://msc.fema.gov/portal/        Oct. 4, 2021..........       125147
                                    of St. Johns County    Chair, St. Johns County Board   Administration Building,       advanceSearch.
                                    (21-04-0576P).         of County Commissioners, 500    4020 Lewis Speedway, St.
                                                           San Sebastian View, St.         Augustine, FL 32095.
                                                           Augustine, FL 32084.
Idaho:
    Ada..........................  City of Boise (21-10-  The Honorable Lauren McLean,    City Hall, 150 North Capitol   https://msc.fema.gov/portal/        Sep. 24, 2021.........       160002
                                    0103P).                Mayor, City of Boise, P.O.      Boulevard, Boise, ID 83701.    advanceSearch.
                                                           Box 500, Boise, ID 83701.
    Ada..........................  City of Star (20-10-   The Honorable Trevor Chadwick,  City Hall, 10769 West State    https://msc.fema.gov/portal/        Aug. 10, 2021.........       160236
                                    0725P).                Mayor, City of Star, P.O. Box   Street, Star, ID 83669.        advanceSearch.
                                                           130, Star, ID 83669.
    Ada..........................  Unincorporated Areas   Mr. Rod Beck, Chairman, County  Ada County Courthouse, 200     https://msc.fema.gov/portal/        Aug. 10, 2021.........       160001
                                    of Ada County (20-10-  Commissioner, District 2, Ada   West Front Street, Boise, ID   advanceSearch.
                                    0725P).                County, 200 West Front          83702.
                                                           Street, 3rd Floor, Boise, ID
                                                           83702.
Illinois:
    Kane.........................  Unincorporated Areas   The Honorable Corinne Pierog,   Kane County Government         https://msc.fema.gov/portal/        Sep. 10, 2021.........       170896
                                    of Kane County (21-    Chairman, Kane County Board,    Center, Water Resources        advanceSearch.
                                    05-0452P).             Kane County Government          Department, 719 South
                                                           Center, 719 South Batavia       Batavia Avenue, Building A,
                                                           Avenue, Building A, Geneva,     Geneva, IL 60134.
                                                           IL 60134.
    Kane.........................  Village of Pingree     The Honorable Steve Wiedmeyer,  Village Hall, 555 Reinking     https://msc.fema.gov/portal/        Sep. 10, 2021.........       171078
                                    Grove (21-05-0452P).   Village President, Village of   Road, Pingree Grove, IL        advanceSearch.
                                                           Pingree Grove, 555 Reinking     60140.
                                                           Road, Pingree Grove, IL
                                                           60140.
Nevada:

    Clark........................  City of Henderson (21- The Honorable Debra March,      Public Works Department, 240   https://msc.fema.gov/portal/        Oct. 1, 2021..........       320005
                                    09-0235P).             Mayor, City of Henderson,       South Water Street,            advanceSearch.
                                                           City Hall, 240 South Water      Henderson, NV 89015.
                                                           Street, Henderson, NV 89015.
    Clark........................  Unincorporated Areas   The Honorable Marilyn           Clark County, Office of the    https://msc.fema.gov/portal/        Sep. 9, 2021..........       320003
                                    of Clark County (21-   Kirkpatrick, Chair, Board of    Director of Public Works,      advanceSearch.
                                    09-0038P).             Commissioners, Clark County,    500 South Grand Central
                                                           500 South Grand Central         Parkway, 2nd Floor, Las
                                                           Parkway, 6th Floor, Las         Vegas, NV 89155.
                                                           Vegas, NV 89155.
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[FR Doc. 2021-14114 Filed 6-30-21; 8:45 am]
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[Federal Register Volume 78, Number 215 (Wednesday, November 6, 2013)]
[Notices]
[Pages 66743-66744]
[FR Doc No: 2013-26570]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]

Draft Guidance for Industry on Bioequivalence Recommendations for
Iron Sucrose; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Bioequivalence
Recommendations for Iron Sucrose.'' The recommendations provide
specific guidance on the design of bioequivalence (BE) studies to
support abbreviated new drug applications (ANDAs) for iron sucrose
injection. The draft guidance is a revised version of a previously
issued draft guidance on the same subject.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comments on
this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by January 6, 2014.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kris Andre, Center for Drug Evaluation
and Research (HFD-600), Food and Drug Administration, 7520 Standish
Pl., Rockville, MD 20855,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products,'' which
explained the process that would be used to make product-specific BE
recommendations available to the public on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. As described in that guidance, FDA adopted this process as
a means to develop and disseminate product-specific BE recommendations
and provide a meaningful opportunity for the public to consider and
comment on those recommendations. This notice announces the
availability of draft BE recommendations for iron sucrose injection
(Draft Iron Sucrose Injection BE Recommendations of 2013).
    Venofer (iron sucrose injection), new drug application 021135, was
initially approved by FDA in November 2000. There are no approved ANDAs
for this product.
    In March 2012, FDA posted on its Web site a draft guidance for
industry on the Agency's recommendations for BE studies to support
ANDAs for iron sucrose injection (Draft Iron Sucrose Injection BE
Recommendations of 2012). In that draft guidance, FDA recommended an in
vivo fasting BE study with pharmacokinetic endpoints and in vitro
studies. FDA has reconsidered the recommendations in the Draft Iron
Sucrose Injection BE Recommendations of 2012 and has decided to revise
it. At this time, FDA is withdrawing the Draft Iron Sucrose Injection
BE Recommendations of 2012 and is issuing a revised draft guidance for
industry, the Draft Iron Sucrose Injection BE Recommendations of 2013.
In this revised draft guidance, FDA recommends that for the in vivo
pharmacokinetic study the difference between total iron and
transferrin-bound iron be used to demonstrate BE of generic iron
sucrose injection products. FDA is no longer recommending baseline-
adjusted total iron and baseline-adjusted transferrin-bound iron be
used to demonstrate BE of generic iron sucrose injection products. The
revised draft guidance also provides updated information about the
recommended studies for in vitro characterization and criteria for
waiver of in vivo testing.
    In March 2005, Luitpold Pharmaceuticals, Inc. (Luitpold),
manufacturer of the reference listed drug, Venofer, submitted (through
its attorneys) a citizen petition requesting that FDA withhold approval
of any ANDA or 505(b)(2) application for a generic iron sucrose
injection unless certain conditions were satisfied, including
conditions related to demonstrating BE (Docket No. FDA-2005-P-0319,
formerly 2005P-0095/CP1). FDA is reviewing the issues raised in the
petition and is also reviewing the supplemental information and
comments that have been submitted to the docket for that petition. FDA
will consider any comments on the Draft Iron Sucrose Injection BE
Recommendations of 2013 before responding to Luitpold's citizen
petition.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on the design
of BE studies to support ANDAs for iron sucrose injection. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used if such
approach satisfies the

requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: October 31, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-26570 Filed 11-5-13; 8:45 am]
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