[Federal Register Volume 78, Number 116 (Monday, June 17, 2013)]
[Notices]
[Pages 36222-36223]
[FR Doc No: 2013-14288]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2013-0002; Internal Agency Docket No. FEMA-B-1326]

Proposed Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: Comments are requested on proposed flood hazard
determinations, which may include additions or modifications of any
Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area
(SFHA) boundary or zone designation, or regulatory floodway on the
Flood Insurance Rate Maps (FIRMs), and where applicable, in the
supporting Flood Insurance Study (FIS) reports for the communities
listed in the table below. The purpose of this notice is to seek
general information and comment regarding the preliminary FIRM, and
where applicable, the FIS report that the Federal Emergency Management
Agency (FEMA) has provided to the affected communities. The FIRM and
FIS report are the basis of the floodplain management measures that the
community is required either to adopt or to show evidence of having in
effect in order to qualify or remain qualified for participation in the
National Flood Insurance Program (NFIP). In addition, the FIRM and FIS
report, once effective, will be used by insurance agents and others to
calculate appropriate flood insurance premium rates for new buildings
and the contents of those buildings.

DATES: Comments are to be submitted on or before September 16, 2013.

ADDRESSES: The Preliminary FIRM, and where applicable, the FIS report
for each community are available for inspection at both the online
location and the respective Community Map Repository address listed in
the tables below. Additionally, the current effective FIRM and FIS
report for each community are accessible online through the FEMA Map
Service Center at www.msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-1326, to
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance
and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC
20472,<PHONE_NUMBER>, or (email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
FEMA, 500 C Street SW., Washington, DC 20472,<PHONE_NUMBER>, or
(email<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard
determinations 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 flood hazard determinations, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own or pursuant to policies
established by other Federal, State, or regional entities. These flood
hazard determinations are used to meet the floodplain management
requirements of the NFIP and also are used to calculate the appropriate
flood insurance premium rates for new buildings built after the FIRM
and FIS report become effective.
    The communities affected by the flood hazard determinations are
provided in the tables below. Any request for reconsideration of the
revised flood hazard information shown on the Preliminary FIRM and FIS
report that satisfies the data requirements outlined in 44 CFR 67.6(b)
is considered an appeal. Comments unrelated to the flood hazard
determinations also will be considered before the FIRM and FIS report
become effective.
    Use of a Scientific Resolution Panel (SRP) is available to
communities in support of the appeal resolution process. SRPs are
independent panels of experts in hydrology, hydraulics, and other
pertinent sciences established to review conflicting scientific and

technical data and provide recommendations for resolution. Use of the
SRP only may be exercised after FEMA and local communities have been
engaged in a collaborative consultation process for at least 60 days
without a mutually acceptable resolution of an appeal. Additional
information regarding the SRP process can be found online at http://floodsrp.org/pdfs/srp_fact_sheet.pdf.
    The watersheds and/or communities affected are listed in the tables
below. The Preliminary FIRM, and where applicable, FIS report for each
community are available for inspection at both the online location and
the respective Community Map Repository address listed in the tables.
Additionally, the current effective FIRM and FIS report for each
community are accessible online through the FEMA Map Service Center at
www.msc.fema.gov for comparison.

