[Federal Register Volume 78, Number 225 (Thursday, November 21, 2013)]
[Notices]
[Page 69849]
[FR Doc No: 2013-27994]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2012-0780; FRL-9403-1]

Issuance of an Experimental Use Permit

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA has granted an experimental use permit (EUP) to the
pesticide applicant Monsanto Company. An EUP permits use of a pesticide
for experimental or research purposes only in accordance with the
limitations in the permit.

FOR FURTHER INFORMATION CONTACT: Robert McNally, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. Although this
action may be of particular interest to those persons who conduct or
sponsor research on pesticides, the Agency has not attempted to
describe all the specific entities that may be affected by this action.

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPP-2012-0780, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

II. EUP

    EPA has issued the following EUP:
    524-EUP-104. (EPA-HQ-OPP-2012-0780). Issuance. Monsanto Company,
800 N. Lindbergh Blvd., St. Louis, MO 63167. This EUP, issued on March
1, 2013, allows planting and associated activities, e.g., collection of
field data, harvesting, processing of corn plant incorporated
protectants (PIPs) seeds containing active ingredients, corn PIPs with
MON 87410 and MON 87411. The PIPs contain a Dv49 double stranded RNA
(dsRNA) suppression cassette in combination with Bacillus thuringiensis
(Bt) Cry Proteins (Cry1A.105, Cry2Ab2, Cry1F, Vip3Aa20, Cry3Bb1,
Cry34Ab1/Cry35Ab1, and eCry3.1Ab). Tests to control corn root worm
(CRW) are authorized from March 1, 2013, through February 28, 2015.
Field trials will be conducted in the U.S. territory of Puerto Rico and
in the following 22 U.S. states: Arkansas, California, Colorado,
Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Michigan,
Minnesota, Mississippi, Missouri, Nebraska, North Carolina, Ohio,
Pennsylvania, South Carolina, South Dakota, Tennessee, and Wisconsin.
Approximately 3,392,742 pounds (lb) of seed containing 48.41 lb (21,958
grams) of active ingredient (2.54, 4.04, 1.57, 12.68, 2.2 x
10-5, 8.45, 16.65, 0.41, and 2.07 lb of Cry1F, Cry1A.105,
Cry2Ab2, Vip3Aa20, Dv49 dsRNA, Cry3Bb1, Cry34Ab1, Cry35Ab1, eCry3.1Ab,
respectively) are to be planted over 20,893 acres, including Bt and
dsRNA PIP (17,740) and non-PIP (3,153) acreage. The two protocols in
the EUP include: (1) Seed development and increase for future testing
including nursery observations of traits in various genetic
backgrounds; and (2) product characterization work including phenotypic
and agronomic observations, efficacy and yield benefit evaluations
regulatory data generation.

    Authority: 7 U.S.C. 136c.

List of Subjects

    Environmental protection, Experimental use permits.

    Dated: November 7, 2013.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2013-27994 Filed 11-20-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 85 (Wednesday, May 3, 2023)]
[Notices]
[Pages 27900-27901]
[FR Doc No: 2023-09399]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-2870]

Decentralized Clinical Trials for Drugs, Biological Products, and
Devices; Draft Guidance for Industry, Investigators, and Other
Stakeholders; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry, investigators, and
other stakeholders entitled ``Decentralized Clinical Trials for Drugs,
Biological Products, and Devices.'' This draft guidance provides
recommendations for sponsors, investigators, and other stakeholders
regarding the implementation of decentralized clinical trials (DCTs)
for drugs, biological products, and devices. In this draft guidance, a
DCT refers to a clinical trial where some or all of the trial-related
activities occur at locations other than traditional clinical trial
sites.

DATES: Submit either electronic or written comments on the draft
guidance by August 1, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-2022-D-2870 for ``Decentralized Clinical Trials for Drugs,
Biological Products, and Devices.'' Received comments will be placed in
the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    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, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; or
the Office of Policy, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431,
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.

