[Federal Register Volume 79, Number 82 (Tuesday, April 29, 2014)]
[Notices]
[Pages 23998-23999]
[FR Doc No: 2014-09725]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2014-0002]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final Notice.

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SUMMARY: New or modified Base (1% annual-chance) Flood Elevations
(BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries
or zone designations, and/or the regulatory floodway (hereinafter
referred to as flood hazard determinations) as shown on the indicated
Letter of Map Revision (LOMR) for each of the communities listed in the
table below are finalized. Each LOMR revises the Flood Insurance Rate
Maps (FIRMs), and in some cases the Flood Insurance Study (FIS)
reports, currently in effect for the listed communities. The flood
hazard determinations modified by each LOMR will be used to calculate
flood insurance premium rates for new buildings and their contents.

DATES: The effective date for each LOMR is indicated in the table
below.

ADDRESSES: Each LOMR is available for inspection at both the respective
Community Map Repository address listed in the table below and online
through the FEMA Map Service Center at www.msc.fema.gov.

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 Federal Emergency Management Agency
(FEMA) makes the final flood hazard determinations as shown in the
LOMRs for each community listed in the table below. Notice of these
modified flood hazard determinations has been published in newspapers
of local circulation and ninety (90) days have elapsed since that
publication. The Deputy Associate Administrator for Mitigation has
resolved any appeals resulting from this notification.
    The modified flood hazard determinations are made pursuant to
section 206 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.
    For rating purposes, the currently effective community number is
shown and must be used for all new policies and renewals.
    The new or modified flood hazard determinations are the basis for
the floodplain management measures that the community is required
either to adopt or to show evidence of being already in effect in order
to remain qualified for participation in the National Flood Insurance
Program (NFIP).
    These new or modified flood hazard determinations, together with
the floodplain management criteria required by 44 CFR 60.3, are the
minimum that are required. They should not be construed to mean that
the community must change any existing ordinances that are more
stringent in their floodplain management requirements. The community
may at any time enact stricter requirements of its own or pursuant to
policies established by other Federal, State, or regional entities.
    These new or modified flood hazard determinations are used to meet
the floodplain management requirements of the NFIP and also are used to
calculate the appropriate flood insurance premium rates for new
buildings, and for the contents in those buildings. The changes in
flood hazard determinations are in accordance with 44 CFR 65.4.
    Interested lessees and owners of real property are encouraged to
review the final flood hazard information available at the address
cited below for each community or online through the FEMA Map Service
Center at www.msc.fema.gov.

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                                                              Chief executive
         State and county             Location and  case        officer of        Community map repository  Effective date  of modification   Community
                                             No.                 community                                                                       No.
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Arkansas: Washington (FEMA Docket   City of Fayetteville   The Honorable         Development Services       February 11, 2014..............       050216
 No.: B-1354).                       (13-06-1658P).         Lioneld Jordan,       Building, 125 West
                                                            Mayor, City of        Mountain Street,
                                                            Fayetteville, 113     Fayetteville, AR 72701.
                                                            West Mountain
                                                            Street,
                                                            Fayetteville, AR
                                                            72701.
Oklahoma: Oklahoma (FEMA Docket     City of Oklahoma City  The Honorable Mick    420 West Main Street,      February 6, 2014...............       405378
 No.: B-1354).                       (13-06-1918P).         Cornett, Mayor,       Suite 700, Oklahoma
                                                            City of Oklahoma      City, OK 73102.
                                                            City, 200 North
                                                            Walker Avenue, 3rd
                                                            Floor, Oklahoma
                                                            City, OK 73102.
Texas:

    Bexar (FEMA Docket No.: B-      City of San Antonio    The Honorable Julian  Department of Public       February 3, 2014...............       480045
     1354).                          (13-06-3687P).         Castro, Mayor, City   Works, Storm Water
                                                            of San Antonio,       Engineering, 1901 South
                                                            P.O. Box 839966,      Alamo Street, 2nd Floor,
                                                            San Antonio, TX       San Antonio, TX 78204.
                                                            78283.
    Bexar (FEMA Docket No.: B-      City of San Antonio    The Honorable Julian  Department of Public       February 10, 2014..............       480045
     1354).                          (13-06-3350P).         Castro, Mayor, City   Works, Storm Water
                                                            of San Antonio,       Engineering, 1901 South
                                                            P.O. Box 839966,      Alamo Street, 2nd Floor,
                                                            San Antonio, TX       San Antonio, TX 78204.
                                                            78283.
    Bexar (FEMA Docket No.: B-      Unincorporated areas   The Honorable Nelson  Bexar County Public Works  February 3, 2014...............       480035
     1354).                          of Bexar County (13-   W. Wolff, Bexar       Department, 233 North
                                     06-2845P).             County Judge, Paul    Pecos-La Trinidad
                                                            Elizondo Tower, 101   Street, Suite 420, San
                                                            West Nueva Street,    Antonio, TX 78207.
                                                            10th Floor, San
                                                            Antonio, TX 78205.
    Bexar (FEMA Docket No.: B-      Unincorporated areas   The Honorable Nelson  Bexar County Public Works  February 3, 2014...............       480035
     1354).                          of Bexar County (13-   W. Wolff, Bexar       Department, 233 North
                                     06-3349P).             County Judge, Paul    Pecos-La Trinidad
                                                            Elizondo Tower, 101   Street, Suite 420, San
                                                            West Nueva Street,    Antonio, TX 78207.
                                                            10th Floor, San
                                                            Antonio, TX 78205.
    Dallas (FEMA Docket No.: B-     City of Garland (13-   The Honorable         Engineering Department,    February 10, 2014..............       485471
     1354).                          06-1717P).             Douglas Athas,        800 West Main Street,
                                                            Mayor, City of        Garland, TX 75040.
                                                            Garland, 200 North
                                                            5th Street,
                                                            Garland, TX 75040.
    Dallas (FEMA Docket No.: B-     City of Rowlett (12-   The Honorable Todd    Development Services       February 7, 2014...............       480185
     1354).                          06-3599P).             Gottel, Mayor, City   Building, 3901 Main
                                                            of Rowlett, 4000      Street, Rowlett, TX
                                                            Main Street,          75088.
                                                            Rowlett, TX 75088.
    Denton (FEMA Docket No.: B-     Unincorporated areas   The Honorable Mary    Denton County Planning     February 6, 2014...............       480774
     1354).                          of Denton County (13-  Horn, Denton County   Department, 1505 East
                                     06-3201P).             Judge, 110 West       McKinney Street, Suite
                                                            Hickory Street, 2nd   175, Denton, TX 76209.
                                                            Floor, Denton, TX
                                                            76201.
    Fort Bend (FEMA Docket No.: B-  City of Sugar Land     The Honorable James   City Hall, 2700 Town       February 14, 2014..............       480234
     1358).                          (13-06-4003P).         Thompson, Mayor,      Center Boulevard North,
                                                            City of Sugar Land,   Sugar Land, TX 77479.
                                                            P.O. Box 110, Sugar
                                                            Land, TX 77487.
    Fort Bend and Harris (FEMA      City of Houston (13-   The Honorable Annise  Floodplain Management      February 6, 2014...............       480296
     Docket No.: B-1354).            06-1908P).             D. Parker, Mayor,     Office, Public Works and
                                                            City of Houston,      Engineering, 1002
                                                            P.O. Box 1562,        Washington Avenue, 3rd
                                                            Houston, TX 77251.    Floor, Houston, TX 77002.
    Grayson (FEMA Docket No.: B-    Unincorporated areas   The Honorable Drue    Grayson County             February 6, 2014...............       480829
     1354).                          of Grayson County      Bynum, Grayson        Courthouse, 100 West
                                     (12-06-3502P).         County Judge, 100     Houston Street, Sherman,
                                                            West Houston          TX 75090.
                                                            Street, Sherman, TX
                                                            75090.
    Harris (FEMA Docket No.: B-     Unincorporated areas   The Honorable Ed M.   Harris County, 10555       February 6, 2014...............       480287
     1354).                          of Harris County (12-  Emmett, Harris        Northwest Freeway,
                                     06-3910P).             County Judge, 1001    Houston, TX 77092.
                                                            Preston Street,
                                                            Suite 911, Houston,
                                                            TX 77002.
    Potter (FEMA Docket No.: B-     City of Amarillo (13-  The Honorable Paul    City Hall, 509 Southeast   February 3, 2014...............       480529
     1354).                          06-1845P).             Harpole, Mayor,       7th Avenue, Amarillo, TX
                                                            City of Amarillo,     79105.
                                                            P.O. Box 1971,
                                                            Amarillo, TX 79105.
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(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. 2014-09725 Filed 4-28-14; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 84, Number 123 (Wednesday, June 26, 2019)]
[Notices]
[Pages 30125-30127]
[FR Doc No: 2019-13554]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-2223]