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
           Barnstable County, Massachusetts All Jurisdictions
------------------------------------------------------------------------
Maps Available for Inspection Online at: www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
------------------------------------------------------------------------
Town of Barnstable.....................  Barnstable Town Hall, 367 Main
                                          Street, Hyannis, MA 02601.
Town of Bourne.........................  Bourne Town Hall, 24 Perry
                                          Avenue, Buzzards Bay, MA
                                          02532.
Town of Brewster.......................  Town Office, 2198 Main Street,
                                          Brewster, MA 02631.
Town of Chatham........................  Town Hall, 549 Main Street,
                                          Chatham, MA 02633.
Town of Dennis.........................  Dennis Town Hall, Conservation
                                          Department, 485 Main Street,
                                          South Dennis, MA 02660.
Town of Eastham........................  Town Hall, 2500 State Highway,
                                          Eastham, MA 02642.
Town of Falmouth.......................  Town Hall, 59 Town Hall Square,
                                          Falmouth, MA 02540.
Town of Harwich........................  Town Hall, 732 Main Street,
                                          Harwich, MA 02645.
Town of Mashpee........................  Town Hall, 16 Great Neck Road
                                          North, Mashpee, MA 02649.
Town of Orleans........................  Town Hall, 19 School Road,
                                          Orleans, MA 02653.
Town of Provincetown...................  Town Hall, 260 Commercial
                                          Street, Provincetown, MA
                                          02657.
Town of Sandwich.......................  Town Hall, 130 Main Street,
                                          Sandwich, MA 02563.
Town of Truro..........................  Town Hall, 24 Town Hall Road,
                                          Truro, MA 02666.
Town of Wellfleet......................  Town Hall, 300 Main Street,
                                          Wellfleet, MA 02667.
Town of Yarmouth.......................  Yarmouth Town Hall, 1146 Route
                                          28, South Yarmouth, MA 02664.
------------------------------------------------------------------------
            Plymouth County, Massachusetts All Jurisdictions
------------------------------------------------------------------------
Maps Available for Inspection Online at: www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
------------------------------------------------------------------------
Town of Duxbury........................  Town Hall, 878 Tremont Street,
                                          Duxbury, MA 02332.
Town of Kingston.......................  Town Hall, 26 Evergreen Street,
                                          Kingston, MA 02364.
Town of Marshfield.....................  Town Hall, 870 Moraine Street,
                                          Marshfield, MA 02050.
Town of Norwell........................  Town Hall, 345 Main Street,
                                          Norwell, MA 02061.
Town of Plymouth.......................  Town Hall, 11 Lincoln Street,
                                          Plymouth, MA 02360.
Town of Scituate.......................  Town Hall, 600 Chief Justice
                                          Cushing Highway, Scituate, MA
                                          02066.
------------------------------------------------------------------------

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

    Dated: June 3, 2013.
Roy E. Wright,
Deputy Associate Administrator for Mitigation, Department of Homeland
Security, Federal Emergency Management Agency.
[FR Doc. 2013-14288 Filed 6-14-13; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 77, Number 32 (Thursday, February 16, 2012)]
[Notices]
[Pages 9298-9301]
[FR Doc No: 2012-2897]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Office of Hazardous Materials Safety; Actions on Special Permit
Applications

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Notice of actions on Special Permit Applications.

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SUMMARY: In accordance with the procedures governing the application
for, and the processing of, special permits from the Department of
Transportation's Hazardous Material Regulations (49 CFR Part 107,
Subpart B), notice is hereby given of the actions on special permits
applications in (November to January 2012). The mode of transportation
involved are identified by a number in the ``Nature of Application''
portion of the table below as follows: 1--Motor vehicle, 2--Rail
freight, 3--Cargo vessel, 4--Cargo aircraft only, 5--Passenger-carrying
aircraft. Application numbers prefixed by the letters EE represent
applications for Emergency Special Permits. It should be noted that
some of the sections cited were those in effect at the time certain
special permits were issued.

    Issued in Washington, DC, on February 02, 2012.
Donald Burger,
Chief, Special Permits and Approvals Branch.