FOR FURTHER INFORMATION CONTACT: Ryan Robinson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3342, Silver Spring, MD 20993, 240-402-
9756; Diane Maloney, Center for Biologics Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993,<PHONE_NUMBER>; Soma Kalb, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. G318, Silver Spring, MD 20993-0002, 301-
796-6359; or Paul Kluetz, Oncology Center of Excellence, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2223, Silver
Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for
industry, investigators, and other stakeholders entitled
``Decentralized Clinical Trials for Drugs, Biological Products, and
Devices.'' This guidance fulfills the requirements set forth in section

3606(a)(1) of the Food and Drug Omnibus Reform Act (FDORA). The content
described in section 3606(b) of FDORA is further addressed through this
guidance's reference to FDA's draft guidance for industry,
investigators, and other stakeholders entitled ``Digital Health
Technologies for Remote Data Acquisition in Clinical Investigations''
(December 2021). In this draft guidance, a DCT refers to a clinical
trial where some or all of the trial-related activities occur at
locations other than traditional clinical trial sites. These trial-
related activities may take place at the location of trial participants
or in local healthcare facilities that are close to trial participants'
locations.
    DCTs may involve different levels of decentralization. In fully
decentralized clinical trials, all activities take place at locations
other than traditional trial sites. In hybrid DCTs, some activities
involve in-person visits by trial participants to traditional clinical
trial sites, and other visits or activities are conducted at locations
other than traditional clinical trial sites. FDA's regulatory
requirements are the same for DCTs and traditional site-based clinical
trials.
    DCTs may include the use of local healthcare providers and local
clinical laboratory facilities in the management of trial participants
and the use of telehealth and digital health technologies to remotely
acquire data. By allowing remote participation and reducing the need to
travel for face-to-face visits, DCTs may enhance convenience for study
participants, facilitate research on diseases affecting populations
with limited mobility, and reduce the burden on caregivers.
    The investigator in a DCT is responsible for the conduct of the DCT
and oversight of individuals delegated to perform trial-related
activities. In a DCT, the investigator still ensures that appropriate
informed consent is obtained, the investigational product is
appropriately administered in accordance with the protocol, and other
required safety and efficacy assessments are done with appropriate
documentation. Specific issues related to the feasibility, design,
implementation, or analysis of a DCT should be discussed with the
relevant FDA review division.
    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 current thinking of FDA on
``Decentralized Clinical Trials for Drugs, Biological Products, and
Devices.'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 11 have been approved under OMB control
number 0910-0303; the collections of information in 21 CFR part 312,
including Form FDA 1572, have been approved under OMB control number
0910-0014; the collections of information in 21 CFR part 812 and
812.140 have been approved under OMB control number 0910-0078; and the
collections of information in 21 CFR parts 50 and 56 have been approved
under OMB control number 0910-0130.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: April 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-09399 Filed 5-2-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 82 (Tuesday, April 29, 2014)]
[Notices]
[Pages 23993-23996]
[FR Doc No: 2014-09734]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2014-0002: Internal Agency Docket No. FEMA-B-1417]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

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 Title
44, Part 65 of the Code of Federal Regulations (44 CFR Part 65). 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 become effective 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 ninety (90)
days in which to request through the community that the Deputy
Associate Administrator for 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 www.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: 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: 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 www.msc.fema.gov for comparison.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         Chief executive                         Online location of
        State and county           Location and case       officer of         Community map        Letter of Map        Effective date of     Community
                                          No.               community          repository             Revision             modification          No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Arizona:
    Maricopa....................  City of Phoenix (13- The Honorable Greg  Street              http://                June 6, 2014.........       040051
                                   09-1002P).           Stanton, Mayor,     Transportation      www.msc.fema.gov/
                                                        City of Phoenix,    Department, 200     lomc.
                                                        200 West            West Washington
                                                        Washington          Street, 5th
                                                        Street, 11th        Floor, Phoenix,
                                                        Floor, Phoenix,     AZ 85003.
                                                        AZ 85003.
    Maricopa....................  City of Scottsdale   The Honorable W.J.  City Hall, 3939     http://                May 16, 2014.........       045012
                                   (13-09-2519P).       Lane, Mayor, City   North Drinkwater    www.msc.fema.gov/
                                                        of Scottsdale,      Boulevard,          lomc.
                                                        3939 North          Scottsdale, AZ
                                                        Drinkwater          85251.
                                                        Boulevard,
                                                        Scottsdale, AZ
                                                        85251.
    Maricopa....................  City of Scottsdale   The Honorable W.J.  City Hall, 3939     http://                May 23, 2014.........       045012
                                   (13-09-2520P).       Lane, Mayor, City   North Drinkwater    www.msc.fema.gov/
                                                        of Scottsdale,      Boulevard,          lomc.
                                                        3939 North          Scottsdale, AZ
                                                        Drinkwater          85251.
                                                        Boulevard,
                                                        Scottsdale, AZ
                                                        85251.
California:

