[Federal Register: January 26, 2006 (Volume 71, Number 17)]
[Rules and Regulations]
[Page 4244]
[DOCID:fr26ja06-8]

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SECURITIES AND EXCHANGE COMMISSION

17 CFR Part 240

Schedule 14A--Information Required in Proxy Statement

CFR Correction

    In Title 17 of the Code of Federal Regulations, part 240 to end,
revised as of April 1, 2005, on page 216, in Sec.  240.14a-101, Item
10, paragraph (c) and Instruction 1 to paragraph (c), is moved to the
second column before the undesignated heading Instructions.

[FR Doc. 06-55504 Filed 1-25-06; 8:45 am]

BILLING CODE 1505-01-D


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

	   Issued by the Department of Transportation on September 27, 2000

NOTICE OF ACTION TAKEN -- DOCKET OST-99-6644

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant:  Air Engiadina AG									Date Filed:  December 14, 1999

Relief requested:  Exemption from 49 U.S.C. 41301 and statement of
authorization under 14 CFR 212 of the Department’s regulations to
permit Air Engiadina to display the airline designator code of Northwest
Airlines, Inc., on flights operated by Air Engiadina between Amsterdam,
Netherlands, and Berne, Switzerland.

If renewal, date and citation of last action:  New authority

Applicant representative:  Charles Donley<PHONE_NUMBER>

Responsive pleadings:  None

	DISPOSITION

Action:  Approved									Action date:  September 27, 2000

Effective dates of exemption authority granted:  September 27, 2000  -
September 27, 2002

Effective dates of statement of authorization granted:  Indefinite,
subject to the code-share conditions, attached

Basis for approval (bilateral agreement/reciprocity): The authority is
provided for in the U.S.-Switzerland Air Transport Agreement.  We found,
based on the record, that the carrier is substantially owned and
effectively controlled by citizens of Switzerland, properly licensed,
and operationally and financially qualified to undertake the proposed
operations.  Finally, the FAA has advised us that it knows of no reason
to withhold this authority.

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations indicated:

 X Standard exemption conditions (attached)        __ Foreign air
carrier permit conditions (Order   -  -  )

Action taken by:   Paul L. Gretch, Director

		      Office of International Aviation

________________________________________________________________________
____________________________________________________________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) immediate action was required and was
consistent with Department policy; (2) grant of the authority was
consistent with the public interest; and (3) grant of the authority
would not constitute a major regulatory action under the Energy Policy
and Conservation Act of 1975.  To the extent not
granted/deferred/dismissed, we denied all requests in the referenced
Docket.  We may amend, modify, or revoke the authority granted in this
Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within ten (10) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp

												        Appendix A

FOREIGN AIR CARRIER CONDITIONS OF AUTHORITY

In the conduct of the operations authorized, the holder shall:

(1)  Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

(2)  Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36;

(3)  Comply with the requirements for minimum insurance coverage
contained in 14 CFR Part 205, and, prior to the commencement of any
operations under this authority, file evidence of such coverage, in the
form of a completed OST Form 6411, with the Federal Aviation
Administration’s Program Management Branch (AFS-260), Flight Standards
Service (any changes to, or termination of, insurance also shall be
filed with that office);

(4)  Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

(5)  Conform to the airworthiness and airman competency requirements of
its Government for international air services;

(6)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR Part 203,
concerning waiver of Warsaw Convention liability limits and defenses;

(7)  Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are:

   (a)  based on its operations in international air transportation
that, according to the contract of carriage, include a point in the
United States as a point of origin, point of destination, or agreed
stopping place, or for which the contract of carriage was purchased in
the United States; or

   (b)  based on a claim under any international agreement or treaty
cognizable in any court or other tribunal of the United States.

In this condition, the term "international air transportation" means
"international transportation" as defined by the Warsaw Convention,
except that all States shall be considered to be High Contracting
Parties for the purpose of this definition;

(8)  Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

(9)  Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

(10) If charter operations are authorized, comply (except as otherwise
provided in the applicable bilateral agreement) with the Department's
rules governing charters (including 14 CFR Parts 212 and 380); and

(11) Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department, with all applicable orders or regulations of other U.S.
agencies and courts, and with all applicable laws of the United States.

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code (formerly the
Federal Aviation Act of 1958, as amended).

(41301/40109) 9/98

Air Engiadina AG - Docket OST-99-6644

The code-share operations authorized here are subject to the following
conditions:

(a)  The statement of authorization will remain in effect only as long
as (i) Air Engiadina and Northwest continue to hold the necessary
underlying authority to operate the code-share services at issue, and
(ii) the code-share and/or alliance agreement providing for the
code-share operations remains in effect.

(b)  Air Engiadina and Northwest must promptly notify the Department if
the code-share agreement providing for the code-share operations is no
longer effective or the carriers decide to cease operating any or all of
the approved code-share services.    We expect this notification to be
received within 10 days of such non-effectiveness or of such decision.
Such notices should be filed in Docket OST-999-6644.

(c)  The code-sharing operations conducted under this authority must
comply with 14 CFR 257 and with any amendments to the Department’s
regulations concerning code-share arrangements that may be adopted.
Notwithstanding any provisions in the contract between the carriers, our
approval here is expressly conditioned upon the requirements that the
subject foreign air transportation be sold in the name of the carrier
holding out such service in computer reservation systems and elsewhere;
that the carrier selling such transportation (i.e., the carrier shown on
the ticket) accept responsibility for the entirety of the code-share
journey for all obligations established in its contract of carriage with
the passenger; that the passenger liability of the operating carrier be
unaffected; and that the operating carrier shall not permit the code of
its U.S. code-sharing partner to be carried on any flight that enters,
departs, or transits the airspace of any area for whose airspace the
Federal Aviation Administration has issued a flight prohibition; and

(d)  The authority granted here is specifically conditioned so that
neither Air Engiadina nor Northwest shall give any force or effect to
any contractual provisions between themselves that are contrary to these
conditions.

We may amend, modify, or revoke this authority at any time without
hearing.


[Federal Register Volume 79, Number 48 (Wednesday, March 12, 2014)]
[Notices]
[Pages 14074-14077]
[FR Doc No: 2014-05315]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2014-0002; Internal Agency Docket No. FEMA-B-1357]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice lists communities where the addition or
modification of Base Flood Elevations (BFEs), base flood depths,
Special Flood Hazard Area (SFHA) boundaries or zone designations, or
the regulatory floodway (hereinafter referred to as flood hazard
determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and
where applicable, in the supporting Flood Insurance Study (FIS)
reports, prepared by the Federal Emergency Management Agency (FEMA) for
each community, is appropriate because of new scientific or technical
data. The FIRM, and where applicable, portions of the FIS report, have
been revised to reflect these flood hazard determinations through
issuance of a Letter of Map Revision (LOMR), in accordance with Title
44, Part 65 of the Code of Federal Regulations (44 CFR Part 65). The
LOMR will be used by insurance agents and others to calculate
appropriate flood insurance premium rates for new buildings and the
contents of those buildings. For rating purposes, the currently
effective community number is shown in the table below and must be used
for all new policies and renewals.

DATES: These flood hazard determinations will become effective on the
dates listed in the table below and revise the FIRM panels and FIS
report in effect prior to this determination for the listed
communities.
    From the date of the second publication of notification of these
changes in a newspaper of local circulation, any person has ninety (90)
days in which to request through the community that the Deputy
Associate Administrator for Mitigation reconsider the changes. The
flood hazard determination information may be changed during the 90-day
period.

ADDRESSES: The affected communities are listed in the table below.
Revised flood hazard information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table 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.
    Submit comments and/or appeals to the Chief Executive Officer of
the community as listed in the table below.

FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
FEMA, 500 C Street SW., Washington, DC 20472,<PHONE_NUMBER>, or
(email<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The specific flood hazard determinations are
not described for each community in this notice. However, the online
location and local community map repository address where the flood
hazard determination information is available for inspection is
provided.
    Any request for reconsideration of flood hazard determinations must
be submitted to the Chief Executive Officer of the community as listed
in the table below.
    The modifications are made pursuant to section 201 of the Flood
Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance
with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq.,
and with 44 CFR part 65.
    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).
    These 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. The flood hazard determinations are in accordance with 44 CFR
65.4.
    The affected communities are listed in the following table. Flood
hazard determination information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table 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.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                       Chief executive                       Online location
        State and county          Location and case      officer of        Community map    of  letter of map        Effective date of        Community
                                         no.              community          repository          revision              modification              No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Alabama: Tuscaloosa............  City of Tuscaloosa  The Honorable       Engineering        www.msc.fema.gov/  February 7, 2014............       010203
                                  (13-04-7373P).      Walter Maddox,      Department, 2201   lomc.
                                                      Mayor, City of      University
                                                      Tuscaloosa, 2201    Boulevard,
                                                      University          Tuscaloosa, AL
                                                      Boulevard,          35401.
                                                      Tuscaloosa, AL
                                                      35401.
Arizona:
    Pima.......................  Unincorporated      The Honorable       97 East Congress   www.msc.fema.gov/  January 24, 2014............       040073
                                  areas of Pima       Ramon Valadez,      Street, 3rd        lomc.
                                  County (13-09-      Chairman, Pima      Floor, Tucson,
                                  0833P).             County Board of     AZ 85701.
                                                      Supervisors, 130
                                                      West Congress
                                                      Street, 11th
                                                      Floor, Tucson, AZ
                                                      85701.
    Pinal......................  City of Maricopa,   The Honorable       City Clerk's       www.msc.fema.gov/  January 24, 2014............       040052
                                  (13-09-0781P).      Christian Price,    Department,        lomc.
                                                      Mayor, City of      39700 West Civic
                                                      Maricopa, P.O.      Center Plaza,
                                                      Box 610,            Maricopa, AZ
                                                      Maricopa, AZ        85138.
                                                      85139.
California:
    Los Angeles................  City of Santa       The Honorable Bob   City Hall, 23920   www.msc.fema.gov/  February 7, 2014............       060729
                                  Clarita (13-09-     Kellar, Mayor,      Valencia           lomc.
                                  2046P).             City of Santa       Boulevard, Santa
                                                      Clarita, 23920      Clarita, CA
                                                      Valencia            91355.
                                                      Boulevard, Santa
                                                      Clarita, CA 91355.
    San Luis Obispo............  City of San Luis    The Honorable Jan   Public Works       www.msc.fema.gov/  January 31, 2014............       060310
                                  Obispo (13-09-      Howell Marx,        Department, 919    lomc.
                                  2401P).             Mayor, City of      Palm Street, San
                                                      San Luis Obispo,    Luis Obispo, CA
                                                      990 Palm Street,    93401.
                                                      San Luis Obispo,
                                                      CA 93401.
    Ventura....................  City of Camarillo   The Honorable       Public Works       www.msc.fema.gov/  January 31, 2014............       065020
                                  (13-09-1000P).      Charlotte Craven,   Department, 601    lomc.
                                                      Mayor, City of      Carmen Drive,
                                                      Camarillo, 601      Camarillo, CA
                                                      Carmen Drive,       93010.
                                                      Camarillo, CA
                                                      93010.
    Ventura....................  Unincorporated      The Honorable       Ventura County     www.msc.fema.gov/  January 31, 2014............       060413
                                  areas of Ventura    Peter C. Foy,       Hall of            lomc.
                                  County (13-09-      Chairman, Ventura   Administration,
                                  1000P).             County Board of     Public Works
                                                      Supervisors, 800    Agency, 800
                                                      South Victoria      South Victoria
                                                      Avenue, Ventura,    Avenue, Ventura,
                                                      CA 93009.           CA 93009.
Colorado:
    Boulder....................  City of Lafayette   The Honorable       City Hall, 1290    www.msc.fema.gov/  January 24, 2014............       080026
                                  (13-08-0605P).      Carolyn Cutler,     South Public       lomc.
                                                      Mayor, City of      Road, Lafayette,
                                                      Lafayette, 1290     CO 80026.
                                                      South Public
                                                      Road, Lafayette,
                                                      CO 80026.
    Boulder....................  City of Louisville  The Honorable Bob   City Hall, 749     www.msc.fema.gov/  January 24, 2014............       085076
                                  (13-08-0605P).      Muckle, Mayor,      Main Street,       lomc.
                                                      City of             Louisville, CO
                                                      Louisville, 1101    80027.
                                                      Lincoln Avenue,
                                                      Louisville, CO
                                                      80027.
    Denver.....................  City and County of  The Honorable       Department of      www.msc.fema.gov/  February 12, 2014...........       080046
                                  Denver (13-08-      Michael B.          Public Works,      lomc.
                                  0332P).             Hancock, Mayor,     201 West Colfax
                                                      City and County     Avenue, Denver,
                                                      of Denver, 1437     CO 80202.
                                                      North Bannock
                                                      Street, Suite
                                                      350, Denver, CO
                                                      80202.
Florida:
    Collier....................  City of Naples (13- The Honorable John  Building           www.msc.fema.gov/  January 24, 2014............       125130
                                  04-5410P).          F. Sorey, III,      Department, 295    lomc.
                                                      Mayor, City of      Riverside
                                                      Naples, 735 8th     Circle, Naples,
                                                      Street South,       FL 34102.
                                                      Naples, FL 34102.
    Orange.....................  City of Orlando     The Honorable       Permitting         www.msc.fema.gov/  February 7, 2014............       120186
                                  (13-04-2963P).      Buddy Dyer,         Services           lomc.
                                                      Mayor, City of      Department, 400
                                                      Orlando, P.O. Box   South Orange
                                                      4990, Orlando, FL   Avenue, Orlando,
                                                      32808.              FL 32801.
    Orange.....................  Unincorporated      The Honorable       Orange County      www.msc.fema.gov/  February 7, 2014............       120179
                                  areas of Orange     Teresa Jacobs,      Stormwater         lomc.
                                  County (13-04-      Mayor, Orange       Management
                                  2963P).             County, 201 South   Division, 4200
                                                      Rosalind Avenue,    South John Young
                                                      5th Floor,          Parkway,
                                                      Orlando, FL 32801.  Orlando, FL
                                                                          32839.
    Sarasota...................  City of Sarasota    The Honorable       City Hall, 1565    www.msc.fema.gov/  January 31, 2014............       125150
                                  (13-04-6594P).      Shannon Snyder,     1st Street,        lomc.
                                                      Mayor, City of      Sarasota, FL
                                                      Sarasota, 1565      34236.
                                                      1st Street, Room
                                                      101, Sarasota, FL
                                                      34236.