------------------------------------------------------------------------
                                                      Nature of special
    S.P. No.         Applicant      Regulation(s)      permit thereof
------------------------------------------------------------------------
                   MODIFICATION SPECIAL PERMIT GRANTED
------------------------------------------------------------------------
14447-M.........  SNF Holding      49 CFR 177.834.  To modify the
                   Company                           special permit to
                   Riceboro, GA.                     authorize the
                                                     addition of Class
                                                     3, 8 and Division
                                                     6.1 hazardous
                                                     materials.
14763-M.........  Weatherford      49 CFR 173.302a  To modify the
                   International    and 173.301(f).  special permit to
                   Forth Worth,                      change the minimum
                   TX.                               elongation from 12%
                                                     to 10%.
12629-M.........  TEA              49 CFR           To modify the
                   Technologies,    173.34(e).       special permit to
                   Inc. Amarillo,                    add the retesting
                   TX.                               of DOT 107A
                                                     cylinder (tubes) by
                                                     means of acoustic
                                                     emission (AE) and
                                                     ultrasonic
                                                     examination (UE) in
                                                     lieu of hydrostatic
                                                     testing.
14584-M.........  WavesinSolids    49 CFR 173.302   To modify the
                   LLC State        and 180.209.     special permit to
                   College, PA.                      authorize
                                                     additional
                                                     cylinders and to
                                                     allow cylinders to
                                                     be charged to 110
                                                     percent of the
                                                     usual settled
                                                     filled pressure or
                                                     110 percent of the
                                                     stamped service
                                                     pressure (whichever
                                                     is greater) and to
                                                     extend the retest
                                                     period from 5 years
                                                     to 10.
9758-M..........  Coleman          49 CFR           To modify the
                   Company, Inc.    173.304(d)(3)(   special permit to
                   The Wichita,     ii); 178.33.     authorize the
                   KS.                               transportation in
                                                     commerce of an
                                                     additional Division
                                                     2.1 material.
14921-M.........  ERA Helicopters  49 CFR           To modify the
                   LLC Lake         173.302(f).      special permit
                   Charles, LA.                      issued on an
                                                     emergency basis to
                                                     a permanent special
                                                     permit.

