[Federal Register: September 25, 2008 (Volume 73, Number 187)]
[Proposed Rules]
[Page 55469-55473]
[DOCID:fr25se08-22]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 67

[Docket No. FEMA-B-1007]

Proposed Flood Elevation Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Proposed rule.

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

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 December 24, 2008.

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-1007, 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:

----------------------------------------------------------------------------------------------------------------
                                                                  * Elevation in feet
                                                                 (NGVD) + Elevation in
                                                                 feet (NAVD)
         Flooding source(s)            Location of referenced     Depth in feet above      Communities affected
                                            elevation **                ground
                                                              --------------------------
                                                                Effective     Modified
----------------------------------------------------------------------------------------------------------------
                                 Mohave County, Arizona, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Williams Wash.......................  Approximately 250 feet    2         +703  City of Bullhead City.
                                       upstream of confluence
                                       Highland/Green Wash.
                                      Approximately 622 feet          None        +1471
                                       upstream of La Puerta
                                       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 Bullhead City
Maps are available for inspection at 1255 Marina Blvd, Bullhead City, AZ 86442.
----------------------------------------------------------------------------------------------------------------
                                 Brown County, Illinois, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Illinois River......................  From the limit of               +447         +448  Unincorporated Areas of
                                       flooding affecting                                 Brown County.
                                       community at river
                                       mile 71.3 in Pike
                                       County; 0.7 miles
                                       downstream of the Pike/
                                       Brown County Border at
                                       approximately State
                                       Hwy 104.
                                      To the Schuyler/Morgan          +448         +450
                                       County Border at river
                                       mile 83.8;
                                       approximately the
                                       mouth of the La Moine
                                       River.
----------------------------------------------------------------------------------------------------------------
* 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 Brown County
Maps are available for inspection at Brown County Courthouse, 200 West Court Street, Mt. Sterling, IL 62353.
----------------------------------------------------------------------------------------------------------------
                                Anderson County, Kentucky, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Kentucky River......................  Anderson County and             None         +509  Unincorporated Areas of
                                       Franklin County                                    Anderson County.
                                       corporate limits.
                                      Anderson County and             None         +527
                                       Mercer County
                                       corporate limits..
----------------------------------------------------------------------------------------------------------------
* 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 Anderson County
Maps are available for inspection at 139 Main Street, Lawrenceburg, KY 40342.
----------------------------------------------------------------------------------------------------------------
                               Henderson County, Kentucky, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Canoe Creek.........................  Just upstream US-41....         None         +376  Unincorporated Areas of
                                                                                Henderson County, City
                                                                                of Henderson.
                                      At confluence with Elam         None         +383
                                       Ditch.
Elam Ditch..........................  At confluence with              None         +383  Unincorporated Areas of
                                       Canoe Creek.                                       Henderson County.
                                      At Airline Road (KY-            None         +393
                                       812).

Elam Ditch Tributary 1..............  At confluence with Elam         None         +384  Unincorporated Areas of
                                       Ditch.                                             Henderson County.
                                      Approximately 1250 feet         None         +395
                                       downstream Toy
                                       Anthoston Road (KY-
                                       2677).
Elam Ditch Tributary 2..............  At confluence with Elam         None         +384  Unincorporated Areas of
                                       Ditch.                                             Henderson County.
                                      Just downstream Airline         None         +395
                                       Road (KY-812).
Elam Ditch Tributary 3..............  At confluence with Elam         None         +384  Unincorporated Areas of
                                       Ditch.                                             Henderson County.
                                      Just downstream Toy             None         +389
                                       Anthoston.
Kimsey Lane Left Tributary..........  At confluence with              +387         +388  Unincorporated Areas of
                                       North Fork Canoe Creek.                            Henderson County, City
                                                                                of Henderson.
                                      Approximately 750 feet          +387         +388
                                       upstream Van Wyk Road.
Kimsey Lane Right Tributary.........  At confluence with              +387         +388  Unincorporated Areas of
                                       North Fork Canoe Creek.                            Henderson County, City
                                                                                of Henderson.
                                      At Kinsey Lane (KY-             +387         +388
                                       6112).
Middle Canoe Creek..................  At confluence with              +379         +382  Unincorporated Areas of
                                       Sellers Ditch.                                     Henderson County, City
                                                                                of Henderson.
                                      At confluence with Elam         +380         +382
                                       Ditch.
North Fork Canoe Creek..............  At confluence with              +378         +382  Unincorporated Areas of
                                       Canoe Creek.                                       Henderson County, City
                                                                                of Henderson.
                                      At approximately 4000           +387         +389
                                       feet upstream Kimsey
                                       Lane (KY-6112).
Sellers Ditch.......................  At confluence with              +377         +376  Unincorporated Areas of
                                       Canoe Creek.                                       Henderson County.
                                      Approximately 200 feet          +379         +382
                                       upstream Old Madison
                                       Road.
Tiger Ditch (Formerly Highway 812     At confluence with              +379         +382  Unincorporated Areas of
 Tributary).                           North Fork Canoe Creek.                            Henderson County, City
                                                                                of Henderson.
                                      Approximately 150 feet          None         +391
                                       downstream Zion Road.
Tiger Ditch Tributary 1.............  At confluence with              None         +385  Unincorporated Areas of
                                       Tiger Ditch (Formerly                              Henderson County, City
                                       Highway 812 Tributary).                            of Henderson.
                                      Just downstream Adams           None         +390
                                       Lane.
Upper Canoe Creek...................  At confluence with              +379         +382  Unincorporated Areas of
                                       Sellers Ditch.                                     Henderson County.
                                      Approximately 3800 feet         +382         +385
                                       upstream confluence
                                       with East Fork Canoe
                                       Creek.
----------------------------------------------------------------------------------------------------------------
* 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 Henderson
Maps are available for inspection at 222 First Street, Henderson, KY 42419.