    Sarasota...................  Unincorporated      The Honorable       Sarasota County    www.msc.fema.gov/  February 12, 2014...........       125144
                                  areas of Sarasota   Carolyn Mason,      Stormwater         lomc.
                                  County (13-04-      Chair, Sarasota     Management
                                  6707P).             County              Division, 1001
                                                      Commission, 1660    Sarasota Center
                                                      Ringling            Boulevard,
                                                      Boulevard,          Sarasota, FL
                                                      Sarasota, FL        34240.
                                                      34236.
    Sumter.....................  Unincorporated      The Honorable Doug  Sumter County      www.msc.fema.gov/  February 7, 2014............       120296
                                  areas of Sumter     Gilpin, Chairman,   Planning           lomc.
                                  County (13-04-      Sumter County       Department, 7375
                                  5645P).             Board of            Powell Road,
                                                      Commissioners,      Wildwood, FL
                                                      7375 Powell Road,   34785.
                                                      Wildwood, FL
                                                      34785.
Georgia: Forsyth...............  Unincorporated      The Honorable R.J.  Forsyth County     www.msc.fema.gov/  January 9, 2014.............       130312
                                  areas of Forsyth    Amos, Chairman,     Administration     lomc.
                                  County (13-04-      Forsyth County      Building, 110
                                  6334P).             Board of            East Main
                                                      Commissioners,      Street, Suite
                                                      110 East Main       120, Cumming, GA
                                                      Street, Suite       30040.
                                                      210, Cumming, GA
                                                      30040.
Hawaii: Hawaii.................  Hawaii County (13-  The Honorable       Hawaii County      www.msc.fema.gov/  February 7, 2014............       155166
                                  09-2129P).          William P. Kenoi,   Office Building,   lomc.
                                                      Mayor, Hawaii       Department of
                                                      County, 25 Aupuni   Public Works,
                                                      Street, Suite       101 Pauahi
                                                      1401, Hilo, HI      Street, Suite 7,
                                                      96720.              Hilo, HI 96720.
Kentucky: Christian............  City of             The Honorable Dan   Lackey Municipal   www.msc.fema.gov/  January 31, 2014............       210055
                                  Hopkinsville (13-   Kemp, Mayor, City   Building, 101      lomc.
                                  04-5407P).          of Hopkinsville,    North Main
                                                      101 North Main      Street,
                                                      Street,             Hopkinsville, KY
                                                      Hopkinsville, KY    42240.
                                                      42240.
Nevada: Douglas................  Unincorporated      The Honorable Greg  Douglas County     www.msc.fema.gov/  January 27, 2014............       320008
                                  areas of Douglas    Lynn, Chairman,     Community          lomc.
                                  County (13-09-      Douglas County      Development
                                  2041P).             Board of            Department,
                                                      Commissioners,      Planning
                                                      P.O. Box 218,       Division, 1594
                                                      Minden, NV 89423.   Esmeralda
                                                                          Avenue, Minden,
                                                                          NV 89423.
North Carolina:
    Lee........................  Unincorporated      The Honorable       Summit Building,   www.msc.fema.gov/  January 15, 2014............       370331
                                  areas of Lee        Charlie Parks,      408 Summit         lomc.
                                  County (11-04-      Chairman, Lee       Drive, Sanford,
                                  7013P).             County Board of     NC 27331.
                                                      Commissioners,
                                                      P.O. Box 1968,
                                                      Sanford, NC 27331.
    Henderson..................  Unincorporated      The Honorable       100 North King     www.msc.fema.gov/  January 2, 2014.............       370125
                                  areas of            Charles Messer,     Street,            lomc.
                                  Henderson County    Chairman,           Hendersonville,
                                  (12-04-1370P).      Henderson County    NC 28792.
                                                      Board of
                                                      Commissioners, 1
                                                      Historic
                                                      Courthouse
                                                      Square, Suite 1,
                                                      Hendersonville,
                                                      NC 28792.
    McDowell...................  Unincorporated      The Honorable       County             www.msc.fema.gov/  December 26, 2013...........       370148
                                  areas of McDowell   David N. Walker,    Administration     lomc.
                                  County (11-04-      Chairman,           Building, 60
                                  8431P).             McDowell County     East Court
                                                      Board of            Street, Marion,
                                                      Commissioners,      NC 28752.
                                                      County
                                                      Administration
                                                      Building, 60 East
                                                      Court Street,
                                                      Marion, NC 28752.
    Wake.......................  Town of Cary (12-   The Honorable       Stormwater         www.msc.fema.gov/  February 13, 2014...........       370238
                                  04-8021P).          Harold              Services           lomc.
                                                      Weinbrecht, Jr.,    Division, 316
                                                      Mayor, Town of      North Academy
                                                      Cary, P.O. Box      Street, Cary, NC
                                                      8005, Cary, NC      27512.
                                                      27512.
    Wake.......................  Town of Cary (13-   The Honorable       Stormwater         www.msc.fema.gov/  January 30, 2014............       370238
                                  04-3068P).          Harold,             Services           lomc.
                                                      Weinbrecht, Jr.,    Division, 316
                                                      Mayor, Town of      North Academy
                                                      Cary, P.O. Box      Street, Cary, NC
                                                      8005, Cary, NC      27512.
                                                      27512.
South Carolina:
    Charleston.................  City of Charleston  The Honorable       Department of      www.msc.fema.gov/  January 31, 2014............       455412
                                  (13-04-5644P).      Joseph P. Riley,    Public Service,    lomc.
                                                      Jr., Mayor, City    75 Calhoun
                                                      of Charleston,      Street, 3rd
                                                      P.O. Box 652,       Floor,
                                                      Charleston, SC      Charleston, SC
                                                      29402.              29401.
                                 Unincorporated      The Honorable       Charleston County  www.msc.fema.gov/  January 31, 2014............       455413
                                  areas of            Teddie E. Pryor,    Public Services    lomc.
                                  Charleston County   Sr., Chairman,      Building, 4045
                                  (13-04-5644P).      Charleston County   Bridge View
                                                      Council, 4045       Drive, North
                                                      Bridge View         Charleston, SC
                                                      Drive, North        29405.
                                                      Charleston, SC
                                                      29405.
South Dakota: Lawrence.........  City of Spearfish   The Honorable Dana  Public Works       www.msc.fema.gov/  February 12, 2014...........       460046
                                  (13-08-0834P).      Boke, Mayor, City   Department, 625    lomc.
                                                      of Spearfish, 625   North 5th
                                                      North 5th Street,   Street,
                                                      Spearfish, SD       Spearfish, SD
                                                      57783.              57783.
Utah:

    Davis......................  City of Farmington  The Honorable       City Hall, 160     www.msc.fema.gov/  February 7, 2014............       490044
                                  (13-08-0082P).      Scott Harbertson,   South Main         lomc.
                                                      Mayor, City of      Street,
                                                      Farmington, P.O.    Farmington, UT
                                                      Box 160,            84025.
                                                      Farmington, UT
                                                      84025.
    Davis......................  Unincorporated      The Honorable John  Davis County       www.msc.fema.gov/  February 7, 2014............       490038
                                  areas of Davis      Petroff, Jr.,       Planning           lomc.
                                  County (13-08-      Chairman, Davis     Department, 61
                                  0082P).             County Board of     South Main
                                                      Commissioners,      Street,
                                                      P.O. Box 618,       Farmington, UT
                                                      Farmington, UT      84025.
                                                      84025.
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(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: January 31, 2014.
Roy Wright,
Deputy Associate Administrator for Mitigation, Department of Homeland
Security, Federal Emergency Management Agency.
[FR Doc. 2014-05315 Filed 3-11-14; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 83, Number 20 (Tuesday, January 30, 2018)]
[Notices]
[Pages 4228-4229]
[FR Doc No: 2018-01778]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2017-0125]

Collection of Information Under Review by Office of Management
and Budget; OMB Control Number: 1625-0121

AGENCY: Coast Guard, DHS.

ACTION: Thirty-day notice requesting comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995 the
U.S. Coast Guard is forwarding an Information Collection Request (ICR),
abstracted below, to the Office of Management and Budget (OMB), Office
of Information and Regulatory Affairs (OIRA), requesting an extension
of its approval for the following collection of information without
change: 1625-0121, United States Coast Guard Academy Introduction
Mission Program Application and Supplemental Forms. Our ICR describes
the information we seek to collect from the public. Review and comments
by OIRA ensure we only impose paperwork burdens commensurate with our
performance of duties.

DATES: Comments must reach the Coast Guard and OIRA on or before March
1, 2018.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2017-0125] to the Coast Guard using the Federal
eRulemaking Portal at http://www.regulations.gov. Alternatively, you
may submit comments to OIRA using one of the following means:
    (1) Email: [email protected].
    (2) Mail: OIRA, 725 17th Street NW, Washington, DC 20503, attention
Desk Officer for the Coast Guard.
    A copy of the ICR is available through the docket on the internet
at http://www.regulations.gov. Additionally, copies are available from:
COMMANDANT (CG-612), ATTN: PAPERWORK REDUCTION ACT

MANAGER, U.S. COAST GUARD, 2703 MARTIN LUTHER KING JR AVE SE, STOP
7710, WASHINGTON, DC 20593-7710.