12247-M.........  Weldship         49 CFR 172.301,  To modify the
                   Corporation      173.302a(b)(2)   special permit to
                   Bethlehem, PA.   , (b)(3) and     authorize
                                    (b)(4);          ultrasonic testing
                                    180.205(c) and   of DOT-SP 9001,
                                    (g) and          9370, 9421, 9706,
                                    180.209(a).      9791, 9909, 10047,
                                                     10869, and 11692
                                                     cylinders.
14743-M.........  TIER             49 CFR 173.24b   To modify the
                   Environmental    and 173.244.     special permit to
                   Services, Inc.                    authorize the one-
                   (Former                           time, one-way
                   Grantee TIER                      transportation in
                   DE, Inc.) Gap,                    commerce of an
                   PA.                               additional non-DOT
                                                     specification metal
                                                     tank containing
                                                     approximately 1320
                                                     lbs. of sodium by
                                                     motor vehicle.
11281-M.........  E.I. du Pont de  49 CFR 172.101,  To modify the
                   Nemours &        Column 7,        special permit to
                   Company          Special          authorize the use
                   Wilmington, DE.  Provisions       of an additional UN
                                    B14, T38.        portable tank
                                                     specification.
15132-M.........  National         49 CFR 173.301   To modify the
                   Aeronautics      and 178.53.      special permit to
                   and Space                         authorize the
                   Administration                    transportation in
                   (NASA)                            commerce of certain
                   Washington, DC.                   Division 2.1 and
                                                     2.2 gases in
                                                     alterative
                                                     packaging when
                                                     transported by
                                                     motor vehicle.
10597-M.........  Thermo King      49 CFR           To modify the
                   Corporation      177.834(1)(2)(   special permit to
                   Minneapolis,     i).              authorize a new
                   MN.                               series of heaters
                                                     containing Class 3
                                                     liquids and/or
                                                     Division 2.1 gases.
13601-M.........  DS Containers,   49 CFR           To modify the
                   Inc. Batavia,    173.306(b)(1).   special permit to
                   IL.                               authorize an
                                                     alternative
                                                     pressure relief
                                                     device.
14509-M.........  Pacific          49 CFR           To modify the
                   Consolidated     173.302(a)(1),   special permit to
                   Industries,      173.304a(a)(1)   authorize the
                   LLC Riverside,   , 175.3.         transportation of
                   CA.                               cylinders
                                                     containing
                                                     oxidizing gases
                                                     without a rigid
                                                     outer packaging
                                                     capable of passing
                                                     the Flame
                                                     Penetration and
                                                     Resistance Test and
                                                     the Thermal
                                                     Resistance Test.
14728-M.........  International    49 CFR           To modify the
                   Isotopes Inc.    173.416(c).      special permit to
                   Idaho Falls,                      authorize an
                   ID.                               increase in the
                                                     number of times the
                                                     packaging can be
                                                     used.
------------------------------------------------------------------------
                       NEW SPECIAL PERMIT GRANTED
------------------------------------------------------------------------
14839-N.........  Matheson Tri-    49 CFR 180.209.  To authorize the
                   Gas,Inc.                          transportation in
                   Basking Ridge,                    commerce of certain
                   NJ.                               DOT Specification
                                                     3A and 3AA
                                                     cylinders
                                                     containing Division
                                                     2.2 gases that have
                                                     been tested every
                                                     15 years instead of
                                                     every 10 years.
                                                     (modes 1, 2, 3, 4,
                                                     5)
15257-N.........  GFS Chemicals    49 CFR           To authorize the
                   Columbus, OH.    173.242(d) and   transportation of
                                    173.243(d).      perchloric acid, a
                                                     short distance from
                                                     one facility to
                                                     another, in
                                                     intermediate bulk
                                                     containers not
                                                     otherwise
                                                     authorized. (mode
                                                     1)
15274-N.........  Coastal          49 CFR 172.101   To authorize the
                   Helicopters      Column (9B).     transportation in