                                    Unincorporated Areas of Henderson County
Maps are available for inspection at 20 North Main Street, Henderson, KY 42420.
----------------------------------------------------------------------------------------------------------------
                                Jackson County, Michigan, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Grand River.........................  Upstream side of High           None         +935  City of Jackson,
                                       Street.                                            Township of Leoni,
                                                                                Township of Napoleon,
                                                                                Township of Summit.
                                      Approximately 1,400             +941         +942
                                       feet upstream of
                                       Porbert Road.
Grand River.........................  Downstream side of              None         +909  Township of Rivas.
                                       Maple Grove Road.
                                      Approximate 0.5 mile            None         +910
                                       upstream of Maple
                                       Grove Road.
North Branch Grand River............  At confluence with              None         +935  Township of Leoni.
                                       Grand River.

                                      Downstream side of 5th          None         +936
                                       Street.
North Branch Kalamazoo River........  Approximately 0.6 mile          None         +988  Township of Concord.
                                       upstream of N. Main
                                       Street.
                                      Approximately 1 mile            None         +988
                                       upstream of N. Main
                                       Street.
Vineyard Lake.......................  Entire shoreline of             None         +970  Township of Norvell,
                                       Vineyard Lake.                                     Township of Columbia.
----------------------------------------------------------------------------------------------------------------
* 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 Jackson
Maps are available for inspection at 161 W Michigan Avenue, Jackson, MI 49201.

Township of Columbia
Maps are available for inspection at 8500 Jefferson Road, Brooklyn, MI 49230.

Township of Concord
Maps are available for inspection at 402 South Main Street, Concord, MI 49237.

Township of Leoni
Maps are available for inspection at 913 Fifth Street, Michigan Center, MI 49254.

Township of Napoleon
Maps are available for inspection at 6755 Brooklyn Road, Napoleon, MI 49261.

Township of Norvell
Maps are available for inspection at 106 E Commercial Street, Norvell, MI 49263.

Township of Rivas
Maps are available for inspection at 106 Main Street, Jackson, MI 49201.

Township of Summit
Maps are available for inspection at 2121 Ferguson Road, Jackson, MI 49201.
----------------------------------------------------------------------------------------------------------------
                                Missoula County, Montana, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Clarks Fork.........................  Approximately 50 feet          +3160        +3157  Unincorporated Areas of
                                       upstream of Reserve                                Missoula County, City
                                       Street.                                            of Missoula.
                                      Approximately 500 feet         +3168        +3169
                                       downstream of Russell
                                       Street.
La Valle Creek......................  Approximately 150 feet          None        +3075  Unincorporated Areas of
                                       upstream of the                                    Missoula County.
                                       Frenchtown Irrigation
                                       District Ditch.
                                      Just upstream of                None        +3081
                                       Dechamps Bridge.
----------------------------------------------------------------------------------------------------------------
* 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 Missoula
Maps are available for inspection at 435 Ryman St, Missoula, MT 59802.