FOR FURTHER INFORMATION CONTACT: Mr. Anthony Smith, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>,
for questions on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collection. There is one
ICR for each Collection. The Coast Guard invites comments on whether
this ICR should be granted based on the Collection being necessary for
the proper performance of Departmental functions. In particular, the
Coast Guard would appreciate comments addressing: (1) The practical
utility of the Collection; (2) the accuracy of the estimated burden of
the Collection; (3) ways to enhance the quality, utility, and clarity
of information subject to the Collection; and (4) ways to minimize the
burden of the Collection on respondents, including the use of automated
collection techniques or other forms of information technology. These
comments will help OIRA determine whether to approve the ICR referred
to in this Notice.
    We encourage you to respond to this request by submitting comments
and related materials. Comments to Coast Guard or OIRA must contain the
OMB Control Number of the ICR. They must also contain the docket number
of this request, [USCG-2017-0125], and must be received by March 1,
2018.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at http://www.regulations.gov and
can be viewed by following that website's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).
    OIRA posts its decisions on ICRs online at http://www.reginfo.gov/public/do/PRAMain after the comment period for each ICR. An OMB Notice
of Action on each ICR will become available via a hyperlink in the OMB
Control Number: 1625-0121.

Previous Request for Comments

    This request provides a 30-day comment period required by OIRA. The
Coast Guard published the 60-day notice (82 FR 55386, November 21,
2017) required by 44 U.S.C. 3506(c)(2). That Notice elicited no
comments. Accordingly, no changes have been made to the Collection.

Information Collection Request

    Title: United States Coast Guard Academy Introduction Mission
Program Application and Supplemental Forms.
    OMB Control Number: 1625-0121.
    Summary: This collection contains the application and all
supplemental forms required to be considered as an applicant to the
U.S. Coast Guard Academy Introduction Mission (AIM) Program.
    Need: The information is needed to select applicants for
participation in a one-week summer recruiting and training program for
prospective Cadets interested in attending the U.S. Coast Guard
Academy.
    Forms: USCGA-AIM1, Travel update; USCGA-AIM2, Scholarship Request;
USCGA-AIM3, Medical Release; Online Application; High School
Transcript; and Personal Reference.
    Respondents: Approximately 2,000 applicants apply annually to
attend the AIM Program. Approximately 3,000 individuals will submit
letters of recommendation for these applicants.
    Frequency: Applicants must apply only once per year.
    Hour Burden Estimate: The estimated burden is 9,000 annual hours.

    Authority:  The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended.

    Dated: January 25, 2018.
James D. Roppel,
U.S. Coast Guard, Acting Chief, Office of Information Management.
[FR Doc. 2018-01778 Filed 1-29-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 80, Number 72 (Wednesday, April 15, 2015)]
[Notices]
[Pages 20230-20231]
[FR Doc No: 2015-08617]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-2347]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Food and Cosmetic
Export Certificate Application Process

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by May 15,
2015.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-NEW and
title ``Food and Cosmetic Export Certificate Application Process (21
U.S.C. 381(e)).'' Also include the FDA docket number found in brackets
in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Road; COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Food and Cosmetic Export Certificate Application Process (21 U.S.C.
381(e)) (OMB Control Number 0910-NEW)

    Some foreign countries require manufacturers of FDA-regulated
products to provide an export certificate for the products they wish to
export to that country. A Certificate of Free Sale is a certificate
(not pertaining to a particular production lot or export consignment)
that indicates that the particular product is marketed in the United
States or eligible for export, and that the particular manufacturer has
no unresolved enforcement actions pending before or taken by FDA. FDA's
Center for Food Safety and Applied Nutrition (CFSAN) issues such
certificates for food, food additives, seafood, dietary supplements,
and cosmetics. Interested persons may request a certificate by using
the electronic CFSAN Certificate Application Process, which is part of
FDA Unified Registration and Listing System, or by submitting a paper
Form FDA 3613d for cosmetic products or a paper Form FDA 3613e for food
products. We use the information submitted to determine whether to
issue the requested certificate.
    OMB has approved the submission of requests for export certificates
on paper Forms FDA 3613d and FDA 3613e and, electronically, via the
CFSAN Certificate Application Process under OMB control number 0910-
0498. This notice announces that, to ensure the efficient review of the
information collection by OMB under the PRA, we are seeking to obtain a
new OMB Control Number for Forms FDA 3613d and FDA 3613e and the CFSAN
Certificate Application Process to reflect that the electronic
submission system for food and cosmetic export certificates is separate
from the electronic submission system associated with export
certificates for other FDA-regulated products approved under OMB
control number 0910-0498. Upon OMB approval of this information
collection request, we will adjust the burden hours associated with
Forms FDA 3613d and FDA 3613e and the CFSAN Certificate Application
Process approved under OMB control number 0910-0498.
    We request the following information on Form FDA 3613d and the
CFSAN Certificate Application Process, as currently approved by OMB:
The name of and contact information for the requester; the name of and
contact information for the exporting company (if different from
requester); a designation of the type of certificate requested
(``general'' or ``product-specific''); if product-specific, a list of
the exact brand names of the products; the contact person, company name
and address where the requested certificate should be sent; and, the
name and account number (if applicable) of the requester's preferred
carrier for delivery of the certificate. Finally, Form FDA 3613d and
the CFSAN Certificate Application Process requires the requester's
signature, the name and title of the person signing the form, as well
as the date signed.
    We request the following information on Form FDA 3613e and the
CFSAN Certificate Application Process, as currently approved by OMB:
The name of and contact information for the manufacturer, as well as
the manufacturer's state license or registration number; the name of
and contact information for the exporting company (if different from
manufacturer), as well as the exporting company's state license or
registration number; a description of the shipment including the
product, the common name, the manufacturer, and a description or
additional comments; the name of the country to which the requester of
the certificate intends to ship the product; the contact person, firm
name and address where the requested certificate should be sent; and,
the name and account number (if applicable) of the requester's
preferred carrier for delivery of the certificate. Form FDA 3613e and
the CFSAN Certificate Application Process requires the requestor to
submit an original or copy of the applicable product label or labels.
Finally, Form FDA 3613e and the CFSAN Certificate Application Process

