[Federal Register: October 23, 2008 (Volume 73, Number 206)]
[Proposed Rules]
[Page 63116-63127]
[DOCID:fr23oc08-27]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 67

[Docket No. FEMA-B-1012]

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 percent 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 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 January 21, 2009.

ADDRESSES: The corresponding preliminary Flood Insurance Rate Map
(FIRM) for the proposed BFEs for each community are 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-1012, to
William R. Blanton, Jr., Chief, Engineering Management Branch,
Mitigation Directorate, Federal Emergency Management Agency, 500 C
Street, SW., Washington, DC 20472,<PHONE_NUMBER>, or (e-mail)
<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: William R. Blanton, Jr., Chief,
Engineering Management Branch, Mitigation Directorate, Federal
Emergency Management Agency, 500 C Street, SW., Washington, DC 20472,
(202) 646-3151 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 are also used to calculate the appropriate flood insurance
premium rates for new buildings built after these elevations are made
final, and for the contents in these 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.
    Administrative Procedure Act Statement. This matter is not a
rulemaking governed by the Administrative Procedure Act (APA), 5 U.S.C.
553. FEMA publishes flood elevation determinations for notice and
comment; however, they are governed by the Flood Disaster Protection
Act of 1973, 42 U.S.C. 4105, and the National Flood Insurance Act of
1968, 42 U.S.C. 4001 et seq., and do not fall under the APA.
    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)
                State                      City/town/county                  Source of flooding                                     Location **                            Depth in feet above
                                                                                ground
                                                                                -------------------------
                                                                                Existing     Modified
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                                                                                City of Campbell, Ohio
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Ohio.................................  City of Campbell........  Mahoning River...........................  Approximately 1,400 feet upstream of Bridge Road..........         None         +827
                                                                                Approximately 7,700 feet upstream of Bridge Road..........         None         +831
                                                                                Approximately 2,700 feet downstream of Center Street......         None         +833
                                                                                Approximately 2,000 feet downstream of Center Street......         None         +833
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* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.

** 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 William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.
                                                                                ADDRESSES

City of Campbell
Maps are available for inspection at Administration and Finance Office, 351 Tenney Avenue, Campbell, OH 44405.
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                                                                                City of Radford, Virginia
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Virginia.............................  City of Radford.........  Plum Creek...............................  Approximately 300 feet downstream of U.S. Highway 11......        +1738        +1739
                                                                                Approximately at the upstream corporate limits for the            +1768        +1782
                                                                                City of Radford.
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* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.

** 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 William R. Blanton, Jr., Chief, Engineering Management
 Branch, Mitigation Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.

                                                                                ADDRESSES

City of Radford
Maps are available for inspection at City of Radford Engineering Department, 619 Second Street, Radford, VA 24141.
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----------------------------------------------------------------------------------------------------------------
                                                                    * Elevation in feet
                                                                  (NGVD)  + Elevation in
                                                                  feet (NAVD)
         Flooding source(s)            Location of referenced       Depth in feet above     Communities affected
                                            elevation **                  ground
                                                                --------------------------
                                                                  Effective     Modified
----------------------------------------------------------------------------------------------------------------
                                Hancock County, Illinois, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Mississippi River..................  From the Hancock/Adams             +495         +494  Unincorporated Areas
                                      county boundary at River                              of Hancock County,
                                      Mile 347.4; approximately                             City of Dallas City,
                                      4 miles upstream of Lock                              City of Hamilton,
                                      and Dam No. 20.                                       City of Nauvoo, City
                                                                                of Warsaw, Village
                                                                                of Pontoosuc.
                                     To the Hancock/Henderson           +528         +529
                                      county boundary at River
                                      Mile 390.85,
                                      approximately Oak Street
                                      in Dallas City.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.

+ North American Vertical Datum.
 Depth in feet above ground.

** 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 William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.
                                                    ADDRESSES

City of Dallas City
Maps are available for inspection at 261 Oak Street, P.O. Box 454, Dallas City, IL 62330.

City of Hamilton
Maps are available for inspection at Hamilton City Hall, 1010 Broadway Street, Hamilton, IL 62341.

City of Nauvoo
Maps are available for inspection at 60 North Bluff Street, P.O. Box 85, Nauvoo, IL 62354.

City of Warsaw
Maps are available for inspection at 210 North Fourth Street, P.O. Box 12, Warsaw, IL 62379.

                                     Unincorporated Areas of Hancock County
Maps are available for inspection at 500 Main Street, P.O. Box 444, Carthage, IL 62321.

Village of Pontoosuc
Maps are available for inspection at Pontoosuc Village Hall, 200 Mustard Street, Pontoosuc, IL 62368.
----------------------------------------------------------------------------------------------------------------
                                Thurston County, Nebraska, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Logan Creek........................  Approximately 2.20 miles           None        +1318  Unincorporated Areas
                                      downstream of State                                   of Thurston County,
                                      Highway 94.                                           Omaha Indian Tribe.
                                     Approximately 1.65 miles           None        +1332
                                      upstream of State Highway
                                      94.
Middle Creek.......................  Approximately 0.81 mile            None        +1405  Unincorporated Areas
                                      downstream of Avenue B.                               of Thurston County,
                                                                                Village of Emerson,
                                                                                Winnebago Indian
                                                                                Tribe.
                                     Approximately 0.27 mile            None        +1425
                                      upstream of County Road
                                      15.
Unnamed Tributary to Logan Creek...  Approximately 0.75 mile            None        +1333  Unincorporated Areas
                                      upstream of State Highway                             of Thurston County,
                                      9.                                                    Omaha Indian Tribe.
                                     Approximately 0.30 mile            None        +1347
                                      upstream of State Highway
                                      9.
Unnamed Tributary to Middle Creek..  Approximately 530 feet             None        +1419  Village of Emerson,
                                      downstream of Lagan                                   Winnebago Indian
                                      Street.                                               Tribe.
                                     Approximately 750 feet             None        +1441
                                      upstream of 1st Street.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.