Clinical Investigations for Prostate Tissue Ablation Devices;
Draft Guidance for Industry and Food and Drug Administration Staff;
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 the draft guidance entitled ``Clinical
Investigations for Prostate Tissue Ablation Devices.'' This draft
guidance provides recommendations for clinical investigations for high
intensity ultrasound systems for prostate tissue ablation and new types
of prostatic tissue ablation devices. This draft guidance is not final
nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft
guidance by August 26, 2019 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-2019-D-2223 for ``Clinical Investigations for Prostate Tissue
Ablation 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.
     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.gpo.gov/fdsys/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.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Clinical Investigations for Prostate Tissue Ablation Devices'' to the
Office of Policy, Guidance and Policy Development, 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 request.

FOR FURTHER INFORMATION CONTACT: John Baxley, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G210, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance provides draft recommendations for: (1)
Complying with the clinical testing special control under 21 CFR
876.4340(b)(8) for premarket notifications (510(k)s) for high intensity
ultrasound systems for prostate tissue ablation and (2) collecting
clinical data to support marketing submissions for new types of
prostatic tissue ablation devices. High intensity ultrasound systems
for prostate tissue ablation transmit high intensity therapeutic
ultrasound energy into the prostate to thermally ablate a defined,
targeted volume of tissue. Other prostate ablation devices achieve the
same clinical effect of ablating targeted tissue volumes using
different sources of energy.
    The scope of this draft guidance is limited to the clinical
investigations of prostate tissue ablation systems to support marketing
authorization for a general indication for ablation of prostatic
tissue. This draft guidance does not address the clinical
investigations of devices that are intended to treat specific prostatic
diseases (e.g., prostate cancer or benign prostatic hyperplasia).
Additionally, this document does not address recommendations for non-
clinical testing of prostate tissue ablation systems.

II. Significance of Guidance

    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 ``Clinical
Investigations for Prostate Tissue Ablation 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. This guidance
is not subject to Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov. Persons unable to download an
electronic copy of ``Clinical Investigations for Prostate Tissue
Ablation Devices'' may send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the document.
Please use the document number 16011 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction

Act of 1995 (44 U.S.C. 3501-3520). The collections of information in
the following FDA regulations and guidance have been approved by OMB as
listed in the following table:

------------------------------------------------------------------------
                                                            OMB control
      21 CFR part or guidance               Topic               No.
------------------------------------------------------------------------
807, subpart E....................  Premarket                  0910-0120
                                     notification.
812...............................  Investigational            0910-0078
                                     Device Exemption.
``De Novo Classification Process    De Novo                    0910-0844
 (Evaluation of Automatic Class      classification
 III Designation)''.                 process.
``Requests for Feedback on Medical  Q-submissions.......       0910-0756
 Device Submissions: The Pre-
 Submission Program and Meetings
 with Food and Drug Administration
 Staff``.
50, 56............................  Protection of Human        0910-0755
                                     Subjects: Informed
                                     Consent;
                                     Institutional
                                     Review Boards.
56................................  Institutional Review       0910-0130
                                     Boards.
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    Dated: June 20, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13554 Filed 6-25-19; 8:45 am]
BILLING CODE 4164-01-P