    Nevada......................  Town of Truckee (13- The Honorable       Planning Division,  http://                May 19, 2014.........       060762
                                   09-1067P).           Patrick Flora,      10183 Truckee       www.msc.fema.gov/
                                                        Mayor, Town of      Airport Road,       lomc.
                                                        Truckee, 10183      Truckee, CA 96161.
                                                        Truckee Airport
                                                        Road, Truckee, CA
                                                        96161.
    Riverside...................  City of Indio (13-   The Honorable       City Hall, 100      http://                May 12, 2014.........       060255
                                   09-3081P).           Michael Wilson,     Civic Center        www.msc.fema.gov/
                                                        Mayor, City of      Mall, Indio, CA     lomc.
                                                        Indio, 100 Civic    92201.
                                                        Center Mall,
                                                        Indio, CA 92201.
    Sacramento..................  City of Sacramento   The Honorable       Stormwater          http://                May 12, 2014.........       060266
                                   (13-09-0004P).       Kevin Johnson,      Management          www.msc.fema.gov/
                                                        Mayor, City of      Department, 1395    lomc.
                                                        Sacramento, 915 I   35th Avenue,
                                                        Street, 5th         Sacramento, CA
                                                        Floor,              95822.
                                                        Sacramento, CA
                                                        95814.
    Sacramento..................  Unincorporated       The Honorable       Municipal Services  http://                May 12, 2014.........       060262
                                   areas of             Susan Peters,       Agency,             www.msc.fema.gov/
                                   Sacramento County    Chair, Sacramento   Department of       lomc.
                                   (13-09-0004P).       County Board of     Water Resources,
                                                        Supervisors, 700    827 7th Street,
                                                        H Street, Room      Suite 301,
                                                        2450, Sacramento,   Sacramento, CA
                                                        CA 95814.           95814.
    San Diego...................  City of San Diego    The Honorable Todd  Development         http://                May 23, 2014.........       060295
                                   (13-09-1496P).       Gloria, Interim     Services Center,    www.msc.fema.gov/
                                                        Mayor, City of      1222 1st Avenue,    lomc.
                                                        San Diego, 202 C    3rd Floor, San
                                                        Street, 11th        Diego, CA 92101.
                                                        Floor, San Diego,
                                                        CA 92101.
    Sutter......................  City of Live Oak     The Honorable       Building            http://                June 13, 2014........       060395
                                   (14-09-0812P).       Steve Alvarado,     Department, 9955    www.msc.fema.gov/
                                                        Mayor, City of      Live Oak            lomc.
                                                        Live Oak, 9955      Boulevard, Live
                                                        Live Oak            Oak, CA 95953.
                                                        Boulevard, Live
                                                        Oak, CA 95953.
Colorado:
    Elbert......................  Unincorporated       The Honorable       Elbert County       http://                May 23, 2014.........       080055
                                   areas of Elbert      Robert Rowland,     Community and       www.msc.fema.gov/
                                   County (13-08-       Chairman, Elbert    Development         lomc.
                                   1173P).              County Board of     Services
                                                        Commissioners,      Department, P.O.
                                                        P.O. Box 7,         Box 7, Kiowa, CO
                                                        Kiowa, CO 80117.    80117.
Florida:
    Charlotte...................  Unincorporated       The Honorable Ken   Charlotte County    http://                May 15, 2014.........       120061