** 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 William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.
                                                    ADDRESSES

Omaha Indian Tribe
Maps are available for inspection at 100 Main Street, Macy, NE 68039.

                                     Unincorporated Areas of Thurston County
Maps are available for inspection at 106 South 5th Street, Pender, NE 68047.

Village of Emerson
Maps are available for inspection at 211 West Front Street, Emerson, NE 68733.

Winnebago Indian Tribe
Maps are available for inspection at 100 Buff Street, Winnebago, NE 68071.
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
                                                                    * Elevation in feet
                                                                  (NGVD)  + Elevation in
                                                                  feet (NAVD)
                                                                    Depth in feet above
         Flooding source(s)            Location of referenced         ground  [caret]       Communities affected
                                            elevation **            Elevation in meters
                                                                           (MSL)
                                                                --------------------------
                                                                  Effective     Modified
----------------------------------------------------------------------------------------------------------------
                                Suffolk County, New York, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Atlantic Ocean.....................  Approximately 700 feet              +11           +8  Town of Babylon,
                                      west of the Oak Beach                                 Shinnecock Indian
                                      Road dead end.                                        Reservation, Town of
                                                                                Brookhaven, Town of
                                                                                East Hampton, Town
                                                                                of Islip, Town of
                                                                                Southampton, Village
                                                                                of Amityville,
                                                                                Village of Babylon,
                                                                                Village of Bellport,
                                                                                Village of East
                                                                                Hampton, Village of
                                                                                Lindenhurst, Village
                                                                                of Ocean Beach,
                                                                                Village of Quogue,
                                                                                Village of
                                                                                Sagaponack, Village
                                                                                of Saltaire, Village
                                                                                of Southampton,
                                                                                Village of West
                                                                                Hampton Dunes,
                                                                                Village of
                                                                                Westhampton Beach.
                                     Approximately 160 feet              +13          +23
                                      south of Beach Lane
                                      extended.
Barley Field Cove..................  Approximately 1,000 feet            +10           +8  Town of Southold.
                                      east of the intersection
                                      of East End Drive and
                                      Brooks Point Road.
                                     Shoreline approximately             +14          +16
                                      1,425 feet east of the
                                      intersection of East End
                                      Drive and Brooks Point
                                      Road.
Bellport Bay.......................  At the intersection of             None           +5  Village of Bellport,
                                      Thorn Hedge Road and                                  Town of Brookhaven,
                                      Bayberry Road.                                        Village of
                                                                                Patchogue.
                                     Shoreline at southwestern            +7           +8
                                      end of South Howells
                                      Point Road.
Block Island Sound.................  Approximately 850 feet               +8           +5  Town of East Hampton,
                                      northwest of the                                      Town of Southold.
                                      intersection of Montauk
                                      County Park Road and East
                                      Lake Drive.
                                     Fishers Island--Shoreline           +11          +21
                                      approximately 900 feet
                                      east of the intersection
                                      of Montauk Highway and
                                      Old Montauk Highway.
Block Island Sound.................  Approximately 1,700 feet             +8   2  Town of East Hampton.
                                      southwest of the
                                      intersection of Soundview
                                      Drive and Captain Kidd's
                                      Path.
Bostwick Bay.......................  Gardiners Island--                   +8           +7  Town of East Hampton.
                                      Approximately 1.4 miles
                                      northwest of the
                                      intersection of Gardiner
                                      Island Road and 4wd Road.
                                     Gardiners Island--                  +10          +12
                                      Approximately 1.2 miles
                                      northwest of the
                                      intersection of Gardiner
                                      Island Road and 4wd Road.
Centerport Harbor..................  Approximately 500 feet              +11           +9  Town of Huntington,
                                      south of the intersection                             Village of
                                      of Prospect Road and Mill                             Huntington Bay,
                                      Dam Road.                                             Village of North
                                                                                Haven.
                                     Shoreline approximately             +13          +14
                                      1,500 feet northeast of
                                      the intersection of
                                      Monroe Drive and Garfield
                                      Street.
Cocomount Cove.....................  Approximately 500 feet               +9           +8  Town of Southold.
                                      northwest of the
                                      intersection of East End
                                      Drive and Brooks Point
                                      Road.
                                     Shoreline approximately             +12          +13
                                      735 feet northwest of the
                                      intersection of East End
                                      Drive and Brooks Point
                                      Road.
Coecles Inlet......................  Burns Road, approximately            +8           +7  Town of Shelter
                                      1,200 feet east of the                                Island, Village of
                                      intersection with North                               Dering Harbor.
                                      Cartwright Avenue.
                                     Shoreline at eastern end            +11          +10
                                      of Burns Road.
Cold Spring Harbor.................  Approximately 150 feet              +11           +9  Town of Huntington.
                                      north of the intersection
                                      of Shore Road and Spring
                                      Street.
                                     Approximately 1,325 feet            +11          +33
                                      west of the intersection
                                      of Dogwood Lane and Fort
                                      Hill Drive.
Conscience Bay.....................  Approximately 175 feet              +10           +8  Town of Brookhaven,
                                      southwest of the                                      Village of Old
                                      intersection of Bobs Lane                             Field, Village of
                                      and Chickadee Way.                                    Poquott, Village of
                                                                                Port Jefferson.
                                     Shoreline approximately             +10          +14
                                      1,340 feet west of the
                                      intersection of Gaul Road
                                      North and Gun Path.