                   Juneau, AK.                       commerce certain
                                                     materials which are
                                                     forbidden for
                                                     transportation by
                                                     air for exceed
                                                     quantity
                                                     limitations, to be
                                                     transported by
                                                     cargo aircraft
                                                     within the State of
                                                     Alaska when other
                                                     means of
                                                     transportation are
                                                     impracticable or
                                                     not available.
                                                     (mode 4)
15384-N.........  TEA              49 CFR 180.509.  To authorize an
                   Technologies,                     alternative method
                   Inc. Amarillo,                    of retest for DOT
                   TX.                               Specification 107A
                                                     cylinders for use
                                                     in transporting
                                                     liquified or
                                                     nonliquefied
                                                     compressed gases,
                                                     or mixtures. (modes
                                                     1, 2, 3)
15373-N.........  Flinn            49 CFR           To authorize the
                   Scientific       173.13(c)(2).    manufacture, mark,
                   Inc. Batavia,                     sale and use of the
                   IL.                               specially designed
                                                     combination
                                                     packagings
                                                     described herein
                                                     for transportation
                                                     in commerce of the
                                                     materials listed in
                                                     paragraph 6 without
                                                     hazard labels or
                                                     placards, with
                                                     quantity limits not
                                                     exceeding 25 grams.
                                                     (mode 1)
15386-N.........  MAC, LLC Bay     49 CFR 173.56..  To authorize the one-
                   Saint Louis,                      time, one-way
                   MS.                               transportation in
                                                     commerce of two (2)
                                                     5-gallon buckets
                                                     containing wetted
                                                     waste primers and
                                                     three (3) 5-gallon
                                                     buckets containing
                                                     wetted waste
                                                     propellant by a
                                                     contract carrier
                                                     for disposal
                                                     without an EX
                                                     approval. (mode 1)
15404-N.........  Proserv UK Ltd.  49 CFR 173.201,  To authorize the
                   Aberdeen, AB12.  173.302,         manufacture,
                                    173.304, 3BT     marking, sale and
                                    178.35(e) and    use of a non-DOT
                                    178.36.          specification
                                                     seamless titanium
                                                     pressurized sample
                                                     cylinder. (modes 1,
                                                     2, 3, 4)
15425-N.........  National         49 CFR 177.848.  To authorize the
                   Aeronautics &                     transportation in
                   Space                             commerce of certain
                   Administration                    hydrazine fuels on
                   (NASA)                            the same motor
                   Washington, DC.                   vehicle without
                                                     regard to
                                                     segregation
                                                     requirements. (mode
                                                     1)
15427-N.........  The Proctor &    49 CFR           To authorize the
                   Gamble Company   173.306(a)(3)(   transportation in
                   LeGrange, GA.    v).              commerce of certain
                                                     aerosols containing
                                                     a Division 2.2
                                                     compressed gas in
                                                     certain non-
                                                     refillable aerosol
                                                     containers which
                                                     are not subject to
                                                     the hot water bath
                                                     test. (modes 1, 2,
                                                     3, 4, 5, 6)
15428-N.........  Space            49 CFR Part 172  To authorize the
                   Exploration      and 173.         transportation in
                   Technologies                      commerce of certain
                   Corp.                             hazardous material
                   Hawthorne, CA.                    as part of the
                                                     Dragon space
                                                     capsule without
                                                     requiring shipping
                                                     papers, marking and
                                                     labeling. (mode 1)