                                   areas of Charlotte   Doherty,            Community           www.msc.fema.gov/
                                   County (14-04-       Chairman,           Development         lomc.
                                   0121P).              Charlotte County    Department, 18500
                                                        Board of            Murdock Circle,
                                                        Commissioners,      Port Charlotte,
                                                        18500 Murdock       FL 33948.
                                                        Circle, Port
                                                        Charlotte, FL
                                                        33948.
    Charlotte...................  Unincorporated       The Honorable Ken   Charlotte County    http://                May 30, 2014.........       120061
                                   areas of Charlotte   Doherty,            Community           www.msc.fema.gov/
                                   County (14-04-       Chairman,           Development         lomc.
                                   0645P).              Charlotte County    Department, 18500
                                                        Board of            Murdock Circle,
                                                        Commissioners,      Port Charlotte,
                                                        18500 Murdock       FL 33948.
                                                        Circle, Port
                                                        Charlotte, FL
                                                        33948.
    Escambia....................  Pensacola Beach-     The Honorable       Development         http://                June 2, 2014.........       125138
                                   Santa Rosa Island    Thomas A.           Department, 1 Via   www.msc.fema.gov/
                                   Authority (13-04-    Campanella,         De Luna,            lomc.
                                   6705P).              Chairman,           Pensacola Beach,
                                                        Pensacola Beach-    FL 32562.
                                                        Santa Rosa Island
                                                        Authority Board
                                                        of Commissioners,
                                                        P.O. Box 1208,
                                                        Pensacola Beach,
                                                        FL 32562.
    Escambia....................  Unincorporated       The Honorable Gene  Escambia County     http://                June 16, 2014........       120080
                                   areas of Escambia    M. Valentino,       Development         www.msc.fema.gov/
                                   County (13-04-       Chairman,           Services            lomc.
                                   7536P).              Escambia County     Department, 3363
                                                        Board of            West Park Place,
                                                        Commissioners,      Pensacola, FL
                                                        221 Palafox         32505.
                                                        Place, Suite 400,
                                                        Pensacola, FL
                                                        32502.
    Pinellas....................  City of Dunedin (13- The Honorable Dave  Engineering         http://                June 9, 2014.........       125103
                                   04-7013P).           Eggers, Mayor,      Department, 542     www.msc.fema.gov/
                                                        City of Dunedin,    Main Street,        lomc.
                                                        542 Main Street,    Dunedin, FL 34698.
                                                        Dunedin, FL 34698.
Georgia:
    Bryan.......................  Unincorporated       The Honorable       Bryan County        http://                May 15, 2014.........       130016
                                   areas of Bryan       Jimmy Burnsed,      Planning and        www.msc.fema.gov/
                                   County (13-04-       Chairman, Bryan     Zoning              lomc.
                                   1675P).              County Board of     Department, 66
                                                        Commissioners,      Captain Matthew
                                                        173 Davis Road,     Freeman Drive,
                                                        Richmond Hill, GA   Suite 201,
                                                        31324.              Richmond Hill, GA
                                                                            31324.