Cutchogue Harbor...................  Shoreline approximately 50           +7           +6  Town of Southold.
                                      feet west of the
                                      intersection of Skunk
                                      Lane and Sterling Road.
                                     Shoreline approximately              +7          +16
                                      1,260 feet south of the
                                      intersection of Haywaters
                                      Road and West Cove Road.
                                     At the intersection of               +7   1
                                      Orchard Street and 1st
                                      Street.
                                     Approximately 65 feet                +7   2
                                      northwest of the
                                      southeastern terminus of
                                      Old Harbor Road.
Dering Harbor......................  Approximately 700 feet               +7           +5  Town of Shelter
                                      east of the intersection                              Island, Village of
                                      of North Ferry Road and W                             Dering Harbor,
                                      Neck Road.                                            Village of
                                                                                Greenport.
                                     Shoreline approximately              +9          +17
                                      540 feet north of the
                                      intersection of North
                                      Ferry Road and Winthrop
                                      Road.
Duck Island Harbor.................  Approximately 200 feet             None          +11  Town of Huntington,
                                      east of the end of South                              Village of
                                      Harbor Road.                                          Asharoken, Village
                                                                                of Huntington Bay,
                                                                                Village of
                                                                                Northport.
                                     Approximately 1,200 feet            +11          +16
                                      southeast of the
                                      intersection of Ponnell
                                      Road and South Harbor
                                      Road.
Fishers Island Sound...............  Approximately 1,400 feet           None           +7  Town of Southold.
                                      north of the intersection
                                      of East End Drive and
                                      Clay Point Road.
                                     Approximately 1,600 feet            +12          +46
                                      northwest of the
                                      intersection of Fox
                                      Avenue and Crescent
                                      Avenue.
Flanders Bay.......................  At the intersection of               +7           +6  Town of Riverhead,
                                      Meeting House Creek Road                              Town of Southampton.
                                      and Harbor Road.
                                     Shoreline approximately              +7          +13
                                      1,850 feet east of the
                                      intersection of Indian
                                      Point Road and Circle
                                      Drive.
Flanders Bay.......................  At the intersection of             None   2  Town of Riverhead.
                                      Indian Point Road and
                                      Circle Drive.
                                     Approximately 75 feet east           +7   2
                                      of the intersection of
                                      Harbor Road and Meeting
                                      House Creek Road.
Fort Pond Bay......................  Approximately 425 feet               +9           +5  Town of East Hampton.
                                      west of the intersection
                                      of South Erie Avenue and
                                      South Embassy Street.
                                     Shoreline approximately             +10          +19
                                      1,500 feet west of the
                                      end of Wills Point Road.
                                     Shoreline approximately              +8   2
                                      600 feet north of the end
                                      of Wills Point Road.
                                     Shoreline approximately              +8   2
                                      1,600 feet north of the
                                      end of Wills Point Road.
                                     Shoreline approximately              +8   2
                                      850 feet south of the end
                                      of Wills Point Road.
Gardiners Bay......................  Approximately 420 feet               +8           +5  Town of East Hampton,
                                      southwest of the                                      Town of Shelter
                                      intersection of Kings                                 Island, Town of
                                      Point Road and Hog Creek                              Southold, Village of
                                      Lane.                                                 Dering Harbor.
                                     Along the shoreline,                +12          +19
                                      approximately 1,500 feet
                                      west of Plum Gut Harbor.
Great Peconic Bay..................  At the intersection of               +7           +6  Town of Riverhead,
                                      West Street and 2nd                                   Town of Southampton,
                                      Street.                                               Town of Southold.
                                     Approximately 750 feet               +7          +11
                                      east 1st Street and Bray
                                      Avenue.
                                     West Street approximately            +7   1
                                      300 feet southeast of the
                                      intersection with 2nd
                                      Street.
                                     Oak Street approximately             +7   2
                                      175 feet southeast of the
                                      intersection with Bayside
                                      Avenue.
Great South Bay....................  Intersection of Gibson               +5           +4  Town of Babylon, Town
                                      Street and Huma Avenue.                               of Islip, Village of
                                                                                Amityville, Village
                                                                                of Babylon, Village
                                                                                of Brightwaters,
                                                                                Village of
                                                                                Lindenhurst.
                                     At southern end of Norman            +8          +10
                                      Avenue.
Greenport Harbor...................  At the intersection of               +7           +6  Town of Southold,
                                      Sterling Avenue and                                   Town of Shelter
                                      Sterling Street.                                      Island, Village of
                                                                                Greenport.
                                     Shoreline approximately              +9          +10
                                      170 feet east-southeast
                                      of the intersection of
                                      Sterling Avenue and
                                      Sterling Street.