requires the submitter's signature, the name and title of the person
signing the form, as well as the date signed.
    Description of Respondents: The respondents to this collection of
information are firms interested in exporting U.S.-manufactured food
and cosmetic products to foreign countries that require export
certificates.
    In the Federal Register of January 9, 2015 (80 FR 1422), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. We received four comments in response to the
notice. The comments generally supported the necessity and practical
utility of the information collected during the export certificate
application process for food, however no comments were received
regarding the export certificate application process for cosmetics. Our
responses to the comments are discussed below.
    One comment had concerns about our request for the manufacturer's
(and exporter's, if different from manufacturer) state license or
registration number on Form FDA 3613e, stating that doing so could
allow third parties unnecessary and/or unauthorized access to
confidential commercial information. We appreciate this comment and
note that we do not place the firm's state license or registration
numbers on the certificates we issue. In addition, confidential
commercial information is protected from disclosure under the Freedom
of Information Act under sections 552(a) and (b) (5 U.S.C. 552(a) and
(b)), and under our regulations at 21 CFR part 20. At the same time,
the state license or registration number is necessary for our review of
the application. We verify the license or registration and investigate
inspection data on the listed products.
    One comment suggested ways we might modify the electronic
submission system, including expanding the number of characters that
may be entered per data field; developing corporate identification
numbers and passwords, permitting a product label to be submitted
electronically through the CFSAN Certificate Application Process; and,
permitting a submitter to pay the application fees electronically
within the CFSAN Certificate Application Process. Similarly, another
comment discussed possible changes to the content of the Export
Certificates or the Certificates of Free Sale that we issue for food,
including incorporating pagination to indicate the number of sequential
pages that would be part of the certificate; adding statements that the
product is fit for human consumption, may be freely sold or exported in
the United States, and, is produced in a manner consistent with good
manufacturing practice; and providing the applicant the ability to
request the type of certificate referenced on the header of the
document and to request additional services, such as a notarized
certificate document or expedited processing. While we are not able to
accommodate the suggested modifications at this time, we will consider
them as we contemplate future revisions to the relevant forms and
solicit additional comments at that time through a notice published in
the Federal Register.
    Finally, one comment was received that did not respond to any of
the four information collection topics solicited and is therefore not
addressed by the Agency.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                        Average
                        Category                             FDA form        Number of     responses per   Total annual     burden per      Total hours
                                                              No.\2\        respondents     respondent       responses       response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cosmetics...............................................           3613d             600               1             600             1.5             900
Conventional Food (Including Seafood)...................           3613e             398               1             398             1.5             597
Dietary Supplements, Food for Special Dietary Use,                 3613e           2,129               4           2,129             1.5           3,194
 Infant Formula, & Medical Foods........................
Food Additives and Food Contact Substances..............           3613e             167               1             167             1.5             251
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............  ..............           4,942
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.
\2\ Forms FDA 3613d and FDA 3613e may be submitted electronically via the Certificate Application Process.

    For the purpose of this information collection request, we are
basing our estimate of the average burden per response in column 6 of
table 1 on the estimates previously submitted to and approved by OMB
under control number 0910-0498. Our estimate of the average burden per
response in column 6 of table 1 varies according to the product
category for which the certificate is requested. We base our estimates
of the total annual responses in column 5 of table 1 on our experience
with certificate applications received in the past 2 fiscal years. Some
respondents send in requests as often as three or four times a month
while others may submit only periodic requests.
    We expect that most if not all firms requesting export certificates
in the next 3 years will choose to take advantage of the option of
electronic submission via the CFSAN Certificate Application Process.
Thus, our burden estimates in table 1 are based on the expectation of
100 percent participation in the electronic submission process. The
opportunity to provide the information in electronic format could
reduce the Agency's previous estimates for the time to prepare each
submission. However, as a conservative approach for the purpose of this
analysis, we are assuming that the opportunity to submit the
information in electronic format will have no effect on the average
time to prepare a submission.

    Dated: March 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-08617 Filed 4-14-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 204 (Tuesday, October 24, 2017)]
[Notices]
[Pages 49225-49226]
[FR Doc No: 2017-23064]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2017-0032; OMB No. 1660-0039]

Agency Information Collection Activities: Proposed Collection;
Comment Request; National Fire Academy Long-Term Evaluation Form for
Supervisors and National Fire Academy Long-Term Evaluation Form for
Students/Trainees

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice and request for comments.

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

SUMMARY: The Federal Emergency Management Agency, as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public to take this opportunity to comment on a revision of
a currently approved information collection. In accordance with the
Paperwork Reduction Act of 1995, this notice seeks comments concerning
the long-term evaluation forms used to evaluate all National Fire
Academy resident training.

DATES: Comments must be submitted on or before December 26, 2017.

ADDRESSES: To avoid duplicate submissions to the docket, please use
only one of the following means to submit comments:
    (1) Online. Submit comments at www.regulations.gov under Docket ID
FEMA-2017-0032. Follow the instructions for submitting comments.
    (2) Mail. Submit written comments to Docket Manager, Office of
Chief Counsel, DHS/FEMA, 500 C Street SW., 8NE, Washington, DC 20472-
3100.
    All submissions received must include the agency name and Docket
ID. Regardless of the method used for submitting comments or material,
all submissions will be posted, without change, to the Federal
eRulemaking Portal at http://www.regulations.gov, and will include any
personal information you provide. Therefore, submitting this
information makes it public. You may wish to read the Privacy Act
notice that is available via the link in the footer of
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Dawn Long, Statistician, FEMA,
National Fire Academy at<PHONE_NUMBER>. You may contact the Records
Management Division for copies of the proposed collection of
information at email address: [email protected].

SUPPLEMENTARY INFORMATION: The National Fire Academy (NFA) is mandated
under the Fire Prevention and Control Act of 1974 (Pub. L. 93-498) to
provide training and education to the Nation's fire service and
emergency service personnel. The state of-the-art programs offered by
the NFA serve as models of excellence and State and local fire service
agencies rely heavily on the curriculum to train their personnel. To
maintain the quality of these training programs, it is critical that
courses be evaluated after students have had the opportunity to apply
the knowledge and skills gained from their training. Information
collected from the evaluation forms enables the U.S. Fire
Administration (USFA) and NFA staff to monitor and recommend changes in
course materials, individual subject selection criteria, and to make
curriculum-wide reviews and assessments. FEMA is seeking a revision of
a currently approved information collection because we are modifying
the two forms. One question was added to each form to better reflect
and measure the NFA's progress toward the USFA's goals. Two questions
were removed from the student/trainee form that are no longer relevant
to NFA's data collection.

Collection of Information

    Title: National Fire Academy Long-Term Evaluation Form for
Supervisors and National Fire Academy Long-Term Evaluation Form for
Students/Trainees.
    Type of Information Collection: Revision of a currently approved
information collection.

    OMB Number: 1660-0039.
    FEMA Forms: FEMA Form 078-0-2, National Fire Academy Long-Term
Evaluation Form for Supervisors; FEMA Form 078-0-2A, National Fire
Academy Long-Term Evaluation Form for Students/Trainees.
    Abstract: The National Fire Academy Long-Term Evaluation Forms will
be used to evaluate all National Fire Academy (NFA) on-campus resident
training courses. Course graduates and their supervisors will be asked
to evaluate the impact of the training on both individual job
performance and the performance of the fire and emergency response
department where the student works. The data provided by students and
supervisors is used to update existing NFA course materials and to
develop new courses that reflect the emerging issues and needs of the
Nation's fire service.
    Affected Public: State, local or Tribal Government.
    Estimated Number of Respondents: 3,000.
    Estimated Number of Responses: 3,000.
    Estimated Total Annual Burden Hours: 405 hours.
    Estimated Total Annual Respondent Cost: $17,154.30.
    Estimated Respondents' Operation and Maintenance Costs: $0.
    Estimated Respondents' Capital and Start-Up Costs: $0.
    Estimated Total Annual Cost to the Federal Government: $44,786.65.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses.

    Dated: October 16, 2017.
Tammi Hines,
Acting Records Management Program Chief, Mission Support, Federal
Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2017-23064 Filed 10-23-17; 8:45 am]
 BILLING CODE 9111-45-P


P-21-0135 Sanitized Support Documents Index:
 P-21-0135 Sanitized Premanufacture Notice (linked)
 P-21-0135 Sanitized Determination Document (linked)
 P-21-0135 Sanitized CHEM Report (attached)
 P-21-0135 Sanitized ECO Report (attached)
 P-21-0135 Sanitized ENG Report (attached)
 P-21-0135 Sanitized EXP Report (attached)
 P-21-0135 Sanitized Fate Report (attached)
 P-21-0135 Sanitized HLTH Report_POST-FOCUS FINAL (attached)