    Coweta......................  City of Newnan (14-  The Honorable       City Hall, 25       http://                May 30, 2014.........       130062
                                   04-1178P).           Keith Brady,        LaGrange Street,    www.msc.fema.gov/
                                                        Mayor, City of      Newnan, GA 30263.   lomc.
                                                        Newnan, 25
                                                        LaGrange Street,
                                                        Newnan, GA 30263.
    Muscogee....................  City of Columbus-    The Honorable       Department of       http://                June 2, 2014.........       135158
                                   Muscogee County      Teresa Tomlinson,   Engineering, 420    www.msc.fema.gov/
                                   (Consolidated        Mayor, City of      10th Street,        lomc.
                                   Government) (12-04-  Columbus-Muscogee   Columbus, GA
                                   2939P).              County              31901.
                                                        (Consolidated
                                                        Government), 100
                                                        10th Street,
                                                        Columbus, GA
                                                        31901.
North Carolina:
    Avery.......................  Town of Newland (14- The Honorable       Town Hall, 301      http://                April 11, 2014.......       370012
                                   04-0936P).           Valerie Jaynes,     Cranberry Street,   www.msc.fema.gov/
                                                        Mayor, Town of      Newland, NC 28657.  lomc.
                                                        Newland, P.O. Box
                                                        429, Newland, NC
                                                        28657.
    Avery.......................  Unincorporated       The Honorable       Avery County        http://                April 11, 2014.......       370010
                                   areas of Avery       Kenny Poteat,       Planning            www.msc.fema.gov/
                                   County (14-04-       Chairman, Avery     Department, P.O.    lomc.
                                   0936P).              County Board of     Box 640, Newland,
                                                        Commissioners,      NC 28657.
                                                        P.O. Box 640,
                                                        Newland, NC 28657.
    Buncombe....................  Unincorporated       Ms. Wanda Greene,   Buncombe County     http://                May 12, 2014.........       370031
                                   areas of Buncombe    Buncombe County     Planning            www.msc.fema.gov/
                                   County (13-04-       Manager, 200        Department, 46      lomc.
                                   1379P).              College Street,     Valley Street,
                                                        Suite 300,          Asheville, NC
                                                        Asheville, NC       28801.
                                                        28801.
    Chatham.....................  Unincorporated       The Honorable       Chatham County      http://                May 2, 2014..........       370299
                                   areas of Chatham     Walter Petty,       Planning            www.msc.fema.gov/
                                   County (13-04-       Chairman, Chatham   Department, 80-A    lomc.
                                   7171P).              County Board of     East Street,
                                                        Commissioners,      Pittsboro, NC
                                                        P.O. Box 1809,      27312.
                                                        Pittsboro, NC
                                                        27312.
    Forsyth.....................  City of Winston-     The Honorable       Inspections         http://                May 13, 2014.........       375360
                                   Salem (13-04-        Allen Joines,       Department, 100     www.msc.fema.gov/
                                   0816P).              Mayor, City of      East 1st Street,    lomc.
                                                        Winston-Salem,      Suite 328,
                                                        101 North Main      Winston-Salem, NC
                                                        Street, Suite       27101.
                                                        150, Winston-
                                                        Salem, NC 27101.
    Guilford....................  City of Greensboro   The Honorable       Water Resources     http://                June 17, 2014........       375351
                                   (13-04-6581P).       Nancy Vaughn,       Department,         www.msc.fema.gov/
                                                        Mayor, City of      Planning and        lomc.
                                                        Greensboro, P.O.    Engineering
                                                        Box 3136,           Section, 2602
                                                        Greensboro, NC      South Elm-Eugene
                                                        27402.              Street,
                                                                            Greensboro, NC
                                                                            27406.
    Lenoir......................  City of Kinston (13- The Honorable B.J.  City Hall, 207      http://                June 13, 2014........       370145
                                   04-6410P).           Murphy, Mayor,      East King Street,   www.msc.fema.gov/
                                                        City of Kinston,    Kinston, NC 28501.  lomc.
                                                        207 East King
                                                        Street, Kinston,
                                                        NC 28501.
    Rutherford..................  Town of              The Honorable       Town Hall, 129      http://                April 16, 2014.......       370219
                                   Rutherfordton (14-   Jimmy Dancy,        North Main          www.msc.fema.gov/
                                   04-0666P).           Mayor, Town of      Street,             lomc.
                                                        Rutherfordton,      Rutherfordton, NC
                                                        129 North Main      28139.
                                                        Street,
                                                        Rutherfordton, NC
                                                        28139.
    Surry.......................  Unincorporated       The Honorable       Surry County        http://                April 11, 2014.......       370364
                                   areas of Surry       Eddie Harris,       Planning and        www.msc.fema.gov/
                                   County (14-04-       Chairman, Surry     Development         lomc.
                                   0937P).              County Board of     Department, 122
                                                        Commissioners,      Hamby Road,
                                                        118 Hamby Road,     Dobson, NC 27017.
                                                        Dobson, NC 27017.
    Transylvania................  Unincorporated       The Honorable Mike  Transylvania        http://                May 9, 2014..........       370230
                                   areas of             Hawkins,            County              www.msc.fema.gov/
                                   Transylvania         Chairman,           Inspections         lomc.
                                   County (13-04-       Transylvania        Department, 98
                                   8461P).              County Board of     East Morgan
                                                        Commissioners, 21   Street, Brevard,
                                                        East Main Street,   NC 28712.
                                                        Brevard, NC 28712.
    Union.......................  City of Monroe (14-  The Honorable       City Hall, 300      http://                April 10, 2014.......       370236
                                   04-0931P).           Bobby Kilgore,      West Crowell        www.msc.fema.gov/
                                                        Mayor, City of      Street, Monroe,     lomc.
                                                        Monroe, 300 West    NC 28112.
                                                        Crowell Street,
                                                        Monroe, NC 28112.
    Wake........................  Town of Garner (14-  The Honorable       Town Hall, 900 7th  http://                April 10, 2014.......       370240
                                   04-0933P).           Ronnie Williams,    Avenue, Garner,     www.msc.fema.gov/
                                                        Mayor, Town of      NC 27529.           lomc.
                                                        Garner, 900 7th
                                                        Avenue, Garner,
                                                        NC 27529.
South Carolina:

    Lexington...................  Unincorporated       The Honorable       Lexington County    http://                June 6, 2014.........       450129
                                   areas of Lexington   William B.          Planning            www.msc.fema.gov/
                                   County (14-04-       Banning, Sr.,       Department,         lomc.
                                   0721P).              Chairman,           County
                                                        Lexington County    Administration
                                                        Council, 2109       Building, 212
                                                        Beaver Lane, West   South Lake Drive,
                                                        Columbia, SC        Lexington, SC
                                                        29169.              29072.
    Richland....................  City of Columbia     The Honorable       Department of       http://                May 26, 2014.........       450172
                                   (14-04-0393P).       Steve Benjamin,     Engineering, P.O.   www.msc.fema.gov/
                                                        Mayor, City of      Box 147,            lomc.
                                                        Columbia, P.O.      Columbia, SC
                                                        Box 147,            29217.
                                                        Columbia, SC
                                                        29217.
--------------------------------------------------------------------------------------------------------------------------------------------------------

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

    Dated: April 14, 2014.
Roy E. Wright,
Deputy Associate Administrator for Mitigation, Department of Homeland
Security, Federal Emergency Management Agency.
[FR Doc. 2014-09734 Filed 4-28-14; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 80, Number 76 (Tuesday, April 21, 2015)]
[Rules and Regulations]
[Pages 22116-22118]
[FR Doc No: 2015-09257]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 64

[Docket ID FEMA-2015-0001: Internal Agency Docket No. FEMA-8379]

Suspension of Community Eligibility

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule.

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

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. Also, information identifying
the current participation status of a community can be obtained from
FEMA's Community Status Book (CSB). The CSB is available at http://www.fema.gov/fema/csb.shtm.

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 Bret Gates, Federal Insurance and
Mitigation Administration, Federal Emergency Management Agency, 500 C
Street SW., Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The NFIP enables property owners to purchase
Federal flood insurance that is not otherwise generally available from
private insurers. In return, communities agree to adopt and administer
local floodplain management measures 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 the sale
of NFIP flood insurance 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. We recognize that 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 to be eligible for the sale of
NFIP flood insurance. A notice withdrawing the suspension of such
communities will be published in the Federal Register.
    In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that
identifies the Special Flood Hazard Areas (SFHAs) in these communities.
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 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 FIRM for 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 procedures 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, Section
1315, 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.
    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:

----------------------------------------------------------------------------------------------------------------
                                                 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
----------------------------------------------------------------------------------------------------------------
           Region III