Hay Harbor.........................  Approximately 300 feet              +10          +11  Town of Southold.
                                      north of the intersection
                                      of Equestrian Avenue and
                                      Winthrop Drive.
                                     Approximately 0.5 mile              +12          +16
                                      north of the intersection
                                      of Equestrian Avenue and
                                      Winthrop Drive.
Huntington Bay.....................  Approximately 50 feet               +11           +9  Town of Huntington,
                                      south of the intersection                             Village of
                                      of Surf Lane and                                      Asharoken, Village
                                      Lighthouse Road.                                      of Huntington Bay,
                                                                                Village of Lloyd
                                                                                Harbor.
                                     Shoreline approximately             +13          +21
                                      1,000 feet east of the
                                      end of Crescent Beach
                                      Drive.
Huntington Harbor..................  Approximately 400 feet              +11           +9  Town of Huntington,
                                      south of the intersection                             Village of
                                      of Bouton Road and Pine                               Huntington Bay,
                                      Point Road.                                           Village of Lloyd
                                                                                Harbor.
                                     Shoreline approximately             +11          +12
                                      760 feet southeast of the
                                      intersection of Bouton
                                      Road and Pine Point Road.
Lake Montauk.......................  Farragut Road,                       +8           +5  Town of East Hampton.
                                      approximately 1,400 feet
                                      northeast of the
                                      intersection with West
                                      Lake Drive.
                                     Approximately 350 feet               +9          +11
                                      west of the intersection
                                      of Prospect Hill Lane and
                                      East Lake Drive.
Little Peconic Bay.................  Approximately 350 feet               +7           +6  Town of Southold.
                                      south of the intersection
                                      of Arrowhead Lane and
                                      Campfire Lane.
                                     Approximately 1,700 feet             +7          +16
                                      northeast of the
                                      intersection of Arrowhead
                                      Lane and Campfire Lane.
                                     Approximately 400 feet               +7   1
                                      northeast of the
                                      intersection of Nassau
                                      Point Road and
                                      Broadwaters Road.
                                     Approximately 400 feet               +7   2
                                      southeast of the
                                      intersection of Nassau
                                      Point Road and
                                      Broadwaters Road.
Lloyd Harbor.......................  Approximately 700 feet              +11           +9  Village of Lloyd
                                      west of the intersection                              Harbor.
                                      of Lloyd Harbor Road and
                                      Fiddlers Green Drive.
                                     Shoreline approximately             +15          +14
                                      825 feet east-northeast
                                      of the intersection of
                                      Lloyd Harbor Road and
                                      Fiddlers Green Drive.
Long Island Sound..................  Approximately 1,300 feet             +9           +6  Village of Lloyd
                                      north of the intersection                             Harbor, Town of
                                      of Main Road and Cove                                 Brookhaven, Town of
                                      Beach Road.                                           Huntington, Town of
                                                                                Riverhead, Town of
                                                                                Shelter Island, Town
                                                                                of Smithtown, Town
                                                                                of Southold, Village
                                                                                of Asharoken,
                                                                                Village of Belle
                                                                                Terre, Village of
                                                                                Dering Harbor,
                                                                                Village of
                                                                                Greenport, Village
                                                                                of Head of The
                                                                                Harbor, Village of
                                                                                Huntington Bay,
                                                                                Village of
                                                                                Nissequogue, Village
                                                                                of Northport,
                                                                                Village of Old
                                                                                Field, Village of
                                                                                Poquott, Village of
                                                                                Port Jefferson,
                                                                                Village of Shoreham.
                                     Approximately 500 feet              +14          +46
                                      west of East Point on
                                      Plum Island.
Long Island Sound..................  At the intersection of               +9   2  Town of Southold.
                                      Carole Road and Old Cove
                                      Road.
Majors Harbor......................  Along the shoreline,                 +8           +5  Town of Shelter
                                      approximately 2,200 feet                              Island, Town of
                                      southeast from the end of                             Southampton, Village
                                      Mashomack Preserve Road.                              of North Haven.
                                     Shoreline at Majors Point.           +9           +8
Moriches Bay.......................  At the intersection of               +8           +7  Town of Brookhaven,
                                      South County Road and                                 Poospatuck Indian
                                      Raynor Drive.                                         Reservation, Town of
                                                                                Southampton, Village
                                                                                of West Hampton
                                                                                Dunes, Village of
                                                                                Westhampton Beach.
                                     Shoreline, approximately             +9          +12
                                      400 feet north of the
                                      intersection of Dune Road
                                      and Dune Lane.

Napeague Bay.......................  Approximately 150 feet               +7           +5  Town of East Hampton.
                                      south of the intersection
                                      of Little Alberts Road
                                      and Alberts Landing.
                                     Shoreline approximately             +10          +14
                                      0.6 mile west of the
                                      intersection of Bayview
                                      Avenue and Lazy Point
                                      Road.
                                     Approximately 1,400 feet           None   1
                                      southeast of the
                                      intersection of Waters
                                      Edge and Barnes Hole Road.
Nicoll Bay.........................  At the intersection of             None           +5  Town of Islip.
                                      Cross Road and West Shore
                                      Road.
                                     Approximately 700 feet               +3           +7
                                      south of the intersection
                                      of Shore Drive and
                                      Edgewood Avenue.
Northeast Branch Nissuquogue River.  Approximately 425 feet             None          +46  Town of Smithtown.
                                      upstream of Branch Drive.
                                     Approximately 525 feet             None          +46
                                      upstream of Branch Drive.
Northport Bay......................  Approximately 45 feet west         None           +9  Town of Huntington,
                                      of the intersection of                                Village of
                                      Eatons Neck Road and                                  Asharoken, Village
                                      Steers Avenue.                                        of Huntington Bay,
                                                                                Village of
                                                                                Northport.
                                     Shoreline approximately             +13          +21
                                      1,100 feet northeast of
                                      the intersection of East
                                      Neck Road and Crest Road.
Northport Harbor...................  At the intersection of             None           +9  Town of Huntington,
                                      Scudder Avenue and                                    Village of
                                      Bayview Avenue.                                       Northport.
                                     Approximately 1,400 feet            +13          +16
                                      northwest of the
                                      intersection of Bluff
                                      Point Road and Duffy Road.
Northwest Harbor...................  Approximately 500 feet               +8           +5  Town of East Hampton.
                                      north of the intersection
                                      of Alewife Brook Road and
                                      Terrys Trail.
                                     Shoreline approximately             +10          +19
                                      1,900 feet north of the
                                      western terminus of
                                      Alewife Brook Road.
Noyack Bay.........................  At the intersection of Bay           +8           +6  Town of Southampton,
                                      Avenue and Noyack Avenue.                             Village of North
                                                                                Haven, Village of
                                                                                Sag Harbor.
                                     Shoreline approximately              +9          +23
                                      560 feet west of the
                                      intersection of Bay View
                                      Court and North Haven Way.
Orient Harbor......................  At the intersection of Bay           +8           +6  Town of Southold,
                                      Avenue and Rabbit Lane.                               Town of Shelter
                                                                                Island, Village of
                                                                                Dering Harbor.
                                     Shoreline at the                    +10           +9
                                      southeastern end of Bay
                                      Avenue.
                                     Approximately 875 feet               +8   1
                                      northeast of the
                                      intersection of East
                                      Gillette Drive and
                                      Cleaves Point Road.
Oyster Bay.........................  Approximately 150 feet              +11           +9  Town of Huntington,
                                      north of the intersection                             Village of
                                      of Shore Road and Spring                              Huntington Bay,
                                      Street.                                               Village of Lloyd
                                                                                Harbor.
                                     Approximately 750 feet              +11          +39
                                      southwest of Turtle Lane
                                      and Mallard Drive.
Patchogue Bay......................  At the intersection of             None           +5  Village of Patchogue,
                                      Harrison Street and South                             Town of Brookhaven,
                                      Ocean Avenue.                                         Town of Islip.
                                     Shoreline at southern end            +7           +8
                                      of Durkee Lane.
Pipes Cove.........................  Approximately 190 feet               +7           +6  Town of Southold,
                                      north of the intersection                             Town of Shelter
                                      of Bayshore Road and                                  Island, Village of
                                      August Road.                                          Greenport.
                                     Shoreline approximately              +7          +13
                                      220 feet east of the
                                      intersection of Bayshore
                                      Road and August Road.
Port Jefferson Harbor..............  Approximately 750 feet              +10           +8  Town of Brookhaven,
                                      northwest of the                                      Village of Belle
                                      intersection of Barnum                                Terre, Village of
                                      Avenue and Maple Place.                               Old Field, Village
                                                                                of Poquott, Village
                                                                                of Port Jefferson.
                                     Shoreline approximately             +13          +24
                                      350 feet northeast of the
                                      intersection of
                                      Washington Street and
                                      Chestnut Avenue.
Reeves Bay.........................  Approximately 100 feet             None           +7  Town of Southampton,
                                      south of the intersection                             Town of Riverhead.
                                      of Flanders Road and Wood
                                      Road Trail.
                                     Approximately 300 feet               +9          +10
                                      west of the intersection
                                      of Long Neck Boulevard
                                      and Fantasy Drive.
Sag Harbor Bay.....................  Approximately 300 feet              +10           +6  Village of Sag
                                      south of the intersection                             Harbor, Town of East
                                      of Woodland Drive and                                 Hampton, Village of
                                      Division Avenue.                                      North Haven.