13
3
U.S
.C. 552(a) and 1 CFR part 51, or another method equivalent in accuracy, precision, and
sensitivity to AOCS Official Method Ca 3a-46. You may obtain copies of the method from
AOCS (http://www.aocs.org) 2211 W. Bradley Ave. Champaign, IL 61821.  Copies may be
examined at the Center for Food Safety and Applied Nutrition’s Library, 5100 Paint Branch
Pkwy., College Park, MD 20740, or at the National Archives and records Administration
(NARA).  For information on the availability of this material at NARA, call<PHONE_NUMBER>, or go
to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(7)  Tallow derivative means any chemical obtained through initial hydrolysis,
saponification, or trans-esterification of tallow; chemical conversion of material obtained by
hydrolysis, saponification, or trans-esterification may be applied to obtain the desired product.
(b)  Requirements.  (1)  At a minimum, except as provided in paragraphs (b)(2) and (b)(4)
of this section, no biological product intended for use in humans shall be manufactured from, or
otherwise contain, prohibited cattle materials obtained from cattle slaughtered on or after [insert
effective date of final rule].
(2) The requirements in paragraph (b)(1) of this section with respect to prohibited cattle
materials shall not apply if FDA grants written permission for an exception or alternative to such
requirements.
(i)  To obtain written permission from FDA, you must send a written request to the
Director of the Center for Biologics Evaluation and Research (see § 600.2 for mailing address) or
the Director of the Center for Drug Evaluation and Research, Food and Drug Administration,
560
0 Fishers lane, Rockville, MD 20857, depending on the Center with primary jurisdiction over
the product.  Your written request must reference its application number. The Center Director
may also grant written permission for an exception or alternative to the requirements in

13
4
paragraph (b)(1) of this section on his own initiative and shall base such a determination on an
evaluation of the criteria described in paragraph (b)(2)(ii) of this section.  You must maintain a
record of any exception or alternative to the requirements in paragraph (b)(1) of this section that
is granted by FDA, in accordance with paragraph (c) of this section.
(ii)  A written request for an exception or alternative to the requirements in paragraph
(b)(1) of this section must include, for each applicable product:
(A)  A statement of the reasons why an exception or alternative is needed;
(B)  A description of the product, including the type of prohibited cattle materials used in
its manufacturing, its manufacturing and purification processes, and its route of administration;
(C)  A description of the source of the prohibited cattle materials, including information
on the location where the cattle were born, raised, and slaughtered, and any other information
relevant to the likelihood of the cattle having ingested material prohibited under § 589.2000 of
this chapter;
(D)  A description of how the requirements in paragraph (b)(1) in this section are not
necessary based on the risks of the prohibited cattle materials in the product and the benefits of
the product or how such restrictions are not necessary to ensure the safety of the product; and
(E)  Any other relevant information.
(iii)  FDA shall respond in writing to all requests for an exception or alternative to the
requirements and may impose conditions in granting any request.
(3)
The small intestine is not considered prohibited cattle material if the distal ileum is
removed by a procedure that removes at least 80 inches of the uncoiled and trimmed small
intestine, as measured from the caeco-colic junction and progressing proximally towards the

13
5
jejunum, or by a procedure that the establishment can demonstrate is equally effective in
ensuring complete removal of the distal ileum.
(4) Biological products that are not intended for use in or on the body (e.g., in vitro
diagnostics) are not subject to the requirements of paragraph (b)(1) of this section.
(c)  Records. (1) Establishments that manufacture a biological product intended for use in
or on the body that is manufactured from, or otherwise contains, cattle material must establish
and maintain records sufficient to demonstrate that the material is not manufactured from, and
does not contain, prohibited cattle materials.
(2) Records must be retained consistent with § 600.12(b).
(3)
Records must be retained at the manufacturer’s establishment or at a reasonably
accessible location.  Records are considered to be reasonably accessible if they are accessible
from an onsite location.
(4)
Records required by this section must be available to FDA for inspection and
copying.  All the records must be in English.
(5)
When filing entry with the U.S. Customs and Border Protection, the importer of
record of a biological product intended for use in or on the body that was manufactured from, or
otherwise contains, cattle material must affirm that the product was manufactured from, or
otherwise contains, cattle material and must affirm that the product was manufactured in
accordance with this section.  If a product was manufactured from, or otherwise contains, cattle
material, then the importer of record must, if requested, provide to FDA within 5 days records
that are sufficient to demonstrate that the product is not manufactured from, and does not
contain, prohibited cattle material.

13
6
(d) A biological product that is a drug and that is not in compliance with the
requirements of paragraph (b)  of this section is adulterated under section 501(a)(2)(B) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351(a)(2)(B)) and not safe, pure, and potent
under section 351 of the PHS Act (42 U.S.C. 262).
(e)  Failure of an applicant or manufacturer of a biological product that is a drug to
comply with the requirements of paragraph (c) of this section renders such product adulterated
under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
351
(a)(2)(B)) and not safe, pure, and potent under section 351 of the PHS Act (42 U.S.C. 262).
(f)  Failure of an importer of record to comply with the requirements of paragraph (c) of
this section causes a biological product to appear to be adulterated under section 801(a) of the act
(21 U.S.C. 381).
(g) A biological product that is a new drug and that is not in compliance with the
requirements of paragraph (b) of this section is in violation of section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355) and section 351 of the PHS Act (42 U.S.C. 262).
(h) A biological product that is a device and that is not in compliance with the
requirements of paragraph (b) of this section is adulterated under section 501(g) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351(g)) and in violation of section 351 of the PHS Act
(42 U.S.C. 262).
(i)  Failure of an applicant or manufacturer to comply with the requirements of paragraph
(c) of this section is a violation of section 301(e) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 331(e)).
(j)  Any person who violates the requirements of paragraph (b) or (c) of this section shall
be subject to the penalties provided in section 368 of the PHS Act (42 U.S.C. 271).

13
7
PART 895--BANNED DEVICES
1
4
.  The authority citation for 21 CFR part 895 is revised to read as follows:
Authority:  21 U.S.C. 331, 351, 352, 360f, 360h, 360i, 371, 381; 42 U.S.C. 264, 271.
1
5
.  Section 895.102 is added to subpart B to read as follows:
§ 895.102  Prohibited cattle materials.
(a)  Definitions.  The definitions and interpretations of terms contained in section 201 of
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321) apply to such terms when
used in this section.  The following definitions also apply:
(1) Prohibited cattle materials means specified risk materials; small intestine of all cattle
except as provided in paragraph (b)(3) of this section; material from nonambulatory disabled
cattle; material from cattle not inspected and passed; or mechanically separated beef.  Prohibited
cattle materials do not include tallow that contains no more that 0.15 percent insoluble
impurities, tallow derivatives, hides and hide-derived products, and milk and milk products.
Prohibited cattle materials also do not include materials obtained from fetal calves of cows that
were inspected and passed, as long as the materials were obtained by procedures adequate to
prevent contamination with specified risk materials.
(2)
Inspected and passed means that the material is from an animal that has been
inspected and passed for human consumption by the appropriate regulatory authority, and at the
time the animal was inspected and passed, it was found to be not adulterated.
(3) Mechanically separated beef means a meat food product that is finely comminuted,
resulting from the mechanical separation and removal of most of the bone from attached skeletal
muscle of cattle carcasses and parts of carcasses, that meets the specifications contained in 9

13
8
CFR 319.5, the U. S. Department of Agriculture’s (USDA’s) regulation that prescribes the
standard of identity for Mechanically Separated (Species).
(4) Nonambulatory disabled cattle means cattle that cannot rise from a recumbent
position or that cannot walk, including, but not limited to, those with broken appendages, severed
tendons or ligaments, nerve paralysis, fractured vertebral column, or metabolic conditions.
(5) Specified risk materials means the brain, skull, eyes, trigeminal ganglia, spinal cord,
vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and
lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months or
older and the tonsils and distal ileum of the small intestine of all cattle.
(6)
Tallow means the rendered fat of cattle obtained by pressing or by applying any other
extraction process to tissues derived directly from discrete adipose tissue masses or to other
carcass parts and tissues. Tallow must be produced from tissues that are not prohibited cattle
materials or must contain not more than 0.15 percent insoluble impurities determined by the
method entitled “Insoluble Impurities” (AOCS Official Method Ca 3a-46), American Oil
Chemists’ Society (AOCS), 5
th
Edition, 1997, incorporated by reference in accordance with 5
U.S
.C. 552(a) and 1 CFR part 51, or another method equivalent in accuracy, precision, and
sensitivity to AOCS Official Method Ca 3a-46. You may obtain copies of the method from
AOCS (http://www.aocs.org) 2211 W. Bradley Ave. Champaign, IL 61821.  Copies may be
examined at the Center for Food Safety and Applied Nutrition’s Library, 5100 Paint Branch
Pkwy., College Park, MD 20740, or at the National Archives and Records Administration
(NARA).  For information on the availability of this material at NARA, call<PHONE_NUMBER>, or go
to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