Virginia:
    Accomack County,                   510001  January 10, 1974,  May 18, 2015..........  May 18, 2015.
     Unincorporated Areas.                      Emerg; June 1,
                                                1984, Reg; May
                                                18, 2015, Susp.
    Belle Haven, Town of,              510242  N/A, Emerg;        ......do *............   Do.
     Accomack County.                           February 8,
                                                2001, Reg; May
                                                18, 2015, Susp.
    Chincoteague, Town of,             510002  March 4, 1974,     ......do..............   Do.
     Accomack County.                           Emerg; March 1,
                                                1977, Reg; May
                                                18, 2015, Susp.
    Middlesex County,                  510098  October 18, 1974,  ......do..............   Do.
     Unincorporated Areas.                      Emerg; January
                                                18, 1989, Reg;
                                                May 18, 2015,
                                                Susp.
    Onancock, Town of, Accomack        510298  February 17,       ......do..............   Do.
     County.                                    1976, Emerg;
                                                December 15,
                                                1981, Reg; May
                                                18, 2015, Susp.
    Saxis, Town of, Accomack           510003  March 11, 1976,    ......do..............   Do.
     County.                                    Emerg; November
                                                17, 1982, Reg;
                                                May 18, 2015,
                                                Susp.
    Tangier, Town of, Accomack         510004  March 28, 1975,    ......do..............   Do.
     County.                                    Emerg; October
                                                15, 1982, Reg;
                                                May 18, 2015,
                                                Susp.
    Urbanna, Town of, Middlesex        510292  May 21, 1975,      ......do..............   Do.
     County.                                    Emerg; November
                                                3, 1989, Reg;
                                                May 18, 2015,
                                                Susp.
    Wachapreague, Town of,             510005  January 28, 1975,  ......do..............   Do.
     Accomack County.                           Emerg; September
                                                2, 1982, Reg;
                                                May 18, 2015,
                                                Susp.

            Region V

Indiana:
    Gentryville, Town of,              180394  July 3, 1975,      ......do..............   Do.
     Spencer County.                            Emerg; September
                                                16, 1988, Reg;
                                                May 18, 2015,
                                                Susp.
    Grandview, Town of, Spencer        180238  April 14, 1975,    ......do..............   Do.
     County.                                    Emerg; July 18,
                                                1983, Reg; May
                                                18, 2015, Susp.
    Rockport, City of, Spencer         180239  March 21, 1975,    ......do..............   Do.
     County.                                    Emerg; July 18,
                                                1983, Reg; May
                                                18, 2015, Susp.
    Spencer County,                    180237  August 18, 1972,   ......do..............   Do.
     Unincorporated Areas.                      Emerg; May 1,
                                                1978, Reg; May
                                                18, 2015, Susp.
Minnesota:
    Breckenridge, City of,             275232  September 4,       ......do..............   Do.
     Wilkin County.                             1970, Emerg;
                                                September 4,
                                                1970, Reg; May
                                                18, 2015, Susp.
    Campbell, City of, Wilkin          270521  March 1, 1976,     ......do..............   Do.
     County.                                    Emerg; June 8,
                                                1984, Reg; May
                                                18, 2015, Susp.
    Doran, City of, Wilkin             270522  N/A, Emerg; March  ......do..............   Do.
     County.                                    5, 2013, Reg;
                                                May 18, 2015,
                                                Susp.
    Wilkin County,                     270519  June 6, 1973,      ......do..............   Do.
     Unincorporated Areas.                      Emerg; September
                                                29, 1978, Reg;
                                                May 18, 2015,
                                                Susp.
    Wolverton, City of, Wilkin         270524  March 22, 2011,    ......do..............   Do.
     County.                                    Emerg; November
                                                21, 2012, Reg;
                                                May 18, 2015,
                                                Susp.
Ohio:
    Clay Center, Village of,           390875  March 27, 1979,    ......do..............   Do.
     Ottawa County.                             Emerg; June 20,
                                                1980, Reg; May
                                                18, 2015, Susp.
    Elmore, Village of, Ottawa         390610  October 9, 1975,   ......do..............   Do.
     County.                                    Emerg; April 1,
                                                1982, Reg; May
                                                18, 2015, Susp.
    Genoa, Village of, Ottawa          390612  March 21, 1978,    ......do..............   Do.
     County.                                    Emerg; May 3,
                                                1982, Reg; May
                                                18, 2015, Susp.