15461-N.........  Kidde Products   49 CFR 171.23..  To authorize the
                   High Bentham,                     transportation in
                   Yo.                               commerce of non-DOT
                                                     specification
                                                     cylinders
                                                     containing a
                                                     Division 2.2
                                                     compressed gas.
                                                     (modes 1, 2, 3)
15470-N.........  Wilson           49 CFR 172.101   To authorize the
                   Construction     Column (9B),     transportation in
                   Company Canby,   172.204(c)(3),   commerce of certain
                   OR.              173.27(b)(2),    hazardous materials
                                    175.30(a)(1),    by cargo aircraft
                                    and 172.200.     including by
                                                     external load in
                                                     remote areas of the
                                                     U.S. without being
                                                     subject to hazard
                                                     communication
                                                     requirements and
                                                     quantity
                                                     limitations where
                                                     no other means of
                                                     transportation is
                                                     available. (mode 4)
15468-N.........  Prism            49 CFR 172.101   To authorize the
                   Helicopters      Column (9B).     transportation in
                   Inc. Wasilla,                     commerce of certain
                   AK.                               Class 1 explosive
                                                     materials which are
                                                     forbidden for
                                                     transportation by
                                                     air, to be
                                                     transported by
                                                     cargo aircraft
                                                     within the State of
                                                     Alaska when other
                                                     means of
                                                     transportation are
                                                     impracticable or
                                                     not available.
                                                     (mode 4)
15471-N.........  National         49 CFR 173.172.  To authorize the
                   Aeronautics &                     transportation in
                   Space                             commerce of a Space
                   Administration                    Shuttle Orbiter
                   (NASA)                            Auxiliary Power
                   Washington, DC.                   Unit subsystem fuel
                                                     propellant tank
                                                     containing the
                                                     residue of
                                                     Hydrazine,
                                                     anhydrous which
                                                     does not meet the
                                                     requirements of 49
                                                     CFR 173.172. (mode
                                                     1)
15473-N.........  Eagle            49 CFR 172.101   To authorize the
                   Helicopters      Column (9B),     transportation in
                   Inc. dba         172.204(c)(3),   commerce of certain
                   Kachina          173.27(b)(2),    hazardous materials
                   Aviation         175.30(a)(1),    by cargo aircraft
                   Nampa, ID.       and 172.200.     including by
                                                     external load in
                                                     remote areas of the
                                                     U.S. without being
                                                     subject to hazard
                                                     communication
                                                     requirements and
                                                     quantity
                                                     limitations where
                                                     no other means of
                                                     transportation is
                                                     available. (mode 4)
15443-N.........  Iliamna Air      49 CFR 172.101   To authorize the
                   Guides, DBA      Column (9B),     transportation in
                   Soloy            172.204(c)(3),   commerce of certain
                   Helicopters,     173.27(b)(2),    Class 1 hazardous
                   LLC Wasilla,     175.30(a)(1),    materials by cargo
                   AK.              172.200,         aircraft including
                                    172.300 and      by external load in
                                    172.400.         remote areas of the
                                                     U.S. without being
                                                     subject to hazard
                                                     communication
                                                     requirements and
                                                     quantity
                                                     limitations where
                                                     no other means of
                                                     transportation is
                                                     available. (mode 3)
15466-N.........  The Boeing       49 CFR 173.309   To authorize the
                   Company/Boeing   in that the      transportation in
                   Commerical       cylinders        commerce of certain
                   Airplanes        covered under    non-DOT
                   Seattle, WA.     this special     specification and
                                    permit are not   DOT-4DA and 4DS
                                    authorized as    specification
                                    fire             cylinders, used as
                                    extinguishers,   fire suppression
                                    except as        systems in aircraft
                                    specified        to be shipped, as
                                    herein, and      fire extinguishers.
                                    Sec.             (modes 1, 2, 3, 4,
                                    172.301(c) in    5)
                                    that marking
                                    each cylinder
                                    with the
                                    special permit
                                    number is
                                    waived.
15479-N.........  Korean Air       49 CFR 172.101   To authorize the one-
                   Lines Co. Ltd.   Column (9B).     time transportation
                   (KAL)                             in commerce of
                   Arlington, VA.                    certain explosives
                                                     that are forbidden
                                                     for transportation
                                                     by cargo only
                                                     aircraft. (mode 4)
15493-N.........  Carleton         49 CFR 173.302a  To authorize the
                   Technologies                      manufacture,
                   dba Cobham                        marking, sale and
                   Mission                           use of a
                   Systems                           nonrefillable non-
                   Orchard Park,                     DOT specification
                   NY.                               cylinder similar to
                                                     a DOT specification
                                                     39 cylinder for use
                                                     in transporting
                                                     Division 2.2 non-
                                                     flammable
                                                     compressed gas.
                                                     (modes 1, 2, 4, 5)
15476-N.........  Swanson Group    49 CFR 172.101   To authorize the
                   Aviation, LLC    Column (9B),     transportation in
                   Grants Pass,     172.204(c)(3),   commerce of certain
                   OR.              173.27(b)(2),    hazardous materials
                                    175.30(a)(1),    by external load on
                                    and 172.200.     cargo aircraft in
                                                     remote areas of the
                                                     U.S. without being
                                                     subject to hazard
                                                     communication
                                                     requirements and
                                                     quantity
                                                     limitations where
                                                     no other means of
                                                     transportation is
                                                     available. (mode 4)
------------------------------------------------------------------------
                    EMERGENCY SPECIAL PERMIT GRANTED
------------------------------------------------------------------------
11077-M.........  U.S. Department  49 CFR           To modify the
                   of Defense       173.226(b);      special permit by
                   Scott AFB, IL.   173.227(b).      removing one
                                                     Division 6.1
                                                     hazardous materials
                                                     and adding an
                                                     additional Division
                                                     6.1 hazardous
                                                     material. (mode 1)
15326-M.........  Chemtura         49 CFR 178.337-  To modify the
                   Corporation      8(a)(3).         special permit to
                   Middlebury, CT.                   extend the
                                                     expiration date
                                                     three months to
                                                     allow time to
                                                     modify the special
                                                     permit from
                                                     emergency to
                                                     permanent. (mode 1)
15243-N.........  Katmai Air, LLC  49 CFR           Authorizes the
                   Anchorage, AK.   175.310(c).      carriage of
                                                     gasoline in non-DOT
                                                     specification
                                                     polyethylene
                                                     containers
                                                     overpacked in
                                                     plywood boxes in
                                                     small, passenger-
                                                     carrying aircraft
                                                     within the State of
                                                     Alaska to meet the
                                                     needs of a
                                                     passenger. (modes
                                                     4, 5)
15448-N.........  U.S. Department  49 CFR 172.320,  To authorize the
                   of Defense       173.51,          transportation in
                   Scott AFB, IL.   173.56, 173.57   commerce of certain
                                    and 173.58.      Class 1 materials
                                                     under an Interim
                                                     Hazard
                                                     Classification.
                                                     (modes 1, 2, 3, 4,
                                                     5)