13
9
(7) Tallow derivative means any chemical obtained through initial hydrolysis,
saponification, or trans-esterification of tallow; chemical conversion of material obtained by
hydrolysis, saponification, or trans-esterification may be applied to obtain the desired product.
(b) Requirements.  (1)  At a minimum, except as provided in paragraph (b)(2) of this
section, no medical device for humans that is intended for use in or on the body shall be
manufactured from, or otherwise contain, prohibited cattle materials obtained from cattle
slaughtered on or after [effective date of final rule].
(2) The requirements in paragraph (b)(1) of this section with respect to prohibited cattle
materials shall not apply if FDA grants written permission for an exception or alternative to such
requirements.
(i)  To obtain written permission from FDA, you must send a written request to the
Director of the Center for Devices and Radiological Health, 9200 Corporate Blvd., Rockville,
MD 20850.  For a device subject to premarket approval or premarket clearance, your written
request must reference its application number.  The Center Director may also grant written
permission for an exception or alternative to the requirements in paragraph (b)(1) of this section
on his own initiative and shall base such a determination on an evaluation of the criteria
described in paragraph (b)(2)(ii) of this section.  You must maintain a record of any exception or
alternative to the requirements in paragraph (b)(1) of this section that is granted by FDA, in
accordance with paragraph (c) of this section.
(ii)  A written request for an exception or alternative to the requirements in paragraph
(b)(1) of this section must include, for each applicable product:
(A)  A statement of the reasons why an exception or alternative is needed;

14
0
(B)  A description of the product, including the type of prohibited cattle materials used in
its manufacturing, its manufacturing and purification processes, and its route of administration;
(C)  A description of the source of the prohibited cattle materials, including information
on the location where the cattle were born, raised, and slaughtered, and any other information
relevant to the likelihood of the cattle having ingested material prohibited under § 589.2000 of
this chapter;
(D)  A description of how the requirements in paragraph (b)(1) of this section are not
necessary based on the risks of the prohibited cattle materials in the product and the benefits of
the product or how such restrictions are not necessary to ensure the safety of the product; and
(E)  Any other relevant information.
(iii)  FDA shall respond in writing to all requests for an exception or alternative to the
requirements and may impose conditions in granting any such request.
(3)
The small intestine is not considered prohibited cattle material if the distal ileum is
removed by a procedure that removes at least 80 inches of the uncoiled and trimmed small
intestine, as measured from the caeco-colic junction and progressing proximally towards the
jejunum, or by a procedure that the establishment can demonstrate is equally effective in
ensuring complete removal of the distal ileum.
(c)  Records. (1) Applicants and manufacturers of a medical device that is intended for
use in or on the body that is manufactured from, or otherwise contains, cattle material must
establish and maintain records sufficient to demonstrate that the material is not manufactured
from, and does not contain, prohibited cattle materials.
(2) Records must be retained consistent with § 820.180(b) of this chapter.

14
1
(3)
Records must be retained at the applicant’s or manufacturer’s establishment or at a
reasonably accessible location.  Records are considered to be reasonably accessible if they are
accessible from an onsite location.
(4)
Records required by this section must be available to FDA for inspection and
copying.  All the records must be in English.
(5)
When filing entry with the U.S. Customs and Border Protection, the importer of
record of a medical device intended for use in or on the body that was manufactured from, or
otherwise contains, cattle material must affirm that the device was manufactured from, or
otherwise contains, cattle material and must affirm that the device was manufactured in
accordance with this section.  If a device was manufactured from, or otherwise contains, cattle
material, then the importer of record must, if requested, provide to FDA within 5 days records
that are sufficient to demonstrate that the device is not manufactured from, and does not contain,
prohibited cattle material.
(d)
A medical device that is intended for use in or on the body that is not in compliance
with the requirements of paragraph (b) of this section is adulterated under section 501(g) of the
act (21 U.S.C. 351(g)).
(e)  Failure of an applicant or manufacturer of a medical device that is intended for use in
or on the body to comply with the requirements of paragraph (c) of this section renders the
device misbranded under section 502(t) of the act (21 U.S.C. 352(t)).
(f)  Failure of an importer of record to comply with the requirements of paragraph (c) of
this section causes a medical device that is intended for use in or on the body to appear to be
adulterated under section 801 of the act (21 U.S.C. 381).

14
2
(g) Failure of an applicant or manufacturer to comply with the requirements of paragraph
(c) of this section is a violation of section 301(e) of the act (21 U.S.C. 331(e)).
(h) Any person who violates the requirements of paragraph (b) or (c) of this section shall
be subject to the penalties provided in section 368 of the Public Health Service Act (42 U.S.C.
271
).
PART 1271--HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED
PRODUCTS
1
6
.  The authority citation for 21 CFR part 1271 continues to read as follows:
Authority:  42 U.S.C. 216, 243, 263a, 264, 271.
1
7
.  Part 1271 is amended by adding new subpart G to read as follows:
Sec.
127
1.46
5  Applicability.
127
1.47
0  Prohibited cattle materials.
Subpart G--Prohibited Cattle Materials
§ 1271.465  Applicability.
The provisions set forth in this subpart are applicable only to HCT/Ps described in §
127
1.10
and regulated solely under section 361 of the Public Health Service Act (the PHS Act)
(42 U.S.C. 264) and the regulations in this part, and to the establishments that manufacture those
HCT/Ps.  HCT/Ps that are drugs or devices regulated under the Federal Food, Drug, and
Cosmetic Act, or are biological products regulated under section 351 of the PHS Act (42 U.S.C.
262
), are not subject to the regulations set forth in this subpart.  Such products are subject to the
applicable regulations for biological products and for drugs or devices.

14
3
§ 1271.470  Prohibited cattle materials.
(a)  Definitions.  The following definitions apply to this section:
(1) Prohibited cattle materials means specified risk materials; small intestine of all cattle
except as provided in paragraph (b)(3) of this section; material from nonambulatory disabled
cattle; material from cattle not inspected and passed; or mechanically separated beef.  Prohibited
cattle materials do not include tallow that contains no more than 0.15 percent insoluble
impurities, tallow derivatives, hides and hide-derived products, and milk and milk products.
Prohibited cattle materials also do not include materials obtained from fetal calves of cows that
were inspected and passed, as long as the materials were obtained by procedures adequate to
prevent contamination with specified risk materials.
(2)
Inspected and passed means that the material is from an animal that has been
inspected and passed for human consumption by the appropriate regulatory authority, and at the
time the animal was inspected and passed, it was found to be not adulterated.
(3) Mechanically separated beef means a meat food product that is finely comminuted,
resulting from the mechanical separation and removal of most of the bone from attached skeletal
muscle of cattle carcasses and parts of carcasses, that meets the specifications contained in 9
CFR 319.5, the U. S. Department of Agriculture’s (USDA’s) regulation that prescribes the
standard of identity for Mechanically Separated (Species).
(4) Nonambulatory disabled cattle means cattle that cannot rise from a recumbent
position or that cannot walk, including, but not limited to, those with broken appendages, severed
tendons or ligaments, nerve paralysis, fractured vertebral column, or metabolic conditions.
(5) Specified risk materials means the brain, skull, eyes, trigeminal ganglia, spinal cord,
vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and