    Marblehead, Village of,            390748  May 29, 1979,      ......do..............   Do.
     Ottawa County.                             Emerg; February
                                                1, 1984, Reg;
                                                May 18, 2015,
                                                Susp.
    Oak Harbor, Village of,            390433  April 28, 1977,    ......do..............   Do.
     Ottawa County.                             Emerg; April 1,
                                                1982, Reg; May
                                                18, 2015, Susp.
    Ottawa County,                     390432  April 25, 1973,    ......do..............   Do.
     Unincorporated Areas.                      Emerg; October
                                                17, 1978, Reg;
                                                May 18, 2015,
                                                Susp.
    Port Clinton, City of,             390434  April 5, 1973,     ......do..............   Do.
     Ottawa County.                             Emerg; September
                                                30, 1977, Reg;
                                                May 18, 2015,
                                                Susp.
    Put-In-Bay, Village of,            390600  July 25, 1973,     ......do..............   Do.
     Ottawa County.                             Emerg; September
                                                30, 1977, Reg;
                                                May 18, 2015,
                                                Susp.

           Region VII

Iowa:
    Jones County,                      190919  March 21, 1979,    ......do..............   Do.
     Unincorporated Areas.                      Emerg; September
                                                30, 1988, Reg;
                                                May 18, 2015,
                                                Susp.
    Monticello, City of, Jones         190175  November 27,       ......do..............   Do.
     County.                                    1974, Emerg;
                                                April 2, 1979,
                                                Reg; May 18,
                                                2015, Susp.

          Region VIII

Montana:
    Big Timber, City of, Sweet         300106  N/A, Emerg; June   ......do..............   Do.
     Grass County.                              6, 1997, Reg;
                                                May 18, 2015,
                                                Susp.
    Sweet Grass County,                300167  April 4, 1978,     ......do..............   Do.
     Unincorporated Areas.                      Emerg; August 2,
                                                1982, Reg; May
                                                18, 2015, Susp.
 Wyoming:
    Casper, City of, Natrona           560037  February 4, 1972,  ......do..............   Do.
     County.                                    Emerg; September
                                                15, 1977, Reg;
                                                May 18, 2015,
                                                Susp.
    Evansville, Town of,               560071  June 2, 1975,      ......do..............   Do.
     Natrona County.                            Emerg; July 17,
                                                1978, Reg; May
                                                18, 2015, Susp.
    Mills, Town of, Natrona            560076  November 16,       ......do..............   Do.
     County.                                    1979, Emerg;
                                                December 1,
                                                1986, Reg; May
                                                18, 2015, Susp.
    Natrona County,                    560036  June 20, 1973,     ......do..............   Do.
     Unincorporated Areas..                     Emerg; August
                                                15, 1978, Reg;
                                                May 18, 2015,
                                                Susp.

            Region X

Washington:
    Ilwaco, City of, Pacific           530127  April 2, 1974,     ......do..............   Do.
     County.                                    Emerg; February
                                                1, 1979, Reg;
                                                May 18, 2015,
                                                Susp.
    Long Beach, City of,               530128  September 27,      ......do..............   Do.
     Pacific County.                            1974, Emerg;
                                                August 1, 1979,
                                                Reg; May 18,
                                                2015, Susp.
    Pacific County,                    530126  January 17, 1974,  ......do..............   Do.
     Unincorporated Areas.                      Emerg; January
                                                5, 1978, Reg;
                                                May 18, 2015,
                                                Susp.
    Raymond, City of, Pacific          530129  April 2, 1974,     ......do..............   Do.
     County.                                    Emerg; July 16,
                                                1979, Reg; May
                                                18, 2015, Susp.
    Shoalwater Bay Indian              530341  N/A, Emerg;        ......do..............   Do.
     Tribe, Pacific County.                     January 4, 2002,
                                                Reg; May 18,
                                                2015, Susp.
    South Bend, City of,               530130  October 16, 1974,  ......do..............   Do.
     Pacific County.                            Emerg; November
                                                15, 1979, Reg;
                                                May 18, 2015,
                                                Susp.
----------------------------------------------------------------------------------------------------------------
*......do =Ditto.
Code for reading third column: Emerg.--Emergency; Reg.--Regular; Susp.--Suspension.

    Dated: April 8, 2013.
Roy E. Wright,
Deputy Associate Administrator for Mitigation, Federal Insurance and
Mitigation Administration, Department of Homeland Security, Federal
Emergency Management Agency.
[FR Doc. 2015-09257 Filed 4-20-15; 8:45 am]
 BILLING CODE 9110-12-P