15505-N.........  Boasso America   49 CFR           To authorize the
                   Corp.            173.32(f)(5).    transportation in
                   Chalmette, LA.                    commerce of a
                                                     portable tank that
                                                     is not filled to
                                                     80% capacity for a
                                                     short distance by
                                                     motor vehicle so
                                                     that the portable
                                                     tank can be topped
                                                     off. (mode 1)
15531-N.........  National         49 CFR           This request seeks
                   Aeronautics      173.302(a).      relief from the
                   and Space                         requirement for the
                   Administration                    IV-TEPC Detectors
                   (NASA)                            to be DOT
                   Washington, DC.                   specification
                                                     cylinders. The
                                                     Detectors contain
                                                     less than 0.04
                                                     grams of propane
                                                     gas. Design details
                                                     are provided to
                                                     justify that the
                                                     Detectors are
                                                     constructed and
                                                     packaged robustly,
                                                     with multiple
                                                     containment
                                                     barriers. These
                                                     Detectors have been
                                                     deemed safe by NASA
                                                     to fly onboard
                                                     manned spacecraft.
                                                     (modes 1, 2, 3, 4,
                                                     5, 6)
------------------------------------------------------------------------
                  MODIFICATION SPECIAL PERMIT WITHDRAWN
------------------------------------------------------------------------
13736-M.........  ConocoPhillips   49 CFR 172.101   To modify the
                   Anchorage, AK.   Table, Col.      special permit to
                                    (9B).            authorize an
                                                     increase in the
                                                     capacity from 350
                                                     to 4500 U.S.
                                                     gallons for bulk
                                                     containers.
------------------------------------------------------------------------
                   EMERGENCY SPECIAL PERMIT WITHDRAWN
------------------------------------------------------------------------
14929-N.........  Alaska Island    49 CFR           To authorize the
                   Air, Inc.        173.302(f).      transportation in
                   Togiak, AK.                       commerce of
                                                     cylinders of
                                                     compressed oxygen
                                                     without rigid outer
                                                     packaging within
                                                     the State of Alaska
                                                     when no other means
                                                     of transportation
                                                     exist. (mode 4)
15495-N.........  Dow Corning      49 CFR 180.407.  To authorize the
                   Corp Midland,                     transportation in
                   MI.                               commerce of a MC331
                                                     cargo tank motor
                                                     vehicle containing
                                                     hydrogen chloride,
                                                     refrigerated liquid
                                                     that is past its
                                                     test date. (mode 1)
------------------------------------------------------------------------
                                 DENIED
------------------------------------------------------------------------
12412-M.........  Request by FMC Corporation Tonawanda, NY December 07,
                   2011. To modify the special permit to allow hoses to
                   remain attached to discharge outlets while in
                   transportation.
14813-N.........  Request by Organ Recovery Systems Des Plaines, IL
                   January 30, 2012. To authorize the transportation of
                   the LifePort Kidney Transporter by air without being
                   accompanied by a person qualified to operate it.
15266-N.........  Request by 3AL Testing Corp. Denver, CO November 16,
                   2011. To authorize the transportation in commerce of
                   certain DOT 3AL 6061-T6 cylinders used exclusively in
                   medical oxygen service to be requalified every 10
                   years rather than every 5 years.
15405-N.........  Request by Giant Resource Recovery--Attalla, Inc.
                   Attalla, AL November 30, 2011. To authorize the one-
                   time transportation in commerce of aerosols in
                   alternative packaging for the purposes of testing.
15429-N.........  Request by Demex International Inc. Picayune, MS
                   January 12, 2012. To authorize the transportation in
                   commerce of certain explosives by vessel in an
                   alternative stowage configuration.
15464-N.........  Request by Alliant Techsystems Operations LLC. Eden
                   Prairie, MN January 20, 2012. To authorize the
                   transportation in commerce of ammunition and
                   components that have been combined with non-hazardous
                   materials and are being transported as hazardous
                   waste without a new EX classification.
                 -------------------------------------------------------
14741-M.........  Weatherford      49 CFR 173.304.  To modify the
                   International                     special permit to
                   Fort Worth, TX.                   authorize rail
                                                     freight as an
                                                     additional mode of
                                                     transportation.
------------------------------------------------------------------------