                                     Shoreline approximately             +11          +13
                                      190 feet north of the
                                      intersection of Meredith
                                      Avenue and Terry Drive.
Shelter Island Sound...............  Approximately 700 feet               +7           +5  Town of Shelter
                                      southwest of the                                      Island, Town of
                                      intersection of Nostrand                              Southold, Village of
                                      Parkway and Bootleggers                               North Haven.
                                      Alley.
                                     Approximately 550 feet               +9          +23
                                      west of the intersection
                                      of North Haven Way and On
                                      the Bluff.
Shelter Island Sound...............  Approximately 140 feet               +7   1  Town of Shelter
                                      northwest of the                                      Island, Town of
                                      intersection of Peconic                               Southold, Village of
                                      Avenue and Brander                                    Dering Harbor,
                                      Parkway.                                              Village of North
                                                                                Haven.
                                     Approximately 800 feet               +7   2
                                      west-southwest of the
                                      intersection of Nostrand
                                      Parkway and Bootleggers
                                      Alley.
Shinnecock Bay.....................  Approximately 100 feet             None           +8  Town of Southampton,
                                      east of the intersection                              Village of Quogue.
                                      of Bonita Road and
                                      Whiting Road.
                                     Shoreline approximately              +9          +14
                                      900 feet northeast of the
                                      intersection of Dune Road
                                      and Triton Lane.
Smith Cove.........................  Approximately 370 feet               +8           +5  Town of Shelter
                                      north of the intersection                             Island, Village of
                                      of Thompson Road and                                  North Haven.
                                      Irene Lane.
                                     Approximately 700 feet               +9          +21
                                      southeast of the
                                      intersection of Thompson
                                      Road and Irene Lane.
Smithtown Bay......................  At the intersection of              +12           +9  Town of Smithtown,
                                      Riviera Drive and                                     Village of
                                      Magnolia Drive.                                       Nissequogue.
                                     Approximately 1,200 feet            +15          +17
                                      north of the intersection
                                      of Old Dock Road and
                                      Upper Dock Road.
Southold Bay.......................  Approximately 850 feet               +7           +6  Town of Southold,
                                      east of the intersection                              Town of Shelter
                                      of Route 25 and Town                                  Island.
                                      Harbor Lane.
                                     Approximately 275 feet               +7          +21
                                      north of the intersection
                                      of Basin Road and
                                      Paradise Point Road.
Tobaccolot Bay.....................  Approximately 1.1 miles              +8           +6  Town of East Hampton.
                                      east of the intersection
                                      of Gardiner Island Road
                                      and 4WD Road.
                                     Approximately 1.4 miles             +10          +11
                                      east of the intersection
                                      of Gardiner Island Road
                                      and 4WD Road.
West Harbor........................  Approximately 0.6 mile               +9           +7  Town of Southold.
                                      east of the intersection
                                      of East End Drive and
                                      Peninsula Road.
                                     Shoreline, approximately            +12          +19
                                      1,200 feet east of the
                                      intersection of Montauk
                                      Avenue and Hedge Street.
West Neck Harbor...................  Approximately 1,000 feet             +7           +5  Town of Shelter
                                      west of the intersection                              Island, Village of
                                      of Lake Drive and South                               North Haven.
                                      Midway Road.
                                     Shoreline approximately             +10           +8
                                      1,500 feet south of the
                                      intersection of Sea Gate
                                      Drive and South Midway
                                      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 William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.
                                                    ADDRESSES

Poospatuck Indian Reservation
Maps are available for inspection at Poospatuck Indian Reservation Administrative Offices, 138 Elleanor Avenue,
 Mastic, NY.

Shinnecock Indian Reservation
Maps are available for inspection at Shinnecock Indian National Tribal Office, 100 Church Street, Southampton,
 NY.

Town of Babylon
Maps are available for inspection at Babylon Town Hall, 200 East Sunrise Highway, Lindenhurst, NY.

Town of Brookhaven
Maps are available for inspection at Brookhaven Town Hall, One Independence Hill, Farmingville, NY.

