[Federal Register: September 29, 2010 (Volume 75, Number 188)]
[Proposed Rules]
[Page 60013-60017]
[DOCID:fr29se10-28]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 67

[Docket ID FEMA-2010-0003; Internal Agency Docket No. FEMA-B-1140]

Proposed Flood Elevation Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Proposed rule.

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SUMMARY: Comments are requested on the proposed Base (1% annual-chance)
Flood Elevations (BFEs) and proposed BFE modifications for the
communities listed in the table below. The purpose of this notice is to
seek general information and comment regarding the proposed regulatory
flood elevations for the reach described by the downstream and upstream
locations in the table below. The BFEs and modified BFEs are a part 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). In addition,

these elevations, once finalized, will be used by insurance agents and
others to calculate appropriate flood insurance premium rates for new
buildings and the contents in those buildings.

DATES: Comments are to be submitted on or before December 28, 2010.

ADDRESSES: The corresponding preliminary Flood Insurance Rate Map
(FIRM) for the proposed BFEs for each community is available for
inspection at the community's map repository. The respective addresses
are listed in the table below.
    You may submit comments, identified by Docket No. FEMA-B-1140, to
Roy E. Wright, Deputy Director, Risk Analysis Division, Federal
Insurance and Mitigation Administration, Federal Emergency Management
Agency, 500 C Street, SW., Washington, DC 20472,<PHONE_NUMBER>, or (e-
mail<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Roy E. Wright, Deputy Director, Risk
Analysis Division, Federal Insurance and Mitigation Administration,
Federal Emergency Management Agency, 500 C Street, SW., Washington, DC
20472,<PHONE_NUMBER>, or (e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) proposes to make determinations of BFEs and modified BFEs for
each community listed below, in accordance with section 110 of the
Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR
67.4(a).
    These proposed BFEs and modified BFEs, 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 proposed elevations
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 built after these elevations are made final,
and for the contents in those buildings.
    Comments on any aspect of the Flood Insurance Study and FIRM, other
than the proposed BFEs, will be considered. A letter acknowledging
receipt of any comments will not be sent.
    National Environmental Policy Act. This proposed rule is
categorically excluded from the requirements of 44 CFR part 10,
Environmental Consideration. An environmental impact assessment has not
been prepared.
    Regulatory Flexibility Act. As flood elevation determinations are
not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-
612, a regulatory flexibility analysis is not required.
    Executive Order 12866, Regulatory Planning and Review. This
proposed rule is not a significant regulatory action under the criteria
of section 3(f) of Executive Order 12866, as amended.
    Executive Order 13132, Federalism. This proposed rule involves no
policies that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This proposed rule
meets the applicable standards of Executive Order 12988.

List of Subjects in 44 CFR Part 67

    Administrative practice and procedure, Flood insurance, Reporting
and recordkeeping requirements.
    Accordingly, 44 CFR part 67 is proposed to be amended as follows:

PART 67--[AMENDED]

    1. The authority citation for part 67 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.  67.4  [Amended]

    2. The tables published under the authority of Sec.  67.4 are
proposed to be amended as follows:

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                                                                * Elevation in feet (NGVD)  + Elevation in feet
                                                                 (NAVD)   Depth in feet  above ground
         Flooding source(s)            Location of referenced          [caret] Elevation in meters (MSL)
                                             elevation        --------------------------------------------------
                                                                Effective     Modified     Communities affected
----------------------------------------------------------------------------------------------------------------
                               Vermilion County, Illinois, and Incorporated Areas
================================================================================================================
East Branch Lick Creek..............  Approximately 650 feet          None         +613  City of Danville,
                                       upstream of U.S. Route                             Unincorporated Areas
                                       136.                                               of Vermilion County.
                                      Approximately 350 feet          None         +644
                                       downstream of Lynch
                                       Road.
North Fork Vermilion River..........  Approximately 940 feet          None         +543  Unincorporated Areas of
                                       downstream of Williams                             Vermilion County.
                                       Street/Hungry Hollow
                                       Road.
                                      Approximately 0.75 mile         None         +549
                                       upstream of the water
                                       treatment plant dam.
Stoney Creek........................  Just upstream of Winter         None         +612  Unincorporated Areas of
                                       Avenue.                                            Vermilion County
                                      Approximately 0.5 mile          None         +615
                                       upstream of Winter
                                       Avenue.
Vermilion River.....................  Approximately 0.75 mile         None         +533  Unincorporated Areas of
                                       downstream of I-74.                                Vermilion County.
                                      Approximately 0.85 mile         None         +542
                                       upstream of the
                                       railroad crossing
                                       upstream of the
                                       confluence of North
                                       Fork Vermilion River
                                       and parallel to H
                                       Avenue.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate.