14
4
lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months and
older, and the tonsils and distal ileum of the small intestine of all cattle.
(6)
Tallow means the rendered fat of cattle obtained by pressing or by applying any other
extraction process to tissues derived directly from discrete adipose tissue masses or to other
carcass parts and tissues.  Tallow must be produced from tissues that are not prohibited cattle
materials or must contain not more than 0.15 percent insoluble impurities as determined by the
method entitled “Insoluble Impurities” (AOCS Official Method Ca 3a-46), American Oil
Chemists’ Society (AOCS), 5
th
Edition, 1997, incorporated by reference in accordance with 5
U.S
.C. 552(a) and 1 CFR part 51, or another method equivalent in accuracy, precision, and
sensitivity to AOCS Official Method Ca 3a-46. You may obtain copies of the method from
AOCS (http://www.aocs.org) 2211 W. Bradley Ave. Champaign, IL 61821.  Copies may be
examined at the Center for Food Safety and Applied Nutrition’s Library, 5100 Paint Branch
Pkwy., College Park, MD 20740, or at the National Archives and Records Administration
(NARA).  For information on the availability of this material at NARA, call<PHONE_NUMBER>, or go
to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(7)  Tallow derivative means any chemical obtained through initial hydrolysis,
saponification, or trans-esterification of tallow; chemical conversion of material obtained by
hydrolysis, saponification, or trans-esterification may be applied to obtain the desired product.
(b) Requirements. (1)  At a minimum, except as provided in paragraph (b)(2) of this
section, no HCT/P intended for use in humans shall be manufactured using, or otherwise contain,
prohibited cattle materials obtained from cattle slaughtered on or after [effective date of final
rule].

14
5
(2) The requirements in paragraph (b)(1) of this section with respect to prohibited cattle
materials shall not apply if FDA grants written permission for an exception or alternative to such
requirements.
(i)  To obtain written permission from FDA, you must send a written request to the
Director of the Center for Biologics Evaluation and Research (see § 600.2 of this chapter for
mailing address).  The Center Director may also grant written permission for an exception or
alternative to the requirements in paragraph (b)(1) of this section on his own initiative and
sh145ll base such a determination on an evaluation of the criteria described in paragraph
(b)(2)(ii) of this section.  You must maintain a record of any exception or alternative from the
requirements in paragraph (b)(1) of this section that is granted by FDA, in accordance with
paragraph (c) of this section.
(ii)  A written request for an exception or alternative to the requirements in paragraph
(b)(1) of this section must include, for each applicable product:
(A)  A statement of the reasons why an exception or alternative is needed;
(B)  A description of the product, including the type of prohibited cattle materials used in
its manufacturing, its manufacturing and purification processes, and its route of administration;
(C)  A description of the source of the prohibited cattle materials, including information
on the location where the cattle were born, raised, and slaughtered, and any other information
relevant to the likelihood of the cattle having ingested material prohibited under § 589.2000 of
this chapter;
(D)  A description of how the requirements in paragraph (b)(1) of this section are not
necessary based on the risks of the prohibited cattle materials in the product and the benefits of
the product or how such restrictions are not necessary to ensure the safety of the product; and

14
6
(E)  Any other relevant information.
(iii)  FDA shall respond in writing to all requests for an exception or alternative to the
requirements and may impose conditions in granting any request.
(3)
The small intestine is not considered prohibited cattle material if the distal ileum is
removed by a procedure that removes at least 80 inches of the uncoiled and trimmed small
intestine, as measured from the caeco-colic junction and progressing proximally towards the
jejunum, or by a procedure that the establishment can demonstrate is equally effective in
ensuring complete removal of the distal ileum.
(c)  Records. (1)  Establishments that manufacture an HCT/P that is manufactured using,
or otherwise contains, cattle material must establish and maintain records sufficient to
demonstrate that the material is not manufactured using, and does not contain, prohibited cattle
materials.
(2) Records must be retained for the period specified in § 1271.270(d).
(3)
Records must be retained at the manufacturer’s establishment or at a reasonably
accessible location.  Records are considered to be reasonably accessible if they are accessible
from an onsite location.
(4)
Records required by this section must be available to FDA for inspection and
copying.  All the records must be in English.
(5)
When filing entry with the U.S. Customs and Border Protection, the importer of
record of an HCT/P manufactured using, or otherwise containing, cattle material must affirm that
the HCT/P was manufactured using, or otherwise contains, cattle material and must affirm that
the HCT/P was manufactured in accordance with this section.  If an HCT/P was manufactured
using, or otherwise contains, cattle material, then the importer of record must, if requested,

14
7
provide to FDA within 5 days records that are sufficient to demonstrate that the HCT/P is not
manufactured using, and does not contain, prohibited cattle material.
(d)
An HCT/P that is not in compliance with the requirements of paragraph (b) or (c) of
this section is a violative HCT/P that is subject to retention, recall, destruction, and/or cessation
of manufacturing under § 1271.440.

14
8
Dated:


[Federal Register Volume 78, Number 22 (Friday, February 1, 2013)]
[Rules and Regulations]
[Pages 7265-7266]
[FR Doc No: 2013-02133]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2012-0087]

Security Zone; Protection of Military Cargo, Captain of the Port
Zone Puget Sound, WA

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce the Sitcum Waterway Security Zone
in Commencement Bay, Tacoma, Washington from 6 a.m. on February 1,
2013, through 11:59 p.m. on February 7, 2013, unless cancelled sooner
by the Captain of the Port. This action is necessary for the security
of Department of Defense assets and military cargo in the navigable
waters of Puget Sound and adjacent waters. Entry into this zone is
prohibited unless otherwise exempted or excluded under 33 CFR 165.1321
or unless authorized by the Captain of the Port or his Designated
Representative.

DATES: The regulations in 33 CFR 165.1321 will be enforced for the
security zone described in paragraph (c)(2) of that section from 6 a.m.
on February 1, 2013, through 11:59 p.m. on February 7, 2013, unless
cancelled sooner by the Captain of the Port.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or email Ensign Nathaniel P. Clinger, Sector Puget Sound Waterways
Management Division, Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will activate and enforce
the Sitcum Waterway Security Zone set forth in 33 CFR 165.1321(c)(2)
from 6 a.m. on February 1, 2013, through 11:59 p.m. on February 7,
2013, unless cancelled sooner by the Captain of the Port or Designated
Representative. In

2004, the Coast Guard established regulations for the security of
Department of Defense assets and military cargo in the navigable waters
of Puget Sound to and adjacent waters. (See 69 FR 52600, Aug. 27,
2004). When subject to enforcement, this regulation prohibits persons
and vessels from the immediate vicinity of these facilities during
military cargo loading and unloading operations. The security zone will
also provide for the regulation of vessel traffic in the vicinity of
military cargo loading facilities in the navigable waters of the United
States. In addition, the regulation establishes requirements for all
vessels to obtain permission of the COTP or Designated Representative,
including the Vessel Traffic Service (VTS), to enter, move within, or
exit these security zones when they are enforced. Entry into this zone
is prohibited unless otherwise exempted or excluded under 33 CFR
165.1321 or unless authorized by the Captain of the Port or Designated
Representative.
    This notice is issued under authority of 33 CFR 165.1321 and 5
U.S.C. 552 (a). In addition to this notice in the Federal Register, the
Coast Guard will provide the maritime community with notification of
this enforcement period via marine information broadcasts and on-scene
assets. If the COTP determines that the regulated area need not be
enforced for the full duration stated in this notice, a Broadcast
Notice to Mariners may be used to grant general permission to enter the
regulated area.

    Dated: January 23, 2013.
S.J. Ferguson,
Captain, U.S. Coast Guard, Captain of the Port, Puget Sound.
[FR Doc. 2013-02133 Filed 1-31-13; 8:45 am]
BILLING CODE 9110-04-P