Town of East Hampton
Maps are available for inspection at East Hampton Town Hall, 159 Pantigo Road, East Hampton, NY.

Town of Huntington
Maps are available for inspection at Huntington Town Hall, 100 Main Street, Huntington, NY.

Town of Islip
Maps are available for inspection at Islip Town Hall, 655 Main Street, Islip, NY.

Town of Riverhead
Maps are available for inspection at Riverhead Town Hall, 201 Howell Avenue, Riverhead, NY.

Town of Shelter Island
Maps are available for inspection at Shelter Island Town Hall, 38 North Ferry Road, Shelter Island, NY.

Town of Smithtown
Maps are available for inspection at Smithtown Town Hall, 99 West Main Street, Smithtown, NY.

Town of Southampton
Maps are available for inspection at Southampton Town Hall, 116 Hampton Road, Southampton, NY.

Town of Southold
Maps are available for inspection at Southold Town Hall, 53095 Routh 25, Southold, NY.

Village of Amityville
Maps are available for inspection at Amityville Village Hall, 21 Greene Avenue, Amityville, NY.

Village of Asharoken
Maps are available for inspection at Asharoken Village Hall, 1 Asharoken Avenue, Northport, NY.

Village of Babylon
Maps are available for inspection at Babylon Village Hall, 153 West Main Street, Babylon, NY.

Village of Belle Terre
Maps are available for inspection at Belle Terre Village Hall, 1 Cliff Road, Belle Terre, NY.

Village of Bellport
Maps are available for inspection at Bellport Village Hall, 29 Bellport Lane, Bellport, NY.

Village of Brightwaters
Maps are available for inspection at Brightwaters Village Hall, 40 Seneca Drive, Brightwaters, NY.

Village of Dering Harbor
Maps are available for inspection at Dering Harbor Village Hall, 23 Locust Point Road, Shelter Island Heights,
 NY.

Village of East Hampton
Maps are available for inspection at East Hampton Village Hall, 86 Main Street, East Hampton, NY.

Village of Greenport
Maps are available for inspection at Greenport Village Hall, 236 Third Street, Greenport, NY.

Village of Head of The Harbor
Maps are available for inspection at Head of the Harbor Village Hall, 500 North Country Road, Saint James, NY.

Village of Huntington Bay
Maps are available for inspection at Huntington Bay Village Hall, 244 Vineyard Road, Huntington Bay, NY.

Village of Lindenhurst
Maps are available for inspection at Lindenhurst Village Hall, 430 South Wellwood Avenue, Lindenhurst, NY.

Village of Lloyd Harbor
Maps are available for inspection at Lloyd Harbor Village Hall, 32 Middle Hollow Road, Huntington, NY.

Village of Nissequogue
Maps are available for inspection at Nissequogue Village Hall, 631 Moriches Road, St. James, NY.

Village of North Haven
Maps are available for inspection at North Haven Village Hall, 335 Ferry Road, Sag Harbor, NY.

Village of Northport
Maps are available for inspection at Northport Village Hall, 224 Main Street, Northport, NY.

Village of Ocean Beach
Maps are available for inspection at Ocean Beach Village, 315 Cottage Walk, Ocean Beach, NY.

Village of Old Field
Maps are available for inspection at Old Field Village Hall, 207 Old Field Road, Setauket, NY.

Village of Patchogue
Maps are available for inspection at Patchogue Village Hall, 14 Baker Street, Patchogue, NY.

Village of Poquott
Maps are available for inspection at Poquott Village Hall, 45 Birchwood Avenue, East Setauket, NY.

Village of Port Jefferson
Maps are available for inspection at Port Jefferson Village Hall, 121 West Broadway, Port Jefferson, NY.

Village of Quogue
Maps are available for inspection at Quogue Village Hall, 7 Village Lane, Quogue, NY.

Village of Sag Harbor
Maps are available for inspection at Sag Harbor Village Hall, 22 Main Street, Sag Harbor, NY.

Village of Sagaponack
Maps are available for inspection at Sagaponack Village Hall, 20 Sagg Main Street, Sagaponack, NY.

Village of Saltaire
Maps are available for inspection at Saltaire Village Hall, 103 Broadway, Saltaire, NY.

Village of Shoreham

Maps are available for inspection at Shoreham Village Hall, 80 Woodville Road, Shoreham, NY.

Village of Southampton
Maps are available for inspection at Southampton Village Hall, 23 Main Street, Southampton, NY.

Village of West Hampton Dunes
Maps are available for inspection at West Hampton Dunes Village Hall, 4 Arthur Street, West Hampton Beach, NY.

Village of Westhampton Beach
Maps are available for inspection at Westhampton Beach Village Hall, 165 Mill Road, Westhampton Beach, NY.
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
                                                                    * Elevation in feet
                                                                  (NGVD)  + Elevation in
                                                                  feet (NAVD)
         Flooding source(s)            Location of referenced       Depth in feet above     Communities affected
                                            elevation **                  ground
                                                                --------------------------
                                                                  Effective     Modified
----------------------------------------------------------------------------------------------------------------
                                   Greene County, Ohio, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Possum Run.........................  Approximately 900 feet             None         +931  City of Centerville.
                                      downstream of Wilmington
                                      Pike.
                                     At Wilmington Pike North           None         +940
                                      Branch.
Shawnee Park Tributary.............  Approximately 4,200 feet           +929         +924  City of Xenia.
                                      upstream of Monroe Drive.
                                     Approximately 40 feet              +942         +943
                                      downstream of U.S. Route
                                      42.
Shawnee Park Tributary.............  Approximately 700 feet             +934         +930  Unincorporated Areas
                                      downstream of U.S. Route                              of Greene County.
                                      42.
                                     Downstream of U.S. Route           +942         +943
                                      42.
South Fork Massies Creek...........  Approximately 2,800 feet          +1042        +1041  Unincorporated Areas
                                      upstream of Railroad.                                 of Greene County.
                                     Approximately 240 feet            +1051        +1050
                                      downstream of Weimer Road.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.