Map located at the community map repository (see below) for exact locations of all BFEs to be changed.
Send comments to Roy E. Wright, Deputy Director, Risk Analysis Division, Federal Insurance and Mitigation
 Administration, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.

                                                    ADDRESSES
City of Danville
Maps are available for inspection at City Hall, 17 West Main Street, Danville, IL 61832.

                                    Unincorporated Areas of Vermilion County
Maps are available for inspection at the Vermilion County Courthouse, 6 North Vermilion Street, Danville, IL
 61832.
----------------------------------------------------------------------------------------------------------------
                               Pottawatomie County, Kansas, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
North Unnamed Tributary.............  Approximately 500 feet          None   2  City of Wamego,
                                       northeast of the                                   Unincorporated Areas
                                       intersection of U.S.                               of Pottawatomie
                                       Route 24 and Walsh                                 County.
                                       Road.
                                      Approximately 1.0 mile          None   2
                                       northeast of the
                                       intersection of U.S.
                                       Route 24 and Walsh
                                       Road.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.
** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to Roy E. Wright, Deputy Director, Risk Analysis Division, Federal Insurance and Mitigation
 Administration, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.

                                                    ADDRESSES
City of Wamego
Maps are available for inspection at City Hall, 430 Lincoln Avenue, Wamego, KS 66547.

                                   Unincorporated Areas of Pottawatomie County
Maps are available for inspection at the Pottawatomie County Courthouse, 207 North 1st Street, Westmoreland, KS
 66549.
----------------------------------------------------------------------------------------------------------------
Yellowstone River...................  Approximately 3.26              None        +4357  City of Livingston,
                                       miles downstream of                                Unincorporated Areas
                                       Northern Pacific                                   of Park County.
                                       Railroad.
                                      Approximately 4.14              None        +4953  .......................
                                       miles downstream of
                                       Tom Miner Creek Road.
Yellowstone River East Branch.......  Approximately 0.76 mile         None        +4493  City of Livingston,
                                       downstream of I-90.                                Unincorporated Areas
                                                                                of Park County.
                                      Approximately 0.94 mile         None        +4519
                                       upstream of I-90.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.
** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to Roy E. Wright, Deputy Director, Risk Analysis Division, Federal Insurance and Mitigation
 Administration, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.

                                                    ADDRESSES
City of Livingston
Maps are available for inspection at 414 East Callender Street, Livingston, MT 59047.

                                       Unincorporated Areas of Park County
Maps are available for inspection at 414 East Callender Street, Livingston, MT 59047.
----------------------------------------------------------------------------------------------------------------
                                  Elk County, Pennsylvania (All Jurisdictions)
----------------------------------------------------------------------------------------------------------------
Alysworth Run.......................  Approximately 1,192            +1400        +1397  Township of Ridgway.
                                       feet upstream of West
                                       Main Street.
                                      Approximately 75 feet          +1424        +1420
                                       downstream of Grant
                                       Road.

Clarion River.......................  Approximately 935 feet          None        +1374  Township of Ridgway.
                                       upstream of the
                                       confluence with
                                       Alysworth Run.
                                      Approximately 1,193             None        +1374
                                       feet downstream of
                                       Gillis Ave.
Clarion River.......................  Approximately 1,200             None        +1384  Township of Ridgway.
                                       feet downstream of the
                                       confluence with Mason
                                       Creek.
                                      Approximately 0.56 mile         None        +1387
                                       upstream of the
                                       confluence with Mason
                                       Creek.
Elk Creek...........................  Approximately 1.18 mile         None        +1408  Township of Ridgway.
                                       upstream of the
                                       confluence with Mohan
                                       Run.
                                      Approximately 0.44 mile         None        +1414
                                       downstream of U.S.
                                       Route 219.
Elk Creek...........................  Approximately 1,867             None        +1473  Township of Ridgway.
                                       feet downstream of the
                                       confluence with Elk
                                       Creek Tributary 1.
                                      Approximately 1,885             None        +1474
                                       feet upstream of the
                                       confluence with
                                       Daguscahonda Run.
Little Toby Creek...................  Approximately 0.71 mile        +1680        +1674  Township of Fox.
                                       downstream of the
                                       bridge over Coal
                                       Hollow Road.
                                      Approximately 0.62 mile        +1690        +1692
                                       downstream of the
                                       bridge over Coal
                                       Hollow Road.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.
** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to Roy E. Wright, Deputy Director, Risk Analysis Division, Federal Insurance and Mitigation
 Administration, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472..
                                                    ADDRESSES
Township of Fox
Maps are available for inspection at the Fox Township Municipal Building, 116 Irishtown Road, Kersey, PA 15846.