                                     Unincorporated Areas of Missoula County
Maps are available for inspection at 435 Ryman St, Missoula, MT 59802.
----------------------------------------------------------------------------------------------------------------

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

    Dated: September 16, 2008.
Michael K. Buckley,
Acting Assistant Administrator, Mitigation Directorate, Department of
Homeland Security, Federal Emergency Management Agency.
[FR Doc. E8-22523 Filed 9-24-08; 8:45 am]

BILLING CODE 9110-12-P


[Federal Register Volume 82, Number 157 (Wednesday, August 16, 2017)]
[Notices]
[Pages 38910-38911]
[FR Doc No: 2017-17302]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-P-0495]

Determination That CORDARONE (Amiodarone Hydrochloride) Tablets,
200 milligrams, Were 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 or Agency) has
determined that CORDARONE (amiodarone hydrochloride) tablets, 200
milligrams (mg), were not withdrawn from sale for reasons of safety or
effectiveness. This determination means that FDA will not begin
procedures to withdraw approval of abbreviated new drug applications
(ANDAs) that refer to this drug product, and it will allow FDA to
continue to approve ANDAs that refer to the product as long as they
meet relevant legal and regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Jennifer Forde, Center for Drug

Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6213, Silver Spring, MD 20993-0002, 301-
348-3035.

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.
    CORDARONE (amiodarone hydrochloride) tablets, 200 mg, are the
subject of NDA 018972, held by Wyeth Pharmaceuticals, Inc. (a
subsidiary of Pfizer, Inc.), and initially approved on December 24,
1985. CORDARONE is indicated for the treatment of the following
documented, life-threatening recurrent ventricular arrhythmias when
these have not responded to documented adequate doses of other
available antiarrhythmics or when alternative agents could not be
tolerated: (1) Recurrent ventricular fibrillation and (2) recurrent
hemodynamically unstable ventricular tachycardia.
    In correspondence dated February 7, 2017, Pfizer, Inc. notified FDA
that CORDARONE (amiodarone hydrochloride) tablets, 200 mg, were being
discontinued, and FDA moved the drug product to the ``Discontinued Drug
Product List'' section of the Orange Book.
    Lachman Consultant Services, Inc. submitted a citizen petition
dated January 25, 2017 (Docket No. FDA-2017-P-0495), under 21 CFR
10.30, requesting that the Agency determine whether CORDARONE
(amiodarone hydrochloride) tablets, 200 mg, were withdrawn from sale
for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that CORDARONE (amiodarone hydrochloride) tablets,
200 mg, were not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
CORDARONE (amiodarone hydrochloride) tablets, 200 mg, were withdrawn
for reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of CORDARONE (amiodarone
hydrochloride) tablets, 200 mg, from sale. We have also independently
evaluated relevant literature and data for possible postmarketing
adverse events. We have reviewed the available evidence and determined
that this drug product was not withdrawn from sale for reasons of
safety or effectiveness.
    Accordingly, the Agency will continue to list CORDARONE (amiodarone
hydrochloride) tablets, 200 mg, 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. FDA will not begin procedures to withdraw approval of
approved ANDAs that refer to this drug product. Additional ANDAs for
this drug product may also be approved by the Agency as long as they
meet all other legal and regulatory requirements for the approval of
ANDAs. If FDA determines that labeling for this drug product should be
revised to meet current standards, the Agency will advise ANDA
applicants to submit such labeling.

    Dated: August 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-17302 Filed 8-15-17; 8:45 am]
 BILLING CODE 4164-01-P


February 12, 2004 Mr. Allen Biaggi, Administrator Nevada Division of Environmental Protection 333 N. Nye Lane, Room 138 Carson City, Nevada 89706 Re: Recommendation on Designation for the Federal PM2.5 Standard   Clark County Dear Mr. Biaggi:

In accordance with EPA guidance regarding attainment status with the PM2.5 National Ambient Air Quality Standard ( NAAQS), we have reviewed the relevant data and have made a determination Clark County is in attainment of the 24 hour and annual average NAAQS for PM2.5. Based on the 2000 2002 quality assured data for all sites monitored in Clark County by the Department of Air Quality Management ( DAQM), the 3rd highest 24 hour value is in compliance with the NAAQS. The average of the 12 quarterly averages is also in compliance with the annual NAAQS. Given this information, it is our recommendation that Clark County be designed as Attainment/ Unclassifiable.

Enclosed is the DAQM monitoring data for the ambient sites in Clark County for your review. If you have any questions or need clarification on any item related to this issue, please contact Mrs. Catherine MacDougall of my staff at ( 702) 455 1602.

In Public Service,

Christine Robinson, Director Enc Cc: Jolaine Johnson, NDEP Colleen Cripps, NDEP Jacob Snow, General Manager, RTC Richard Holmes, Assistant County Manager Alan Pinkerton, Assistant Director, Comprehensive Planning Catherine MacDougall, Assistant Director, DAQM John Koswan, Assistant Planning Manager, DAQM