[FR Doc. 2012-2897 Filed 2-15-12; 8:45 am]
BILLING CODE 4909-60-M


[Federal Register Volume 87, Number 203 (Friday, October 21, 2022)]
[Rules and Regulations]
[Pages 63947-63948]
[FR Doc No: 2022-22876]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 216

[Docket No. FDA-2015-N-0030]

Extension of the Period Before the Food and Drug Administration
Intends To Begin Enforcing the Statutory 5 Percent Limit on Out-of-
State Distribution of Compounded Human Drug Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; extension of period before enforcement.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
extending the period before FDA intends to begin enforcing the
statutory 5 percent limit on distribution of compounded human drug
products out of the State in which they are compounded in States that
have not entered into a standard memorandum of understanding (MOU) with
FDA addressing certain distributions of compounded human drug products.
FDA is extending the period, which was scheduled to end on October 27,
2022, until the effective date of a final rule regarding certain
distributions of compounded human drug products and publication of an
updated standard MOU.

DATES: FDA is extending the period before FDA intends to begin
enforcing the statutory 5 percent limit on distribution of compounded
human drug products out of the State in which they are compounded in
States that have not entered into a standard MOU with FDA as of October
21, 2022.

FOR FURTHER INFORMATION CONTACT: Dominic Markwordt, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5104, Silver Spring, MD 20993-0002, 301-
796-9349.

SUPPLEMENTARY INFORMATION: Section 503A of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 353a) describes the conditions that
must be satisfied for drug products compounded by a licensed pharmacist
in a State licensed pharmacy or a Federal facility, or a licensed
physician, to be exempt from the following sections of the FD&C Act:
(1) section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning current
good manufacturing practice (CGMP) requirements), (2) section 502(f)(1)
(21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate
directions for use), and (3) section 505 (21 U.S.C. 355) (concerning
the approval of drugs under new drug applications or abbreviated new
drug applications).
    One of the conditions to qualify for the exemptions listed in
section 503A of the FD&C Act is that: (1) the drug product is
compounded in a State that has entered into an MOU with the FDA that
addresses the distribution of inordinate amounts of compounded drug
products interstate and provides for appropriate investigation by a
State agency of complaints relating to compounded drug products
distributed outside such State or (2) if the drug product is compounded
in a State that has not entered into such an MOU, the licensed
pharmacist, pharmacy, or physician does not distribute, or cause to be
distributed, compounded drug products out of the State in which they
are compounded in quantities that exceed 5 percent of the total
prescription orders dispensed or distributed by such pharmacy or
physician (statutory 5 percent limit) (see section 503A(b)(3)(B)(i) and
(ii) of the FD&C Act).
    In the Federal Register of October 27, 2020 (85 FR 68074), FDA
announced the availability of a standard MOU describing the
responsibilities of a State Board of Pharmacy or other appropriate
State agency that chooses to sign the standard MOU in investigating and
responding to complaints related to drug products compounded in such
State and distributed outside such State and in addressing the
interstate distribution of inordinate amounts of compounded human drug
products.
    In the October 27, 2020, Federal Register notice, FDA stated that
it was providing a 365-day period that was scheduled to end on October
27, 2021, for States to decide whether to sign the standard MOU before
FDA intended to begin enforcing the statutory 5 percent limit in States
that do not sign the standard MOU. Soon after announcing the
availability of the standard MOU, FDA was sued by several compounding
pharmacies regarding the standard MOU in the U.S. District Court for
the District of Columbia (Wellness Pharmacy, Inc. v. Becerra (D.D.C.
Sep. 21, 2021)).
    In the Federal Register of August 9, 2021 (86 FR 43550), FDA
extended the period to October 27, 2022, before FDA intends to begin
enforcing the statutory 5 percent limit in States that do not sign the
standard MOU.
    On September 21, 2021, the Court remanded the standard MOU to FDA
to either certify that it will not have a significant economic effect
on small businesses or prepare a regulatory flexibility analysis. To
undertake this analysis more fully and ensure a robust framework for
these important public health protections, FDA intends to engage in
notice-and-comment rulemaking regarding certain distributions of
compounded human drug products under section 503A of the FD&C Act. FDA
considers the standard MOU published in October 2020 to be suspended.
This means that during the rulemaking process, FDA will not enter into
new agreements with States based on the October 2020 standard MOU. FDA
does not expect States that have signed the October 2020 standard MOU
to carry out the activities described in the MOU. The October 2020
standard MOU will be updated based on the content of a final rule, and
FDA intends to announce a new opportunity for all

States to consider and sign the updated standard MOU.
    FDA is now extending the period before FDA intends to begin
enforcing the statutory 5 percent limit in States that have not entered
into a standard MOU with FDA until the effective date of a final rule
regarding certain distributions of compounded human drug products under
section 503A of the FD&C Act and publication of an updated standard
MOU.\1\
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    \1\ The Office of the Federal Register has published this
document under the category ``Rules and Regulations'' pursuant to 1
CFR 5.9(b). We note that the categorization as such for purposes of
publication in the Federal Register does not affect the legal
content or intent of the document. See, 1 CFR 5.1(c).

    Dated: October 17, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22876 Filed 10-20-22; 8:45 am]
BILLING CODE 4164-01-P