Township of Ridgway
Maps are available for inspection at the Township Municipal Building, 164 Ridgway Drive, Ridgway, PA 15853.
----------------------------------------------------------------------------------------------------------------
Armstrong Creek.....................  Approximately 100 feet          None         +740  Unincorporated Areas of
                                       downstream of                                      Ellis County.
                                       Waterworks Road.
                                      Approximately 1,040             None         +746
                                       feet upstream of
                                       Waterworks Road.
Bedford Branch......................  Approximately 0.5 mile          None         +538  City of Grand Prairie,
                                       downstream of Southern                             Unincorporated Areas
                                       Pacific Railroad.                                  of Ellis County.
                                      Approximately 275 feet          None         +567
                                       upstream of Southern
                                       Pacific Railroad.
Cottonwood Creek....................  Approximately 0.74 mile         None         +574  City of Grand Prairie,
                                       upstream of Old Fort                               Unincorporated Areas
                                       Worth Road.                                        of Ellis County.
                                      At the confluence with          None         +584
                                       Newton Branch.
East Fork to Soap Creek.............  At the confluence with          None         +594  City of Midlothian,
                                       Soap Creek.                                        Unincorporated Areas
                                                                                of Ellis County.
                                      Just upstream of                None         +616
                                       Weatherford Road.
Hollings Branch.....................  Approximately 0.66 mile         None         +641  City of Cedar Hill.
                                       downstream of Magic
                                       Valley Lane.
                                      Approximately 725 feet          None         +659
                                       downstream of Magic
                                       Valley Lane.
Joe Pool Lake.......................  Approximately 0.48 mile         None         +538  City of Grand Prairie,
                                       downstream of Southern                             Unincorporated Areas
                                       Pacific Railroad.                                  of Ellis County.
                                      Approximately 0.37 mile         None         +540
                                       upstream of FM 661.
Newton Branch.......................  At the confluence with          None         +550  City of Grand Prairie,
                                       Soap Creek.                                        City of Midlothian,
                                                                                Unincorporated Areas
                                                                                of Ellis County.
                                      Approximately 1,360             None         +564
                                       feet upstream of
                                       Kimble Road.

Soap Creek..........................  At the confluence with          None         +540  City of Grand Prairie,
                                       Joe Pool Lake.                                     City of Midlothian,
                                                                                Unincorporated Areas
                                                                                of Ellis County.
                                      Approximately 0.26 mile         None         +598
                                       downstream of U.S.
                                       Route 67.
West Soap Creek.....................  At the confluence with          None         +581  Unincorporated Areas of
                                       Soap Creek.                                        Ellis County.
                                      Approximately 0.5 mile          None         +601
                                       upstream of Ray White
                                       Road.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.
** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate.
Map located at the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to Roy E. Wright, Deputy Director, Risk Analysis Division, Federal Insurance and Mitigation
 Administration, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.

                                                    ADDRESSES

City of Cedar Hill
Maps are available for inspection at City Hall, 502 Cedar Street, Cedar Hill, TX 75104.

City of Grand Prairie
Maps are available for inspection at City Hall, 317 College Street, Grand Prairie, TX 75053.

City of Midlothian
Maps are available for inspection at City Hall, 104 West Avenue East, Midlothian, TX 76065.