** 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 William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.
                                                    ADDRESSES

City of Centerville
Maps are available for inspection at Municipal Building, 100 West Spring Valley Road, Centerville, OH 45458.

City of Xenia
Maps are available for inspection at City Hall, 101 North Detroit Street, Xenia, OH 45385.

                                      Unincorporated Areas of Greene County
Maps are available for inspection at Greene County Building Regulation, 667 Dayton-Xenia Road, OH 45385.
----------------------------------------------------------------------------------------------------------------

                                  Hamilton County, Ohio, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Little Miami River.................  65 feet upstream of                None         +501  Unincorporated Areas
                                      Norfolk and Western                                   of Hamilton County,
                                      railroad crossing.                                    Village of Fairfax,
                                                                                Village of
                                                                                Mariemont.
                                     665 feet downstream of             None         +501
                                      Harvard Street in Village
                                      of Mariemont.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.

** 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 William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.
                                                    ADDRESSES

                                     Unincorporated Areas of Hamilton County
Maps are available for inspection at Hamilton County Department of Public Works, 138 East Court Street, Room
 800, Cincinnati, OH 45202.

Village of Fairfax
Maps are available for inspection at Fairfax Municipal Building, 5903 Hawthorne Avenue, Fairfax, OH 45227.

Village of Mariemont
Maps are available for inspection at Mariemont Municipal Building, 6907 Wooster Pike, Mariemont, OH 45227.
----------------------------------------------------------------------------------------------------------------
                               Claiborne County, Tennessee, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Clinch River/Norris Lake...........  Approximately 2.3 miles            None        +1055  Unincorporated Areas
                                      downstream of the                                     of Claiborne County.
                                      confluence of Big Barren
                                      Creek.
                                     Approximately 3.3 miles            None        +1055
                                      upstream of U.S. Highway
                                      25.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.

** 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 William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.
                                                    ADDRESSES

                                    Unincorporated Areas of Claiborne County
Maps are available for inspection at County Courthouse, 1740 Main Street, Tazewell, TN 37879.
----------------------------------------------------------------------------------------------------------------
                               Montgomery County, Virginia, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Plum Creek.........................  Approximately 900 ft              +1754        +1755  Unincorporated Areas
                                      upstream of U.S. Highway                              of Montgomery
                                      11.                                                   County.
                                     Approximately at the               None        +1918
                                      intersection of Gate Road
                                      and Plum Creek Road.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.

** 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 William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.
                                                    ADDRESSES

                                    Unincorporated Areas of Montgomery County
Maps are available for inspection at Planning and GIS Services, 755 Roanoke Street, Christiansburg, VA 24073.
----------------------------------------------------------------------------------------------------------------
                                 Pepin County, Wisconsin, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Chippewa River.....................  Approximately 7,000 feet           None         +712  City of Durand,
                                      downstream of the new                                 Unincorporated Areas
                                      U.S. Highway 10 Bridge.                               of Pepin County.
                                     Approximately 6,000 feet           None         +717
                                      upstream of the
                                      confluence of Bear Creek.
Mississippi River..................  Approximately at the               +682         +681  Village of Stockholm,
                                      intersection of Lakeport                              Unincorporated Areas
                                      Road and State Highway 35.                            of Pepin County.
                                     At the county boundary             +682         +681
                                      with Pierce County..
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.

** 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 William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.
                                                    ADDRESSES

City of Durand
Maps are available for inspection at City Hall, 104 East Main Street, Durand, WI 54736.

                                      Unincorporated Areas of Pepin County
Maps are available for inspection at Pepin County Government Center, 740 7th Avenue West, Pepin, WI 54736.

Village of Stockholm
Maps are available for inspection at Village Hall, 2041 Spring Street, Stockholm, WI 54769.
----------------------------------------------------------------------------------------------------------------

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

    Dated: October 9, 2008.
Michael K. Buckley,
Acting Assistant Administrator, Mitigation Directorate, Department of
Homeland Security, Federal Emergency Management Agency.
[FR Doc. E8-25263 Filed 10-22-08; 8:45 am]

BILLING CODE 9110-12-P


[Federal Register Volume 80, Number 174 (Wednesday, September 9, 2015)]
[Notices]
[Pages 54294-54295]
[FR Doc No: 2015-22673]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-P-0248]

Determination That GLUCAGON (Glucagon Hydrochloride) for
Injection, Equivalent to 1 Milligram Base/Vial and Equivalent to 10
Milligram Base/Vial, Was Not Withdrawn From Sale for Reasons of Safety
or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined that
GLUCAGON (glucagon hydrochloride) for injection, equivalent to (EQ) 1
milligram (mg) base/vial and EQ 10 mg base/vial, was not withdrawn from
sale for reasons of safety or effectiveness. This determination will
allow FDA to approve abbreviated new drug applications (ANDAs) for
glucagon hydrochloride for injection, EQ 1 mg base/vial and EQ 10 mg
base/vial, if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Daniel Orr, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6206, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).