                                      Unincorporated Areas of Ellis County
Maps are available for inspection at the Ellis County Courthouse, 101 West Main Street, Waxahachie, TX 75165.
----------------------------------------------------------------------------------------------------------------

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

    Dated: September 17, 2010.
Sandra K. Knight,
Deputy Federal Insurance and Mitigation Administrator, Mitigation,
Department of Homeland Security, Federal Emergency Management Agency.
[FR Doc. 2010-24370 Filed 9-28-10; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 83, Number 230 (Thursday, November 29, 2018)]
[Notices]
[Pages 61385-61387]
[FR Doc No: 2018-25958]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-4337]

Prescription Drug User Fee Act of 2017; Electronic Submissions
and Data Standards; Announcement of Public Meeting; Request for
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the following public meeting entitled ``Prescription Drug User Fee Act
of 2017; Electronic Submissions and Data Standards.'' FDA is also
requesting public comments on the subject. The purpose of the meeting
and the request for comments is to fulfill FDA's commitment to seek
stakeholder input related to data standards and the electronic
submission system's past performance, future targets, emerging industry
needs, and technology initiatives. FDA will use the information from
the public meeting as well as from comments submitted to the docket to
provide input into data standards initiatives, the FDA Information
Technology (IT) Strategic Plan, and electronic submissions gateway
target timeframes.

DATES: The public meeting will be held on April 10, 2019, from 9 a.m.
to 4 p.m. Submit either electronic or written comments by April 10,
2019. See the SUPPLEMENTARY INFORMATION section for registration date
and information.

ADDRESSES: The public meeting will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Building 31 Conference Center, the Great Room
(Rm. 1503, Section A), Silver Spring, MD 20993-0002. Entrance for
public meeting participants (non-FDA employees) is through Building 1,
where routine security check procedures will be performed. For parking
and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before April 10, 2019. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of April 10, 2019. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.

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-2018-N-4337 for ``Prescription Drug User Fee Act of 2017;
Electronic Submissions and Data Standards.'' Received comments, those
filed in a timely manner (see ADDRESSES), 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 laws. 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.

FOR FURTHER INFORMATION CONTACT: Chenoa Conley, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1117, Silver Spring, MD 20993-0002, 301-
796-0035, [email protected], or Stephen Ripley, Center for
Biologics Evaluation and Research, Food and Drug Administration, Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is committed to achieve the long-term goal of improving the
predictability and consistency of the electronic submission process and
enhancing transparency and accountability of FDA information
technology-related activities. In the PDUFA VI commitment letter, FDA
agreed to hold annual public meetings to seek stakeholder input related
to electronic submissions and data standards to inform the FDA IT
Strategic Plan and published targets. The commitment letter outlines
FDA's performance goals and procedures under the PDUFA program for the
years 2018 through 2022. The commitment letter can be found at https://www.fda.gov/forindustry/userfees/prescriptiondruguserfee/ucm446608.htm.
    FDA will consider all comments made at this meeting or received
through the docket (see ADDRESSES).

II. Participating in the Public Meeting

    Registration: To register to attend ``Prescription Drug User Fee
Act of 2017; Electronic Submissions and Data Standards,'' please
register at https://www.eventbrite.com/e/pdufa-vi-public-meeting-on-electronic-submissions-and-data-standards-tickets-49895060469. Please
provide complete contact information for each attendee, including name,
title, affiliation, address, email, and telephone. A draft agenda will
be posted approximately 1 month prior to the meeting.
    Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
meeting on April 10, 2019, must register by 11:59 p.m. on March 22,
2019, Eastern Time. Early registration is recommended because seating
is limited; therefore, FDA may limit the number of participants from
each organization. Registrants will receive confirmation when they have
been accepted.
    Request for Oral Presentations: During online registration, you may
indicate if you wish to present during the public

comment session and which topic(s) you would like to address. FDA will
do its best to accommodate requests to make public comments.
Individuals and organizations with common interests are urged to
consolidate or coordinate their presentations. Following the close of
registration, FDA will determine the amount of time allotted to each
presenter and the approximate time each oral presentation is to begin
and will select and notify participants by March 27, 2019. All requests
to make oral presentations must be received by the close of
registration at 11:59 on March 22, 2019, Eastern Time. If selected for
presentation, any presentation materials must be emailed to
[email protected] no later than April 3, 2019. No
commercial or promotional material will be permitted to be presented or
distributed at the public meeting.
    If you need special accommodations due to a disability, please
contact Chenoa Conley,<PHONE_NUMBER>, email [email protected],
no later than April 3, 2019.
    Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at https:/www.fda.gov/forindustry/userfees/
prescriptiondruguserfee/ucm446608.htm.

    Dated: November 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-25958 Filed 11-28-18; 8:45 am]
 BILLING CODE 4164-01-P