    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    GLUCAGON (glucagon hydrochloride) for injection, EQ 1 mg base/vial
and EQ 10 mg base/vial, is the subject of NDA 12-122 held by Eli Lilly,
and initially approved onNovember 14, 1960. GLUCAGON is indicated for
treatment of severe hypoglycemia and as a diagnostic aid in the
radiologic examination of the stomach, duodenum, small bowel, and
colon.
    Under NDA 12-122, GLUCAGON (glucagon hydrochloride) for injection,
EQ 1 mg base/vial and EQ 10 mg base/vial, was produced from animal
sources. On September 11, 1998, FDA approved Eli Lilly's NDA 20-928 for
GLUCAGON (glucagon rDNA origin), 1mg/vial. Subsequently, Eli Lilly
discontinued sales of animal-sourced GLUCAGON in 2002. In 2005, FDA
moved animal-sourced GLUCAGON (glucagon hydrochloride) for injection,
EQ 1 mg base/vial and EQ 10 mg base/vial, to the ``Discontinued Drug
Product List'' section of the Orange Book.
    Walter G. Jump, on behalf of Cornerstone Regulatory, submitted a
citizen petition dated August 7, 2007 (Docket No. FDA-2007-P-0248),
under 21 CFR 10.30, requesting that the Agency determine whether
animal-sourced GLUCAGON (glucagon hydrochloride) for injection, EQ 1 mg
base/vial and EQ 10 mg base/vial, was withdrawn from sale for reasons
of safety or effectiveness.
    After considering the citizen petition, reviewing Agency records,
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that GLUCAGON (glucagon hydrochloride) for
injection, EQ 1 mg base/vial and EQ 10 mg base/vial, was not withdrawn
for reasons of safety or effectiveness. The petitioner has identified
no data or other information suggesting that GLUCAGON (glucagon
hydrochloride) for injection, EQ 1 mg base/vial and EQ 10 mg base/vial,
was withdrawn for reasons of safety or effectiveness. We have carefully
reviewed our files for records concerning the withdrawal from sale of
GLUCAGON (glucagon hydrochloride) for injection, EQ 1 mg base/vial and
EQ 10 mg base/vial. We have also independently evaluated relevant
literature and data for possible postmarketing adverse events. We have
reviewed the available evidence and determined that the product was not
withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list GLUCAGON (glucagon
hydrochloride) for injection, EQ 1 mg base/vial and EQ 10 mg base/vial,
in the ``Discontinued Drug Product List'' section of the Orange Book.
The ``Discontinued Drug Product List'' delineates, among other items,
drug products that have been discontinued from marketing for reasons
other than safety or effectiveness. ANDAs that refer to GLUCAGON
(glucagon hydrochloride) for injection, EQ 1 mg base/vial and EQ 10 mg
base/vial, may be approved by the Agency as long as they meet all other
legal and regulatory requirements for the approval of ANDAs. However,
it is the Agency's view that it would be challenging for a prospective
applicant to provide adequate data to meet the statutory requirements
for an ANDA that relies on NDA 12-122 for GLUCAGON (glucagon
hydrochloride) for injection in the absence of comparative data with
the animal-sourced glucagon approved in NDA 12-122.

    Dated: September 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-22673 Filed 9-8-15; 8:45 am]
 BILLING CODE 4164-01-P


From:
"Tunno, Brett J"<EMAIL_ADDRESS>Sent:
Mon, 12 Sep 2022 16:35:03
To:
"Jones; DonnaLee"<EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS>Cc:
Raymond, Gabrielle<EMAIL_ADDRESS>Shappley, Ned<EMAIL_ADDRESS>Mcginn, Kevin<EMAIL_ADDRESS>Dzurinko, Mike G<EMAIL_ADDRESS>Subject:
RE: [External]-RE: U. S. Steel - Clairton Plant - Monitoring Plan Submission
Good afternoon Dr. Jones,

Attached is the revised monitoring plan for the U. S. Steel  -  Clairton Plant, as requested.

Have a nice evening,

Brett Tunno, DrPH, CPH
Environmental Affairs
United States Steel Corporation
Office:<PHONE_NUMBER>
Cell:<PHONE_NUMBER>
Email<EMAIL_ADDRESS><EMAIL_ADDRESS>

<<USS Revised Monitoring Plan-Test Plan-QAPP.pdf>>

From: Jones, DonnaLee<EMAIL_ADDRESS>Sent: Tuesday, August 30, 2022 1:53 PM
To: Tunno, Brett J<EMAIL_ADDRESS>Dzurinko, Mike G<EMAIL_ADDRESS>Cc: GABRIELLE RAYMOND<EMAIL_ADDRESS><EMAIL_ADDRESS>Shappley, Ned<EMAIL_ADDRESS>Mcginn, Kevin<EMAIL_ADDRESS>Subject: [External]-RE: U. S. Steel - Clairton Plant - Monitoring Plan Submission

Hello Brett and Mike: Thank you for the submission of your QAPP in response to the 2022 Clean Air Act section 114 test request for the Coke Ovens RTR. We reviewed your submission and had the following comments and requests:

"The SODAR met station should be used for the testing. The interior sample locations are good, but the TO-15 upwind fenceline location should be moved to the same location as the TO-13 upwind site, which appears to be better sited for removing potential interferents. The usage status of the two storage tanks excluded from the fenceline perimeter should be confirmed to ensure their exclusion is appropriate."

Please submit a revised QAPP documents addressing these deficiencies by Monday, September 12, 2022 COB.

Thank you for your efforts wth this 114 request.

Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D243-02)
Research Triangle Park, NC  27711
Tele:<PHONE_NUMBER>
--------------------------------------------------------------------------------
Fax<PHONE_NUMBER>
"Reasonableness never fails to be appreciated."  - anon.

Pronouns - She/Her/Hers
Salutation - Dr./Ms.

From: Tunno, Brett J<EMAIL_ADDRESS><EMAIL_ADDRESS>>
Sent: Tuesday, August 16, 2022 5:20 PM
To: Coke ICR2<EMAIL_ADDRESS><EMAIL_ADDRESS>>
Cc: Dzurinko, Mike G<EMAIL_ADDRESS><EMAIL_ADDRESS>>
Subject: U. S. Steel - Clairton Plant - Monitoring Plan Submission

Good afternoon,

Attached is the proposed U. S. Steel  -  Clairton Plant Fugitive Monitoring Plan as required by the ICR.  Please reach out to Mike Dzurinko and me if you have any questions.

Thanks,

Brett Tunno, DrPH, CPH
Environmental Affairs
United States Steel Corporation
Office:<PHONE_NUMBER>
Cell:<PHONE_NUMBER>
Email<EMAIL_ADDRESS>